Confounders and co-interventions identified in non-randomized studies of interventions

Maria M Pufulete*, Kalaivani Mahadevan, Thomas W Johnson, Christalla Pithara-McKeown, Sabi M Redwood, Umberto Benedetto, Julian P T Higgins, Barnaby C Reeves

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

3 Citations (Scopus)
118 Downloads (Pure)

Abstract

Abstract
Objectives: To identify potential confounders and co-interventions systematically to optimise control for confounding for three non-randomized studies of interventions (NRSI) designed to quantify bleeding in populations exposed to different dual antiplatelet therapies (DAPT).
Study Design and Setting: Systematic review, interviews and surveys with clinicians. We searched Ovid Medline, Ovid Embase and the Cochrane Library to identify randomised controlled trials and cohort studies of DAPT interventions. Two researchers independently screened citations, identified eligible studies and extracted data. We conducted individual semi structured interviews with 6 cardiologists and 6 cardiac surgeons to elicit factors clinicians consider when they prescribe DAPT. We administered two online surveys to members of professional cardiology and cardiac surgery organisations.
Results: We screened 2544 records, identified 322 eligible studies and extracted data from 47. We identified 10 co-interventions and 70 potential confounders: review 31 (91%); interviews 19 (56%); surveys 31 (91%). 16/34 (47%) were identified by all three methods while 3/34 (9%) were picked up by one method only.
Conclusion: The review identified the majority of factors, but the interviews identified hard-to-measure factors such as perceived patient adherence and local prescribing culture. The methods could, in principle, be widely applied when designing or reviewing NRSI.
Original languageEnglish
Pages (from-to)115-123
Number of pages9
JournalJournal of Clinical Epidemiology
Volume148
Early online date25 Mar 2022
DOIs
Publication statusE-pub ahead of print - 25 Mar 2022

Bibliographical note

Funding Information:
Funding: This project was funded by the National Institute for Health and Social Care (NIHR) Health Technology Assessment (HTA) programme (HTA 14/192/89). The British Heart Foundation and the NIHR Biomedical Research Center at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol funded some staff time (MP, JH, BCR, TWJ). This research was supported by the National Institute for Health Research (NIHR) Applied Research Collaboration West (NIHR ARC West). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. This study is based on data from the CPRD obtained under licence from the UK Medicines and Healthcare products Regulatory Agency and data from NHS Digital. The funders had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; or preparation, review or approval of the manuscript for submission.

Funding Information:
Funding: This project was funded by the National Institute for Health and Social Care (NIHR) Health Technology Assessment (HTA) programme ( HTA 14/192/89 ). The British Heart Foundation and the NIHR Biomedical Research Center at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol funded some staff time (MP, JH, BCR, TWJ). This research was supported by the National Institute for Health Research (NIHR) Applied Research Collaboration West (NIHR ARC West). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. This study is based on data from the CPRD obtained under licence from the UK Medicines and Healthcare products Regulatory Agency and data from NHS Digital. The funders had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; or preparation, review or approval of the manuscript for submission.

Publisher Copyright:
© 2022

Structured keywords

  • BTC (Bristol Trials Centre)

Keywords

  • Non-randomized studies of interventions (NRSI)
  • target trial
  • confounders
  • dual antiplatelet therapy (DAPT)
  • acute coronary syndrome (ACS)
  • percutaneous coronary intervention (PCI)
  • coronary artery bypass grafting (CABG)
  • bleeding
  • Clinical Practice Research Datalink (CPRD)
  • Hospital Episode Statistics (HES)

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