International Society For Pharmacoeconomics And Outcomes Research Research Articles

Finnish translation and linguistic validation of the FACE-Q Head and Neck Cancer Module.

Head and neck cancer (HNC) and its treatment can result in permanent changes to a patient's appearance, speaking, eating, and psychosocial well-being. To better assess the impact of the disease on HNC patients, the FACE-Q Head and Neck Cancer Module, a health-related quality-of-life instrument, was developed. The aim of this study was to produce and linguistically validate a Finnish version of the module. The module was translated into Finnish following the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. A total of 51 patients who had undergone tumour resection and reconstruction of the oral cavity, tonsil, or tongue area between 2019 and 2021 were approached for a pilot study. They completed the translated module and provided feedback on any linguistic issues. Adjustments were made based on the pilot study comments. The FACE-Q Head and Neck Cancer Module translated well into Finnish. Twenty-one (41%) patients participated in the survey, 12 men (57%) and nine women (43%) with a median age of 66 years (range 48-89 years). The median time since surgery was 3 years (range 1-4 years). Based on the feedback from the pilot study participants, one word was changed, and one question was rewritten. Otherwise, no deficiencies were identified in the language of the module. In summary, this study produced a linguistically valid Finnish version of the FACE-Q Head and Neck Cancer Module, enabling its application in evaluating the health-related quality-of-life among Finnish HNC patients who have undergone reconstructive surgery.

Chinese translation and validation of the Personalized Psychological Flexibility Index (PPFI) for medical college students

BackgroundPsychological flexibility (PF) is defined as the ability to pursue valuable life goals despite the existence of distress. The Personalized Psychological Flexibility Index (PPFI) is a new measure of psychological flexibility that can address existing deficiencies. This study aimed to translate and validate the psychometric characteristics of the Chinese version of the PPFI among medical college students.MethodsThe study was conducted in two phases. Phase 1 involved the translation and cross-cultural adaptation of the PPFI according to guidelines recommended by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Phase 2 was a cross-sectional survey conducted on 945 medical college students in China. The psychometric performances of the scale were assessed using construct validity, divergent validity, criterion validity, incremental validity, internal consistency, and test-rest reliability.ResultsThe exploratory factor analysis (EFA, n1 = 440) showed that the Chinese version of the PPFI consisted of 3 factors, with a total of 15 items. The confirmatory factor analysis (CFA, n2 = 440) showed that the three-factor structure fit well (χ2/df\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$df$$\\end{document}=2.469, SRMR = 0.051, RMSEA = 0.058, GFI = 0.94, CFI = 0.985). The total Chinese PPFI score had a moderate positive association with the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT, r = 0.344) and a negative association with the Acceptance and Action Questionnaire-II (AAQ-II, r = -0.334). Furthermore, the Chinese PPFI demonstrated good internal consistency (Cronbach's α = 0.826) and test–retest reliability (ICC = 0.817, p < 0.001).ConclusionThe 15-item Chinese version of the PPFI is a reliable and valid tool for measuring PF in Chinese medical students. However, additional studies are needed to validate its psychometric properties in more generalizable samples and other contexts.

The Romanian Translation and Cultural Adaptation of the Early Arthritis for Psoriatic Patients (EARP) Questionnaire, Psoriasis Epidemiology Screening Tool (PEST), and Toronto Psoriatic Arthritis Screen 2 (ToPAS 2).

Psoriasis is a chronic inflammatory condition mediated by the immune system with various manifestations. The increased prevalence of subclinical joint involvement has led to the development of early diagnostic methods for psoriatic arthritis, including several instruments that have been validated and used in clinical practice. The aim of this study was to perform the Romanian translation, cultural adaptation, and validation of three assessment tools: the Early Arthritis for Psoriatic Patients (EARP) Questionnaire, Psoriasis Epidemiology Screening Tool (PEST), and Toronto Psoriatic Arthritis Screen 2 (TOPAS 2), which are designed to evaluate early-stage arthritis in patients with psoriasis. All the activities were carried out in accordance with the internationally recognized methodology recommended by the International Society for Pharmacoeconomics and Outcome Research (ISPOR), the recommendations of the World Health Organization (WHO) regarding the translation process and the validation of instruments, and data from the international literature. These three questionnaires were administered to 29 patients with psoriasis diagnosed by biopsy. A descriptive study was conducted and the data were analyzed with appropriate statistical tests using the PSPP program. A reliability test was assessed using Cronbach's alpha coefficient. The obtained values were significant for the first two questionnaires, with a value of 0.89 for the EARP and 0.63 for the PEST, but the value was not as significant for ToPAS2, at 0.40. This pilot study revealed that the Romanian and original versions of the three questionnaires are similar.

