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Trusted evidence.
Informed decisions.
Better health.
Meeting or Conference
Location
Date
Cochrane &
Cochrane Eyes and Visi...
Cochrane’s central functions are funded by royalties from its
publishers, John Wiley and Sons Limited, which come from
the...
Table of Contents for Slide Set
Section Topic Slide numbers
A Introduction to Cochrane 4-11
B Introduction to Cochrane Eye...
Cochrane : A little background
Cochrane’s vision: a world of improved health where
decisions about health and health care ...
Why “Cochrane”?
Archibald Leman Cochrane
(1909-1988)
"It is surely a great criticism of our
profession that we have not
or...
What is a Systematic Review?
A review of existing knowledge that uses explicit, scientific methods
• Structured and transp...
Types of Review Articles
All reviews
Systematic
reviews with
meta-analyses
Individual patient
data (IPD) meta-
analyses
Pa...
Central Editorial Unit
Editorial Board
Cochrane Central Executive
Cochrane is a not-for-profit international network of 37,000 contributors
from over 130 countries.
Over 70% of these peopl...
World map showing locations of all Cochrane Centers (blue) and
Branches (red)
(http://www.community.Cochrane.org, accessed...
“The Cochrane Collaboration is an enterprise
that rivals the Human Genome Project in its
potential implications for modern...
Cochrane Eyes and Vision
Cochrane Eyes and Vision (CEV) is an
international network of individuals working to
prepare, mai...
CEV is one of 53 Cochrane Review Groups
and has an editorial base and 2 satellites
CEV-UK Editorial
Base:
London School of...
Richard Wormald
Coordinating Editor
Iris Gordon
Trials Search Coordinator
Anupa Shah
Managing Editor
Jennifer Evans
Deputy...
CEV US Satellite – Baltimore, Maryland (CEV@US)
Kay Dickersin, PhD, MA Principal Investigator
Kristina Lindsley, MS Projec...
CEV@US serves as a methodological “hub” to train and assist
content experts and consumers with methodology of
systematic r...
CEV@US is funded by the National Eye Institute,
National Institutes of Health, US
• Expand awareness of evidence-based health care
• Develop a critical mass of vision researchers who are able to
perform a...
In-person workshops:
1. Developing a Cochrane Systematic Review
Takes place twice a year in Baltimore, Maryland
• Purpose:...
1. Understanding Evidence-based Healthcare
Course Developers: Kay Dickersin, MA, PhD and Musa Mayer, MS,
MFA
Designed to h...
US Contributors’ meeting
at the 2014 Cochrane
Colloquium
Doctoral student Ian
Saldanha wins ‘Best Oral
Presentation’ award...
Systematic Reviews in Eyes and Vision
“The ultimate goal of Cochrane reviews is to
organize medical research information i...
• We aim to prepare, maintain and promote access to systematic reviews of
all the interventions used to prevent, treat, or...
Glaucoma
14%
Corneal Diseases
10%
Retinal
Degeneration
13%
Retinal Diseases
10%Lens Diseases
8%
Ocular Motility
Diseases
7...
A recent study found that CEV reviews “allow, in
approximately half of the cases, the reader to reach a
clinically applica...
Application and Impact of CEV Reviews
"The commissioners were most
persuaded by the recent
independent Cochrane review of
...
Accessing CEV Reviews in the Cochrane Library
Accessing CEV Reviews in the Cochrane Library
Recent Publications (2016):
Over the counter (OTC) artificial tear drops for dry eye
syndrome
Pucker AD, Ng SM, Nichols JJ...
Peripheral iridotomy for pigmentary glaucoma
Michelessi M, Lindsley K. (February 2016)
Authors’ conclusions:
We found insu...
Elements of a Cochrane Review
Why Publish a Cochrane Review?
 Identify targeted areas where evidence is needed to answer ...
Sections of a Cochrane Review
1. Abstract
2. Plain Language Summary
3. Background
4. Objective
5. Methods
 Formulation of...
What the background section addresses
• What is the problem and why is it important?
• Why do people think the interventio...
Focused Research Question
Translation of clinical problem into a structured
question and identification of the key concept...
Assessment of Potentially Eligible Studies
• A two-stage process often is used to access studies for
the review
–Screening...
Data Collection
• Which data were extracted and by whom?
–Develop and pilot data extraction forms
–Extract data by 2 extra...
Qualitative Synthesis of Included Studies
Context of the evidence
• What are the differences in study characteristics amon...
Quantitative Synthesis of Included Studies
Meta-analysis
• Statistical pooling of study results to obtain a single
summary...
Discussion and Conclusions
Discussion
• Summary of main results
• Overall completeness and applicability of the evidence
•...
Interactive Roadmap
to completing a
Cochrane systematic review
Updated 7 August 2015
Welcome to CEV
This interactive roadmap provides a step by step
reference for completing a review with CEV.
Our editorial ...
The Cochrane Systematic Review
Process
 Review proposal
 Title registration
 Protocol preparation
 Editorial and peer ...
Preparing to do a Cochrane Review
Things to consider before undertaking a Cochrane review:
Time: It takes about 18 months ...
Timeline for Cochrane Reviews
Protocol
Submission
Protocol Publication
Review Submission
Review Publication
6-8 weeks 9-12...
CEV Timeline
55
68
41
39.1
183
132
84
39.3
45
33
36
38.7
0 50 100 150 200 250 300
15 or more Studies (n=4)
5-7 Included St...
CEV Timeline
Topics for Cochrane Reviews
• Cochrane reviews focus on evidence from randomized
controlled trials (RCTs) and quasi-random...
Building Your Review Team
Co-authors: At least one co-author is needed to assist with the
review. The co-author duplicates...
Review Proposal Process
Once you have decided on a review topic, you should contact Ms.
Anupa Shah with your interest in i...
