Over the past decade interest in the economic evaluation of health care interventions has risen1 Reviews of published studies have, however, shown gaps in the quality of work2 3 4 5 As far back as 1974 Williams listed the essential elements of economic evaluations,6 and more recently Drummond and colleagues set out the methodological areas generally agreed among economists7 Guidelines for economic evaluations have been promulgated and reviewed by many bodies,8 9 10 11 12 13 14 but few medical journals have explicit guidelines for peer review of economic evaluations or consistently use economist reviewers for economic papers even though they are a major publication outlet for economic evaluations15 16 17 In January 1995 the BMJ set up a working party on economic evaluation to improve the quality of submitted and published economic articles

It was not our intention to be unduly prescriptive or stifle innovative methods; our emphasis is on improving the clarity of economic evaluations We also did not address those issues of conduct that have been emphasised in other guidelines13 14 15 16 17 18

The working party's objectives were to improve the quality of submitted and published economic evaluations by agreeing acceptable methods and their systematic application before, during, and after peer review Its task was to produce: (a) guidelines for economic evaluation, together with a comprehensive supporting statement which could be easily understood by both specialist and non-specialist readers; (b) a checklist for use by referees and authors; and (c) a checklist for use by editors

In producing the guidelines the working party has concentrated on full economic evaluations comparing two or more health care interventions and considering both costs and consequences19 Articles sent to the BMJ and other medical journals are often more broadly based “economic …

/pdf/guidelines-for-authors-and-peer-reviewers-of-economic-uz9mnnz1jd.pdf

Guidelines for authors and peer reviewers of economic submissions to the BMJ. The BMJ Economic Evaluation Working Party.

https://www.niph.go.jp/journal/data/62-6/201362060009.pdf

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.

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. A copy of the statement, accompanying checklist, and this report can be found on the ISPOR Health Economic Evaluations Publication Guidelines Task Force website (www.ispor.org/TaskForces/ EconomicPubGuidelines.asp). We hope CHEERS will lead to better reporting, and ultimately, better health decisions. To facilitate dissemination and uptake, the CHEERS statement is being co-published across 10 health economics and medical journals. We encourage other journals and groups, to endorse CHEERS. The author team plans to review the checklist for an update in five years.

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Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement

on behalf of the CHEERS Task Force. 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

Objective. —This article, the third in a 3-part series, describes recommendations for the reporting of cost-effective analyses (CEAs) intended to improve the quality and accessibility of CEA reports. Participants. —The Panel on Cost-Effectiveness in Health and Medicine, a nonfederal panel with expertise in CEA, clinical medicine, ethics, and health outcomes measurement, convened by the US Public Health Service. Evidence. —The panel reviewed the theoretical foundations of CEA, current practices, alternative methods, published critiques of CEAs, and criticisms of general CEA methods and reporting practices. Consensus Process. —The panel developed recommendations through 21/2 years of discussions. Comments on preliminary drafts were solicited from federal government methodologists, health agency officials, and academic methodologists. Conclusion. —These recommendations are proposed to enhance the transparency of study methods, assist analysts in providing complete information, and facilitate the presentation of comparable cost-effectiveness results across studies. Adherence to reporting conventions and attention to providing information required to understand and interpret study results will improve the relevance and accessibility of CEAs.

Recommendations for Reporting Cost-effectiveness Analyses

Objectives To (1) provide medication therapy management (MTM) services to patients, (2) measure the clinical effects associated with the provision of MTM services, (3) measure the percent of patients achieving Healthcare Effectiveness Data and Information Set (HEDIS) goals for hypertension and hyperlipidemia in the MTM services intervention group in relationship to a comparison group who did not receive MTM services, and (4) compare patients' total health expenditures for the year before and after receiving MTM services. Design Prospective study. Setting Six ambulatory clinics in Minnesota from August 1, 2001, to July 31, 2002. Patients 285 intervention group patients with at least 1 of 12 medical conditions using prestudy health claims; 126 comparison group patients with hypertension and 126 patients with hyperlipidemia were selected among 9 clinics without MTM services for HEDIS analysis. Intervention MTM services provided by pharmacists to BlueCross BlueShield health plan beneficiaries in collaboration with primary care providers. Main outcome measures Drug therapy problems resolved; percentage of patients goals of therapy achieved and meeting HEDIS measures for hypertension and hypercholesterolemia. Total health expenditures per person were measured for a 1-year period before and after enrolling patients in MTM services. Results 637 drug therapy problems were resolved among 285 intervention patients, and the percentage of patients' goals of therapy achieved increased from 76% to 90%. HEDIS measures improved in the intervention group compared with the comparison group for hypertension (71% versus 59%) and cholesterol management (52% versus 30%). Total health expenditures decreased from $11,965 to $8,197 per person (n = 186, P Conclusion Patients receiving face-to-face MTM services provided by pharmacists in collaboration with prescribers experienced improved clinical outcomes and lower total health expenditures. Clinical outcomes of MTM services have chronic care improvement and value-based purchasing implications, and economic outcomes support inclusion of MTM services in health plan design.