Stated Preferences of At-Risk Populations for the Treatment of Osteoporosis: A Systematic Review.

Poor adherence to anti-osteoporosis treatment is a well-recognized problem, partly due to misalignment with patient preferences. In recent years, several quantitative preference studies have been conducted. This study aimed to systematically review stated preference research to provide a comprehensive overview of patient preferences in osteoporosis, in particular on conditional relative attribute importance and preference heterogeneity. This systematic review was conducted in MEDLINE and Embase up to February 29th, 2024. It includes all English-language, peer-reviewed, stated preference articles related to osteoporosis management and treatment in patients with or at risk of osteoporosis. Conditional relative importance of attributes as well as heterogeneity was assessed, and attributes classified into outcome, process, and cost attributes. Quality assessment was performed using a combined checklist of Purpose, Respondents, Explanation, Findings, and Significance (PREFS) and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) items. Fourteen studies including 4714 participants were evaluated. Attributes were mostly classified as process related (50%) and outcome related (40%), both of which significantly influence patient preferences. In pairwise attribute comparison, efficacy was dominant over cost, administration, and side-effects. Preference heterogeneity was observed in the majority of studies (86%). Quality assessment indicated an overall improvement in study quality over time, with recent studies adhering more closely to established methodological standards. The findings highlight the importance of considering patient preferences in the management of osteoporosis, underscoring the need for a patient-centered approach. The readiness of patients to engage in trade-offs between attributes suggests that healthcare providers should ensure treatments are aligned with individual patient preferences to improve adherence and optimize outcomes.

Polish translation, cultural adaptation, and validity confirmation of the Scored Patient-Generated Subjective Global Assessment

PurposeThe Scored Patient-Generated Subjective Global Assessment (PG-SGA©) is a validated nutritional screening, assessment, triage, and monitoring tool. The aim of this study was to perform translation, cultural adaptation, linguistic, and content validation of the translated and culturally adapted version of the PG-SGA for the Polish setting.MethodsThe study was performed in concordance with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Principles. Patients (n = 174) and healthcare professionals (HCPs, n = 188) participated in the study. Comprehensibility and difficulty were assessed by patients for the PG-SGA Short Form, and by HCPs for the professional component. Content validity was assessed for the full PG-SGA by HCPs only. Evaluations were operationalized by a 4-point scale. Item and scale indices were calculated using the average item ratings divided by the number of respondents. Item indices < 0.78 required further analysis of the item, while scale indices ≥ 0.90 were defined as excellent and 0.80–0.89 as acceptable.ResultsThe PG-SGA Short Form was rated as excellent for content validity (Scale-CVI = 0.90) by HCPs and easy to comprehend (Scale-CI = 0.96) and use (Scale-DI = 0.94) by patients. The professional component of the PG-SGA was perceived as acceptable for content validity (Scale-CVI = 0.80), comprehension (Scale-CI = 0.87), and difficulty (Scale-DI = 0.80). The physical exam was rated the least comprehensible and the most difficult, and with the lowest content validity. We found significant differences in scale indices (p < 0.05 for all) between HCPs with different professions and between those being familiar with PG-SGA and not.ConclusionTranslation and cultural adaptation of the PG-SGA for the Polish setting preserved the purpose and conceptual meaning of the original PG-SGA. Validation revealed that the Polish version of PG-SGA is well understood and easy to complete by patients and professionals, and is considered relevant by professionals. However, detailed results indicate the need for appropriate training of the Polish HCPs, especially physicians and nurses, mainly in the worksheets related to the metabolic demand and physical exam.

RWD4 A Real-World Data Landscape Review of the 2023 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Conference

RWD4 A Real-World Data Landscape Review of the 2023 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Conference

Translation and cross-cultural adaptation of the Get Active Questionnaire for Pregnancy in Colombian Spanish.

