4-DOMAIN SPORTS PROM TRANSLATION AND CULTURAL ADAPTATION INTO PORTUGUESE 4-DOMAIN

Introduction: The literature presents several scientifically validated and cross-culturally adapted questionnaires in the area of orthopedics and Sports Medicine scientifically validated and cross-culturally adapted. However, they are anatomically specific, and do not consider the specific needs of athletes. The “4-Domain PROM for Orthopedic and Sports Medicine” (4-Domain Sports PROM) is the first questionnaire, in the literature (International Journal of Sports Medicine - 2021), designed to assess athletes and highly active sports practitioners, and their specificities. physical and psychological. It comprises four domains: athlete without injury, after sports injury, expectation of treatment, athlete’s assessment of the treatment received. Objectives: This work aims to carry out the translation and cross-cultural adaptation (TCA) to the Portuguese language. Methods: The questionnaire was self-administered by 50 participants, regular physical and sports activities practitioners. The translation and cultural adaptation process involved six steps: translation; synthesis; back translation; pre-test; review by the Expert Committee, clinical application and author approval of the original version. The Equivalence of translation and relevance of questionnaire items were evaluated. RESULTS: The Portuguese version of the 4-DOMAIN SPORTS PROM had a translation equivalence of 0.94, and item relevance was 0.98, while the percentage of agreement between patients for understanding was 0.98. Conclusion: The translation and cross-cultural adaptation of the 4 Domain Sports PROM into the Portuguese version proved to be understandable and reproducible in all questionnaire domains (agreement above 90% and content validity index of 100%) to assess the treatment of the population of athletes and regular sports practitioners. Level of Evidence II; A cross-sectional qualitative study.


INTRODUCTION
2][3] Historically, outcomes have been broadly assessed from a clinical perspective. 4,5owever, recording patients' perceptions of the outcome of their treatment has become the focus of recent research efforts for both the medical and social sciences.Thus, measuring outcomes based on patient reports (PROMs) has become integral to the evaluation process, as decision-making should primarily benefit patients.Therefore it is essential to consider their expectations regarding treating their injury. 6,7he literature presents a considerable variety of PROMs used in the field.These include IKDC (knee ligament injuries), DASH (upper extremity), FAOS (foot and ankle), EQ-5D (health-related quality of life), Lysholm (knee ligament injury and TKA), KOOS (Total Knee Replacement), HAAS (High-Activity Arthroplasty Score), and have been scientifically validated and culturally adapted. 8However, they are anatomically specific, focus on a particular joint or anatomical location, and do not consider the needs of athletes. 9t is important to emphasize that the development and improvement of the treatment of sports injuries is based on the careful analysis of risks and benefits inherent in the therapeutic approach, but mainly on the voices and opinions of patients about the treatment received. 7,9,10hus, the collection of information regarding the patient's perspective, quality of life, functional capacity, pain scales, and satisfaction with the treatment received, combined with physical, functional, social, and emotional aspects, allows a more comprehensive analysis of the health situation, recovery after therapeutic approach -PROMs (Patient Reported Outcomes Mesures). 5,11,12he application of these questionnaires (PROMs) can be made by a wide variety of electronic devices and interfaces available, such as smartphones, tablets, and web tools that optimize data collection, and currently, studies for the cross-cultural adaptation of these instruments are constantly being developed. 13,14lthough the orthopedic literature presents different PROMs validated for clinical practice, it is critical to recognize the apparent gap of a specific PROM for Sports Medicine.After all, athletes have different demands and expectations from the general population. 9,11,13n this context, the "4-Domain Patient Reported Outcome Measures (PROM) for Orthopedic and Sports Medicine" (4-DOMAIN SPORTS PROM) 15 is a specific tool for assessing this population.It is organized into four domains, each with a specific purpose.This organization allows comparative analysis between the domains (pillars) or by selecting specific questions within each domain to compare with the others. 14,15

OBJECTIVES
The general objective of this study was to translate and culturally adapt the questionnaire "4-Domain Patient Reported Outcome Measures (PROM) for Orthopedic and Sports Medicine" (4-DOMAIN SPORTS PROM), 15 so that it can be used reliably in Brazil, proceeding to content validation, obtained by evaluating the instrument by a reliable and reproducible method.(Annex 1) The specific objectives in validating its use in Portuguese are to apply it in developing scientific research and health protocols and contribute to improving the therapeutic approach in sports injuries.

