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Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) Statement: Updated Reporting Guidance for Health Economic Evaluations.

Don Husereau1,2, Michael Drummond3, Federico Augustovski4,5,6, Esther de Bekker-Grob7, Andrew H Briggs8, Chris Carswell9, Lisa Caulley10,11,12, Nathorn Chaiyakunapruk13, Dan Greenberg14, Elizabeth Loder15,16, Josephine Mauskopf17, C Daniel Mullins18, Stavros Petrou19, Raoh-Fang Pwu20, Sophie Staniszewska21.   

Abstract

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, and the increased role of stakeholder involvement, including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as healthcare, public health, education, social care, etc.). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer-reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.
© 2021. The Author(s).

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Year:  2022        PMID: 35015272      PMCID: PMC9130151          DOI: 10.1007/s40273-021-01112-8

Source DB:  PubMed          Journal:  Pharmacoeconomics        ISSN: 1170-7690            Impact factor:   4.558


Introduction

Economic evaluations of health interventions are comparative analyses of alternative courses of action in terms of their costs and consequences. They can provide useful information to policy makers, payers, health professionals, patients, and the public about choices that affect health and the use of resources. Economic evaluations are a particular challenge for reporting because substantial information must be conveyed to allow scrutiny of study findings. Despite a growth in published economic evaluations [1-3], and the availability of reporting guidance [4], there is a considerable lack of standardisation and transparency in reporting [5, 6]. There remains a need for reporting guidance to help authors, journal editors, and peer reviewers in their identification and interpretation. The goal of the original Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement [4] was to recommend the minimum amount of information required for reporting of published health economic evaluations. The statement consisted of a 24-item checklist and an explanation and elaboration report [4]. CHEERS was intended to help authors provide accurate information on which health interventions are being compared and in what context, how the evaluation was undertaken, what the findings are, and other details that may aid readers and reviewers in interpretation and use of the study. In doing so, it can also aid interested researchers in replicating research findings. Some checklist items (such as title, abstract) were also included to aid those researching economic evaluation literature. The CHEERS statement consolidated previous health economic evaluation reporting guidelines [7-18] into one current, useful reporting guidance. Since the original publication of the CHEERS statement, there have been several developments that have motivated an update. These include feedback on perceived limitations of CHEERS, including criticism of its neglect to address reporting of cost-benefit analyses (CBAs) [19]. CHEERS has also been observed being used inappropriately as a tool to assess quality of methods, for which other tools exist [20], rather than the quality of reporting [5]. It has also been used as a tool to quantitatively score studies in systematic reviews, an approach that could mislead readers and reviewers [21] as it was not designed for this purpose. Methods developments in economic evaluation have also motivated an update. This includes an update of methods proposed by the Second Panel on Cost-Effectiveness in Health and Medicine, which contained new recommendations concerning the perspective of economic evaluations, the classification of costs and benefits in a structured table, and the inclusion of related and unrelated healthcare costs in added years of life [22]. Health technology assessment bodies have also updated their guidance on conducting and appraising economic evaluations [23, 24]. There have also been increasing calls for the use of health economic analysis plans [25] and open source models [26-30]. The latter may be of particular importance as published economic evaluations are increasingly available in journals with broad data-sharing policies. Increased use of, and guidance for, economic evaluations to support policy decisions in immunisation programmes [31, 32] and global health in lower- and middle-income countries [33] has also motivated an update. The number of economic evaluations attempting to capture consequences extending beyond health outcomes, such as equity and distributional effects, has also increased [34, 35]. Finally, the increased role of stakeholder involvement in health research and health technology assessment, including patients and the public, suggests the need for reporting guidance to recognise a broader audience [36-38]. All of these developments suggest the scope of guidance for reporting economic evaluations should be expanded and updated. The objective of this article is to provide a brief overview of the CHEERS 2022 statement, which consists of a 28-item checklist and an explanation and elaboration report with accompanying user tools and guidance. More detailed guidance and illustrative examples on how to use the checklist can be found in the larger explanation and elaboration report [39]. To ensure health economic evaluations are interpretable and useful for decision making, authors need to provide sufficient detail about the healthcare context and decision under investigation, analytic approach, and findings, and the potential impact on patients, service recipients, and public, or application in policy or patient care. This article provides a brief overview of the CHEERS 2022 statement, which provides updated reporting guidance that reflects the need for a broader application to all types of health economic evaluations and health interventions, new methods and developments in the field, as well as the increased role of participation from patients, service recipients, and other key stakeholders. The CHEERS 2022 statement consists of a 28-item checklist, and an explanation and elaboration report with accompanying user tools and guidance. The CHEERS 2022 statement is intended to be used for any form of health economic evaluation and is primarily intended for researchers reporting economic evaluations for peer-reviewed journals as well as the peer reviewers and editors assessing them for publication. The statement is not intended as a scoring tool or a tool to assess the appropriateness of methods. Budget impact analyses and constrained optimisation studies are beyond the scope of the guidance. We anticipate familiarity with reporting requirements will be useful for analysts when planning studies and useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.

