Capturing quality of life in pouch anal and vaginal fistula: Development of PAVF-QoL-14, a patient-reported outcome measure

Capturing quality of life in pouch anal and vaginal fistula: Development of PAVF-QoL-14, a patient-reported outcome measure | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Capturing quality of life in pouch anal and vaginal fistula: Development of PAVF-QoL-14, a patient-reported outcome measure Lillian Reza, Laith Alrubaiy, Lara Bapir, Nusrat Iqbal, Charlene Sackitey, and 10 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8500549/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 7 You are reading this latest preprint version Abstract Introduction Perianal pouch fistula can significantly affect quality of life, yet no disease-specific patient reported outcome measure (PROM) exists. We have developed and validated a 14-item PROM - the Pouch Anal and Vaginal Fistula Quality of Life scale (PAVF-QoL-14). Methods COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidance for PROM development was used to develop and validate PAVF-QoL-14. A systematic literature review and semi-structured patient interviews (n = 14) identified key domains. Cognitive interviews and item-level content validity index with experts refined the draft questionnaire. Psychometric evaluation included principal component analysis (PCA), internal consistency testing, and construct validity assessment against Hospital Anxiety and Depression Scale (HADS) and Short-Form 12 (SF-12). Test-rest analysis was performed on 76 patients. Results An initial 34-item draft scale was generated and refined through cognitive interviews (n = 10) and psychometric testing (n = 76). Flesch readability score was 63%. Kaiser-Meyer-Olkin test confirmed sampling adequacy (KMO = 0.905), and correlations between items were found significant using Bartlett’s test of sphericity (p < 0.001). Four domains (symptoms, discharge, faecal incontinence, and future concerns) were extracted, explaining 63.7% of the total variance. Following stepwise regression, a 14-item short-form was developed, demonstrating excellent internal consistency (Cronbach’s α = 0.920). Responsiveness and stability were robust. Construct validity was excellent as PAVF-QoL-14 exhibited strong correlations with HADS (r = 0.589, p < 0.001) and SF-12 (r = 0.525, p < 0.001). Conclusion PAVF-QoL-14 provides a concise, validated, and disease-specific measure of quality of life for pouch-related fistula, ready for use in clinical practice and trials. Ileoanal pouch Inflammatory bowel disease Core outcome set Patient reported outcomes Figures Figure 1 Plain English Summary People who have an ileoanal pouch can sometimes develop a pouch anal or vaginal fistula, which is an abnormal connection that may cause ongoing discharge, pain, infections, and emotional distress. These symptoms can have a major impact on daily activities, relationships, work, and overall wellbeing. Despite this, there has been no questionnaire specifically designed to measure how pouch-related fistulas affect quality of life from the patient’s perspective. In this study, we developed and tested a new questionnaire called the Pouch Anal and Vaginal Fistula Quality of Life questionnaire (PAVF-QoL-14). Patients with lived experience of pouch fistula were involved throughout the process, starting with interviews to identify the symptoms and concerns that mattered most to them. The questionnaire was then refined through patient feedback and expert review to ensure that the questions were clear, relevant, and easy to understand. We tested the questionnaire in a group of patients and showed that it is reliable, meaning people gave similar answers when their condition had not changed, and responsive, meaning scores changed appropriately when symptoms improved or worsened. The final questionnaire contains 14 questions covering areas such as symptoms, discharge, bowel control, tiredness, emotional wellbeing, intimacy, and worries about the future. PAVF-QoL-14 is a short, patient-centred tool that can be used in routine clinical care and in research studies to better understand the impact of pouch fistula and to assess whether treatments improve quality of life. Introduction The ileoanal pouch was developed with the aim of improving quality of life for patients requiring proctocolectomy( 1 – 3 ). Pouch fistula is a debilitating complication that can significantly impair quality of life (QoL) and is associated with an increased risk of pouch failure. The pooled prevalence of pouch fistula is 5%( 4 ). Systematic review of existing studies report the prevalence of pouch failure at 10%. However, the development of fistula is associated with a substantial escalation in risk, with pouch failure rates rising to as high as 50% in some units ( 5 ). Despite this impact pouch fistula research is sparse. Patient-Reported Outcomes (PROMs) after pouch surgery have historically been poorly reported. ‘Ileoanal pouch syndrome’ has been recently defined as a constellation of symptoms patients experience following surgery ( 6 ) and has been used to validate the ileoanal pouch syndrome severity (IPSS) score for the assessment of pouch function. The IPSS score quantifies severity of symptoms and their impact on quality of life( 7 ). Patients with long term complications such as pouchitis, pelvic sepsis and fistula were found to have higher IPSS scores suggesting a greater impact on pouch function and QoL( 7 ). While IPSS quantifies overall pouch function, it lacks specificity for the psychosocial and symptom burden of fistula. Existing generic PROMs such as SF-12 are insufficiently sensitive to detect fistula-related changes, underscoring the need for a disease-specific measure ( 8 ). The pouch anal and vaginal fistula core outcome set (PAVFCOS) Delphi consensus study has established the core outcomes that should be measured in all interventional studies of pouch fistula, and this includes QoL outcomes such as global assessment of quality of life and impact on quality of life of fistula discharge (Fig. 1)( 9 ). This study aimed to develop a disease-specific QoL measurement tool in pouch anal and vaginal fistula (PAVF-QoL) that could be utilised for COS implementation in research and clinical assessment. Method Study Design and Reporting Standards The development of the PAVF-QoL scale followed the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) taxonomy, which provides a structured approach for the development and evaluation of patient-reported outcome measures (PROMs)( 10 ). This study is reported in line with the COSMIN study design checklist for PROMs, ensuring transparency, methodological rigour, and adherence to best practice guidelines for outcome instrument development( 11 ). Ethical approval was granted by the Wales Research Ethics Committee 3 (REC reference: 20/WA/0308), and the Health Research Authority (HRA) and Health and Care Research Wales. Research Aim Our aim was to develop and validate a disease specific PROM to assess the impact of pouch anal and vaginal fistula symptoms, and their treatment, on health-related quality of life of patients with an ileoanal pouch. Study Management Group The study was overseen by a multidisciplinary management group comprising patients and clinicians. Patients with lived experience of pouch-related fistula were involved from the outset to ensure that the instrument captured relevant aspects of their lived experience. The clinical members of the team included pouch dysfunction specialist colorectal surgeons and gastroenterologist, specialist pouch nurses, and a radiologist with expertise in pouch imaging. In addition, the group included clinicians and researchers with experience in PROM development and qualitative methodology. The study management group (SMG) guided each stage of the development process, from defining the construct, generating items, to reviewing content validity and refining the instrument. Patients contributed throughout, ensuring that themes reflected patient priorities rather than researcher assumptions. Definition of construct and conceptual framework PAVF-QoL was developed to assess the impact of pouch-related perianal fistula and their treatments on the physical, psychological, and social functioning of patients with an ileoanal pouch. The construct being measured is health-related quality of life in chronic perineal fistulising disease in patients with an ileoanal pouch. Instrument design was informed by Wilson and Cleary’s model of health-related quality of life, which provides a structured framework linking biological and physiological factors (e.g. the presence of a fistula) to symptoms, functional status, general health perceptions, and overall quality of life. This model was previously and successfully applied in the development of the Anal Fistula Quality of Life scale (AF-QoL), a disease-specific PROM for cryptoglandular anal fistula( 12 ) and in the development of Crohn’s Anal Fistula Quality of Life (CAF-QoL) scale for patients with Crohn’s anal fistula( 13 ). Both highlighting the complex, multidimensional impact of fistula disease on quality of life. Patients with pouch-related fistula experience a similarly multifaceted burden but often with additional symptoms specific to pouch anatomy and function. Pouch-specific symptoms, including altered bowel habit, pouchitis, and pouch dysfunction required careful delineation and exclusion during item generation to ensure that the scale reflected the impact of the fistula and its treatment, not general pouch function or dysfunction( 7 ). By focusing specifically on fistula-related morbidity rather than general pouch function, PAVF-QoL aims to isolate the impact of chronic perineal sepsis, drainage, and surgical intervention on everyday life, intimacy, and psychological wellbeing. Target population PAVF-QoL has been developed to assess QoL in patients with pouch-related perianal fistula arising from anastomotic leak, non-Crohn’s active inflammatory bowel disease (IBD), Crohn’s disease or cryptoglandular disease related aetiologies – as described in the literature( 14 ). The instrument is applicable regardless of fistula duration, complexity, or treatment stage, allowing its use across a broad spectrum of clinical presentations. PAVF-QoL has been designed to aid clinical assessment, measure impact of intervention and provide standardisation in outcome reporting in clinical research. Participant eligibility selection Adults aged 18 to 80 years with a diagnosis of pouch-related perianal or vaginal fistula were eligible to take part in PROM development. Eligible participants were required to have capacity to provide informed consent and understand both written and spoken English. Purposive sampling recruitment was used to ensure representation of a broad range of experiences, fistula complexity, and chronicity. Primary recruitment was conducted at a tertiary pouch centre. Patients were also recruited through the Red Lion pouch patient support group and social media. Recruitment via social media enabled inclusion of patients with less healthcare engagement or those managed in non-specialist centres, thereby enhancing the instrument’s generalisability between October 2022- August 2024. The methodology for instrument development has been modelled on the study developing the AF-QoL scale( 12 ) and this has been described according to three distinct phases. Phase 1: Item generation Item generation utilised inductive and deductive methods to ensure comprehensive content coverage and robust conceptual validity. Items were derived from semi-structured interviews with patients with pouch fistula. These semi-structured interviews were conducted using a topic guide (see supplementary file) by a researcher trained in qualitative interviews. Interviews were recorded and transcribed verbatim. Qualitative interviews and thematic analysis was described in the development of pouch anal and vaginal fistula core outcome set (PAVFCOS) which was conducted in parallel to this study( 9 ). Findings from the interviews were supplemented with a systematic review of existing PROMs used in studies of pouch fistula( 8 ). Interviews explored patients’ lived experiences of the condition, including its physical, psychological, and social impact, as well as the consequences of treatment. Thematic analysis identified recurrent themes, and these were mapped to defined by Wilson and Cleary’s model of health related quality of life framework. Patient representatives in the study management group ensured that verbatim responses from patient interviews were appropriately converted into items using patient derived language and reflected a distinct QoL construct. Items were mapped to physical symptoms, impact of symptoms on mental health, sex and intimacy, and global quality of life. Survey instructions, item wording and responses were developed with patient representatives to ensure readability, clinical relevance and acceptability. A recall period was set at 4–6 weeks to limit recall bias. Flesch Reading Ease and Flesch–Kincaid grade level was assessed to determine readability. Statistical analysis was conducted using SPSS Version 29. Phase 2: Scale Development Cognitive interviews The draft scale was assessed for relevance, comprehensiveness and comprehensibility using cognitive interviews with patient participants. Participants completed the draft scale using the think-aloud technique and were probed for feedback using a predetermined probing questionnaire (see supplementary file). Interviews were conducted by a qualitative researcher, recorded and transcribed verbatim. Interviews were analysed to amend the draft questionnaire. Three consecutive interviews were analysed at a time until no further changes were suggested. The item level content validity index (I-CVI) was assessed by experts in pouch fistula using a Likert scale (1 = not at all relevant, 4 = extremely relevant) to rate the relevance of each item in the assessment of QoL. Items with an I-CVI 0.90 demonstrated excellent content validity( 10 ). Phase 3: Psychometric analysis The test phase recruited patient participants from clinics, social media and patient groups. The draft PAVF-QoL questionnaire was