Title Registration
Once your title is approved by the CEV editors, we will register your title in
Archie. Archie is Cochra...
Key Deadlines
A first draft of a protocol should be submitted to the editorial
base by three months after title registrati...
Protocol Preparation
 We strongly recommend downloading RevMan and
completing the tutorial before you begin work on your
...
Protocol Preparation
 To access your protocol:
 In RevMan, select the option “Check out” from the File
menu or “Go to My...
Things to Consider While Drafting
Your Protocol
General background information
Description of the condition
Description ...
Submitting Your Protocol
• All protocols must be submitted to CEV editors using RevMan. When
you “check in” your protocol,...
Editorial and Peer Review of the
Protocol
All Cochrane protocols undergo a multi-step editorial process
1. CEV methodologi...
Editorial and Peer Review of the
Protocol (continued)
5. The CEV Coordinating Editor will review your protocol and may
res...
Publication of the Protocol
Shortly after your protocol is accepted for publication, the
CEV Trials Search Coordinator wil...
Systematic Review Preparation
Two authors independently screen the titles and abstracts
from the search results and classi...
Screening and Selection of Studies
Walline et al, The Cochrane Library 2011
Systematic Review Preparation
Remember to document reasons for excluding studies from
your review. You will need to enter ...
Systematic Review Preparation
Check the bibliographies of included studies, conference
proceedings, and the Science Citati...
Systematic Review Preparation
CEV provides authors with assistance from methodologists
(epidemiologists, statisticians) an...
Methodology “Hubs” at CEV@US:
 Provide methodological and administrative assistance to US-
based systematic review author...
Methodology “Hubs” at CEV@US:
CEV@US will pair you with a trained methodologist to
assist with the following procedures:
...
Methodology “Hubs” at CEV@US:
 Handsearch journals and conference proceedings for
reports of clinical trials
 Conduct wo...
Data Extraction and Risk of Bias
Assessments
At least two authors should independently
Assess the risk of bias of the inc...
Data Extraction and Risk of Bias
Assessments
 Contact the authors of included studies for missing or
unclear information
...
Data Analysis
 Select the appropriate measure of effect for each
outcome (e.g., dichotomous, continuous)
 Test for heter...
Things to Consider While Drafting
Your Systematic Review
Confirm that the review methods are consistent with the published...
Submitting Your Systematic Review
•Before you submit your review, you will need to check that
your review meets the method...
Editorial and Peer Review of the
Systematic Review
The editorial review process for full reviews is
similar to the editori...
Publication of the Systematic Review
Congratulations!
You have completed a Cochrane Review
Your review will be submitted f...
Updating the Review
• Once your review is published you will receive a free
subscription to the Cochrane Library
• Your re...
Now let’s take a look at an
example of a CEV Systematic
Review…
Characteristics of Included Studies
Risk of bias assessment
Methodological quality of
studies included in review
 Random sequence
 Allocation concealment
 ...
Walline et al, The Cochrane Library 2011
Anti-muscarinic agents vs. placebo
Cochrane Tools
Tools and Resources for:
• Review authors
• Handsearchers
• Healthcare users
• Patients/Consumers
Online Cochrane Resources
 Website – www.cochrane.org
• 2 Handbooks:
– Reviews of interventions
– Reviews of diagnostic t...
Cochrane Tools: Handbook
Higgins, J. P. T., and Green, S. (Eds.). Cochrane handbook for
systematic reviews of intervention...
Cochrane Tools: RevMan
 Review Manager (RevMan)
 Mandatory software for writing
and publishing your review
 Available f...
Cochrane Tools: Archie
Cochrane’s central database
 Stores all reviews and author contact information
 The Cochrane Libr...
Cochrane Tools: Review Management
Via Cochrane Training: http://www.slideshare.net/mirandacumpston/12-introduction-to-rev-...
Cochrane Tools: Training
CEV offers two Systematic Review training
workshops each year
Free online courses:
Translating ...
Web-based course on Peer Review – Launched May 2011
Module 1. Introduction to editorial peer review
 Lec 1. Peer review: ...
Getting Involved with CEV
• Prepare a systematic review
• Peer review our systematic reviews
• Handsearch journals and con...
What’s new at CEV@US
Current CEV@US
Research Projects
CEV Partnerships
Professional societies
 American Academy of Ophthalmology
 American Academy of Optometry
 American Gla...
Evidence Gap Project (E-Gap)
CEV@US is examining the evidence underpinning clinical
practice guidelines, and together with...
E-Gap: What Evidence Is Needed?
1. Extract recommendations and supporting evidence from the American
Academy of Ophthalmol...
Database of Systematic Reviews in
Eyes and Vision
Aim To identify and assess the quality of systematic reviews in
eyes and...
Network Meta-Analysis
Medical Interventions for Primary Open Angle
Glaucoma (POAG)
 To synthesize direct and indirect evi...
Progress:
• Completed data abstraction and analysis of
monotherapy interventions
• Published 2 papers
Next steps:
• Comple...
Network Meta-Analysis
Application of Network Meta-Analysis for
Clinical Practice Guidelines
Objective: to compare the guid...
CompARE Project
Comparison of Abstract Reports as Evidence
Background
• Conference abstracts not peer-reviewed
• Not all a...
Objectives
 Assess concordance of data between conference abstracts and full-
publications of RCTs
 Assess factors assoc...
Other CEV Methods Research Projects
 Registration of eye trials (Bobbi Scherer, PLoS One 2012)
 Agreement between primar...