METHODS
The process of translation and cultural adaptation of the 4-PROM questionnaire followed the methodological criteria described by Guillemin, Bombardier, and Beat, 1993 16,17 and Beaton, Bombardier, and Guilemin, 2000, 18 used by the American Academy of Orthopaedic Surgeons (AAOS) and the International Quality of Life Assessment (IQOLA).
The present study was approved by the Research Ethics Committee of this University (CAAE: 52301221.0.0000.5404)and was authorized by the authors of the original version of the questionnaire.The participants signed the Informed Consent Form, which will keep their identities confidential.
Patients who met the inclusion criteria and did not meet the exclusion criteria shown in Table 1 were introduced to the project and judged whether or not they would participate in the study.
Demographic data such as age, gender, level of education, and sports practice were collected for better characterization and sample evaluation.The translation and cultural adaptation process involved six steps: 1) translation; 2) synthesis; 3) back-translation ; 4) pre-test; 5) Expert committee; • An orthopedic doctor and professor at a Brazilian state university whose line of research is sports medicine; • An orthopedic physician and professor at a Brazilian state university whose line of research is musculoskeletal disorders of the shoulder; • An orthopedic doctor graduated from a Brazilian federal university with a post-graduate degree in sports medicine; • A physiotherapist graduated from a Brazilian federal university.
• A nurse works in the inpatient care of the orthopedic surgical center.
6) approval of the author of the original version for publication of the final version.Phase 1 (Initial translation) -The 4-PROM was translated into Portuguese by two sworn translators, working independently, with their mother tongue, Portuguese, and fluency in English.T1 and T2 versions were created.Phase 2 (Synthesis) -The two versions were compared, and joint adjustments were made in this phase, thus originating a new version of the instrument -S1.Phase 3 (Backtranslation) -In the process of back-translation into English, the text is returned to the original by two certified translators with a mother tongue of English, unaware of the original questionnaire.In this way, translation problems can be amplified.Phase 4 (Testing of pre-final version) -Testing the questionnaire to patients.Feedback will be considered for the need to reword the questionnaire for the final version.Phase 5 (Expert Committee) -In this phase, the need for cultural adaptation, the relevance of the items, and the level of understanding of what was being asked were assessed.The sample of the expert committee (Table 2) was critically reviewed for content.The evaluation method was the Content Validity Index, normally used to analyze the extent to which a measure achieves its purpose; the instrument is considered valid if it obtains a CVI of 0.80, ideally greater than 0.90.
The experts were asked to rate each item's relevance in the instrument: 1 = item not relevant; 2 = item needs revision to assess relevance; 3 = item relevant, needs minor changes; 4 = item absolutely relevant.Being considered 3 and 4 as approved relevance.(Figure 1) Similarly to translation equivalence 1 = item not equivalent; 2 = item needs revision to assess equivalence; 3 = item equivalence, needs minor changes; 4 = item absolutely equivalent.
A simple measure of inter-observer agreement was considered to assess comprehension, 19 with an agreement rate of 0.9 or higher being acceptable. 20,21Each item was rated from 1 to 4, like a 4-point Likert scale by patients where 1" corresponds to "unclear/unintelligible" "2" corresponds to "unclear/needs adjustment" "3" corresponds to "fairly clear/easy to understand" "4" corresponds to "very clear/very good understanding".(Figure 2) After analyzing all versions of the questionnaire, the final version of the "4-DOMAIN SPORTS PROM" questionnaire was developed.The evaluation data were organized in summary tables for better visualization and understanding.
Phase 6 (Final version) -All versions were evaluated and, together with the backtranslation, sent to the original authors of the "4-Domain Sports PROM".With the approval of the original authors, the final version is summarized.

RESULTS
In the translation process into Brazilian Portuguese, the two versions (T1 and T2) did not differ significantly (Table 3), all items of the versions were discussed to formulate the consensus version.
There was consensus among the committee to choose different words without changing the understanding or identification of what the questionnaire is about.The same happened with back-translation, with no problems occurring for the translation of the questions (back--translation 1 and back-translation 2).
The questions, after evaluation by the multi-professional committee of experts, were considered suitable for the pre-final version through the Likert scale; from these points, minor changes were made in grammatical structures of some items to acquire better equivalence between words, between languages, and cultural context adaptations.(Table 4) The 4-DOMAIN SPORTS PROM (pre-final version 1) was self-administered by 50 participants, with demographic data organized in Table 5.The Content Validity Index for committee members was applied in this test, where translation equivalence was evaluated at 0.94 and item relevance at 0.98.The percentage of agreement between patients for comprehension was calculated as 0.98.
All versions and step data were emailed to the authors of the original version of the 4-DOMAIN SPORTS PROM, who did not suggest any

