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Speaker
Dr. Alison Booth Senior Research Fellow, University of York, UK
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2. The need for prospective registration
u Systematic reviews usually provide
the evidence base upon which
health and social care decisions are
made so they should be robust and
free from bias
u Health research resources are finite
so need to be allocated carefully:
avoiding unnecessary duplication
3. Why register systematic reviews:
publication bias
u Likely that just as for clinical trials there may be
publication bias associated with systematic reviews
u Evidence that unpublished systematic reviews exist
(Tricco et al J Clinical Epidemiology 2009)
u 248 survey respondents reported 12% of 1604 completed
reviews as unpublished
u Respondents reason for non-publication was lack of time
u 2009 PRISMA statement advocated registration
4. Why register systematic reviews:
reporting bias
u Emerging evidence that reporting biases similar to
those observed for clinical trials were also
operating for systematic reviews (Kirkham et al PLoS
ONE 2010)
u New reviews from 3 consecutive issues Cochrane Library
u 22% of 288 review/protocol pairings were discrepant in
at least one outcome
u Prospective registration of systematic reviews
could guard against bias - in the same way as for
prospective registration of clinical trials
5. How registration can help avoid bias
u Registration facilitates transparency
u Provides permanent public record of key features of a
systematic review even if the completed review is never
published
u Enables comparison of what was planned with what is
reported:
u can assess if any discrepancies likely to have introduced bias
u encouraging clear reporting of any changes with justifications
u Reviews registered prospectively with audit trail of
amendments (not unreasonable to make changes, but
need to know why they were made and at what stage)
u Unique registration number to enable linkage between
the record and review publications
6. Duplication of reviews
u Unplanned duplication of reviews is a waste of
resource
u 73 meta-analyses: two thirds had at least one
overlapping meta-analysis (Siontis et al BMJ 2013)
u Call for sources to identify research in progress
(Chalmers et al Lancet 2014)
u Registration allows those planning reviews to check
whether there are any ongoing reviews that address
their topic or specific question of interest
u Offers opportunities for collaboration
7. Requirements of a register
u Searchable and accessible to all
u Free to use
u Accept registrations from anyone
u Require provision of a minimum data set
u Validate entries (within scope and complete)
u Provide a unique identification number for each record
u Permanent entries
Criteria established by the ICMJE for clinical trial registers
8. Developing PROSPERO
u International advisory group
u Establishing a minimum dataset
u Should not be overly burdensome
u Aim to collect sufficient information to
u enable informed judgement about potential risk of bias
u determine whether reviews already in ‘pipeline’ meet
identified need without undertaking a new review
u Not to capture wider information that should be
included in a full protocol for a systematic review
9. International consultation
u Inform register design
u Reach consensus on data items required for
registration
u Generate support for registration
u Raise awareness of the forthcoming register
u Modified Delphi
u (Booth A et al. PLoS ONE 2011; 6(11): e27319)
10. Registration minimum dataset:
Review design fields (19/40)
• Review question(s)*
• Searches*
• URL to search strategy
• Condition or domain being
studied*
• Participants/population*
• Intervention(s), exposure(s)*
• Comparator(s)/control*
• Types of study for inclusion*
• Context
• Main outcome(s)*
• Additional outcomes*
• Data extraction (selection and
coding)*
• Risk of bias (quality)
assessment*
• Strategy for data synthesis*
• Analysis of subgroups/sets*
• Type and method of review*
• Reference/URL to full protocol
• Dissemination plans
• Details of final report/
publication (added over time)
* these fields are mandatory
11. Registration minimum dataset:
Administrative fields (21/40)
• Review title*
• Original language title
• Anticipated or actual start
date*
• Anticipated completion date*
• Stage of review*
• Named contact*
• Named contact email*
• Named contact address
• Named contact phone number
• Organisational affiliation*
• Review team members and
affiliations*
• Funding sources/sponsors*
• Conflict of interests*
• Collaborators
• Language
• Country*
• Other registration details
• Key words
• Existing review by same
authors
• Current review status*
• Any additional information
* these fields are mandatory
12. PROSPERO
u Web based
u Free to search
u Free to register
u Registrants create, amend and update their own records
u Minimum data set to be completed
u Record content is the responsibility of the named contact
u Administrators check for “sense”: there is no peer review
u Provide a unique identification number for each record
u Entries are permanent
Launched in Feb 2011
(Booth A et al. Syst Rev. 2012;1)
13. What will you find in PROSPERO
Systematic reviews of
u Interventions (including qualitative and IPD reviews
u Diagnostic accuracy
u Prognostic factors
u Prevention
u Epidemiological reviews relevant to health and social care
u Public health
u Service delivery in health and social care
u Methodology
u Cochrane reviews automatically uploaded (technical issue in Feb 2020)
u Protocols for systematic reviews of animal studies for human health