Cochrane Eyes and Vision : Overview for Advisory Board 2016
Cochrane Eyes and Vision : Overview for Advisory Board 2016
Cochrane Eyes and Vision : Overview for Advisory Board 2016
Cochrane Eyes and Vision : Overview for Advisory Board 2016
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Cochrane Eyes and Vision : Overview for Advisory Board 2016

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To promote evidence informed health decision-making by producing high-quality, relevant, accessible systematic reviews and other synthesized research evidence

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Cochrane Eyes and Vision : Overview for Advisory Board 2016

  1. 1. Trusted evidence. Informed decisions. Better health. Meeting or Conference Location Date Cochrane & Cochrane Eyes and Vision
  2. 2. Cochrane’s central functions are funded by royalties from its publishers, John Wiley and Sons Limited, which come from the sales of subscriptions to The Cochrane Library. The individual entities of Cochrane, such as Centers and Review Groups, are funded by a large variety of governmental, institutional and private funding sources and are bound by organization-wide policy limiting uses of funds from corporate sponsors. Funding and support for CEV National Eye Institute - United States National Health Service (NHS) Research and Development Programme - UK
  3. 3. Table of Contents for Slide Set Section Topic Slide numbers A Introduction to Cochrane 4-11 B Introduction to Cochrane Eyes and Vision 12-31 C Elements to a Cochrane Review 32-40 D Roadmap to Completing a Cochrane Review 41-75 E Example of a Cochrane Eyes and Vision Review 76-82 F Cochrane Tools 83-91 G CEV@US Research Projects 92-102
  4. 4. Cochrane : A little background Cochrane’s vision: a world of improved health where decisions about health and health care are informed by high-quality, relevant, and up-to-date synthesized research evidence Cochrane’s mission: to promote evidence informed health decision-making by producing high-quality, relevant, accessible systematic reviews and other synthesized research evidence
  5. 5. Why “Cochrane”? Archibald Leman Cochrane (1909-1988) "It is surely a great criticism of our profession that we have not organised a critical summary, by specialty or subspecialty, adapted periodically, of all relevant randomised controlled trials.”  His challenge led to the establishment during the 1980s of an international collaboration to develop the Oxford Database of Perinatal Trials.  Inspired the first Ophthalmic epidemiological study – the Ferndale Glaucoma Study in the Rhondda Valley, Wales
  6. 6. What is a Systematic Review? A review of existing knowledge that uses explicit, scientific methods • Structured and transparent process • Comprehensive search for relevant articles • Explicit methods of appraisal and synthesis Synthesizes methods and results of similar but separate studies May or may not combine results quantitatively (meta-analysis)
  7. 7. Types of Review Articles All reviews Systematic reviews with meta-analyses Individual patient data (IPD) meta- analyses Pai M, McCulloch M, Gorman JD, et al. Systematic reviews and meta-analyses: An illustrated, step-by-step guide. Natl Med J India 2004;17(2):86-95. Systematic reviews Reviews that are not systematic (traditional, narrative reviews)
  8. 8. Central Editorial Unit Editorial Board Cochrane Central Executive
  9. 9. Cochrane is a not-for-profit international network of 37,000 contributors from over 130 countries. Over 70% of these people are authors of Cochrane Reviews. The number of contributors has increased by about 20% each year for the last five years The increase in the number of contributors from low, lower-middle and upper-middle income countries has been even greater, increasing by 42% since 2013. (http://www.community.Cochrane.org, accessed May, 2015)
  10. 10. World map showing locations of all Cochrane Centers (blue) and Branches (red) (http://www.community.Cochrane.org, accessed May, 2015)
  11. 11. “The Cochrane Collaboration is an enterprise that rivals the Human Genome Project in its potential implications for modern medicine” -- CD Naylor. The Lancet, April 1995 The Cochrane Library Impact factor was 6.035 in 2014
  12. 12. Cochrane Eyes and Vision Cochrane Eyes and Vision (CEV) is an international network of individuals working to prepare, maintain and promote access to systematic reviews of interventions to treat or prevent eye diseases or visual impairment. http://eyes.cochrane.org/
  13. 13. CEV is one of 53 Cochrane Review Groups and has an editorial base and 2 satellites CEV-UK Editorial Base: London School of Hygiene and Tropical Medicine, International Centre for Eye Health Diagnostic Test Accuracy Satellite: University of Florence, Italy CEV-US Satellite: Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland Who we are
  14. 14. Richard Wormald Coordinating Editor Iris Gordon Trials Search Coordinator Anupa Shah Managing Editor Jennifer Evans Deputy Coordinating Editor CEV Editorial Base
  15. 15. CEV US Satellite – Baltimore, Maryland (CEV@US) Kay Dickersin, PhD, MA Principal Investigator Kristina Lindsley, MS Project Director Roberta Scherer, PhD Co-Investigator & Handsearching Unit Director Tianjing Li, MD, PhD Co-Investigator Barbara Hawkins, PhD Co-Investigator Ian Saldanha, MD, PhD Co-Investigator Sonal Singh, MD Co-Investigator Andrew Hua Law, MHS Methodologist Elizabeth Clearfield, MHS Methodologist Nan Zhang, MHS Methodologist Sueko Ng, MHS Methodologist Lori Rosman, MLS, AHIP Claire Twose, MLIS Reva Datar, MPH Informationist Informationist Coordinator
  16. 16. CEV@US serves as a methodological “hub” to train and assist content experts and consumers with methodology of systematic reviews, Review Manager (RevMan), searching for studies, screening titles and abstracts, data abstraction, and write-up and publication.
