Evidence map›Paper›PMID 33292715›Full record

ArticlePilot and feasibility studies2020

More pilot trials could plan to use qualitative data: a meta-epidemiological study.

Tejan Baldeh, Tonya MacDonald, Sarah Daisy Kosa, Daeria O Lawson, Rosa Stalteri, Oluwatobi R Olaiya, Ahlam Alotaibi, Lehana Thabane, Lawrence Mbuagbaw

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

12 citing papers in PubMed.

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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

9 authors.

Tejan BaldehDepartment of Health Research Methods, Evidence and Impact, McMaster University Health Sciences Centre, McMaster University, 1280 Main Street West, Hamilton, ON, L8N 4K1, Canada. baldeht@mcmaster.ca.ORCID http://orcid.org/0000-0001-9194-3319
Tonya MacDonaldDepartment of Health Research Methods, Evidence and Impact, McMaster University Health Sciences Centre, McMaster University, 1280 Main Street West, Hamilton, ON, L8N 4K1, Canada.
Sarah Daisy KosaDepartment of Health Research Methods, Evidence and Impact, McMaster University Health Sciences Centre, McMaster University, 1280 Main Street West, Hamilton, ON, L8N 4K1, Canada.
Daeria O LawsonDepartment of Health Research Methods, Evidence and Impact, McMaster University Health Sciences Centre, McMaster University, 1280 Main Street West, Hamilton, ON, L8N 4K1, Canada.
Rosa StalteriDepartment of Health Research Methods, Evidence and Impact, McMaster University Health Sciences Centre, McMaster University, 1280 Main Street West, Hamilton, ON, L8N 4K1, Canada.
Oluwatobi R OlaiyaMichael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
Ahlam AlotaibiDepartment of Pediatrics, Princess Noura University, Riyadh, Saudi Arabia.
Lehana ThabaneDepartment of Health Research Methods, Evidence and Impact, McMaster University Health Sciences Centre, McMaster University, 1280 Main Street West, Hamilton, ON, L8N 4K1, Canada.
Lawrence MbuagbawDepartment of Health Research Methods, Evidence and Impact, McMaster University Health Sciences Centre, McMaster University, 1280 Main Street West, Hamilton, ON, L8N 4K1, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPilot trials often use quantitative data such as recruitment rate and retention rate to inform the design and feasibility of a larger trial. However, qualitative data such as patient, healthcare provider, and research staff perceptions of an intervention may also provide insights for a larger trial.

methodsAs part of a larger study investigating the reporting of progression criteria in pilot studies, we sought to determine how often pilot studies planned to use qualitative data to inform the design and feasibility of a larger trial and the factors associated with plans to use qualitative data. We searched for protocols of pilot studies of randomized trials in PubMed between 2013 and 2017.

resultsWe included 227 articles. Only 92 (40.5%; 95% confidence interval [CI] 34.1-47.2) reported plans to collect qualitative data. The factors associated with collecting qualitative data were large studies (defined as sample size ≥ 60; adjusted odds ratio [aOR] 2.77; 95% CI 1.47-5.23; p = 0.002) and studies from Europe (aOR 3.86; 95% CI 1.68-8.88; p = 0.001) compared to North America and the rest of the world. Pilot trials with pharmacological interventions were less likely to plan to collect qualitative data (aOR 0.20; 95% CI 0.07-0.58; p = 0.003).

conclusionsQualitative data is not used enough in pilot trials. Large pilot trials, pilot trials from Europe, and pilot trials of non-pharmacological interventions are more likely to plan for qualitative data.

Indexed as

FeasibilityPilotProtocolsQualitative dataTrials

Identifiers

PMID33292715
PMCPMC7597013

What OpenQuestion holds

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Registered trials

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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.