scholarly journals International perspectives on suboptimal patient‐reported outcome trial design and reporting in cancer clinical trials: A qualitative study

2021 ◽  
Author(s):  
Ameeta Retzer ◽  
Melanie Calvert ◽  
Khaled Ahmed ◽  
Thomas Keeley ◽  
Jo Armes ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Qualitative Study ◽  
Trial Design ◽  
Patient Reported Outcome ◽  
Cancer Clinical Trials ◽  
International Perspectives ◽  
Patient Reported ◽  
Outcome Trial

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 PCN129 A DATABASE REVIEW OF PATIENT-REPORTED OUTCOME STUDIES IN EORTC CANCER CLINICAL TRIALS

2010 ◽  
Vol 13 (7) ◽  
pp. A276
Author(s):  
A Bottomley ◽  
C Quinten ◽  
M Mauer ◽  
M Taphoorn ◽  
HH Flechtner ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Reported Outcome ◽  
Outcome Studies ◽  
Cancer Clinical Trials ◽  
Patient Reported

The State of the Science in Patient-Reported Outcomes for Patients with Lung Cancer

2020 ◽  
Vol 41 (03) ◽  
pp. 377-385
Author(s):  
Canhua Xiao ◽  
Newton Hurst ◽  
Benjamin Movsas
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Clinical Decision Making ◽  
Treatment Effectiveness ◽  
Clinical Decision ◽  
Patient Reported Outcome ◽  
Cancer Clinical Trials ◽  
Cancer Type ◽  
Patient Reported ◽  
State Of The Science

AbstractTraditionally, clinicians have assumed the primary responsibility for evaluating disease- and treatment-related outcomes. In the past few decades, however, a series of recommendations and standards promulgated by professional societies and regulatory agencies have resulted in increased use of patient-reported outcome (PRO) measures in cancer clinical trials. PROs, such as quality of life (QOL) measures, are important in establishing overall treatment effectiveness in cancer clinical trials, and they can inform clinical decision making. This article discusses the current state of the science in PRO research for patients with lung cancer, the cancer type with the highest incidence rate and the lowest survival rate worldwide. The discussion focuses on (1) PRO and survival; (2) electronic PRO reporting and interventions; (3) PROs and immunotherapy; (4) PRO, biomarkers, and precision health; (5) key issues in applying PROs in clinical trials; and (6) future directions for research.

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

Funding Patient-Reported Outcomes in Cancer Clinical Trials

2007 ◽  
Vol 25 (32) ◽  
pp. 5100-5105 ◽  
Author(s):  
Carol M. Moinpour ◽  
Andrea M. Denicoff ◽  
Deborah Watkins Bruner ◽  
Alice B. Kornblith ◽  
Stephanie R. Land ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Trial Data ◽  
Patient Reported Outcome ◽  
National Institutes Of Health ◽  
Cancer Clinical Trials ◽  
Cooperative Groups ◽  
Funding Sources ◽  
Community Clinical Oncology Program ◽  
Patient Reported ◽  
Cost Components

We surveyed four cooperative groups to identify current funding sources for the collection and analysis effort associated with the inclusion of patient-reported outcome (PRO) data in cancer clinical trials. Survey questions included what proportion of staff effort was funded through the Cancer Therapy Evaluation Program (CTEP) and the Community Clinical Oncology Program (CCOP) grants. In addition, the groups were asked to what extent outside funding was solicited to cover an underfunded PRO effort (eg, the pharmaceutical industry, foundations, or National Institutes of Health grants). All four groups noted the challenge of making limited resources cover a number of trial responsibilities. PRO effort is usually bundled with effort required for all clinical trial data. There is variation in the use of the CTEP and CCOP grants to fund PRO research. The groups differed with respect to both the types and amount of outside funding used. This survey focused on funding sources for the conduct of PRO research in cooperative group trials; it did not assess the specific cost components associated with collecting and analyzing these data. In general, the costs for conducting PRO research have been bundled with other study costs because in most cases, the PRO has been considered an integral component of the trial. However, these data also suggest that PRO research has required the use of outside funding sources in the four surveyed cooperative groups and that PRO economic issues require attention if we are to continue the inclusion of these outcomes in cancer clinical trials.

scholarly journals Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

BMJ Open ◽  
2016 ◽  
Vol 6 (9) ◽  
pp. e012863 ◽  
Author(s):  
Khaled Ahmed ◽  
Derek Kyte ◽  
Thomas Keeley ◽  
Fabio Efficace ◽  
Jo Armes ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Study Protocol ◽  
Patient Reported Outcome ◽  
Systematic Evaluation ◽  
Cancer Clinical Trials ◽  
Patient Reported

scholarly journals Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e017282 ◽  
Author(s):  
Ameeta Retzer ◽  
Thomas Keeley ◽  
Khaled Ahmed ◽  
Jo Armes ◽  
Julia M Brown ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Research Collaboration ◽  
Patient Reported Outcome ◽  
Cancer Clinical Trials ◽  
Trial Management ◽  
National Cancer Research Institute ◽  
Patient Reported ◽  
Group Members ◽  
Cancer Trials ◽  
The Uk

IntroductionPatient-reported outcomes (PROs) are increasingly included within cancer clinical trials. If appropriately collected, analysed and transparently reported, these data might provide invaluable evidence to inform patient care. However, there is mounting indication that the design and reporting of PRO data in cancer trials may be suboptimal. This programme of research will establish via three interlinked studies whether these findings are applicable to UK cancer trials, and if so, how to best enhance the way PROs are assessed, managed and reported in clinical trials. This study will explore with key stakeholders factors that influence optimal PRO protocol content, implementation and reporting and make recommendations for training and guidance.Methods and analysisSemistructured interviews will be conducted with members of key stakeholder groups. The purposive sample of up to 48 participants will include: (1) trial chief investigators, trial management group members, statisticians and research nurses of cancer trials including primary or secondary PRO recruited via the National Cancer Research Institute (NCRI) Clinical Studies Group and Consumer Liaison Group and the UK Clinical Research Collaboration Registered UK Clinical Trial Unit Network; (2) NCRI Consumer Liaison Group members; (3) international experts in PRO oncology trial design; and (4) journal editors and funding bodies. Data will be analysed using directed thematic analysis employing a coding frame and modified as analysis progresses. Formal triangulation of coding and member checking will be employed to enhance credibility.Ethics and disseminationThis study was approved by the University of Birmingham Ethics Committee (Ref: ERN_17–0085). Findings will be disseminated via conference presentations, peer-reviewed journals, patient groups and social media (@CPROR_UoB;http://www.birmingham.ac.uk/cpror).PROSPERO registration numberCRD42016036533.

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