ABSTRACT
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.
Keywords:
Outcome; Process Assessment, Health Care; Patient Outcome Assessment; Patient-Reported Outcome Measures; Sports Medicine
RESUMEN
Introducción:
La literatura presenta varios cuestionarios científicamente validados y transculturalmente adaptados en el área de la ortopedia y Medicina del Deporte. Sin embargo, son anatómicamente específicos y no consideran las necesidades específicas de los atletas. El “4-Domain PROM for Orthopaedic and Sports Medicine” (4-Domain Sports PROM) es el primer cuestionario, en la literatura (International Journal of Sports Medicine - 2021), diseñado para evaluar atletas y practicantes de deportes altamente activos, y sus especificidades físicas y psicológicas. Comprende cuatro dominios: atleta sin lesión, después de una lesión deportiva, expectativa de tratamiento, evaluación del atleta sobre el tratamiento recibido.
Objetivos:
El objetivo de este trabajo es realizar la traducción y adaptación transcultural (TCA) a la lengua portuguesa.
Métodos:
El cuestionario fue autoadministrado por 50 participantes, practicantes habituales de actividades físicas y deportivas. El proceso de traducción y adaptación cultural involucró seis pasos: traducción; síntesis; traducción inversa; prueba previa; revisión por el comité de expertos; aplicación clínica y aprobación del autor de la versión original. Se evaluaron la equivalencia de traducción y la relevancia de los ítems del cuestionario.
Resultados:
La versión portuguesa del 4-DOMAIN SPORTS PROM tuvo una equivalencia de traducción de 0,94 y la relevancia de los ítems fue de 0,98, mientras que el porcentaje de acuerdo entre los pacientes para la comprensión fue de 0,98.
Conclusión:
La traducción y adaptación transcultural del 4-DOMAIN SPORTS PROM al portugués amplía las posibilidades de evaluar los diferentes momentos que involucran el tratamiento de lesiones deportivas, ya que este cuestionario fue diseñado para capturar datos sobre la percepción de los pacientes antes de la lesión, después de la lesión, expectativa y evaluación del trato recibido en deportistas y practicantes habituales de actividad física. Nivel de Evidencia II; Estudio Cualitativo Transversal.
RESUMO
Introdução:
A literatura apresenta diversos questionários cientificamente validados e adaptados transculturalmente na área de na Ortopedia e Medicina Esportiva validados cientificamente e adaptados transculturalmente. Entretanto, eles são anatomicamente específicos, e não consideram as necessidades especificas dos atletas. O “4-Domain PROM for Orthopedic and Sports Medicine” (4-Domain Sports PROM) é o primeiro questionário, na literatura (International Journal of Sports Medicine - 2021), concebido para avaliar atletas e praticantes de esportes altamente ativos, e suas especificidades físicas e psicológicas. Ele compreende quatro domínios: atleta sem lesão, após lesão esportiva, expectativa do tratamento, avaliação do atleta sobre o tratamento recebido.
Objetivos:
O objetivo deste trabalho é realizar a tradução e a adaptação transcultural (TCA) à língua portuguesa.
Métodos:
O questionário foi autoadministrado por 50 participantes, praticantes regulares de atividades físicas e esportivas. O processo de tradução e adaptação cultural envolveu seis etapas: tradução; síntese; retrotradução; pré-teste; revisão pelo comitê de experts; aplicação clínica e aprovação do autor da versão original. Foi avaliado a Equivalência da tradução e relevância de itens do questionário.
Resultados:
A versão em português do 4-DOMAIN SPORTS PROM apresentou equivalência da tradução de 0,94 e relevância dos itens foi de 0,98, enquanto a porcentagem de concordância entre os pacientes para compreensão foi de 0,98.