distributed with a demographic questionnaire, Short Form-12 (SF-12)( 15 ), Hospital Anxiety and Depression Scale (HADS)( 16 ) and the patient reported component of the Perianal Disease Activity Index (PDAI)( 17 ). For test-retest analysis, the questionnaire was resent with an interval of 4–6 weeks alongside a background form with questions to assess change in symptoms, disease severity and patient perceived impact on quality of life since last completion of PAVF-QoL (see supplementary file). The background form contained composite anchor questions which identified patients with stable disease and unstable disease. Psychometric analysis was performed to evaluate the validity, reliability, responsiveness, and interpretability of the PAVF-QoL( 18 , 19 ). The complete questionnaire utilised in the test-retest phase is included in supplementary files. Internal Consistency Internal consistency of PAVF-QoL was measured using the Cronbach's alpha statistic with an eigen > 0.7 deemed acceptable( 20 ). Item–total and item–item correlations (ITC and IIC) were examined at baseline (index completion of PAVF-QoL) to identify redundancy. Items showing excessive correlation with the total score or with other items were considered for exclusion to reduce duplication. Items with ITC 0.80 were flagged as duplicative( 20 , 21 ). Factor structure Principal factor analysis (PFA) was used to explore the underlying domains of PAVF-QoL. Kaiser–Meyer–Olkin (KMO) test and Bartlett’s test of sphericity were applied to confirm factorability. Exploratory PCA is a statistical technique used to identify clusters of questions that measure similar constructs and explain the greatest variance within the scale. Domains were considered important if their corresponding eigen value exceeded 1 and they explained more than 5% of the total variance. Items were considered to contribute meaningfully to a domain if their loading was ≥ 0.4. Items not loading onto any important domain were considered for removal from the final instrument( 20 ). Stepwise regression The best subset of items that explained the largest percentage of variance in the overall PAVF-QoL score was then determined using stepwise regression. Final item retention was based on clinical relevance, patient-prioritised content, and conceptual balance across domains( 22 , 23 ). Construct Validity Construct validity measures how consistently a scale aligns with other validated scales assessing similar traits. Correlations between PAVF-QoL scores and recognised indicators of psychological wellbeing, symptom burden, and functional status were evaluated to investigate construct validity. Pearson's correlation coefficients were calculated for PAVF-QoL in relation to the patient-reported scores from the Perianal Disease Activity Index (PDAI), Short Form-12 (SF-12), and the Hospital Anxiety and Depression Scale (HADS). Significant relationships are indicated by correlation coefficients ranging from 0.4 to 0.8( 19 , 21 , 24 ). Test-retest Reliability In patients with stable disease, Pearson correlation coefficient was used to measure correlation between two responses. A value of greater than 0.75 suggested acceptable correlation. Intraclass correlation (ICC) was calculated using analysis of variance with an acceptable ICC being > 0.70( 19 ). Responsiveness Responsiveness reflects the ability of the PAVF-QoL to detect clinical change. It was assessed in patients who reported improvement or deterioration in their fistula condition between assessments, in contrast to reliability which was tested in stable patients( 20 ). Three metrics were used: Responsiveness ratio (RR): mean change in scores of patients reporting improvement or deterioration, divided by the SD of baseline scores in stable patients( 25 ). Effect size (ES): mean change in scores of patients reporting improvement or deterioration, divided by the SD of baseline scores in that same group. ES values of 0.2–0.49 were considered small, 0.5–0.79 moderate, and ≥ 0.8 large( 25 ). Standardised response mean (SRM): mean change in scores of patients with improvement or deterioration, divided by the SD of the change scores between assessments. SRM > 0.8 was considered very good( 25 , 26 ). The retest sample was grouped by reported symptom status: no change, improvement, or worsening. Mean test-retest score differences with confidence intervals (CIs) were calculated and compared using paired t-tests, with significance set at p < 0.05. Interpretability Patients completed a self-reported visual analogue score (VAS) rating how bothersome their fistula was on a scale of 1–10 (1 = not bothersome at all, 10 = extremely bothersome). The minimally important change (MIC) was defined as the mean change in PAVF-QoL score among patients who reported a 1–2 point change on the VAS. This represents the smallest difference in score perceived as important by patients, providing a threshold for interpreting whether changes reflect meaningful improvement or deterioration following intervention( 12 , 27 ). Results Study population Across the three phases, 99 patients participated (Phase 1: n = 14; Phase 2: n = 9; Phase 3: n = 76). In the psychometric testing cohort, two-thirds were female ( n = 51, 67%) with a median age of 53 years (IQR 40–60). The majority had a disease duration > 48 months ( n = 48, 63%), with a smaller proportion reporting 25–48 months ( n = 15, 20%) or < 24 months ( n = 10, 13%). At the time of testing, 70% ( n = 53) reported an active fistula, 26% ( n = 20) were inactive, and 4% ( n = 3) were unsure. Fistula type was anal in 54% ( n = 41), vaginal in 28% ( n = 21), and both anal and vaginal in 9% ( n = 7), while 9% ( n = 7) were unspecified (Table 1 ). Table 1 Participant demographics in each phase Phase 1 Item generation ( N = 14), n (%) Phase 2 Cognitive Interviews ( N = 9), n (%) Phase 3 Psychometric Testing (N = 76), n (%) Gender Male 6 (43) 4 (44) 25 (33) Female 9 (57) 5 (56) 51 (67) Median age (years) (IQR) 47 (40–59) 41 (32–50) 53 (40–60) years Duration of diagnosis 0–24 5 (36) 2 ( 22 ) 10 ( 13 ) 25–48 5 (36) 4 (44) 15 ( 20 ) > 48 4 ( 28 ) 3 (34) 48 (63) Unknown 3 ( 4 ) Active fistula Yes 8 (57) 7 (78) 53 (70) No 4 ( 29 ) 1 ( 11 ) 20 ( 26 ) Not sure 2 ( 14 ) 1 ( 11 ) 3 ( 4 ) Fistula type Anal 4 ( 29 ) 7 (78) 41(54) Vaginal 6 (43) 2 ( 22 ) 21( 28 ) Both 3 ( 21 ) 7 ( 9 ) Unknown 7 ( 9 ) Stoma 1 ( 7 ) 14 ( 18 ) Phase 1: Item generation The study management group produced the first draft of PAVF-QoL with 32 items using themes generated from 14 patient interviews, and systematic review of the literature( 9 ). Phase 2: Scale development Cognitive interviews A total of 9 patients were interviewed over 3 rounds to revise wording of items and responses. Three additional questions were suggested with multiple revisions made to structure of questions and responses. The initial three cognitive interviews were on average 30 minutes in length while in the final round the interviews ranged between 5–7 minutes demonstrating improvement in structure and readability. Of the three new questions suggested, the SMG found one suggested question to be closely related to an existing item and the other two questions were included in the draft (see supplementary table 1 ). Content validity was assessed by 8 experts and reported with the mean individual item rankings (I-CVI). The SMG decided to retain all items including the two items with an I-CVI < 0.78 as these were highly prioritised by patients in the interviews (see supplementary table 2 ). Phase 3: Psychometric testing A total of 76 patients completed the draft PAVF-QoL with 34 items along with the validated questionnaires and background form. The second round was completed by 55 patients. Scoring of PAVF-QoL The 14 items were each rated on a scale from 1 to 5. The total scores range from 14 to 70. For question 16 and 19, the “Not applicable” response is assigned a value of zero. Higher total scores indicate a greater impact of symptoms and worse quality of life. Item reduction Table 2 demonstrates Item-item correlations. Items with ITC < 0.30 were flagged for review but not removed at this stage. All items were carried forward into principal factor analysis and subsequent stepwise regression. Clinical relevance determined the final items retained in PAVF-QoL-14. Table 2 Item–total correlations (ITC) for candidate PAVF-QoL items at baseline Item-total correlations PQOL1 = Do you get swelling around the anus/vagina because of your fistula? 0.712 PQOL2 = How often do you experience discharge (pus/mucus/blood) from your fistula? 0.575 PQOL3 = Do you need to use pads/gauze because of discharge from your fistula? 0.714 PQOL4 = How much pain have you had around your anus/vagina because of the fistula in the past 6 weeks? 0.760 PQOL5 = How often do you experience discomfort from your fistula? 0.748 PQOL6 = Do you get skin irritation (chafing) because of discharge from your fistula? 0.749 PQOL7 = How often do you need to use medication for pain from your fistula? 0.687 PQOL8 = How often have you felt unwell because of your fistula in the past 6 weeks? 0.753 PQOL9 = How often have you leaked stool through your fistula in the past 6 weeks? 0.744 PQOL10 = How often do you use medication (e.g. Loperamide, codeine) to control leakage of stool through your fistula? 0.505 PQOL11 = How often are you bothered by side effects of medications (loperamide, codeine, antibiotics, biologics, immunomodulators) used to treat your fistula? 0.522 PQOL12 = I have to modify my diet to control the symptoms of my fistula 0.609 PQOL13 = I feel tired or drained because of my fistula 0.849 PQOL14 = I am worried others may be able to smell the discharge from my fistula 0.754 PQOL15 = I worry about what others might think as I need to frequently use the toilet because of my fistula 0.720 PQOL16 = I worry about becoming incontinent, or losing control of my pouch because of fistula surgery 0.282 PQOL17 = I worry that I may need to have more surgery in the future for my fistula 0.608 PQOL18 = I worry about getting another fistula or abscess 0.465 PQOL19 = I worry about needing a stoma because of my fistula 0.376 PQOL20 = I feel embarrassed about having a fistula 0.637 PQOL21 = I feel sad/depressed because of my fistula 0.748 PQOL22 = I worry about having children in the future as it may worsen my fistula symptoms 0.226 PQOL23 = I worry about not being able to work, or needing to make changes to my job in the future due to my fistula (e.g. having to work from home) 0.640 PQOL24 = Symptoms from my fistula (e.g. pain/discharge) affect my sexual activity 0.674 PQOl25 = Symptoms from my fistula affect my ability or desire to get physically close/ be intimate with someone 0.640 PQOL26 = How often has your sleep been disturbed because of your fistula? 0.830 PQOL27 = How often is your ability to concentrate disturbed because of your fistula? 0.816 PQOL28 = How often has the fistula limited your ability to work (household or work outside the home)? 0.807 PQOL29 = How often has the fistula limited physical activities that you would like to do (swimming/exercise/running/cycling)? 0.814 PQOL30 = How often does your fistula affect your choice of transportation (travelling by car, bus, train)? 0.730 PQOl31 = I avoid attending social events because of my fistula 0.728 PQOL32 = I have had to leave social events early because of my fistula 0.770 PQOL 33 = I only attend social events if I know there will be toilets nearby because of my fistula 0.742 PQOL34 = I feel supported by my family and friends to manage my fistula − .151 Principal factor analysis Sampling adequacy was excellent (KMO = 0.905), and Bartlett’s test was highly significant (p 1, contribution to > 5% of variance, and principal factor analysis in supplementary table 3 ), supported retention of four key domains - ‘symptoms’, ‘discharge’, ‘faecal incontinence’, and ‘future concerns’ that the items could be grouped in to. Scree plot inspection demonstrated a marked elbow at the fourth domain, after which eigen values plateaued, supporting retention of four domains (supplementary Fig. 1). These four domains were extracted and rotated using Varimax with Kaiser normalization, explaining a cumulative 63.7% of the total variance. Items were considered meaningful if they loaded ≥ 0.4 on one of the four domains. The retained items were well distributed across the four domains, confirming the multidimensional structure of the PAVF-QoL. Table 3 demonstrates factor loadings of PAVF-QoL-14 items following Varimax rotation (Kaiser normalization). Supplementary table 3 includes PFA and factor loadings of PAVF-QoL-34 items following Varimax rotation (Kaiser normalization). Table 3 Factor loadings of PAVF-QoL-14 items following Varimax rotation (Kaiser normalization). The items retained for PAVF-QoL 14 are bold. Domains / PCA Factors Q PAVF-QoL-14 Symptoms Discharge Faecal incontinence Future concerns 1. PQOL3 = Do you need to use pads/gauze because of discharge from your fistula? . .571 .513 2. PQOL4 = How much pain have you had around your anus/vagina because of the fistula in the past 6 weeks? .734 3. PQOL6 = Do you get skin irritation (chafing) because of discharge from your fistula? .495 .473 4. PQOL7 = How often do you need to use medication for pain from your fistula? .678 5. PQOL9 = How often have you leaked stool through your fistula in the past 6 weeks? .475 .590 . 6. PQOL13 = I feel tired or drained because of my fistula .657 7. PQOL16 = I worry about becoming incontinent, or losing control of my pouch because of fistula surgery .894 8. PQOL18 = I worry about getting another fistula or abscess .475 .466 9. PQOL20 = I feel embarrassed about having a fistula .411 .512 10. PQOL24 = Symptoms from my fistula (e.g. pain/discharge) affect my sexual activity . .895 11. PQOL26 = How often has your sleep been disturbed because of your fistula? .534 .418 .435 12. PQOL28 = How often has the fistula limited your ability to work (household or work outside the home)? .809 13. PQOL29 = How often has the fistula limited physical activities that you would like to do (swimming/exercise/running/cycling)? .677 .381 14. PQOL32 = I have had to leave social events early because of my fistula .584 .473 Stepwise regression Following stepwise regression the first 12 items were retained. PQOL 3 and PQOL 4 were retained, reflecting the strong emphasis placed on their relevance during patient interviews. Table 4 demonstrates stepwise regression analysis and comparison of the draft 34 and the final PAVF-QoL-14 scale. Internal consistency remained very high (Cronbach’s α = 0.920 vs 0.954 for the full scale). Construct validity was maintained, with strong positive correlations with the PDAI (r = 0.783, p < 0.01) and HADS (r = 0.589, p < 0.01), and negative correlations with SF-12 physical and mental component scores (r = − 0.525 and − 0.400, p < 0.01 respectively). The final 14-item PAVF-QoL retained 63.7% of the variance explained by the original 34-item version, indicating that the shorter instrument captures most of the variability in patient responses. Table 4: Stepwise regression analysis with comparison of PAVF-QoL 34 item and 14 item scale PAVF-QoL-34 PVFQoL-14 Cumulative % I feel tired or drained because of my fistula 0.717 How often have you leaked stool through your fistula in the past 6 weeks? 0.816 I feel embarrassed about having a fistula 0.869 How often has the fistula limited your ability to work (household or work outside the home)? 0.911 Do you get skin irritation (chafing) because of discharge from your fistula? 0.929 I worry about getting another fistula or abscess 0.947 How often has your sleep been disturbed because of your fistula? 0.960 I have had to leave social events early because of my fistula 0.969 How often are you bothered by side effects of medications (loperamide, codeine, antibiotics, biologics, immunomodulators) used to treat your fistula?** 0.975 How often has the fistula limited physical activities that you would like to do (swimming/exercise/running/cycling)? 0.979 Symptoms from my fistula (e.g. pain/discharge) affect my sexual activity and/or ability to be intimate** 0.982 I worry about becoming incontinent, or losing control of my pouch because of fistula surgery*** 0.984 How often do you use medication (e.g. Loperamide, codeine) to control leakage of stool through your fistula 0.986 I avoid attending social events because of my fistula 0.988 I worry that I may need to have more surgery in the future for my fistula 0.990 How often have you felt unwell because of your fistula in the past 6 weeks? 0.991 Do you need to use pads/gauze because of discharge from your fistula? 0.992 I worry about having children in the future as it may worsen my fistula symptoms 0.993 I feel supported by my family and friends to manage my fistula 0.994 I only attend social events if I know there will be toilets nearby because of my fistula 0.995 I am worried others may be able to smell the discharge from my fistula 0.995 I worry about needing a stoma because of my fistula*** 0.996 How often do you need to use medication for pain from your fistula? 0.996 I worry about what others might think as I need to frequently use the toilet because of my fistula 0.997 I worry about not being able to work, or needing to make changes to my job in the future due to my fistula (e.g. having to work from home) 0.997 How much pain have you had around your anus/vagina because of the fistula in the past 6 weeks?** 0.998 How often do you experience discharge (pus/mucus/blood) from your fistula? 0.998 I feel sad/depressed because of my fistula 0.998 I have to modify my diet to control the symptoms of my fistula 0.999 Symptoms from my fistula affect my ability or desire to get physically close/ be intimate with someone 0.999 How often does your fistula affect your choice of transportation (travelling by car, bus, train)? 0.999 How often do you experience discomfort from your fistula? 0.999 How often is your ability to concentrate disturbed because of your fistula? 0.999 Internal consistency (Cronbach's α) 0.954 0.920 Construct validity P < 0.01 PDAI .766 * .783 ** HADS (total) .622* .589* HADS (Anxiety) .586 * .553 * HADS (Depression) .560 * .530 * SF-12 PCS (Physical component) -.570 * -.525 * SF-12 MCS (Mental component) -.398 * -.400 * Pearson correlation co-efficient* Negative coefficients show that generic measures increase while disease specific measures decrease. Wording of item changed by SMG** Questions with ‘not applicable’ as a possible response Negative coefficients show that generic measures increase while disease specific measures decrease. Wording of item changed by SMG** Questions with ‘not applicable’ as a possible response Test–retest reliability Of the 55 patients who returned the retest questionnaire, 37 reported no change in symptoms and were included in reliability testing, while 18 reported a change and were included in sensitivity analyses. In the stable cohort, test–retest reliability was excellent, with intraclass correlation coefficients (ICC) of 0.943 for the full PAVF-QoL and 0.924 for the shortened PAVF-QoL-14 (both p < 0.01). Responsiveness In patients reporting change ( n = 18), both instruments demonstrated strong responsiveness. The responsiveness ratio (RR) was 0.643 for PAVF-QoL-34 and 0.639 for the PAVF-QoL-14. Effect sizes (ES) were 0.71 and 0.77, respectively, indicating moderate responsiveness. Standardised response means (SRM) were 0.945 for PAVF-QoL-34 and 1.071 for PAVF-QoL-14, both exceeding 0.8 and indicating very good responsiveness. Interpretability (MIC) The MIC was 6 points for the original PAVF-QoL and 3 points for the PAVF-QoL-14, representing the smallest patient-perceived change considered clinically meaningful. PAVF-QoL-14 The final PAVF-QoL questionnaire consisted of 14 items and has a Flesch reading ease score of 67.4 and a Flesch-Kincaid grade level of 7.6 (reading age 12–14 years). The item reporting the impact of pain (PQOL 4) was modified to include discomfort in the wording as this reflects the scale of pain which could have varying degrees of impact on QoL. PQOL 10 wording was modified to reflect the burden of medication use to manage fistula. PQOL 24 includes ‘and/or ability to be intimate’ to ensure it reflects variation in experience. Item level content validity index (I-CVI) was reassessed by experts in pouch fistula for PAVF-QoL-14 and all items were rated > 0.80. Patients in the SMG agreed with the changes. Discussion We have developed and validated a disease-specific PROM for pouch anal and vaginal fistula (PAVF-QoL-14) in accordance with COSMIN standards, addressing a longstanding measurement gap in pouch outcomes research. We derived items from qualitative interviews and the existing literature, and refined content through cognitive interviews and expert I-CVI assessment. Early and sustained patient involvement was central to the development of PAVF-QOL, a key methodological strength which ensures robust face and content validity and an instrument that reflects patient prioritised outcomes. Four-domains were identified using factor analysis (KMO 0.905; Bartlett p < 0.001) explaining 63.7% variance: symptoms, discharge, faecal incontinence, and future concerns. Stepwise regression reduced the 34-item draft to a user friendly 14-item tool without loss of measurement performance. Internal consistency remained excellent (α = 0.920 vs 0.954), construct validity correlations with PDAI, HADS and SF-12 were preserved in magnitude and direction, and test–retest reliability was robust (ICC 0.924–0.943). Importantly, item retention decisions were not solely statistical: items with high patient relevance or clinical face validity were kept despite borderline statistics to maintain conceptual balance. The reduced form improved psychometric efficiency without sacrificing meaning. Responsiveness was acceptable to strong (RR ≈ 0.64; ES 0.71–0.77; SRM 0.95–1.07), and anchor-based interpretability thresholds (MIC 6 points for the full scale; 3 points for the 14-item scale) provide an objective measure of clinical change. PAVF-QoL-14 is a patient-centred tool designed to measure the multidimensional impact of pouch fistula and is concise for application in both clinical practice and research. It complements existing pouch function tools (e.g. IPSS) by isolating fistula-specific morbidity and its psychosocial impact, where symptoms from pouch function and fistula may otherwise be conflated( 7 ). Prior pouch literature leans on generic PROMs or non-validated symptom checklists, limiting comparability and effect-size detection. PAVF-QoL- 14 advances the field by (i) focusing on fistula-specific lived burden, (ii) reporting transparent scoring and (iii) demonstrating responsiveness to clinical change. PAVF-QoL-14 includes psychometric evaluation of structure, reliability, validity, responsiveness, and interpretability. The four domains of PAVF-QoL identified using exploratory principal factor analysis reflects the core outcomes established in the PAVF core outcome set – pain related to fistula, global assessment of incontinence, fistula discharge, new fistula or abscess and need for rescue intervention( 9 ). PAVF-QoL-14 is a suitable instrument for global quality of life assessment thus enabling COS implementation. There were limitations and challenges in validating a disease specific QoL scale in patients with pouch fistula. Patient recruitment proved challenging as anal and vaginal fistula are rare in the context of ileoanal pouch, occurring in 5% of an already small patient cohort. Although there is no set guidance on the number of patients required to validate a QoL scale, there is evidence that 5–10 patient responses may be required per item to validate the item and ensure it accurately reflects impact on QoL( 28 , 29 ). The number of participants (n = 76) in the test phase is sufficient to validate 14 items and KMO 0.905; Bartlett p < 0.001 analysis suggests that there were adequate participants to perform psychometric analysis of the scale. Patients were mostly recruited from a single-centre, tertiary service which may limit generalisability but conversely a sufficient cohort of patients with pouch fistula could only be found at a referral centre specialising in complex pouch complications, and this rare and complex problem should generally be managed in a such centres, with experience of pouch dysfunction and complex fistula. Test–retest reliability was assessed with a 4–6 week gap to minimise recall bias while acknowledging that some patients may change clinically over this interval, which can attenuate reliability estimates. Future Direction Future work should include ( 1 ) multi-centre external validation of the scale with diverse pouch fistula aetiologies ( 2 ) test–retest reliability and longitudinal responsiveness across treatment stages ( 3 ) complete cross-cultural adaptation and translation ( 3 ) assessment of PAVF-QoL-14 for inclusion in a pouch anal and vaginal fistula core outcome measurement set ( 4 ) embedding PAVF-QoL-14 in prospective trials to test real-world responsiveness and usability. PAVF-QOL – 14 could be adapted for electronic administration, which may enable effortless, longitudinal outcome collection. Formal electronic format validation and usability testing will be important next steps for digital implementation. Conclusion PAVF-QoL-14 is a validated PROM specifically designed for pouch-related fistula, demonstrating strong psychometric properties. It is a concise, conceptually clear instrument that is suitable for use in both clinical monitoring and measurement of research outcomes future studies. Declarations Competing interests: The authors have no relevant financial or non-financial interests to disclose. Ethical approval: The study was granted ethical approval from the Wales Research Ethics Service (REC reference 20/WA/0308) Consent to participate: Written consent was taken from patients for qualitative interviews. Funding: PAVF-QOL was funded by the Robin Phillips Fistula Research Unit at St Mark’s Hospital and Academic institute. Author Contribution All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Ms Lillian Reza, Professor Laith Alrubaiy, Dr Lara Bapir, Ms Nusrat Iqbal, Ms Charlene Sackitey and Mr Easan Anand. Clinical oversight and specialist input were contributed by Professor Laith Alrubaiy, Professor Ailsa Hart, Professor Sue Clark, Dr Pillip Lung, and Mr Phil Tozer. Nursing expertise and clinical pathway input were provided by Rali Marinova, Petya Marinova, and Pearl Avery. Patient perspective and co-design input were provided by Sally Hughes and Mina Babbar. The first draft of the manuscript was written by Ms Lillian Reza, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript. Acknowledgement With thanks to Kirsty Morrison, Senior Information Specialist, Royal College of Surgeons of England Library and Archives Team. Study conception and dissemination was supported by the Ileostomy and Internal Pouch Association and the Red Lion Pouch Support Group at St Mark’s Hospital. Data Availability All data supporting the findings of this study are available within the paper and its Supplementary Information. References Parks, A. 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Supplementary Files SupplementaryFigure1.docx PlainEnglishSummary.docx TopicGuideforSemiStructuredinterviews.docx SupplementaryTables13.docx GuideforCognitiveInterviews.docx PAVFQOLfullstudyquestionnaire.pdf FinalPAVFQoL14Questionnaire.pdf Supplementaryfilesanddata.docx Cite Share Download PDF Status: Under Review Version 1 posted Reviews received at journal 01 May, 2026 Reviewers agreed at journal 28 Apr, 2026 Reviewers agreed at journal 21 Apr, 2026 Reviewers invited by journal 22 Jan, 2026 Editor assigned by journal 02 Jan, 2026 Submission checks completed at journal 02 Jan, 2026 First submitted to journal 02 Jan, 2026 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8500549","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":578595388,"identity":"14d26b4b-c715-4327-853f-546c4442ddde","order_by":0,"name":"Lillian 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10:33:46","extension":"docx","order_by":8,"title":"","display":"","copyAsset":false,"role":"supplement","size":15207,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementaryfilesanddata.docx","url":"https://assets-eu.researchsquare.com/files/rs-8500549/v1/e90e98168dd99d5160e6b1eb.