The Bahrain Branch of the UK Cochrane Centre In Collaboration with Reyada Training & Management Consultancy, Dubai-UAE Cochrane Collaboration and Systematic Review Workshop, February 2007, Dubai - UAE Dr. Zbys Fedorowicz, Dr. Dunia Al Hashimi, Dr. Ahmed Al Asfoor W11

Developing a Protocol

Alhashimi3 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

Alhashimi4 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

Alhashimi5 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

Alhashimi6 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

Alhashimi8 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

Alhashimi9 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

Alhashimi10 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

Alhashimi11 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

Alhashimi12 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.

Alhashimi13 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

Alhashimi14 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

Alhashimi15 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

Alhashimi16 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.

Alhashimi17 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

Alhashimi18 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

Alhashimi19 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.

Alhashimi20 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

Alhashimi22 Establishing a Search Strategy Identification of relevant trials Description of Studies included in the review Description of Studies excluded from the review Writing the Systematic review

Alhashimi23 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

Alhashimi24 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

Alhashimi25 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

Alhashimi26 Data Extraction/ Collection Data Analysis Methodological quality of included studies Results Reviewers’ Conclusion Implication for practice Implication for research Discussion Writing the Systematic Review (cont)

Alhashimi27 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)

Alhashimi28 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.