Post-trial follow-up methodology in large randomised controlled trials: a systematic review
Abstract Background Randomised controlled clinical trials typically have a relatively brief in-trial follow-up period which can underestimate safety signals and fail to detect long-term hazards, which may take years to appear. Extended follow-up after the scheduled closure of the trial allows detect...
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| Format: | Article |
| Language: | English |
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BMC
2018-05-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-018-2653-0 |
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| author | Rebecca Llewellyn-Bennett Danielle Edwards Nia Roberts Atticus H. Hainsworth Richard Bulbulia Louise Bowman |
| author_facet | Rebecca Llewellyn-Bennett Danielle Edwards Nia Roberts Atticus H. Hainsworth Richard Bulbulia Louise Bowman |
| author_sort | Rebecca Llewellyn-Bennett |
| collection | DOAJ |
| description | Abstract Background Randomised controlled clinical trials typically have a relatively brief in-trial follow-up period which can underestimate safety signals and fail to detect long-term hazards, which may take years to appear. Extended follow-up after the scheduled closure of the trial allows detection of both persistent or enhanced beneficial effects following cessation of study treatment (i.e. a legacy effect) and the emergence of possible adverse effects (e.g. development of cancer). Methods A systematic review was conducted following PRISMA guidelines to qualitatively compare post-trial follow-up methods used in large randomised controlled trials. Five bibliographic databases, including Medline and the Cochrane Library, and one trial registry were searched. All large randomised controlled trials (more than 1000 adult participants) published from March 2006 to April 2017 were evaluated. Two reviewers screened and extracted data attaining > 95% concordance of papers checked. Assessment of bias in the trials was evaluated using the Cochrane Risk of Bias tool. Results Fifty-seven thousand three hundred and fifty-two papers were identified and 65 trials which had post-trial follow-up (PTFU) were included in the analysis. The majority of trials used more than one type of follow-up. There was no evidence of an association between the retention rates of participants in the PTFU period and the type of follow-up used. Costs of PTFU varied widely with data linkage being the most economical. It was not possible to assess associations between risk of bias during the in-trial period and proportions lost to follow-up during the PTFU period. Discussion Data captured during the post-trial follow-up period can add scientific value to a trial. However, there are logistical and financial barriers to overcome. Where available, data linkage via electronic registries and records is a cost-effective method which can provide data on a range of endpoints. Systematic review registration Not applicable for PROSPERO registration. |
| first_indexed | 2024-12-23T10:19:45Z |
| format | Article |
| id | doaj.art-e92180bc7c3a4e8faf7e8be3dd4dec69 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-23T10:19:45Z |
| publishDate | 2018-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-e92180bc7c3a4e8faf7e8be3dd4dec692022-12-21T17:50:43ZengBMCTrials1745-62152018-05-0119111210.1186/s13063-018-2653-0Post-trial follow-up methodology in large randomised controlled trials: a systematic reviewRebecca Llewellyn-Bennett0Danielle Edwards1Nia Roberts2Atticus H. Hainsworth3Richard Bulbulia4Louise Bowman5MRC Population Health Research Unit, Clinical Trial Service Unit (CTSU), Nuffield Department of Population Health, University of OxfordMRC Population Health Research Unit, Clinical Trial Service Unit (CTSU), Nuffield Department of Population Health, University of OxfordBodleian Health Care Libraries, University of OxfordMolecular and Clinical Sciences Research Institute, St George’s University of LondonMedical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of OxfordMedical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of OxfordAbstract Background Randomised controlled clinical trials typically have a relatively brief in-trial follow-up period which can underestimate safety signals and fail to detect long-term hazards, which may take years to appear. Extended follow-up after the scheduled closure of the trial allows detection of both persistent or enhanced beneficial effects following cessation of study treatment (i.e. a legacy effect) and the emergence of possible adverse effects (e.g. development of cancer). Methods A systematic review was conducted following PRISMA guidelines to qualitatively compare post-trial follow-up methods used in large randomised controlled trials. Five bibliographic databases, including Medline and the Cochrane Library, and one trial registry were searched. All large randomised controlled trials (more than 1000 adult participants) published from March 2006 to April 2017 were evaluated. Two reviewers screened and extracted data attaining > 95% concordance of papers checked. Assessment of bias in the trials was evaluated using the Cochrane Risk of Bias tool. Results Fifty-seven thousand three hundred and fifty-two papers were identified and 65 trials which had post-trial follow-up (PTFU) were included in the analysis. The majority of trials used more than one type of follow-up. There was no evidence of an association between the retention rates of participants in the PTFU period and the type of follow-up used. Costs of PTFU varied widely with data linkage being the most economical. It was not possible to assess associations between risk of bias during the in-trial period and proportions lost to follow-up during the PTFU period. Discussion Data captured during the post-trial follow-up period can add scientific value to a trial. However, there are logistical and financial barriers to overcome. Where available, data linkage via electronic registries and records is a cost-effective method which can provide data on a range of endpoints. Systematic review registration Not applicable for PROSPERO registration.http://link.springer.com/article/10.1186/s13063-018-2653-0MethodologyPost-trialRetentionRandomised controlled trialCostLong-term |
| spellingShingle | Rebecca Llewellyn-Bennett Danielle Edwards Nia Roberts Atticus H. Hainsworth Richard Bulbulia Louise Bowman Post-trial follow-up methodology in large randomised controlled trials: a systematic review Trials Methodology Post-trial Retention Randomised controlled trial Cost Long-term |
| title | Post-trial follow-up methodology in large randomised controlled trials: a systematic review |
| title_full | Post-trial follow-up methodology in large randomised controlled trials: a systematic review |
| title_fullStr | Post-trial follow-up methodology in large randomised controlled trials: a systematic review |
| title_full_unstemmed | Post-trial follow-up methodology in large randomised controlled trials: a systematic review |
| title_short | Post-trial follow-up methodology in large randomised controlled trials: a systematic review |
| title_sort | post trial follow up methodology in large randomised controlled trials a systematic review |
| topic | Methodology Post-trial Retention Randomised controlled trial Cost Long-term |
| url | http://link.springer.com/article/10.1186/s13063-018-2653-0 |
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