Objective: To evaluate the sensitivity and precision of various extended search methods in identifying randomized controlled trials (RCTs) for systematic reviews.

Method: Prospective analysis of extended search methods (specialized databases or trial registries, reference lists, hand-searching, personal communication, and Internet) used in two systematic reviews of RCTs. The gold standard was the total number of RCTs identified by major databases (MEDLINE, EMBASE, etc.) and extended search strategies combined. Sensitivity was the proportion of all known RCTs identified by any extended search method. Precision reflected the proportion of all items uncovered by any extended search method that actually were RCTs.

Results: The extended search identified 94 additional RCTs for the systematic reviews beyond those identified with the major databases. Specialized databases and trial registries had the highest sensitivity and precision for the lipid-lowering project (13.6% and 52.7%, respectively; p < .05) followed by scanning of reference lists (7.2% sensitivity and 41.9% precision; p < .05). Hand-searching was more effective than personal communication and Internet searching (1.7% sensitivity and 12.2% precision; p < .05). The acupuncture project had slightly different results, with the specialized databases and trial registries tied with the review of reference lists for highest sensitivity (14.2%). The precision followed the same trend as the lipid-lowering project (17.6% specialized databases; 8.3% reference lists; p < .05). A post-hoc analysis showed that 75 of the 94 RCTs were indexed in the major databases but missed by the major database search.

Conclusions: Extended searching identified additional RCTs for the systematic reviews beyond those found in major databases. Specialized databases and trial registries were most effective. An important number of RCTs were missed by the major database search. Timing and accuracy of indexing may explain this finding. The definitive measure, whether there is an association between the method used to uncover RCTs, the quality of the items uncovered and their impact on systematic review results, is yet to be determined.

Objectives: To assess the annual direct and indirect costs of skin diseases caused by ultraviolet radiation.

Methods: A model for cost-of-illness, including costs for hospital care, primary care, pharmaceuticals, mortality, and morbidity, for approximately 1.8 million inhabitants in Stockholm.

Results: The total annual discounted cost-of-illness in Stockholm was approximately 162 million SEK (MSEK; approximate 2002 exchange rate: 1 U.S. dollar=10 SEK). The indirect costs were predominant and constituted approximately 91 MSEK (56% of total costs), mainly due to an estimated cost of mortality for cutaneous malignant melanoma of 84 MSEK. The direct costs of these diseases, approximately 71 MSEK, were predominated by hospital ambulatory care costs of approximately 33 MSEK. The direct costs constituted approximately 0.4% of the overall health-care costs for hospital care and primary health care in the area.

Conclusions: Skin diseases caused by ultraviolet radiation result in moderate economic losses in the community. Therefore, it may not be easy to make successful prevention of these diseases economically beneficial.

Objective: Health technology assessment (HTA) can be used both to promote access to safe, efficacious, and cost-effective technologies, and to discourage access to undesirable ones. Yet HTA has had less success than might be hoped in pursuing the latter goal. This paper examines the scope of HTA as currently practiced to contribute to regulation of access to undesirable technologies.

Design: The study design is a critical analysis of HTA's methods, based on an exposition of the normative issues involved in restriction of access to health technologies. The paper classifies technologies that might figure as potential candidates for exclusion into five categories and underscores the key social and ethical dilemmas associated with limiting their use.

Results: For four of the five categories of technology outlined, limitation of access necessarily involves denial of benefit. Limitation of access thus inevitably raises difficult normative issues. We show that these are ill-addressed by the range of “evidence” typically considered in technology assessments, which centers predominantly on clinical and technical features such as efficacy, safety, and costs.

Conclusions: If HTA is to enhance our ability to make reasonable decisions concerning the use and diffusion of health technologies, it must better integrate consideration of the social, political, and ethical dimensions of health technologies into the process of technology assessment. We suggest a framework within which to approach this goal.

Objectives: This study estimates the cost-effectiveness (CE) of the adjunctive use of hyperbaric oxygen (HBO2) therapy in the treatment of diabetic ulcers based on the payer's and societal perspectives.

Methods: The study population was a hypothetical cohort of 1,000 patients sixty years of age with severe diabetic foot ulcers. A decision tree model was constructed to estimate the CE of HBO2 therapy in the treatment of diabetic ulcers at years 1, 5, and 12. Scenario and one-way sensitivity analyses were also undertaken to identify parameters that may significantly influence the estimates.

Results: The CE model estimated that the incremental cost per additional quality-adjusted life year (QALY) gained at years 1, 5, and 12, was $27,310, $5,166, and $2,255, respectively.

Conclusions: The study results indicate that HBO2 therapy in the treatment of diabetic ulcers is cost-effective, particularly based on a long-term perspective. However, the results are limited by the clinical studies that provide the basis of the CE estimation.

Objectives: This preliminary study had two objectives: a) charting the considerations relevant to decisions about acquisition of new medical technology at the hospital level; and b) creating a basis for the development of a research tool that will examine the function of the Israeli health system in assessment of new medical technologies.

Methods: A comprehensive literature review and in-depth interviews with decision makers at different levels allowed formulation of criteria considered by decision makers when they decide to purchase and use (or disallow the use) of new medical technology. The resulting questionnaire was sent to medical center directors, along with a letter explaining the goals of the study. The questionnaire included 31 possible considerations for decision making concerning the acquisition of new medical technology by medical centers. The interviewees were asked to indicate the relevance of each consideration in the decision-making process.

