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There is a need for improved guidance in future trials that support trial personnel in conducting optimal PROM data collection to inform patient care.This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited.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).
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.
The respondents’ most recent experience of a trial collecting PROMs was predominantly in the secondary care setting, with trials ranging across clinical specialities (most commonly oncology).
Trials appeared to use a number of different PROMs, of which the most common were the five-dimension European Quality of Life instrument (EQ-5D), Hospital Anxiety and Depression scale (HADS), the Short-Form Health Survey 12-item (SF-12) and 36-item (SF-36) questionnaires, the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) and the Health Assessment Questionnaire (HAQ).
The survey was anonymised to encourage respondents to freely discuss potentially controversial aspects surrounding PRO assessment/PRO alerts and to maximise responses.
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An email containing information about the study, and a link to the online survey, was distributed via 55 UK Clinical Research Collaboration Registered Clinical Trials Units (CRC-RCTUs) and 19 Comprehensive Local Research Networks (CLRNs).
Such data are generally considered ‘not missing at random’, rather they may be missing from those participants with the poorest outcomes, rendering it non-ignorable.6 Retrospective PRO data capture is frequently not possible; therefore, missing data of this type can result in bias if such participants are concentrated in a particular trial arm.6 7Trials should therefore be designed to ensure that PROMs are administered in a standardised way across trial sites and are routinely screened for avoidable missing data in order to maximise data quality and reduce the risk of systematic bias.6 8–10 PROM administration guidance should, therefore, be included in the trial protocol and in site start-up training, and may also be incorporated into supporting trial documentation such as standard operating procedures (SOPs).7 12 Recent qualitative evidence, however, has raised concerns about the conduct of PRO measurement in UK trials.13 The study, conducted by the authors, outlined three main findings.13 First, there were reported inconsistencies in the way in which PROMs were administered that could adversely affect the quality of PRO trial data and potentially bias results.
Second, there was a reported lack of PRO-specific protocol content, training and education available to trial staff.
No other changes to the survey questions were necessary.
The study recruitment methods have been reported elsewhere.15 In brief, an anonymised online exploratory cross-sectional national survey of UK research nurses, data managers/coordinators, trial managers and chief and principal investigators (CPIs) involved in clinical trials using either a primary or secondary PRO was conducted in 2013/2014.