Cross-cultural adaptation of the Pelvic Floor Dysfunction SENTINEL screening tool for German-speaking female athletes

Cross-cultural adaptation of the Pelvic Floor Dysfunction SENTINEL screening tool for German-speaking female athletes | 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 Cross-cultural adaptation of the Pelvic Floor Dysfunction SENTINEL screening tool for German-speaking female athletes Nina Albers, Markus Huebner, Silvia Giagio, Andrea Turolla, Paolo Pillastrini, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3982539/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Introduction: Pelvic floor dysfunction (PFD), such as urinary or fecal incontinence or pelvic organ prolapse, is a common medical condition with increasing awareness in female athletes since they suffer more frequently from PFD than non-athletes. For female athletes PFD can be very disabling and stressful and may even lead to withdrawal from sport. Recently, a screening tool for PFD in female athletes was introduced (PFD-SENTINEL screening tool). In this study, we aimed to translate and culturally adapt the PFD-SENTINEL screening tool into German. Methods: Following an international guideline, forward and backtranslations of the screening tool were conducted throughout six progressive phases. A pre-final version of the PFD-SENTINEL screening tool for the German language was tested in a cohort of 27 potential users. Subsequently, a final version was adjusted and presented. Results: Twenty-two of the 27 potential users were female athletes (median age 24 years). Five of the potential users were healthcare professionals (median age 28 years). None of the participants had difficulties understanding the questionnaire, either linguistically or in terms of content. The final version was approved by the original developers. Conclusions: The PFD-SENTINEL screening tool holds promise to prompt specialist care and assessment, detecting potential PFD and helping to estimate the related prevalence in female athletes. Its successful translation and adaptation to the German language allows for future testing of its psychometric properties and application in German-speaking regions. Athlete Pelvic Floor Disorders Pelvic Organ Prolapse Questionnaire Screening Sports Medicine Urinary Incontinence Women Figures Figure 1 1. Introduction Pelvic floor dysfunction (PFD), such as urinary or fecal incontinence and pelvic organ prolapse, affect up to one third of women in the general population [ 1 , 2 ]. Parity, age and overweight are known to be risk factors for these conditions [ 3 , 4 ]. The most common PFD, stress urinary incontinence (SUI), shows a high prevalence not only among older women, but also among young nulliparous women [ 5 ]. Especially athletes are more frequently affected by this condition compared to non-athletes [ 6 – 8 ]. The prevalence is particularly high in medium- and high-impact sports, such as volleyball, soccer, gymnastics or running. In trampoline athletes (high-impact), approximately 80% of athletes were estimated to be affected [ 9 , 10 ]. Moreover, athletes in this domain often experience pelvic organ prolapse or anal incontinence at comparably young ages [ 11 ]. PFD are often considered a taboo subject, and many athletes lack knowledge about their pelvic floor [ 12 , 13 ]. The current lack of awareness in sports medicine further predisposes athletes for accepting and downplaying PFD. Beyond that, validated screening methods to timely identify risk factors for PFD, or even prevalent PFD, in order to refer athletes to specialists have not been established [ 14 , 15 ]. This leads to the underdiagnosis of PFD, worsening of symptoms, performance decline, and even withdrawal from sports [ 16 , 17 ]. Moreover, healthcare professionals specialized in PFD are scarce. Various questionnaires for PFD in the general population already exist [ 18 – 21 ]. However, there are currently no common screening tools or questionnaires specifically for PFD in athletes. The recently published PFD screening tool by Giagio et al. (PFD-SENTINEL) aims to fill this gap and better screen for pelvic floor dysfunction in athletes [ 22 ]. The original version was published in English and currently, a German version does not exist. The aim of this work was to conduct the translation and cross-cultural adaptation of the PFD-SENTINEL screening tool for the German language. 2. Materials and Methods 2.1. Study design The cross-cultural adaptation of the PFD-SENTINEL screening tool was carried out according to the international guideline by Beaton et al. [ 23 ]. The Ethics Committee of the Medical Center - University of Freiburg, Freiburg, Germany, approved the project (23-1225-S1). 2.1.1. Procedure description for the translation and cross-cultural adaption According to the guideline by Beaton et al. [ 23 ], the process of translation and cross-cultural adaptation was carried out in six consecutive phases as described below: Independent translation of the original questionnaire from English to German by two German-speaking translators. One translator was a physiotherapist, and the other was a physician. Comparison of the two translations in a consensus meeting were held to create a unified translation. All initial discrepancies were documented. The two translators and a linguistically proficient physician participated in this process. The consensus translation, along with both independent translations, was documented in an Excel table. Back-translation of the questionnaire into English was carried out by two English native speakers without a medical background. Both English native speakers were proficient in the German language. The back translation was conducted in a blinded manner compared to the original English version. The prefinal version of the PDF-SENTINEL screening tool for German-speaking athletes was established in an expert committee consensus meeting. A translation that reflects equivalence to the English version was collectively formulated during this meeting. The five-member expert committee consisted of the four translators and a physician who chaired the meeting. Testing of the prefinal version was conducted on a pilot sample of 22 female athletes and 5 potential users. All participants gave written informed consent. Each participant received the prefinal questionnaire and a comprehension questionnaire. The aim was to assess whether the translated and culturally adapted questionnaire was comprehensible and applicable in a real-world context within the target population. Based on the pre-testing results and approval from the expert committee, a final version of the questionnaire was created. Detailed written documentation was provided for all steps of the translation and cultural adaptation process. These protocols can be provided upon request. The workflow is illustrated in Fig. 1 . 