John M. Eisenberg

Sociologic Influences on Decision-Making by Clinicians

Recent articles on clinical decision-making have proposed sophisticated quantitative methods for improving the physicians clinical judgment. Actual clinical decisions, however, are influenced by interactions between the clinician, the patient, and the sociocultural milieu as well as by biomedical considerations. This paper explores these sociologic influences on the decision-making process. Four types of sociologic factors influence the clinicians judgment: the characteristics of the patient; the characteristics of the clinician; the clinicians interaction with his profession and the health care system; and the clinicians relationship with the patient. To illustrate sociologic influences on clinical decision-making, this paper presents observations from the literature of sociology, clinical psychology, psychiatry, and medicine. Further studies are needed to provide additional empirical information.

Study protocol: a randomized clinical trial of total parenteral nutrition in malnourished surgical patients.

CSP #221 is a randomized multiinstitutional clinical trial to assess the efficacy of 10 d of perioperative total parenteral nutrition (TPN) in reducing morbidity and mortality in malnourished patients undergoing intraperitoneal and/or intrathoracic operations. In this paper a detailed protocol for the clinical efficacy trial is presented primarily as a reference document for use in interpretation of the results of the clinical trial. It is also anticipated, however, that review of this protocol may be useful to other investigators planning future clinical nutrition intervention trials.

Avoiding bias in the conduct and reporting of cost-effectiveness research sponsored by pharmaceutical companies.

Because of the growing focus on containing health care costs, pharmaceutical companies are trying to demonstrate the cost effectiveness of their products relative to alternatives. In Europe and Aus...

Economic analysis of health care technology: A report on principles

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

Pneumatic Dilatation or Esophagomyotomy Treatment for Idiopathic Achalasia: Clinical Outcomes and Cost Analysis

The choice between pneumatic dilatation and surgical esophagomyotomy as the initial treatment for achalasia is controversial. The aims of this study were to determine the long term clinical outcome and costs of treating achalasia initially with pneumatic dilatation as compared to esophagomyotomy. Of 123 patients undergoing an initial pneumatic dilatation for achalasia at our institution from 1976 to 1986, 71 (58%) received no further treatment for achalasia during a mean follow up of 4.7±2.8 years. Only 15 of these 123 patients (12%) eventually underwent surgical esophagomyotomy, (two for perforation during pneumatic dilatation, 13 for persistent or recurrent symptoms). The degree of dysphagia at follow up was improved to a similar degree in patients treated with an initial pneumatic dilatation as compared to patients treated with an initial esophagomyotomy. Patients with age≥45, years at time of initial pneumatic dilatation had fewer subsequent treatments for persistent or recurrent symptoms and had less dysphagia on follow up as compared to patients <45 years. Subsequent pneumatic dilatations to treat persistent or recurrent symptoms were less beneficial than an initial pneumatic dilation. The cost of esophagomyotomy was 5 times greater than the cost of pneumatic dilatation. When costs were analyzed to include subsequent treatments of symptomatic patients, the total expectant costs of treating with an initial esophagomyotomy remained 2.4 times greater than treating with an initial pneumatic dilatation. This study suggests that an initial pneumatic dilatation will be the only treatment needed for the majority of patients with achalasia. A treatment regimen starting with penumatic dilatation has less overall costs than starting with esophagomyotomy. For each subsequent pneumatic dilatation, however, the clinical benefit leans toward, surgery.

An educational program to modify laboratory use by house staff.

An earlier study showed that the prothrombin time determination is overutilized as a routine admission laboratory test. In the present study the investigator evaluated the effectiveness of an educational program in decreasing utilization of the prothrombin time determination by house staff physicians at a teaching hospital. Six months after the educational program, use of the prothrombin time determination as a routine admission test had decreased significantly from 87 percent to 55 percent. Eighteen months after the educational program, the use of this test by the study group had returned to initial levels. These results emphasize the need to measure the long-term outcome of educational programs aimed at modifying the clinical behavior of physicians and to institute follow-up programs to ensure that an educational effort will have a lasting effect.

Cost Effectiveness of Low-Dose Zidovudine Therapy for Asymptomatic Patients with Human Immunodeficiency Virus (HIV) Infection

We did a cost-effectiveness analysis of zidovudine therapy for asymptomatic patients with human immunodeficiency virus (HIV) infection. The incremental direct medical costs of zidovudine therapy were determined, and data on the effects of therapy were derived from the report of the Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group Protocol 019. Zidovudine therapy has an annual incremental cost of

What is the Cost of Nephrotoxicity Associated with Aminoglycosides

2653 per person. The cost per year of life saved ranges between

The Internist as Gatekeeper: Preparing the General Internist for a New Role

6553 and

Use of Diagnostic Services by Physicians in Community Practice

70 526, depending on which epidemiologic model of potential long-term zidovudine effect is used (in sensitivity analyses, the cost per year of life saved ranges between