Peer Review Checklist for Protocol

Cochrane Cystic Fibrosis & Genetic Disorders Group Cochrane Intervention Review Peer reviewer checklist

Title:

Authors:

Name of peer reviewer:

Date sent:

Date to be returned to editorial base:

Our review process is in two stages and begins with a protocol, which clearly defines the framework for the review. Each protocol is published on The Cochrane Library. The protocol is replaced by the full review, which identifies and summarises all evidence from randomised controlled trials, and presents this information in a format understandable to both healthcare professionals and users of health care.

Please note: we ask peer reviewers to comment on both the protocol and later the full review.

We operate a system of open peer review and your comments will be forwarded onto the review authors.

We are asking you to use the checklist and your own skills to comment and help improve the review before publication. Please indicate where improvements can be made carefully and constructively, either on the checklist or with your comments on a separate sheet, or both. If you would like any more information on the items in this checklist, please go to the relevant sections in the Cochrane Handbook (http://www.cochrane-handbook.org/).

Please also complete the ‘Declaration of Interests’ section at the end of the checklist and return with your comments.

Thank you for your contribution to the Group. You will be listed as one of our peer reviewers in The Cochrane Library.

Review ID: Page 1 Please tick one of the three boxes in the right hand column of the form where appropriate, and add comments where indicated. There is a separate section (no.7) for you to add more comments.

1. Title No Yes No comment a. Is the review question important? b. Is the title a good reflection of the review question? Additional comment:

2. Abstract No Yes No comment a. Is there clarity and consistency with the main text? b. Are the main findings are correctly highlighted? Additional comment:

3. Plain Language Summary No Yes No comment a. Is there clarity and consistency with the main text? b. Are the main findings are correctly highlighted? c. Is the language appropriate for lay readers? Additional comment:

4. Background No Yes No comment a. Does the background describe the global health issue including incidence and prevalence, how it occurs, who is affected and how? b. Does the background clearly describe the intervention?

c. Does the background describe how the intervention works? d. Does the background clearly state the rationale for the review and explain why the questions being asked are important? Additional comment:

Review ID: Page 2 5. Objectives No Yes No comment a. Is the main objective of the review specified in terms of clinical problem, population, intervention(s) and comparison (s), and outcome(s) (both beneficial and harmful)? Additional comment:

6. Criteria for considering studies for this review No Yes No comment Types of studies: a. Are the types of studies to be included (randomised trials, quasi-randomised trials or other designs) described? b. Is the choice of study types appropriate to the population, intervention(s), comparison(s) and outcome(s)? Additional comment:

Types of participants: c. Are the participants adequately described and are the reasons for any restrictions appropriate? Additional comment:

Types of interventions: d. Are the study interventions and comparators clearly described? Additional comment:

Types of outcome measures e. Are the outcomes listed useful and appropriate? NB. No more than three primary outcomes including at least one desirable and one undesirable outcome (to assess beneficial and adverse effects respectively).

f. Are all other important (beneficial and harmful) outcomes considered? Additional comment:

Review ID: Page 3 7. Search methods for identification of studies No Yes No comment a. Will there be a thorough unrestricted search for relevant studies using appropriate sources? b. Are there any additional resources that should be searched? Additional comment:

8. Data collection and analysis If you have any comments on the data collection and analysis sections, please complete the appropriate box(es) below. a. Please comment on the methods used to apply the selection criteria.

b. Please comment on methods described for extracting and managing data (e.g. process, time-points, methods for processing data in preparation for analysis, etc).

c. Please comment on the methods described for assessing the risk of bias (e.g. domains clearly stated and appropriate).

d. Please comment on whether the effect measures for analysing data are clearly described and appropriate for the outcome measures listed.

e. Please comment on whether appropriate strategies for unit of analysis issues e.g. cross-over trials are adequately discussed.

f. Please comment on whether strategies for dealing with missing data are adequately described.

g. Please comment on whether clinical and statistical heterogeneity will be adequately assessed.

Review ID: Page 4 h. Please comment on whether all potential reporting biases will be adequately assessed.

i. Please comment on whether the choice of meta-analysis method is appropriate.

j. Please comment on whether investigation of heterogeneity is adequately described. NB. it is recommended there are no more than four planned subgroup analyses.

k. Please comment on the appropriateness of planned sensitivity analyses.

9. Description of studies No Yes No comment a. Included studies – are these adequately and comprehensively described? b. Excluded studies – are reasons for exclusion reasonable and comprehensive? Additional comment:

10.Risk of bias No Yes No comment a. Are the risk of bias assessments appropriate (given details provided)? Please also refer to ‘Characteristics of included studies’ (Risk of bias tables) for more detailed information. Additional comment:

11.Effects of interventions No Yes No comment

Review ID: Page 5 a. Were data presented in meta-analyses combined and presented appropriately? b. Does the text describe the graphs accurately? c. Are any statements made that cannot be justified given the evidence presented? d. For data that are not able to be entered into meta-analyses, are these presented clearly? Additional comment:

12. Discussion No Yes No comment a. Are the main findings summarised appropriately and in a balanced way?

b. Is the evidence presented and discussed clearly relevant to the review question? c. Has the quality of the evidence presented been adequately and accurately discussed? d. Have any potential biases in the review process been discussed?

e. Has the review been put into context with other available evidence? Additional comment:

13. Authors’ conclusions No Yes No comment a. Implications for practice - are these justifiable from the evidence presented in the review? b. Implications for research – is an appropriate research agenda outlined (relevant

trial design / participants / outcomes, etc)? Additional comment:

14.Additional comments from peer reviewer

Please use the space below to add any other comments you may have.

Review ID: Page 6

15.Overall assessment

Please select one of the following options and add any final comments in the space provided below. The review is acceptable for publication in its present form. The review is acceptable for publication with minor revisions. The review is acceptable for publication with substantial revisions. Additional comments:

16.Potential conflicts of interest: Peer reviewer statement

Do you have any potential conflict of interest? Yes (details below) No conflict of interest You should declare and describe any present or past affiliations or other involvement in any organisation or entity with an interest in the outcome of the review that might lead to a real or perceived conflict of interest. This includes acting as an investigator of a study that might be included in this review. You should declare potential conflicts even if you are confident that your judgement is not influenced. Peer reviewer’s conflict of interest statement:

17. Peer reviewer acknowledgement Yes No

Please complete: I am happy to be acknowledged in the published review.

Name: ______

Date: ______

Review ID: Page 7 Please return the full form to the appropriate Managing Editor at the Cochrane Cystic Fibrosis & Genetic Disorders Review Group: Tracey Remmington ([email protected]) or Nikki Jahnke ([email protected]).

Review ID: Page 8