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Capturing quality of life in pouch anal and vaginal fistula: Development of PAVF-QoL-14, a patient-reported outcome measure","fulltext":[{"header":"Plain English Summary","content":"\u003cp\u003ePeople who have an ileoanal pouch can sometimes develop a pouch anal or vaginal fistula, which is an abnormal connection that may cause ongoing discharge, pain, infections, and emotional distress. These symptoms can have a major impact on daily activities, relationships, work, and overall wellbeing. Despite this, there has been no questionnaire specifically designed to measure how pouch-related fistulas affect quality of life from the patient\u0026rsquo;s perspective.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn this study, we developed and tested a new questionnaire called the Pouch Anal and Vaginal Fistula Quality of Life questionnaire (PAVF-QoL-14). Patients with lived experience of pouch fistula were involved throughout the process, starting with interviews to identify the symptoms and concerns that mattered most to them. The questionnaire was then refined through patient feedback and expert review to ensure that the questions were clear, relevant, and easy to understand. We tested the questionnaire in a group of patients and showed that it is reliable, meaning people gave similar answers when their condition had not changed, and responsive, meaning scores changed appropriately when symptoms improved or worsened. The final questionnaire contains 14 questions covering areas such as symptoms, discharge, bowel control, tiredness, emotional wellbeing, intimacy, and worries about the future. PAVF-QoL-14 is a short, patient-centred tool that can be used in routine clinical care and in research studies to better understand the impact of pouch fistula and to assess whether treatments improve quality of life.\u003c/p\u003e"},{"header":"Introduction","content":"\u003cp\u003eThe ileoanal pouch was developed with the aim of improving quality of life for patients requiring proctocolectomy(\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). Pouch fistula is a debilitating complication that can significantly impair quality of life (QoL) and is associated with an increased risk of pouch failure. The pooled prevalence of pouch fistula is 5%(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). Systematic review of existing studies report the prevalence of pouch failure at 10%. However, the development of fistula is associated with a substantial escalation in risk, with pouch failure rates rising to as high as 50% in some units (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Despite this impact pouch fistula research is sparse. Patient-Reported Outcomes (PROMs) after pouch surgery have historically been poorly reported. \u0026lsquo;Ileoanal pouch syndrome\u0026rsquo; has been recently defined as a constellation of symptoms patients experience following surgery (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) and has been used to validate the ileoanal pouch syndrome severity (IPSS) score for the assessment of pouch function. The IPSS score quantifies severity of symptoms and their impact on quality of life(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). Patients with long term complications such as pouchitis, pelvic sepsis and fistula were found to have higher IPSS scores suggesting a greater impact on pouch function and QoL(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). While IPSS quantifies overall pouch function, it lacks specificity for the psychosocial and symptom burden of fistula. Existing generic PROMs such as SF-12 are insufficiently sensitive to detect fistula-related changes, underscoring the need for a disease-specific measure (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe pouch anal and vaginal fistula core outcome set (PAVFCOS) Delphi consensus study has established the core outcomes that should be measured in all interventional studies of pouch fistula, and this includes QoL outcomes such as global assessment of quality of life and impact on quality of life of fistula discharge (Fig.\u0026nbsp;1)(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). This study aimed to develop a disease-specific QoL measurement tool in pouch anal and vaginal fistula (PAVF-QoL) that could be utilised for COS implementation in research and clinical assessment.\u003c/p\u003e "},{"header":"Method","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design and Reporting Standards\u003c/h2\u003e \u003cp\u003eThe development of the PAVF-QoL scale followed the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) taxonomy, which provides a structured approach for the development and evaluation of patient-reported outcome measures (PROMs)(\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). This study is reported in line with the COSMIN study design checklist for PROMs, ensuring transparency, methodological rigour, and adherence to best practice guidelines for outcome instrument development(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). Ethical approval was granted by the Wales Research Ethics Committee 3 (REC reference: 20/WA/0308), and the Health Research Authority (HRA) and Health and Care Research Wales.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eResearch Aim\u003c/h3\u003e\n\u003cp\u003eOur aim was to develop and validate a disease specific PROM to assess the impact of pouch anal and vaginal fistula symptoms, and their treatment, on health-related quality of life of patients with an ileoanal pouch.\u003c/p\u003e\n\u003ch3\u003eStudy Management Group\u003c/h3\u003e\n\u003cp\u003eThe study was overseen by a multidisciplinary management group comprising patients and clinicians. Patients with lived experience of pouch-related fistula were involved from the outset to ensure that the instrument captured relevant aspects of their lived experience. The clinical members of the team included pouch dysfunction specialist colorectal surgeons and gastroenterologist, specialist pouch nurses, and a radiologist with expertise in pouch imaging. In addition, the group included clinicians and researchers with experience in PROM development and qualitative methodology. The study management group (SMG) guided each stage of the development process, from defining the construct, generating items, to reviewing content validity and refining the instrument. Patients contributed throughout, ensuring that themes reflected patient priorities rather than researcher assumptions.\u003c/p\u003e\n\u003ch3\u003eDefinition of construct and conceptual framework\u003c/h3\u003e\n\u003cp\u003ePAVF-QoL was developed to assess the impact of pouch-related perianal fistula and their treatments on the physical, psychological, and social functioning of patients with an ileoanal pouch. The construct being measured is health-related quality of life in chronic perineal fistulising disease in patients with an ileoanal pouch.\u003c/p\u003e \u003cp\u003eInstrument design was informed by Wilson and Cleary\u0026rsquo;s model of health-related quality of life, which provides a structured framework linking biological and physiological factors (e.g. the presence of a fistula) to symptoms, functional status, general health perceptions, and overall quality of life. This model was previously and successfully applied in the development of the Anal Fistula Quality of Life scale (AF-QoL), a disease-specific PROM for cryptoglandular anal fistula(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e) and in the development of Crohn\u0026rsquo;s Anal Fistula Quality of Life (CAF-QoL) scale for patients with Crohn\u0026rsquo;s anal fistula(\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Both highlighting the complex, multidimensional impact of fistula disease on quality of life. Patients with pouch-related fistula experience a similarly multifaceted burden but often with additional symptoms specific to pouch anatomy and function. Pouch-specific symptoms, including altered bowel habit, pouchitis, and pouch dysfunction required careful delineation and exclusion during item generation to ensure that the scale reflected the impact of the fistula and its treatment, not general pouch function or dysfunction(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). By focusing specifically on fistula-related morbidity rather than general pouch function, PAVF-QoL aims to isolate the impact of chronic perineal sepsis, drainage, and surgical intervention on everyday life, intimacy, and psychological wellbeing.\u003c/p\u003e\n\u003ch3\u003eTarget population\u003c/h3\u003e\n\u003cp\u003ePAVF-QoL has been developed to assess QoL in patients with pouch-related perianal fistula arising from anastomotic leak, non-Crohn\u0026rsquo;s active inflammatory bowel disease (IBD), Crohn\u0026rsquo;s disease or cryptoglandular disease related aetiologies \u0026ndash; as described in the literature(\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). The instrument is applicable regardless of fistula duration, complexity, or treatment stage, allowing its use across a broad spectrum of clinical presentations. PAVF-QoL has been designed to aid clinical assessment, measure impact of intervention and provide standardisation in outcome reporting in clinical research.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eParticipant eligibility selection\u003c/h2\u003e \u003cp\u003eAdults aged 18 to 80 years with a diagnosis of pouch-related perianal or vaginal fistula were eligible to take part in PROM development. Eligible participants were required to have capacity to provide informed consent and understand both written and spoken English. Purposive sampling recruitment was used to ensure representation of a broad range of experiences, fistula complexity, and chronicity. Primary recruitment was conducted at a tertiary pouch centre. Patients were also recruited through the Red Lion pouch patient support group and social media. Recruitment via social media enabled inclusion of patients with less healthcare engagement or those managed in non-specialist centres, thereby enhancing the instrument\u0026rsquo;s generalisability between October 2022- August 2024.\u003c/p\u003e \u003cp\u003eThe methodology for instrument development has been modelled on the study developing the AF-QoL scale(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e) and this has been described according to three distinct phases.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003ePhase 1: Item generation\u003c/h3\u003e\n\u003cp\u003eItem generation utilised inductive and deductive methods to ensure comprehensive content coverage and robust conceptual validity. Items were derived from semi-structured interviews with patients with pouch fistula. These semi-structured interviews were conducted using a topic guide (see supplementary file) by a researcher trained in qualitative interviews. Interviews were recorded and transcribed verbatim. Qualitative interviews and thematic analysis was described in the development of pouch anal and vaginal fistula core outcome set (PAVFCOS) which was conducted in parallel to this study(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). Findings from the interviews were supplemented with a systematic review of existing PROMs used in studies of pouch fistula(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Interviews explored patients\u0026rsquo; lived experiences of the condition, including its physical, psychological, and social impact, as well as the consequences of treatment. Thematic analysis identified recurrent themes, and these were mapped to defined by Wilson and Cleary\u0026rsquo;s model of health related quality of life framework. Patient representatives in the study management group ensured that verbatim responses from patient interviews were appropriately converted into items using patient derived language and reflected a distinct QoL construct. Items were mapped to physical symptoms, impact of symptoms on mental health, sex and intimacy, and global quality of life. Survey instructions, item wording and responses were developed with patient representatives to ensure readability, clinical relevance and acceptability. A recall period was set at 4\u0026ndash;6 weeks to limit recall bias.\u003c/p\u003e \u003cp\u003eFlesch Reading Ease and Flesch\u0026ndash;Kincaid grade level was assessed to determine readability. Statistical analysis was conducted using SPSS Version 29.\u003c/p\u003e\n\u003ch3\u003ePhase 2: Scale Development\u003c/h3\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eCognitive interviews\u003c/h2\u003e \u003cp\u003eThe draft scale was assessed for relevance, comprehensiveness and comprehensibility using cognitive interviews with patient participants. Participants completed the draft scale using the think-aloud technique and were probed for feedback using a predetermined probing questionnaire (see supplementary file). Interviews were conducted by a qualitative researcher, recorded and transcribed verbatim. Interviews were analysed to amend the draft questionnaire. Three consecutive interviews were analysed at a time until no further changes were suggested. The item level content validity index (I-CVI) was assessed by experts in pouch fistula using a Likert scale (1\u0026thinsp;=\u0026thinsp;not at all relevant, 4\u0026thinsp;=\u0026thinsp;extremely relevant) to rate the relevance of each item in the assessment of QoL. Items with an I-CVI\u0026thinsp;\u0026lt;\u0026thinsp;0.78 were assessed for exclusion. The scale level content validity was calculated and a level\u0026thinsp;\u0026gt;\u0026thinsp;0.90 demonstrated excellent content validity(\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003ePhase 3: Psychometric analysis\u003c/h2\u003e \u003cp\u003eThe test phase recruited patient participants from clinics, social media and patient groups. The draft PAVF-QoL questionnaire was distributed with a demographic questionnaire, Short Form-12 (SF-12)(\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e), Hospital Anxiety and Depression Scale (HADS)(\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e) and the patient reported component of the Perianal Disease Activity Index (PDAI)(\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). For test-retest analysis, the questionnaire was resent with an interval of 4\u0026ndash;6 weeks alongside a background form with questions to assess change in symptoms, disease severity and patient perceived impact on quality of life since last completion of PAVF-QoL (see supplementary file). The background form contained composite anchor questions which identified patients with stable disease and unstable disease. Psychometric analysis was performed to evaluate the validity, reliability, responsiveness, and interpretability of the PAVF-QoL(\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). The complete questionnaire utilised in the test-retest phase is included in supplementary files.