DISCUSSION
Although the orthopedic literature presents a considerable number of PROMs developed to assess outcomes of treatment of musculoskeletal conditions, 8 recently a systematic review showed that currently, available PROMs have not been useful to assess, for example, postoperative outcomes in athletes and highly active practicing sports.In addition, this review showed that there is no uniformity in the type of scores commonly used to assess postoperative outcomes of the same clinical problem, i.e., ACL injury. 9thletes and practitioners of highly active sports cannot be considered ordinary people, as they have physical expectations and psychological goals that differ from the general population. 10,11,12This fact reinforces the importance of a PROM designed "tailor-made" to more reliably capture the needs and desires inherent to this population and that, at the same time, can be applied to different sports modalities and sports injuries regardless of the anatomical site that it occurred. 10,12,14 this way, patient-reported independent measures (PROMs) can be analyzed in conjunction with physiological, mechanical, and imaging measures to provide a more holistic assessment of treatment.
This study developed the Portuguese translation and cultural adaptation of the 4-DOMAIN SPORTS PROM questionnaire, the first questionnaire in the literature specifically developed to capture patient-reported data (athletes and physically active individuals) on all aspects of clinical care, including surgery.In this way, global, disease-specific, and joint-specific outcomes can be explored.
Guillemin 16 and Guillemim, Bombardier, and Beato, 17,18 published a procedure for translation and cultural adaptation of instruments that follows standardized steps.Previously, the process was more difficult to carry out depending on the population studied, the type of instrument, and the authors.Although it is widely accepted and widely used in the health area, 22 followed and cited in several studies, and the criteria are internationally recognized, the complexity of the steps, the long duration, and high cost are questioned points. 23,24he Content Validity Index used refers to the measure of the extent to which a measure achieves its purpose.Content validity is important for all measurements, and its focus is to determine whether the items included in a tool represent the content of interest of the instrument.This validity can be measured by the Content Validity Index -CVI, which assesses the   AUTHORS' CONTRIBUTIONS: Each author contributed individually and significantly to the development of this paper.SRP: substantial contribution to the study in conception, design, data collection, analysis and interpretation of data, writing and critical revision of its intellectual content and approval of the final version of the manuscript to be published; AHNT: data collection, analysis, and interpretation, writing and critical revision of its intellectual content and approval of the final version of the manuscript to be published; RAV, MFF, and AP: writing and critical revision of the intellectual content and approval of the final version of the manuscript to be published.
agreement of experts regarding the representativeness/importance of the measure in relation to the content studied.It allows you to analyze each item individually and then the instrument as a whole.This method employs a Likert-type scale 25,26 with scores ranging from one to five.To assess the committee' s maintenance of relevance, responses included: 1 = "not relevant or not representative", 2 = "item needs major revision to be representative", 3 = "item needs minor revision to be representative" and 4 = "relevant or representative item".Patients' understanding of the questionnaire items was assessed as 1 = "unclear/unintelligible", 2 = "unclear/needs adjustment", 3 = "quite clear/easy to understand" and 4 = "very clear/very good understanding".By this method, the items and the instrument as a whole are considered valid if they obtain a CVI of 0.80 or greater, ideally greater than or equal to 0.9024; in this case, using the formula CVI = Number of responses "3" or "4"/ Total number of responses (Figure 1 and 2), being considered valid by the evaluated if the response is 3 or 4.
Publications have presented different methods to quantify the degree of agreement among experts during the process of assessing the content validity of an instrument. 27,28This study used the "percentage of agreement", a method employed to calculate the percentage of agreement among participants.As it is a simple measure of interobserver agreement, 19 when using this method, an acceptable rate of agreement of 90% between raters should be considered.(Figure 3) 20,21 Some of the answers to each question of the "4-DOMAIN SPORTS PROM" 15 are in visual analog scale (VAS) format.There was no difficulty in understanding how to answer them by the patients, as the researchers gave instructions about the questionnaire and clearly explained how to use this type of scale.There are reports of how patients may be confused when giving their answers or find the Likert scale easier in contrast to the VAS.Although better understood using the Likert scale, no significant differences were found. 23ter defining the final version of the questionnaire for the target language, it was important to apply it to a significant sample to assess validity, reproducibility, and sensitivity to change.These, statistically evaluated and approved by the CVI, we obtained agreement above 90% for both the committee and the patients evaluated, in which the CVI was evaluated in both groups as valid in all responses, being then evaluated as 1.0 (100%).Thus, determining that the questionnaire is adequately understandable and useful for its original purpose.The results themselves showed that all domains of the questionnaire had adequate reproducibility, and there were no major difficulties with translation and cultural adaptation.The use of the pre-established criteria already mentioned, associated with the exchange of information, availability, and collaboration of the authors of the original version, facilitated the steps of the process.The Brazilian version of the questionnaire is available for use in Brazil.

CONCLUSION
The translation and cultural adequacy of the 4-DOMAIN SPORTS PROM into Portuguese proved to be understandable and reproducibility adequate in all domains of the questionnaire (agreement above 90% and Content Validity Index of 100%) to assess the treatment of the population of individuals athletes and regular practitioners of sports.
All authors declare no potential conflict of interest related to this article

Table 2 .
Inicial translation.jeito nenhum Questão 10 -"your postoperative care" T1 -seu cuidado pós operatório seu acompanhamento pós operatório T2 -seu manejo pós operatório Questão 11 -"at the end of treatment" T1 -ao fim do tratamento ao fim do tratamento T2 -ao final do tratamento changes.There were no "not understood" items, which the doctor could clarify in case of need.After the result of this test, the final Brazilian version of the 4-DOMAIN SPORTS PROM was defined; in its final version, it kept the denomination "4-DOMAIN SPORTS PROM".(Annex 2)

Table 5 .
Expert committee content validity index.

Table 3 .
Modifications to facilitate understanding assessed by the committee.

Table 4 .
Expert committee content validity index.