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Cited by 15Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsPharmaceutical industry and healthcare

Intention-to-treat and transparency of related practices in randomized, controlled trials of anti-infectives

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Beckett, Robert D., Loeser, Kathryn C., Bowman, Kathryn R., Towne, Trent G.·2016·BMC Medical Research Methodology
DOI 10.1186/s12874-016-0215-2PMC PMC4997732
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Abstract

BACKGROUND: Intention-to-treat (ITT) analysis is commonly recommended for use, due to its benefits on external validity, in randomized, controlled trials (RCTs). No published reports describe how ITT analysis, as well as alternative approaches, are used in anti-infective RCTs. The purpose of this study is to describe the extent to which ITT analysis and alternative data approaches are used, the practices used to handle missing subject data, and whether non-inferiority trials present both ITT and per protocol (PP) analyses. Results of this analysis will help guide end users of infectious diseases primary drug literature. METHODS: A cross-sectional study of RCTs of anti-infectives published from January 1, 2013 through December 31, 2014 was conducted. A PubMed search identified relevant articles published in five specialty infectious diseases journals and four general medical journals. Each article was reviewed by two independent investigators with discrepancies resolved by consensus. Descriptive statistics were used to quantify results. RESULTS: One hundred four articles met study criteria. The most common medication classes represented in the RCTs were hepatitis C antivirals (26 %), antibacterials (25 %), and antiretrovirals (21 %). Thirty studies (29 %) were non-inferiority trials. Most studies (77 %) described use of ITT or modified ITT (mITT) in their methods. Of the ITT and mITT studies, most (73 %) did not describe practices used to handle missing data. Most (97 %) non-inferiority trials described use of ITT, mITT, or both; however, only 15 (50 %) also described use of PP. CONCLUSIONS: RCTs of anti-infectives commonly employ ITT and mITT. Most do not describe how missing data were addressed. Non-inferiority trials of anti-infectives do not consistently employ both ITT and PP populations.

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  • A per protocol approach will be used as a complement to ITT to facilitate interpretation of findings.

    “To manage the issue of missing data, a per protocol approach will be used as a complement to ITT to facilitate interpretation of the findings (Beckett et al., 2016).”

    From Internet-based treatment for vulvodynia (EMBLA) – Study protocol for a randomised controlled study (2021) · cites this paper as Beckett et al., 2016

    The Background recommends presenting both ITT and per-protocol (PP) results for non-inferiority trials, supporting PP as a complement to ITT for interpretation in that setting. It discusses missing-data methods separately, naming approaches such as last observation carried forward and assuming treatment failure; it does not recommend PP as a way to manage missing data. (LLM, conf=0.86)

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  • ITT analysis has the advantage of preserving balance afforded by randomisation, minimising risk of type I error, and resembling clinical practice.

    “Whilst ITT analysis has the advantage to preserve the balance afforded by randomisation, minimising the risk of for type I error and resembling clinical practice (Beckett et al., 2016; McCoy, 2017), a per-protocol approach may provide the true efficacy of an intervention among completers.”

    From Internet-based treatment for vulvodynia (EMBLA) – Study protocol for a randomised controlled study (2021) · cites this paper as Beckett et al., 2016

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Research works printed but not linked: 4

  1. [10]American Society for Microbiology. About: Antimicrobial Agents and Chemotherapy. 2016. http://aac.asm.org/site/misc/about.xhtml (Accessed 2 Aug 2016).
  2. [11]Elsevier Limited. About the Lancet Infectious Diseases medical journal. 2016. http://www.thelancet.com/laninf/about. Accessed 2 Aug 2016.
  3. [12]BMJ Publishing Group. About the BMJ. 2016. http://www.bmj.com/about-bmj. Accessed 2 Aug 2016.
  4. [13]Massachusetts Medical Society. New England Journal of Medicine. Media center fact sheet. 2016. http://www.nejm.org/page/media-center/fact-sheet. Accessed 2 Aug 2016.

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Authors
Beckett, R. D., Loeser, K. C., Bowman, K. R., & Towne, T. G.
Affiliations
  • Manchester University (US)
  • Columbus Regional Healthcare System (US)
  • CVS Health (United States) (US)
Corresponding author
  • Beckett, Robert D.
  • Loeser, Kathryn C.
  • Bowman, Kathryn R.
  • Towne, Trent G.
ORCID
Beckett, Robert D.
Venue
BMC Medical Research Methodology
Publisher
Springer Science and Business Media LLC
Published
2016-08-24
Volume
16
Issue
1
Pages
106-106
ISSN
1471-2288 (ISSN-L)
DOI
10.1186/s12874-016-0215-2
PMC
PMC4997732
OpenAlex
W2510802190
Cited by
15
References
21
Citations by year
2024: 2 · 2023: 1 · 2022: 3 · 2021: 4 · 2020: 3 · 2019: 1 · 2017: 1
FWCI
0.68
Type
journal article
Language
en
Open access
Licence
Locations
  • BMC Medical Research Methodology (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
No funding was provided for the conduction of this study.
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
Keywords
intention-to-treat analysis, anti-infective agents, randomized controlled trials, missing data handling, per-protocol analysis, antibacterial agents, antiretroviral drugs, reporting practices, generalizability
MeSH terms
Anti-Infective Agents, Cross-Sectional Studies, Humans, Research Design, Randomized Controlled Trials as Topic, Treatment Outcome, Disclosure, PubMed, Intention to Treat Analysis, Research Report

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