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Cochrane Database of Systematic Reviews

Antibiotics for secondary prevention of coronary heart disease

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Information

DOI:
https://doi.org/10.1002/14651858.CD003610.pub3Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 18 July 2017see what's new
Type:
  1. Intervention
Stage:
  1. Protocol
Cochrane Editorial Group:
  1. Cochrane Heart Group

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Naqash J Sethi

    Correspondence to: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

    [email protected]

  • Sanam Safi

    Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

  • Steven Kwasi Korang

    Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

  • Asbjørn Hróbjartsson

    Center for Evidence‐Based Medicine, Odense University Hospital and University of Southern Denmark, Odense C, Denmark

  • Maria Skoog

    Löddeköpinge, Sweden

  • Christian Gluud

    The Cochrane Hepato‐Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

  • Janus C Jakobsen

    The Cochrane Hepato‐Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

    Department of Cardiology, Holbaek Hospital, Holbaek, Denmark

Contributions of authors

Naqash Javaid Sethi drafted the protocol, based on a previous version authored by Maria Skoog, Berit Grevstad, Asbjørn Hróbjartsson, Jørn Wetterslev, and Christian Gluud.

Janus Christian Jakobsen, Sanam Safi, Steven Kwasi Korang, Asbjørn Hróbjartsson, Maria Skoog, and Christian Gluud amended the protocol. All the authors read and approved the final manuscript.

Sources of support

Internal sources

  • Copenhagen Trial Unit, Denmark.

External sources

  • The 1991 Pharmacy Foundation, Denmark.

  • The Danish Medical Research Council, Denmark.

Declarations of interest

The performance of this review is free of any real or perceived bias introduced by receipt of any benefit in cash or kind, or any subsidy derived from any source that may have or be perceived to have an interest in the outcomes of the review.

Naqash J. Sethi (NJS): no conflict on interest.

Sanam Safi (SS): no conflict of interest.

Steven Kwasi Korang (SKK): no conflict of interest.

Maria Skoog (MS): Involved in a randomised trial (CLARICOR) in which the intervention drug (Klacid Uno®) and placebo were donated by Abbott.

Asbjørn Hróbjartsson (AH): no conflict of interest.

Christian Gluud (CG): member of The Copenhagen Trial Unit task force for developing TSA methods, manual, and software. Involved in a randomised trial (CLARICOR) in which the intervention drug (Klacid Uno®) and placebo were donated by Abbott.

Januc C. Jakobsen (JCJ): no conflict of interest.

Acknowledgements

We thank Cochrane Heart for their expert assistance in creating the search strategy and the provision of a template protocol.

Version history

Published

Title

Stage

Authors

Version

2021 Feb 23

Antibiotics for secondary prevention of coronary heart disease

Review

Naqash J Sethi, Sanam Safi, Steven Kwasi Korang, Asbjørn Hróbjartsson, Maria Skoog, Christian Gluud, Janus C Jakobsen

https://doi.org/10.1002/14651858.CD003610.pub4

2017 Jul 18

Antibiotics for secondary prevention of coronary heart disease

Protocol

Naqash J Sethi, Sanam Safi, Steven Kwasi Korang, Asbjørn Hróbjartsson, Maria Skoog, Christian Gluud, Janus C Jakobsen

https://doi.org/10.1002/14651858.CD003610.pub3

2013 Feb 28

Antibiotics for secondary prevention of coronary heart disease

Protocol

Maria Skoog, Berit Grevstad, Jørn Wetterslev, Asbjørn Hróbjartsson, Christian Gluud

https://doi.org/10.1002/14651858.CD003610.pub2

2002 Apr 22

Antibiotics for secondary prevention of coronary heart disease

Protocol

Tea Monk‐Hansen, Eva Prescott, Bodil Als‐Nielsen, Asbjørn Hróbjartsson, Jørn Wetterslev, Christian Gluud

https://doi.org/10.1002/14651858.CD003610

Notes

This is a re‐publication of a protocol (DOI: 10.1002/14651858.CD003610.pub2) due to changes in authorship and methods.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Table 1. The Cochrane tool for assessing risk of bias

Domain

Description

Random sequence generation

  • Low risk: if sequence generation was achieved using computer random number generator or a random numbers table. Drawing lots, tossing a coin, shuffling cards, and throwing dice were also considered adequate if performed by an independent adjudicator.

  • Unclear risk: if the method of randomisation was not specified, but the trial was still presented as being randomised.

  • High risk: if the allocation sequence was not randomised or only quasi‐randomised. We will exclude these trials.

Allocation concealment

  • Low risk: if the allocation of participants was performed by a central independent unit, on‐site locked computer, identical‐looking numbered sealed envelopes, drug bottles, or containers prepared by an independent pharmacist or investigator.

  • Uncertain risk: if the trial was classified as randomised but the allocation concealment process was not described.

  • High risk: if the allocation sequence was familiar to the investigators who assigned participants.

Blinding of participants and personnel

  • Low risk: if the participants and the personnel were blinded to intervention allocation and this was described.

  • Uncertain risk: if the procedure of blinding was insufficiently described.

  • High risk: if blinding of participants and the personnel was not performed.

Blinding of outcome assessment

  • Low risk of bias: if it was mentioned that outcome assessors were blinded and this was described.

  • Uncertain risk of bias: if it was not mentioned if the outcome assessors in the trial were blinded, or the extent of blinding was insufficiently described.

  • High risk of bias: if no blinding or incomplete blinding of outcome assessors was performed.

Incomplete outcome data

  • Low risk of bias: if missing data were unlikely to make treatment effects depart from plausible values. This could either be: 1) there were no drop‐outs or withdrawals for all outcomes, or 2) the numbers and reasons for the withdrawals and drop‐outs for all outcomes were clearly stated and could be described as being similar in both groups. Generally, the trial is judged as at a low risk of bias due to incomplete outcome data if drop‐outs are less than 5%. However, the 5% cut‐off is not definitive.

  • Uncertain risk of bias: if there was insufficient information to assess whether missing data were likely to induce bias on the results.

  • High risk of bias: if the results were likely to be biased due to missing data either because the pattern of drop‐outs could be described as being different in the two intervention groups or the trial used improper methods in dealing with the missing data (e.g. last observation carried forward).

Selective outcome reporting

  • Low risk of bias: if a protocol was published before or at the time the trial was begun and the outcomes specified in the protocol were reported on. If there is no protocol or the protocol was published after the trial has begun, reporting of all‐cause mortality and serious adverse events will grant the trial a grade of low risk of bias.

  • Uncertain risk of bias: if no protocol was published and the outcomes all‐cause mortality and serious adverse events were not reported on.

  • High risk of bias: if the outcomes in the protocol were not reported on.

Other risks of bias

  • Low risk of bias: if the trial appears to be free of other components (for example, academic bias or for‐profit bias) that could put it at risk of bias.

  • Unclear risk of bias: if the trial may or may not be free of other components that could put it at risk of bias.

  • High risk of bias: if there are other factors in the trial that could put it at risk of bias (for example, authors have conducted trials on the same topic, for‐profit bias etc).

Overall risk of bias

  • Low risk of bias: the trial will be classified as overall 'low risk of bias' only if all of the bias domains described in the above paragraphs are classified as 'low risk of bias'.

  • High risk of bias: the outcome result will be classified 'high risk of bias' if any of the bias risk domains described in the above are classified as 'unclear' or 'high risk of bias'.

Figures and Tables -
Table 1. The Cochrane tool for assessing risk of bias