1. GLOBAL ADVANCES
I N H E A L T H A N D M E D I C I N E
www.CARE-statement.org 1
EPYQ and TIDieR
— Health Research Reporting Guidelines —
Steffany Haaz Moonzs PhD
Marland University of Integrative Health
smoonaz@muih.edu
David Riley MD
Portland, Oregon
dsriley@integrativemed.org
2. www.CARE-statement.org 2
Health Research Reporting Guidelines (HRRGs)
Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting
guidelines. PLoS Med 2010;7:e1000217.
• “High-quality research reports contribute to more efficient
translations of new research findings into clinical practice and help
advance scientific knowledge and patient care.
• Reporting health research in a complete, accurate, transparent,
and timely manner is a shared responsibility of all stakeholders
involved in research funding, conduct, and publication.
• We all benefit from these collective efforts.”
Why Guidelines?
3. www.CARE-statement.org 3
Health Research Reporting Guidelines (HRRGs)
History of Health Research Reporting Guidelines
• 1962: Kefauver-Harris amendment to the Food, Drug and Cosmetic
Act required preapproval efficacy and safety testing that led to the
rise of the randomized controlled trial (RCT).
• 1980: Lancet editorial on meta-analysis—by Richard Peto—evaluating
the role of aspirin in the prevention of recurrent heart attacks.
• 1996 – CONSORT guidelines for RCTs
• 2006 – The Equator Network
4. www.CARE-statement.org 4
The EQUATOR Network (www.equator-network.org)
The EQUATOR Network (Enhancing the QUAlity and Transparency
Of health Research) is an international initiative that began with
the CONSORT guidelines in 1996.
Participants have included reporting guideline development groups,
journal editors, peer reviewers, medical writers and funders. Its
goal is to promote accurate, transparent and responsible reporting
of health research.
5. www.CARE-statement.org 5
The Equator Network is focused on the principles of responsible research
reporting and the implementation of reporting guidelines. It provides an up
to date centralized resource for:
• Researchers and scientists reporting research
• Peer reviewer assessment of research manuscripts; and
• Editorial evaluation of journal manuscripts
Simera I, Moher D, Hirst A, Hoey J, Schulz K, Altman DG. Transparent and accurate reporting
increases reliability, utility, and impact of your research: reporting guidelines and EQUATOR
Network. BMC Med. 2010; 8: 24. doi:10.1186/1741-7015-8-24 PMCID: PMC2874506
The EQUATOR Network (www.equator-network.org)
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CONSORT Guidelines – Randomized Controlled Trials
(www.consort-statement.org)
CONSORT stands for Consolidated Standards of Reporting Trials
and encompasses various initiatives developed by the
CONSORT Group to alleviate the problems arising from
inadequate reporting of randomized controlled trials.
The CONSORT Statement two primary parts: a 25-item checklist
and a flow diagram focused on reporting trial design, analysis
and interpretation. Extensions of the CONSORT Statement and
other HRRGs have been developed to give additional guidance
for clinical trials with specific designs, data and interventions.
9. www.CARE-statement.org 9
CONSORT Guidelines Extensions
• STRICTA Controlled trials of acupuncture: PLoS Med.
2010;7(6):e1000261.
• CONSORT PRO (Patient Reported Outcomes): JAMA.
2013;309(8):814-22.
• CONSORT-CENT (N of 1): BMJ. 2015;350:h1738.
• CONSORT for orthodontic trials: Am J Orthod Dentofacial Orthop.
2015;147(6):663-679.
• TIDieR (Intervention Reporting): BMJ. 2014;348:g1687.
10. www.CARE-statement.org 10
STROBE Guidelines – Observational Studies
(www.strobe-statement.org)
STROBE, like CONSORT is designed to strengthen the
completeness, accuracy and transparency of health research
involving observational studies. STROBE focuses on three main
research designs: cohort, case-control, and cross-sectional
studies and provides checklists for each of these observational
study designs.
STROBE checklists are available for cohort, case-control, and
cross-sectional studies as well as for conference abstracts.
11. GLOBAL ADVANCES
I N H E A L T H A N D M E D I C I N E
www.CARE-statement.org 11
The CARE guidelines support transparency and accuracy in the
collection and reporting of information from patient encounters
and the publication of case reports.
This information:
(1) provides early signals of effectiveness, harms and cost,
(2) informs clinical practice and clinical practice guidelines, and
(3) generates evidence-based, testable hypotheses for clinical
research.
C A R E G U I D E L I N ES — C A S E R E P O RT S
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TIDieR: better reporting of interventions
— A Health Research Reporting Guideline Extension —
• TIDieR improves the accuracy, completeness and transparency of
interventions published in the medical literature so that clinicians
and patients can clearly choose interventions, and researchers can
conduct high quality clinical trials that build on the results of
previous research.
• The 12 item TIDieR checklist is an extension designed to be used
with existing HRRGs. EPYQ can be used as a TIDieR health research
reporting guidelines extension for clinical trials involving yoga as
an intervention for RCTs, observational studies, and case reports.
Hoffmann TC, Glasziou PP, Milne R, Perera R, Moher D, Altman DG, Barbour V, et al. Better reporting of interventions:
template for intervention description and replication (TIDieR checklist and guide. BMJ 2014;348:g1687 doi:
10.1136/bmj.g1687 (Published 6 March 2014)