Evidence map›Paper›PMID 27145883›Full record

ArticleBMC medical research methodology2016

Patient enrollment and logistical problems top the list of difficulties in clinical research: a cross-sectional survey.

Stéphane Cullati, Delphine S Courvoisier, Angèle Gayet-Ageron, Guy Haller, Olivier Irion, Thomas Agoritsas, Sandrine Rudaz, Thomas V Perneger

Abstract read
In one paragraph

Article in BMC medical research methodology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing 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

17 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

8 authors.

Stéphane CullatiDivision of Clinical Epidemiology, Geneva University Hospitals, University of Geneva, Rue Gabrielle Perret-Gentil 6, CH-1211, Geneva 14, Switzerland. stephane.cullati@hcuge.ch.
Delphine S CourvoisierDivision of Clinical Epidemiology, Geneva University Hospitals, University of Geneva, Rue Gabrielle Perret-Gentil 6, CH-1211, Geneva 14, Switzerland.
Angèle Gayet-AgeronDivision of Clinical Epidemiology, Geneva University Hospitals, University of Geneva, Rue Gabrielle Perret-Gentil 6, CH-1211, Geneva 14, Switzerland.
Guy HallerDivision of Clinical Epidemiology, Geneva University Hospitals, University of Geneva, Rue Gabrielle Perret-Gentil 6, CH-1211, Geneva 14, Switzerland.
Olivier IrionDepartment of Gynecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.
Thomas AgoritsasDivision of Clinical Epidemiology, Geneva University Hospitals, University of Geneva, Rue Gabrielle Perret-Gentil 6, CH-1211, Geneva 14, Switzerland.
Sandrine RudazDivision of Clinical Epidemiology, Geneva University Hospitals, University of Geneva, Rue Gabrielle Perret-Gentil 6, CH-1211, Geneva 14, Switzerland.
Thomas V PernegerDivision of Clinical Epidemiology, Geneva University Hospitals, University of Geneva, Rue Gabrielle Perret-Gentil 6, CH-1211, Geneva 14, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMany medical research projects encounter difficulties. The objective of this study was to assess the self-reported frequency of difficulties encountered by medical researchers while conducting research and to identify factors associated with their occurrence.

methodsThe authors conducted a cross-sectional survey in 2010 among principal investigators of 996 study protocols approved by the Research Ethics Committee in Geneva, Switzerland, between 2001 and 2005. The authors asked principal investigators to rate the level of difficulty (1: none, to 5: very great) encountered across the research process.

results588 questionnaires were sent back (participation rate 59.0 %). 391 (66.5 %) studies were completed at the time of the survey. Investigators reported that the most frequent difficulties were related to patient enrollment (44.3 %), data collection (26.7 %), data analysis and interpretation (21.5 %), collaboration with caregivers (21.0 %), study design (20.4 %), publication in peer-reviewed journal (20.2 %), hiring of competent study personnel (20.2 %), and getting funding (19.2 %). On average, investigators reported 2.8 difficulties per project (SD 2.8, range 0 to 12). In multivariable analysis, the number of difficulties was higher for studies initiated by public sponsors (vs. private), single center studies (vs. multicenter), and studies about treatment, diagnosis or prognosis (i.e., clinical vs. other studies).

conclusionsMedical researchers reported substantial logistical difficulties in conducting clinical research.

Indexed as

Patient SelectionClinical Trials as TopicCross-Sectional StudiesHealth Care SurveysHumansMultivariate AnalysisRisk FactorsBarriersClinical researchDifficultiesMedical researchersResearch protocolsSwitzerland

Identifiers

PMID27145883
PMCPMC4855713

What OpenQuestion holds

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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 OpenQuestion graph.