To ensure safe, optimal, and personalized physical activity, exercise, or sport during pregnancy, the Canadian Society for Exercise Physiology (CSEP), the Society of Obstetricians and Gynaecologists of Canada (SOGC), the College of Family Physicians of Canada, the Women's Health Division of the Canadian Physiotherapy Association, developed the Get Active Questionnaire for Pregnancy (GAQ_P) as a pre-assessment to identify women who may have a relative or absolute contraindication to prenatal exercise that requires further consultation with a health professional to determine if exercise can or should be continued or initiated during pregnancy. This study aims to translate and cross-culturally adapt the GAQ_P for use in Colombian Spanish. The original instrument was developed in English and French for the evaluation of the health of pregnant women before the beginning of physical activity and the guidelines for the same. Ten steps were followed according to the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Translation and Cultural Adaptation guidelines, with the participation of 4 experts. The comprehensibility of the instrument was 99% which shows a high percentage of intelligibility of the document. This article describes the translation and cross-cultural adaptation of the GAQ_P for use in Colombian Spanish, contributing positively to pre-exercise screening during pregnancy in Colombia.

Dutch translation and cultural adaptation of new LYMPH-Q- scales measuring impact on work and lymphedema worry

BackgroundBreast cancer-related lymphedema (BCRL) is a significant complication of breast cancer treatment that can impact patients’ quality of life. This study focuses on the translation and cultural adaptation of two new LYMPH-Q scales ‘Impact on Work’ and ‘Lymphedema worry’ into Dutch to assess the work-related challenges and worries experienced by patients with BCRL in the Netherlands.MethodsThe translation process followed established guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the World Health Organization (WHO). Forward and back translations, expert panel reviews, cognitive debriefing interviews with patients with BCRL, and proofreading were conducted to refine the Dutch translation of the scales. The translation aimed to ensure conceptual equivalence and cultural relevance.ResultsThe translation process resulted in the Dutch versions of the LYMPH-Q ‘Impact on Work’ and ‘Lymphedema worry’ scales. The forward translation revealed discrepancies in meaning, word order and synonyms. The back translation and review resulted in changes in item formulation. The expert panel meeting and cognitive debriefing interviews provided valuable input for further refinement.ConclusionThe translated LYMPH-Q ‘Impact on Work’ and ‘Lymphedema worry’ scales provide healthcare professionals with an instrument to assess and monitor the impact of BCRL on work-related challenges and on worries. This comprehensive translation process, involving patients with BCRL and experts, ensured the linguistic accuracy, cultural relevance, and clarity of the Dutch versions. The translated scales will contribute to a better understanding of the multifaceted impact of BCRL and facilitate the development of tailored interventions to improve patients’ well-being and functional outcomes.Level of Evidence:Not ratable

(PM-24) TRANSLATION AND CULTURAL ADAPTATION OF THE KAROLINSKA INTERPERSONAL VIOLENCE SCALE INTO BRAZILIAN PORTUGUESE: A METHODOLOGICAL STUDY

Abstract Introduction Interpersonal violence is a global concern with significant implications for mental health and mortality. The Karolinska Institute in Sweden developed the Karolinska Interpersonal Violence Scale (KIVS), a semi-structured interview assessing interpersonal violence experiences as victims or aggressors across childhood and adulthood. Objective Our aim was to translate and culturally adapt the KIVS for use in the Brazilian population. Methods: The translation process involved ten stages based on The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. Back-translation was performed by a clinical psychologist unfamiliar with the original scale. The English versions were cross compared by the original instrument author. The consensus version underwent comprehension evaluation by eight participants, comprising four healthcare professionals and four patients from the AISEP - Excessive Sexual Drive and Prevention of Negative Outcomes Related with Sexual Behavior at Instituto de Psiquiatria of Hospital das Clínicas of São Paulo. A 5-point Likert scale assessed participant comprehension, with 80% agreement indicating successful equivalence. Sentences were revised until this consensus was achieved. The finalized translation, incorporating contextual revisions, underwent syntactic and spelling review. Results After application to eight participants (4 women and 4 men), 7 rated with the highest comprehension score (5.0), and 1 with 4.9. A final report documented the entire KIVS translation and validation process. Conclusion The translation and cultural adaptation of the KIVS into Brazilian Portuguese were successful. Minor adjustments were made to enhance comprehension without compromising meaning. This adaptation provides a valuable tool for assessing interpersonal violence in the Brazilian context, with implications for research and clinical practice. Financing FAPESP.

