Skip to main content


We’d like to understand how you use our websites in order to improve them. Register your interest.

Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists


To explore reported inconsistencies in health related quality of life (HRQL) data collection in clinical trials.


Semi-structured interviews were conducted with research nurses, data managers and trial coordinators involved in the collection of HRQL data in clinical trials. Recruitment took place across five sites in the UK: one primary care and two secondary care NHS trusts, and two clinical trials units. We used conventional content analysis, including methods of constant comparison and deviant case analysis, to analyze and interpret our data. Several processes were employed to ensure rigor, including regular team meetings aimed at facilitating reflexivity, member checking of interview summaries, peer review of verbatim interview transcripts and formal triangulation of coding.


26 individuals were interviewed. 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 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 and training. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training aimed at supporting researchers to carry out high quality data collection.

Author information



Corresponding author

Correspondence to Derek Kyte.

Rights and permissions

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Reprints and Permissions

About this article

Cite this article

Kyte, D., Ives, J., Draper, H. et al. Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists. Trials 14, O56 (2013).

Download citation


  • Secondary Care
  • Research Nurse
  • Clinical Trial Unit
  • Trial Coordinator
  • Trial Staff


By submitting a comment you agree to abide by our Terms and Community Guidelines. If you find something abusive or that does not comply with our terms or guidelines please flag it as inappropriate. Please note that comments may be removed without notice if they are flagged by another user or do not comply with our community guidelines.