The Fertility Quality of Life (FertiQoL) tool: development and general psychometric properties.

Men and women experiencing fertility difficulties with and without medical experience were sampled from one fertility clinic each in Australia, Canada, New Zealand, and the United Kingdom and two clinics in the United States. Patient advocacy websites in these countries (i.e., Access, American Fertility Association, Resolve, Infertility Awareness Association of Canada, International Consumer Support for Infertility, Infertility Network UK) hosted the online survey. The clinical sample consisted of 291 women and 75 men, and the online sample consisted of 1,014 women and 34 men. The Ethics Committee of the School of Psychology, Cardiff University, approved the online study, and the Internal Review Board of each clinic approved the clinical studies. The Background Information Form covered sociodemographic status (e.g., age, education), medical history (e.g., current illness), and fertility-related characteristics (e.g., duration of infertility). The FertiQol items were designed to translate abstract concepts (e.g., commitment, sense of belonging) into quantitative items that collectively could indicate the impact of fertility problems on QoL. Full details of item generation for the prototype are described in the Supplemental Methods (available on line at www.fertstert.org ) and briefly presented here. As shown in Table 1 , item-generation involved four stages: generating potential items; eliminating redundant, irrelevant and outlier items; validation among people with fertility problems; and cross-cultural survey of acceptability and feasibility. A comprehensive literature review and consultation with psychosocial infertility experts generated an initial pool of 302 items on consequences of fertility problems on QoL in 14 areas (e.g., marriage/partnership, social network, emotions, cognitions, coping, treatment, physical health). The authors classified the 302 items into three levels of increasing concept specificity—dimensions (e.g., interpersonal), domains (e.g., partner relationship) and facets (e.g., intimacy)—to form groups of items tapping into related aspects of QoL. Classification and subsequent focus groups reduced this pool to 102 items, which were submitted to the acceptability and feasibility study ( Table 1 ). The prototype evaluated in the present study included these 102 core items and 27 optional treatment items identified through the feasibility and acceptability phase. Table 1 Steps in FertiQoL item generation, selection, and reduction carried out before this psychometric evaluation. Task and aim Participants Materials Outcome Literature review and expert consultation to generate potential items Psychosocial experts in reproductive health (n = 17) FertiQoL steering committee (n = 10) Groups included researchers, psychologists, social workers, counselors, patients, gynecologists, nurses, and clinicians in 11 countries: Australia, Canada, Denmark, France, Germany, Italy, New Zealand, Sweden, Switzerland, UK, USA Psychosocial studies Existing fertility-related tools Treatment evaluation tools QoL measures WHO development manual 302 items in 14 domains (e.g., partnership, self-esteem, career) Classification and reduction of item pool to eliminate redundant or irrelevant items or rare QoL effects FertiQoL technical working group (Boivin, Takefman, Braverman) and expert panel WHO selection criteria: items should be revealing of QoL, cover key domains, use simple language, ask about single issues, be free of ambiguity, etc. Item pool reduced to 116 items WHO response scales matched to items Focus groups with patients to validate the items generated by the experts and uncover any effects overlooked by the experts 17 focus groups (n = 136 participants): Canada, Germany, Mexico, USA, Italy a Purposive sampling for age (< or ≥35 years), gender, duration of infertility (< or ≥2 years) and parity (< or ≥1 child) Psychosocial experts facilitated open, unstructured discussion groups followed by structured feedback exercise on FertiQoL item pool; duration 1.5–2 h Structured interview guide (facilitators), workbooks (participants), and 116-item pool FertiQoL Item decrease from 116 to 102 (22 items eliminated and 8 added) based on > or <50% endorsement Added 18 treatment items; wording corrected; eliminated and/or combined redundant items; improved face validity; ensured items pertained to QoL and response scale appropriate Survey to assess acceptability and feasibility of FertiQoL item style in different languages n = 525 men and women in 10 countries: Argentina (n = 48), Brazil (n = 