Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations — TEI-tagged view

Don HusereaupersName, Michael DrummondpersName, Federico AugustovskipersName, Esther de Bekker-GrobpersName, Andrew H. BriggspersName, Chris CarswellpersName, Lisa CaulleypersName, Nathorn ChaiyakunaprukpersName, Dan GreenbergpersName, Elizabeth LoderpersName, Josephine MauskopfpersName, C. Daniel MullinspersName, Stavros PetroupersName, Raoh-Fang PwupersName, Sophie StaniszewskapersName (2022date). “Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations.” BMC Medicinetitle·j.

Object of study — reporting guidanceterm·mth for health economic evaluationsterm·mth

Research question — how the CHEERSterm·key reporting checklistterm·key should be updated for all types of health economic evaluationterm·mth

Contribution — the CHEERS 2022term statement: a 28-item checklistterm·key replacing CHEERSterm·key 2013date

Full text — tagged

Consolidated Health Economic Evaluationterm·mth Reporting Standards 2022date (CHEERS 2022term) statement: updated reporting guidanceterm·mth for health economic evaluationsterm·mth Abstract Health economic evaluationsterm·mth are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluationterm·mth Reporting Standards (CHEERSterm·key) statement, published in 2013date, was created to ensure health economic evaluationsterm·mth 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 2022term statement replaces previous CHEERSterm·key reporting guidanceterm·mth. It reflects the need for guidance that can be more easily applied to all types of health economic evaluationterm·mth, new methods and developments in the field, as well as 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 health care, public health, education, social care, etc). This summary article presents the new CHEERS 2022term 28-item checklistterm·key and recommendations for each item. The CHEERS 2022term 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.

The online version contains supplementary material available at 10.1186/s12916-021-02204-0.

Background 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 availability of reporting guidanceterm·mth [ 4 ], there is a considerable lack of standardisation and transparency in reporting [ 5 , 6 ]. There remains a need for reporting guidanceterm·mth to help authors, journal editors, and peer reviewers in their identification and interpretation.

The goal of the original Consolidated Health Economic Evaluationterm·mth Reporting Standards (CHEERSterm·key) statement [ 4 ], was to recommend the minimum amount of information required for reporting of published health economic evaluationsterm·mth. The statement consisted of a 24-item checklistterm·key and Explanation and Elaboration Report [ 4 ]. CHEERSterm·key 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 checklistterm·key items (such as title, abstract) were also included to aid those researching economic evaluation literature. The CHEERSterm·key statement consolidated previous health economic evaluationterm·mth reporting guidelines [ 7 – 18 ] into one current, useful reporting guidanceterm·mth.

Since the original publication of the CHEERSterm·key statement, there have been several developments that have motivated an update. These include feedback on perceived limitations of CHEERSterm·key, including criticism of its neglect of addressing reporting of cost-benefit analyses [ 19 ]. CHEERSterm·key has also been observed to be 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 has not been designed for this purpose.

There have also been methods developments in economic evaluation motivating an update. This includes an update of methods proposed by the Second Panelterm on Cost-Effectivenessterm·key in Health and Medicine (“Second Panelterm”), 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 the use of 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 ] have also motivated an update. There has also been an increase in the number of economic evaluations that attempt to capture consequences extending beyond health outcomes, such as equity and distributional effects [ 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 guidanceterm·mth 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 2022term statement, which consists of a 28-item checklistterm·key, and an Explanation and Elaboration report with accompanying user tools and guidance. More detailed guidance and illustrative examples on how to use the checklistterm·key can be found in the larger Explanation and Elaboration report [ 39 ].

Summary points • To ensure health economic evaluationsterm·mth 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 2022term statement, which provides updated reporting guidanceterm·mth that reflects the need for a broader application to all types of health economic evaluationterm·mth 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 2022term statement consists of a 28-item checklistterm·key, and an Explanation and Elaboration report with accompanying user tools and guidance.

