Information for authors

On  the  Cochrane training website page authors of systematic reviews will find everything they need to conduct their reviews https://training.cochrane.org/online-learning/author-guidelines . 

The aim of a Cochrane review is to assess systematically and thoroughly the best possible scientific evidence about the effects of a health care intervention(s). Everything about the review should aim to minimise the possibility of ending in a conclusion that is biased (systematic error either through domains or through design) or based on play of chance (random errors). This means:

  • the conduct of the review and its analyses should follow clear, pre-specified criteria - with checks along the way
  • it should be easy to understand
  • any conflict of interest of the people doing the review should be declared
  • effort must be made to find every possible study that might be eligible for the review
  • the studies included in the review's analyses should be ones which have as little bias in them as possible
  • outcomes that are important to the consumers of the interventions must be considered - whether or not they have been measured by researchers - to avoid conclusions being based on a narrow picture of relaity
  • the analyses should take into account statistical methods that may reduce the risk of random errors
  • the final review should follow the pre-specified criteria, addressing all the important issues originally raised, and highlight any issues and gaps in the information that should be addressed by researchers in future

People who wish to propose a review title should visit https://www.cochranelibrary.com/about/author-information for detailed information. The title can be agreed in advance with the CHBG Editorial Team office.

References for every article or book identified in the text of the manuscript need to be listed, complying with Cochrane standard format for references and citations (see the Cochrane Style Manual).

Authors must get familiar with and must follow the Conflicts of interest and Cochrane Reviews.

At a CHBG Editorial Team Group meeting in Copenhagen in April 2009, CHBG editors decided that CHBG review authors should be encouraged to use trial sequential analyses of their important meta-analyses. In the recent years, the central Cochrane editorial team suggested the use of Trial Sequential Analysis only as a sensitivity analysis of imprecision and compare this assessment with the assessment of imprecision with GRADE (Thomas 2019).

The Trial Sequential Analysis (TSA) software is free to download and use. The Trial Sequential Analysis Manual can be downloaded from the TSA website. Review authors should follow the instructions at www.ctu.dk/tools-and-links/tools-and-links.aspx when creating images for publication in their reviews with RevMan web.  

Please contact the CHBG editorial Team office for an example of Trial Sequential Analysis text in protocols and reviews. 

Reporting of reviews

For policies on the reporting of reviews (for example, on the discussion of results, the use of tables and figures, and the naming of studies), authors must follow the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions.

Core outcomes for chronic hepatitis B (CHB) virus infection

Critical outcomes

  • All-cause mortality or hepatitis B-related morbidity (number of participants who developed cirrhosis, ascites, variceal bleeding, hepato-renal syndrome, hepatocellular carcinoma, or hepatic encephalopathy and who have not died). These outcomes will be tested as a composite outcome as well as individually (mortality or morbidity). Such composite outcomes need to be interpreted with caution, especially if the components are influenced differently by the intervention.
  • Health-related quality of life (any valid assessment scale, filled out by the participant).
  • Serious adverse events, that is, any untoward medical occurrence that results in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect (The International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (ICH_GCP 1997)).

Important outcomes

  • Mortality due to hepatitis B-related liver disease.
  • Proportion of people with adverse events considered nonserious (any untoward medical occurrence in a participant or clinical investigation participant, that does not meet the above criteria for a serious adverse event, is defined as a non-serious adverse effect).
  • Proportion of people without histological improvement.
  • Proportion of people with detectable HBV-DNA in serum or plasma.
  • Proportion of people with detectable HBsAg in serum or plasma.
  • Proportion of people with detectable HBeAg in serum or plasma (this outcome is only relevant for HBeAg-positive participants).
  • Proportion of people without HBeAg seroconversion in serum or plasma (this outcome is only relevant for HBeAg-positive participants).
  • Proportion of people without normalisation of transaminases (i.e. biochemical response).

References:

International Conference on Harmonisation Expert Working Group. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice CFR & ICH Guidelines. Vol. 1. Philadelphia (PA): Barnett International/PAREXEL, 1997.

Core outcomes for chronic hepatitis C virus infection

Critical outcomes

  • All-cause mortality or hepatitis C-related morbidity (number of participants who developed cirrhosis, ascites, variceal bleeding, hepato-renal syndrome, hepatocellular carcinoma, or hepatic encephalopathy and who have not died). These outcomes will be tested as a composite outcome as well as individually (mortality or morbidity). Such composite outcomes need to be interpreted with caution, especially if the components are influenced differently by the intervention.
  • Health-related quality of life (any valid assessment scale, filled out by the participant).
  • Serious adverse events, that is, any untoward medical occurrence that results in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect (The International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (ICH-GCP 1997)).

Important outcomes

  • Mortality due to hepatitis C-related liver disease.
  • Non-serious adverse events. Any untoward medical occurrence in a participant or clinical investigation participant that does not meet the above criteria for a serious adverse event is defined as a non-serious adverse events.
  • Number of participants without histological improvement.
  • Failure of virological response: number of participants without sustained virological response, i.e., number of participants with detectable hepatitis C virus RNA (i.e., above lower limit of detection) in the serum by a sensitive PCR-based essay or by a transcription-mediated amplification testing 12 and 24 weeks after end of treatment.

The below outcome can also be considered:

  • Number of participants without normalisation of transaminases.

References:

International Conference on Harmonisation Expert Working Group. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice CFR & ICH Guidelines. Vol. 1. Philadelphia (PA): Barnett International/PAREXEL, 1997.

Information on core outcome sets can be found on www.comet-initiative.org/