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eInternal Consistency\u003c/h2\u003e \u003cp\u003eInternal consistency of PAVF-QoL was measured using the Cronbach's alpha statistic with an eigen\u0026thinsp;\u0026gt;\u0026thinsp;0.7 deemed acceptable(\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). Item\u0026ndash;total and item\u0026ndash;item correlations (ITC and IIC) were examined at baseline (index completion of PAVF-QoL) to identify redundancy. Items showing excessive correlation with the total score or with other items were considered for exclusion to reduce duplication. Items with ITC\u0026thinsp;\u0026lt;\u0026thinsp;0.30 were flagged for weak association with the construct; pairs with IIC\u0026thinsp;\u0026gt;\u0026thinsp;0.80 were flagged as duplicative(\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eFactor structure\u003c/h2\u003e \u003cp\u003ePrincipal factor analysis (PFA) was used to explore the underlying domains of PAVF-QoL. Kaiser\u0026ndash;Meyer\u0026ndash;Olkin (KMO) test and Bartlett\u0026rsquo;s test of sphericity were applied to confirm factorability. Exploratory PCA is a statistical technique used to identify clusters of questions that measure similar constructs and explain the greatest variance within the scale. Domains were considered important if their corresponding eigen value exceeded 1 and they explained more than 5% of the total variance. Items were considered to contribute meaningfully to a domain if their loading was \u0026ge;\u0026thinsp;0.4. Items not loading onto any important domain were considered for removal from the final instrument(\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eStepwise regression\u003c/h2\u003e \u003cp\u003eThe best subset of items that explained the largest percentage of variance in the overall PAVF-QoL score was then determined using stepwise regression. Final item retention was based on clinical relevance, patient-prioritised content, and conceptual balance across domains(\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eConstruct Validity\u003c/h2\u003e \u003cp\u003eConstruct validity measures how consistently a scale aligns with other validated scales assessing similar traits. Correlations between PAVF-QoL scores and recognised indicators of psychological wellbeing, symptom burden, and functional status were evaluated to investigate construct validity. Pearson's correlation coefficients were calculated for PAVF-QoL in relation to the patient-reported scores from the Perianal Disease Activity Index (PDAI), Short Form-12 (SF-12), and the Hospital Anxiety and Depression Scale (HADS). Significant relationships are indicated by correlation coefficients ranging from 0.4 to 0.8(\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eTest-retest Reliability\u003c/h2\u003e \u003cp\u003eIn patients with stable disease, Pearson correlation coefficient was used to measure correlation between two responses. A value of greater than 0.75 suggested acceptable correlation. Intraclass correlation (ICC) was calculated using analysis of variance with an acceptable ICC being \u0026gt;\u0026thinsp;0.70(\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eResponsiveness\u003c/h2\u003e \u003cp\u003eResponsiveness reflects the ability of the PAVF-QoL to detect clinical change. It was assessed in patients who reported improvement or deterioration in their fistula condition between assessments, in contrast to reliability which was tested in stable patients(\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). Three metrics were used:\u003c/p\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eResponsiveness ratio (RR): mean change in scores of patients reporting improvement or deterioration, divided by the SD of baseline scores in stable patients(\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e).\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eEffect size (ES): mean change in scores of patients reporting improvement or deterioration, divided by the SD of baseline scores in that same group. ES values of 0.2\u0026ndash;0.49 were considered small, 0.5\u0026ndash;0.79 moderate, and \u0026ge;\u0026thinsp;0.8 large(\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e).\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eStandardised response mean (SRM): mean change in scores of patients with improvement or deterioration, divided by the SD of the change scores between assessments. SRM\u0026thinsp;\u0026gt;\u0026thinsp;0.8 was considered very good(\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e).\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003cp\u003eThe retest sample was grouped by reported symptom status: no change, improvement, or worsening. Mean test-retest score differences with confidence intervals (CIs) were calculated and compared using paired t-tests, with significance set at p\u0026thinsp;\u0026lt;\u0026thinsp;0.05.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eInterpretability\u003c/h2\u003e \u003cp\u003ePatients completed a self-reported visual analogue score (VAS) rating how bothersome their fistula was on a scale of 1\u0026ndash;10 (1\u0026thinsp;=\u0026thinsp;not bothersome at all, 10\u0026thinsp;=\u0026thinsp;extremely bothersome). The minimally important change (MIC) was defined as the mean change in PAVF-QoL score among patients who reported a 1\u0026ndash;2 point change on the VAS. This represents the smallest difference in score perceived as important by patients, providing a threshold for interpreting whether changes reflect meaningful improvement or deterioration following intervention(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eStudy population\u003c/h2\u003e \u003cp\u003eAcross the three phases, 99 patients participated (Phase 1: \u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;14; Phase 2: \u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;9; Phase 3: \u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;76). In the psychometric testing cohort, two-thirds were female (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;51, 67%) with a median age of 53 years (IQR 40\u0026ndash;60). The majority had a disease duration\u0026thinsp;\u0026gt;\u0026thinsp;48 months (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;48, 63%), with a smaller proportion reporting 25\u0026ndash;48 months (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;15, 20%) or \u0026lt;\u0026thinsp;24 months (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;10, 13%). At the time of testing, 70% (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;53) reported an active fistula, 26% (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;20) were inactive, and 4% (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;3) were unsure. Fistula type was anal in 54% (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;41), vaginal in 28% (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;21), and both anal and vaginal in 9% (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;7), while 9% (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;7) were unspecified (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eParticipant demographics in each phase\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePhase 1\u003c/p\u003e \u003cp\u003eItem generation\u003c/p\u003e \u003cp\u003e(\u003cem\u003eN\u0026thinsp;=\u003c/em\u003e\u0026thinsp;14), \u003cem\u003en\u003c/em\u003e (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePhase 2\u003c/p\u003e \u003cp\u003eCognitive Interviews\u003c/p\u003e \u003cp\u003e(\u003cem\u003eN\u0026thinsp;=\u003c/em\u003e\u0026thinsp;9), \u003cem\u003en\u003c/em\u003e (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePhase 3 Psychometric Testing (N\u0026thinsp;=\u0026thinsp;76), \u003cem\u003en\u003c/em\u003e (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGender\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (43)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (44)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e25 (33)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (57)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (56)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e51 (67)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMedian age (years) (IQR)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e47 (40\u0026ndash;59)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e41 (32\u0026ndash;50)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e53 (40\u0026ndash;60) years\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDuration of diagnosis\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e0\u0026ndash;24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (36)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e10 (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e25\u0026ndash;48\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (36)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (44)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15 (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;48\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (34)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e48 (63)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUnknown\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eActive fistula\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (57)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (78)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e53 (70)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e20 (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNot sure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eFistula type\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAnal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (78)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e41(54)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVaginal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (43)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e21(\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBoth\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e7 (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUnknown\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e7 (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eStoma\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e14 (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003ePhase 1: Item generation\u003c/h2\u003e \u003cp\u003eThe study management group produced the first draft of PAVF-QoL with 32 items using themes generated from 14 patient interviews, and systematic review of the literature(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e).\u003c/p\u003e \u003cdiv id=\"Sec23\" class=\"Section3\"\u003e \u003ch2\u003ePhase 2: Scale development\u003c/h2\u003e \u003cdiv id=\"Sec24\" class=\"Section4\"\u003e \u003ch2\u003eCognitive interviews\u003c/h2\u003e \u003cp\u003eA total of 9 patients were interviewed over 3 rounds to revise wording of items and responses. Three additional questions were suggested with multiple revisions made to structure of questions and responses. The initial three cognitive interviews were on average 30 minutes in length while in the final round the interviews ranged between 5\u0026ndash;7 minutes demonstrating improvement in structure and readability. Of the three new questions suggested, the SMG found one suggested question to be closely related to an existing item and the other two questions were included in the draft (see supplementary table \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Content validity was assessed by 8 experts and reported with the mean individual item rankings (I-CVI). The SMG decided to retain all items including the two items with an I-CVI\u0026thinsp;\u0026lt;\u0026thinsp;0.78 as these were highly prioritised by patients in the interviews (see supplementary table \u003cspan refid=\"MOESM2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec25\" class=\"Section3\"\u003e \u003ch2\u003ePhase 3: Psychometric testing\u003c/h2\u003e \u003cp\u003eA total of 76 patients completed the draft PAVF-QoL with 34 items along with the validated questionnaires and background form. The second round was completed by 55 patients.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec26\" class=\"Section3\"\u003e \u003ch2\u003eScoring of PAVF-QoL\u003c/h2\u003e \u003cp\u003eThe 14 items were each rated on a scale from 1 to 5. The total scores range from 14 to 70. For question 16 and 19, the \u0026ldquo;Not applicable\u0026rdquo; response is assigned a value of zero. Higher total scores indicate a greater impact of symptoms and worse quality of life.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec27\" class=\"Section3\"\u003e \u003ch2\u003eItem reduction\u003c/h2\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e demonstrates Item-item correlations. Items with ITC\u0026thinsp;\u0026lt;\u0026thinsp;0.30 were flagged for review but not removed at this stage. All items were carried forward into principal factor analysis and subsequent stepwise regression. Clinical relevance determined the final items retained in PAVF-QoL-14.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cb\u003eItem\u0026ndash;total correlations (ITC) for candidate PAVF-QoL items at baseline\u003c/b\u003e\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eItem-total correlations\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL1\u0026thinsp;=\u0026thinsp;Do you get swelling around the anus/vagina because of your fistula?