Translation and Cross-Cultural Adaptation into French of the Harris Hip Score and the Modified Harris Hip Score.

The objective of this study was to develop a cross-cultural adaptation and translation into French of the original Harris Hip Score (HHS) and the modified Harris Hip Score (mHHS). The translation and cultural-adaptation of the questionnaire were performed following a 10-step process as recommended by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). During the cognitive debriefing, each item of the questionnaire has been rated between 1 and 10 according to the comprehension level of 8 patients who underwent total hip arthroplasty. The cross-cultural adaptation process required the modification of the walking distance item by converting the number of blocks into meters but also in walking time (minutes). All the different steps have been performed without any other important changes on the translated questionnaire which has been found highly understandable by interviewed patients (9.6 ± 1.1). This study successfully reports the French version development of the original HHS (HHS-Fr) and its modified patient-reported version (mHHS-Fr), thereby providing to clinicians a standardised version for the evaluation of French-speaking patients suffering from hip osteoarthritis.

(281) Linguistic and Cultural Validation of the Satisfaction Survey for Inflatable Penile Implant (SSIPI) for Brazilian Portuguese and Tri-Continental Spanish Speakers

Abstract Introduction The Satisfaction Survey for Inflatable Penile Implants (SSIPI) has been validated in English. No validated Portuguese and Spanish versions currently exist. Objective We aimed to linguistically validate SSIPI in Portuguese and Spanish to evaluate satisfaction outcomes with a validated instrument. Methods Our methodology adhered to best practices established by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and involved: forward translation of the 16-item SSIPI into Portuguese and Spanish by 2 independent IPP surgeons, reconciliation, back translation into English by 2 different independent bilingual IPP surgeons, and comparison to the original SSIPI for conceptual equivalence. The translated SSIPI versions underwent in-parallel cognitive debriefing (CD) at the US, Colombia, Spain, and Brazil centers. All interviews were recorded in person or via secure video conference to determine if misunderstandings or modifications were needed. Results 12 and 17 native Portuguese and Spanish speakers, respectively, with IPPs, participated in the CD process for their native language SSIPI. Interviews lasted approximately 1 hour each. The Portuguese SSIPI validation was conducted at 2 different centers in Brazil, resulting in 83% of the patients reporting that the survey was easy to answer. Of 16 questions, only 3 (Q7, Q11, and Q16) raised concerns for 6 patients. 5 patients had issues with the concept of the word “naturalness” and “spontaneity” from Q7 and Q16. One patient struggled with interpreting the word “conceal” in Q11. Regarding the duration taken to answer, 10/12 patients said it was acceptable. The Spanish SSIPI was tested at 4 US, Colombia, and Spain academic centers. 63% indicated the survey was easy to answer. In most cases, replacing a single word in the item with another was proposed. 53% had difficulties comprehending the answer choice options with Q3; however, all participants perceived the time required to complete the SSIPI as reasonable. Conclusions While the Portuguese SSIPI has been demonstrated to be easier to read and interpret than the Spanish SSIPI, with minor changes to wording/phrasing, both versions have the potential to improve IPP outcomes literature globally. Concerning questions will be modified before conducting the final validation steps. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Roman.

Polish Translation and Linguistic Validation of the SCAR-Q.

Introduction Patient-reported outcome measurements (PROMs) are gaining considerable popularity as tools to assess the effectiveness of the treatment in plastic surgery, being a complement to surgical outcomes. The SCAR-Q questionnaire has been recently developed for patients with surgical, traumatic, and burn scars. Aim The study aims to describe the process of translation and linguistic validation of the scar questionnaire (SCAR-Q) for use in Polish patients undergoing scar treatment. Material and methods An official Polish translation and language validation of the SCAR-Q were done in adherence to International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. The process consisted of four steps: two independent forward translations, a back translation, a review of the back translation, and cognitive participant interviews. Results The field-tested version of the SCAR-Q consisted of 29 items across three scales measuring appearance concerns, symptoms, and the psychosocial impact of the scar. The forward translation was done by two independent translators and revealed specific difficulties in translation to the Polish language (4/29 items). The back translation showed no significant differences compared to the original English version. Cognitive debriefing interviews involved nine Polish patients with postraumatic scars, burn scars, and scars after skin tumor resection. Participants have not reported any major difficulties in understanding the content of the questionnaire. Conclusions The ISPOR provides a straightforward and thorough guideline for the PROMs translation process. The new SCAR-Q is an accessible and efficient PROM that can be implemented in Polish patients to assess the effectiveness of scar treatment.