96), Canada (n = 59), France (n = 63), Germany (n = 37), Greece (n = 32), Italy (n = 47), Mexico (n = 46), New Zealand (n = 11), Spain (n = 43), UK (n = 79) and USA (n = 43) 102 Core FertiQoL + 27 optional Treatment items Additional items inquired about clarity, coverage, and problems with item pool Material translated by experts Final Core FertiQol pool for psychometric phase was 102 items + 27 optional Treatment items FertiQoL well accepted, perceived to be important and timely Items easy to understand and relevant FertiQoL completing in 15–20 minutes Main problems: items that did not apply to all people (e.g., single or untreated) and time frame for “instructions” required Note: FertiQoL technical working group involved in all aspects of project development. QoL = quality of life; WHO = World Health Organization. a Focus groups in Singapore canceled owing to the severe acute respiratory syndrome virus. Steps in FertiQoL item generation, selection, and reduction carried out before this psychometric evaluation. Note: FertiQoL technical working group involved in all aspects of project development. QoL = quality of life; WHO = World Health Organization. Focus groups in Singapore canceled owing to the severe acute respiratory syndrome virus. FertiQoL was produced in English and translated into 20 languages: Arabic, Chinese, Croatian, Danish, Dutch, English, Finnish, French, German, Greek, Hindi, Italian, Portuguese, Romanian, Russian, Serbian, Spanish, Swedish, Turkish, and Vietnamese (available online at www.fertiqol.org ). At the time of writing, Korean and Hungarian versions were in progress. Cardiff University professional translators carried out the first translation, and two local fertility experts reviewed it to ensure it was appropriate to local customs and fertility references. Cross-cultural data will be presented in a separate paper. The items in the prototype FertiQoL survey were randomly presented and rated on a scale of 0 to 4, where higher scores indicated more favorable QoL. The online survey (prototype FertiQoL and Background Information Form) was designed using SurveyTracker software (Training Technologies, 2008), and the paper version for clinic distribution was designed using InDesign. Webmasters were provided with a hyperlink to the survey. In clinics, FertiQoL coordinators at each site distributed the study pack to consecutive patients, who returned completed surveys anonymously in a marked collection box in the patient waiting room. Data were screened, and duplicate internet protocol (IP) addresses were eliminated unless of different gender and response pattern. Descriptive statistics and correlations were used to identify the best items for each a priori domain of QoL (e.g., emotional, mind/body, relational, social). This a priori work was done to ensure that conceptually similar groups of items were entered into the factor analysis. Factor analyses (orthogonal rotation) were computed (clinic, online) to ascertain relations among these items. Items with factor loadings <0.30 and eigenvalues <1 were eliminated. The FertiQoL total and subscale scores were computed and transformed to scaled scores and summary statistics (e.g., reliability coefficient, mean, SD) produced. Scaled scores were computed to achieve a range of 0 to 100, making comparisons between scales easier. For scaling, items were reverse scored where necessary and all items then summed and multiplied by 25/k, where k was the number of items in the desired subscale or total scale. Higher scores mean better QoL. For the sake of brevity, only final analyses are shown here. These analyses generated the final FertiQoL, which comprised 24 core items, plus 10 optional treatment items. The final FertiQoL in all languages and with scoring instructions is available online at www.fertiqol.org .

Table 2 shows background characteristics, and these show that the clinical group were older and included more men, single women, same-sex couples, and people with a university education, but fewer American and UK residents and people living in rural/suburban areas compared with the online sample. The clinical sample was more likely to have at least one child and a shorter duration of infertility, but less likely to have other health problems. Table 2 Demographic characteristics of the online and clinic samples. a Variable Online (n = 1,048) Clinic (n = 366) Test statistic (χ 2 or t ) Demographics  Age (y), mean (SD) 32.9 (4.9) 35.2 (4.0) 7.9 b  Women, % (n) 96.8 (1014) 79.5 (291) 113.4 b Relationship status, % (n) 49.4 b  Single .2 (3) 4.0 (13)  In stable relationship  Same-sex 1.7 (18) 6.2 (20)  Heterosexual 98.0 (1027) 89.8 (289) Duration of partnership (y), mean (SD) d 6.85 (3.9) 7.0 (3.9) .6 University education, % (n) 57.1 (598) 66.2 (139) 9.5 c Residence, % (n) 40.4 b  Urban 28.3 (296) 27.1 (95)  Suburban 55.8 (584) 69.5 (244)  Rural 15.9 (166) 3.4 (12) Country, % (n) 243.4 b  Australia/NZ 14.5 (152) 25.1 (92)  Canada 10.3 (108) 42.0 (154)  UK 8.7 (91) 2.7 (10)  USA 64.1 (672) 30.2 (111)  Other 2.4 (25) — Reproductive characteristics  Parenthood, % (n) 18.9 (197) 30.1 (108) 19.8 b  Years infertile, mean (SD) 3.4 (2.9) 2.9 (2.0) 2.4 c  Know why infertile, % (n) 75.4 (790) 70.3 (225) 3.3 Perceived diagnosis, % (n) 82.4 b  Unexplained 10.9 (86) 14.0 (38)  Female factor 44.5 (351) 18.0 (49)  Male factor 19.9 (157) 21.7 (59)  Mixed 11.9 (94) 14.7 (40)  Same-sex 1.6 (13) 3.3 (9)  Age-related 4.1 (32) 8.8 (24)  Other 7.1 (56) 19.5 (53) Other health problems, % (n) 30.8 (309) 24.0 (260) 5.8 c Years treated, mean (SD) 2.03 (2.4) 2.43 (1.8) 1.6 Note: 491 people did not provide data for years of treatment because of no treatment experience or missing data. a Sample size varies per variable. b P <.001. c P <.05. d For people in partnerships. Demographic characteristics of the online and clinic samples. a Note: 491 people did not provide data for years of treatment because of no treatment experience or missing data. Sample size varies per variable. P <.001. P <.05. For people in partnerships. Descriptive and inferential statistics were used to screen for problematic items. Items were deleted for several reasons (i.e., highly skewed distribution, high intercorrelations (>0.80 among item set, poor scale coherence, interpretive issues). Other items were deleted because they measured broad constructs (e.g., self-esteem) that could be better captured by measures designed for that purpose and that, if retained, would confound associations with those measures in future research. The final FertiQoL item set submitted for exploratory factor analysis comprised 24 items from the core set of items and 10 items from the optional treatment module. The 24 core items were conceptualized as reflecting QoL in the emotional, mind-body (i.e., cognitive and physical), relational, and social domains. The 10 optional treatment items were conceptualized as indexing treatment environment and treatment tolerability. An additional two items measuring satisfaction with QoL and physical health were retained for the FertiQoL measure to indicate general physical and QoL satisfaction, but they were not included in the factor analysis. Kaiser-Meyer-Olkin measures of sampling adequacy were >0.80, demonstrating sufficient intercorrelation among items to perform factor analyses. Table 3 presents factor loadings for the online and (in parentheses) clinical samples for the Core FertiQoL and optional Treatment module. The first factor explaining item variance in the Core FertiQoL was the Emotional subscale, explaining 31.8% (online) and 37.8% (clinic) of the item variability. Other factors (Mind/Body, Relational, Social) explained ≤10% of the item variance, but all eigenvalues were >1. Loadings showed that items conceptualized to tap into the same concepts all had high factor loadings (>0.30) on their designated factor. Cross-loadings were observed for items of the Mind/Body (i.e., concentration, life on hold) and Social domains (i.e., isolation, shame) onto the Emotional domains. For the optional Treatment module, the first factor was Treatment Environment, explaining 34.0% (online) and 38.0% (clinic) of item variance. There were no cross-loadings for the Treatment Quality and Treatment Tolerability subscales. Table 4 presents summary information for all FertiQoL scales. Core FertiQoL and Treatment FertiQoL were normally distributed, and individual subscales were normally distributed (data not shown), with only the relational subscale showing mild positive skew toward more favorable QoL in this domain. Table 3 Factor loadings for online and clinical (in parenthesis) samples on FertiQoL items. Core FertiQoL Optional FertiQoL Treatment module Emotional Relational Mind/Body Social Treatment Environment Treatment Tolerability Angry 0.752 (0.800) Grief/loss 0.763 (0.792) Sad/depressed 0.730 (0.772) Fluctuate hope/despair 0.643 (0.759) Jealousy and resentment 0.737 (0.634) Unable to cope 0.640 (0.594) Affectionate 0.749 (0.732) Difficult to talk 0.629 (0.696) Negative impact on relationship 0.707 (0.633) Content relationship 0.768 (0.616) Strengthen relationship 0.713 (0.603) Satisfied sexual relationship 0.575 (0.600) Fatigue 0.731 (0.745) Pain/discomfort 0.566 (0.663) Feel worn out b 0.620 (0.627) Disrupt activities 0.704 (0.625) Concentration (0.634) a 0.554 (0.413) Life on hold b (0.577) a 0.572 (0.355) Family understand 0.669 (0.669) Friend support 0.751 (0.649) Society expect 0.495 (0.446) Isolated (0.558) a 0.509 (0.531) Handle/pregnant others b 0.538 a (0.589) a 0.306 (0.350) Shame, embarrassment b 0.527 a (0.580) a 0.319 (0.440) Interactions with staff 0.813 (0.784) Quality treatment information 0.802 (0.784) Quality surgery and medical treatment 0.780 (0.763) Fertility staff understand us 0.728 (0.750) Quality emotional services 0.632 (0.664) Medical services desired available 0.576 (0.585) Bothered effect daily activities and work 0.799 (0.790) Bothered physical effects 0.792 (0.732) Complicated medication and procedures 0.645 (0.715) Treatment effects on mood 0.645 (0.681) Online eigenvalue (% variance) 7.62 (31.8) 2.61 (10.9) 1.44 (6.0) 1.16 (4.8) 3.48 (34.9) 1.92 (19.3) Clinical eigenvalue (% variance) 8.93 (37.8) 2.37 (9.9) 1.23 (5.1) 1.08 (4.5) 3.80 (38.0) 1.68 (16.8) Note: Some items reversed to avoid negative loadings. Only factor loadings >0.30 are shown. Factor loadings for Clinic sample in parentheses. Final FertiQoL item wording, response scale wording, and downloads in 20 languages are available at www.fertiqol.org . a Cross-loadings. b Wording for these items changed as a result of psychometric evaluation and participant feedback. Table 4 Means and standard deviations for FertiQoL subscales and total scaled scores for the validation sample (online and clinical combined). Scale n QoL domain No. of items Cronbach alpha Mean (SD) scaled score 0–100 Core subscales  Emotional 1,349 Impact on emotions (e.g., causes sadness, resentment, grief) 6 0.90 45.10 (23.2)  Mind-Body 1,338 Impact on physical health (e.g., fatigue, pain), cognition (e.g., poor concentration) and behavior (e.g., disrupted daily activities) 6 0.84 54.86 (21.2)  Relational 1,330 Impact on partnership (e.g., sexuality, communication, commitment) 6 0.80 68.70 (19.2)  Social 1,343 Impact on social aspects (e.g., social inclusion, expectations, support) 6 0.75 51.10 (20.6) Core FertiQoL 1,226 Overall core fertility quality of life 24 0.92 54.60 (16.8) Treatment subscales  Environment 1,072 Impacts related to treatment environment (e.g., access, quality, interactions with staff) 6 0.84 61.53 (19.6)  Treatment tolerability 1,093 Impacts due to consequences of treatment (e.g., physical and mode effects, daily disruptions) 4 0.72 58.81 (20.6) Treatment FertiQoL 1,043 Overall treatment quality of life 10 0.81 60.43 (16.2) Total FertiQoL 930 Overall fertility quality of life 34 0.92 55.43 (14.8) Note: All items reversed or scored so that higher scores indicate more favorable quality of life. Final FertiQoL item wording, response scale wording, and downloads in 20 languages are available at www.fertiqol.org . Factor loadings for online and clinical (in parenthesis) samples on FertiQoL items. Note: Some items reversed to avoid negative loadings. Only factor loadings >0.30 are shown. Factor loadings for Clinic sample in parentheses. Final FertiQoL item wording, response scale wording, and downloads in 20 languages are available at www.fertiqol.org . Cross-loadings. Wording for these items changed as a result of psychometric evaluation and participant feedback. Means and standard deviations for FertiQoL subscales and total scaled scores for the validation sample (online and clinical combined). Note: All items reversed or scored so that higher scores indicate more favorable quality of life. Final FertiQoL item wording, response scale wording, and downloads in 20 languages are available at www.fertiqol.org . Potential moderators of QoL (gender, parenthood status, and recruitment source) were examined in relation to FertiQoL scores. Women had a significantly lower Core FertiQoL (mean 53.3, SD 16.2) than did men (mean 72.1, SD 14.7; t (1,224) = 10.3; P <.001). Core FertiQoL was significantly lower for participants without children (mean 53.3, SD 16.3) than for participants with children (mean 59.5, SD 17.7; t (1,217) = 5.27; P <.001). Participants recruited from the online patient advocacy and support sites had significantly lower scores (mean 50.7, SD 15.1) than participants recruited from clinics (mean 67.8, SD 15.6; t (1,224) = 16.6; P <.001). The relationship between Treatment subscales and six treatment persistence items (e.g., likelihood of trying further treatment, couple agreeing to persist, thinking of ending treatment) was also examined. Greater intention to persist with treatment was significantly associated with better Treatment FertiQoL ( r (1,026) = 0.172; P <.001), especially in the clinical sample ( r (206) = 0.289; P <.001).

