Evidence map›Paper›PMID 35260450›Full record

ArticleBMJ open2022

Effects of ACE inhibitors and angiotensin receptor blockers: protocol for a UK cohort study using routinely collected electronic health records with validation against the ONTARGET trial.

Paris J Baptiste, Angel Y S Wong, Anna Schultze, Marianne Cunnington, Johannes F E Mann, Catherine Clase, Clémence Leyrat, Laurie A Tomlinson, Kevin Wing

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2022. 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
1.5field-weighted citation impact, top 17% 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, 9 citations in OpenAlex.

  1. Article
  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

9 authors at 4 institutions in 3 countries.

Paris J BaptisteDepartment of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK paris.baptiste1@lshtm.ac.uk.ORCID 0000-0002-2565-8525
Angel Y S WongDepartment of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.
Anna SchultzeDepartment of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.
Marianne CunningtonEpidemiology, Value & Evidence Outcomes, GlaxoSmithKline Research and Development Welwyn, Stevenage, UK.
Johannes F E MannDepartment of Medicine 4, Friedrich-Alexander-Universitat Erlangen-Nurnberg, Erlangen, Germany.
Catherine ClaseDepartment of Medicine and Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
Clémence LeyratDepartment of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
Laurie A TomlinsonDepartment of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.
Kevin WingDepartment of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.
London School of Hygiene & Tropical Medicine · GBFriedrich-Alexander-Universität Erlangen-Nürnberg · DEGlaxoSmithKline (United Kingdom) · GBImpact · CA

Funding

Medical Research Council MR/T032448/1
6 · The paper itself

Abstract

introductionCardiovascular disease is a leading cause of death globally, responsible for nearly 18 million deaths worldwide in 2017. Medications to reduce the risk of cardiovascular events are prescribed based on evidence from clinical trials which explore treatment effects in an indicated sample of the general population. However, these results may not be fully generalisable because of trial eligibility criteria that generally restrict to younger patients with fewer comorbidities. Therefore, evidence of effectiveness of medications for groups underrepresented in clinical trials such as those aged ≥75 years, from ethnic minority backgrounds or with low kidney function may be limited.Using individual anonymised data from the Ongoing Telmisartan Alone and the Ramipril Global Endpoint Trial (ONTARGET) trial, in collaboration with the original trial investigators, we aim to investigate clinical trial replicability within a real-world setting in the area of cardiovascular disease. If the original trial results are replicable, we will estimate treatment effects and risk in groups underrepresented and excluded from the original clinical trial. METHODS AND ANALYSIS: We will develop a cohort analogous to the ONTARGET trial within the Clinical Practice Research Datalink between 1 January 2001 and 31 July 2019 using the trial eligibility criteria and propensity score matching. The primary outcome is a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for congestive heart failure. If results from the cohort study fall within pre-specified limits, we will expand the cohort to include under represented and excluded groups. ETHICS AND DISSEMINATION: Ethical approval has been granted by the London School of Hygiene & Tropical Medicine Ethics Committee (Ref: 22658). The study has been approved by the Independent Scientific Advisory Committee of the UK Medicines and Healthcare Products Regulatory Agency (protocol no. 20_012). Access to the individual patient data from the ONTARGET trial was obtained by the trial investigators. Findings will be submitted to peer-reviewed journals and presented at conferences.

Indexed as

Cardiovascular DiseasesRamiprilAgedAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsClinical Trials as TopicCohort StudiesDrug Therapy, CombinationElectronic Health RecordsEthnicityHumansMinority GroupsTelmisartanUnited KingdomAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsRamiprilTelmisartanclinical trialsepidemiologystatistics & research methodsvascular medicine

Identifiers

PMID35260450
PMCPMC8905982
OpenAlexW4220927861

What OpenQuestion holds

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LicenceCC BY-NC
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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.