https://www.japha.org/article/S1544-3191(15)31230-9/pdf

Clinical and economic outcomes of medication therapy management services: The Minnesota experience

Preamble Although economic outcomes research is an evolving field in health services research, there are correct and incorrect ways to conduct and report on economic outcomes studies. Research practices that help to minimize real or perceived bias will increase the quality and usefulness of such studies for those who sponsor, publish, and use them. Because of public concerns about the potential for bias in the design, analysis, and reporting of economic analyses of health care technology, we formed a task force to develop principles to enhance the credibility of these studies. The Task Force on Principles for Economic Analysis of Health Care Technology included participants from academia, the pharmaceutical industry, the public sector, and private research organizations. As health care resources become increasingly constrained, the information used to make resource allocation decisions must be as reliable, valid, and free of bias as possible. Getting it right at the level at which economic results are produced will help to protect consumers and will advance the health of the public. Bias stems from two broad categories: lack of appropriate independence for researchers and lack of consensus about methods. We focused heavily on the first of these categories for two major reasons. First, few have yet considered the unique issues of researcher independence in economic outcomes research [1, 2]. Second, other investigators have begun to consider and define proper methods for economic outcomes work (an area of considerable controversy) [3-5]. We also looked closely at the requirements for the reporting of economic analyses, which are intended to ensure methodologic transparency and accountability. The Need for Voluntary Guidelines Widespread use of economic analysis as part of the development of pharmaceutical, biotechnologic, and medical devices is relatively new. To date, many economic analyses of health care have focused on pharmaceutical agents, and many such studies have been funded by pharmaceutical companies. Results of these economic outcomes studies are used by medical technology firms to support the pricing and marketing of new interventions and to influence national health care systems and third-party payers in their development of coverage and payment decisions. Managed care organizations, hospitals, and government-subsidized health care programs rely on economic analysis of medical technology to help make formulary purchasing and utilization decisions. Physicians may use the results of these analyses to help guide treatment and prescription decisions. Health care economic outcomes projects are sponsored and conducted by pharmaceutical, biotechnologic, and medical device companies; government agencies; nonprofit foundations; academic investigators; and private research and consulting firms. The standards and methods used to evaluate the safety and efficacy of pharmaceutical products in randomized, controlled trials have evolved over 50 years of collaboration among researchers in private, public, and academic settings. Compared with those established to ensure the safety and efficacy of clinical trials, the principles and methods for the conduct of economic studies of health care technology are far less developed. Problems of conduct, reporting, and bias exist in all types of research [6-14]. In response, codes of conduct, such as those developed by the American Federation for Clinical Research and the Institute of Medicine, have been developed for many scientific disciplines [15-24]. These are good models on which to base principles of conduct for economic outcomes analysis. Although many published principles apply to economic studies, others should be modified and new ones should be developed to guide the conduct and reporting of economic outcomes analyses. Economic outcomes research requires unique guidelines for the following reasons: 1) As a field, it continues to evolve and is often misunderstood by end users; 2) peer review of it requires special expertise that often exceeds the capabilities of reviewers and scientific journals; 3) it often uses secondary data and requires that many assumptions be made [for example, attribution of a dollar cost to a unit of resource use]; 4) it offers unique methodologic choices, such as which types of costs to include (direct, indirect, intangible, induced), which perspective to apply (that of society, payer, provider, patient), which design to adopt (cost-identification, costbenefit, cost-effectiveness, costutility), from where to obtain costs [indemnity database, managed care or capitated database, hospital cost systems, Medicare, Medicaid], and whether to collect resource consumption data prospectively or retrospectively through various modeling techniques; and 5) economic studies play an increasingly important role in health care decision making because of increasing financial constraints throughout the health care industry. The financial and medical implications of decision making done on the basis of these studies, coupled with the lack of widely accepted guidelines about the conduct and reporting of economic analyses, undermine the credibility of this research. A major issue is that the primary source of funding for this research is often the primary financial beneficiary of positive study results. Unfortunately, even valid studies done under the best of circumstances may be suspect [25-29]. This has led at least one major journal to conclude that these analyses should be viewed much like editorials or review articles are viewed in terms of potential for conflicts of interest [30]. We developed the guidelines reported here after extensive consultation with experts from the public, private, and academic sectors. We recommend that researchers and sponsors adhere to these guidelines, and we suggest they state publicly within their manuscripts that they have done so. End users, including journal editors and readers, consumers, and social decision makers, may then feel more secure in accepting the results of the research, while recognizing that intensive critique of the research will always be necessary. Operations of the Task Force The Task Force on Principles for Economic Analysis of Health Care Technology was initiated and organized by faculty from the Leonard Davis Institute (LDI) Center for Health Policy of the University of Pennsylvania. However, because not all LDI faculty were involved, this paper does not represent an official LDI position statement. The Task Force was funded by a coalition of pharmaceutical companies (Appendix A). Funding was also requested (but not obtained) from various government and private foundations. All funding was provided in the form of unrestricted research grants or gifts to the University of Pennsylvania. Guidelines derive their credibility in part from the composition of the panel that creates them and the process by which they are developed. Candidates for participation in the Task Force from the private sector and the academic research community were identified by the frequency with which they were cited in the health economics literature, which was obtained using a MEDLINE search of literature related to economic analyses of medical technology published between 1983 and 1992. Approximately 15 members attended each meeting. Minutes were distributed after each meeting and approved by all members present. Members from the sponsoring pharmaceutical companies and the academic organizers rotated so that they numbered three and one, respectively, at the table for each formal Task Force meeting. Several professional and governmental organizations, including the Institute of Medicine, the Agency for Health Care Policy and Research, the Food and Drug Administration (FDA), the Health Care Financing Administration, the Centers for Disease Control and Prevention, and a managed care organization, were asked to suggest persons who might participate. In addition, other organizations with a stake in economic analyses were each asked to suggest a person who, because of his or her professional background, had extensive knowledge of or experience with economic analyses. An academic pharmacist, an academic researcher, a private researcher, an ethicist and patient advocate, and an attorney specializing in medical ethics rounded out the Task Force (Appendix B). Two members withdrew from participation. A small audience consisting of industry sponsors, academic organizers, staff, and a few other interested parties were invited to each meeting and allowed to comment. Four formal meetings of the Task Force were held in Philadelphia during 1993 and 1994, and the most substantial work was done by various subcommittees between these meetings. The three main subcommittees were titled Ethical Conduct, Responsibility and Control (the findings of these two subcommittees were later merged into one report), and Reporting Requirements for Economic Evaluations (Appendix C). The Task Force was assisted by a professional facilitator. Although Task Force members sought consensus wherever possible on the key issues, consensus was not forced and recommendations were issued only when substantial agreement existed among the members. Task Force members were not asked to formally represent any organization. Formal endorsement of the final document was not sought. Copies of this report will be distributed to all organizations that were asked to suggest a participant and to other parties who responded to announcements placed in The New England Journal of Medicine, Scrip, and the Pink Sheet. The Task Force findings will also be reported at academic conferences, medical profession meetings, and appropriate trade conventions. Findings and Recommendations Valid approaches to economic analyses can be defined; acceptable methods can be differentiated from unacceptable ones. Bias in economic research stems from two major sources: lack of appropriate independence for researc