Approach

The process of revising CHEERS followed that of the Professional Society for Health Economics and Outcomes Research (ISPOR) Good Practices Task Force reports [40] as well as guidance developed by the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) network [41], where the CHEERS 2022 update is also registered. An informal review was undertaken of reporting guidelines published since CHEERS, and new items were proposed and consolidated along with the existing CHEERS checklist. In parallel with this, a task force was convened and a group of patient and public involvement and engagement (PPIE) contributors was formed to review the consolidated checklist and provide suggestions on language and the need for additional items. The draft checklist was finalised by CHEERS Task Force members. Experts in economic evaluation, as well as those with perspectives in journal editing, decision making, health technology assessment, and commercial life sciences, were invited to participate in a modified Delphi panel (‘Delphi’) process. Further details on how the Task Force and PPIE members were chosen is available in the explanation and elaboration document [39]. Panellists and the PPIE contributors were subsequently invited to participate by email and directed to a web-based survey. Feedback from each round of the Delphi process was discussed by Task Force members, who ultimately finalised the checklist based on the input provided. A guiding principle for CHEERS is that economic evaluations made available publicly should be understandable, interpretable, and replicable to those who use them. A completed Guidance for Reporting Involvement of Patients and the Public—version 2 (GRIPP2) [42] checklist is in Appendix A in the electronic supplementary material (ESM). The protocol for the Delphi process, as well as panel composition, size, response rates, and analytic approach, can be found in Appendix B in the ESM.

The CHEERS 2022 Statement

Scope

The CHEERS 2022 statement is intended to be used for any form of health economic evaluation [43]. This includes analyses that only examine costs and cost offsets (that is, cost analysis) or those that examine both costs and consequences. The latter includes analyses that consider health consequences (such as cost-effectiveness analyses [CEAs]/cost-utility analyses [CUAs], cost-minimisation analyses, and CBAs/benefit-cost analyses), and broader measures of benefit and harm to individuals (such as extended CEAs/CBAs), including measures of equity (such as distributional CEAs). Although we are aware some studies comparing costs are labelled as CBAs, we recommend the use of this term for studies that include a monetary valuation of health outcomes. Although linked to economic evaluation, budget impact analyses and constrained optimisation studies are beyond the scope of CHEERS guidance, as they require additional reporting that addresses population dynamics and feasibility constraints and are addressed in other guidance reports [44, 45]. The primary audiences for the CHEERS 2022 statement are researchers reporting economic evaluations as well as peer reviewers and editors assessing them for publication. Although the statement is not intended to guide the conduct of economic evaluation, familiarity with reporting requirements will be useful for analysts when planning studies. CHEERS may be similarly useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making [46]. Health technology assessment and the use of economic evaluation is also becoming more commonplace globally [3]. In developing the guidelines, the CHEERS Task Force considered issues that may be specific to regions with developing economies and healthcare systems, including providing examples of these by item in the larger report [39] to ensure the reporting guidance will be useful in any social or political context. CHEERS is relevant for any intervention intended to affect health and should also be widely applicable for both simple and complex interventions, including programmes of care involving researcher-driven or commercialised products (such as drugs, macromolecules, cell, gene, and tissue-based therapies, vaccines, and medical devices); public health and social care interventions; processes of care (such as e-health, care coordination, clinical decision rules, clinical pathways, information and communication, medical and allied health services); and re-organisation of care (such as insurance redesign, alternative financing approaches, integrated care, scope of practice change, and workplace interventions). CHEERS is also applicable to studies based on mathematical modelling or empirical research (such as patient-level or cluster-level human studies). Although CHEERS can be used for systematic reviews of economic evaluation, its use should be limited to assessing the quality of reporting of a study rather than the quality of its conduct. As there is no validated scoring system for the checklist, using it as a scoring tool could lead to misleading findings and is strongly discouraged [21]. If used to assess the quality of reporting in a systematic review, a qualitative assessment of completeness of reporting by item is a more appropriate approach. When applying the CHEERS statement, users may need to refer to additional reporting guidance (for example, for randomised controlled trials, patient and public involvement, modelling, health state preference measures), and these are referenced throughout the explanation and elaboration report [39].

