Evidence map›Paper›PMID 29903781›Full record

ArticleBMJ open2018

How good are GPs at adhering to a pragmatic trial protocol in primary care? Results from the ADDITION-Cambridge cluster-randomised pragmatic trial.

Michael Laxy, Edward C F Wilson, Clare E Boothby, Simon J Griffin

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 21% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. 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

4 authors at 1 institution in 2 countries.

Michael LaxyInstitute of Health Economics, Helmholtz Zentrum München, Neuherberg, Germany.ORCID 0000-0001-8775-7417
Edward C F WilsonCambridge Centre for Health Services Research, University of Cambridge, Cambridge, UK.ORCID 0000-0002-8369-1577
Clare E BoothbyMRC Epidemiology Unit, University of Cambridge, Cambridge, UK.
Simon J GriffinMRC Epidemiology Unit, University of Cambridge, Cambridge, UK.
University of Cambridge · GB

Funding

Department of Health RP-PG-0606-1259Medical Research Council G0001164Medical Research Council MC_UU_12015/4Wellcome TrustWellcome Trust G061895
6 · The paper itself

Abstract

objectiveTo assess the fidelity of general practitioners' (GPs) adherence to a long-term pragmatic trial protocol.

designRetrospective analyses of electronic primary care records of participants in the pragmatic cluster-randomised ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment In People with Screen Detected Diabetes in Primary Care)-Cambridge trial, comparing intensive multifactorial treatment (IT) versus routine care (RC). Data were collected from the date of diagnosis until December 2010.

settingPrimary care surgeries in the East of England. STUDY SAMPLE/

participantsA subsample (n=189, RC arm: n=99, IT arm: n=90) of patients from the ADDITION-Cambridge cohort (867 patients), consisting of patients 40-69 years old with screen-detected diabetes mellitus.

interventionsIn the RC arm treatment was delivered according to concurrent treatment guidelines. Surgeries in the IT arm received funding for additional contacts between GPs/nurses and patients, and GPs were advised to follow more intensive treatment algorithms for the management of glucose, lipids and blood pressure and aspirin therapy than in the RC arm. OUTCOME MEASURES: The number of annual contacts between patients and GPs/nurses, the proportion of patients receiving prescriptions for cardiometabolic medication in years 1-5 after diabetes diagnosis and the adherence to prescription algorithms.

resultsThe difference in the number of annual GP contacts (β=0.65) and nurse contacts (β=-0.15) between the study arms was small and insignificant. Patients in the IT arm were more likely to receive glucose-lowering (OR=3.27), ACE-inhibiting (OR=2.03) and lipid-lowering drugs (OR=2.42, all p values <0.01) than patients in the RC arm. The prescription adherence varied between medication classes, but improved in both trial arms over the 5-year follow-up.

conclusionsThe adherence of GPs to different aspects of the trial protocol was mixed. Background changes in healthcare policy need to be considered as they have the potential to dilute differences in treatment intensity and hence incremental effects. TRIAL REGISTRATION NUMBER: ISRCTN86769081.

Indexed as

Pragmatic Clinical Trials as TopicAgedCardiotonic AgentsCardiovascular DiseasesDiabetes Mellitus, Type 2EnglandFemaleGeneral PracticeGuideline AdherenceHumansLinear ModelsMaleMiddle AgedPractice Patterns, Physicians'Retrospective StudiesCardiotonic Agentsdiabetes mellituspragmatic trialprimary careprotocol adherence

Identifiers

PMID29903781
PMCPMC6009504
OpenAlexW2739479405

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.