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Cited by 80Advanced Causal Inference TechniquesStatistical Methods in Clinical TrialsStatistical Methods and Bayesian Inference

Analysis of randomised trials with long-term follow-up

Open access
Herbert, Robert D., Kasza, Jessica, Bø, Kari·2018·BMC Medical Research Methodology
DOI 10.1186/s12874-018-0499-5PMC PMC5975460
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Abstract

Randomised trials with long-term follow-up can provide estimates of the long-term effects of health interventions. However, analysis of long-term outcomes in randomised trials may be complicated by problems with the administration of treatment such as non-adherence, treatment switching and co-intervention, and problems obtaining outcome measurements arising from loss to follow-up and death of participants. Methods for dealing with these issues that involve conditioning on post-randomisation variables are unsatisfactory because they may involve the comparison of non-exchangeable groups and generate estimates that do not have a valid causal interpretation. We describe approaches to analysis that potentially provide estimates of causal effects when such issues arise. Brief descriptions are provided of the use of instrumental variable and propensity score methods in trials with imperfect adherence, marginal structural models and g-estimation in trials with treatment switching, mixed longitudinal models and multiple imputation in trials with loss to follow-up, and a sensitivity analysis that can be used when trial follow-up is truncated by death or other events. Clinical trialists might consider these methods both at the design and analysis stages of randomised trials with long-term follow-up.

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  • For exercise training there are additional long-term study challenges such as non-adherence to maintenance training.

    “For exercise training there are additional challenges such as non-adherence to maintenance training [93, 94].”

    From International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training (2022) · cites this paper as [94]

    The Background identifies exercise programs as sustained interventions, and the Main text, under “Non-adherence and non-compliance,” says non-adherence is more common with sustained interventions and discusses adherence to exercise. These passages support non-adherence as a challenge for exercise trials, but do not specifically address maintenance training. Page numbers are not available in our copy. (LLM, conf=0.83)

    Experimental — accuracy not yet measured

  • Long-term studies of any intervention face general challenges from loss to follow-up, co-interventions, treatment switching and competing events.

    “There are general challenges to long-term studies of any intervention due to loss-to follow-up, co-interventions, treatment switching and competing events [93, 94].”

    From International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training (2022) · cites this paper as [94]

    The Abstract and Background identify loss to follow-up, co-intervention, treatment switching, and death or other events as challenges in randomised trials with long-term follow-up. The claim is broader than the paper: it refers to long-term studies of any intervention, while the paper focuses on randomised trials and its Background table says treatment switching affects intermittent or sustained interventions. (LLM, conf=0.85)

    Experimental — accuracy not yet measured

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Research works printed but not linked: 1

  1. [28]Evans I Thornton H Chalmers I Glasziou P Testing treatments 2011 2 London Pinter & Martin 22171402

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Authors
Herbert, R. D., Kasza, J., & Bø, K.
Affiliations
  • Monash University (AU)
  • Akershus University Hospital (NO)
ORCID
Venue
BMC Medical Research Methodology
Publisher
Springer Science and Business Media LLC
Published
2018-05-29
Volume
18
Issue
1
Pages
48-48
ISSN
1471-2288 (ISSN-L)
DOI
10.1186/s12874-018-0499-5
PMC
PMC5975460
OpenAlex
W2806048670
Cited by
80
References
34
Citations by year
2026: 10 · 2025: 12 · 2024: 7 · 2023: 12 · 2022: 14 · 2021: 13 · 2020: 9 · 2019: 3
FWCI
5.15
Type
journal article
Language
en
Open access
Licence
Locations
  • BMC Medical Research Methodology (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Monash University Research Portal (Monash University) (acceptedVersion, other-oa)
  • UNSWorks (University of New South Wales, Sydney, Australia) (submittedVersion, cc-by-nc-nd)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • NORA - Norwegian Open Research Archives (submittedVersion, cc-by)
Funders
National Health and Medical Research Council (RG153190)
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods and Bayesian Inference
Keywords
randomised trials, long-term follow-up, medication adherence, treatment switching, co-interventions, loss to follow-up, causal inference, instrumental variables, propensity score methods, marginal structural models, G-estimation, multiple imputation, sensitivity analysis, truncation by death
MeSH terms
Follow-Up Studies, Humans, Time Factors, Randomized Controlled Trials as Topic, Drug Monitoring, Outcome Assessment, Health Care

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