Conclusão:
A tradução e adequação cultural do 4-DOMAIN SPORTS PROM para língua portuguesa mostrou-se compreensível e reprodutibilidade adequada em todos os domínios do questionário (concordância acima de 90% e Índice de Validade de Conteúdo de 100%) para avaliar o tratamento de população de indivíduos atletas e praticantes regulares de esportes. Nível de Evidência II; Estudo Qualitativo Transversal.
INTRODUCTION
Assessment of patient benefits is critical to guide the duration and treatment that best meets the proposed goal.11 Ruzbarsky JJ, Marom N, Marx RG. Measuring Quality and Outcomes in Sports Medicine. Clin Sports Med. 2018;37(3):463-82.–33 Higginson IJ, Carr AJ. Measuring quality of life: Using quality of life measures in the clinical setting. BMJ. 2001;322(7297):1297-300. Historically, outcomes have been broadly assessed from a clinical perspective.44 Weldring T, Smith SMS. Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs). Health Serv Insights. 2013;6:61-8. doi:10.4137/HSI.S11093.
https://doi.org/10.4137/HSI.S11093...
,55 Churruca K, Pomare C, Ellis LA, Long JC, Henderson SB, Murphy LED, et al. Patient-reported outcome measures (PROMs): A review of generic and condition-specific measures and a discussion of trends and issues. Health Expect. 2021;24(4):1015-24. doi:10.1111/hex.13254.
https://doi.org/10.1111/hex.13254...
However, 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.66 Prinsen CAC, Mokkink LB, Bouter LM, Alonso J, Patrick DL, de Vet HCW, et al. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res. 2018;27(5):1147-57. doi:10.1007/s11136-018-1798-3.
https://doi.org/10.1007/s11136-018-1798-...
,77 Mercieca-Bebber R, King MT, Calvert MJ, Stockler MR, Friedlander M. The importance of patient-reported outcomes in clinical trials and strategies for future optimization. Patient Relat Outcome Meas. 2018;9:353-67.
The 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.88 American Academy of Orthopaedic Surgeons. Disponível em: https://www5.aaos.org/CustomTemplates/landingPage.aspx?id=4294968282&ssopc=1
https://www5.aaos.org/CustomTemplates/la...
However, they are anatomically specific, focus on a particular joint or anatomical location, and do not consider the needs of athletes.99 Rocha Piedade S, Hutchinson MR, Maffulli N. Presently PROMs are not tailored for athletes and high-performance sports practitioners: a systematic review. J ISAKOS. 2019;4(5):248-53.
It 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.77 Mercieca-Bebber R, King MT, Calvert MJ, Stockler MR, Friedlander M. The importance of patient-reported outcomes in clinical trials and strategies for future optimization. Patient Relat Outcome Meas. 2018;9:353-67.,99 Rocha Piedade S, Hutchinson MR, Maffulli N. Presently PROMs are not tailored for athletes and high-performance sports practitioners: a systematic review. J ISAKOS. 2019;4(5):248-53.,1010 Davis JC, Bryan S. Patient Reported Outcome Measures (PROMs) have arrived in sports and exercise medicine: Why do they matter?. J Sports Med. 2015;49(24):1545-6. doi:10.1136/bjsports-2014-093707.
https://doi.org/10.1136/bjsports-2014-09...
Thus, 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).55 Churruca K, Pomare C, Ellis LA, Long JC, Henderson SB, Murphy LED, et al. Patient-reported outcome measures (PROMs): A review of generic and condition-specific measures and a discussion of trends and issues. Health Expect. 2021;24(4):1015-24. doi:10.1111/hex.13254.
https://doi.org/10.1111/hex.13254...
,1111 Valier AR, Jennings AL, Parsons JT, Vela LI. Benefits of and barriers to using patient-rated outcome measures in athletic training. J Athl Train. 2014;49(5):674-83.,1212 Piedade SR, Ferretti M, Ferreira DM, Sullitel DA, Patnaik S, Samitier Maffulli N. PROMs in Sports Medicine. In: Rocha Piedade S., Imhoff A., Clatworthy M., Cohen M., Espregueira-Mendes J. (eds) The Sports Medicine Physician. Springer, Cham; 2019. doi:10.1007/978-3-030-10433-7.
https://doi.org/10.1007/978-3-030-10433-...
