Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures.

Within current literature and practice, the category of patient-reported outcome (PRO) measures has been expanded into the broader category of clinical outcome assessments (COAs), which includes the subcategory of PRO, as well as clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO) measure subcategories. However, despite this conceptual expansion, recommendations associated with translation, cultural adaptation, and linguistic validation of COAs remain focused on PRO measures, which has created a gap in specific process recommendations for the remaining types. This lack of recommendations has led to inconsistent approaches being implemented, leading to uncertainty in the scientific community regarding suitable methods. To address this gap, the ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) has developed recommendations specific to each of the three COA types currently lacking such documentation to support a standardized approach to their translation, cultural adaptation, and linguistic validation. The recommended process utilized to translate ObsRO, ClinRO and PerfO measures from one language to another aligns closely with the industry standard process for PRO measures. The substantial differences between respondent categories across COA types require targeted approaches to the cognitive interviewing procedures utilized within the linguistic validation process, including the use of patients for patient-facing text in ClinRO measures, and the need to interview the targeted observers for ObsROs measures.

To what degree are orphan drugs patient-centered? A review of the current state of clinical research in rare diseases.

BACKGROUND: Over the past 30 years, the healthcare industry has increasingly turned its attention to rare diseases. Regulators have emphasized the need for clinical research in this area to be patient-centered. However, there is a lack of evidence concerning whether this need is actually met. In this paper, we aim to address this gap. METHODS: First, we describe the state of patient-centricity in clinical research in rare diseases based on a targeted literature review. Second, we discuss recommendations from scientific bodies on patient-reported outcome (PRO) measures in rare diseases. Third, we analyze data collected from EMA's and FDA's websites concerning rare disease labeling claims and data from Clinicaltrials.gov concerning the use of PRO measures in rare disease pivotal trials. Fourth, we perform an exhaustive literature review on the use of PRO measures in the pharmaceutical industry, including all phases of clinical research, observational/registry studies, and instrument development and validation. RESULTS: There is limited information on rare disease patient engagement in study design, recruitment, and retention. None of the initiatives describing methods for developing PRO measures in rare diseases provide the clear guidance clinical researchers need. Only 17.4% of orphan drug labels contain a PRO measure. Less than half of pivotal trials in orphan drugs have a PRO measure as a primary or a secondary endpoint. Although the number of publications about PRO measures in rare diseases has risen in the past fifteen years, our results indicate that substantial improvements are needed to achieve patient-centricity. CONCLUSIONS: The nature and extent of patient engagement in rare disease research is under-documented. The current paradigm for developing and using PRO measures in clinical research is failing to meet the needs of rare disease patients. Not only are PROs rarely used as high-level endpoints in clinical trials or taken into account in labeling claims, they are also under-researched overall - there are too few measures for the multitude of rare diseases. We call for a clear guidance on patient engagement and suggest a realistic approach to the adaptation of PRO strategy to the specific context of clinical research in rare diseases.

Clinical and linguistic validation of the Polish version of VascuQol: a disease-specific quality-of-life questionnaire assessing patients with chronic limb ischemia

INTRODUCTION Objective clinical assessments should include patient­reported outcome measures. VascuQol is an established disease­specific questionnaire assessing the quality of life in patients with peripheral artery disease (PAD). Quality­of­life questionnaires require geographical localization and validation. OBJECTIVES The goal of this study was to validate the Polish version of the VascuQol: a patient­reported health­related quality­of­life (HRQoL) instrument specific for PAD. PATIENTS AND METHODS The linguistic validation of VascuQol followed Mapi Institute methodology. Clinical validation process compared VascuQol, EQ­5D­3L, and SF­36 questionnaires in 100 patients with both intermittent claudication and critical limb­threatening ischemia. Cronbach α coefficients for reliability, receiver operating characteristic curves for clinical discriminative performance, standardized response means for responsiveness, and Pearson correlations for construct validity were evaluated. Additionally, in a separate cohort of 58 patients with stable disease, the test­retest was characterized with intraclass correlation, Bland­Altman analysis, and Pearson correlation coefficients. RESULTS VascuQol proved to perform better than SF­36 and EQ­5D­3L. Cronbach α coefficients showed good internal consistency (α values >0.9 for all summary scores). All test­retest Pearson r values for VascuQol were above 0.70. The intraclass correlation of absolute agreement consistency exceeded 0.8. The Bland­Altman 95% limits of agreement were between 2.72 and 4.87. There were strong and moderate correlations for total scores in all domains between VascuQol and SF­36, and for most of the domains between VascuQol and EQ­5D­3L. CONCLUSIONS The Polish version of VascuQol is a sensitive, accurate, and reliable tool for assessing HRQoL in patients with PAD.