Culturally adapted translation of LYMPH-Q upper extremity module from English to Mandarin Chinese

BackgroundBreast cancer-related lymphedema (BCRL) is one of the debilitating complications after breast cancer treatment. Several forms of patient-reported outcome measures (PROMs) were developed to evaluate the severity of BCRL based on the patients’ perspective. LYMPH-Q Upper Extremity Module is a newly developed questionnaire for BCRL. This study aimed to demonstrate the process of translation and cultural adaption from English to Mandarin Chinese. Methods and resultsThe translation process followed the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) best-practice guidelines for the translation and cultural adaption of PROM. The process included four steps: forward translation, back translation, back translation review, and patient interviews. In total, five patients with BCRL were recruited for patient interviews.The forward translation step involved two professional translators whose native language was Mandarin Chinese. A reconciled translated version was produced. In the back translation step, the reconciled translated version in Mandarin Chinese was sent to another professional translator whose native language was English. The back-translated version in English was sent back to the developer of LYMPH-Q for review. In this step, 22 items were revised. In the final step of patient interviews, 15 items were revised based on the patients’ feedback. ConclusionThe development of Mandarin Chinese version of LYMPH-Q Upper Extremity Module and its utilization in conjunction with the existing objective measures could provide a more well-rounded picture of the status of patients with BCRL worldwide.

Reliability and validity of the Japanese version of the Survey of Perceived Organizational Support.

This study aimed to examine the reliability and validity of the Japanese version of the Survey of Perceived Organizational Support (SPOS-J) for the Japanese workforce. The translation of the SPOS into Japanese followed the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force guidelines. An online baseline survey with 6220 Japanese workers assessed the SPOS-J and related scales, followed by a follow-up survey with 452 respondents 2weeks later. We developed the SPOS-J and evaluated its factorial, convergent, and known-group validities, as well as its internal consistency, test-retest reliability, and interpretability. Exploratory and confirmatory factor analysis (EFA and CFA) indicated that the SPOS-J, diverging from the original version's 1-factor structure, adopted a 2-factor structure comprising 2 subscales: the SPOS-J (Sufficiency of Positive Aspects [SPA]) and the SPOS-J (Minimality of Negative Aspects [MNA]). The final version of the SPOS-J, consisting of 8 items selected by the item response theory analysis, demonstrated acceptable model fit in the CFA. Cronbach a values for SPOS-J (SPA) and SPOS-J (MNA) were .92 and .84; intraclass coefficients were 0.72 and 0.55, respectively. The correlations between SPOS-J (SPA) and related variables, as well as the score distributions by demographic characteristics, supported the convergent and known-group validity of SPOS-J (SPA). In contrast, SPOS-J (MNA) showed lower correlation coefficients with all related variables and supported known-group validity. The SPOS-J (SPA), a subscale of the 8-item SPOS-J, is a reliable and valid measure for assessing perceived organizational support among Japanese workers.

Transcultural Adaptation and Validation of the Spanish Version of the Visual Analogue Scale for the Foot and Ankle (VASFA).

The main aim of this study is to perform a cross-cultural adaptation and validation of the Visual Analogue Scale for the Foot and Ankle (VASFA) questionnaire, creating a Spanish-language version (VASFA-Sp), and to determine the measurement properties of this instrument. VASFA was cross-culturally translated into Spanish following the guidelines of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). The study sample was composed of 228 participants who were recruited from February to May 2022. All were at least 18 years old, gave signed informed consent to take part and properly completed the Foot and Ankle Ability Measures-Sp and VASFA-Sp questionnaires. Cronbach's alpha and test/re-test reliability values were calculated. Structural validity was assessed via exploratory factor analysis. The 228 patients included in the final analysis presented the following characteristics: 35.53% were male and 64.47% were female; the mean age was 35.95 (18-81) years; and the mean body mass index was 23.79. Internal consistency was excellent. The Cronbach's alpha for VASFA-Sp was 0.96 and the intraclass correlation coefficient was 0.932 (95% CI; 0.84 to 0.97). Exploratory factor analysis identified one main factor. VASFA-Sp is a reliable, valid and sensitive questionnaire that is suitable for measuring perceived foot and ankle function impairment in a Spanish-speaking population.