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.712\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL2\u0026thinsp;=\u0026thinsp;How often do you experience discharge (pus/mucus/blood) from your fistula?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.575\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL3\u0026thinsp;=\u0026thinsp;Do you need to use pads/gauze because of discharge from your fistula?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.714\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL4\u0026thinsp;=\u0026thinsp;How much pain have you had around your anus/vagina because of the fistula in the past 6 weeks?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.760\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL5\u0026thinsp;=\u0026thinsp;How often do you experience discomfort from your fistula?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.748\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL6\u0026thinsp;=\u0026thinsp;Do you get skin irritation (chafing) because of discharge from your fistula?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.749\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL7\u0026thinsp;=\u0026thinsp;How often do you need to use medication for pain from your fistula?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.687\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL8\u0026thinsp;=\u0026thinsp;How often have you felt unwell because of your fistula in the past 6 weeks?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.753\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL9\u0026thinsp;=\u0026thinsp;How often have you leaked stool through your fistula in the past 6 weeks?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.744\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL10\u0026thinsp;=\u0026thinsp;How often do you use medication (e.g. Loperamide, codeine) to control leakage of stool through your fistula?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.505\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL11\u0026thinsp;=\u0026thinsp;How often are you bothered by side effects of medications (loperamide, codeine, antibiotics, biologics, immunomodulators) used to treat your fistula?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.522\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL12\u0026thinsp;=\u0026thinsp;I have to modify my diet to control the symptoms of my fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.609\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL13\u0026thinsp;=\u0026thinsp;I feel tired or drained because of my fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.849\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL14\u0026thinsp;=\u0026thinsp;I am worried others may be able to smell the discharge from my fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.754\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL15\u0026thinsp;=\u0026thinsp;I worry about what others might think as I need to frequently use the toilet because of my fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.720\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL16\u0026thinsp;=\u0026thinsp;I worry about becoming incontinent, or losing control of my pouch because of fistula surgery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.282\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL17\u0026thinsp;=\u0026thinsp;I worry that I may need to have more surgery in the future for my fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.608\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL18\u0026thinsp;=\u0026thinsp;I worry about getting another fistula or abscess\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.465\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL19\u0026thinsp;=\u0026thinsp;I worry about needing a stoma because of my fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.376\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL20\u0026thinsp;=\u0026thinsp;I feel embarrassed about having a fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.637\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL21\u0026thinsp;=\u0026thinsp;I feel sad/depressed because of my fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.748\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL22\u0026thinsp;=\u0026thinsp;I worry about having children in the future as it may worsen my fistula symptoms\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.226\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL23\u0026thinsp;=\u0026thinsp;I worry about not being able to work, or needing to make changes to my job in the future due to my fistula (e.g. having to work from home)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.640\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL24\u0026thinsp;=\u0026thinsp;Symptoms from my fistula (e.g. pain/discharge) affect my sexual activity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.674\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOl25\u0026thinsp;=\u0026thinsp;Symptoms from my fistula affect my ability or desire to get physically close/ be intimate with someone\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.640\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL26\u0026thinsp;=\u0026thinsp;How often has your sleep been disturbed because of your fistula?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.830\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL27\u0026thinsp;=\u0026thinsp;How often is your ability to concentrate disturbed because of your fistula?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.816\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL28\u0026thinsp;=\u0026thinsp;How often has the fistula limited your ability to work (household or work outside the home)?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.807\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL29\u0026thinsp;=\u0026thinsp;How often has the fistula limited physical activities that you would like to do (swimming/exercise/running/cycling)?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.814\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL30\u0026thinsp;=\u0026thinsp;How often does your fistula affect your choice of transportation (travelling by car, bus, train)?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.730\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOl31\u0026thinsp;=\u0026thinsp;I avoid attending social events because of my fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.728\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL32\u0026thinsp;=\u0026thinsp;I have had to leave social events early because of my fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.770\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL 33\u0026thinsp;=\u0026thinsp;I only attend social events if I know there will be toilets nearby because of my fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.742\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePQOL34\u0026thinsp;=\u0026thinsp;I feel supported by my family and friends to manage my fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e\u0026minus;\u0026thinsp;.151\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec28\" class=\"Section2\"\u003e \u003ch2\u003ePrincipal factor analysis\u003c/h2\u003e \u003cp\u003eSampling adequacy was excellent (KMO\u0026thinsp;=\u0026thinsp;0.905), and Bartlett\u0026rsquo;s test was highly significant (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), indicating that the data were suitable for factor analysis. Initial analysis suggested nine potential domains, however applying standard criteria (eigenvalue\u0026thinsp;\u0026gt;\u0026thinsp;1, contribution to \u0026gt;\u0026thinsp;5% of variance, and principal factor analysis in supplementary table \u003cspan refid=\"MOESM3\" class=\"InternalRef\"\u003e3\u003c/span\u003e), supported retention of four key domains - \u0026lsquo;symptoms\u0026rsquo;, \u0026lsquo;discharge\u0026rsquo;, \u0026lsquo;faecal incontinence\u0026rsquo;, and \u0026lsquo;future concerns\u0026rsquo; that the items could be grouped in to. Scree plot inspection demonstrated a marked elbow at the fourth domain, after which eigen values plateaued, supporting retention of four domains (supplementary Fig.\u0026nbsp;1). These four domains were extracted and rotated using Varimax with Kaiser normalization, explaining a cumulative 63.7% of the total variance. Items were considered meaningful if they loaded\u0026thinsp;\u0026ge;\u0026thinsp;0.4 on one of the four domains. The retained items were well distributed across the four domains, confirming the multidimensional structure of the PAVF-QoL. Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e demonstrates factor loadings of PAVF-QoL-14 items following Varimax rotation (Kaiser normalization). Supplementary table \u003cspan refid=\"MOESM3\" class=\"InternalRef\"\u003e3\u003c/span\u003e includes PFA and factor loadings of PAVF-QoL-34 items following Varimax rotation (Kaiser normalization).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eFactor loadings of PAVF-QoL-14 items following Varimax rotation (Kaiser normalization). The items retained for PAVF-QoL 14 are bold.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c6\" namest=\"c3\"\u003e \u003cp\u003eDomains / PCA Factors\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eQ\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePAVF-QoL-14\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSymptoms\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDischarge\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eFaecal incontinence\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eFuture concerns\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePQOL3\u0026thinsp;=\u0026thinsp;Do you need to use pads/gauze because of discharge from your fistula?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e.571\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e.513\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePQOL4\u0026thinsp;=\u0026thinsp;How much pain have you had around your anus/vagina because of the fistula in the past 6 weeks?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.734\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePQOL6\u0026thinsp;=\u0026thinsp;Do you get skin irritation (chafing) because of discharge from your fistula?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.495\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e.473\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePQOL7\u0026thinsp;=\u0026thinsp;How often do you need to use medication for pain from your fistula?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.678\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e5.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePQOL9\u0026thinsp;=\u0026thinsp;How often have you leaked stool through your fistula in the past 6 weeks?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e.475\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e.590\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e6.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePQOL13\u0026thinsp;=\u0026thinsp;I feel tired or drained because of my fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.657\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e7.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePQOL16\u0026thinsp;=\u0026thinsp;I worry about becoming incontinent, or losing control of my pouch because of fistula surgery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e.894\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e8.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePQOL18\u0026thinsp;=\u0026thinsp;I worry about getting another fistula or abscess\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.475\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e.466\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e9.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePQOL20\u0026thinsp;=\u0026thinsp;I feel embarrassed about having a fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.411\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e.512\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e10.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePQOL24\u0026thinsp;=\u0026thinsp;Symptoms from my fistula (e.g. pain/discharge) affect my sexual activity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e.895\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e11.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePQOL26\u0026thinsp;=\u0026thinsp;How often has your sleep been disturbed because of your fistula?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.534\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e.418\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e.435\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e12.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePQOL28\u0026thinsp;=\u0026thinsp;How often has the fistula limited your ability to work (household or work outside the home)?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.809\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e13.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePQOL29\u0026thinsp;=\u0026thinsp;How often has the fistula limited physical activities that you would like to do (swimming/exercise/running/cycling)?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.677\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e.381\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e14.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePQOL32\u0026thinsp;=\u0026thinsp;I have had to leave social events early because of my fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.584\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e.473\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec29\" class=\"Section2\"\u003e \u003ch2\u003eStepwise regression\u003c/h2\u003e \u003cp\u003eFollowing stepwise regression the first 12 items were retained. PQOL 3 and PQOL 4 were retained, reflecting the strong emphasis placed on their relevance during patient interviews. Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e demonstrates stepwise regression analysis and comparison of the draft 34 and the final PAVF-QoL-14 scale.\u003c/p\u003e \u003cp\u003eInternal consistency remained very high (Cronbach\u0026rsquo;s α\u0026thinsp;=\u0026thinsp;0.920 vs 0.954 for the full scale). Construct validity was maintained, with strong positive correlations with the PDAI (r\u0026thinsp;=\u0026thinsp;0.783, p\u0026thinsp;\u0026lt;\u0026thinsp;0.01) and HADS (r\u0026thinsp;=\u0026thinsp;0.589, p\u0026thinsp;\u0026lt;\u0026thinsp;0.01), and negative correlations with SF-12 physical and mental component scores (r = \u0026minus;\u0026thinsp;0.525 and \u0026minus;\u0026thinsp;0.400, p\u0026thinsp;\u0026lt;\u0026thinsp;0.01 respectively). The final 14-item PAVF-QoL retained 63.7% of the variance explained by the original 34-item version, indicating that the shorter instrument captures most of the variability in patient responses.\u003c/p\u003e \u003cp\u003e\u003cstrong\u003eTable 4: Stepwise regression analysis with comparison of PAVF-QoL 34 item and 14 item scale\u003c/strong\u003e\u003c/p\u003e\n\u003cdiv style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;'\u003e\n \u003ctable style=\"border-collapse: collapse;border: none;width: 655px;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-color: rgb(21, 41, 53) rgb(224, 224, 224) rgb(174, 174, 174);border-style: solid;border-width: 1pt;padding: 0cm;height: 10.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: 1pt solid rgb(21, 41, 53);border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 10.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003ePAVF-QoL-34\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: 1pt solid rgb(21, 41, 53);border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 10.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003ePVFQoL-14\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: 1pt solid rgb(21, 41, 53);border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 10.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eCumulative %\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 3.3pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eI feel tired or drained because of my fistula\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 3.3pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 3.3pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 3.3pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.717\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.35pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eHow often have you leaked stool through your fistula in the past 6 weeks?\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.35pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.35pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.35pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.816\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eI feel embarrassed about having a fistula\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.869\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eHow often has the fistula limited your ability to work (household or work outside the home)?\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.911\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eDo you get skin irritation (chafing) because of discharge from your fistula?\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.929\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eI worry about getting another fistula or abscess\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.947\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eHow often has your sleep been disturbed because of your fistula?\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.960\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eI have had to leave social events early because of my fistula\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.969\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 15.65pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eHow often are you bothered by side effects of medications (loperamide, codeine, antibiotics, biologics, immunomodulators) used to treat your fistula?**\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 15.65pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 15.65pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 15.65pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.975\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eHow often has the fistula limited physical activities that you would like to do (swimming/exercise/running/cycling)?\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.979\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eSymptoms from my fistula (e.g. pain/discharge) affect my sexual activity and/or ability to be intimate**\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.982\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eI worry about becoming incontinent, or losing control of my pouch because of fistula surgery***\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.984\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eHow often do you use medication (e.g. Loperamide, codeine) to control leakage of stool through your fistula\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.986\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eI avoid attending social events because of my fistula\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.988\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eI worry that I may need to have more surgery in the future for my fistula\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.990\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eHow often have you felt unwell because of your fistula in the past 6 weeks?\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.991\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eDo you need to use pads/gauze because of discharge from your fistula?\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.992\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eI worry about having children in the future as it may worsen my fistula symptoms\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.993\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eI feel supported by my family and friends to manage my fistula\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.994\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eI only attend social events if I know there will be toilets nearby because of my fistula\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.995\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eI am worried others may be able to smell the discharge from my fistula\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.995\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eI worry about needing a stoma because of my fistula***\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.996\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eHow often do you need to use medication for pain from your fistula?\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.996\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eI worry about what others might think as I need to frequently use the toilet because of my fistula\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.997\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eI worry about not being able to work, or needing to make changes to my job in the future due to my fistula (e.g. having to work from home)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.997\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eHow much pain have you had around your anus/vagina because of the fistula in the past 6 weeks?**\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.998\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eHow often do you experience discharge (pus/mucus/blood) from your fistula?\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.998\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eI feel sad/depressed because of my fistula\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.998\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eI have to modify my diet to control the symptoms of my fistula\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.999\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eSymptoms from my fistula affect my ability or desire to get physically close/ be intimate with someone\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 30.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.999\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eHow often does your fistula affect your choice of transportation (travelling by car, bus, train)?\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.999\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eHow often do you experience discomfort from your fistula?\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 18.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.999\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eHow often is your ability to concentrate disturbed because of your fistula?\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);background: rgb(127, 127, 127);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.999\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height: 150%;font-family:\"Times New Roman\",serif;'\u003eInternal consistency (Cronbach\u0026apos;s \u0026alpha;)\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.954\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e0.920\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height: 150%;font-family:\"Times New Roman\",serif;'\u003eConstruct validity\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eP \u0026lt; 0.01\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height: 150%;font-family:\"Times New Roman\",serif;'\u003ePDAI\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt 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style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height: 150%;font-family:\"Times New Roman\",serif;'\u003eHADS (Depression)\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e.560\u003csup\u003e*\u003c/sup\u003e\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e.530\u003csup\u003e*\u003c/sup\u003e\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height: 150%;font-family:\"Times New Roman\",serif;'\u003eSF-12 PCS (Physical component)\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e-.570\u003csup\u003e*\u003c/sup\u003e\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n 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\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 232.05pt;border-top: none;border-left: 1pt solid rgb(224, 224, 224);border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;margin-bottom:8.0pt;text-align:center;line-height:150%;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height: 150%;font-family:\"Times New Roman\",serif;'\u003eSF-12 MCS (Mental component)\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 65.15pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e-.398\u003csup\u003e*\u003c/sup\u003e\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63.8pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e-.400\u003csup\u003e*\u003c/sup\u003e\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 130.85pt;border-top: none;border-left: none;border-bottom: 1pt solid rgb(174, 174, 174);border-right: 1pt solid rgb(224, 224, 224);padding: 0cm;height: 19.25pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0cm;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;line-height:150%;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003ePearson correlation co-efficient*\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNegative coefficients show that generic measures increase while disease specific measures decrease.\u003c/p\u003e\n\u003cp\u003eWording of item changed by SMG**\u003c/p\u003e\n\u003cp\u003eQuestions with \u0026lsquo;not applicable\u0026rsquo; as a possible response\u003c/p\u003e \u003cp\u003eNegative coefficients show that generic measures increase while disease specific measures decrease.\u003c/p\u003e \u003cp\u003eWording of item changed by SMG**\u003c/p\u003e \u003cp\u003eQuestions with \u0026lsquo;not applicable\u0026rsquo; as a possible response\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eTest–retest reliability\u003c/h3\u003e\n\u003cp\u003eOf the 55 patients who returned the retest questionnaire, 37 reported no change in symptoms and were included in reliability testing, while 18 reported a change and were included in sensitivity analyses. In the stable cohort, test\u0026ndash;retest reliability was excellent, with intraclass correlation coefficients (ICC) of 0.943 for the full PAVF-QoL and 0.924 for the shortened PAVF-QoL-14 (both p\u0026thinsp;\u0026lt;\u0026thinsp;0.01).\u003c/p\u003e \u003cdiv id=\"Sec31\" class=\"Section2\"\u003e \u003ch2\u003eResponsiveness\u003c/h2\u003e \u003cp\u003eIn patients reporting change (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;18), both instruments demonstrated strong responsiveness. The responsiveness ratio (RR) was 0.643 for PAVF-QoL-34 and 0.639 for the PAVF-QoL-14. Effect sizes (ES) were 0.71 and 0.77, respectively, indicating moderate responsiveness. Standardised response means (SRM) were 0.945 for PAVF-QoL-34 and 1.071 for PAVF-QoL-14, both exceeding 0.8 and indicating very good responsiveness.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec32\" class=\"Section2\"\u003e \u003ch2\u003eInterpretability (MIC)\u003c/h2\u003e \u003cp\u003eThe MIC was 6 points for the original PAVF-QoL and 3 points for the PAVF-QoL-14, representing the smallest patient-perceived change considered clinically meaningful.\u003c/p\u003e \u003cdiv id=\"Sec33\" class=\"Section3\"\u003e \u003ch2\u003ePAVF-QoL-14\u003c/h2\u003e \u003cp\u003eThe final PAVF-QoL questionnaire consisted of 14 items and has a Flesch reading ease score of 67.4 and a Flesch-Kincaid grade level of 7.6 (reading age 12\u0026ndash;14 years). The item reporting the impact of pain (PQOL 4) was modified to include discomfort in the wording as this reflects the scale of pain which could have varying degrees of impact on QoL. PQOL 10 wording was modified to reflect the burden of medication use to manage fistula. PQOL 24 includes \u0026lsquo;and/or ability to be intimate\u0026rsquo; to ensure it reflects variation in experience. Item level content validity index (I-CVI) was reassessed by experts in pouch fistula for PAVF-QoL-14 and all items were rated\u0026thinsp;\u0026gt;\u0026thinsp;0.80. Patients in the SMG agreed with the changes.