Projects per year
Abstract
BACKGROUND: Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem.
METHODS AND FINDINGS: We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden.
CONCLUSIONS: Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting researchers to carry out high quality data collection.
Original language | English |
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Article number | e76625 |
Journal | PLoS ONE |
Volume | 8 |
Issue number | 10 |
DOIs | |
Publication status | Published - 4 Oct 2013 |
Keywords
- Bias (Epidemiology)
- Clinical Trials as Topic
- Data Collection
- Humans
- Qualitative Research
- Quality of Life
- Questionnaires
- Research Design
- Research Personnel
ASJC Scopus subject areas
- General Agricultural and Biological Sciences
- General Biochemistry,Genetics and Molecular Biology
- General Medicine
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- 1 Finished
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Linked to a/c DJAB RRAK13548 - Midland Hub for Trials Methodology Research at University of Birmingham
Billingham, L., Bryan, S., Calvert, M., Deeks, J., Delaney, B., Freemantle, N., Gray, R., Hobbs, R., Johnson, P., Lilford, R., Wheatley, K. & Zeegers, M.
1/06/09 → 31/05/14
Project: Research Councils