How to optimize the prescription of laboratory tests? Success and failures in an academic hospital.

In the context of the flat-rate reimbursements in healthcare, we reviewed physicians' behavior towards laboratory test ordering. We demonstrated how it could be improved when a specific stage of the patient management is considered. We took a multi-step approach to analyze the laboratory test orders in the context of planned laparoscopic cholecystectomy in a general teaching hospital. A reference order set was defined through a collaborative analysis between clinicians and laboratory physicians. The clinical and financial impacts were then evaluated over a period of 24 months. After the introduction of the reference order set, the number of laboratory tests per order decreased significantly for patients with cholecystitis of low severity. Above the monitoring of repeated orderings during a single stay, the major impacts were achieved by a drastic reduction of inappropriate orders, particularly in the field of bacteriology. The main effects of the order set were maintained throughout a follow-up period of 24 months. Our study demonstrated that, when considering laboratory test ordering optimization, reference order sets could achieve high levels of efficiency. To ensure high compliance to reference order sets, extensive collaboration between clinicians and laboratory physician is mandatory even if very sophisticated information systems are available.

Shadows amid sunshine: regulating financial conflicts in medical research.

Under brand new rules implementing the Physician Payments Sunshine Act (Sunshine Act), a wide range of financial relationships, including many research-related payments, between industry, physicians, and teaching hospitals will be publicly disclosed through comprehensive, standardized payment reporting. The Sunshine Act represents the latest in a series of regulatory attempts to address financial conflicts of interest that may bias research conduct and threaten subject safety. This article summarizes the major aspects of the Sunshine Act affecting medical research, how it interacts with existing laws and policies, and identifies important unresolved issues and implementation challenges that still lie ahead with the rollout of the legislation underway. The Sunshine Act primarily depends on disclosure as a regulatory tool. As such, its long-term impact remains open to question. Disclosure in this context may have limited utility given, among other reasons, uncertainty about who the intended recipients are and their ability to use the information effectively. Apart from the insufficiency of transparency, this article further explores how proportionality, fairness, and accountability considerations make optimal regulation of financial conflicts in medical research quite challenging.

When money and principles clash: the ethics of a surgical teaching service.

During your preoperative visit, a very wealthy patient, Gill Bates, who donated a wing to the large teaching hospital in which you practice, has an unusual request: He does not want any residents involved with his care. He is scheduled for an open infrarenal aneurysmectomy. He explains that his decision is based on the experience of a relative many years ago who was harmed by a resident's error. You clarify that you will do the procedure but that this is a teaching hospital and residents provide excellent assistance and postoperative care. He is resolute in demanding that only grown-up surgeons provide his care.

The physician payments sunshine act: what the average radiologist and manager need to know.

The Physician Payments Sunshine Act (PPSA) was enacted in 2010 and requires applicable manufacturers of medical devices, drugs, biological material, or medical supplies to report payments or transfers of value that are provided to physicians or teaching hospitals. PPSA has value in creating greater transparency in the financial relationships between industry, physicians, and teaching hospitals, and in potentially reducing problematic conflicts of interest. PPSA requires that this data be published, in searchable form, on a public website. CMS has delayed the reporting under PPSA until after January 1, 2013, and has yet to issue its final rules for PPSA; however, Physician Payments data already exist in a publically searchable database. It is important to realize that names of individuals may appear in the PPSA public database, even if those individuals did not actually receive a transfer of value. As with all broad-stroke legislation, consequences not anticipated or not considered sufficiently important for our government leaders may well present a problem for individuals. It behooves all physicians and healthcare managers to carefully follow the CMS PPSA regulations. In advance of meeting or interacting with any PPSA-applicable manufacturer, obtain a clear and mutual understanding regarding what reportable value, if any, will be prepared for and provided by the applicable manufacturer. In this, as in all situations in which government regulations are at play, "knowledge is strength."

Can academic departments maintain industry relationships while promoting physician professionalism?

The authors describe the development of a comprehensive policy for relationships of full-time and volunteer faculty and residents with industry. The underlying philosophy was that an academic approach to relations with industry that emphasizes objective outcomes and internal change will be more effective than rote restrictions on behavior that assume that physicians cannot learn new behaviors and that are impossible to enforce. The policy, developed through much discussion and debate with stakeholders, involves elimination of industry-supplied meals, gifts, and favors; integration of industry-sponsored and academic research; education of faculty and residents about the ways in which industry marketing influences clinical decision making; and comprehensive disclosure by faculty, including to patients, of financial interests in industry. At occasional points in the psychopharmacology curriculum and at a departmental "pharma symposium," industry representatives or industry-sponsored guest speakers are allowed to present peer-reviewed articles followed by comments by a faculty member with relevant expertise about aspects of the presentation that are accurate or misleading and by a general discussion of research and clinical implications of the research and the manner in which it is presented. Adherence to new protocols has been high because faculty and residents participated in developing them and are involved in their implementation. Acceptance by industry representatives has been variable. Experience with this approach suggests that it is possible to develop a collaborative relationship with industry that maintains appropriate boundaries between industry and academia.