• The CHEERS 2022term statement is intended to be used for any form of health economic evaluationterm·mth 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 toolterm·mth or a tool to assess the appropriateness of methods.

• Budget impact analysesterm·mth 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 CHEERSterm·key followed that of ISPOR Good Practices Task Force reports [ 40 ] as well as guidance developed by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network [ 41 ], where the CHEERS 2022term update is also registered. An informal review was undertaken of reporting guidelines published since CHEERSterm·key, and new items were proposed and consolidated along with the existing CHEERSterm·key Checklistterm·key. 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 checklistterm·key and provide suggestions on language and the need for additional items. The draft checklistterm·key was finalised by CHEERSterm·key 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 along with 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 checklistterm·key based on the input provided. A guiding principle for CHEERSterm·key 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 ] checklistterm·key is in Appendix A . The protocol for the Delphi process, as well as panel composition, size, response rates, and analytic approach can be found in Appendix B .

The CHEERS 2022term statement Scope The CHEERS 2022term statement is intended to be used for any form of health economic evaluationterm·mth [ 43 ]. This includes analyses that only examine costs and cost offsets (that is, cost analysisterm·mth) or those that examine both costs and consequences. The latter include analyses that consider health consequences (such as, cost-effectivenessterm·key/utility analyses (CEAs/CUAs), cost minimisation, cost-benefit/benefit-cost analyses (CBAsterm·mth)), and broader measures of benefit and harm to individuals (such as extended CEAs/CBAsterm·mth), including measures of equity (such as distributional CEAs). While we are aware some studies comparing costs are labelled as CBAsterm·mth, we recommend the use of this term for studies which include a monetary valuation of health outcomes. Although linked to economic evaluation, budget impact analysesterm·mth and constrained optimisation studies are beyond the scope of CHEERSterm·key 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 2022term statement are researchers reporting economic evaluations as well as peer reviewers and editors assessing them for publication. While the statement is not intended to guide the conduct of economic evaluation, familiarity with reporting requirements will be useful for analysts when planning studies. CHEERSterm·key 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 CHEERSterm·key 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 guidanceterm·mth will be useful in any social or political context.

CHEERSterm·key 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).

CHEERSterm·key is also applicable to studies based on mathematical modelling or empirical research (such as patient level or cluster level human studies). Although CHEERSterm·key 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 checklistterm·key, using it as a scoring toolterm·mth 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 CHEERSterm·key statement, users may need to refer to additional reporting guidanceterm·mth (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 CHEERSterm·key The CHEERS 2022term statement (checklistterm·key and Explanation and Elaboration report) replaces the 2013date CHEERSterm·key statement, which should no longer be used. The new CHEERSterm·key checklistterm·key contains 28 items with accompanying descriptions (Table 1 ). Major changes from CHEERSterm·key 2013date are described in Table 2 . Checklistterm·key 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 checklistterm·key should first consult the Explanation and Elaboration report [ 39 ] to ensure the appropriate interpretation of each item description.

The CHEERS 2022term checklistterm·key Major changes in the CHEERS 2022term statement (compared with CHEERSterm·key 2013date) Those using the checklistterm·key 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), checklistterm·key users are encouraged to report “Not applicable.” If information is otherwise not reported, checklistterm·key users are encouraged to write “Not reported.” Users should avoid the term “Not conducted” as CHEERSterm·key is intended to guide and capture reporting.

As before, in developing the CHEERSterm·key 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.

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/CHEERSterm·key/ ), and further educational materials for authors, to facilitate appropriate use of the guidance. We encourage authors to visit the CHEERSterm·key [ 47 ] and EQUATOR [ 48 ] websites to locate copies of the checklistterm·key, 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 CHEERSterm·key statement will be useful to those who need to identify, prepare and interpret reports of health economic evaluationsterm·mth. Despite the promotion and increased number of available health economic evaluationsterm·mth, as well as the availability of CHEERSterm·key in multiple languages since 2013date, there is some indication CHEERSterm·key could be more widely and appropriately used. A convenience sample of 50 articles citing CHEERSterm·key revealed only 42% (95% confidence interval 28% to 56%) made an appropriate use of CHEERSterm·key [ 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 CHEERSterm·key has increased from its time of publication.

