Evidence map›Paper›PMID 35590285›Full record

ArticleBMC medical research methodology2022

Scoping review and characteristics of publicly available checklists for assessing clinical trial feasibility.

Viktoria Gloy, Benjamin Speich, Alexandra Griessbach, Ala Taji Heravi, Alexandra Schulz, Thomas Fabbro, Christiane Pauli Magnus, Stuart McLennan, Wendy Bertram, Matthias Briel

Abstract readScoping Review
In one paragraph

Article in BMC medical research methodology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. DynamicAntibiotics (Basel, Switzerland) · 2024
    Review
  2. Article
  3. Article
  4. Review
  5. 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

10 authors.

Viktoria GloyBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Spitalstrasse 12, 4031, Basel, Switzerland. viktoria.gloy@usb.ch.
Benjamin SpeichBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Alexandra GriessbachBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Ala Taji HeraviBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Alexandra SchulzClinical Trial Unit, Department of Clinical Research, University Hospital Basel, Basel, Switzerland.
Thomas FabbroClinical Trial Unit, Department of Clinical Research, University Hospital Basel, Basel, Switzerland.
Christiane Pauli MagnusClinical Trial Unit, Department of Clinical Research, University Hospital Basel, Basel, Switzerland.
Stuart McLennanInstitute of History and Ethics in Medicine, TUM School of Medicine, Technical University of Munich, Munich, Germany.
Wendy BertramMusculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School University of Bristol, Bristol, UK.
Matthias BrielBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Spitalstrasse 12, 4031, Basel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhether there is sufficient capacity and capability for the successful conduct and delivery of a clinical trial should be assessed by several stakeholders according to transparent and evidence-based criteria during trial planning. For this openly shared, user-tested, and validated tools are necessary. Therefore, we systematically examined the public availability and content of checklists which assess the study-level feasibility in the planning phase of clinical trials.

methodsIn our scoping review we systematically searched Medline, EMBASE, and Google (last search, June 2021). We included all publicly available checklists or tools that assessed study level feasibility of clinical trials, examined their content, and checked whether they were user-tested or validated in any form. Data was analysed and synthesised using conventional content analysis.

resultsA total of 10 publicly available checklists from five countries were identified. The checklists included 48 distinct items that were classified according to the following seven different domains of clinical trial feasibility: regulation, review and oversight; participant recruitment; space, material and equipment; financial resources; trial team resources; trial management; and pilot or feasibility studies. None of the available checklists appeared to be user-tested or validated.

conclusionsAlthough a number of publicly available checklists to assess the feasibility of clinical trials exist, their reliability and usefulness remain unclear. Openly shared, user-tested, and validated feasibility assessment tools for a better planning of clinical trials are lacking.

Indexed as

ChecklistClinical Trials as TopicFeasibility StudiesHumansReproducibility of ResultsChecklistFeasibility assessmentRandomized controlled trialsValidation

Identifiers

PMID35590285
PMCPMC9118562

What OpenQuestion holds

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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.