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Structured Abstract
Objective:
To develop two checklists for the quality of observational studies of incidence or risk factors of diseases.
Study design and setting:
Initial development of the checklists was based on a systematic literature review. The checklists were refined after pilot trials of validity and reliability were conducted by seven experts, who tested the checklists on 10 articles.
Results:
The checklist for studies of incidence or prevalence of chronic disease had six criteria for external validity and five for internal validity. The checklist for risk factor studies had 6 criteria for external validity, 13 criteria for internal validity, and 2 aspects of causality. A Microsoft Access database produced automated standardized reports about external and internal validities. Pilot testing demonstrated face and content validities and discrimination of reporting vs. methodological qualities. Interrater agreement was poor. The experts suggested future reliability testing of the checklists in systematic reviews with preplanned protocols, a priori consensus about research-specific quality criteria, and training of the reviewers.
Conclusions:
We propose transparent and standardized quality assessment criteria of observational studies using the developed checklists. Future testing of the checklists in systematic reviews is necessary to develop reliable tools that can be used with confidence.
Acknowledgments
We would like to thank our reviewers, David Atkins, MD, John Hoey, MD, and Christine Laine, MD, for reviewing and commenting on the draft; our collaborating experts, Ethan Balk, MD, Chantelle Garritty, and Thomas Trikalinos, PhD, for their scientific input throughout this project; and Carmen Kelly, PharmD, our Task Order Officer from AHRQ, and Stephanie Chang, MD, MPH, Medical Officer at AHRQ, for their guidance throughout the project. We also want to thank the librarian, Judith Stanke, for her contributions to the literature search; research assistants Stacy Dickinson, MPH, Emily Zabor, MS candidate in biostatistics, and Akweley Ablorh, MS candidate in biostatistics, for data abstraction, quality control, and synthesis of evidence; Zhihua Bian MS candidate in biostatistics, for her statistical help; Zhiyuan Xu, MS candidate in applied economics, for his work creating the ACCESS database; Dean McWilliams for his assistance in database development; Qi Wang, research fellow, for her statistical expertise in reliability testing; Susan Duval, PhD, for her help estimating sample size; Marilyn Eells for editing and formatting the report; and Nancy Russell and Rebecca Schultz for their assistance gathering data from the experts and formatting the tables.
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-02-0009 Prepared by: Minnesota Evidence-based Practice Center Minneapolis, Minnesota
Suggested citation:
Shamliyan T, Kane RL, Ansari MT, Raman G, Berkman ND, Grant M, Janes G, Maglione M, Moher D, Nasser M, Robinson KA, Segal JB, Tsouros S. Development of the Quality Criteria To Evaluate Nontherapeutic Studies of Incidence, Prevalence, or Risk Factors of Chronic Diseases: Pilot Study of New Checklists. Agency for Healthcare Research and Quality; January 2011. Methods Research Report. AHRQ Publication No. 11-EHC008-EF. Available at http://effectivehealthcare.ahrq.gov/.
The information in this report is intended to help clinicians, employers, policymakers, and others ake informed decisions about the provision of health care services. This report is intended as a reference and not as a substitute for clinical judgment.
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
This document was written with support from the Effective Health Care Program at AHRQ. None of the authors has a financial interest in any of the products discussed in this document. This document is in the public domain and may be used and reprinted without permission except those copyrighted materials noted, for which further reproduction is prohibited without the specific permission of copyright holders.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
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.ahrq.gov
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- Development of Quality Criteria To Evaluate Nontherapeutic Studies of Incidence,...Development of Quality Criteria To Evaluate Nontherapeutic Studies of Incidence, Prevalence, or Risk Factors of Chronic Diseases: Pilot Study of New Checklists
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