OP87 A Roadmap for Increasing The Usefulness And Impact Of Patient Preference Studies In Health Technology Assessment (HTA)

IntroductionThe number of patient preference studies in health has increased dramatically. There is growing use of patient preferences in a wide variety of contexts, including health technology assessment. Patient preference studies can help inform decision makers on the needs and priorities of patients and the tradeoffs they are willing to make about health technologies.MethodsThis International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force included international experts, health preference researchers and others from diverse backgrounds, including regulatory, health technology assessment, medicine, patient advocacy, and the pharmaceutical industry. The report underwent two rounds of written reviews by ISPOR Preferences Special Interest Group members until a final consensus was reached. The Task Force focused on developing a roadmap that would: (i) apply to the wide variety of preference methods, (ii) identify key domains to guide researchers and other stakeholders in making patient preference studies more useful to decision makers, and (iii) detail important questions to guide researchers conducting preference studies and those critically appraising them.ResultsThis Task Force report provides a novel roadmap that invites patient-preference researchers to work with decision makers, patients and other stakeholders to do even more to ensure that studies are useful and impactful. The ISPOR Roadmap consists of five key elements: (i) Context; (ii) Purpose; (iii) Population; (iv) Method; and (v) Impact. In this report, we define these five elements and provide good practices on how patient-preference researchers can actively contribute to increasing the usefulness and impact of patient preference studies in decision-making. We also present a set of key questions that can support researchers and other stakeholders in assessing efforts that promote preference studies’ intended and unintended impact.ConclusionsThis roadmap can help increase the usefulness and impact of patient preference studies in decision-making by challenging researchers to engage and partner with decision makers, patients and others, and together consider the intended and unintended impacts of patient preference studies on decision-making while actively fostering positive impact.

Danish translation and linguistic validation of the LIMB-Q, a PROM for traumatic lower limb injuries and amputations

BackgroundThe LIMB-Q is a newly developed patient-reported outcome measure (PROM), applicable for lower extremity trauma patients requiring fracture treatment, soft tissue debridement, reconstruction, and/or amputation. The aim of this study was to translate and linguistically validate the LIMB-Q from English to Danish.MethodThe translation and linguistic validation were performed by combining guidelines from the World Health Organization (WHO) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). This approach involved 2 forward translations, a backward translation, an expert panel meeting, and 2 rounds of cognitive patient interviews. The main goal of these steps was to achieve a conceptual translation with simple and clear items. Feedback from the Danish translation was used in combination with psychometric analyses for item reduction of the final international version of LIMB-Q.ResultsIn the forward translation, 6 items were found difficult to translate into Danish. The two translations were harmonized to form the backward translation. From the backward translation, 1 item was identified with a conceptually different meaning and was re-translated. The revised version was presented at the expert panel meeting leading to revision of 10 items. The cognitive patient interviews led to revision of 11 items. The translation process led to a linguistically validated and conceptually equivalent Danish version of the LIMB-Q.ConclusionThe final Danish LIMB-Q version consisting of 16 scales is conceptually equivalent to the original and ready for field-testing in Denmark.Level of evidence: Not gradable.

Cross-Cultural Adaptation and Validation of a Marathi Version of the Versus Arthritis Musculoskeletal Health Questionnaire (MSK-HQ).

