Evidence map›Paper›PMID 29126461›Full record

Trial reportTrials2017

Impact of a deferred recruitment model in a randomised controlled trial in primary care (CREAM study).

Victoria Shepherd, Emma Thomas-Jones, Matthew J Ridd, Kerenza Hood, Katy Addison, Nick A Francis

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 22% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

6 authors at 2 institutions in 1 country.

Victoria ShepherdCentre for Trials Research, Cardiff University, Cardiff, UK. ShepherdVL1@cardiff.ac.uk.ORCID http://orcid.org/0000-0002-7687-0817
Emma Thomas-JonesCentre for Trials Research, Cardiff University, Cardiff, UK.
Matthew J RiddSchool of Social and Community Medicine, University of Bristol, Bristol, UK.
Kerenza HoodCentre for Trials Research, Cardiff University, Cardiff, UK.
Katy AddisonCentre for Trials Research, Cardiff University, Cardiff, UK.
Nick A FrancisDivision of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.
Cardiff University · GBUniversity of Bristol · GB

Funding

Department of Health 09/118/03Department of Health CTF-01-12-06Health Technology Assessment Programme 09/118/03Medical Research Council MR/K025643/1
6 · The paper itself

Abstract

backgroundRecruitment of participants is particularly challenging in primary care, with less than a third of randomised controlled trials (RCT) achieving their target within the original time frame. Participant identification, consent, randomisation and data collection can all be time-consuming. Trials recruiting an incident, as opposed to a prevalent, population may be particularly affected. This paper describes the impact of a deferred recruitment model in a RCT of antibiotics for children with infected eczema in primary care, which required the recruitment of cases presenting acutely.

methodsEligible children were identified by participating general practitioners (GPs) and referred to a study research nurse, who then visited them at home. This allowed the consent and recruitment processes to take place outside the general practice setting. Information was recorded about patients who were referred and recruited, or if not, the reasons for non-recruitment. Data on recruitment challenges were collected through semi-structured interviews and questionnaires with a sample of participating GPs. Data were thematically analysed to identify key themes.

resultsOf the children referred to the study 34% (58/171) were not recruited - 48% (28/58) because of difficulties arranging a baseline visit within the defined time frame, 31% (18/58) did not meet the study inclusion criteria at the time of nurse assessment, and 21% (12/58) declined participation. GPs had positive views about the recruitment process, reporting that parents valued and benefitted from additional contact with a nurse. GPs felt that the deferred recruitment model did not negatively impact on the study.

conclusionsGPs and parents recognised the benefits of deferred recruitment, but these did not translate into enhanced recruitment of participants. The model resulted in the loss of a third of children who were identified by the GP as eligible, but not subsequently recruited to the study. If the potential for improving outcomes in primary care through complex studies is to be realised, new approaches to recruitment into primary care trials need to be developed and evaluated.

trial registrationInternational Standard Randomised Controlled Trials, ISRCTN96705420 . Registered on 27 June 2012.

Indexed as

Eligibility DeterminationPatient SelectionPrimary Health CareAge FactorsAnti-Bacterial AgentsAttitude of Health PersonnelEczemaGeneral PractitionersHealth Knowledge, Attitudes, PracticeHouse CallsHumansInformed ConsentInterviews as TopicNursesNurse's RoleParentsAnti-Bacterial AgentsClinical trial recruitmentInformed consentPrimary careRandomised controlled trialRecruitment challenges

Identifiers

PMID29126461
PMCPMC5681763
OpenAlexW2767437121

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.