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eWe have developed and validated a disease-specific PROM for pouch anal and vaginal fistula (PAVF-QoL-14) in accordance with COSMIN standards, addressing a longstanding measurement gap in pouch outcomes research. We derived items from qualitative interviews and the existing literature, and refined content through cognitive interviews and expert I-CVI assessment. Early and sustained patient involvement was central to the development of PAVF-QOL, a key methodological strength which ensures robust face and content validity and an instrument that reflects patient prioritised outcomes.\u003c/p\u003e \u003cp\u003eFour-domains were identified using factor analysis (KMO 0.905; Bartlett p\u0026thinsp;\u0026lt;\u0026thinsp;0.001) explaining 63.7% variance: symptoms, discharge, faecal incontinence, and future concerns. Stepwise regression reduced the 34-item draft to a user friendly 14-item tool without loss of measurement performance. Internal consistency remained excellent (α\u0026thinsp;=\u0026thinsp;0.920 vs 0.954), construct validity correlations with PDAI, HADS and SF-12 were preserved in magnitude and direction, and test\u0026ndash;retest reliability was robust (ICC 0.924\u0026ndash;0.943). Importantly, item retention decisions were not solely statistical: items with high patient relevance or clinical face validity were kept despite borderline statistics to maintain conceptual balance. The reduced form improved psychometric efficiency without sacrificing meaning. Responsiveness was acceptable to strong (RR\u0026thinsp;\u0026asymp;\u0026thinsp;0.64; ES 0.71\u0026ndash;0.77; SRM 0.95\u0026ndash;1.07), and anchor-based interpretability thresholds (MIC 6 points for the full scale; 3 points for the 14-item scale) provide an objective measure of clinical change.\u003c/p\u003e \u003cp\u003ePAVF-QoL-14 is a patient-centred tool designed to measure the multidimensional impact of pouch fistula and is concise for application in both clinical practice and research. It complements existing pouch function tools (e.g. IPSS) by isolating fistula-specific morbidity and its psychosocial impact, where symptoms from pouch function and fistula may otherwise be conflated(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). Prior pouch literature leans on generic PROMs or non-validated symptom checklists, limiting comparability and effect-size detection. PAVF-QoL- 14 advances the field by (i) focusing on fistula-specific lived burden, (ii) reporting transparent scoring and (iii) demonstrating responsiveness to clinical change.\u003c/p\u003e \u003cp\u003ePAVF-QoL-14 includes psychometric evaluation of structure, reliability, validity, responsiveness, and interpretability. The four domains of PAVF-QoL identified using exploratory principal factor analysis reflects the core outcomes established in the PAVF core outcome set \u0026ndash; pain related to fistula, global assessment of incontinence, fistula discharge, new fistula or abscess and need for rescue intervention(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). PAVF-QoL-14 is a suitable instrument for global quality of life assessment thus enabling COS implementation.\u003c/p\u003e \u003cp\u003eThere were limitations and challenges in validating a disease specific QoL scale in patients with pouch fistula. Patient recruitment proved challenging as anal and vaginal fistula are rare in the context of ileoanal pouch, occurring in 5% of an already small patient cohort. Although there is no set guidance on the number of patients required to validate a QoL scale, there is evidence that 5\u0026ndash;10 patient responses may be required per item to validate the item and ensure it accurately reflects impact on QoL(\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e, \u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e). The number of participants (n\u0026thinsp;=\u0026thinsp;76) in the test phase is sufficient to validate 14 items and KMO 0.905; Bartlett p\u0026thinsp;\u0026lt;\u0026thinsp;0.001 analysis suggests that there were adequate participants to perform psychometric analysis of the scale.\u003c/p\u003e \u003cp\u003ePatients were mostly recruited from a single-centre, tertiary service which may limit generalisability but conversely a sufficient cohort of patients with pouch fistula could only be found at a referral centre specialising in complex pouch complications, and this rare and complex problem should generally be managed in a such centres, with experience of pouch dysfunction and complex fistula. Test\u0026ndash;retest reliability was assessed with a 4\u0026ndash;6 week gap to minimise recall bias while acknowledging that some patients may change clinically over this interval, which can attenuate reliability estimates.\u003c/p\u003e"},{"header":"Future Direction","content":"\u003cp\u003eFuture work should include (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) multi-centre external validation of the scale with diverse pouch fistula aetiologies (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) test\u0026ndash;retest reliability and longitudinal responsiveness across treatment stages (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) complete cross-cultural adaptation and translation (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) assessment of PAVF-QoL-14 for inclusion in a pouch anal and vaginal fistula core outcome measurement set (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) embedding PAVF-QoL-14 in prospective trials to test real-world responsiveness and usability. PAVF-QOL \u0026ndash; 14 could be adapted for electronic administration, which may enable effortless, longitudinal outcome collection. Formal electronic format validation and usability testing will be important next steps for digital implementation.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003ePAVF-QoL-14 is a validated PROM specifically designed for pouch-related fistula, demonstrating strong psychometric properties. It is a concise, conceptually clear instrument that is suitable for use in both clinical monitoring and measurement of research outcomes future studies.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eCompeting interests:\u003c/h2\u003e \u003cp\u003eThe authors have no relevant financial or non-financial interests to disclose.\u003c/p\u003e \u003c/p\u003e\u003cp\u003e \u003ch2\u003eEthical approval:\u003c/h2\u003e \u003cp\u003e The study was granted ethical approval from the Wales Research Ethics Service (REC reference 20/WA/0308)\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eConsent to participate:\u003c/strong\u003e \u003cp\u003eWritten consent was taken from patients for qualitative interviews.\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eFunding:\u003c/h2\u003e \u003cp\u003ePAVF-QOL was funded by the Robin Phillips Fistula Research Unit at St Mark\u0026rsquo;s Hospital and Academic institute.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eAll authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Ms Lillian Reza, Professor Laith Alrubaiy, Dr Lara Bapir, Ms Nusrat Iqbal, Ms Charlene Sackitey and Mr Easan Anand. Clinical oversight and specialist input were contributed by Professor Laith Alrubaiy, Professor Ailsa Hart, Professor Sue Clark, Dr Pillip Lung, and Mr Phil Tozer. Nursing expertise and clinical pathway input were provided by Rali Marinova, Petya Marinova, and Pearl Avery. Patient perspective and co-design input were provided by Sally Hughes and Mina Babbar. The first draft of the manuscript was written by Ms Lillian Reza, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eWith thanks to Kirsty Morrison, Senior Information Specialist, Royal College of Surgeons of England Library and Archives Team. Study conception and dissemination was supported by the Ileostomy and Internal Pouch Association and the Red Lion Pouch Support Group at St Mark\u0026rsquo;s Hospital.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eAll data supporting the findings of this study are available within the paper and its Supplementary Information.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eParks, A. G., Nicholls, R. J., \u0026amp; Belliveau, P. Proctocolectomy with ileal reservoir and anal anastomosis. British Journal of Surgery [Internet]. 1980 Dec 7 [cited 2019 Sep 23];67(8):533\u0026ndash;8. 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Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://pubmed.ncbi.nlm.nih.gov/25518049/\u003c/span\u003e\u003cspan address=\"https://pubmed.ncbi.nlm.nih.gov/25518049/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNunnally, J. C. (1978). Psychometric Theory (2nd ed.). New York McGraw-Hill. - References - Scientific Research Publishing [Internet]. [cited 2025 Sep 26]. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.scirp.org/reference/ReferencesPapers?ReferenceID=1867797\u003c/span\u003e\u003cspan address=\"https://www.scirp.org/reference/ReferencesPapers?ReferenceID=1867797\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"quality-of-life-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"qure","sideBox":"Learn more about [Quality of Life Research](https://www.springer.com/journal/11136)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/qure/default.aspx","title":"Quality of Life Research","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Ileoanal pouch, Inflammatory bowel disease, Core outcome set, Patient reported outcomes","lastPublishedDoi":"10.21203/rs.3.rs-8500549/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8500549/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eIntroduction\u003c/h2\u003e \u003cp\u003ePerianal pouch fistula can significantly affect quality of life, yet no disease-specific patient reported outcome measure (PROM) exists. We have developed and validated a 14-item PROM - the Pouch Anal and Vaginal Fistula Quality of Life scale (PAVF-QoL-14).\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eCOnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidance for PROM development was used to develop and validate PAVF-QoL-14. A systematic literature review and semi-structured patient interviews (n\u0026thinsp;=\u0026thinsp;14) identified key domains. Cognitive interviews and item-level content validity index with experts refined the draft questionnaire. Psychometric evaluation included principal component analysis (PCA), internal consistency testing, and construct validity assessment against Hospital Anxiety and Depression Scale (HADS) and Short-Form 12 (SF-12). Test-rest analysis was performed on 76 patients.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eAn initial 34-item draft scale was generated and refined through cognitive interviews (n\u0026thinsp;=\u0026thinsp;10) and psychometric testing (n\u0026thinsp;=\u0026thinsp;76). Flesch readability score was 63%. Kaiser-Meyer-Olkin test confirmed sampling adequacy (KMO\u0026thinsp;=\u0026thinsp;0.905), and correlations between items were found significant using Bartlett\u0026rsquo;s test of sphericity (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Four domains (symptoms, discharge, faecal incontinence, and future concerns) were extracted, explaining 63.7% of the total variance. Following stepwise regression, a 14-item short-form was developed, demonstrating excellent internal consistency (Cronbach\u0026rsquo;s α\u0026thinsp;=\u0026thinsp;0.920). Responsiveness and stability were robust. Construct validity was excellent as PAVF-QoL-14 exhibited strong correlations with HADS (r\u0026thinsp;=\u0026thinsp;0.589, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001) and SF-12 (r\u0026thinsp;=\u0026thinsp;0.525, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001).\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003ePAVF-QoL-14 provides a concise, validated, and disease-specific measure of quality of life for pouch-related fistula, ready for use in clinical practice and trials.\u003c/p\u003e","manuscriptTitle":"Capturing quality of life in pouch anal and vaginal fistula: Development of PAVF-QoL-14, a patient-reported outcome measure","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-01-27 10:27:04","doi":"10.21203/rs.3.rs-8500549/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2026-05-02T02:32:10+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"155103814136956340497856730995041517715","date":"2026-04-28T07:00:15+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"210215875347662369737709694323695287296","date":"2026-04-21T12:46:02+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-01-22T08:18:24+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-01-02T18:21:14+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-01-02T18:20:10+00:00","index":"","fulltext":""},{"type":"submitted","content":"Quality of Life Research","date":"2026-01-02T11:26:59+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"quality-of-life-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"qure","sideBox":"Learn more about [Quality of Life Research](https://www.springer.com/journal/11136)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/qure/default.aspx","title":"Quality of Life Research","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"7a4e968e-942f-4956-af9c-69bfd86aa15c","owner":[],"postedDate":"January 27th, 2026","published":true,"recentEditorialEvents":[{"type":"editorInvitedReview","content":"","date":"2026-05-02T02:32:10+00:00","index":50,"fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-01-27T10:27:06+00:00","versionOfRecord":[],"versionCreatedAt":"2026-01-27 10:27:04","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8500549","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8500549","identity":"rs-8500549","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}