When is medical industry backing lacking?

A sales representative from Megastint approached Dr A. Krasia with an offer to financially support future educational conferences and allow his institution to be a training center if he participates in a new study comparing an old product to a recently approved and more expensive one. Dr Krasia and his department currently use Megastint's products. The medical center's utilization committee must approve the addition of more expensive pharmaceuticals, devices, or equipment, and Dr Krasia is the chair. How should Dr Krasia respond to Megastint's offer of financial support and to become a training center?

The impact of productivity committees being established in different hospitals of the Isfahan University of Medical Sciences in 2008.

INTRODUCTION: One of the most important issues in today's health sector is productivity, and more attention should be paid to this topic by health managers and correspondingly by those in charge. It is believed that providing a suitable culture is necessary to improve productivity. We tried to provide this culture by establishing a Productivity Committee in different hospitals and academic medical centers of the Isfahan University of Medical Sciences (IUMS). The present study aimed to explore the managers' perspectives on the influences and roles of this productivity improvement committee. METHODOLOGY: This cross-sectional study was conducted in 2008. The study population included all managers of 30 hospitals and academic medical centers of the IUMS. Data were collected by questionnaire after having tested its validity and reliability and analyzed using SPSS software. RESULTS: From the perspective of the center's managers, establishing a productivity committee had a great deal of influence on improving the quality of the services provided. Influence on increasing income and customer satisfaction was ranked second, followed by the influence on decreasing costs. CONCLUSION: Alternatives such as conducting more training courses and workshops (about productivity) for managers and other decision makers, supervising the committees and their performance, establishing central productivity committees, issuing more guidelines and regulations are suggested to promote productivity in the health sector.

Searching for an efficient institutional review board review model: Interrelationship of trainee-investigators, funding, and initial approval.

In this study we sought to identify variables associated with institutional review board (IRB) decisions to develop an efficient "pre-IRB" review model. We explored several variables, including relationships among the identification of trainees as investigators, external sources of funding, and initial approval. The sample consisted of all new submissions reviewed by the 2 medical IRBs at the University of Miami (UM) during a 1-year period. Trainees included students, residents, and fellows. At least 1 trainee had to be identified for a proposal to be considered a trainee submission. The medical-science committees (MSCs) were similar with regard to the numbers of new submissions they reviewed during convened meetings (MSC-A 242, MSC-B 241) and the percentages of proposals that were initially approved (MSC-A 52.9%, MSC-B 53.1%). Approved submissions were defined as those initially approved or conditionally approved pending minor modifications. We noted a robust statistical difference between the percentages of trainee submissions initially approved (39.9%) and submissions that did not identify a trainee (59.4%) ( P <.0001). Of the proposals that were initially not approved (tabled [deferred] or rejected [not approved]), 28.9% of those including a trainee were rejected, compared with 11.0% without a trainee ( P <.001). Proposals in which the source of funding was identified were more likely to be approved (64.2%) than were those in which it was not (30.8%) ( P <.0001). Funding also seemed to influence the trainee and initial-approval interaction. Our results show that new submissions that identified trainee investigators were more likely to be deferred or not approved than those that did not. Nonapproved proposals that identified a trainee were 3.8 times more likely to be initially rejected than those that did not. A prereview model could target those submissions that list a trainee, lack funding, or both.

Reliability of clinical guideline development using mail-only versus in-person expert panels.

BACKGROUND: Clinical practice guidelines quickly become outdated. One reason they might not be updated as often as needed is the expense of collecting expert judgment regarding the evidence. The RAND-UCLA Appropriateness Method is one commonly used method for collecting expert opinion. We tested whether a less expensive, mail-only process could substitute for the standard in-person process normally used. METHODS: We performed a 4-way replication of the appropriateness panel process for coronary revascularization and hysterectomy, conducting 3 panels using the conventional in-person method and 1 panel entirely by mail. All indications were classified as inappropriate or not (to evaluate overuse), and coronary revascularization indications were classified as necessary or not (to evaluate underuse). Kappa statistics were calculated for the comparison in ratings from the 2 methods. RESULTS: Agreement beyond chance between the 2 panel methods ranged from moderate to substantial. The kappa statistic to detect overuse was 0.57 for coronary revascularization and 0.70 for hysterectomy. The kappa statistic to detect coronary revascularization underuse was 0.76. There were no cases in which coronary revascularization was considered inappropriate by 1 method, but necessary or appropriate by the other. Three of 636 (0.5%) hysterectomy cases were categorized as inappropriate by 1 method but appropriate by the other. CONCLUSIONS: The reproducibility of the overuse and underuse assessments from the mail-only compared with the conventional in-person conduct of expert panels in this application was similar to the underlying reproducibility of the process. This suggests a potential role for updating guidelines using an expert judgment process conducted entirely through the mail.

The high price of quality: a cost analysis of NCQA accreditation.

Payers and consumers across the United States are expressing discontent with their health plans. We are witnessing a market-based demand for accreditation as a guarantee of acceptable quality in health services. Increasingly, accreditation by the National Committee for Quality Assurance (NCQA) is being viewed as the "gold standard" for health plans. This article presents a model for allocating resources and a cost analysis of anticipated expenditures associated with achieving this objective.

Clinical trials at AHCs: the perspective of an academic clinical trials office.

Industry-sponsored clinical trials represent a substantial portion of the clinical investigator's portfolio of patient-oriented research. In academia's efforts to reclaim lost ground with respect to the performance of industry-sponsored clinical trials, many academic health centers have established clinical trials offices. An underlying assumption has been that with improved service on the part of universities will come new opportunities for clinical research. The experiences and vantage points of academic research offices have sometimes been ignored and an analysis of what new business might ensue has not been reported. The authors discuss the rationale for creating a centralized clinical trials office and the means of financing such an effort. They then describe the initial experiences (1997-2000) of a central clinical trials office (the Research Services Organization, or RSO) at the University of Minnesota Academic Health Center, analyze the value of such an office to the academic health center, and, based on their experiences with the RSO and elsewhere, consider how industry and academia might further enhance their collaborations. Of 354 clinical research proposals evaluated by the RSO, only 62% were found to be acceptable or highly likely to be acceptable to investigators and the institution. Reasons for not participating in specific clinical trials are discussed. Academic health centers contemplating developing clinical trials offices must be aware of the significant overhead cost associated with evaluating the appropriateness and feasibility of clinical trial proposals that may never be performed. Valuable lessons learned from working with sponsors and from working with investigators are also reviewed.

Prototyping: a key to managing product development.

Extended development cycles put companies at risk through loss of sales, margins, market share, and credibility as innovators. The author suggests constructing early-stage models to provide a dress rehearsal for new products and help companies develop products in less time.