Non-English language validation of patient-reported outcome measures in cancer clinical trials

2020 ◽  
Vol 28 (6) ◽  
pp. 2503-2505 ◽  
Author(s):  
Stephen R. Grant ◽  
Sonal S. Noticewala ◽  
Walker Mainwaring ◽  
Timothy A. Lin ◽  
Austin B. Miller ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
English Language ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Cancer Clinical Trials ◽  
Patient Reported

scholarly journals Systematic review of the use of translated patient-reported outcome measures in cancer trials

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
A. L. Slade ◽  
A. Retzer ◽  
K. Ahmed ◽  
D. Kyte ◽  
T. Keeley ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Ethnic Group ◽  
Outcome Measures ◽  
Trial Design ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Recruitment Strategies ◽  
Cancer Clinical Trials ◽  
Patient Reported ◽  
The Impact

AbstractBackgroundPatient-reported outcomes (PROs) are used in clinical trials to assess the effectiveness and tolerability of interventions. Inclusion of participants from different ethnic backgrounds is essential for generalisability of cancer trial results. PRO data collection should include appropriately translated patient-reported outcome measures (PROMs) to minimise missing data and sample attrition.MethodsProtocols and/or publications from cancer clinical trials using a PRO endpoint and registered on the National Institute for Health Research Portfolio were systematically reviewed for information on recruitment, inclusion of ethnicity data, and use of appropriately translated PROMs. Semi-structured interviews were conducted with key stakeholders to explore barriers and facilitators for optimal PRO trial design, diverse recruitment and reporting, and use of appropriately translated PROMs.ResultsEighty-four trials met the inclusion criteria, only 14 (17%) (n = 4754) reported ethnic group data, and ethnic group recruitment was low, 611 (13%). Although 8 (57%) studies were multi-centred and multi-national, none reported using translated PROMs, although available for 7 (88%) of the studies.Interviews with 44 international stakeholders identified a number of perceived barriers to ethnically diverse recruitment including diverse participant engagement, relevance of ethnicity to research question, prominence of PROs, and need to minimise investigator burden. Stakeholders had differing opinions on the use of translated PROMs, the impact of trial designs, and recruitment strategies on diverse recruitment. Facilitators of inclusive research were described and examples of good practice identified.ConclusionsGreater transparency is required when PROs are used as primary or secondary outcomes in clinical trials. Protocols and publications should demonstrate that recruitment was accessible to diverse populations and facilitated by trial design, recruitment strategies, and appropriate PROM usage. The use of translated PROMs should be made explicit when used in cancer clinical trials.

scholarly journals Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Theresa M. Coles ◽  
Adrian F. Hernandez ◽  
Bryce B. Reeve ◽  
Karon Cook ◽  
Michael C. Edwards ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
Contextual Factors ◽  
The United States ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Think Tank ◽  
Level Of Evidence ◽  
Patient Reported ◽  
Evidentiary Standards

Abstract Objectives There has been limited success in achieving integration of patient-reported outcomes (PROs) in clinical trials. We describe how stakeholders envision a solution to this challenge. Methods Stakeholders from academia, industry, non-profits, insurers, clinicians, and the Food and Drug Administration convened at a Think Tank meeting funded by the Duke Clinical Research Institute to discuss the challenges of incorporating PROs into clinical trials and how to address those challenges. Using examples from cardiovascular trials, this article describes a potential path forward with a focus on applications in the United States. Results Think Tank members identified one key challenge: a common understanding of the level of evidence that is necessary to support patient-reported outcome measures (PROMs) in trials. Think Tank participants discussed the possibility of creating general evidentiary standards depending upon contextual factors, but such guidelines could not be feasibly developed because many contextual factors are at play. The attendees posited that a more informative approach to PROM evidentiary standards would be to develop validity arguments akin to courtroom briefs, which would emphasize a compelling rationale (interpretation/use argument) to support a PROM within a specific context. Participants envisioned a future in which validity arguments would be publicly available via a repository, which would be indexed by contextual factors, clinical populations, and types of claims. Conclusions A publicly available repository would help stakeholders better understand what a community believes constitutes compelling support for a specific PROM in a trial. Our proposed strategy is expected to facilitate the incorporation of PROMs into cardiovascular clinical trials and trials in general.