Linguistic Validation of the Phenylketonuria - Quality of Life (PKU-QOL) Questionnaire Into Brazilian Portuguese

Abstract The phenylketonuria - quality of life (PKU-QOL) questionnaire was developed to assess the impact of phenylketonuria (PKU) and its treatment on the health-related quality of life (HRQL) of patients and their caregivers. Available in four versions (child, adolescent, adult and parent), it was developed and validated in eight countries. The objective of this study was to linguistically validate the PKU-QOL questionnaire in Brazilian Portuguese for use in Brazil by clinicians who take care of PKU patients. The translation method used a standard linguistic validation process. The British English version served as a basis for translation. No major cultural or semantic issues were found during the process. The main difficulty was the use of the acronym "PKU" in the first translations. During the cognitive interviews, respondents made the confusion between the disease itself and the food supplement since it is written "PKU" or "COMIDA-PKU" on the packaging of the product. To overcome this issue, it was decided to use fenilcetonuria (fenil) or fenil alone throughout all versions. The PKU-QOL will be valuable for Brazilian healthcare providers in individualizing treatment and managing patients with PKU.

Reflection paper on copyright, patient-reported outcome instruments and their translations.

With the growth of patient-reported outcome (PRO) measurement, questions arise regarding how copyright protection applies to PRO instruments in general and to their translations in particular. The main objectives of this reflection paper are: 1) to help authors of PRO instruments understand basic rules of intellectual property and copyright that protect the integrity of their instruments and derivatives; and 2) to provide recommendations to authors and users of PRO instruments to prevent misuse or abuse.National laws on intellectual property (IP) and the international Berne Convention fully apply to PRO instruments since they are creations of the mind. Therefore, the copyright holder / owner / claimant of a PRO instrument, i.e., the person or legal entity who owns the copyright of the instrument, is granted exclusive rights that are divided into two main categories: moral and economic rights. Moral rights are: 1) the right of attribution (or right of paternity), i.e., the right to claim authorship of the work, 2) the right against false attribution, and 3) the right of integrity, i.e., the right to object to any mutilation, deformation or modification of the work. Economic rights represent the exclusive rights of the author to make or authorize reproduction, development of derivative works, distribution and communication to the public. In other words, the PRO instrument's copyright holder controls access (distribution, reproduction), and authorizes all derivative works, i.e., adaptations (e.g., electronic formats), modifications (e.g., shorter versions), and translations. Hence, the access to and use of an original PRO instrument and its derivatives in any kind of research should always be associated with the identification of its copyright holder. However, in some cases, this identification may be challenging, in particular when copyright ownership is not clearly defined. To prevent ownership conflicts as well as misuse or abuse of PRO instruments, the ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) provides recommendations to authors of PRO instruments and their users. In particular, the TCA-SIG recommends that the ownership of PRO instruments and their derivatives should be defined from the beginning (i.e., from the development of the instrument) and along the life cycle of the instrument between all parties involved. These recommendations apply not only to PRO instruments but also to all the other clinical outcome assessments (COAs), since they are also creations of the mind.

Assessing patients' acceptance of their medication to reveal unmet needs: results from a large multi-diseases study using a patient online community.

BACKGROUND: Patients with chronic conditions are required to take long-term treatments for their disease itself or to prevent any potential health risks. Measuring patient acceptance of their medication should help to better understand and predict patients' behavior toward treatment. This study aimed to describe the level of patient acceptance toward various long-term treatments in real life using an online patient community. METHODS: This was an observational, cross-sectional study conducted through the French Carenity platform. All Carenity patient members were invited to complete an online questionnaire including the 25-item ACCEptance by the Patients of their Treatment (ACCEPT©) questionnaire. ACCEPT© measures patient acceptance toward their medication and includes one general acceptance dimension (Acceptance/General) and six treatment-attribute specific dimensions (scores 0-100; lowest to highest acceptance): Acceptance/Medication Inconvenience, Acceptance/Long-term Treatment, Acceptance/Regimen Constraints, Acceptance/Side effects, Acceptance/Effectiveness, and Acceptance/Numerous Medications. Patients included in the analysis were treated adults experiencing any chronic diseases and who responded to at least one ACCEPT© item. RESULTS: Among the 4193 patients included in the analysis, more than 270 chronic diseases were represented, amidst which 19 included more than 30 patients. Mean ACCEPT© Acceptance/General score for those 19 diseases were 61.2 (SD = 31.9) for type 1 diabetes, 59.8 (SD = 32.3) for asthma, 56.3 (SD = 34.3) for hypertension, 52.0 (SD = 32.2) for chronic obstructive pulmonary disease, 51.7 (SD = 27.0) for epilepsy, 50.1 (SD = 33.1) for bipolar disorder, 49.9 (SD = 33.1) for type 2 diabetes, 48.6 (SD = 31.6) for multiple sclerosis, 46.1 (SD = 34.5) for Crohn's disease/ulcerative colitis, 44.3 (SD = 31.5) for depression, 42.8 (SD = 31.5) for lupus, 42.3 (SD = 33.0) for arthrosis, 41.8 (SD = 32.6) for Parkinson's disease, 40.5 (SD = 32.2) for rheumatoid arthritis, 38.6 (SD = 31.7) for breast cancer, 36.4 (SD = 36.4) for myocardial infarction, 35.8 (SD = 32.0) for ankylosing spondylitis, 34.1 (SD = 32.3) for psoriasis, and 33.7 (SD = 31.7) for fibromyalgia. CONCLUSIONS: This first of its kind study enabled ACCEPT© data to be collected in real life for a variety of chronic diseases. These data may help in evaluating and interpreting levels of acceptance in future studies and provide valuable insights about patient priorities and current unmet needs.

Integrating Qualitative and Quantitative Data in the Development of Outcome Measures: The Case of the Recovering Quality of Life (ReQoL) Measures in Mental Health Populations.

While it is important to treat symptoms, there is growing recognition that in order to help people with mental health problems lead meaningful and fulfilling lives, it is crucial to capture the impact of their conditions on wider aspects of their social lives. We constructed two versions of the Recovering Quality of Life (ReQoL) measure—ReQoL-10 and ReQoL-20—for use in routine settings and clinical trials from a larger pool of items by combining qualitative and quantitative evidence covering six domains. Qualitative evidence was gathered through interviews and focus groups with over 76 service users, clinicians, and a translatability assessment. Psychometric evidence generated from data from over 6200 service users was obtained from confirmatory factor models and item response theory analyses. In this paper we present an approach based on a traffic light pictorial format that was developed to present qualitative and quantitative evidence to a group of service users, clinicians, and researchers to help to make the final selection. This work provides a pragmatic yet rigorous approach to combining qualitative and quantitative evidence to ensure that ReQoL is psychometrically robust and has high relevance to service users and clinicians. This approach can be extended to the development of patient reported outcome measures in general.

Developing fit-for-purpose self-report instruments for assessing consumer responses to tobacco and nicotine products: the ABOUT™ Toolbox initiative.

