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.
Qualitative themes and illustrative respondent quotations are also presented.
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.
Frequency distributions were used to describe respondent characteristics and survey responses. An exploratory prespecified logistic regression analysis was also undertaken to investigate which factors were associated with the appropriate management of missing PRO data by data collection staff, as this can represent an important potential source of bias.
Existing literature recommends routine checking of completed PROMs and subsequent ‘chasing’ of missing data.16 Thus, the dependent variable in the model was the appropriate management of missing data, defined as: ‘whether the completed PROM was checked for missing data participants were subsequently asked to complete missing items/questionnaires’.
Survey respondents’ experiences of PRO alerts and their management are presented in a separate publication.15 In this paper, we present the results of the survey specific to PROM administration, with the following objectives: An online survey (see online supplementary file 1) was developed by investigators with PRO and ethics expertise, and the content informed by the results of our qualitative study.13 The survey contained questions on: (1) demographics, (2) the participants’ experiences of PROM administration with reference to the most recent trial in which they had been involved, (3) the provision of PRO-specific guidance within the trial and (4) PRO guidance/training they would like to see in future trials.