Test evaluation trials present different challenges for trial managers compared to intervention trials
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METHODOLOGY
Open Access
Test evaluation trials present different challenges for trial managers compared to intervention trials Caroline Rick1*† , Sue Mallett2†, James Brown3, Ryan Ottridge3, Andrew Palmer3, Victoria Parker3, Lee Priest3 and Jonathan J. Deeks3,4,5
Abstract Introduction: Test evaluation trials present different challenges for trial managers compared to intervention trials. There has been very little research on the management of test evaluation trials and how this impacts on trial success, in comparison with intervention trials. Evaluations of medical tests present specific challenges, because they are a pivot point bridging the complexities of pathways prompting testing with treatment decision-making. We systematically explored key differences in the trial design and management of test evaluation trials compared to intervention trials at the different stages of study design and delivery. We identified challenges in test evaluation trials that were more pronounced than in intervention trials, based on experience from 10 test evaluation trials. Methods: We formed a focus group of 7 trial managers and a statistician who had been involved in the day-to-day management of both test evaluation trials and intervention trials. We used discussion and content analysis to group challenges from 10 trials into a structured thematic format. The trials covered a range of medical conditions, diagnostic tests, clinical pathways and conditions including chronic kidney disease, chronic pelvic pain, colitis, detrusor overactivity, group B streptococcal colonisation, tuberculosis and colorectal, lung, ovarian and thyroid cancers. Results: We identified 10 common themes underlying challenges that are more pronounced in test evaluation compared to intervention trials. We illustrate these themes with examples from 10 trials, including with 31 specific challenges we experienced. The themes were ethics/governance; accessing patient populations; recruitment; patient preference; test processes, clinical pathways and samples storage; uncertainty of diagnostic results; verifying diagnosis (reference standard); follow-up; adverse effects; and diagnostic impact. Conclusion: We present 10 common themes, including 31 challenges, in test evaluation trials that will be helpful to others designing and managing future test evaluation trials. Proactive identification of potential challenges at the design and planning stages of test evaluation trials will enable strategies to improve trial design and management that may be different from standard strategies used for intervention trials. Future work could extend this topic to include challenges for other trial stakeholders including participants, clinicians, statisticians and funders. (Continued on next page)
* Correspondence: [email protected] † C. Rick and S. Mallett contributed equally to this work. 1 Nottingham Clinical Trials Unit Building 42, University of Nottingham, Nottingham NG7 2RD, UK Full list of author information is available at the end of the article © The A
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