2.2. The PFD-SENTINEL screening tool The screening tool consists of two pages. The first page provides general information about the tool, its usage instructions, and an explanation of the algorithm. The second page is a checklist divided into two sections. The first section specifically inquires about 5 symptoms that indicate PFD. The second section is divided into 20 items and 8 sport-related characteristics, thus assessing general and sport-specific risk factors. If a symptom and/or item are present and satisfied, a checkmark is placed in the corresponding box. The screening tool was developed to be used by a healthcare specialist (physician, physiotherapist) and not as a patient-reported outcome measure (PROM). With the use of the screening tools algorithm, the healthcare specialist who screened the athlete gets instructions on how to further proceed, depending on the estimated score. Score A: If at least one symptom was checked in the "Symptoms" section, a direct referral to a specialist in PFD should be made. If no checkmark is set (no symptom is present in the first "Symptoms" section), the symptom score is 0, and the screening continues to the second section for general and sport-related risk factors. Score B: If the total score is 14 or higher, the female athlete should be referred to a specialist in PFD. Score C: If the total score is below 14 points, monitoring of the athlete's general health status in a multidisciplinary team is recommended. Regular application and reevaluation with the use of the screening tool is advised, especially during the season preparation or if a mandatory break is required, particularly due to pelvic floor complaints. Further investigations are recommended for returning to sport postpartum and for parasport athletes. 2.3. Inclusion and exclusion criteria for athletes and potential users The pre-final version of the PFD-SENTINEL screening tool underwent testing among both female athletes and potential users. Participant recruitment took place within sports clubs in Freiburg, a university town in southwestern Germany, contributing to the notable presence of students in the participant cohort. To qualify as an athlete for participation, individuals had to meet the following criteria: The participant had to be 18 years of age or older. Sex: Female. Active athlete (defined as regular participation in competitions or membership in a sports club). A written informed consent was provided. Moreover, the Screening Tool was distributed among potential users who were instructed to review it as if they would apply it to an athlete. The criteria for being considered a potential user of the PFD-SENTINEL were as follows: The participant had to be 18 years of age or older. Occupational qualification in one of the specified application areas (e.g. physician or physiotherapist) A written informed consent was provided. 2.4. Sample size calculation The sample size chosen for evaluating the prefinal version of the instrument adhered to the guidelines for the cultural adaptation and validation of questionnaires and PROMs, recommending the inclusion of 20–30 participants in the testing process [ 23 ]. 3. Results 3.1. Translation and cross-cultural adaptation During the translation and cultural adaptation process, no major difficulties were encountered. Care was taken to maintain the original structure, including the four sections of the questionnaire: "Main information about the Tool", "The Tool Algorithm", "Instructions", and "Items." This ensured that the applicability and purpose of the questionnaire were preserved. Minor linguistic inconsistencies arose during the forward and backward translation, mainly concerning unspecific wording. However, these were resolved through group discussions during the consensus meetings. The characteristics of the German language were taken into consideration, including the need for gender-specific terms such as "Athletinnen" (female athletes). Inclusive language, such as "Athlet:innen," was chosen. The cultural adaptation to the German-speaking context was straightforward, requiring only minor linguistic and cultural adjustments. The English term "prevalence" was paraphrased due to the infrequent use of the German word "Prävalenz" in everyday language. Similarly, the English term "bulge" was paraphrased as "vaginalen Druck- oder Fremdkörpergefühl" (vaginal pressure or foreign body sensation) as there is no adequate translation commonly used in the German-speaking context. The term "constipation" was translated as "Verstopfungen" to ensure general understanding. Expressions such as "to whom it applies" were summarized as "Zielgruppe" in the German translation. The term "national ranking list" used in the Anglo-American context was translated into "Kaderathlet:innen" in German as the concept of a national ranking list is not commonly practiced in Germany. 3.2 Testing of the prefinal version Using a questionnaire, both athletes and potential users were asked about their comprehension of the language and understanding of the application of the screening tool. The questionnaire was segmented into four sections: "General Information about the screening tool," "Algorithm of the screening tool," "Symptoms," and "Items." Participants were asked for feedback on each section, inquiring whether they comprehended everything or encountered any unclear terms or questions. A total of 27 participants were included. Of 22 female athletes, 21 athletes were participating in medium- and high-impact sports (triathlon, soccer, running, volleyball). One participant was a swimmer. The median age of the screened athletes was 24 years old (Interquartile range [22,27]). Further descriptive data on the sample of female athletes are presented in Table 1 . Table 1 Characteristics of the female athletes Variables Female Athletes n 22 Age (in years) 24 (22;27) BMI (kg/m 2 ) 20,2 (19,3;21,0) Sports Running Triathlon Sprint Volleyball Soccer Tennis Swimming Road cycling Hockey 7 (31,82%) 5 (22,73%) 1 (4,55%) 1 (4,55%) 3 (13,64%) 2 (9,09%) 1 (4,55%) 1 (4,55%) 1 (4,55%) Years of training 6,5 (5;10) Sessions / week 5,5 (4;7) Hours / session 2 (2, 2,75) Highest educational attainment State examination/Master/Diploma Bachelor / Physicum Apprenticeship Abitur or equal qualification 7 (31,82%) 6 (27,27%) 1 (4,55%) 8 (36,36%) Profession Student 12 (54,55%) Medical doctor 3 (13,64%) Engineer 1 (4,55%) Physiotherapist 1 (4,55%) Sports Scientist 1 (4,55%) Police Officer 1 (4,55%) Pharmacist 1 (4,55%) Event manager 1 (4,55%) PhD 1 (4,55%) Working hours/week 38 (20;40) Continuous variables are presented as median (quartile 1; quartile 3). Nominal variables are shown as frequencies (%). The prefinal version was also presented to five potential users. Descriptive data of the five potential users to whom the screening tool was presented are presented in Table 2 . Table 2 Characteristics of the potential users Variables Potential users n 5 Age (in years) 28 (27;33) Sex Female Male 3 (60%) 2 (40%) Profession Medical doctor 4 (80%) Physiotherapist 1 (20%) Specialisation Gynaecology Cardiology Sport Physiotherapist 3 (60%) 1 (20%) 1 (20%) Working years 2 (1;3) Continuous variables are presented as median (quartile 1; quartile 3). Nominal variables are shown as frequencies (%). All 27 participants reported no issues with comprehension, affirming their understanding of all questions and terms. Based on these findings, it was determined that no revisions of the pre-final version of the PFD-SENTINEL screening tool were necessary. Consequently, the prefinal version was officially designated as the final version for the German language. Thereafter the final version of the screening tool together with all documentation of the process were sent to the authors of the original version for approval. In a consensus meeting minor adaptions, which had been suggested by the developers of the original English version of the screening tool during the approval process, were made. “Fitnessstufe” was changed to “Leistungsniveau” in the German version of the PFD-SENTINEL screening tool. The corrected final version and documentation have been resent to the authors of the original version. The final German version and documents were checked again and approved. It is essential to note that the PFD-SENTINEL screening tool is not intended as a "patient-reported outcome" to be completed independently by the athlete. Instead, it serves as a screening tool to be administered by experts in the fields of sports medicine, physiotherapy, or gynecology. 