The effect of industry support on participants' perceptions of bias in continuing medical education.

PURPOSE: To obtain prospective evidence of whether industry support of continuing medical education (CME) affects perceptions of commercial bias in CME activities. METHOD: The authors analyzed information from the CME activity database (346 CME activities of numerous types; 95,429 participants in 2007) of a large, multispecialty academic medical center to determine whether a relationship existed among the degree of perceived bias, the type of CME activity, and the presence or absence of commercial support. RESULTS: Participants per activity ranged from 1 to 3,080 (median: 276). When asked the yes/no question, "Overall, was this activity satisfactorily free from commercial bias?" 97.3% to 99.2% (mean: 98.4%) of participants answered "yes." In responding on a four-point scale to the request, "Please rate the degree to which this activity met the Accreditation Council for Continuing Medical Education requirement that CME activities must be free of commercial bias for or against a specific product," 95.8% to 99.3% (mean: 97.2%) of participants answered "excellent" or "good." When analyzed by type of funding relative to commercial support--none (149), single source (79), or multiple source (118)--activities were deemed to be free of commercial bias by 98% (95% CI: 97.3, 98.8), 98.5% (97.5, 99.5), and 98.3% (97.4, 99.1) of participants, respectively. None of the comparisons showed statistically significant differences. CONCLUSIONS: This large, prospective analysis found no evidence that commercial support results in perceived bias in CME activities. Bias level seem quite low for all types of CME activities and is not significantly higher when commercial support is present.

Perspective: Conflict of interest and professional organizations: considerations and recommendations.

There are differences in conflicts of interest (COIs) in professional organizations compared with academic medical centers. The authors discuss nine major questions pertaining to industry relationships of professional organizations: (1) What makes COI management different in professional membership organizations? (2) What COI challenges are specific to professional organizations? (3) What are potential impacts of perceived or real COIs involving professional organizations and the management of COIs? (4) Is regulation necessary, or should professional organizations proactively resolve COI issues independently? (5) Are guidelines portable from academic medical centers to professional organizations? (6) What approaches may be considered for managing COIs of the organization's leaders? (7) What approaches are reasonable for managing COI issues at professional meetings? (8) What approaches are important for integrity of educational programs, publications, and products? and (9) What approaches are reasonable for managing and enforcing COI guidelines on an ongoing basis? Responses to these questions focus on four principles: First, a code of ethics governing general behavior of members and safeguarding the interest of patients must be in place; second, the monitoring and management of COI for leadership, including, in some cases, recusal from certain activities; third, the pooling and consistent, transparent management of unrestricted grants from corporate sponsors; and, fourth, the management of industry marketing efforts at membership meetings to ensure their appropriateness. The perspectives offered are intended to encourage individuals and learned bodies to further study and provide commentary and recommendations on managing COIs of a professional organization.

Impact of ethics and economics on end-of-life decisions in an Indian neonatal unit.

OBJECTIVE: The aim of this article was to describe how providers in an Indian NICU reach life-or-death treatment decisions. METHODS: Qualitative in-depth interviews, field observations, and document analysis were conducted at an Indian nonprofit private tertiary institution that provided advanced neonatal care under conditions of resource scarcity. RESULTS: Compared with American and European units with similar technical capabilities, the unit studied maintained a much higher threshold for treatment initiation and continuation (range: 28-32 completed gestational weeks). We observed that complex, interrelated socioeconomic reasons influenced specific treatment decisions. Providers desired to protect families and avoid a broad range of perceived harms: they were reluctant to risk outcomes with chronic disability; they openly factored scarcity of institutional resources; they were sensitive to local, culturally entrenched intrafamilial dynamics; they placed higher regard for "precious" infants; and they felt relatively powerless to prevent gender discrimination. Formal or regulatory guidelines were either lacking or not controlling. CONCLUSIONS: In a tertiary-level academic Indian NICU, multiple factors external to predicted clinical survival of a preterm newborn influence treatment decisions. Providers adjust their decisions about withdrawing or withholding treatment on the basis of pragmatic considerations. Numerous issues related to resource scarcity are relevant, and providers prioritize outcomes that affect stakeholders other than the newborn. These findings may have implications for initiatives that seek to improve global neonatal health.

Priority setting in developing countries health care institutions: the case of a Ugandan hospital.