How to Use CHEERS

The CHEERS 2022 statement (checklist and explanation and elaboration report) replaces the 2013 CHEERS statement, which should no longer be used. The new CHEERS checklist contains 28 items with accompanying descriptions (Table 1). Major changes from CHEERS 2013 are described in Box 1. Checklist items are subdivided into seven main categories: (1) title, (2) abstract, (3) introduction, (4) methods, (5) results, (6) discussion, and (7) other relevant information. Users of the checklist should first consult the explanation and elaboration report [39] to ensure the appropriate interpretation of each item description.
Table 1

The CHEERS 2022 checklist

Section/topicItem no.Guidance for reportingReported in section
Title
 Title1Identify the study as an economic evaluation and specify the interventions being compared
Abstract
 Abstract2Provide a structured summary that highlights context, key methods, results, and alternative analyses
Introduction
 Background and objectives3Give the context for the study, the study question, and its practical relevance for decision making in policy or practice
Methods
 Health economic analysis plan4Indicate whether a health economic analysis plan was developed and where available
 Study population5Describe characteristics of the study population (such as age range, demographics, socioeconomic, or clinical characteristics)
 Setting and location6Provide relevant contextual information that may influence findings
 Comparators7Describe the interventions or strategies being compared and why chosen
 Perspective8State the perspective(s) adopted by the study and why chosen
 Time horizon9State the time horizon for the study and why appropriate
 Discount rate10Report the discount rate(s) and reason chosen
 Selection of outcomes11Describe what outcomes were used as the measure(s) of benefit(s) and harm(s)
 Measurement of outcomes12Describe how outcomes used to capture benefit(s) and harm(s) were measured
 Valuation of outcomes13Describe the population and methods used to measure and value outcomes
 Measurement and valuation of resources and costs14Describe how costs were valued
 Currency, price date, and conversion15Report the dates of the estimated resource quantities and unit costs, plus the currency and year of conversion
 Rationale and description of model16If modelling is used, describe in detail and why used. Report if the model is publicly available and where it can be accessed
 Analytics and assumptions17Describe any methods for analysing or statistically transforming data, any extrapolation methods, and approaches for validating any model used
 Characterising heterogeneity18Describe any methods used for estimating how the results of the study vary for subgroups
 Characterising distributional effects19Describe how impacts are distributed across different individuals or adjustments made to reflect priority populations
 Characterising uncertainty20Describe methods to characterise any sources of uncertainty in the analysis
 Approach to engagement with patients and others affected by the study21Describe any approaches to engage patients or service recipients, the general public, communities, or stakeholders (such as clinicians or payers) in the design of the study
Results
 Study parameters22Report all analytic inputs (such as values, ranges, references) including uncertainty or distributional assumptions
 Summary of main results23Report the mean values for the main categories of costs and outcomes of interest and summarise them in the most appropriate overall measure
 Effect of uncertainty24Describe how uncertainty about analytic judgements, inputs, or projections affect findings. Report the effect of choice of discount rate and time horizon, if applicable
 Effect of engagement with patients and others affected by the study25Report on any difference patient/service recipient, general public, community, or stakeholder involvement made to the approach or findings of the study
Discussion
 Study findings, limitations, generalisability, and current knowledge26Report key findings, limitations, ethical or equity considerations not captured and how these could affect patients, policy, or practice
Other relevant information
 Source of funding27Describe how the study was funded and any role of the funder in the identification, design, conduct, and reporting of the analysis
 Conflicts of interest28Report authors’ conflicts of interest according to journal or International Committee of Medical Journal Editors requirements
Those using the checklist should indicate the section of the manuscript where relevant information can be found. If an item does not apply to a particular economic evaluation (for example, items 11–13 for cost analyses, or items 16 and 22 for non-modelling studies), checklist users are encouraged to report ‘not applicable’. If information is otherwise not reported, checklist users are encouraged to write ‘not reported’. Users should avoid the term ‘not conducted’ as CHEERS is intended to guide and capture reporting. As before, in developing the CHEERS statement, the Task Force recognises that the amount of information required for adequate reporting will exceed conventional space limits of most journal reports. Therefore, in making our recommendations, we assume that authors and journals will make necessary information available to readers using online and supplementary appendices or other means. To facilitate appropriate use of the guidance, in addition to the open access explanation and elaboration report [39], we have also made available templates, an interactive form (https://don-husereau.shinyapps.io/CHEERS/), and further educational materials for authors. We encourage authors to visit the CHEERS [47] and EQUATOR [48] websites to locate copies of the checklist, the explanation and elaboration report [39], links to educational resources, templates, translations, a link to the interactive form, and future updates.