4. Discussion This study is the first standardized approach to translate and culturally adapt the Pelvic Floor Dysfunction (PFD-SENTINEL) screening tool for female athletes, developed by Giagio et al., into another language [ 22 ]. This work will provide sports medicine professionals, gynecologists, and physiotherapists in Germany a tool to screen female athletes for the presence of PFD, facilitating timely referrals to urogynecology specialists. By using the methodology proposed in the international guideline by Beaton et al. [ 23 ] we applied a strict translation protocol without altering content or clarity of the PFD-SENTINEL screening tool. The sample size of 27 participants fulfills the recommendation in the guideline for translation and cultural adaption of instruments. The testing of the pre-final version did not reveal any linguistic ambiguities or comprehension issues. Our results demonstrate that the German version of the PFD-SENTINEL screening tool is comprehensible to all users (health care professionals and female athletes) and ready to be used in the field. Added value The translated version of the PFD screening tool is the first PFD screening tool specifically designed for female athletes in German language. Various studies have indicated the need to consider different sports-specific symptoms and features of athletes [ 7 , 9 – 11 , 24 ]. Until now, in the German-speaking region, the German Pelvic Floor Questionnaire was frequently used for urogynecological conditions in the general population [ 19 ]. It was designed for evaluation of symptoms and their effects on quality of life and therefore focused on typical symptoms of PFD, rather than assessing a woman’s clinical and sports-specific (e.g., impact, training volume, etc.) characteristics. Beyond that, other urogynecology questionnaires, such as Kings Health Questionnaire and International Consultation on Incontinence Modular Questionnaire (ICIQ) were neither designed nor evaluated for the assessment of pelvic floor dysfunction in athletes [ 18 , 21 ]. The unique approach of the PFD-SENTINEL screening tool is that it was designed to be applied by health care professionals, as opposed to the self-reported design of the German Pelvic Floor Questionnaire. The fact that the tool was designed to be applied by an health care professional poses the risk of response bias. Athletes may not consistently disclose the full range of their symptoms, since pelvic floor dysfunctions still carry a considerable stigma [ 25 ]. In the future, a critical comparison with the German Pelvic Floor Questionnaire is needed to evaluate a potential benefit of the PFD-SENTINEL screening tool in assessing and managing PFD in female athletes. This quality criteria assessment is integral to ensuring the reliability, concurrent validity, and relevance of the tool in the specific context of athletes. In the future, a nuanced adjustment of terminology is suggested, with the potential replacement of ‘pelvic surgery’ (Becken Operationen) with the more precise term ‘pelvic floor surgery’ (Beckenboden Operationen) or surgery within the small pelvis (Operationen innerhalb des kleinen Beckens). Moreover, it is crucial to note substantial differences in meaning when referring to a pelvic surgery, a pelvic floor surgery, or a surgery within the small pelvis. A more precise clarification of the term ‘pelvic surgery’ (Becken Operation) would be advantageous in a subsequent version. Further, deliveries are currently assessed without accounting for the number of gestations or births, and individual items in the PFD-SENTINEL screening tool have different impact on score calculation. However, whereas of superior relevance for subsequent validation studies, evaluation of this risk stratification approach was beyond the scope of the present study. Limitations This study has several limitations that need careful consideration in interpreting the results. Most prominently, the mandate for strict translation without substantial content alterations limited the study's ability to refine specific aspects of the PFD SENTINEL screening tool. Moreover, the educational background of the participants, primarily comprising athletes with higher educational levels, is due to the recruitment setting within a university environment. However, this should not impact applicability, given that the screening tool is designed to be administered by doctors and physiotherapists, together with their athletes, who will not use the screening tool without the help of medical professionals. Nevertheless, a subsequent validation study needs to address a broader population of athletes to allow for rigorous extrapolations. Conclusion In summary, the PFD-SENTINEL screening tool has the potential to drive significant advances in screening female athletes for pelvic floor dysfunctions. Successful translation of this tool and cultural adaptation into German paved the way for future validation and application of the PFD-SENTINEL screening tool in the German-speaking area. Declarations Acknowledgments The authors would like to thank Linda Detering and Nicholas Dunham for having participated in the forward and backward translations and having taking part in the consensus meetings. Ethics approval and consent to participate This study was performed in line with the principles of the Declaration of Helsinki. The Ethics Committee of the Medical Center - University of Freiburg, Freiburg, Germany, approved the project (23-1225-S1). All female athletes who were screened in this study and all potential users who were asked to apply the screening tool were informed about the study and gave written informed consent prior to participate. Consent for publication: Not applicable Availability of data and materials The datasets used and analysed during the current study available from the corresponding author on reasonable request . Competing interests : Each author certifies that he or she has no commercial associations (such as consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article. None of the authors received any funding or financial support in connection to this work. Funding: The authors declare that no funds, grands, or other support were received in connection with this project. Authors contributions: Albers: Ethics Committee approval, data collection, data management, data analysis, manuscript writing and editing Giagio: manuscript editing Turolla: manuscript editing Pillastrini: manuscript editing Stein-Brueggemann: other (supervision) Rudolph: other (translation) Juhasz-Boess: others (supervision) Huebner: Ethics Committee approval, manuscript editing, other (supervision) Hollander: Project development, manuscript editing, other (supervision) Marques: Project development, Ethics Committee approval, manuscript writing and editing, others (supervision) References Islam RM, Oldroyd J, Rana J, et al. Prevalence of symptomatic pelvic floor disorders in community-dwelling women in low and middle-income countries: a systematic review and meta-analysis. Int Urogynecol J. 2019;30:2001–11. 