  17. 17. CEV@US is funded by the National Eye Institute, National Institutes of Health, US
  18. 18. • Expand awareness of evidence-based health care • Develop a critical mass of vision researchers who are able to perform and interpret systematic reviews, and train others to do the same • Develop a critical mass of clinicians who use the results of systematic reviews as an evidence base to guide their practice and to train others to do the same • Generate an increased number of systematic reviews in priority vision research areas, published in The Cochrane Library and in the traditional vision research literature Aims of CEV@US
  19. 19. In-person workshops: 1. Developing a Cochrane Systematic Review Takes place twice a year in Baltimore, Maryland • Purpose: To guide participants through the steps of developing a systematic review • Target Audience: Cochrane review authors • Includes: Presentations about Cochrane methodology & hands-on practice using the Cochrane Collaboration’s RevMan software 2. Evidence-based Ophthalmology Takes place as requested • Purpose: To teach participants how to find, appraise and apply the best research evidence to clinical practice • Target Audience: Ophthalmologists • Includes: a mix of both didactic and small group sessions; small groups provide experience using specific patient cases as a basis for evaluating research evidence for clinical care
  20. 20. 1. Understanding Evidence-based Healthcare Course Developers: Kay Dickersin, MA, PhD and Musa Mayer, MS, MFA Designed to help consumer advocates understand the fundamentals of evidence-based healthcare concepts and skills. A complementary course adapted for clinicians with Steve Goodman, MD, PhD 2. Translating Critical Appraisal for a Manuscript into Meaningful Peer Review An acclaimed team of Cochrane scientists and clinicians with research interests in evidence-based healthcare have developed an online course on journal peer review of the biomedical literature. 3. Cochrane Handsearching Training Course Course Developer: Roberta Scherer, PhD This short distance education course will prepare participants for manually screening peer-reviewed biomedical journals, conference proceedings, and other publications for the best-available evidence. Online training:
  21. 21. US Contributors’ meeting at the 2014 Cochrane Colloquium Doctoral student Ian Saldanha wins ‘Best Oral Presentation’ award CEV members check out the sights in Hyderabad, India in September 2014 Cochrane Colloquium: • Methodological workshops and training • Dissemination of research • Networking opportunities
  22. 22. Systematic Reviews in Eyes and Vision “The ultimate goal of Cochrane reviews is to organize medical research information in a systematic way that allows end-users to reach practical conclusions in the interests of evidence-based medicine” Allen C, Richmond K. The Cochrane Collaboration: international activity within Cochrane Review Groups in the first decade of the twenty-first century. J Evid Based Med 2011, 4:2-7.
  23. 23. • We aim to prepare, maintain and promote access to systematic reviews of all the interventions used to prevent, treat, or diagnose eye diseases and/or visual impairment. • Our reviews focus on randomized or quasi-randomized controlled trials and provide descriptive syntheses where such data are lacking. • The main outcome for our reviews is visual function, which can be assessed in a variety of ways including measurement of visual acuity, assessment of visual field, and assessment of vision related quality of life. • Other outcomes are included as necessary within individual reviews. Scope of CEV Systematic Reviews
  24. 24. Glaucoma 14% Corneal Diseases 10% Retinal Degeneration 13% Retinal Diseases 10%Lens Diseases 8% Ocular Motility Diseases 7% Other* 38% CEV REVIEWS BY SUBTOPIC *Other: • Coexisting Eye disease • Conjunctival Diseases • Eye Haemorrhage • Eye injuries • Eye neoplasms • Eyelid Diseases • Lacrimal apparatus diseases • Optic nerve diseases • Orbital diseases • Refractive errors • Rehabilitation • Retinal vascular occlusion • Uveal and choroid diseases Accessed: July 12, 2015 at http://eyes.cochrane.org/our-reviews
  25. 25. A recent study found that CEV reviews “allow, in approximately half of the cases, the reader to reach a clinically applicable conclusion.” …. But how do we improve this? For ophthalmologic studies, “larger total number of participants, total number of eyes studied, and number of rigorous RCTs performed all can improve the conclusiveness of review findings.” CEV encourages researchers in the field to conduct more clinical trials using high-quality research methods that will yield reliable, trustworthy results. Mimouni M, Mimouni F, Segev Fani. Conclusiveness of the Cochrane Eye and Vision Group Reviews. BMC Research Notes 2015, 8:242.
  26. 26. Application and Impact of CEV Reviews "The commissioners were most persuaded by the recent independent Cochrane review of the evidence for the two drugs, which said Lucentis was not superior….That was a Cochrane review, independent of everything else, concluding that Avastin is of comparable efficacy and safety. From our point of view, that is good enough.” -- Julie Wood, NHS Clinical Commissioners Published: May 17th, 2015
  27. 27. Accessing CEV Reviews in the Cochrane Library
  28. 28. Accessing CEV Reviews in the Cochrane Library
  29. 29. Recent Publications (2016): Over the counter (OTC) artificial tear drops for dry eye syndrome Pucker AD, Ng SM, Nichols JJ. (February 2016) Authors’ conclusions: OTC artificial tears may be safe and effective means for treating dry eye syndrome; the literature indicates that the majority of OTC artificial tears may have similar efficacies. This conclusion could be greatly skewed by the inconsistencies in study designs and inconsistencies in reporting trial results. Additional research is therefore needed before we can draw robust conclusions about the effectiveness of individual OTC artificial tear formulations.
  30. 30. Peripheral iridotomy for pigmentary glaucoma Michelessi M, Lindsley K. (February 2016) Authors’ conclusions: We found insufficient evidence of high quality on the effectiveness of peripheral iridotomy for pigmentary glaucoma or pigment dispersion syndrome. Although adverse events associated with peripheral iridotomy may be minimal, the long-term effects on visual function and other patient- important outcomes have not been established. Future research on this topic should focus on outcomes that are important to patients and the optimal timing of treatment in the disease process (eg, pigment dispersion syndrome with normal IOP, pigment dispersion syndrome with established ocular hypertension, pigmentary glaucoma).
