Evidence map›Paper›PMID 32713349›Full record

Trial reportBMC medicine2020

Effectiveness of the Ready to Reduce Risk (3R) complex intervention for the primary prevention of cardiovascular disease: a pragmatic randomised controlled trial.

Jo L Byrne, Helen M Dallosso, Stephen Rogers, Laura J Gray, Ghazala Waheed, Prashanth Patel, Pankaj Gupta, Yvonne Doherty, Melanie J Davies, Kamlesh Khunti

Open access · goldAbstract readPragmatic Clinical TrialRandomized Controlled Trial
In one paragraph

Trial report in BMC medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 18% 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

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Patient-centered education in dyslipidemia management: a systematic review.Asian biomedicine : research, reviews and news · 2022
    Review
  8. Article
  9. 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 at 4 institutions in 1 country.

Jo L ByrneLeicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.
Helen M DallossoLeicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.
Stephen RogersDepartment of Health Sciences, University of Leicester, Leicester, UK.
Laura J GrayDepartment of Health Sciences, University of Leicester, Leicester, UK.
Ghazala WaheedDiabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK.
Prashanth PatelDepartment of Cardiovascular Sciences, University of Leicester, Leicester, UK.
Pankaj GuptaDepartment of Cardiovascular Sciences, University of Leicester, Leicester, UK.
Yvonne DohertyLeicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.
Melanie J DaviesDiabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK.
Kamlesh KhuntiDiabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK. kk22@leicester.ac.uk.
Leicester General Hospital · GBUniversity Hospitals of Leicester NHS Trust · GBUniversity of Leicester · GBNorthamptonshire Healthcare NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCardiovascular disease is responsible for 31% of all global deaths. Primary prevention strategies are needed to improve longer-term adherence to statins and healthy lifestyle behaviours to reduce risk in people at risk of cardiovascular disease.

methodsPragmatic randomised controlled trial recruited between May 2016 and March 2017 from primary care practices, England. Participants (n = 212) prescribed statins for primary prevention of cardiovascular disease with total cholesterol level ≥ 5 mmol/l were randomised: 105 to the intervention group and 107 to the control group, stratified by age and sex. The 3R intervention involved two facilitated, structured group education sessions focusing on medication adherence to statins, lifestyle behaviours and cardiovascular risk, with 44 weeks of medication reminders and motivational text messages and two supportive, coaching phone calls (at approximately 2 weeks and 6 months). The control group continued with usual clinical care. Both groups received a basic information leaflet. The primary outcome was medication adherence to statins objectively measured by a biochemical urine test. Self-reported adherence and practice prescription data provided additional measures. Secondary outcomes included cholesterol profile, blood pressure, anthropometric data, cardiovascular risk score, and self-reported lifestyle behaviours and psychological measures (health/medication beliefs, quality of life, health status). All outcomes were assessed at 12 months.

resultsBaseline adherence to statins was 47% (control) and 62% (intervention). No significant difference between the groups found for medication adherence to statins using either the urine test (OR 1.02, 95% CI 0.34 to 3.06, P = 0.968) or other measures. This may have been due to the higher than expected adherence levels at baseline. The adjusted mean difference between the groups (in favour of the intervention group) for diastolic blood pressure (- 4.28 mmHg (95% CI - 0.98 to - 1.58, P = 0.002)) and waist circumference (- 2.55 cm (95% CI - 4.55 to - 0.55, P = 0.012)). The intervention group also showed greater perceived control of treatment and more coherent understanding of the condition.

conclusionsThe 3R programme successfully led to longer-term improvements in important clinical lifestyle indicators but no improvement in medication adherence, raising questions about the suitability of such a broad, multiple risk factor approach for improving medication adherence for primary prevention of CVD.

trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN16863160), March 11, 2006.

Indexed as

AdultAgedCardiovascular DiseasesFemaleHumansMaleMiddle AgedPrimary PreventionQuality of LifeRisk FactorsYoung AdultBehaviour interventionsCardiovascular diseaseComplex interventionsLifestyle interventionsMedication adherencePatient educationStatins

Identifiers

PMID32713349
PMCPMC7384223
OpenAlexW3044851636

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.