scholarly journals International guidance on the selection of patient-reported outcome measures in clinical trials: a review

2020 ◽  
Author(s):  
Norah L. Crossnohere ◽  
Michael Brundage ◽  
Melanie J. Calvert ◽  
Madeleine King ◽  
Bryce B. Reeve ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Selection Of

Gaps in patient-reported outcome measures in randomized clinical trials of cardiac catheter ablation: a systematic review

2020 ◽  
Vol 6 (4) ◽  
pp. 234-242
Author(s):  
Yang Chen ◽  
Myura Nagendran ◽  
Manuel Gomes ◽  
Peter V Wharton ◽  
Rosalind Raine ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Catheter Ablation ◽  
Outcome Measures ◽  
Comparative Effectiveness ◽  
Randomized Clinical Trials ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Cardiac Catheter ◽  
Patient Reported

Abstract The aim of this systematic review was to evaluate randomized clinical trials (RCTs) of cardiac catheter ablation (CCA) and to assess the prevalence, characteristics and reporting standards of clinically relevant patient-reported outcome measures (PROMs). Electronic database searches of Medline, Embase, CENTRAL, and the WHO Trial Registry were conducted in March 2019. The study protocol was registered on PROSPERO (CRD42019133086). Of 7125 records identified, 237 RCTs were included for analysis, representing 35 427 patients with a mean age of 59 years. Only 43 RCTs (18%) reported PROMs of which 27 included a generic PROM that measured health-related quality of life (HRQL) necessary to conduct comparative effectiveness research. There was notable under-representation of certain patient groups—only 31% were women and only 8% were of non-Caucasian ethnicity, in trials which reported such data. The reporting standard of PROMs was highly variable with 8–62% adherence against CONSORT PRO-specific items. In summary, PROMs play a crucial role in determining the clinical and cost-effectiveness of treatments which primarily offer symptomatic improvement, such as CCA. Their underuse significantly limits evaluation of the comparative effectiveness of treatments. Using CCA as an exemplar, there are additional issues of infrequent assessment, poor reporting and under-representation of many population groups. Greater use of PROMs, and specifically validated HRQL questionnaires, is paramount in giving patients a voice in studies, generating more meaningful comparisons between treatments and driving better patient-centred clinical and policy-level decision-making.

scholarly journals A systematic review of patient-reported outcome measures in paediatric otolaryngology

2017 ◽  
Vol 132 (1) ◽  
pp. 2-7 ◽  
Author(s):  
J Powell ◽  
S Powell ◽  
A Robson
Keyword(s):  
Outcome Measures ◽  
English Language ◽  
Health Assessment ◽  
Paediatric Population ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Specific Patient ◽  
Patient Reported ◽  
The Impact

AbstractBackground:Recently, there has been increased emphasis on the development and application of patient-reported outcome measures. This drive to assess the impact of illness or interventions, from the patient's perspective, has resulted in a greater number of available questionnaires. The importance of selecting an appropriate patient-reported outcome measure is specifically emphasised in the paediatric population. The literature on patient-reported outcome measures used in paediatric otolaryngology was reviewed.Methods:A comprehensive literature search was conducted using the databases Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, and PsycInfo, using the terms: ‘health assessment questionnaire’, ‘structured questionnaire’, ‘questionnaire’, ‘patient reported outcome measures’, ‘PROM’, ‘quality of life’ or ‘survey’, and ‘children’ or ‘otolaryngology’. The search was limited to English-language articles published between 1996 and 2016.Results:The search yielded 656 articles, of which 63 were considered relevant. This included general paediatric patient-reported outcome measures applied to otolaryngology, and paediatric otolaryngology disease-specific patient-reported outcome measures.Conclusion:A large collection of patient-reported outcome measures are described in the paediatric otolaryngology literature. Greater standardisation of the patient-reported outcome measures used in paediatric otolaryngology would assist in pooling of data and increase the validation of tools used.

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