  31. 31. Elements of a Cochrane Review Why Publish a Cochrane Review?  Identify targeted areas where evidence is needed to answer important, as yet unresolved clinical questions (e.g., for CEV, authors focus on eyes and vision research)  Explore variations in practice  Highlight a need for further research  Help patients/consumers and clinicians make well-informed decisions about healthcare
  32. 32. Sections of a Cochrane Review 1. Abstract 2. Plain Language Summary 3. Background 4. Objective 5. Methods  Formulation of a focused research question (PICO)  Definition of inclusion and exclusion criteria  Description of a comprehensive, exhaustive search for evidence  Assessment of potentially eligible studies for eligibility  Data collection and synthesis 6. Results  Qualitative assessment: how study characteristics and bias may influence findings and interpretation  Quantitative assessment: data abstraction and synthesis of study results; sensitivity analysis 7. Discussion 8. Authors’ conclusions 9. References 10. Tables of characteristics of studies and summary of findings 11. Figures of data and analysis
  33. 33. What the background section addresses • What is the problem and why is it important? • Why do people think the intervention might work? • Is there uncertainty about the effectiveness of the intervention(s) being tested? • Why is this review important? Background
  34. 34. Focused Research Question Translation of clinical problem into a structured question and identification of the key concepts (PICO) Inclusion and exclusion criteria of the systematic review should specify the following: • Type of studies • Type of participants • Type of interventions and comparisons • Type of outcomes
  35. 35. Assessment of Potentially Eligible Studies • A two-stage process often is used to access studies for the review –Screening of titles and abstracts to identify possibly relevant studies (by 2 people, independently) –Full reports of these studies are read to determine eligibility (by 2 people, independently) • Study authors are contacted when questions about eligibility exist (e.g., studies not yet published)
  36. 36. Data Collection • Which data were extracted and by whom? –Develop and pilot data extraction forms –Extract data by 2 extractors, independently –Contact study authors when data are unclear or not reported • Who, what, and how were data entered into a software package? –Double data entry: 2 people enter the data into a database to avoid bias and errors –Data entry verification: 1 person enters data into the software and a 2nd person verifies the data entered after duplicate data extraction and adjudication
  37. 37. Qualitative Synthesis of Included Studies Context of the evidence • What are the differences in study characteristics among the studies? How might study characteristics affect the results? • Are studies at risk of bias? How might potential bias affect our confidence in the results? • Is heterogeneity assessed? Is it appropriate to combine the studies in a meta-analysis?
  38. 38. Quantitative Synthesis of Included Studies Meta-analysis • Statistical pooling of study results to obtain a single summary estimate of treatment effect Meta-analysis is appropriate when … • Study outcomes and treatment effects have been measured in similar ways, and • Heterogeneity (clinical, methodological, and statistical) is considered within limited of acceptability
  39. 39. Discussion and Conclusions Discussion • Summary of main results • Overall completeness and applicability of the evidence • Quality of the evidence • Potential biases in the review process • Agreements and disagreements with other studies or reviews Conclusions • Implications for practice • Implications for research
  40. 40. Interactive Roadmap to completing a Cochrane systematic review Updated 7 August 2015
  41. 41. Welcome to CEV This interactive roadmap provides a step by step reference for completing a review with CEV. Our editorial team is available to assist authors at every stage of the review process. Ms. Anupa Shah, the CEV Managing Editor, maintains communication between the editorial team, authors, and other group members. Members in the United States are additionally supported by our satellite team, the CEV US Satellite (CEV@US). There also is a CEV DTA Satellite, which provides editorial and methodological support for systematic reviews of diagnostic test accuracy (DTA).
  42. 42. The Cochrane Systematic Review Process  Review proposal  Title registration  Protocol preparation  Editorial and peer review of the protocol  Publication of the protocol  Systematic review preparation  Editorial and peer review of the systematic review  Publication of the systematic review  Updating the systematic review
  43. 43. Preparing to do a Cochrane Review Things to consider before undertaking a Cochrane review: Time: It takes about 18 months to complete the steps in the systematic review process. Topic: Consider what area interests you and what question you would like to answer. Check current reviews and consult with CEV to ensure that your topic is not already registered. We recommend familiarizing yourself with The Cochrane Handbook for Systematic Reviews of Interventions (updated March 2011)
  44. 44. Timeline for Cochrane Reviews Protocol Submission Protocol Publication Review Submission Review Publication 6-8 weeks 9-12 months 15-18 months
  45. 45. CEV Timeline 55 68 41 39.1 183 132 84 39.3 45 33 36 38.7 0 50 100 150 200 250 300 15 or more Studies (n=4) 5-7 Included Studies (n=5) 2-4 Included Studies (n=5) 0-1 Included Studies (n=11) Time (weeks) PublishedCEVReviews(n)Grouped byNumberofIncludedStudies Average Timelines of Published CEV Reviews (N=25) Time from protocol submission to protocol publication Time from protocol publication to review submission Time from review submission to review publication
  46. 46. CEV Timeline
  47. 47. Topics for Cochrane Reviews • Cochrane reviews focus on evidence from randomized controlled trials (RCTs) and quasi-randomized controlled trials (CCTs) • Begin by creating a PICO outline for your topic. P : I : C : O : Participants (include population/condition of interest) Intervention(s) of interest Comparison(s) of interest (e.g., placebo) Outcome(s) of interest (e.g., visual acuity at 12 months)
  48. 48. Building Your Review Team Co-authors: At least one co-author is needed to assist with the review. The co-author duplicates the main steps of the review process. All authors are expected to contribute to the review. Statistician: It is mandatory that the review team have a statistician as a co-author. • There must be at least one person on the review team with: • Content expertise • Methodological expertise • Statistical expertise • CEV can assist with identifying co-authors if needed
  49. 49. Review Proposal Process Once you have decided on a review topic, you should contact Ms. Anupa Shah with your interest in initiating a Cochrane review. If your topic is approved, you will be asked to complete a Review Proposal Form. Note that there are two Review Proposal Forms, one for reviews of Treatment Interventions and one for reviews of Diagnostic Test Accuracy (DTA). We recommend consulting Chapters 4 and 5 of the Cochrane Handbook. The CEV editorial team will review your proposal and either approve your proposed review topic, respond with comments, or reject your proposal with reasons.