Economic Analysis of Health Care Technology: A Report on Principles

Interventions performed by 89 community pharmacists in 5 states to correct the prescribing problems they identified on new prescription orders were documented by trained observers. Pharmacists intervened to resolve a prescribing-related problem in 623 (1.9%) of 33,011 new prescription orders that were screened and dispensed during the study period. A panel of three expert evaluators concluded that 28.3% of the prescribing problems identified during the study could have caused patient harm if the pharmacist had not intervened to correct the problem. The rate at which pharmacists identified prescribing problems was negatively related to the number of prescriptions they dispensed per hour, suggesting that in pursuing distributive efficiency, some pharmacists may be exceeding their safe dispensing threshold. The authors recommend that the interprofessional system of oversight and verification (i.e., "checks and balances") in the delivery of pharmaceutical care in the community setting should be maintained and strengthened.

Prescribing problems and pharmacist interventions in community practice.

Background Collaboration between physicians and pharmacists is one approach to address drug-related morbidity and achieve therapeutic goals. A collaborative practice of pharmaceutical care has been used in the Fairview Clinics System of Minneapolis-St Paul since 1999. Methods The quality of therapeutic determinations made by pharmacists within this collaborative practice of pharmaceutical care was studied by a 12-member panel of physicians and pharmacists who used randomly selected patient records. This was a quality improvement and care process validation component of a study evaluating the effects of drug therapy management in patients receiving prepaid medical assistance. An implicit review process was used to evaluate the clinical credibility of therapeutic determinations made by pharmaceutical care practitioners. Results A total of 5780 drug therapy problems were resolved for 2524 patients receiving pharmaceutical care. The rate of therapeutic goals achieved increased from 74% at the time of patients' initial pharmaceutical care encounters to 89% at patients' latest encounters. In this quality assessment analysis panel members performed a total of 4779 evaluations of clinical decisions. Panelists indicated agreement with the evaluations in 94.2% of cases, expressed a neutral opinion in 3.6% of cases, and disagreed in 2.2% of cases. Intraclass correlation coefficients ranged from 0.73 to 0.85. Conclusions The decisions made by pharmaceutical care practitioners working in collaboration with physicians to provide drug therapy management services are clinically credible based on the evaluations and comments of a peer review panel. This study provides information on the quality of care provided by pharmacists when collaborating with physicians to provide drug therapy management services.

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Stephen W. Schondelmeyer

Papers

Clinical and economic outcomes of medication therapy management services: The Minnesota experience

Economic Analysis of Health Care Technology: A Report on Principles

Prescribing problems and pharmacist interventions in community practice.

Quality assessment of a collaborative approach for decreasing drug-related morbidity and achieving therapeutic goals.

Documenting Prescribing Errors and Pharmacist Interventions in Community Pharmacy Practice