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.

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.

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.

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.

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.

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.