10.1007/s00192-019-03992-z . Kenne KA, Wendt L, Brooks Jackson J. 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Supplementary Files Appendix1PFDSENTINELStage4BMC.xlsx Appendix2PFDSENTINELprefinalv2.pdf Appendix3PFDSentinelPhaseIBMC.xlsx Appendix4PFDSentinelusersPhaseIBMC.xlsx Appendix5PFDSENTINELFragebogendeutschfinal.pdf Cite Share Download PDF Status: Posted Version 1 posted 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. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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University of Freiburg","correspondingAuthor":false,"prefix":"","firstName":"Ingolf","middleName":"","lastName":"Juhasz-Boess","suffix":""},{"id":276563888,"identity":"c7406d97-304f-4884-af2a-dea0aecce1f7","order_by":8,"name":"Karsten Hollander","email":"","orcid":"","institution":"MSH Medical School Hamburg, University of Applied Sciences and Medical University","correspondingAuthor":false,"prefix":"","firstName":"Karsten","middleName":"","lastName":"Hollander","suffix":""},{"id":276563892,"identity":"f3ec263d-69fb-479e-8149-b260670f794a","order_by":9,"name":"Carlos Marques","email":"","orcid":"","institution":"MSH Medical School Hamburg, University of Applied Sciences and Medical University","correspondingAuthor":false,"prefix":"","firstName":"Carlos","middleName":"","lastName":"Marques","suffix":""}],"badges":[],"createdAt":"2024-02-23 16:47:03","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3982539/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3982539/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":52301103,"identity":"ed50ce42-35e2-4611-bdf4-150efc5c08ec","added_by":"auto","created_at":"2024-03-08 18:37:25","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":215914,"visible":true,"origin":"","legend":"\u003cp\u003eWorkflow with the different phases of the project and respective timeline\u003c/p\u003e","description":"","filename":"WorkflowPFDSENTINELPhaseIBMC.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3982539/v1/6f5ba3cc6ad9c6aa10fe734a.jpg"},{"id":70737710,"identity":"106e2dda-56d8-4bec-b6f3-90215ea8d3a0","added_by":"auto","created_at":"2024-12-06 07:03:07","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":724082,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3982539/v1/922b6270-287a-4e57-816e-8aa1dbabe244.pdf"},{"id":52301104,"identity":"46c54273-d726-41eb-9eb6-4c158e29b493","added_by":"auto","created_at":"2024-03-08 18:37:26","extension":"xlsx","order_by":5,"title":"","display":"","copyAsset":false,"role":"supplement","size":194038,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix1PFDSENTINELStage4BMC.xlsx","url":"https://assets-eu.researchsquare.com/files/rs-3982539/v1/ad1124e1dc4d127bb90fcd97.xlsx"},{"id":52302223,"identity":"48e30cdc-957f-432f-af25-5b3c6a2a069e","added_by":"auto","created_at":"2024-03-08 18:45:26","extension":"pdf","order_by":6,"title":"","display":"","copyAsset":false,"role":"supplement","size":402815,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix2PFDSENTINELprefinalv2.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3982539/v1/99ea6ca05efc2a7653e41f28.pdf"},{"id":52301105,"identity":"caa7baf3-eb0a-4fde-9c2a-dc48fbeaadb0","added_by":"auto","created_at":"2024-03-08 18:37:26","extension":"xlsx","order_by":7,"title":"","display":"","copyAsset":false,"role":"supplement","size":25801,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix3PFDSentinelPhaseIBMC.xlsx","url":"https://assets-eu.researchsquare.com/files/rs-3982539/v1/69d25856ed08ccbeeaeff352.xlsx"},{"id":52301107,"identity":"116afa5c-0250-4616-8772-91146e55d61a","added_by":"auto","created_at":"2024-03-08 18:37:26","extension":"xlsx","order_by":8,"title":"","display":"","copyAsset":false,"role":"supplement","size":10285,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix4PFDSentinelusersPhaseIBMC.xlsx","url":"https://assets-eu.researchsquare.com/files/rs-3982539/v1/797711634068935e4b41d671.xlsx"},{"id":52301109,"identity":"36b0c89b-bff2-43c2-bb05-1e31f53f1c69","added_by":"auto","created_at":"2024-03-08 18:37:26","extension":"pdf","order_by":9,"title":"","display":"","copyAsset":false,"role":"supplement","size":428939,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix5PFDSENTINELFragebogendeutschfinal.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3982539/v1/920b14724d381aaae48f2eca.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Cross-cultural adaptation of the Pelvic Floor Dysfunction SENTINEL screening tool for German-speaking female athletes","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003ePelvic floor dysfunction (PFD), such as urinary or fecal incontinence and pelvic organ prolapse, affect up to one third of women in the general population [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Parity, age and overweight are known to be risk factors for these conditions [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. The most common PFD, stress urinary incontinence (SUI), shows a high prevalence not only among older women, but also among young nulliparous women [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Especially athletes are more frequently affected by this condition compared to non-athletes [\u003cspan additionalcitationids=\"CR7\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. The prevalence is particularly high in medium- and high-impact sports, such as volleyball, soccer, gymnastics or running. In trampoline athletes (high-impact), approximately 80% of athletes were estimated to be affected [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Moreover, athletes in this domain often experience pelvic organ prolapse or anal incontinence at comparably young ages [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e \u003cp\u003ePFD are often considered a taboo subject, and many athletes lack knowledge about their pelvic floor [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. The current lack of awareness in sports medicine further predisposes athletes for accepting and downplaying PFD. Beyond that, validated screening methods to timely identify risk factors for PFD, or even prevalent PFD, in order to refer athletes to specialists have not been established [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. This leads to the underdiagnosis of PFD, worsening of symptoms, performance decline, and even withdrawal from sports [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Moreover, healthcare professionals specialized in PFD are scarce.\u003c/p\u003e \u003cp\u003eVarious questionnaires for PFD in the general population already exist [\u003cspan additionalcitationids=\"CR19 CR20\" citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. However, there are currently no common screening tools or questionnaires specifically for PFD in athletes. The recently published PFD screening tool by Giagio et al. (PFD-SENTINEL) aims to fill this gap and better screen for pelvic floor dysfunction in athletes [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. The original version was published in English and currently, a German version does not exist. The aim of this work was to conduct the translation and cross-cultural adaptation of the PFD-SENTINEL screening tool for the German language.\u003c/p\u003e"},{"header":"2. Materials and Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003e2.1. Study design\u003c/h2\u003e \u003cp\u003e The cross-cultural adaptation of the PFD-SENTINEL screening tool was carried out according to the international guideline by Beaton et al. [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. The Ethics Committee of the Medical Center - University of Freiburg, Freiburg, Germany, approved the project (23-1225-S1).\u003c/p\u003e \u003cdiv id=\"Sec4\" class=\"Section3\"\u003e \u003ch2\u003e2.1.1. Procedure description for the translation and cross-cultural adaption\u003c/h2\u003e \u003cp\u003e According to the guideline by Beaton et al. [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e], the process of translation and cross-cultural adaptation was carried out in six consecutive phases as described below:\u003c/p\u003e \u003cp\u003e\u003col\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eIndependent translation of the original questionnaire from English to German by two German-speaking translators. One translator was a physiotherapist, and the other was a physician.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eComparison of the two translations in a consensus meeting were held to create a unified translation. All initial discrepancies were documented. The two translators and a linguistically proficient physician participated in this process. The consensus translation, along with both independent translations, was documented in an Excel table.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eBack-translation of the questionnaire into English was carried out by two English native speakers without a medical background. Both English native speakers were proficient in the German language. The back translation was conducted in a blinded manner compared to the original English version.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e The prefinal version of the PDF-SENTINEL screening tool for German-speaking athletes was established in an expert committee consensus meeting. A translation that reflects equivalence to the English version was collectively formulated during this meeting. The five-member expert committee consisted of the four translators and a physician who chaired the meeting.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eTesting of the prefinal version was conducted on a pilot sample of 22 female athletes and 5 potential users. All participants gave written informed consent. Each participant received the prefinal questionnaire and a comprehension questionnaire. The aim was to assess whether the translated and culturally adapted questionnaire was comprehensible and applicable in a real-world context within the target population.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eBased on the pre-testing results and approval from the expert committee, a final version of the questionnaire was created.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003c/ol\u003e\u003c/p\u003e \u003cp\u003eDetailed written documentation was provided for all steps of the translation and cultural adaptation process. These protocols can be provided upon request. The workflow is illustrated in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003e2.2. The PFD-SENTINEL screening tool\u003c/h2\u003e \u003cp\u003eThe screening tool consists of two pages. The first page provides general information about the tool, its usage instructions, and an explanation of the algorithm. The second page is a checklist divided into two sections. The first section specifically inquires about 5 symptoms that indicate PFD. The second section is divided into 20 items and 8 sport-related characteristics, thus assessing general and sport-specific risk factors. If a symptom and/or item are present and satisfied, a checkmark is placed in the corresponding box.\u003c/p\u003e \u003cp\u003eThe screening tool was developed to be used by a healthcare specialist (physician, physiotherapist) and not as a patient-reported outcome measure (PROM). With the use of the screening tools algorithm, the healthcare specialist who screened the athlete gets instructions on how to further proceed, depending on the estimated score.\u003c/p\u003e \u003cp\u003eScore A: If at least one symptom was checked in the \"Symptoms\" section, a direct referral to a specialist in PFD should be made. If no checkmark is set (no symptom is present in the first \"Symptoms\" section), the symptom score is 0, and the screening continues to the second section for general and sport-related risk factors.\u003c/p\u003e \u003cp\u003eScore B: If the total score is 14 or higher, the female athlete should be referred to a specialist in PFD.\u003c/p\u003e \u003cp\u003eScore C: If the total score is below 14 points, monitoring of the athlete's general health status in a multidisciplinary team is recommended.\u003c/p\u003e \u003cp\u003eRegular application and reevaluation with the use of the screening tool is advised, especially during the season preparation or if a mandatory break is required, particularly due to pelvic floor complaints. Further investigations are recommended for returning to sport postpartum and for parasport athletes.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003e2.3. Inclusion and exclusion criteria for athletes and potential users\u003c/h2\u003e \u003cp\u003eThe pre-final version of the PFD-SENTINEL screening tool underwent testing among both female athletes and potential users. Participant recruitment took place within sports clubs in Freiburg, a university town in southwestern Germany, contributing to the notable presence of students in the participant cohort. To qualify as an athlete for participation, individuals had to meet the following criteria:\u003c/p\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eThe participant had to be 18 years of age or older.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eSex: Female.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eActive athlete (defined as regular participation in competitions or membership in a sports club).\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eA written informed consent was provided.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003cp\u003eMoreover, the Screening Tool was distributed among potential users who were instructed to review it as if they would apply it to an athlete. The criteria for being considered a potential user of the PFD-SENTINEL were as follows:\u003c/p\u003e \u003cp\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003eThe participant had to be 18 years of age or older.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eOccupational qualification in one of the specified application areas (e.g. physician or physiotherapist)\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eA written informed consent was provided.