The 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.1313 Hutchings HA, Alrubaiy L. Patient-Reported Outcome Measures in Routine Clinical Care: The PROMise of a Better Future?. Dig Dis Sci. 2017;62(8)1841-3.,1414 Piedade SR, Hutchinson MR, Maffulli N. Patient-Reported Outcomes Tailored to Sports Medicine. In: Rocha Piedade, S., Neyret, P., Espregueira-Mendes, J., Cohen, M., Hutchinson, M.R. (eds). Specific Sports-Related Injuries. Springer, Cham; 2021. https://doi.org/10.1007/978-3-030-66321-6.
https://doi.org/10.1007/978-3-030-66321-...
Although 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.99 Rocha Piedade S, Hutchinson MR, Maffulli N. Presently PROMs are not tailored for athletes and high-performance sports practitioners: a systematic review. J ISAKOS. 2019;4(5):248-53.,1111 Valier AR, Jennings AL, Parsons JT, Vela LI. Benefits of and barriers to using patient-rated outcome measures in athletic training. J Athl Train. 2014;49(5):674-83.,1313 Hutchings HA, Alrubaiy L. Patient-Reported Outcome Measures in Routine Clinical Care: The PROMise of a Better Future?. Dig Dis Sci. 2017;62(8)1841-3.
In this context, the “4-Domain Patient Reported Outcome Measures (PROM) for Orthopedic and Sports Medicine” (4-DOMAIN SPORTS PROM)1515 Piedade SR, Hutchinson MR, Ferreira DM, Ferretti M, Maffulli N. Validation and Implementation of 4-domain Patient-reported Outcome Measures (PROMs) Tailored for Orthopedic Sports Medicine. Int J Sports Med. 2021;42(9):853-8. doi:10.1055/a-1327-2970.
https://doi.org/10.1055/a-1327-2970...
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.1414 Piedade SR, Hutchinson MR, Maffulli N. Patient-Reported Outcomes Tailored to Sports Medicine. In: Rocha Piedade, S., Neyret, P., Espregueira-Mendes, J., Cohen, M., Hutchinson, M.R. (eds). Specific Sports-Related Injuries. Springer, Cham; 2021. https://doi.org/10.1007/978-3-030-66321-6.
https://doi.org/10.1007/978-3-030-66321-...
,1515 Piedade SR, Hutchinson MR, Ferreira DM, Ferretti M, Maffulli N. Validation and Implementation of 4-domain Patient-reported Outcome Measures (PROMs) Tailored for Orthopedic Sports Medicine. Int J Sports Med. 2021;42(9):853-8. doi:10.1055/a-1327-2970.
https://doi.org/10.1055/a-1327-2970...
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),1515 Piedade SR, Hutchinson MR, Ferreira DM, Ferretti M, Maffulli N. Validation and Implementation of 4-domain Patient-reported Outcome Measures (PROMs) Tailored for Orthopedic Sports Medicine. Int J Sports Med. 2021;42(9):853-8. doi:10.1055/a-1327-2970.
https://doi.org/10.1055/a-1327-2970...
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
ANNEX 1
4-DOMAIN SPORTS PROM (ORIGINAL VERSION IN ENGLISH).
)
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, 19931616 Guillemin F. Cross-cultural adaptation and validation of health status measures. Scand J Rheumatol. 1995;24(2):61-3.,1717 Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993;46(12):1417-32. and Beaton, Bombardier, and Guilemin, 2000,1818 Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000;25(24):3186-91. 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;
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An orthopedic doctor and professor at a Brazilian state university whose line of research is sports medicine;
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An orthopedic physician and professor at a Brazilian state university whose line of research is musculoskeletal disorders of the shoulder;
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An orthopedic doctor graduated from a Brazilian federal university with a post-graduate degree in sports medicine;
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A physiotherapist graduated from a Brazilian federal university.
