The Bahrain Branch of the UK Cochrane CentreIn Collaboration with

Reyada Training & Management Consultancy, Dubai-UAE

Cochrane Collaboration and Systematic Review Workshop, 20-21 February 2007,

Dubai - UAE

Dr. Zbys Fedorowicz, Dr. Dunia Al Hashimi, Dr. Ahmed Al Asfoor

http://bahrain.cochrane.orghttp://www.rt.ae

W11

Developing a Protocol

Alhashimi 3

Objectives:

• Describe the format of a Cochrane Protocol

• Identify new projects for the Cochrane Library

• Explain the process of registration of a title

• Outline the process of protocol writing

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Review Manager (RevMan)

• The software is designed to help authors construct reviews in the appropriate format and to prepare files required to transfer reviews electronically.

• It helps authors record changes done

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Each protocol consists of:

• a cover sheet – giving the title, citation details and contact addresses

• the text of the protocol – consisting of an introduction (background and objective), methods (selection criteria,  search methods, data collection and data analysis), acknowledgements and conflicts of interest

• tables and figures - relevant to the background or methods

• references

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• The text of a protocol ends just before the results sections. The results sections begin with a description of the studies identified by the review, which should start with a summary of the inclusion/exclusion of studies.

Planning a review- writing the protocol

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Step 3:Registering Title

Step 4: Writing the Protocol

Steps 1:

Formulating A Good Question

Step 2:

Identification of Relevance of Review

Planning the Review

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Step 1: Formulating A Good Question

• Clinical Relevance– Prevalence; duration– Severity– Cost to individuals, society

• Ability to influence practice• Feasibility of assessment• Intervention

– Interest and motivation of reviewers– Ethical, political and social consideration

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Formulating A Good Question

• Formulate the research question in PICO format

• P Population and medical problem to be investigated

• I Intervention

• C Comparator or Control

• O Outcomes of interest

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Step 3:Registering Title

Step 4: Writing the Protocol

Steps 1:

Formulating A Good Question

Step 2:

Identification of Relevance of

Review Planning the Review

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Step 2: Identification of Relevance of the Review

• To avoid unnecessary duplication of effort

• Search for completed and ongoing reviews by contacting relevant review group.

• New review required in the absence of a suitable review.

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• Potential authors adviced on availability of review titles by respective CRG

• Uncovered tiltles and priority topics

• Occasionally updating/expanding an existing review is required

• Titles preferably relevant to the authors region and will help to influence healthcare practice

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Step 3:Registering Title

Step 4: Writing the Protocol

Steps 1:

Formulating A Good Question

Step 2:

Identification of Relevance of Review

Planning the Review

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Registering a title• The first step in the review process is to agree

a review topic with the relevant Collaborative Review Group (CRG).

• A title will be registered, possibly after discussion among the CRG editors, and the review authors will be invited to submit a protocol.

• While questions should be posed in the protocol before initiating the full review, these questions should not become a straightjacket that prevents exploration of unexpected issues

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Registering Title

• The title of the prospective systematic review is registered online in the Cochrane Library

• Authors details and contact numbers included

• Can be edited before the final publication of the review.

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Step 3:Registering Title

Step 4: Writing the Protocol

Steps 1:

Formulating A Good Question

Step 2:

Identification of Relevance of Review

Planning the Review

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Step 4: Writing the Protocol

• Takes as much time as you can put in it but no longer than 3 months

• Protocol is a written in a clear and precise method

• RevMan ( Review Manager ) : the Cochrane Collaboration’s review management software

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Step 4: Writing the Protocol (cont)

• Background first – takes the longest• Protocol will be imported on the RevMan

format and sent to the relevant Review Group who will send it to internal and external peer reviewers who will in turn send their comments.

• Accept/reject with justifications• An accepted version will be edited and sent

for publication.• You will have 12 months time to write the

systematic review.

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Background

• Description of the condition

• Description of the intervention

• How the intervention might work • Why it is important to do this

review

Writing the Systematic Review

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Establishing a Search Strategy

Identificationof relevant trials

Description of Studies included in the review

Description of Studies excluded from the review

Writing the Systematic

review

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Step 5: Writing the Systematic Review

• Establishing a Search Strategy

• Identification of relevant trials

• Description of Studies included in the review

• Description of Studies excluded from the review

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Search Strategy

• Construction of a search strategy should be based on the components of the research question, population and intervention

• Searches are run on Cochrane Trial Register, MEDLINE (from 1966 onwards), EMBASE (from 1974 onwards), CINAHL ( Cumulative Index to Nursing and Allied Health Literature), PsycInfo (from 1967 onwards)

• Handsearching to identify very recent publications or those not included on the electronic datbases

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Step 5: Writing the Systematic Review (cont)

• Data Extraction/ Collection• Data Analysis• Methodological quality of included studies• Results• Discussion• Reviewers’ Conclusion

– Implication for practice– Implication for research

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Data Extraction/

CollectionData Analysis

Methodological quality of included studies

Results

Reviewers’ Conclusion• Implication for practice• Implication for research

Discussion

Writing the Systematic

Review

(cont)

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Methodological Quality Of Included Studies

• This is the degree to which a study employs measures to minimise biases, focussing on internal validity.

• Internal validity (validity) is the degree to which the results of a study are likely to approximate to the ‘truth’. It is a prerequisite for external validity.

• External Validity (generalisability, applicability) is the extent to which the effects observed in a study are applicable outside of the study ( in routine practice)

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Step 6: Publication of The Systematic Review

• Published by Wiley in the Cochrane Library available online for subscribing countries or in CD issued 4 times a year.

• The review is the full responsibility of the reviewer. He/She is committed for alerting for any new relevant RCT’s and updating the review.

• Reviewers who fail to update will risk having their reviews removed from the Cochrane Library .