Background. Determining the public health impact of tobacco harm reduction strategies requires the assessment of consumer perception and behavior associated with tobacco and nicotine products (TNPs) with different exposure and risk profiles. In this context, rigorous methods to develop and validate psychometrically sound self-report instruments to measure consumers' responses to TNPs are needed. Methods. Consistent with best practice guidelines, including the U.S. Food and Drug Administration's "Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims," scientifically designed, fit-for-purpose, reliable, and valid instruments are now being applied to tobacco regulatory research. Results. This brief report presents the ABOUT™ Toolbox ( Assessment of Behavioral OUtcomes related to Tobacco and nicotine products) initiative. This communication: (1) describes the methodological steps followed for the development and validation of the measurement instruments included in the ABOUT™ Toolbox, (2) presents a summary of the high-priority tobacco-related domains that are currently covered in the ABOUT™ Toolbox (i.e., risk perception, dependence, product experience, health and functioning, and use history), and (3) details how the measurement instruments are made accessible to the scientific community. Conclusions. By making the ABOUT™ Toolbox available to the tobacco research and public health community, we envision a rapidly expanding knowledge base, with the goals of (1) supporting consumer perception and behavior research to allow comparisons across a wide spectrum of TNPs, (2) enabling public health and regulatory communities to make better-informed decisions for future regulation of TNPs, and (3) enhancing surveillance activities associated with the impact of TNPs on population health.

Development of the US English version of the phenylketonuria - quality of life (PKU-QOL) questionnaire.

BACKGROUND: Phenylketonuria (PKU) is a rare genetic disorder caused by a defect in the metabolism of phenylalanine (PHE) resulting in elevated blood and brain PHE levels, and leading to cognitive, emotional, and psychosocial problems. The phenylketonuria - quality of life (PKU-QOL) questionnaire was the first self-administered disease-specific instrument developed to assess the impact of PKU and its treatment on the health-related quality of life (HRQL) of patients and their caregivers. Available in four versions (child, adolescent, adult and parent), the PKU-QOL was simultaneously developed and validated in seven countries [i.e., France, Germany, Italy, The Netherlands, Spain, Turkey and the United Kingdom (UK)]. The objectives of our study were to develop and linguistically validate the PKU-QOL questionnaire for use in the United States (US). METHODS: The UK versions served as a basis for the development of the US English PKU-QOL questionnaire. The linguistic validation process consisted of 4 steps: 1) adaptation of the UK versions into US English by a translator native of US English and living in the US; 2) a clinician review; 3) cognitive interviews with patients and caregivers to test the appropriateness, understandability and clarity of the US translations; and 4) two proof-readings. RESULTS: The adaptation from UK to US English revealed the usual syntactic and idiomatic differences between the two languages, such as differences in: 1) Spelling, e.g., "dietician" (UK) vs. "dietitian" (US), or "mum" (UK) vs. "mom" (US); 2) Syntax or punctuation; and 3) Words/expressions use, e.g., "holidays" (UK) vs. "vacation" (US), or "biscuits" (UK) vs. "crackers" (US). The major issue was cultural, and consisted of using a different terminology to describe PKU treatment throughout the questionnaires. The clinician, with the patients and the caregivers, during the interviews suggested to replace "supplement and amino-acid mixture" or "supplements" with "medical formula." This wording was later changed to "medical food" to be consistent with the terminology used in current US published guidelines. CONCLUSIONS: The translation of the UK English PKU-QOL questionnaire into US English did not raise critical semantic and cultural issues. The PKU-QOL will be valuable for US healthcare providers in individualizing treatment and managing patients with PKU.

Emerging good practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) measures.