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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,1919 Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB, Duncan MS, et al. Delineando a pesquisa clínica. 2nd ed. Porto Alegre: Artmed; 2003. with an agreement rate of 0.9 or higher being acceptable.2020 Polit DF, Beck CT. The content validity index: are you sure you know what's being reported? Critique and recommendations. Res Nurs Health. 2006;29(5):489-97.,2121 Topf M. Three estimates of interrater reliability for nominal data. Nurs Res. 1986;35(4):253-5. Each 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 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 ANNEX 2 FINAL VERSION OF THE 4-DOMAIN SPORTS PROM AFTER TRANSLATION AND CULTURAL ADAPTATION TO PORTUGUESE LANGUAGE. )
DISCUSSION
Although the orthopedic literature presents a considerable number of PROMs developed to assess outcomes of treatment of musculoskeletal conditions,88 American Academy of Orthopaedic Surgeons. Disponível em: https://www5.aaos.org/CustomTemplates/landingPage.aspx?id=4294968282&ssopc=1
https://www5.aaos.org/CustomTemplates/la...
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.99 Rocha Piedade S, Hutchinson MR, Maffulli N. Presently PROMs are not tailored for athletes and high-performance sports practitioners: a systematic review. J ISAKOS. 2019;4(5):248-53.
Athletes 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.1010 Davis JC, Bryan S. Patient Reported Outcome Measures (PROMs) have arrived in sports and exercise medicine: Why do they matter?. J Sports Med. 2015;49(24):1545-6. doi:10.1136/bjsports-2014-093707.
https://doi.org/10.1136/bjsports-2014-09...
,1111 Valier AR, Jennings AL, Parsons JT, Vela LI. Benefits of and barriers to using patient-rated outcome measures in athletic training. J Athl Train. 2014;49(5):674-83.,1212 Piedade SR, Ferretti M, Ferreira DM, Sullitel DA, Patnaik S, Samitier Maffulli N. PROMs in Sports Medicine. In: Rocha Piedade S., Imhoff A., Clatworthy M., Cohen M., Espregueira-Mendes J. (eds) The Sports Medicine Physician. Springer, Cham; 2019. doi:10.1007/978-3-030-10433-7.
https://doi.org/10.1007/978-3-030-10433-...
This 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.1010 Davis JC, Bryan S. Patient Reported Outcome Measures (PROMs) have arrived in sports and exercise medicine: Why do they matter?. J Sports Med. 2015;49(24):1545-6. doi:10.1136/bjsports-2014-093707.
https://doi.org/10.1136/bjsports-2014-09...
,1212 Piedade SR, Ferretti M, Ferreira DM, Sullitel DA, Patnaik S, Samitier Maffulli N. PROMs in Sports Medicine. In: Rocha Piedade S., Imhoff A., Clatworthy M., Cohen M., Espregueira-Mendes J. (eds) The Sports Medicine Physician. Springer, Cham; 2019. doi:10.1007/978-3-030-10433-7.
https://doi.org/10.1007/978-3-030-10433-...
,1414 Piedade SR, Hutchinson MR, Maffulli N. Patient-Reported Outcomes Tailored to Sports Medicine. In: Rocha Piedade, S., Neyret, P., Espregueira-Mendes, J., Cohen, M., Hutchinson, M.R. (eds). Specific Sports-Related Injuries. Springer, Cham; 2021. https://doi.org/10.1007/978-3-030-66321-6.
https://doi.org/10.1007/978-3-030-66321-...
In 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.
