Cochrane Metabolic and Endocrine Disorders Group
Department of General Medicine
University Hospital Duesseldorf

Protocol Checklist
Title:			
Contact author: 			
Date:			

STANDARDS
We have prepared the following processes for the preparation of Cochrane reviews within the Cochrane Metabolic and Endocrine Disorders Group (CMED). These have been designed to help maintain and improve the quality of these reviews. The processes will be continuously updated and improved and we are happy to discuss them with people who are, or would like to become, authors of Cochrane reviews with CMED. 
We are making special efforts to improve quality and, in order not to spend too much of the editorial team's time on drafts for protocols and reviews which require substantial revision before being suitable for refereeing (which would use scarce resources that could be better used for reviews that are closer to being ready), we ask all authors to submit a checklist with their protocol/review to indicate that they have done each of a core set of items (see below). If an author would like advice about any of these items, they should contact the editorial base. 
The checklist represents a minimum set of standards which every protocol, review or update needs to meet before it is evaluated further by CMED. This saves time for the editorial base and our referees but, also, for the authors themselves. If a protocol, review or update is submitted without meeting this minimum set of standards we send it back to the authors so that they can make the necessary revisions and re-submit it. If any authors would like to ask that their protocol, review or protocol is dealt with in a different way, this would need to be negotiated on a case by case basis with CMED and might be possible in special circumstances. 
All authors should check the most recent version of the Cochrane Handbook for Systematic Reviews of Interventions (formerly, the Cochrane Reviewers' Handbook) which is freely available within The Cochrane Library and at www.cochrane.org, to ensure that they are following the most up-to-date requirements for Cochrane reviews. The editorial team of CMED also check the Handbook and will amend future versions of this module if there are important changes in policy.
Please document that all Co-authors have seen and checked the review according to the checklist:

	Last Name, First Name	Seen and checked	
Contact author			
Co-author 1			
Co-author 2			
Co-author 3			
Co-author 4			
Co-author 5			
Co-author 6			
Co-author 7			
Co-author 8			

1. General	Done	
- Protocol supplied in RevMan format.		
- Data extraction in section ‘Additional tables’.		

2. Cover sheet		
- Title the same as the registered one (if not, please contact us before sending in your protocol).		
- Reviewers and contribution of reviewers named.		
- Potential conflict of interest declared (or "none known").		

3. Background		
- Intervention(s) as well as potential adverse effects clearly described.		
- Last paragraph: Description of systematic reviews, meta-analyses or health-technology assessment reports regarding the review objectives. If none was found, this has to be declared. Listing of shortcomings of those found in comparison to the new review project.		

4. Objectives		
- General format: "To assess the effects of …."		
- No outcomes in the objectives section.		

5. Types of studies		
- Match the search strategy.		

6. Types of participants		
- Diagnostic criteria are described.		

7. Types of outcome measures
The following outcomes always* have to be investigated: All-cause mortality, morbidity/complications, (health related) quality of life, adverse events, and costs. Even if no data are detected, these findings are very important for consumers, researchers and funders.		
- General format: Primary outcomes, secondary outcomes.		
- Primary outcomes: Three at maximum.
Scientifically, one primary outcome would be justified only. Since many studies name up to three "primary" outcome parameters, this procedure might be reflected in your systematic review.		
- Description of potential effect modifiers/ co-variates / confounders according to a-priori knowledge or clinical reasoning. If nothing comes up, describe as "none known".		
- Description of timing of outcome measurement.		
* Exceptions have to be negotiated with CMED

8. Search strategy for identification of studies		
- Minimum database set to be searched: The Cochrane Library, MEDLINE, EMBASE.		
- MEDLINE search strategy supplied (as an additional table).		
- Ongoing trials databases to be searched named.		

9. Trials selection		
- At least two authors named for trial selection.		
- Inter-rater agreement for sifting the literature planned (kappa statistic - studies where no primary consensus will be reached should be marked and - if included later on eventually subjected to a sensitivity analysis).		
- Description of handling of duplicate, companion publications etc.		

10. Quality assessment of trials		
- In addition to Cochrane quality criteria (A, B, C), investigation of individual quality criteria named.		
- Characterisation of clinical quality criteria. If nothing comes up, description as "none known" should be used.		
- Please state that you will calculate inter-rater agreement (kappa statistic) for concealment of allocation as a minimum, if feasible.		

11. Data extraction		
- Data extraction tables used as additional tables.		

12. Data analysis		
- Heterogeneity: Use of chi-square test at P < 0.10 and I-squared statistic. 		

13. Subgroup analyses		
- Visible attempt to limit the number of subgroup analyses.		

14. Sensitivity analyses		
- Listed according to template of CMED (minimum: quality criteria, statistical model, published / unpublished studies).		

15. References		
- Journal names written out in full.		

In Review Manager go to  File  Check review … and copy the screen to the clipboard (press “ALT” and “Print” simutaneously). Then copy the screen here (press “CTRL” and “v” simutaneously). Make sure you eliminate all errors and reduce warnings as much as possible, before sending your protocol or review: