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A case study method to support and promote recruitment at a multi-centre RCT comparing surgical versus non-surgical treatments

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Realpe, Alba, Dickenson, Edward J., Hobson, Rachel , Griffin, Damian R., Jepson, Marcus and Donovan, Jenny L. (2017) A case study method to support and promote recruitment at a multi-centre RCT comparing surgical versus non-surgical treatments. Trials, 18 (1). P427. doi:10.1186/s13063-017-1902-y

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Official URL: https://doi.org/10.1186/s13063-017-1902-y

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Abstract

Objective

Multi-centre RCT designs provide robust evidence of therapeutic effect of health interventions. However participating centres often differ in how well they conduct the trial and the number of patients successfully recruited. This paper describes barriers different research teams encountered when conducting a complex RCT comparing a surgical procedure with physiotherapy, and the actions taken by the trial management group to overcome obstacles that were hindering recruitment.

Methods

We conducted 22 interviews with principal investigators and research associates at 14 sites involved in the delivery of a surgical RCT that compared hip arthroscopy and physiotherapy for hip pain. Interview transcripts were analysed thematically and case study approaches were utilised to present results to the trial management group.

Results Research teams reported difficulties related to logistics (e.g. Room space); motivation (e.g. PI reluctant to approach patients); and skill (e.g. Lack of knowledge about the treatment arms). Similar Issues were shared by sites that recruited to target and those that did not, however there were differences in the team ’ s response to challenges. Whilst on-target sites found local solutions to issues or support through their research infrastructure or the trial TMG, off-target sites usually did not show proactivity. Site profiles were created and action plans designed based on aspects that were particular to the individual sites. These plans were implemented in collaboration with site teams.

Conclusions

This qualitative study added to the growing evidence of how aspects of team functioning are important for recruitment to complex RCTs. Trial Management Groups can help research teams identify and ad- dress issues, and therefore contributing to a sense of ownership by the research team. Empowering research teams to find solutions at local level is essential to conduct multi-centre RCTs successfully.

Item Type: Journal Item
Subjects: R Medicine > R Medicine (General)
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit
Library of Congress Subject Headings (LCSH): Clinical trials -- Recruiting, Joints -- Examination, Physical therapy
Journal or Publication Title: Trials
Publisher: Biomed Central Ltd
ISSN: 1745-6215
Official Date: 2017
Dates:
DateEvent
2017Published
8 May 2017Accepted
Volume: 18
Number: 1
Article Number: P427
DOI: 10.1186/s13063-017-1902-y
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access (Creative Commons)

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