Evidence map›Paper›PMID 37316946›Full record

ArticlePilot and feasibility studies2023

Empirical progression criteria thresholds for feasibility outcomes in HIV clinical trials: a methodological study.

Lawrence Mbuagbaw, Lucy Huizhu Chen, Eunice Aluko, Maya Stevens-Uninsky, Akudo C J Eze-Onuorah, Michael Cristian Garcia, Larysa Stech, Tariq Atkin-Jones, Nadia Rehman, Amidu Raifu

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 26% of its field
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

6 citing papers in PubMed, 5 citations in OpenAlex.

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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

10 authors at 5 institutions in 3 countries.

Lawrence MbuagbawDepartment of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, ON, L8S4L8, Canada. mbuagblc@mcmaster.ca.ORCID http://orcid.org/0000-0001-5855-5461
Lucy Huizhu ChenDepartment of Medicine, McMaster University, Hamilton, ON, Canada.
Eunice AlukoFaculty of Arts and Science, University of Toronto, Toronto, ON, Canada.
Maya Stevens-UninskyDepartment of Global Health, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Akudo C J Eze-OnuorahFaculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Michael Cristian GarciaTemerty Faculty of Medicine, University of Toronto, Toronto, Canada.
Larysa StechPublic Health, Faculty of Applied Sciences, Brock University, St. Catharines, ON, Canada.
Tariq Atkin-JonesFaculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Nadia RehmanDepartment of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, ON, L8S4L8, Canada.
Amidu RaifuDepartment of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, ON, L8S4L8, Canada.
McMaster University · CAImpact · CAUniversity of Toronto · CABrock University · CAStellenbosch University · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPilot and feasibility trials use predetermined thresholds for feasibility outcomes to decide if a larger trial is feasible. These thresholds may be derived from the literature, observational data, or clinical experience. The aim of this study was to determine empirical estimates for feasibility outcomes to inform future HIV pilot randomized trials.

methodsWe conducted a methodological study of HIV clinical trials indexed in the past 5 years (2017-2021) in the PubMed database. We included trials of people living with HIV individually randomized to any type of intervention and excluded pilot trials and cluster randomized trials. Screening and data extraction were conducted in duplicate. We computed estimates for recruitment, randomization, non-compliance, lost to follow-up, discontinuation, and the proportion analyzed using a random effects meta-analysis of proportions and reported these estimates according to the following subgroups: use of medication, intervention type, trial design, income level, WHO region, participant type, comorbidities, and source of funding. We report estimates with 95% confidence intervals.

resultsWe identified 2122 studies in our search, of which 701 full texts were deemed relevant, but only 394 met our inclusion criteria. We found the following estimates: recruitment (64.1%; 95% CI 57.7 to 70.3; 156 trials); randomization (97.1%; 95% CI 95.8 to 98.3; 187 trials); non-compliance (3.8%; 95% CI 2.8 to 4.9; 216 trials); lost to follow-up (5.8%; 95% CI 4.9 to 6.8; 251 trials); discontinuation (6.5%; 95% CI 5.5 to 7.5; 215 trials); analyzed (94.2%; 95% CI 92.9 to 95.3; 367 trials). There were differences in estimates across most subgroups.

conclusionThese estimates may be used to inform the design of HIV pilot randomized trials with careful consideration of variations due to some of the subgroups investigated.

Indexed as

Clinical trialsFeasibility trialHIVPilot trialProgression criteriaThreshold

Identifiers

PMID37316946
PMCPMC10265819
OpenAlexW4380686214

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.