  50. 50. Title Registration Once your title is approved by the CEV editors, we will register your title in Archie. Archie is Cochrane’s central server and review management system. CEV will set up an Archie user account for all review authors. The Archie server will send a welcome email with further instructions on activating your user account. There also is a Quick start guide to Archie for authors. All authors must activate their Archie account in order to access and edit their protocol, update contact information, and submit publication forms. Your Archie account gives you access to your Review Manager (RevMan) file of the protocol template. RevMan is the software used by Cochrane to prepare systematic reviews.
  51. 51. Key Deadlines A first draft of a protocol should be submitted to the editorial base by three months after title registration; the protocol should be published within six months of title registration. The completed systematic review should be submitted within 12 months and published within 18 months of the protocol being published. It may be helpful to complete the Cochrane Online Learning Modules for Authors before undertaking the review process
  52. 52. Protocol Preparation  We strongly recommend downloading RevMan and completing the tutorial before you begin work on your protocol.  You may access your RevMan file via Archie or RevMan; however, all editing is done in RevMan. The process of retrieving, editing, and saving your protocol is explained in the RevMan tutorial.
  53. 53. Protocol Preparation  To access your protocol:  In RevMan, select the option “Check out” from the File menu or “Go to My Reviews” from the Welcome window.  In Archie, navigate to the Eyes and Vision Group folder, click on the subfolder “Reviews” and then look for your file in the folder “Registered titles” (first time) or “Protocols”.  Each time you make a change to your RevMan file, you should “check it in” to Archie so that the draft is saved on our central server. This process is explained in the RevMan tutorial.
  54. 54. Things to Consider While Drafting Your Protocol General background information Description of the condition Description of the intervention How the intervention might work Why is it important to do this review These items are described in Chapter 4.5 of the Cochrane Handbook. Also feel free to consult our website for additional review author resources.
  55. 55. Submitting Your Protocol • All protocols must be submitted to CEV editors using RevMan. When you “check in” your protocol, RevMan will offer the additional option of submitting it for editorial approval. • Steps in the authoring and editorial processes are tracked using the Workflows system in Archie. The contact author of the protocol will receive a Workflow “ticket” (via email) describing the task needed and the due date to complete the task. When done, the contact author can click the link in the email to mark the task as done. Authors and editors can view tasks assigned to them by logging into Archie and clicking on the Organizer tab.
  56. 56. Editorial and Peer Review of the Protocol All Cochrane protocols undergo a multi-step editorial process 1. CEV methodologists and advisors will review your protocol and may respond with initial comments or forward to the contact editor. 2. CEV contact editors will review the clinical content of the protocol and either respond with comments or approve for peer review. 3. Your protocol will be sent out for external peer review. 4. CEV methodologists and advisors will review your revised protocol and may respond with additional comments or send to the Coordinating Editor for approval.
  57. 57. Editorial and Peer Review of the Protocol (continued) 5. The CEV Coordinating Editor will review your protocol and may respond with comments or approve the protocol for publication. 6. Your protocol will be copy-edited and sent to you for final approval. 7. Your approved protocol will be submitted for publication in the Cochrane Library
  58. 58. Publication of the Protocol Shortly after your protocol is accepted for publication, the CEV Trials Search Coordinator will run the searches and send you the search results (a list of titles and abstracts) in a text file, a reference management file (e.g., EndNote), or upload the search results to Covidence. Your protocol file will be saved in Archie and will be used as the starting point when you begin preparing your review.
  59. 59. Systematic Review Preparation Two authors independently screen the titles and abstracts from the search results and classify each record as 1) definitely relevant, 2) possibly relevant, or 3) definitely not relevant Authors should retrieve and independently review the full-text report of all records designated “definitely relevant” or “possibly relevant” to select a final list of “included studies”
  60. 60. Screening and Selection of Studies Walline et al, The Cochrane Library 2011
  61. 61. Systematic Review Preparation Remember to document reasons for excluding studies from your review. You will need to enter this information in RevMan’s Characteristics of Excluded Studies Table. The CEV editorial team can assist with retrieving full text articles if needed Consult Chapter 7 of the Cochrane Handbook for guidance
  62. 62. Systematic Review Preparation Check the bibliographies of included studies, conference proceedings, and the Science Citation Index for other RCTs and CCTs relevant to your review. Document where you found any additional references. Prepare forms for data extraction and risk of bias assessments. You also will use this information to complete the Characteristics of Included Studies Table
  63. 63. Systematic Review Preparation CEV provides authors with assistance from methodologists (epidemiologists, statisticians) and informationists (trials search coordinators) Methodologists advise and collaborate with researchers during the preparation of their systematic review
  64. 64. Methodology “Hubs” at CEV@US:  Provide methodological and administrative assistance to US- based systematic review authors (“help desk”, office space)  Coordinate editorial process for CEV@US systematic reviews (in collaboration with the editorial base)  Train ophthalmologists, optometrists, other vision researchers to perform and interpret systematic reviews o 152 US-based researchers from over 45 US institutions
  65. 65. Methodology “Hubs” at CEV@US: CEV@US will pair you with a trained methodologist to assist with the following procedures:  Two authors independently screen the titles and abstracts and classify each reference as either:  Include  Unsure  Exclude  Authors should review the full text of all references designated “include” or “unsure” to select a final list of “included studies”  CEV methodologists also help authors develop and modify data abstraction forms as appropriate.
