Test evaluation trials present different challenges for trial managers compared to intervention trials
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...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2020-11-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-020-04861-7 |
| _version_ | 1831522875571437568 |
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| author | Caroline Rick Sue Mallett James Brown Ryan Ottridge Andrew Palmer Victoria Parker Lee Priest Jonathan J. Deeks |
| author_facet | Caroline Rick Sue Mallett James Brown Ryan Ottridge Andrew Palmer Victoria Parker Lee Priest Jonathan J. Deeks |
| author_sort | Caroline Rick |
| collection | DOAJ |
| description | 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 over-activity, 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. Trial registration All trials reviewed in this project were registered and are provided in Table 1. |
| first_indexed | 2024-12-14T03:21:33Z |
| format | Article |
| id | doaj.art-f4f2545b77314da3a6838b7e9e09f222 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-14T03:21:33Z |
| publishDate | 2020-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-f4f2545b77314da3a6838b7e9e09f2222022-12-21T23:19:01ZengBMCTrials1745-62152020-11-0121111010.1186/s13063-020-04861-7Test evaluation trials present different challenges for trial managers compared to intervention trialsCaroline Rick0Sue Mallett1James Brown2Ryan Ottridge3Andrew Palmer4Victoria Parker5Lee Priest6Jonathan J. Deeks7Nottingham Clinical Trials Unit Building 42, University of NottinghamUCL Centre for Medical Imaging, University College LondonBirmingham Clinical Trials Unit, University of BirminghamBirmingham Clinical Trials Unit, University of BirminghamBirmingham Clinical Trials Unit, University of BirminghamBirmingham Clinical Trials Unit, University of BirminghamBirmingham Clinical Trials Unit, University of BirminghamBirmingham Clinical Trials Unit, University of BirminghamAbstract 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 over-activity, 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. Trial registration All trials reviewed in this project were registered and are provided in Table 1.https://doi.org/10.1186/s13063-020-04861-7Diagnostic test accuracyTest evaluationRandomised controlled trialsClinical trialRecruitmentSensitivity and specificity |
| spellingShingle | Caroline Rick Sue Mallett James Brown Ryan Ottridge Andrew Palmer Victoria Parker Lee Priest Jonathan J. Deeks Test evaluation trials present different challenges for trial managers compared to intervention trials Trials Diagnostic test accuracy Test evaluation Randomised controlled trials Clinical trial Recruitment Sensitivity and specificity |
| title | Test evaluation trials present different challenges for trial managers compared to intervention trials |
| title_full | Test evaluation trials present different challenges for trial managers compared to intervention trials |
| title_fullStr | Test evaluation trials present different challenges for trial managers compared to intervention trials |
| title_full_unstemmed | Test evaluation trials present different challenges for trial managers compared to intervention trials |
| title_short | Test evaluation trials present different challenges for trial managers compared to intervention trials |
| title_sort | test evaluation trials present different challenges for trial managers compared to intervention trials |
| topic | Diagnostic test accuracy Test evaluation Randomised controlled trials Clinical trial Recruitment Sensitivity and specificity |
| url | https://doi.org/10.1186/s13063-020-04861-7 |
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