\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003e2.4. Sample size calculation\u003c/h2\u003e \u003cp\u003eThe sample size chosen for evaluating the prefinal version of the instrument adhered to the guidelines for the cultural adaptation and validation of questionnaires and PROMs, recommending the inclusion of 20\u0026ndash;30 participants in the testing process [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e"},{"header":"3. Results","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003e3.1. Translation and cross-cultural adaptation\u003c/h2\u003e \u003cp\u003eDuring the translation and cultural adaptation process, no major difficulties were encountered. Care was taken to maintain the original structure, including the four sections of the questionnaire: \"Main information about the Tool\", \"The Tool Algorithm\", \"Instructions\", and \"Items.\" This ensured that the applicability and purpose of the questionnaire were preserved.\u003c/p\u003e \u003cp\u003eMinor linguistic inconsistencies arose during the forward and backward translation, mainly concerning unspecific wording. However, these were resolved through group discussions during the consensus meetings. The characteristics of the German language were taken into consideration, including the need for gender-specific terms such as \"Athletinnen\" (female athletes). Inclusive language, such as \"Athlet:innen,\" was chosen. The cultural adaptation to the German-speaking context was straightforward, requiring only minor linguistic and cultural adjustments.\u003c/p\u003e \u003cp\u003eThe English term \"prevalence\" was paraphrased due to the infrequent use of the German word \"Pr\u0026auml;valenz\" in everyday language. Similarly, the English term \"bulge\" was paraphrased as \"vaginalen Druck- oder Fremdk\u0026ouml;rpergef\u0026uuml;hl\" (vaginal pressure or foreign body sensation) as there is no adequate translation commonly used in the German-speaking context. The term \"constipation\" was translated as \"Verstopfungen\" to ensure general understanding. Expressions such as \"to whom it applies\" were summarized as \"Zielgruppe\" in the German translation.\u003c/p\u003e \u003cp\u003eThe term \"national ranking list\" used in the Anglo-American context was translated into \"Kaderathlet:innen\" in German as the concept of a national ranking list is not commonly practiced in Germany.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003e3.2 Testing of the prefinal version\u003c/h2\u003e \u003cp\u003eUsing a questionnaire, both athletes and potential users were asked about their comprehension of the language and understanding of the application of the screening tool. The questionnaire was segmented into four sections: \"General Information about the screening tool,\" \"Algorithm of the screening tool,\" \"Symptoms,\" and \"Items.\" Participants were asked for feedback on each section, inquiring whether they comprehended everything or encountered any unclear terms or questions.\u003c/p\u003e \u003cp\u003eA total of 27 participants were included. Of 22 female athletes, 21 athletes were participating in medium- and high-impact sports (triathlon, soccer, running, volleyball). One participant was a swimmer. The median age of the screened athletes was 24 years old (Interquartile range [22,27]). Further descriptive data on the sample of female athletes are presented in Table \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\u003eCharacteristics of the female athletes\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=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariables\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFemale Athletes\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003en\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAge (in years)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24 (22;27)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eBMI (kg/m\u003c/b\u003e\u003csup\u003e\u003cb\u003e2\u003c/b\u003e\u003c/sup\u003e\u003cb\u003e)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20,2 (19,3;21,0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSports\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRunning\u003c/p\u003e \u003cp\u003eTriathlon\u003c/p\u003e \u003cp\u003eSprint\u003c/p\u003e \u003cp\u003eVolleyball\u003c/p\u003e \u003cp\u003eSoccer\u003c/p\u003e \u003cp\u003eTennis\u003c/p\u003e \u003cp\u003eSwimming\u003c/p\u003e \u003cp\u003eRoad cycling\u003c/p\u003e \u003cp\u003eHockey\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (31,82%)\u003c/p\u003e \u003cp\u003e5 (22,73%)\u003c/p\u003e \u003cp\u003e1 (4,55%)\u003c/p\u003e \u003cp\u003e1 (4,55%)\u003c/p\u003e \u003cp\u003e3 (13,64%)\u003c/p\u003e \u003cp\u003e2 (9,09%)\u003c/p\u003e \u003cp\u003e1 (4,55%)\u003c/p\u003e \u003cp\u003e1 (4,55%)\u003c/p\u003e \u003cp\u003e1 (4,55%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eYears of training\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6,5 (5;10)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSessions / week\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5,5 (4;7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eHours / session\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (2, 2,75)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eHighest educational attainment\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eState examination/Master/Diploma\u003c/p\u003e \u003cp\u003eBachelor / Physicum\u003c/p\u003e \u003cp\u003eApprenticeship\u003c/p\u003e \u003cp\u003eAbitur or equal qualification\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (31,82%)\u003c/p\u003e \u003cp\u003e6 (27,27%)\u003c/p\u003e \u003cp\u003e1 (4,55%)\u003c/p\u003e \u003cp\u003e8 (36,36%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eProfession\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStudent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12 (54,55%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedical doctor\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (13,64%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEngineer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (4,55%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePhysiotherapist\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (4,55%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSports Scientist\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (4,55%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePolice Officer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (4,55%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePharmacist\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (4,55%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEvent manager\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (4,55%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePhD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (4,55%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWorking hours/week\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e38 (20;40)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"2\"\u003eContinuous variables are presented as median (quartile 1;\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"2\"\u003equartile 3). Nominal variables are shown as frequencies (%).