  66. 66. Methodology “Hubs” at CEV@US:  Handsearch journals and conference proceedings for reports of clinical trials  Conduct workshops on evidence-based healthcare, peer review, and handsearching  Identify new review authors • CEV Centers for Evidence-based Medicine –Wilmer Eye Institute (35+ review authors) –Truhlsen Eye Institute, University of Nebraska • Advisory Board  Perform methodological research
  67. 67. Data Extraction and Risk of Bias Assessments At least two authors should independently Assess the risk of bias of the included studies and complete a Risk of Bias Table for each study Extract relevant design, conduct, and analysis characteristics and complete a Characteristics of Included Studies Table for each study Extract outcome data (e.g., visual acuity, intraocular pressure)
  68. 68. Data Extraction and Risk of Bias Assessments  Contact the authors of included studies for missing or unclear information  Resolve disagreements by consensus or with a third party  Enter above data into corresponding tables in RevMan  Consult Chapters 7 and 8 of the Cochrane Handbook for additional guidance
  69. 69. Data Analysis  Select the appropriate measure of effect for each outcome (e.g., dichotomous, continuous)  Test for heterogeneity  Perform subgroup analyses if appropriate  Test for publication bias  Conduct sensitivity analyses  Consult Chapters 9 and 10 of the Cochrane Handbook for additional guidance
  70. 70. Things to Consider While Drafting Your Systematic Review Confirm that the review methods are consistent with the published protocol. Discuss deviations from the protocol with your co-authors and the CEV editorial team before submitting the review for publication. Confirm that all required sections of the review are complete:  Main text: Remember to update verbs from future to past tense where appropriate (e.g., change protocol text “We will search MEDLINE” to “We searched MEDLINE”)  References: Included studies, excluded studies, studies awaiting assessment, other references  Tables and figures: Including data tables, risk of bias tables, characteristics of included and excluded studies tables
  71. 71. Submitting Your Systematic Review •Before you submit your review, you will need to check that your review meets the methodological and reporting standards of Cochrane reviews. Checklists for the Methodological Expectations of Cochrane Intervention Reviews (MECIR) are available here. Please note that there are separate checklists for the conduct of reviews, reporting of reviews, and the writing of the Plain Language Summary. •As with protocols, full reviews must be submitted to CEV editors using RevMan. When you “check in” your review, RevMan will offer the additional option of submitting it for editorial approval.
  72. 72. Editorial and Peer Review of the Systematic Review The editorial review process for full reviews is similar to the editorial review process for protocols. Additionally, •All reviews will undergo a pre-publication screening following guidance from the Cochrane Editorial Unit to ensure the quality of the review. •The literature searches may need to be updated prior to publication if the searches are out of date.
  73. 73. Publication of the Systematic Review Congratulations! You have completed a Cochrane Review Your review will be submitted for publication in the Cochrane Library
  74. 74. Updating the Review • Once your review is published you will receive a free subscription to the Cochrane Library • Your review will be indexed on MEDLINE • You also may choose to submit your review to another peer reviewed journal. Please consult Chapter 2 of the Cochrane Handbook for guidance on co-publication • You will need to update your review based on post- publication comments or as new data become available • The CEV editorial team will send you updated search results every year for your consideration • You should plan on updating your review every two years
  75. 75. Now let’s take a look at an example of a CEV Systematic Review…
  76. 76. Characteristics of Included Studies
  77. 77. Risk of bias assessment Methodological quality of studies included in review  Random sequence  Allocation concealment  Masking of participants  Masking of outcome assessors  Masking of data analysts  Incomplete outcome data  Selective reporting  Other bias
  78. 78. Walline et al, The Cochrane Library 2011 Anti-muscarinic agents vs. placebo
  79. 79. Cochrane Tools Tools and Resources for: • Review authors • Handsearchers • Healthcare users • Patients/Consumers
  80. 80. Online Cochrane Resources  Website – www.cochrane.org • 2 Handbooks: – Reviews of interventions – Reviews of diagnostic test accuracy • RevMan – review authoring software • Archie – review management database • Online Learning Modules – training.cochrane.org • Cochrane Register of Studies – Specialized registers of individual review groups
  81. 81. Cochrane Tools: Handbook Higgins, J. P. T., and Green, S. (Eds.). Cochrane handbook for systematic reviews of interventions version 5.1.0 [updated March 2011]. The Cochrane Collaboration. Available from www.cochrane-handbook.org
  82. 82. Cochrane Tools: RevMan  Review Manager (RevMan)  Mandatory software for writing and publishing your review  Available from http://ims.Cochrane.org/revman  Free for Cochrane authors and academic use
  83. 83. Cochrane Tools: Archie Cochrane’s central database  Stores all reviews and author contact information  The Cochrane Library is published directly from Archie  Use RevMan to access reviews in Archie  Requires a user account and password from a Cochrane Review Group
  84. 84. Cochrane Tools: Review Management Via Cochrane Training: http://www.slideshare.net/mirandacumpston/12-introduction-to-rev- man-v10 Accessed on 23 August, 2015
  85. 85. Cochrane Tools: Training CEV offers two Systematic Review training workshops each year Free online courses: Translating Critical Appraisal of a Manuscript into Meaningful Peer Review Understanding Evidence- based Healthcare for Physicians Handsearching: Identifying and Classifying Controlled Trial Reports Understanding Evidence- based Healthcare: A Foundation for Action
