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.

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.Electronic supplementary materialThe online version of this article (10.1186/s41687-018-0035-8) contains supplementary material, which is available to authorized users.

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.

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.

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.