Discussion

We hope this update of the CHEERS statement will be useful to those who need to identify, prepare, and interpret reports of health economic evaluations. Despite the promotion and increased number of available health economic evaluations, as well as the availability of CHEERS in multiple languages since 2013, there is some indication that CHEERS could be more widely and appropriately used. A convenience sample of 50 articles citing CHEERS revealed that only 42% (95% confidence interval 28–56) made appropriate use of it [5]. This is a similar rate to those observed with other major reporting guidelines (CONSORT, PRISMA, ARRIVE). The same study also found that the inappropriate use of CHEERS had increased since its publication. In creating this update, we also wanted to ensure the broadest possible application of CHEERS. Previous concerns raised about its lack of applicability in CBAs were understandable, given the original CHEERS guidance leaned strongly towards proving direction for those conducting CEAs (including CUAs). This was driven, in part, by the small prevalence and impact of published CBAs at the time of the original CHEERS guidance. However, it is clear that broader characterisations of the benefits of healthcare, in concert with the promotion and publication of other forms of economic evaluation, such as distributional CEAs, are becoming increasingly important. Health economic evaluation is also finding increasing application across a wider spectrum of health interventions. We hope the revised CHEERS statement addresses these concerns. We are also aware that the final checklist reflects the perspectives of the Task Force members, PPIE advisers, Delphi panel members, and peer reviewers involved. Although nominal group techniques such as the Delphi approach are intended to minimise the excessive influence of dominant experts in a group, we acknowledge that the output of these processes are only as good as the experience and perspectives represented. A diversity of expertise was sought, but it is possible that more could be said for specific applications of CHEERS for interventions that have impacts beyond health (for example, educational, environmental, social care). We would encourage those who see opportunities to expand CHEERS 2022 items, or to create additional reporting guidance that provides clarification in specific areas, to work with members of the CHEERS Task Force to develop CHEERS extensions in these areas. The updated guidance also anticipates future developments in the conduct and reporting of published health economic evaluations. These include the use of health economic analysis plans, model sharing, and the increasing involvement of stakeholders in health research, including engagement with communities, patients, and the public. While some on the Delphi panel suggested that these developments did not warrant their own reporting items, the Task Force ultimately felt that addressing these developments through the creation of separate items could foster awareness of their use and development. As the need for clarity of information to support healthcare decision making and attention to healthcare expenditure increases, we anticipate that the role of published health economic evaluation will become more important. We hope the CHEERS 2022 statement and accompanying resources will ultimately improve the quality of reporting (and decision making) but acknowledge that the impact of the original CHEERS statement on reporting quality remains uncertain. A formal evaluation study is ongoing, and results will be available in 2022 [49]. In the meantime, we have focused our attention on strategies to increase the appropriate use of CHEERS, including creating a wider range of tools and resources for editors and authors, seeking endorsement across a larger group of journals, and increasing outreach efforts. We also recognise that researchers may wish to translate CHEERS 2022 into other languages. In these cases, we would encourage appropriate methods [41, 50] and collaboration with Task Force members to ensure consistency with CHEERS. We encourage authors, peer reviewers, and editors to regularly consult the CHEERS 2022 webpage and to provide feedback on how it can be improved.

Conclusion

This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer-reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making. Additional Information On behalf of CHEERS 2022 ISPOR Good Research Practices Task Force. This article is a joint publication by Applied Health Economics and Health Policy, BJOG, BMC Health Services Research, BMC Medicine, BMC Public Health, BMJ, Clinical Therapeutics, Health Policy Open, International Journal of Technology Assessment in Health Care, Journal of Managed Care and Specialty Pharmacy, Journal of Medical Economics, MDM Policy and Practice, PharmacoEconomics, The European Journal of Health Economics, Value in Health, and Value in Health Regional (en español). Each publisher holds its own copyright or has licensed the content for use, with the authors retaining copyright. The BMJ managed the peer-review process for this article on behalf of all journals. The CHEERS 2022 checklist Below is the link to the electronic supplementary material. Supplementary file1 (DOCX 2194 kb)
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