Dataset Information

Bias and Loss to Follow-Up in Cardiovascular Randomized Trials: A Systematic Review.

ABSTRACT: Background Loss to follow-up (LTFU) is common in randomized controlled trials. However, its potential impact on primary outcomes from cardiovascular randomized controlled trials is not known. Methods and Results We conducted a prospective systematic review (PROSPERO: CRD42019121959) for randomized controlled trials published in 8 leading journals over 5 years from January 2014 to December 2018. Extent, reporting, and handling of LTFU data were recorded, and the proportion of a trial's primary outcome results that lose statistical significance was calculated after making plausible assumptions for the intervention and control arms. These assumptions could drive differential treatment effects between the groups considering relative event incidence between LTFU participants and those included in the primary outcome. We identified 117 randomized controlled trials of which 91 (78%) trials reported LTFU, 23 (20%) reported no LTFU, and 3 (3%) trials did not report on whether LTFU occurred. The median percentage of study participants lost to follow-up was 2% (interquartile range, 0.33%-5.3%). Only 10 trials (9%) had a low cluster of risk factors for impairment in trial quality. The percentage of trials losing statistical significance varied from 2% when the relative event incidence for LTFU between the randomized groups was 1 for the intervention arm and 1.5 for the control arm to 16% when the relative event incidence was 3 for the intervention arm and 1 for the control arm. Conclusions Almost 1 in 6 (16%) cardiovascular randomized trials published in leading journals may have a change in the primary outcome if plausible assumptions are made about differential event rates of participants lost to follow up. There is scope for improvement arising from LTFU in randomized trials in cardiovascular medicine. Registration URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42019121959.

SUBMITTER: Fong LCW

PROVIDER: S-EPMC7660731 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Bias and Loss to Follow-Up in Cardiovascular Randomized Trials: A Systematic Review.

Fong Lucas Chun Wah LCW Ford Thomas J TJ da Costa Bruno R BR Jüni Peter P Berry Colin C

Journal of the American Heart Association 20200709 14

Background Loss to follow-up (LTFU) is common in randomized controlled trials. However, its potential impact on primary outcomes from cardiovascular randomized controlled trials is not known. Methods and Results We conducted a prospective systematic review (PROSPERO: CRD42019121959) for randomized controlled trials published in 8 leading journals over 5 years from January 2014 to December 2018. Extent, reporting, and handling of LTFU data were recorded, and the proportion of a trial's primary ou ...[more]

PMID: 32646264

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Project description:BACKGROUND: People with cancer receive regular structured follow up after initial treatment, usually by a specialist in a cancer centre. Increasing numbers of cancer survivors prompts interest in alternative structured follow-up models. There is worldwide evidence of increasing interest in delivering cancer follow-up using technology. This review sough evidence supporting the use of technology in cancer follow-up from good quality randomised controlled trials. METHOD: A search strategy was developed to identify randomised controlled trials and reviews of randomised trials of interventions delivering some aspect of structured cancer follow-up using new technologies. Databases searched were: All EBM Reviews; Embase; Medline (No Revisions); Medline (Non-Indexed Citations), and CAB Abstracts. Included articles were published in English between 2000 and 2014. Key words were generated by the research question. Papers were read independently and appraised using a standardised checklist by two researchers, with differences being resolved by consensus [J Epidemiol Community Health, 52:377-384, 1998]. Information was collected on the purpose, process, results and limitations of each study. All outcomes were considered, but particular attention paid to areas under consideration in the review question. RESULTS: The search strategy generated 22879 titles. Following removal of duplicates and abstract review 17 full papers pertaining to 13 randomised controlled studies were reviewed. Studies varied in technologies used and the elements of follow-up delivered, length of follow-up, tumour type and numbers participating. Most studies employed only standard telephone follow-up. Most studies involved women with breast cancer and included telephone follow-up. Together the results suggest that interventions comprising technology had not compromised patient satisfaction or safety, as measured by symptoms, health related quality of life or psychological distress. There was insufficient evidence to comment on the cost effectiveness of technological cancer follow-up interventions. CONCLUSIONS: Modern technology could deliver cancer follow-up that is acceptable and safe. More research is required to develop cancer follow-up systems which exploit modern technology, which should be assessed using randomised trials, with consistent outcomes, so that evidence on the acceptability, safety, cost effectiveness and impact in quality of life of technological follow-up can accumulate and be made available to patients, professionals and policy makers.

Dataset Information

Bias and Loss to Follow-Up in Cardiovascular Randomized Trials: A Systematic Review.

Publications

Bias and Loss to Follow-Up in Cardiovascular Randomized Trials: A Systematic Review.

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