Promoting transparency to avoid costly healthcare mistakes – the CHEERS statement

Donald Husereau highlights the benefits of the recent CHEERS guidelines to biomedical publishing.

More than ever, rising healthcare costs have led to the need for good healthcare decisions. Yet the information needed to make decisions is currently in a state of crisis.

Considerable recent attention has been drawn to clinical trial information that has gone unpublished – creating challenges for reimbursement and regulatory authorities, as well as clinicians. There have been important examples of outcomes or other important study details ignored. This missing information could potentially lead to poor decisions, unnecessary spending and may even cost lives.

 

“This missing information could potentially lead to poor decisions, unnecessary spending and may even cost lives.”

 

In response, there have been increasing efforts to make researchers and research more accountable. Recent events include organized petitions, trial registries, and even legal challenges to ensure information from private sector research is available for public consumption. But a growing body of evidence suggests even publicly funded trials do not have sufficient mechanisms in place to ensure important information is disclosed.

Another tact has been to develop reporting guidelines for clinical researchers. The first widely promoted effort was the Consolidated Standards of Reporting Trials (CONSORT), developed by an international panel and intended to provide editors, peer reviewers and authors with a list of the minimum amount of information necessary to allow scrutiny and interpretation of reports of clinical trials1.

Other efforts followed including QUORUM (now PRISMA) for systematic reviews, STROBE for observational studies, STARD for diagnostic studies, and STREGA for genome studies2-5. In some cases, special extensions have been developed to address areas of specific concern, such as the CONSORT Extension for harms6. Reporting guidelines are not just a good idea in theory – we now know they work. A recent evaluation of CONSORT demonstrated its endorsement led to observed improvements in reporting7.

 

“Reporting guidelines are not just a good idea in theory – we now know they work.”

 

Although there have been previous efforts in economic evaluation, including the widely cited BMJ Checklist (by Drummond and Jefferson), and the CEA Panel (by Gold) a survey of medical editors revealed a need for updating and consolidating these guidance8,9.

To develop the guidance, we created an International task force composed of editors and researchers and supported by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), a 7,000-member strong international non-profit, scientific and educational organization, and recognized global authority for outcomes research and its use in health care decisions. Similar to other reporting guideline efforts and following best practices, we used a Delphi Panel of experts with diverse perspectives to develop the guidance10.

In a wonderful show of solidarity and a commitment to higher quality publication, the output of this effort, called the Consolidated Health Economic Evaluation Reporting Standards, or CHEERS, has now been simultaneously released and endorsed by 10 journals. These include BMC Medicine, BMJ, BJOG: An International Journal of Obstetrics and Gynaecology, Clinical Therapeutics, Cost Effectiveness and Resource Allocation, The European Journal of Health Economics, International Journal of Technology Assessment in Health Care, Journal of Medical Economics, and Pharmacoeconomics, and Value in Health. Participation across different publishers for this effort was commendable and speaks to its importance.

 

“Participation across different publishers for this effort was commendable and speaks to its importance.”

 

Available as a checklist to facilitate its use (figure 1), we hope CHEERS will improve consistency and transparency in study reports and make sure clinicians, patients and health care leaders using these reports do not make costly mistakes. The full task force report, which includes additional examples and explanation intended to further the application of CHEERS is published in ISPOR’s official journal, Value in Health and is available to the public via the ISPOR website11. Full details of the CHEERS task force can be found here.

 

extract of the CHEERS checklist

 

Figure 1: An extract of the CHEERS checklist. To see the full open access version in HTML format, please follow this link: http://www.biomedcentral.com/1741-7015/11/80/table/T1

References

1 Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: c869–c869.

2 Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. Plos Med 2009; 6: e1000097.

3 Vandenbroucke JP, von Elm E, Altman DG, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Plos Med 2007; 4: e297.

4 Bossuyt PM, Reitsma JB, Bruns DE, et al. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Clin Chem 2003; 49: 7–18.

5 Little J. STrengthening the REporting of Genetic Association Studies (STREGA): An Extension of the STROBE Statement. Ann Intern Med 2009; 150: 206.

6 Ioannidis JPA, Evans SJW, Gøtzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004; 141: 781–8.

7 Turner L, Shamseer L, Altman DG, Schulz KF, Moher D. Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review. Syst Rev 2012; 1: 60.

8 Drummond MF, Jefferson TO. Guidelines for authors and peer reviewers of economic submissions to the BMJ. BMJ 1996; 313: 275 –283.

9 Gold MR. Cost-effectiveness in health and medicine. , Oxford University Press, 1996.

10 Moher D, Schulz KF, Simera I, Altman DG. Guidance for Developers of Health Research Reporting Guidelines. Plos Med 2010; 7: e1000217.

11 Husereau D, Drummond M, Petrou S, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS)-Explanation and Elaboration: A Report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. Value Heal J Int Soc Pharmacoeconomics Outcomes Res 2013; 16: 231–50.

 

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About the author:

Don Husereau is a Senior Associate with the Institute of Health Economics. He is also a Senior Scientist at the University for Health Sciences, Medical Informatics and Technology in Tyrol, Austria and an Adjunct Professor of Medicine at The University of Ottawa. He is a former Director and Senior Advisor for the Canadian Agency for Drugs and Technologies in Health (CADTH). He received both his B.Sc in Pharmacy (1993) and his M.Sc (2000) from the University of Alberta’s faculty of Pharmacy and Pharmaceutical Sciences. He is an Editorial Advisor for Value in Health and the Chair of CHEERS, an International Task Force that developed guidelines for the reporting of health economic evaluations. His most recent research has examined value-based pricing and reimbursement for drugs and physician services in Canada and the governance of medical technology through value-based pricing.

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