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Abstract
Objectives Patient-reported outcome measures (PROMs) collected in clinical trials should be administered in a standardised way across sites and routinely screened for avoidable missing data in order to maximise data quality/minimise risk of bias. Recent qualitative findings, however, have raised concerns about the consistency of PROM administration in UK trials. The purpose of this study was to determine the generalisability of these findings across the wider community of trial personnel.
Design Online cross-sectional survey.
Setting Participants were recruited from 55 UK Clinical Research Collaboration Registered Clinical Trials Units and 19 Comprehensive Local Research Networks.
Participants Research nurses, data managers/coordinators, trial managers and chief/principal investigators involved in clinical trials collecting PROMs.
Analysis We undertook descriptive analyses of the quantitative data and directed thematic analysis of free-text comments. Factors associated with the management of missing PRO data were explored using logistic regression.
Results Survey data from 767 respondents supported the generalisability of qualitative study findings, suggesting inconsistencies in PROM administration with regard to: the level of assistance given to trial participants; the timing of PROM completion in relation to the clinical consultation; and the management of missing data. Having ≥10 years experience in a research role was significantly associated with the appropriate management of missing PROM data (OR 2.26 (95% CI 1.06 to 4.82), p=0.035). There was a consensus that more PROM guidance was needed in future trials and agreement between professional groups about the necessary components.
Conclusions There are inconsistencies in the way PROMs are administered by trial staff. Such inconsistencies may reduce the quality of data and have the potential to introduce bias. There is a need for improved guidance in future trials that support trial personnel in conducting optimal PROM data collection to inform patient care.
- Survey
- patient-reported outcomes
- PROs
- patient-reported outcome measures
- PROMs
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Footnotes
Contributors The study was conceived by DK, JI, HD and MC. DK conducted the survey and completed the analysis, with input and supervision from MC, HD and JI. DK prepared the first draft of the manuscript. JI, HD and MC all provided edits and critiqued the manuscript for intellectual content.
Funding The study was supported by a National Institute for Health Research (NIHR) School for Primary Care Research (SPCR) studentship grant. No other funding sources reported.
Disclaimer The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.
Competing interests None declared.
Ethics approval The study was approved by the West Midlands Research Ethics Committee in April 2012 (ref no 12/wm/0068).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.