Evidence map›Paper›PMID 39666716›Full record

ArticlePloS one2024

Methodological review to develop a list of bias items for adaptive clinical trials: Protocol and rationale.

Phillip Staibano, Tyler McKechnie, Alex Thabane, Daniel Olteanu, Keean Nanji, Han Zhang, Carole Lunny, Michael Au, Michael K Gupta, Jesse D Pasternak and 3 more

Abstract read
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. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

13 authors.

Phillip StaibanoDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.ORCID 0000-0002-9095-9543
Tyler McKechnieDepartment of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Alex ThabaneDepartment of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Daniel OlteanuMichael G. DeGroote School of Medicine, Hamilton, Ontario, Canada.ORCID 0009-0002-6819-9995
Keean NanjiDepartment of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Han ZhangDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Carole LunnyTherapeutics Initiative, SPOR Evidence Alliance, Society for Research Synthesis Methods, Cochrane Bias Methods Group, Cochrane Hypertension Review Group at the University of British Columbia, Vancouver, Canada.
Michael AuDivision 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.
Jesse D PasternakEndocrine Surgery Section Head, Division of General Surgery, Department of Surgery, University Health Network, University of Toronto, Toronto, Ontario, Canada.
Sameer ParpiaDepartment of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.ORCID 0000-0002-9407-5622
Jem 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

backgroundRandomized-clinical trials (RCTs) are the gold-standard for comparing health care interventions, but can be limited by early termination, feasibility issues, and prolonged time to trial reporting. Adaptive clinical trials (ACTs), which are defined by pre-planned modifications and analyses that occur after starting patient recruitment, are gaining popularity as they can streamline trial design and time to reporting. As adaptive methodologies continue to be adopted by researchers, it will be critical to develop a risk of bias tool that evaluates the unique methodological features of ACTs so that their quality can be improved and standardized for the future. In our proposed methodological review, we will develop a list of risk of bias items and concepts, so that a risk of bias tool specific to ACTs can be developed. METHODS AND ANALYSIS: We will perform a systematic database search to capture studies that have proposed or reviewed items pertaining to methodological risk, bias, and/or quality in ACTs. We will perform a comprehensive search of citation databases, such as Ovid MEDLINE, EMBASE, CENTRAL, the Cochrane library, and Web of Science, in addition to multiple grey literature sources to capture published and unpublished literature related to studies evaluating the methodological quality of ACTs. We will also search methodological registries for any risk of bias tools for ACTs. All screening and review stages will be performed in duplicate with a third senior author serving as arbitrator for any discrepancies. For all studies of methodological quality and risk of bias, we will extract all pertinent bias items, concepts, and/or tools. We will combine conceptually similar items in a descriptive manner and classify them as referring to bias or to other aspects of methodological quality, such as reporting. We will plan to generate pertinent risk of bias items to generate a candidate tool that will undergo further refinement, testing, and validation in future development stages. ETHICS AND DISSEMINATION: This review does not require ethics approval as human subjects are not involved. As mentioned previously, this study is the first step in developing a tool to evaluate the risk of bias and methodological quality of ACTs. The findings of this review will inform a Delphi study and the development of a risk of bias tool for ACTs. We plan on publishing this review in a peer-reviewed journal and to present these findings at international scientific conferences.

Indexed as

BiasResearch DesignAdaptive Clinical Trials as TopicHumansRandomized Controlled Trials as Topic

Identifiers

PMID39666716
PMCPMC11637403

What Socratic holds

Textmetadata
LicenceCC BY
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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 Socratic graph.