Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement

Economic evaluations of health interventions pose a particular challenge for reporting. There is also a need to consolidate and update existing guidelines and promote their use in a user friendly manner. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines efforts into one current, useful reporting guidance. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. The need for new reporting guidance was identified by a survey of medical editors. A list of possible items based on a systematic review was created. A two round, modified Delphi panel consisting of representatives from academia, clinical practice, industry, government, and the editorial community was conducted. Out of 44 candidate items, 24 items and accompanying recommendations were developed. The recommendations are contained in a user friendly, 24 item checklist.

# Background
Health economic evaluations are conducted to inform resource allocation decisions. Economic evaluation has been defined as "the comparative analysis of alternative courses of action in terms of both their costs and their consequences". All economic evaluations assess costs, but approaches to measuring and valuing the consequences of health interventions may differ (see [fig_ref] Figure 1: Forms of economic evaluation [/fig_ref].
Economic evaluations have been widely applied in health policy, including the assessment of prevention programmes (such as vaccination, screening, and health promotion), diagnostics, treatment interventions (such as drugs and surgical procedures), organisation of care, and rehabilitation. Economic evaluations are increasingly being used for decision making and are an important component of programmes for health technology assessment internationally [bib_ref] Key principles for the improved conduct of health technology assessments for resource..., Drummond [/bib_ref].

## Reporting challenges and shortcomings in health economic evaluations
Compared with clinical studies, which report the consequences of an intervention only, economic evaluations require more reporting space for additional items, such as resource use, costs, preference related information, and cost effectiveness results. This creates challenges for editors, reviewers, and those who wish to scrutinise a study's findings [bib_ref] Pharmacoeconomic analyses, Rennie [/bib_ref]. There is evidence that the quality of reporting of economic evaluations varies widely and could potentially benefit from improved quality assurance mechanisms [bib_ref] Quality of abstracts of papers reporting original cost-effectiveness analyses, Rosen [/bib_ref].
With the increasing number of publications available, and opportunity costs from decisions based on misleading study findings, transparency and clarity in reporting are important. In addition, outside of economic evaluations conducted alongside clinical trials, there are no widespread mechanisms for warehousing economic evaluation data to allow for independent interrogation, such as ethics review proceedings, regulator dossiers, or study registries. Instead, independent analysis may rely on the record keeping of individual investigators.
Even if measures to promote transparency exist, such as registries, biomedical journal editors have increasingly promoted and endorsed the use of reporting guidelines. Endorsement of guidelines by journals for randomised controlled trials has been shown to improve reporting [bib_ref] Does use of the CONSORT Statement impact the completeness of reporting of..., Turner [/bib_ref]. The combination of the risk of making costly decisions due to poor reporting with the lack of mechanisms that promote accountability makes transparency in reporting economic evaluations especially important and a primary concern among journal editors and decision makers [bib_ref] Pharmacoeconomic analyses, Rennie [/bib_ref] [bib_ref] A reappraisal of economic evaluation of pharmaceuticals. Science or marketing?, Drummond [/bib_ref].

## Aim and scope
The aim of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is to provide recommendations, in the form of a checklist, to optimise reporting of health economic evaluations. The need for a contemporary reporting guidance for economic evaluations was recently identified by researchers and biomedical journal editors [bib_ref] The ISPOR Good Practices for Quality Improvement of Cost-Effectiveness Research Task Force..., Mcghan [/bib_ref]. The CHEERS statement attempts to consolidate and update previous efforts [bib_ref] Guidelines for authors and peer reviewers of economic submissions to the BMJ, Drummond [/bib_ref] [bib_ref] Recommendations for reporting cost-effectiveness analyses, Panel on Cost-Effectiveness in Health and Medicine, Siegel [/bib_ref] [bib_ref] Reporting format for economic evaluation: Part II: Focus on modelling studies, Nuijten [/bib_ref] [bib_ref] Design, execution, interpretation, and reporting of economic evaluation studies in obstetrics, Vintzileos [/bib_ref] [bib_ref] Increasing the generalizability of economic evaluations: recommendations for the design, analysis, and..., Drummond [/bib_ref] [bib_ref] Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA..., Ramsey [/bib_ref] [bib_ref] Evidence and value: impact on decisionmaking-the EVIDEM framework and potential applications, Goetghebeur [/bib_ref] [bib_ref] Guidelines for conducting and reporting economic evaluation of fall prevention strategies, Davis [/bib_ref] [bib_ref] Economic evaluation using decision analytical modelling: design, conduct, analysis, and reporting, Petrou [/bib_ref] [bib_ref] Economic evaluation alongside randomised controlled trials: design, conduct, analysis, and reporting, Petrou [/bib_ref] into a single useful reporting guidance.
The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers evaluating their publication potential. We hope the statement (which consists of a 24 item checklist and accompanying recommendations on the minimum amount of information to be included when reporting economic evaluations) is a useful and practical tool for these audiences and will improve reporting and, in turn, health and healthcare decisions. To best understand and apply the recommendations contained within the statement, we encourage readers to access the Explanation and Elaboration Report [bib_ref] Consolidated Health Economic Evaluation Reporting Standards (CHEERS)-Explanation and elaboration: A report of..., Husereau [/bib_ref].