This paper presents emerging Good Practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) Measures. The ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) undertook the review of several TA approaches, with the collaboration of organizations who are involved in conducting TA, and members of the TCA-SIG. The effort led to agreement by the writing group on Good Practices for 1) the terminology to be used in referring to translatability process, 2) the best definition of TA, 3) the methodology that is recommended at each step of the process, 4) the persons involved in TA, 5) the timing of assessment, 6) the review criteria for TA, and 7) the recommendations to be made at the end of the TA process. With input from the TCA-SIG membership and in consultation with experts in the field, these emerging good practices can guide the future use of TA in the development of PROs.

Item Reduction, Scoring, and First Validation of the ACCEPTance by the Patients of their Treatment (ACCEPT©) Questionnaire.

OBJECTIVES: The objectives of this study were to finalize, develop the scoring, and explore the psychometric properties of the ACCEPTance by the Patients of their Treatment (ACCEPT©) questionnaire, as well as to provide the first elements for its interpretation and guidance for its future use. METHODS: ACCEPT© was finalized according to reference methods including testing in a pilot study, i.e., a multi-center, observational, longitudinal study conducted in France, in collaboration with a network of pharmacists. Principal component analysis using Varimax rotation was performed. The loadings of items on components in the principal component analysis were used to inform item selection. Validity of the measurement model of ACCEPT© was confirmed using Multi-trait/Multi-item Analysis based on item-scale Spearman correlations. Internal consistency reliability of the questionnaire was assessed by determining the Cronbach's α coefficient. Linear and logistic regressions were used to identify predictors of general acceptance, and to study predictors of persistence. RESULTS: A total of 189 patients were included. The final version of ACCEPT© is composed of 25 items, distributed in seven dimensions providing a comprehensive appraisal of acceptance of long-term medication, with six scores measuring acceptance of treatment specific attributes and one score measuring general treatment acceptance. The measurement properties of ACCEPT© were overall fairly satisfactory. Regressions showed that Acceptance/Effectiveness is a predictor of general acceptance. However, no predictor of persistence could be identified. CONCLUSION: The self-administered ACCEPT© questionnaire is a valid and reliable instrument for the assessment of patients' acceptance of long-term medication. Disease-specific and large prospective studies are needed to assess the ability of ACCEPT

Patient-reported outcomes in drug development for hematology.

Patient-reported outcomes (PROs) are any outcome evaluated directly by the patient himself and based on the patient's perception of a disease and its treatment(s). PROs are direct outcome measures that can be used as clinical meaningful endpoints to characterize treatment benefit. They provide unique and important information about the effect of treatment from a patient's view. However, PROs will only be considered adequate if the assessment is well-defined and reliable. In 2009, the FDA has issued a guidance, which defines good measurement principles to consider for PRO measures intended to give evidence of treatment benefit in drug development. In hematologic clinical trials, when applied rigorously, they may be used to evaluate overall treatment effectiveness, treatment toxicity, and quality of patient's well-being at short-term and long-term after treatment from a patient's perspective. In situations in which multiple treatment options exist with similar survival outcome or if a new therapeutic strategy needs to be evaluated, the inclusion of PROs as an endpoint can provide additional data and help in clinical decision making. Given the diversity of the hematological field, the approach to measurement needs to be tailored for each specific situation. The importance of PROs in hematologic diseases has been highlighted in a number of international recommendations. In addition, new perspectives in the regulatory field will enhance the inclusion of PRO endpoints in clinical trials in hematology, allowing the voice of the patients with hematologic diseases to be taken into greater consideration in the development of new drugs.

Cross-cultural adaptation of the Schizophrenia Caregiver Questionnaire (SCQ) and the Caregiver Global Impression (CaGI) Scales in 11 languages.