Guillemin1616 Guillemin F. Cross-cultural adaptation and validation of health status measures. Scand J Rheumatol. 1995;24(2):61-3. and Guillemim, Bombardier, and Beato,1717 Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993;46(12):1417-32.,1818 Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000;25(24):3186-91. 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,2222 Hyrkäs K, Appelqvist-Schmidlechner K, Oksa L. Validating an instrument for clinical supervision using an expert panel. Int J Nurs Stud. 2003;40(6):619-25. 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.2323 Fernandes MI. Tradução e validação do questionário de qualidade de vida específico para osteoartrose WOMAC (Western Ontario McMaster Universities) para a língua portuguesa [Dissertation]. São Paulo: Universidade Federal de São Paulo; 2001. Available at: https://repositorio.unifesp.br/handle/11600/19401.
https://repositorio.unifesp.br/handle/11...
,2424 da Mota Falcão D, Ciconelli RM, Ferraz MB. Translation and cultural adaptation of quality of life questionnaires: an evaluation of methodology. J Rheumatol. 2003;30(2):379-85.
The 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 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 scale2525 Rubio DM, Berg-Weger M, Tebb SS, Lee ES, Rauch S. Objectifying content validity: conducting a content validity study in social work research. Soc Work Res. 2003;27(2):94-104. doi:10.1093/swr/27.2.94.
https://doi.org/10.1093/swr/27.2.94...
,2626 Jebb AT, Ng V, Tay L. A Review of Key Likert Scale Development Advances: 1995-2019. Front Psychol. 2021;12:637547. doi:10.3389/fpsyg.2021.637547.
https://doi.org/10.3389/fpsyg.2021.63754...
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.2727 Ferreira TMC, Ferreira JDL, Santos CLJD, Silva KL, Oliveira JDS, Agra G, et al. Validation of an instrument for systematizing nursing care in pediatrics. Rev Bras Enferm. 2021;74(Suppl 4):e20200222. doi:10.1590/0034-7167-2020-0222.
https://doi.org/10.1590/0034-7167-2020-0...
,2828 Bull C, Crilly J, Latimer S, Gillespie BM. Establishing the content validity of a new emergency department patient-reported experience measure (ED PREM): a Delphi study. BMC Emerg Med. 2022;22(1):65. doi:10.1186/s12873-022-00617-5.
https://doi.org/10.1186/s12873-022-00617...
This 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,1919 Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB, Duncan MS, et al. Delineando a pesquisa clínica. 2nd ed. Porto Alegre: Artmed; 2003. when using this method, an acceptable rate of agreement of 90% between raters should be considered. (Figure 3)2020 Polit DF, Beck CT. The content validity index: are you sure you know what's being reported? Critique and recommendations. Res Nurs Health. 2006;29(5):489-97.,2121 Topf M. Three estimates of interrater reliability for nominal data. Nurs Res. 1986;35(4):253-5.
Some of the answers to each question of the “4-DOMAIN SPORTS PROM”1515 Piedade SR, Hutchinson MR, Ferreira DM, Ferretti M, Maffulli N. Validation and Implementation of 4-domain Patient-reported Outcome Measures (PROMs) Tailored for Orthopedic Sports Medicine. Int J Sports Med. 2021;42(9):853-8. doi:10.1055/a-1327-2970.
https://doi.org/10.1055/a-1327-2970...
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.2323 Fernandes MI. Tradução e validação do questionário de qualidade de vida específico para osteoartrose WOMAC (Western Ontario McMaster Universities) para a língua portuguesa [Dissertation]. São Paulo: Universidade Federal de São Paulo; 2001. Available at: https://repositorio.unifesp.br/handle/11600/19401.
https://repositorio.unifesp.br/handle/11...
After 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.
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ANNEX 2 FINAL VERSION OF THE 4-DOMAIN SPORTS PROM AFTER TRANSLATION AND CULTURAL ADAPTATION TO PORTUGUESE LANGUAGE.
Edited by
Publication Dates
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Publication in this collection
18 Sept 2023 -
Date of issue
2024
History
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Received
18 Nov 2022 -
Accepted
16 Mar 2023