In creating this update, we also wanted to ensure the broadest possible application of CHEERSterm·key. Previous concerns raised about its lack of applicability in cost-benefit analyses (CBAsterm·mth) were understandable, given original CHEERSterm·key guidance leaning strongly towards proving direction for those conducting cost-effectivenessterm·key analyses (including cost-utility analyses). This was driven, in part, by the small prevalence and impact of published CBAsterm·mth at the time of the original CHEERSterm·key 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 cost-effectivenessterm·key analysis, are becoming increasingly important. Health economic evaluationterm·mth is also finding increasing application across a wider spectrum of health interventions. We hope the revised CHEERSterm·key statement addresses these concerns.

We are also aware that the final checklistterm·key reflects the perspectives of the Task Force members, PPIE advisors, Delphi Panel members, and peer reviewers involved. While nominal group techniques such as the Delphi approach are intended to minimise the excessive influence of dominant experts in a group, we acknowledge the output of these processes are only as good as the experience and perspectives represented. While a diversity of expertise was sought, it is possible that more could be said for specific applications of CHEERSterm·key for interventions that have impacts beyond health (for example, educational, environmental, social care). We would encourage those who see opportunities to expand CHEERS 2022term items, or to create additional reporting guidanceterm·mth that provides clarification in specific areas, to work with members of the CHEERSterm·key Task Force to develop CHEERSterm·key extensions in these areas.

The updated guidance also anticipates future developments in the conduct and reporting of published health economic evaluationsterm·mth. 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 addressing these developments through the creation of separate items could foster awareness of their use and development.

As there is an increasing need for clarity of information to support healthcare decision making and attention to healthcare expenditure, we anticipate the role of published health economic evaluationterm·mth to become more important. While we hope the CHEERS 2022term statement and accompanying resources will ultimately improve the quality of reporting (and decision making), the impact of the original CHEERSterm·key statement on reporting quality is still uncertain. A formal evaluation study is ongoing, and results will be available in 2022date [ 49 ]. In the meantime, we have focused our attention on strategies to increase the appropriate use of CHEERSterm·key, 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 2022term into other languages. In these cases, we would encourage appropriate methods [ 41 , 50 ] and collaboration with Task Force members to ensure consistency with CHEERSterm·key. We encourage authors, peer reviewers, and editors to regularly consult the CHEERS 2022term webpage and to provide feedback on how it can be improved.

Conclusion This summary article presents the new CHEERS 2022term 28-item checklistterm·key, and recommendations for each item. The CHEERS 2022term statement is primarily intended for researchers reporting economic evaluations for peerreviewed 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.

Supplementary Information Additional file 1: Appendix A: A completed Guidance for Reporting Involvement of Patients and the Public-Version 2 (GRIPP2) checklistterm·key.

Additional file 2: Appendix B: Protocol for the Delphi process.

Acknowledgements We thank the following who participated in the study.

The Patient and Public Involvement and Engagement (PPIE) Advisory Group: Ivett Jakab, Emma Kinloch, Eric Low, Jean Mossman, Declan Noone, Phil Posner, and Jo Watson.

The Editors Advisory Group: Wendy Babidge, Lyn Beamesderfer, Dior Beerens, Chris CarswellpersName, Tillie Cryer, Ana Donnelly, Manuel Espinoza, Dan GreenbergpersName, Wolfgang Greiner, Laura Happe, Mickaël Hiligsmann, Christine Laine, Lin Lee, Ken Lee, Elizabeth LoderpersName, Natalie Pafitis, Julia Robinson Kenneth Stein, Eva Szunyogova, Wim Weber, Timothy Wrightson, and Brian Zikmund-Fisher.