Introduction Musculoskeletal (MSK) well-being plays a crucial role in determining one's quality of life. Musculoskeletal Health Questionnaire (MSK-HQ) score is a tool recently developed by the Versus Arthritis group of Oxford University in English to measure MSK health. Marathi is a regional language in western India spoken by more than 100 million people. There is a scarcity of valid and reliable tools to measure MSK health in this language. Hence, we decided to cross-culturally adapt and translate MSK-HQ to Marathi. Method We translated MSK-HQ score to Marathi (MSK-HQ-Ma) as per the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. We tested its internal consistency, construct validity and reproducibility. It was compared with other health status scores EQ-5D-5L and overall health using the Visual Analogue Scale (VAS). Test-retest reliability was tested in those subjects who were having stable MSK health after two weeks. Results We recruited 158 consecutive subjects attending musculoskeletal clinics who had Marathi as their native language. Mean age was 44.8±17 years, females were 78 (49%).It showed good internal consistency (Cronbach's alpha = 0.95). For construct validity we found a strong correlation between MSK-HQ-Ma and EQ-5D-5L values (Spearman's r = 0.82, p<0.001). There was also a good correlation between MSK-HQ-Ma and overall health by VAS (Spearman's r = 0.76, p<0.001). An excellent test-retest reliability (Spearman's r = 0.94, p<0.001) was seen in 105 subjects who had stable MSK condition after two weeks of first appearance. Conclusion The MSK-HQ-Ma instrument has demonstrated good consistency, reliability and construct validity when evaluating the musculoskeletal health of individuals who can understand the Marathi language. Hence it can be used as a validated tool for the evaluation of musculoskeletal health in western India where Marathi is a commonly used language.

Cross-Cultural Adaptation, Reliability, and Validity Tests of the Thai Version of the Manchester-Oxford Foot Questionnaire in Individuals with Chronic Foot Pain

Objective: To adapt cross-culturally and examine the reliability and validity of the Thai version of MOXFQ (Thai-MOXFQ) among individuals with chronic foot pain. Material and Methods: The Thai-MOXFQ was successfully adapted cross-culturally from the original version with minor changes according to the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. Its reliability and construct validity were then investigated in individuals with chronic foot pain. The test-retest reliability was evaluated among 30 participants by calculating the intraclass correlation coefficient (ICC 3,1). Meanwhile, the internal consistency of the Thai-MOXFQ was studied in 100 participants by computing Cronbach’s alpha. Additionally, the construct validity was analyzed via Spearman’s rank correlation analysis to determine the relationship between the Thai-MOXFQ, Foot and Ankle Ability Measure (FAAM), 36-item Short-Form Health Survey (SF-36), and Visual Analogue Scale (VAS). Results: The Thai-MOXFQ demonstrated a good level of test-retest reliability (ICC of 0.763 to 0.885) and an acceptable level of internal consistency (Cronbach’s alpha of 0.738 to 0.871) when used in individuals with chronic foot pain. Moreover, the Thai-MOXFQ was shown to have moderate to strong relationships with FAAM, SF-36, and VAS (p-value&lt;0.05, Spearman rank correlation coefficients of 0.543 to 0.711). Furthermore, the results of the construct validity of the Thai version were in line with the original English and other translated versions. Conclusion: The Thai-MOXFQ is a reliable and valid, foot-specific, patient-reported outcome measurement (PROM) for assessing outcomes in individuals with chronic foot pain.

Danish translation, cross-cultural adaptation, and electronic migration of the World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonisation Project Endometriosis Patient Questionnaire.

This study aims to translate and cross-culturally adapt the standard version of the World Endometriosis Research Foundation (WERF) EPHect Endometriosis Patient Questionnaire (EPQ) into Danish and to ensure equivalence of a Danish electronic version. The translation, cultural adaption, and electronic migration followed recommendations from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Critical Path Institute. Ten women with endometriosis were enrolled for cognitive debriefing of the paper version (pEPQ) after translation and back translation. The questionnaire was then migrated into an electronic version (eEPQ) and subsequently tested for usability and measurement equivalence by five women with endometriosis. Cross-cultural alterations were needed for medical terms, response options for ethnicity, the educational system, and measurement units. Thirteen questions were altered after back translation, while 21 underwent minor changes after cognitive debriefing. After testing the eEPQ, 13 questions were altered. Questions tested for measurement equivalence across the two modes of administration were found comparable. The median time-to-complete the pEPQ and eEPQ was 62 min (range: 29-110) and 63 min (range: 31-88), respectively. General comments included the questionnaire being relevant but long and repetitive. We find the the Danish pEPQ and eEPQ similar and comparable to the original English instrument. However, attention must be drawn to questions regarding measurement units, ethnicity, and educational systems before cross-country comparison. The Danish pEPQ and eEPQ are suitable for obtaining subjective data on women with endometriosis.