Evidence map›Paper›PMID 38805454›Full record

ArticlePloS one2024

Adaptive clinical trials in surgery: A scoping review of methodological and reporting quality.

Phillip Staibano, Emily Oulousian, Tyler McKechnie, Alex Thabane, Samuel Luo, Michael K Gupta, Han Zhang, Jesse D Pasternak, Michael Au, Sameer Parpia and 2 more

Abstract readScoping Review
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Trends in Facial Reanimation Surgery: A Bibliometric Analysis.Plastic and reconstructive surgery. Global open · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Phillip StaibanoDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.ORCID 0000-0002-9095-9543
Emily OulousianDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Tyler McKechnieDepartment of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.ORCID 0000-0002-7668-4096
Alex ThabaneDepartment of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Samuel LuoDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Michael K GuptaDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Han ZhangDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Jesse D PasternakEndocrine Surgery Section Head, Division of General Surgery, Department of Surgery, University Health Network, University of Toronto, Toronto, Ontario, Canada.
Michael AuDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Sameer ParpiaDepartment of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.ORCID 0000-0002-9407-5622
J E M Ted YoungDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Mohit BhandariDepartment of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

importanceAdaptive surgical trials are scarce, but adopting these methods may help elevate the quality of surgical research when large-scale RCTs are impractical.

objectiveRandomized-controlled trials (RCTs) are the gold standard for evidence-based healthcare. Despite an increase in the number of RCTs, the number of surgical trials remains unchanged. Adaptive clinical trials can streamline trial design and time to trial reporting. The advantages identified for ACTs may help to improve the quality of future surgical trials. We present a scoping review of the methodological and reporting quality of adaptive surgical trials. EVIDENCE REVIEW: We performed a search of Ovid, Web of Science, and Cochrane Collaboration for all adaptive surgical RCTs performed from database inception to October 12, 2023. We included any published trials that had at least one surgical arm. All review and abstraction were performed in duplicate. Risk of bias (RoB) was assessed using the RoB 2.0 instrument and reporting quality was evaluated using CONSORT ACE 2020. All results were analyzed using descriptive methods.

findingsOf the 1338 studies identified, six trials met inclusion criteria. Trials were performed in cardiothoracic, oral, orthopedic, and urological surgery. The most common type of adaptive trial was group sequential design with pre-specified interim analyses planned for efficacy, futility, and/or sample size re-estimation. Two trials did use statistical simulations. Our risk of bias evaluation identified a high risk of bias in 50% of included trials. Reporting quality was heterogeneous regarding trial design and outcome assessment and details in relation to randomization and blinding concealment. CONCLUSION AND RELEVANCE: Surgical trialists should consider implementing adaptive components to help improve patient recruitment and reduce trial duration. Reporting of future adaptive trials must adhere to existing CONSORT ACE 2020 guidelines. Future research is needed to optimize standardization of adaptive methods across medicine and surgery.

Indexed as

Randomized Controlled Trials as TopicAdaptive Clinical Trials as TopicHumansResearch DesignSurgical Procedures, Operative

Identifiers

PMID38805454
PMCPMC11132449

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.