BACKGROUND: The Schizophrenia Caregiver Questionnaire (SCQ) was developed to provide a comprehensive view of caregivers' subjective experiences of the impacts of caring for someone with schizophrenia. The Caregiver Global Impression (CaGI) scales were designed to assess their perception of the severity of the schizophrenia symptoms, of change in schizophrenia symptoms and in the experience of caring since the beginning of the study. The objectives of the study were to translate the SCQ and CaGI scales in 11 languages [French (Canada, France), English (Canada, UK, Australia), German (Germany), Italian (Italy), Spanish (Spain), Dutch (the Netherlands), Finnish (Finland), and Swedish (Sweden)], to present evidence that the translations capture the concepts of the original questionnaires and are well understood by caregivers of patients with schizophrenia in each target country. METHODS: The different language versions were developed using a standard or adjusted linguistic validation process fully complying with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recommended procedures. RESULTS: Interviews were conducted with 55 caregivers of patients with schizophrenia from 10 countries representing the 11 different languages. Participants ranged in age from 28 to 84 years and had 5 to 16 years of education. Women represented 69.1 % (38/55) of the sample. Fourteen out of the 32 items of the SCQ generated difficulties which were mostly of semantic origin (13 items). The translation of the CaGI scales did not raise any major difficulty. Only five out of the 55 caregivers had difficulty understanding the meaning of the translations of "degree" in the expressions "degree of change in experience of caring" and "degree of change in symptoms". CONCLUSIONS: Translations of the SCQ and CaGI scales into 11 languages adequately captured the concepts in the original English versions of the questionnaires, thereby demonstrating the conceptual, semantic, and cultural equivalence of each translation.

Interviewing to develop Patient-Reported Outcome (PRO) measures for clinical research: eliciting patients' experience.

Patient-reported outcome (PRO) measures must provide evidence that their development followed a rigorous process for ensuring their content validity. To this end, the collection of data is performed through qualitative interviews that allow for the elicitation of in-depth spontaneous reports of the patients' experiences with their condition and/or its treatment. This paper provides a review of qualitative research applied to PRO measure development. A clear definition of what is a qualitative research interview is given as well as information about the form and content of qualitative interviews required for developing PRO measures. Particular attention is paid to the description of interviewing approaches (e.g., semi-structured and in-depth interviews, individual vs. focus group interviews). Information about how to get prepared for a qualitative interview is provided with the description of how to develop discussion guides for exploratory or cognitive interviews. Interviewing patients to obtain knowledge regarding their illness experience requires interpersonal and communication skills to facilitate patients' expression. Those skills are described in details, as well as the skills needed to facilitate focus groups and to interview children, adolescents and the elderly. Special attention is also given to quality assurance and interview training. The paper ends on ethical considerations since interviewing for the development of PROs is performed in a context of illness and vulnerability. Therefore, it is all the more important that, in addition to soliciting informed consent, respectful interactions be ensured throughout the interview process.

Usefulness of translatability assessment: results from a retrospective study.

PURPOSE: The purpose of the study is to evaluate the extent to which a retrospectively conducted translatability assessment (TA) could identify the items previously singled out during the validation study as having poor content validity or poor measurement performance. This study was performed with the intent of supporting evidence of the usefulness of TA early in the PRO development process. The Weight module of the Youth Quality-of-Life Instrument (YQOL-W) was used for this appraisal of translatability. METHODS: Two linguists, blinded to the design and results of content validation and psychometric analyses, conducted a TA on the 32-item version of the YQOL-W taken into cross-sectional validation for item reduction. TA results were categorized into (1) issues relating to target culture (cross-cultural issues) and (2) issues relating to the structure of the original questionnaire (structural issues). Items for possible revision or deletion were identified. We compared the results of the TA with the content validity and psychometric results and decisions to eliminate items after cross-sectional validation. RESULTS: Content validation identified seven of the 32 items to be dropped, and psychometric analyses including the 25 remaining items highlighted an additional four to be eliminated, yielding a final instrument with 21 items. Out of these 11 dropped items, TA had identified nine as problematic (82 %) and the developer was advised to drop five of them (45.4 %). In addition, TA results highlighted the need to change the original formulation of eight items for semantic reasons and identified two instances where alternative wording should be used for translation purposes without any change to the original formulation. CONCLUSION: Our study showed that translatability assessment confirmed problematic issues in items previously identified as having poor content validity or poor measurement performance. In general, a translatability assessment offers the possibility for the identification of alternative formulations for translation purposes, modifications of original formulations to optimize subsequent translations efforts, and the early detection and discussion of irrelevant or inappropriate items.