## Development of the cheers statement
The statement was developed by a task force supported by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), as part of a broader initiative to facilitate and encourage the interchange of expert knowledge and develop best practices. The CHEERS Task Force members were chosen by the chair of the task force primarily based on their longstanding academic expertise and contribution to the multidisciplinary field of health economic evaluation. In addition to four members of the task force with doctorates in economics and its sub-discipline of health economics (AHB, MD, JM, SP), members included experts in health Forms of economic evaluationSpecific forms of analysis reflect different approaches to evaluating the consequences of health interventions. Health consequences may be estimated from a single analytical (experimental or nonexperimental) study, a synthesis of studies, mathematical modelling, or a combination of modelling and study information.
Cost consequences analysis examines costs and consequences without attempting to isolate a single consequence or aggregate consequences into a single measure Cost minimisation analysis (CMA)-The consequences of compared interventions are required to be equivalent, and only relative costs are compared Cost effectiveness analysis (CEA) measures consequences in natural units, such as life years gained, disability days avoided, or cases detected. In a variant of CEA, often called cost utility analysis, consequences are measured in terms of preference-based measures of health, such as quality adjusted life years or disability adjusted life years.

## Cost benefit analysis-consequences are valued in monetary units.
Readers should be aware that an economic evaluation might be referred to as a "cost effectiveness analysis" or "cost benefit analysis" even if it does not strictly adhere to the definitions above. Multiple forms may also exist within a single evaluation. Different forms of analysis provide unique advantages or disadvantages for decision making. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement can be used with any form of economic evaluation. The CHEERS Task Force followed current recommendations for developing reporting guidelines [bib_ref] Guidance for developers of health research reporting guidelines, Moher [/bib_ref]. Briefly, the need for new guidance was first identified through a survey of members of the World Association of Medical Editors. Of the 6% (55/965) who responded, 91% (n = 50) indicated they would use a standard if one were widely available [bib_ref] The ISPOR Good Practices for Quality Improvement of Cost-Effectiveness Research Task Force..., Mcghan [/bib_ref]. Next, published checklists or guidance documents related to reporting economic evaluations were identified from a systematic review and survey of task force members [bib_ref] Describing reporting guidelines for health research: a systematic review, Moher [/bib_ref]. Both of these activities were used to create a preliminary list of items to include when reporting economic evaluations. Recommendations of the minimum set of reporting items were then developed through a modified Delphi panel process. Forty eight individuals identified by the task force with broad geographical representation and representing academia, biomedical journal editors, the pharmaceutical industry, government decision makers, and those in clinical practice were invited to participate. Thirty seven agreed to participate. Participants were asked to score importance on a Likert scale and the average scores, weighted by each individual's confidence in ability to score, were then used to rank items. A cut-off point was applied to the ranked list to determine the minimum number of items important for reporting.
The CHEERS statement recommendations have been independently reviewed and subsequently revised by task force members. The recommendations are entirely those of the task force-the sponsors of the study had no role in study design, data analysis, data interpretation, or writing of the final recommendations. A more complete description of the methods and findings of the Delphi panel are found in the larger explanation and elaboration document [bib_ref] Consolidated Health Economic Evaluation Reporting Standards (CHEERS)-Explanation and elaboration: A report of..., Husereau [/bib_ref].

## Checklist items
The final recommendations are subdivided into six main categories: (1) title and abstract; (2) introduction; (3) methods; (4) results; (5) discussion; and (6) other. The recommendations are contained in a user friendly, 24 item checklist [fig_ref] Table 1: CHEERS checklist-Items to include when reporting economic evaluations of health interventions Provide... [/fig_ref] to aid users who wish to

## Concluding remarks
As the number of published health economic evaluations continues to grow, we believe more transparent and complete reporting of methods and findings will be increasingly important to facilitate interpretation and comparison of studies. We hope the CHEERS statement, consisting of recommendations in a 24 item checklist, will be viewed as an effective consolidation and update of previous efforts and serve as a starting point for standard reporting going forward. We believe the CHEERS statement represents a considerable expansion over previous efforts. The strength of our approach is that it was developed in accordance with current recommendations for the development of reporting guidelines, using an international and multidisciplinary team of editors and content experts in economic evaluation and reporting [bib_ref] Guidance for developers of health research reporting guidelines, Moher [/bib_ref]. Similar to the approach taken with other widely accepted guidelines, we have defined a minimum set of criteria though a modified Delphi technique and have translated these into recommendations, an explanatory document with explanations, and a checklist. Unlike some previous reporting guidance for economic evaluation, we have also made every effort to be neutral about the conduct of economic evaluation, allowing analysts the freedom to choose different methods.
There may be several limitations to our approach. A larger Delphi panel with a different composition could have led to a different final set of recommendations [bib_ref] The effect of panel membership and feedback on ratings in a two-round..., Campbell [/bib_ref]. Some less common approaches and contexts (such as public health, developing countries, and system dynamic models) for conducting health economic evaluation may not be well represented by our sample of experts. Additionally, like many Delphi panel processes, we based decisions to reject or accept criteria on arbitrary levels of importance. However, we feel the group recruited to create the statement is sufficiently knowledgeable of the more common applications of economic evaluation, and the rules used to select criteria were created a priori and are consistent with previous efforts.
We believe it will be important to evaluate the effects of implementation of this statement and checklist on reporting in future economic evaluations. As methods for the conduct of economic evaluation continue to evolve, it will also be important to revisit or extend the guidance. The CHEERS Task Force feels that this statement should be reviewed for updating five years from its release.
[fig] Figure 1: Forms of economic evaluation. [/fig]
[table] Table 1: CHEERS checklist-Items to include when reporting economic evaluations of health interventions Provide an explicit statement of the broader context for the study.Present the study question and its relevance for health policy or practice decisions. ___________________ State the time horizon(s) over which costs and consequences are being evaluated and say why appropriate. ___________________ Discount rate 9 Report the choice of discount rate(s) used for costs and outcomes and say why appropriate. ___________________Choice of health outcomes 10Describe what outcomes were used as the measure(s) of benefit in the evaluation and their relevance for the type of analysis performed. ___________________ [/table]