Results: The most relevant criteria for the adoption of new technologies related to the need for a large capital investment, clinical efficacy of the technology as well as its influence on side effects and complication rates, and a formal approval by the Ministry of Health. Most interviewees stated that pressures exerted by the industry, by patients, or by senior physicians in the hospital are less relevant to decision making. Very small and usually not statistically significant differences in the ranking of hospital directors were found according to the hospitals' ownership, size, or location.

Conclusions: The present study is a basis for a future study that will map and describe the function of hospital decision makers within the area of new technology assessment and the decision-making process in the adoption of new healthcare technologies.

Objectives: To identify core issues that contribute to the gap between pre-marketing clinical research and practice as seen from the perspective of medical practice, as well as possible changes and potential barriers for closing this gap.

Methods: Interviews with 47 physicians and pharmacists who were liaised to drug regulation through their role in the pre- and post-marketing shaping of new cardiovascular drugs. Data were analyzed using methods of grounded theory and analytical evaluations.

Results: Six core issues were identified that referred to the standards in drug regulation, the organization of the regulatory system, and conflicting interests. Pre-marketing trials should focus more on populations and research questions relevant to medical practice. In particular, variability in drug responses between subgroups of patients and demonstration of effectiveness should become major principles in drug regulation. An interactive post-marketing process in which public interests are represented was considered necessary to further guide research and development according to the needs in daily practice. Strategies for change could be applied within the present system of drug regulation, or affect its basic principles. Regulatory authorities were primarily identified to initiate changes, but many other parties should be involved. Barriers for change were identified regarding differences in interests between parties, organizational matters, and with respect to broader healthcare policies.

Conclusions: Based on the respondents' opinions, there is a need to focus regulatory standards more on the needs in medical practice. Therefore, regulatory authorities should further develop their influence in the pre- and post-marketing drug development process, together with other parties involved, in order to bridge the gap between clinical research and medical practice.

Objective: The objective of this paper is to determine prevalence and characteristics of acute care for elders (ACE) units and hospital characteristics associated with the presence of an ACE unit.

Methods: Data on characteristics and prevalence of ACE units were obtained by surveying all established geriatric medical divisions across U.S. medical schools. Data on hospital characteristics such as number of beds, revenue, number of Medicare inpatients, and average length of stay were obtained from the 1999 American Hospital Association Annual Survey Data. Descriptive statistics and t test were used to analyze the characteristics of ACE units. Stepwise logistic regression was used to analyze the hospital characteristics associated with the presence of an ACE unit.

Results: The survey identified 16 geriatric divisions and programs with ACE units. Hospitals that have ACE units differ significantly with respect to number of beds and total revenue, compared with institutions that do not have an ACE unit. Stepwise logistic regression indicated total hospital revenue was the only factor significantly associated with the presence of an ACE unit.

Conclusions: ACE units are attractive interdisciplinary models to address the particular needs of the elderly during their hospital stay. Low presence of ACE units warrants further research as to reasons more hospitals have not included them, given the available evidence for clinical, functional, and economic benefits.

This article examines European Union (EU) and member state regulation of medical devices, particularly: a) the similarities and differences between medical devices and prescription drugs, including the respective industries, market authorization pathways, and boundary issues between the two sectors; b) the political background, current nature, and future prospects for EU medical device regulation; and c) regulatory responsibilities of the member states. Included are definitions of medical devices and in vitro diagnostics, and a brief history of their treatment by European law. The erosion of boundaries between exclusive and shared responsibilities of the EU and member states will be addressed, especially as it affects market approval of medical devices, clinical investigations, labeling and instructions for use, price setting and reimbursement, and evidence-based medicine and healthcare technology assessment. Finally, the article discusses medical device reporting and surveillance systems, which may be the weakest link in the EU integrative process. If patient safety is as important to the EU regulatory scheme as free movement and competitiveness, then both Brussels and member states will require additional resources, as well as measures to overcome obstacles to implementation, evaluation, and accountability.

Objective: The objective of this study was to elicit the factors related to worldwide variation in biomedical research productivity.

Methods: Biomedical research articles published in 1990–2000 were accessed through the MEDLINE database. The number of articles (journal articles) originating from each of the countries of the world was elicited and normalized to publication per million population per year.

Results: In a multiple regression model, where publication per million population was the dependent variable and 10 social and economic indicators were independent variables, gross national product (GNP) per capita and research and development (R&D) expenditure emerged as significant factors. In separate simple linear regression analyses, all but two independent variables were found significant.

Conclusions: To increase biomedical research output, GNP per capita and R&D expenditure are the most important factors to address.

Objectives: Obstructive sleep apnea is a common disorder with significant morbidity and effects on quality of life. Management can include a range of mechanical, behavioral, and surgical approaches. This paper aims to devise a model of management options to assist in initial cost-effectiveness investigations.

Methods: In the absence of practice pattern data and widely accepted guidelines, we reviewed published literature and devised a model of treatment options to facilitate initial studies of outcomes, costs, and cost-effectiveness.

Results: Obstructive sleep apnea is rarely addressed by conservative behavioral-based strategies because these options, while inexpensive, have only limited effectiveness. Effective treatment most often relies on nasal continuous positive airway pressure, but poor tolerance or compliance sometimes leads to treatment with oral appliances or surgery. Patients treated by one modality may try another if the initial strategy is ineffective. Laboratory evidence that sleep apnea is effectively treated, and long-term follow-up, are necessary regardless of the treatment modality chosen.

Conclusions: Each patient's treatment plan must be individually tailored, but the management model proposed here reflects available evidence-based literature and the authors' impression of current practice patterns. This model should be useful for initial cost-effectiveness investigations.