Questions of copyright.

The Berne Convention and the national laws on intellectual property fully apply to PRO instruments. The identification of and access to an original PRO instrument is often associated with copyright ownership. This is the copyright holder of the instrument who will control its access (distribution and reproduction), its adaptation or modification, and its translation. Copyright is a means to protect the integrity of an instrument. The ownership of an instrument should be defined in the beginning between all parties involved, and each step of the instrument's life, including distribution, should be anticipated for purpose of copyright.

Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials.

OBJECTIVES: We conducted a literature review to respond to regulatory concerns about the quality of translated patient-reported outcome questionnaires. Our main objective was to answer two questions: What do the methods have in common (and how do they differ)? Is there evidence of the superiority of one method over another? METHODS: We identified 891 references by searching MEDLINE, Embase, and the Mapi Research Trust's database with "quality-of-life,""questionnaires,""health status indicators" matched with "translating,""translation issues,""cross-cultural research," and "cross-cultural comparison." Articles were included if they proposed, compared or criticized translation methods. RESULTS: Forty-five articles met our inclusion criteria: 23 representing 17 sets of methods, and 22 reviews. Most articles recommend a multistep approach involving a centralized review process. Nevertheless, each group proposes its own sequence of translation events and weights each step differently. There is evidence demonstrating that a rigorous and a multistep procedure leads to better translations. Nevertheless, there is no empirical evidence in favor of one specific method. CONCLUSIONS: We need more empirical research on translation methodologies. Several points emerge from this review. First, producing high-quality translations is labor-intensive. Second, the availability of standardized guidelines and centralized review procedures improves the efficiency of the production of translations. Although we did not find evidence in favor of one method, we strongly advise researchers to adopt a multistep approach. In line with the recent Food and Drug Administration recommendations, we developed a checklist summarizing the steps used for translations, which can be used to evaluate the rigor of the applied methodologies.

Translating overactive bladder questionnaires in 14 languages.

OBJECTIVES: Overactive bladder (OAB) affects millions of people worldwide. Identifying patients and measuring OAB's impact on symptom severity and patients' health-related quality-of-life is necessary to ensure proper treatment and facilitate communication among patients, clinicians, and caregivers. To accomplish this, the Overactive Bladder questionnaire (OAB-q) and its subsets instruments, the OAB-q Short-Form and the OAB-V8, were developed in U.S. English. To measure the impact of OAB cross-culturally, we performed the linguistic validation of these instruments in Danish, English (Canada), French (Canada and France), Italian (Switzerland), German (Switzerland), Korean, Norwegian, Polish, Portuguese (Brazil), Romanian, Swedish, and Turkish. The linguistic validation was conducted following a rigorous method to ensure conceptual equivalence between the original and its translations. METHODS: In each country, a specialist monitored the process, which included six steps: (1) two forward translations; (2) comparison and reconciliation of the translations; (3) back-translation; (4) comparison of the source and back-translation; (5) review by one urologist or gynecologist; and (6) a comprehension test using patients. RESULTS: The translation of symptom-related adjectives such as "uncomfortable," "sudden," "accidental," "uncontrollable" proved challenging. The subtle differences in the meaning of symptomatic items increased the difficulties to find equivalents. Issues regarding the appropriateness of certain concepts and idiomatic terms emerged during cognitive debriefing. The terms "urge," "desire," "urination," "commute," "drowsy," and "escape routes" were not retained literally and were replaced by colloquial expressions. CONCLUSIONS: The 14 versions of the OAB-q, OAB-q Short-Form, and OAB-V8 were successfully validated linguistically to facilitate data collection cross-culturally and the international comparison of symptom bother and health-related quality of life in patients with OAB.