Evidence map›Paper›PMID 20594432›Full record

ArticleThe British journal of general practice : the journal of the Royal College of General Practitioners2010

How usual is usual care in pragmatic intervention studies in primary care? An overview of recent trials.

Antonia F H Smelt, Gerda M van der Weele, Jeanet W Blom, Jacobijn Gussekloo, Willem J J Assendelft

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Article in The British journal of general practice : the journal of the Royal College of General Practitioners, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 9 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

53 citing papers in PubMed, 9 syntheses or guidelines pooled it.

  1. Pooled it
  2. Selection and reporting of usual care comparators when designing primary care trials of complex health interventions: a systematic review.The British journal of general practice : the journal of the Royal College of General Practitioners · 2025
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  14. A Care Coordination Intervention Improves Symptoms But Not Charges in High-Risk Patients With Inflammatory Bowel Disease.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2022
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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

5 authors.

Antonia F H SmeltDepartment of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands. a.f.h.smelt@lumc.nl
Gerda M van der Weele
Jeanet W Blom
Jacobijn Gussekloo
Willem J J Assendelft

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBecause pragmatic trials are performed to determine if an intervention can improve current practice, they often have a control group receiving 'usual care'. The behaviour of caregivers and patients in this control group should be influenced by the actions of researchers as little as possible. Guidelines for describing the composition and management of a usual care control group are lacking.

aimTo explore the variety of approaches to the usual care concept in pragmatic trials, and evaluate the influence of the study design on the behaviour of caregivers and patients in a usual care control group. DESIGN OF STUDY: Review of 73 pragmatic trials in primary care with a usual care control group published between January 2005 and December 2009 in the British Medical Journal, the British Journal of General Practice, and Family Practice. Outcome measures were: description of the factors influencing caregiver and patients in a usual care control group related to an individual randomised design versus cluster randomisation.

resultsIn total, 38 individually randomised trials and 35 cluster randomised trials were included. In most trials, caregivers had the freedom to treat control patients according to their own insight; in two studies, treatment options were restricted. Although possible influences on the behaviour of control caregivers and control patients were more often identified in individually randomised trials, these influences were also present in cluster randomised trials. The description of instructions and information provided to the control group was often insufficient, which made evaluation of the trials difficult.

conclusionResearchers in primary care medicine should carefully consider the design of a usual care control group, especially with regard to minimising the risk of study-induced behavioural change. It is recommended that an adequate description of the information is provided to control caregivers and control patients. A proposal is made for an extension to the CONSORT statement that requires authors to specify details of the usual care control group.

Indexed as

Control GroupsPrimary Health CareCluster AnalysisDelivery of Health CareHumansProfessional PracticeRandomized Controlled Trials as Topic

Identifiers

PMID20594432
PMCPMC2894405

What Socratic holds

Textmetadata
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 Socratic graph.