PROM-COM
Research type
Research Study
Full title
A randomised crossover trial to assess the acceptability and feasibility of electronic and paper based data collection of a patient reported outcome measure questionnaire for use in a clinical trial.
IRAS ID
203221
Contact name
Loretta Davies
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
The use of electronic (tablet, laptop/desktop computer, small handheld device) means to collect patient self-reported in the clinical trial setting is becoming more widespread. The advantages of electronic over more traditional paper and pencil administration are well documented: reduction in administration burden, automatic implementation of skip patterns and scoring, avoidance of secondary data entry errors, time and date stamped data, and fewer item of missing data. Studies evaluating the equivalence of data obtained from paper versus electronic based (tablet, laptop/desktop computer, small handheld device) administration have also shown high levels of reliability between the two mode. Despite these reported advantages of electronic administration studies have demonstrated patient preference for the use of paper based questionnaires, in some cases.
The aim of this study is to assess the acceptability and feasibility (mode preference, perception of time taken to complete, ease of use) of electronic and paper based data collection of a patient reported outcome measure (PROM)questionnaire developed for use in a clinical trial of the management of patients with anterior cruciate ligament deficiency (ACL SNNAP). The agreement of response between the electronic and paper based case report form will also be examined.
130 patients will be recruited from approximately 15 NHS physiotherapy and orthopaedic outpatient departments from across the UK over a period of 8 months.
Each participant will be asked to complete two versions of the case report forms (electronic and paper based version). On receipt of consent, participants will be randomly assigned to one of two subgroups, based on the mode of administration to be completed first (electronic or paper).Participants will also be e-mailed a link to complete an online evaluation survey to capture information on preference, problems when using the mode of questionnaire and ease of use.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
16/LO/1546
Date of REC Opinion
22 Aug 2016
REC opinion
Favourable Opinion