  86. 86. Web-based course on Peer Review – Launched May 2011 Module 1. Introduction to editorial peer review  Lec 1. Peer review: What, why, who, and how - Fiona Godlee  Lec 2. What journal editors expect from peer reviewers - Tom Liesegang Module 2. How to critically appraise the literature  Lec 1. What is the study question? - David Friedman  Lec 2. What is the study design and is it appropriate for the study question? - Ann Coleman  Lec 3. Measures of disease frequency, measures of association, and hypothesis testing - Marie Diener-West Appraising validity in:  Lec 4. Studies of intervention effectiveness - Karla Zadnik  Lec 5. Systematic reviews - Donald Minckler  Lec 6. Studies of harm - Ann Ervin  Lec 7. Studies of prognosis - Richard Wormald  Lec 8. Studies of diagnostic test accuracy and effectiveness- Milo Puhan  Lec 9. How should we assess claims of causality? - Joanne Katz
  87. 87. Getting Involved with CEV • Prepare a systematic review • Peer review our systematic reviews • Handsearch journals and conference proceedings • Translate articles into English • Become a CEV Center for Evidence-based Medicine • Join our e-mail listserv (visit our homepage) • Join a Special Interest Group in The Association for Research in Vision and Ophthalmology (ARVO) • Join a workshop for guidelines panel members at American Academy of Ophthalmology (AAO) and the Association of Vision Science Librarians (AVSL)
  88. 88. What’s new at CEV@US Current CEV@US Research Projects
  89. 89. CEV Partnerships Professional societies  American Academy of Ophthalmology  American Academy of Optometry  American Glaucoma Society, and others Research groups  Diabetic Retinopathy Clinical Research Network (DRCRNet)  Pediatric Investigative Group (PedIG)  CEV Centers for Evidence-based Medicine (Wilmer, Truhlsen) Journals  CEV systematic review editors at American Journal of Ophthalmology, JAMA Ophthalmology, Ophthalmology, Optometry and Vision Science  CEV online peer review course acknowledged by American Journal of Ophthalmology, BMC Ophthalmology, Ophthalmology
  90. 90. Evidence Gap Project (E-Gap) CEV@US is examining the evidence underpinning clinical practice guidelines, and together with professional societies and patients, are prioritizing the systematic reviews that are needed:  Primary open angle glaucoma (Tianjing Li) – completed  Primary angle closure glaucoma (Tsung Yu) – completed  Age-related macular degeneration (Kristina Lindsley) – in progress  Diabetic retinopathy (Kay Dickersin, Jimmy Le) – in progress  Dry eye syndrome (Ian Saldanha) – in progress  Cataract (Asieh Golozar) – in progress  + 12 others
  91. 91. E-Gap: What Evidence Is Needed? 1. Extract recommendations and supporting evidence from the American Academy of Ophthalmology’s Preferred Practice Patterns (PPP) 2. Transform the recommendations into answerable clinical questions 3. Identify professional organizations and patient groups as partners 4. Conduct surveys asking professional partners to prioritize the questions to be answered by research 5. Conduct focus groups or survey patients to prioritize and name patient- important outcomes 6. Map highest ranked priority questions to high quality systematic review evidence to determine what new evidence is needed
  92. 92. Database of Systematic Reviews in Eyes and Vision Aim To identify and assess the quality of systematic reviews in eyes and vision Completed Tasks 1. Searched PubMed, EMBASE, and The Cochrane Library for systematic reviews in May 2014 2. Identified and classified over 1,500 systematic reviews in eyes and vision 3. Updated searches in March 2016 In Progress 1. Assess eligibility and classify topic area of records identified from updated searches 2. Describe the quality of systematic reviews 3. Map high quality systematic reviews to research questions
  93. 93. Network Meta-Analysis Medical Interventions for Primary Open Angle Glaucoma (POAG)  To synthesize direct and indirect evidence from over 500 RCTs that evaluated 5 classes of eye drops used to lower eye pressure in patients with POAG  Funded by the National Eye Institute (PI: Kay Dickersin)  Collaboration with Brown/Tufts Evidence-based Practice Center to use the Systematic Review Data Repository (SRDR) for data collection (14 data abstractors, including CEV methodologists, faculty, and graduate research assistants)
  94. 94. Progress: • Completed data abstraction and analysis of monotherapy interventions • Published 2 papers Next steps: • Complete data analysis for combination therapies • Publish two CEV reviews using data from this project • Prepare at least one clinical paper and two methods papers outside of Cochrane Network Meta-Analysis Medical Interventions for Primary Open Angle Glaucoma
  95. 95. Network Meta-Analysis Application of Network Meta-Analysis for Clinical Practice Guidelines Objective: to compare the guideline recommendations in the American of Ophthalmology’s (AAO) Preferred Practice Patterns (PPP) for open angle glaucoma from 1989-2010 with the evidence base determined by network meta-analysis at the time of each major update of the PPP. [paper in press]
  96. 96. CompARE Project Comparison of Abstract Reports as Evidence Background • Conference abstracts not peer-reviewed • Not all abstracts get published (45%-60%) (Scherer 2007, Klassen 2002) • Concern about data accuracy, consistency with published reports
  97. 97. Objectives  Assess concordance of data between conference abstracts and full- publications of RCTs  Assess factors associated with discrepancies  Assess how reliable conference abstracts are for systematic reviewers Methods  Identify abstracts from ARVO 2002-2004  Identify corresponding published reports (through 2010)  Extract data on funding, author conflicts of interest, study characteristics, risk of bias, primary outcomes, results for primary outcomes, conclusions – for both abstracts (completed) and published reports (in process).  Compare and analyze discrepancies CompARE Project
  98. 98. Other CEV Methods Research Projects  Registration of eye trials (Bobbi Scherer, PLoS One 2012)  Agreement between primary outcomes in conference abstracts and CT.gov (Bobbi Scherer)  Investigation and follow-up of eye trials on CT.gov (Stephan Ehrhardt)  Design, Analysis, and Reporting of Crossover Trials for Inclusion in a Meta-Analysis (Tianjing Li, Tsung Yu, Barbara S Hawkins, Kay Dickersin)  Common outcomes used in trials versus systematic reviews (Ian Saldanha)  Wasted data in RCTs of medical treatment for glaucoma (Andrew Law)  Patient-important outcomes in minimally invasive glaucoma surgery (MIGS) (Jimmy Le)

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