(separate form: administered by SYRCLE-CAMARADES team)
129,470
2,633
1,113
14. Searching PROSPERO
u No need to log in
u MeSH interface available
u PROSPERO search filters
u Health area of review
u Type and method of the review
u Source of the review
u Status
u Restrict search to specific fields
u Date added to PROSPERO
16. Registering a review
u Join/log in on the home
page
u Go to My PROSPERO
u Select Register your review now
u Follow steps 1-4
17. Step 1: eligibility
u PROSPERO includes details of any planned or on-going systematic
review that has a health related outcome
u Exclusion criteria:
u Systematic reviews without an outcome of clear relevance to the
health of humans
u Scoping reviews
u Literature reviews that use a systematic search
u Systematic reviews assessing sports performance as an outcome
u Methodological reviews that assess ONLY the quality of reporting
u Step 2: Full protocol should be (near) ready before registering
u Submission must be before data extraction commences (from Oct 2019)
u Forms must be complete and in English
u Steps 3 and 4: Search PROSPERO for existing registrations
18. Step 5: Select the
required form
Respond to a series of
questions…
…if you make it to the
end – click on the link
to register your review
19. Registration form
u Form has 40 fields:
*mandatory fields
u Text can be typed or
“pasted” in
u Form can be saved as a pdf
u Brief and full guidance
available
u Can upload pdf of:
u Search strategy
u Published protocol
20. My PROSPERO
• Edit your details
• Start new
registration
• Ongoing records
• Published or
rejected records
• Records not
submitted
• Access to email trail
21. PROSPERO public interface
u Published records
immediately available on the
PROSPERO site
u Named contact details
available in records
u Fields displayed in a
different order to
registration form
u Can print or save as pdf
22. Challenges: volume of records
u Volume of registrations
u October 2019 - around 54,800
u October 2021 – around 133,216
u Highlighted by COVID submissions (Dotto et al 2021)
u “a massive number of SRs about COVID-19 have been conducted,
whose PROSPERO records present varied characteristics.
Furthermore, many of the assessed records were poorly reported
and would be difficult, if not impossible, to replicate...”
u Can see that unplanned duplication occurs – cannot see
where it is prevented
23. Challenges: level of detail
u Published protocol +/- registration
u of the 96 reviews included, 91 (95%) had not published
their protocol in a journal, making their PROSPERO
registration the only source for planned methods (Tricco
et al 2016)
u Incomplete records
u Significant short fall in items reported compared to
those recommended in PRISMA_P (Booth et al 2020) – so
registration is not a substitute for a published protocol
for identifying potential biases
24. Future
New opportunities for transparency
u Text mining, machine learning technologies
u Open data repositories
u + is that everything for a study can be in one place
u - is no single searchable site for ongoing reviews
u Drivers for change
u Limited resources need to be used wisely
u Public now more aware and asking the right
questions
25. Thank you for listening
u Any questions
u alison.booth@york.ac.uk
www.crd.york.ac.uk/PROSPERO
26. References
u Booth A, Clarke M, Ghersi D, Moher D, Petticrew M, Stewart L. Establishing a minimum dataset for prospective
registration of systematic reviews: an international consultation. PLoS ONE. 2011;6(11).
u Booth A, Clarke M, Dooley G, Ghersi D, Moher D, Petticrew M, et al. The nuts and bolts of PROSPERO: an international
prospective register of systematic reviews. Syst Rev. 2012;1.
u Booth A, Mitchell A, Mott A, James S, Cockayne S, Gascoyne S, et al. An assessment of the extent to which the contents
of PROSPERO records meet the systematic review protocol reporting items in PRISMA-P [version 2; peer review: 2
approved]. F1000Research. 2020;9(773).
u Chalmers I, Bracken MB, Djulbegovic B, Garattini S, Grant J, Gülmezoglu AM, Howells DW, Ioannidis JP, Oliver S. How to
increase value and reduce waste when research priorities are set. Lancet. 2014 Jan 11;383(9912):156-65. doi:
10.1016/S0140-6736(13)62229-1. Epub 2014 Jan 8. PMID: 24411644.
u Dotto, L, Kinalski, MdA, Machado, PS, Pereira, GKR, Sarkis-Onofre, R, dos Santos, MBF. The mass production of
systematic reviews about COVID-19: An analysis of PROSPERO records. J Evid Based Med. 2021; 14: 56– 64
u Kirkham JJ, Altman DG, Williamson PR. Bias due to changes in specified outcomes during the systematic review process.
PLoS ONE. 2010;5.
u Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, Smyth R, et al. The impact of outcome reporting bias in
randomised controlled trials on a cohort of systematic reviews. BMJ. 2010;340.
u Silagy CA, Middleton P, Hopewell S. Publishing protocols of systematic reviews: comparing what was done to what was
planned. JAMA. 2002 Jun 5;287(21):2831-4. doi: 10.1001/jama.287.21.2831.
u Siontis KC, Hernandez-Boussard T, Ioannidis JPA. Overlapping meta-analyses on the same topic: survey of published
studies. BMJ : British Medical Journal. 2013;347.
u Tricco AC, Tetzlaff J, Pham B, Brehaut J, Moher D. Non-Cochrane vs. Cochrane reviews were twice as likely to have
positive conclusion statements: cross-sectional study. Journal of Clinical Epidemiology. 2009;62(4):380-6.e1.
u Tricco AC, Cogo E, Page MJ, Polisena J, Booth A, Dwan K, et al. A third of systematic reviews changed or did not specify
the primary outcome: A PROSPERO register study. Journal of Clinical Epidemiology. 2016. Volume 79, 46 - 54