Inconsistencies in Quality of Life Data Collection in Clinical Trials: A Potential Source of Bias? Interviews with Research Nurses and Trialists

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, ga...

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Vydané v:PloS one Ročník 8; číslo 10; s. e76625
Hlavní autori: Kyte, Derek, Ives, Jonathan, Draper, Heather, Keeley, Thomas, Calvert, Melanie
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: United States Public Library of Science 04.10.2013
Public Library of Science (PLoS)
Predmet:
Bias
Cancer
Clinical trials
Clinical Trials as Topic - standards
Content analysis
Data Collection
Education
Ethics
Health care
Health care policy
Humans
Interviews
Medical personnel
Medical research
Methods
Nurses
Nursing research
Patients
Primary care
Qualitative analysis
Qualitative Research
Quality of Life
Research Design
Research Personnel
Researchers
Studies
Surveys and Questionnaires
Training
Well being
United Kingdom > UK
ISSN:1932-6203, 1932-6203
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Popis
Shrnutí: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. 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. 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.
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Competing Interests: The authors have declared that no competing interests exist.
Conceived and designed the experiments: DK JI HD MC. Performed the experiments: DK TK. Analyzed the data: DK JI HD MC. Wrote the manuscript: DK. Critiqued subsequent drafts each adding important intellectual content JI HD TK MC.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0076625