Participants in the Delphi Panel exercise: Marie-Claude Aubin, Marc Berger, John Campbell, Doug Coyle, Matthew Dyer Richard Edlin, Rita Faria, Veronica Gallegos, Alastair Gray, Scott Grosse, Jason Guertin, Dyfrig Hughes, Florencia Hutter, Denny John, Hanin Farhana Kamaruzaman, David Kim, Murray Krahn, Dan Moldaver, Ku Abd Rahim Ku Nurhasni, Daniela Vianna Pachito, Michael Paulden, Clinton Pecenka, Andrés Pichon-Riviere, John Powell, Lisa Prosser, Dean Regier, Anna Ringborg, Rossana Rivas, Chris Sampson, Marisa Santos, Paul Scuffham, Mark Sculpher, Katia Senna, Eldon Spackman, Lotte Steuten, David Tamblyn, Kilgore Trout, Dick Willke, and Torbjorn Wisloff.

Additional ISPOR reviewers who commented on our drafts: Tadesse Abegaz, Alex Kostyuk, Kelly Lenahan, Nan Luo, Joshua Soboil, Richard White, and members of the PPIE.

Thanks to David Moher for initial advice on approach, and a very special final thanks to Elizabeth Molsen. David Moher served as scientific advisor and reviewed the initial proposal as well as attended initial meetings; all members of the PPIE (Ivett Jakab, Emma Kinloch, Eric Low, Jean Mossman, Declan Noone, Phil Posner, and Jo Watson) critically reviewed the initial checklistterm·key and suggested and provided review and advice on subsequent drafts of the checklistterm·key and Explanation and Elaboration report. Members of the PPIE were invited to participate in the Delphi Panel exercise. All members of the PPIE, and Delphi Panel were invited to review drafts of the checklistterm·key and accompanying report.

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 & Specialty Pharmacy, Journal of Medical Economics, MDM Policy & 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.

Authors' informations Web Extra Extra material supplied by the author Authors’ contributions DH is Task Force co-chair and the submitting and corresponding author; MD is a Task Force co-chair. All other authors (FA, EBG, AHB, CC, LC, NC, DG, EL, JM, CDM, SP, RFP, and SS- listed in alphabetical order by surname) and the co-chairs conceived this paper and designed the Delphi survey conducted to inform the guideline content. DH conducted a literature review, administered the Delphi survey and analysed the data for both. DH and MD prepared materials for each meeting and led the drafting and editing of the article. DH, MD, FA, AHB, EBG, CC, LC, NC, DG, EL, JM, CDM, SP, RFP, and SS drafted particular sections of the article. MD and SS led the PPIE advisory group. DH and CC led the Editors Advisory Group. All authors were involved in revising the article critically for important intellectual content. All authors approved the final version of the article. DH is the guarantor of this work. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

Funding Funding to support ongoing meetings was provided by ISPOR - The Professional Society for Health Economics and Outcomes Research. The funders had no role in considering the study design or in the collection, analysis, interpretation of data, or writing of the report. Funding for DH and the Delphi Panel exercise was provided by 9363980 Canada Inc. SS is part funded by the NIHR Applied Research Collaboration (ARC) West Midlands, the NIHR Health Protection Research Unit (HPRU) Gastrointestinal Infections, and the NIHR HPRU Genomics and Enabling data.

Availability of data and materials Not applicable.

Declarations Ethics approval and consent to participate Not applicable.

Consent for publication Not applicable Competing interests All authors have completed the ICMJE uniform disclosure form and declare no competing interests.

Footnotes References Associated Data Supplementary Materials Additional file 1: Appendix A: A completed Guidance for Reporting Involvement of Patients and the Public-Version 2 (GRIPP2) checklistterm·key.

Additional file 2: Appendix B: Protocol for the Delphi process.

Data Availability Statement Not applicable.