Evidence map›Paper›PMID 21846349›Full record

ReviewBMC medical research methodology2011

Questions asked and answered in pilot and feasibility randomized controlled trials.

Milensu Shanyinde, Ruth M Pickering, Mark Weatherall

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in BMC medical research methodology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 117 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
117citing papers in PubMed, 3 pooled it
–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

117 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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57 more citing papers are in PubMed but not listed here.

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

3 authors.

Milensu ShanyindePrimary Care and Population Sciences, University of Southampton, Southampton General Hospital, Tremona Road, Southampton, UK.
Ruth M Pickering
Mark Weatherall

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the last decade several authors have reviewed the features of pilot and feasibility studies and advised on the issues that should be addressed within them. We extend this literature by examining published pilot/feasibility trials that incorporate random allocation, examining their stated objectives, results presented and conclusions drawn, and comparing drug and non-drug trials.

methodsA search of EMBASE and MEDLINE databases for 2000 to 2009 revealed 3652 papers that met our search criteria. A random sample of 50 was selected for detailed review.

resultsMost of the papers focused on efficacy: those reporting drug trials additionally addressed safety/toxicity; while those reporting non-drug trials additionally addressed methodological issues. In only 56% (95% confidence intervals 41% to 70%) were methodological issues discussed in substantial depth, 18% (95% confidence interval 9% to 30%) discussed future trials and only 12% (95% confidence interval 5% to 24%) of authors were actually conducting one.

conclusionsDespite recent advice on topics that can appropriately be described as pilot or feasibility studies the large majority of recently published papers where authors have described their trial as a pilot or addressing feasibility do not primarily address methodological issues preparatory to planning a subsequent study, and this is particularly so for papers reporting drug trials. Many journals remain willing to accept the pilot/feasibility designation for a trial, possibly as an indication of inconclusive results or lack of adequate sample size.

Indexed as

Feasibility StudiesPilot ProjectsRandomized Controlled Trials as TopicDrug EvaluationDrug-Related Side Effects and Adverse ReactionsHumans

Identifiers

PMID21846349
PMCPMC3170294

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.