BACKGROUND: Because the demand for health services outstrips the available resources, priority setting is one of the most difficult issues faced by health policy makers, particularly those in developing countries. However, there is lack of literature that describes and evaluates priority setting in these contexts. The objective of this paper is to describe priority setting in a teaching hospital in Uganda and evaluate the description against an ethical framework for fair priority setting processes--Accountability for Reasonableness. METHODS: A case study in a 1,500 bed national referral hospital receiving 1,320 out patients per day and an average budget of 13.5 million US dollars per year. We reviewed documents and carried out 70 in-depth interviews (14 health planners, 40 doctors, and 16 nurses working at the hospital). Interviews were recorded and transcribed. Data analysis employed the modified thematic approach to describe priority setting, and the description was evaluated using the four conditions of Accountability for Reasonableness: relevance, publicity, revisions and enforcement. RESULTS: Senior managers, guided by the hospital strategic plan make the hospital budget allocation decisions. Frontline practitioners expressed lack of knowledge of the process. RELEVANCE: Priority is given according to a cluster of factors including need, emergencies and patient volume. However, surgical departments and departments whose leaders "make a lot of noise" are also prioritized. Publicity: Decisions, but not reasons, are publicized through general meetings and circulars, but this information does not always reach the frontline practitioners. Publicity to the general public was through ad hoc radio programs and to patients who directly ask. Revisions: There were no formal mechanisms for challenging the reasoning. Enforcement: There were no mechanisms to ensure adherence to the four conditions of a fair process. CONCLUSION: Priority setting decisions at this hospital do not satisfy the conditions of fairness. To improve, the hospital should: (i) engage frontline practitioners, (ii) publicize the reasons for decisions both within the hospital and to the general public, and (iii) develop formal mechanisms for challenging the reasoning. In addition, capacity strengthening is required for senior managers who must accept responsibility for ensuring that the above three conditions are met.

The pipeline and the porcupine: alternate metaphors of the physician-industry relationship.

Industry and medicine share a complicated relationship that engenders a considerable degree of controversy. Although they share a relationship, industry and medicine have different perspectives toward their involvement with each other. Industry conceives of medicine as one aspect of the "drug pipeline", a larger set of relationships that is necessary for producing and marketing products. In contrast, select physicians refer to medicine's relationship with industry as "dancing with the porcupine", an inherently difficult and dangerous activity. This paper compares the "pipeline" and "porcupine" metaphors, and draws upon ethnographic data from fieldwork conducted among clinical neuroscientists at a Canadian medical school to further elucidate the perspectives of physicians toward industry and the nature of the physician-industry relationship. The paper argues that the physician-industry relationship is akin to a type of gift-exchange known as a total prestation, and that this form of total prestation is part of a strategy of capital reconversion.

Better governance in academic health sciences centres: moving beyond the Olivieri/Apotex Affair in Toronto.

The Toronto experience suggests that there may be several general lessons for academic health sciences complexes to learn from the Olivieri/Apotex affair (OAA) regarding the ethics, independence, and integrity of clinical research sponsored by for profit enterprises. From a local perspective, the OAA occurred when there already was a focus on the complex and changing relationships among the University of Toronto, its medical school, the fully affiliated teaching hospitals, and off campus faculty because of intertwined interests and responsibilities. The OAA became a catalyst that accelerated various systemic reforms, particularly concerning academic/industry relations. In this article, the evolving governance framework for the Toronto academic health sciences complex is reviewed and these policy and process reforms discussed. These reforms have created collaborative activity among research ethics boards and contract research offices of the partner institutions, and allowed the joint university/hospital ethics centre to play a role in governance and policy, while respecting the missions and mandates of the involved institutions. Although few of the policies are dramatically innovative, what is arguably novel is the elaboration of an overarching governance framework that aims to move ethics to a central focus in the academic complex. Time alone will tell how sustainable and effective these changes are.

Luxury primary care, academic medical centers, and the erosion of science and professional ethics.

Medical schools and teaching hospitals have been hit particularly hard by the financial crisis affecting health care in the United States. To compete financially, many academic medical centers have recruited wealthy foreign patients and established luxury primary care clinics. At these clinics, patients are offered tests supported by little evidence of their clinical and/or cost effectiveness, which erodes the scientific underpinnings of medical practice. Given widespread disparities in health, wealth, and access to care, as well as growing cynicism and dissatisfaction with medicine among trainees, the promotion by these institutions of an overt, two-tiered system of care, which exacerbates inequities and injustice, erodes professional ethics. Academic medical centers should divert their intellectual and financial resources away from luxury primary care and toward more equitable and just programs designed to promote individual, community, and global health. The public and its legislators should, in turn, provide adequate funds to enable this. Ways for academic medicine to facilitate this largesse are discussed.