It is currently accepted that to effectively measure the impact of disease, one needs a disease-specific instrument (1) . FertiQol is a reliable and sensitive measurement tool for QoL in individuals with fertility problems. More than 2,000 people with fertility problems contributed to the creation of FertiQoL, and it was developed by using an integrated mixed-methods approach that included literature reviews, international expert consultations, patient focus groups, a cross-cultural feasibility and acceptability survey, and a psychometric survey evaluation. FertiQoL comprises a Core module evaluating the impact of fertility problems on emotional, mind-body, relational, and social domains, and an optional treatment module evaluating treatment environment and tolerability. Subscales and total scales show mainly high reliability and sensitivity of FertiQoL to well established moderators of QoL. FertiQoL is available in 20 languages with more translations in progress. This project was fully realized as a result of collaboration among ESHRE, ASRM, and Merck, Geneva, Switzerland (an affiliate of Merck, Darmstadt, Germany). It is expected that FertiQoL will significantly contribute to future research and clinical endeavors aimed at investigating and ultimately improving quality of life in people with fertility problems. Certain methodologic limitations need to be taken into account. First, despite the multidisciplinary contributions from experts worldwide, focus groups, and a feasibility and acceptability study in 10 countries, the final psychometric evaluation occurred in only five English-speaking countries. Second, targeted efforts to recruit a diverse group of people were not entirely successful for particular subgroups (namely, secondary infertility, men). Indeed, more psychometric research on men is required to fully establish reliability and validity. Third, the major proportion of the final sample was recruited online, and differences between the online and clinical samples were observed. Although data generated online has been shown to be as valid as data collected through traditional methods 15 , 16 , one would need to determine whether the differences observed warrant more in-depth analysis, for example, a different set of norms for clinical samples. We eliminated records coming from the same IP address, but it may be possible that the same person replied more than once to the survey. Finally, the subscales of the Core FertiQoL were not entirely orthogonal with cross-loadings on the social and mind/body domains. Because these associations were expected, we have now modified the final wording of four FertiQoL items to reduce these cross-loadings. Further evaluation of these changes and FertiQoL as a whole on a new sample is required for final validation. These main limitations should be addressed in future psychometric research evaluating FertiQoL. However, the strengths of our mixed-methods approach and consultation with and evaluation from infertile people ensures that FertiQoL captures the key life domains affected by fertility problems. It is hoped that FertiQoL will become a gold standard for the measurement of QoL for individuals experiencing fertility problems, whether in treatment or not. FertiQol will be useful to clinicians and researchers alike. FertiQoL can be used to identify people at risk of impaired QoL so that psychosocial resources can be offered and subscale scores could identify the specific domains where intervention might be most beneficial. Recent research has shown a close correspondence between Core FertiQoL and standardized measures of anxiety and depression in a Dutch sample (17) . The availability of FertiQoL in 20 languages will facilitate essential cross-cultural research particularly in developing nations 18 , 19 . However, whether cross-cultural differences exist, whether different populations have different mean scores, and whether separate cultural norms are needed are all important questions that need to be addressed in future research. A unique aspect of FertiQoL compared with other QoL measures is the optional 10-item treatment module. This module measures QoL in terms of treatment quality (interactions with staff, quality of information) and treatment tolerability (effects on mood, disruptions daily life). These subscales can be used to assess effectiveness of new treatments/medications, to monitor quality of services, and to optimize patient treatment experiences. Research has shown that quality of treatment and its tolerability are predictors of treatment satisfaction (7) and willingness to persist with treatment (20) , the latter also shown in the present study. Furthermore, a recent large multicenter study showed a strong association between a high level of patient-centered care and favorable FertiQoL scores (21) . However, the sensitivity of Treatment FertiQoL for these purposes needs to be investigated in clinical trials of new interventions. In conclusion, the overall aim of the FertiQoL project was to develop an international instrument to measure QoL in men and women experiencing fertility problems, with the collaboration of individuals experiencing fertility problems and international experts in the field. This objective was accomplished, and future use of FertiQoL will be essential to establish FertiQoL as an essential measurement tool for practice, research, health service evaluation, and policy making.