how write up and publish study - geneva health forum...
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How to write up and publish study protocolsGeneva Heath Forum April 2016
Trish GrovesHead of research BMJ, Editor‐in‐chief BMJ Open
What do we mean by “study protocol”?
The English language has several meanings for “protocol”:
1 .The accepted or established code of procedure or behaviour in any group, organization, or situation
2. The original draft of a document
3. A plan for a scientific [or clinical] experiment or study
4. A plan for medical treatment
5. A formal or official record of scientific experimental observations or methods
This module is about #3 ‐ plans/proposals for scientific studies
• writing a protocol is an ethical requirement
• a study protocol is the core part of any application/proposal to:• obtain funding through grant review• seek ethics committee or institutional review board (IRB) approval
• a protocol helps with recruiting study participants, running a study effectively, and increasing a study’s transparency
• many journals ask to see protocols, some publish them•may include important information on a study’s ethics and provide scientific details that are often missing from papers
Why protocols are important
Protocol = ethics requirement for any human study
WMA Declaration of Helsinki 2013 requires that:
• the design and performance of each research study involving human subjects must be clearly described and justified in a research protocol
• the protocol should state the ethical considerations involved
• the protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study
•
Clause 22, World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects 2013 http://www.wma.net/en/30publications/10policies/b3/
NIH checklist for plain language in protocols
http://www.nih.gov/clearcommunication/plainlanguage/gettingstarted/NIH_Plain_Language_Checklist.pdf
Do I know my audience?Did I organize my document for my reader?Have I used an easy‐to‐read style?Have I written this as concisely as possible and kept the message?Have I used the right visuals?Have I written in the active voice?Did I make my document “skimmable”?
Match research question to study design
Descriptive studies answer “what’s happening?”Observational analytic studies answer “why, how, or when is it happening?”Randomised experimental studies (trials) answer “can it work ? or does it work?”
Adapted from: Centre for Evidence Based Medicine, Oxford, UK www.cebm.net
Research papers follow IMRaD (Introduction, Methods, Results, and Discussion) structure
Study protocols focus only on I and M
Methods section of a protocol should clearly describe:
•overall study design • selection and description of participants & outcomes• technical information about the study• stats: sampling, randomising, measuring, testing, analysing• measures to ensure ethical conduct
Methods section of protocol: overview
Follow The Statistical Analyses and Methods in the Published Literature (SAMPL) guidelines by Lang TA and Altman DG, 2013.http://www.equator‐network.org/wp‐content/uploads/2013/03/SAMPL‐Guidelines‐3‐13‐13.pdf
Like a recipe: most important section for informed readers
• describe PECO/PICO elements of the study
• follow reporting guidelines eg CONSORT Statement
• describe measures to ensure ethical conduct
• fully describe and give references for lab/stats methods• Statistical Analyses and Methods in the Published Literature(SAMPL) guidelines *
• provide link to study protocol if available online, or published
Methods section of a protocol: how to write it
http://www.equator‐network.org/wp‐content/uploads/2013/03/SAMPL‐Guidelines‐3‐13‐13.pdf
Equator network http://www.equator‐network.org/
Follow these international standards:
• ICH GCP E6 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: Good Clinical Practice
• SPIRIT 2013 Statement Standard Protocol Items: Recommendations for Interventional Trials
Guidelines for clinical trial protocols
SPIRIT* is an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence‐based set of items
SPIRIT 2013 Statement is the reporting guideline and checklist, with:• a detailed “Explanation and Elaboration” paper with examples• Chinese, Spanish, Korean translation sfor the statement
and coming soon:• French, German, Italian, translations• electronic template for writing protocols
SPIRIT 2013 statement for trial protocols
* SPIRIT Standard Protocol Items: Recommendations for Interventional Trials http://www.spirit‐statement.org/
SPIRIT 2013 Statement: flow diagram for trial
©2013 by British Medical Journal Publishing Group
Chan AW et al. BMJ 2013;346:bmj.e7586
Rules on clinical trial registration: WHO
• World Health Organization (WHO) policy is that all clinical trials should be registered before the first participant receives the first medical intervention in the trial, using WHO’s trial registration minimum dataset of 20 items • WHO International Clinical Trials Registry Platform (ICTRP) provides single point of access to studies registered in various international registries• in 2015 WHO stated that the main findings of clinical trial results must be posted at the trial registry and submitted for journal publication within 12 months of study completion *
* http://www.who.int/ictrp/results/reporting/en/
ICMJE rules on clinical trial registration
The International Committee of Medical Journal Editors (ICMJE) requires that:
Trials randomising human participants or groups of humans to one or more health‐related interventions to evaluate the effects on health outcomes ‐ and that commenced after 1 July 2008 ‐must have been registered prospectively, iebefore enrolment of any participants
ICMJE accepts registration in any registry that is a primary register of the WHO ICTRP or in ClinicalTrials.gov, which is a data provider to the WHO ICTRP
ICMJE lists journals that follow its guidance, and listing implies that all these journals enforce the committee’s trial registration policy
http://www.icmje.org/recommendations/browse/publishing‐and‐editorial‐issues/clinical‐trial‐registration.html
Systematic review protocols: PRISMA Statement
http://www.prisma‐statement.org/
Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) Statement is an evidence‐based minimum set for reporting in systematic reviews and meta‐analyses. Also:• PRISMA for Abstracts• PRISMA‐Equity 2012• PRISMA‐P – for systematic reviews and meta‐analyses protocols
There is no widely accepted reporting guideline for protocols of observational studies, but this guidance will help:
• Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement http://www.strobe‐statement.org
• Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide from AHRQ* http://www.ncbi.nlm.nih.gov/books/NBK126190/
• SPIRIT 2013 Statement: many items will apply to these studies too
Protocols for observational studies: guidance
* US Agency for Healthcare Research and Quality