\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThe prefinal version was also presented to five potential users. Descriptive data of the five potential users to whom the screening tool was presented are presented in Table \u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\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\u003eCharacteristics of the potential users\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=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariables\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePotential users\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003en\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAge (in years)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e28 (27;33)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSex\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (60%)\u003c/p\u003e \u003cp\u003e2 (40%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eProfession\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedical doctor\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (80%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePhysiotherapist\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (20%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSpecialisation\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGynaecology\u003c/p\u003e \u003cp\u003eCardiology\u003c/p\u003e \u003cp\u003eSport Physiotherapist\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (60%)\u003c/p\u003e \u003cp\u003e1 (20%)\u003c/p\u003e \u003cp\u003e1 (20%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWorking years\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (1;3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"2\"\u003eContinuous variables are presented as median (quartile 1;\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"2\"\u003equartile 3). Nominal variables are shown as frequencies (%).\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eAll 27 participants reported no issues with comprehension, affirming their understanding of all questions and terms. Based on these findings, it was determined that no revisions of the pre-final version of the PFD-SENTINEL screening tool were necessary. Consequently, the prefinal version was officially designated as the final version for the German language. Thereafter the final version of the screening tool together with all documentation of the process were sent to the authors of the original version for approval. In a consensus meeting minor adaptions, which had been suggested by the developers of the original English version of the screening tool during the approval process, were made. \u0026ldquo;Fitnessstufe\u0026rdquo; was changed to \u0026ldquo;Leistungsniveau\u0026rdquo; in the German version of the PFD-SENTINEL screening tool. The corrected final version and documentation have been resent to the authors of the original version. The final German version and documents were checked again and approved.\u003c/p\u003e \u003cp\u003eIt is essential to note that the PFD-SENTINEL screening tool is not intended as a \"patient-reported outcome\" to be completed independently by the athlete. Instead, it serves as a screening tool to be administered by experts in the fields of sports medicine, physiotherapy, or gynecology.\u003c/p\u003e \u003c/div\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eThis study is the first standardized approach to translate and culturally adapt the Pelvic Floor Dysfunction (PFD-SENTINEL) screening tool for female athletes, developed by Giagio et al., into another language [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. This work will provide sports medicine professionals, gynecologists, and physiotherapists in Germany a tool to screen female athletes for the presence of PFD, facilitating timely referrals to urogynecology specialists.\u003c/p\u003e \u003cp\u003e By using the methodology proposed in the international guideline by Beaton et al. [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e] we applied a strict translation protocol without altering content or clarity of the PFD-SENTINEL screening tool. The sample size of 27 participants fulfills the recommendation in the guideline for translation and cultural adaption of instruments. The testing of the pre-final version did not reveal any linguistic ambiguities or comprehension issues. Our results demonstrate that the German version of the PFD-SENTINEL screening tool is comprehensible to all users (health care professionals and female athletes) and ready to be used in the field.\u003c/p\u003e \u003cp\u003e \u003cem\u003eAdded value\u003c/em\u003e \u003c/p\u003e \u003cp\u003eThe translated version of the PFD screening tool is the first PFD screening tool specifically designed for female athletes in German language. Various studies have indicated the need to consider different sports-specific symptoms and features of athletes [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan additionalcitationids=\"CR10\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. Until now, in the German-speaking region, the German Pelvic Floor Questionnaire was frequently used for urogynecological conditions in the general population [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. It was designed for evaluation of symptoms and their effects on quality of life and therefore focused on typical symptoms of PFD, rather than assessing a woman\u0026rsquo;s clinical and sports-specific (e.g., impact, training volume, etc.) characteristics. Beyond that, other urogynecology questionnaires, such as Kings Health Questionnaire and International Consultation on Incontinence Modular Questionnaire (ICIQ) were neither designed nor evaluated for the assessment of pelvic floor dysfunction in athletes [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe unique approach of the PFD-SENTINEL screening tool is that it was designed to be applied by health care professionals, as opposed to the self-reported design of the German Pelvic Floor Questionnaire. The fact that the tool was designed to be applied by an health care professional poses the risk of response bias. Athletes may not consistently disclose the full range of their symptoms, since pelvic floor dysfunctions still carry a considerable stigma [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. In the future, a critical comparison with the German Pelvic Floor Questionnaire is needed to evaluate a potential benefit of the PFD-SENTINEL screening tool in assessing and managing PFD in female athletes. This quality criteria assessment is integral to ensuring the reliability, concurrent validity, and relevance of the tool in the specific context of athletes.\u003c/p\u003e \u003cp\u003eIn the future, a nuanced adjustment of terminology is suggested, with the potential replacement of \u0026lsquo;pelvic surgery\u0026rsquo; (Becken Operationen) with the more precise term \u0026lsquo;pelvic floor surgery\u0026rsquo; (Beckenboden Operationen) or surgery within the small pelvis (Operationen innerhalb des kleinen Beckens). Moreover, it is crucial to note substantial differences in meaning when referring to a pelvic surgery, a pelvic floor surgery, or a surgery within the small pelvis. A more precise clarification of the term \u0026lsquo;pelvic surgery\u0026rsquo; (Becken Operation) would be advantageous in a subsequent version. Further, deliveries are currently assessed without accounting for the number of gestations or births, and individual items in the PFD-SENTINEL screening tool have different impact on score calculation. However, whereas of superior relevance for subsequent validation studies, evaluation of this risk stratification approach was beyond the scope of the present study.