Funding for this research was provided by:
Health Research Board (CDA-2018-005)
Text and Data Mining valid from 2021-04-01
Current Referee Status
Referee status: Indexed
Referee Report: https://doi.org/10.21956/HRBOPENRES.14033.R27154, KAMAL R. MAHTANI, CENTRE FOR EVIDENCE‐BASED MEDICINE, NUFFIELD DEPARTMENT OF PRIMARY CARE HEALTH SCIENCES, RADCLIFFE OBSERVATORY QUARTER, UNIVERSITY OF OXFORD, OXFORD, UK, 11 MAY 2020, VERSION 1, INDEXED
Referee Comment: <b>David Byrne</b>; <i>Posted: 26 Jan 2021</i>; <b>Point 1: The authors should provide some details on how they plan to manage the potentially large volumes of data that they may receive. For example, how do they plan to index these volumes as well develop a strategy to search and access data within them?</b> Response: The data management section has been updated to provide further information on the steps that will be followed to index relevant CSR document sections to facilitate searching and extraction of data. <b>Point 2: Although the authors make some partial reference to this, they may wish to state more explicitly how they plan to compare any differences in the published randomised control trial data versus the unpublished clinical study report data.</b> Response: The differences in outcome data between unpublished and published sources is a central focus of this study. We have expanded the data synthesis section to provide more details on dealing with data from various sources, including sensitivity analysis to assess the impact of data source (trial publication, registry, or CSR) on the relevant effect estimates: “Data will be extracted separately from each source, namely trial publication, trial registry and CSR. Both quantitative and qualitative data will be extracted including clinical efficacy and safety outcomes as well as, where relevant, details of trial characteristics and design … Sensitivity analysis will then also be conducted for each outcome to meta-analyse data from each source separately in order to assess the impact on the effect estimate.”
Referee Report: https://doi.org/10.21956/HRBOPENRES.14033.R27365, LI WEI, RESEARCH DEPARTMENT OF PRACTICE AND POLICY, UNIVERSITY COLLEGE LONDON SCHOOL OF PHARMACY, LONDON, UK, 15 MAY 2020, VERSION 1, INDEXED
Referee Comment: <b>David Byrne</b>; <i>Posted: 26 Jan 2021</i>; <b>The outcomes would be clearer if they could be categorised into two groups: efficacy outcomes and safety outcomes as efficacy and safety are two separate concepts.</b> Response: The outcomes section has been updated to reflect the different categories, namely efficacy and safety outcomes. <b>Risk of bias in individual studies will be conducted independently by two reviewers. It is worth to add an extra sentence that any discrepancy will be resolved through discussion or in consultation with a third researcher.</b> Response: The risk of bias section has been updated to outline that a third researcher will review and resolve any issues of discrepancy: “This will be conducted independently by two reviewers with any discrepancies or disagreements resolved with the assistance of a third reviewer”.
Referee Comment: <b>David Byrne</b>; <i>Posted: 26 Jan 2021</i>; <b>The protocol could be improved by clarifying in the abstract that the review will consider all subtypes of heart failure. Although the main text states that all subtypes will be included, this is unclear in the abstract.</b> Response: The abstract was updated to reflect that all categories of heart failure will be included in the analysis: “Heart failure of any subtype or NYHA class will be included”. <b>The list of outcomes is comprehensive, however, it would be helpful to categorise the outcomes by efficacy and safety.</b> Response: The outcomes section has been updated to reflect the different categories, namely efficacy and safety outcomes. <b>Consideration is given for sensitivity and subgroup analyses of published/unpublished and publication/trial registry/CSR, however, the efficacy and safety of treatment within heart failure subtypes should also be considered. How will the reviewers synthesize data where different definitions of HFrEF etc are used?</b> Response: There are variations in the definitions of HFrEF used in various studies, and this is an important issue to address. The evidence synthesis section has been updated to give further clarification on how this will be addressed in this study: “Analysis will be performed using pooled data of all heart failure subtypes. Where estimates of efficacy and safety are available for individual heart failure subtypes and where consistent definitions of ejection fraction are used across studies, analysis will be performed separately for any subtypes e.g. preserved ejection fraction and reduced ejection fraction.”
Grant Information: This doctoral research project is funded by the Health Research Board of Ireland (funding reference CDA-2018-005). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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