\u003c/p\u003e \u003cp\u003e \u003cem\u003eLimitations\u003c/em\u003e \u003c/p\u003e \u003cp\u003eThis study has several limitations that need careful consideration in interpreting the results. Most prominently, the mandate for strict translation without substantial content alterations limited the study's ability to refine specific aspects of the PFD SENTINEL screening tool. Moreover, the educational background of the participants, primarily comprising athletes with higher educational levels, is due to the recruitment setting within a university environment. However, this should not impact applicability, given that the screening tool is designed to be administered by doctors and physiotherapists, together with their athletes, who will not use the screening tool without the help of medical professionals. Nevertheless, a subsequent validation study needs to address a broader population of athletes to allow for rigorous extrapolations.\u003c/p\u003e "},{"header":"Conclusion","content":" \u003cp\u003eIn summary, the PFD-SENTINEL screening tool has the potential to drive significant advances in screening female athletes for pelvic floor dysfunctions. Successful translation of this tool and cultural adaptation into German paved the way for future validation and application of the PFD-SENTINEL screening tool in the German-speaking area.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors would like to thank Linda Detering and Nicholas Dunham for having participated in the forward and backward translations and having taking part in the consensus meetings.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eEthics approval and consent to participate\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThis study was performed in line with the principles of the Declaration of Helsinki. The Ethics Committee of the Medical Center - University of Freiburg, Freiburg, Germany, approved the project (23-1225-S1).\u003c/p\u003e\n\u003cp\u003eAll female athletes who were screened in this study and all potential users who were asked to apply the screening tool were informed about the study and gave written informed consent prior to participate.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eConsent for publication:\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAvailability of data and materials\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and analysed during the current study available from the corresponding author on reasonable request\u003cem\u003e.\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eCompeting interests\u003c/em\u003e:\u003c/p\u003e\n\u003cp\u003eEach author certifies that he or she has no commercial associations (such as consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article. None of the authors received any funding or financial support in connection to this work.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eFunding:\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that no funds, grands, or other support were received in connection with this project.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAuthors contributions:\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAlbers: Ethics Committee approval, data collection, data management, data analysis, manuscript writing and editing\u003c/p\u003e\n\u003cp\u003eGiagio: manuscript editing\u003c/p\u003e\n\u003cp\u003eTurolla: manuscript editing\u003c/p\u003e\n\u003cp\u003ePillastrini: manuscript editing\u003c/p\u003e\n\u003cp\u003eStein-Brueggemann: other (supervision)\u003c/p\u003e\n\u003cp\u003eRudolph: other (translation)\u003c/p\u003e\n\u003cp\u003eJuhasz-Boess: others (supervision)\u003c/p\u003e\n\u003cp\u003eHuebner: Ethics Committee approval, manuscript editing, other (supervision)\u003c/p\u003e\n\u003cp\u003eHollander: Project development, manuscript editing, other (supervision)\u003c/p\u003e\n\u003cp\u003eMarques: Project development, Ethics Committee approval, manuscript writing and editing, others (supervision)\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eIslam RM, Oldroyd J, Rana J, et al. 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Br J Sports Med. 2023;57:1539\u0026ndash;49. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1136/bjsports-2023-107017\u003c/span\u003e\u003cspan address=\"10.1136/bjsports-2023-107017\" targettype=\"DOI\" 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":true,"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":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Athlete, Pelvic Floor Disorders, Pelvic Organ Prolapse, Questionnaire, Screening, Sports Medicine, Urinary Incontinence, Women","lastPublishedDoi":"10.21203/rs.3.rs-3982539/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3982539/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eIntroduction: Pelvic floor dysfunction (PFD), such as urinary or fecal incontinence or pelvic organ prolapse, is a common medical condition with increasing awareness in female athletes since they suffer more frequently from PFD than non-athletes. For female athletes PFD can be very disabling and stressful and may even lead to withdrawal from sport. Recently, a screening tool for PFD in female athletes was introduced (PFD-SENTINEL screening tool). In this study, we aimed to translate and culturally adapt the PFD-SENTINEL screening tool into German.\u003c/p\u003e \u003cp\u003e Methods: Following an international guideline, forward and backtranslations of the screening tool were conducted throughout six progressive phases. A pre-final version of the PFD-SENTINEL screening tool for the German language was tested in a cohort of 27 potential users. Subsequently, a final version was adjusted and presented.\u003c/p\u003e \u003cp\u003eResults: Twenty-two of the 27 potential users were female athletes (median age 24 years). Five of the potential users were healthcare professionals (median age 28 years). None of the participants had difficulties understanding the questionnaire, either linguistically or in terms of content. The final version was approved by the original developers.\u003c/p\u003e \u003cp\u003eConclusions: The PFD-SENTINEL screening tool holds promise to prompt specialist care and assessment, detecting potential PFD and helping to estimate the related prevalence in female athletes. Its successful translation and adaptation to the German language allows for future testing of its psychometric properties and application in German-speaking regions.\u003c/p\u003e","manuscriptTitle":"Cross-cultural adaptation of the Pelvic Floor Dysfunction SENTINEL screening tool for German-speaking female athletes","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-03-08 18:37:21","doi":"10.21203/rs.3.rs-3982539/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"391ee862-da82-461e-8f9b-8e9d4310b4ca","owner":[],"postedDate":"March 8th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-12-06T06:54:55+00:00","versionOfRecord":[],"versionCreatedAt":"2024-03-08 18:37:21","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3982539","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3982539","identity":"rs-3982539","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}