This article discusses and identifies the weaknesses of approaches to assessing computerized decision support (CDS) systems, examining the design of two CDS systems, “DXplain” and the “Problem Knowledge Coupler” (PKC). It suggests that the inadequate assessment of CDS technologies will promote a conservative orientation toward their diffusion.

Carotid endarterectomy and EC/IC bypass grafting have been widely adopted for patients considered at risk from stroke, without good evidence of efficacy. Unjustified claims for surgery usually derive from overestimating the dangers of the disease without surgery, while perioperative risks are underestimated. Inadequate follow-up and choosing irrelevant outcome measures often add to the confusion. All these factors apply to surgery for stroke. A trial of EC/lC bypass in 1,377 patients from three continents took 8 years to complete and showed no benefit in patients randomized to surgery. Reluctance to accept this result led to detailed critiques of this trial in several journals, largely based on the discovery that many patients had been operated on in some centers without having been randomized. In reply, the investigators showed that these cases did not affect the “resounding negativity of the results.” Lack of good data about the prognosis of patients with TlAs or minor strokes was the fundamental reason for so much misplaced surgical effort. This applies equally to carotid endarterectomy, for which large trials are currently being completed. Had there been a reliable data base of patients at risk of stroke, prospectively collected and followed, the efficacy of these two operations could have been determined much sooner, and inappropriate diffusion might have been prevented.

Objectives: This study reviewed the European guidelines of the Committee for Proprietary Medicinal Products (CPMP) on how health-related quality of life (HRQOL) research should be conducted in clinical trials. Published product-level information was also reviewed to investigate the actual role of HRQOL data in the European regulatory process.

Methods: All disease-specific notes for guidance and concept papers on clinical investigations, development and evaluation of human medicinal products, as well as the European Public Assessment Reports (EPAR) of all approved drugs published on the European Agency for the Evaluation of Medicinal Products (EMEA) Web site were evaluated for their HRQOL recommendations.

Results: Only twenty of the fifty CPMP guidance notes for clinical investigation of pharmaceutical products in specific disease areas included a reference to HRQOL. Most of the recommendations were generic and vague, and the terminology used was inconsistent across documents. The EPAR provided nonspecific information about HRQOL and contradictory conclusions on the effect of a drug on HRQOL sometimes occurred in different documents. The criteria used by the CPMP to assess the HRQOL data could not be identified due to an ad hoc approach to the inclusion of data in the EPAR.

Conclusions: A more systematic approach is needed on the way health outcomes data are considered, reviewed, and interpreted by the regulatory authorities. For this to be achieved, CPMP should develop general guidelines on the importance of HRQOL and how research should be conducted if data are to be included in the registration process.

Objectives: The aim of this study was to examine (i) the consistency of reporting research findings presented in conference abstracts and presentations and subsequent full publications, (ii) the ability to judge methodological quality of trials from conference abstracts and presentations, and (iii) the effect of inclusion or exclusion of data from these sources on the pooled effect estimates in a meta-analysis.

Methods: This report is a case study of a selected health technology assessment review (TAR) of a rapidly evolving technology that had identified and included a meta-analysis of trial data from conference abstracts and presentations.

Results: The overall quality of reporting in abstracts and presentations was poor, especially in abstracts. There was incomplete or inconsistent reporting of data in the abstract/presentations. Most often inconsistencies were between conference slide presentations and data reported in published full-text articles. Sensitivity analyses indicated that using data only from published papers would not have altered the direction of any of the results when compared with those using published and abstract data. However, the statistical significance of three of ten results would have changed. If conference abstracts and presentations were excluded from the early analysis, the direction of effect and statistical significance would have changed in one result. The overall conclusions of the original analysis would not have been altered.

Conclusions: There are inconsistencies in data presented as conference abstracts/presentations and those reported in subsequent published reports. These inconsistencies could impact the final assessment results. Data discrepancies identified across sources included in TARs should be highlighted and their impact assessed and discussed. Sensitivity analyses should be carried out with and without abstract/presentation data included in the analysis. Incomplete reporting in conference abstracts and presentations limits the ability of reviewers to assess confidently the methodological quality of trials.

Objectives: The objective of this study is to assess the cost-effectiveness of enhanced external counterpulsation (EECP) compared with no treatment as additional therapy to usual care for the treatment of chronic stable angina from the perspective of the UK National Health Service.

Methods: The study design was a systematic review of published evidence, use of expert clinical opinion, and decision analytic cost-effectiveness model. The systematic review was conducted and statistical methods used to synthesize the effectiveness evidence from randomized control trials. Formal methods were used to elicit opinion from clinical experts where no evidence was available. These provide informed “priors” on key model parameters. A decision analytic model was developed to assess the costs and health consequences associated with the primary outcome of the trials over a lifetime time horizon. The main outcome measures were costs from a health service perspective and outcomes measured as quality-adjusted life-years (QALYs).

Results: The incremental cost-effectiveness ratio of EECP was £18,643 for each additional QALY, with a probability of being cost-effective of 0.44 and 0.70 at cost-effectiveness thresholds of £20,000 and £30,000 per QALY gained, respectively. Results were sensitive to the duration of health-related quality of life (HRQoL) benefits from treatment.

Conclusions: The long-term maintenance of HRQoL benefits of EECP is central to the estimate of cost-effectiveness. The results from a single randomized control trial do not provide firm evidence of the clinical or cost-effectiveness of EECP in stable angina. Long-term follow-up trials assessing quality of life from EECP are required.

The effect of various levels of both diastolic and systolic blood pressure at various times during pregnancy on the rates of intrauterine growth retardation (IUGR) and preterm delivery (PTD) were determined. Low systolic and diastolic pressures were associated with both IUGR and PTD, as were high pressures. Low pressures tended to be associated with spontaneous preterm deliveries, whereas high pressures were associated with more indicated preterm deliveries.

The kidneys are the body's main organs of excretion. They are, however, subject to serious, progressive, and irreversible deterioration, and as a result, to a decreased ability to extract poisonous wastes and excess fluids from the blood. Almost invariably, this condition proceeds to the point where it is termed end-stage renal failure (ESRF). As the name suggests, ESRF is fatal.

The Surveillance, Epidemiology, and End Results (SEER) cancer registry contributed to technology assessment by providing population-based samples for detailed case-control studies, by serving as the control group in comparisons with various experimental groups, by allowing an assessment of selection bias in clinical trials, and by facilitating evaluations of classification and coding systems.

This article reviews milestones in the technological development of mammography since 1970. Mammography is particularly underutilized as a screening procedure for breast cancer and the reasons for its continued inappropriate and under use are explored. Although there are some known barriers to increased utilization among the female adult population, the majority of barriers reside within the domain of referring physicians. Remedies to address the low referral rates for screening mammography are outlined for federal agencies, radiology groups, mammography equipment companies, medical schools, and philanthropic groups. Until the developers of technological procedures such as mammography appreciate that the application of a technology and its appropriate utilization by professionals and the public are important to consider when the technology is developed, utilization rates may not do justice to the technology's potential.

“Technology assessment” is still a relatively new concept, and its application to the field of medicine is even more recent. This results not only from an important effort to develop the scientific basis for health care, but also as a consequence of the growing concern about medical care costs (19). The term refers basically to the evaluation of the costs and effects of a medical technology. The most important methodological approach in this area has been, and still is, the traditional clinical trial, defined by Bradford Hill as “A carefully and ethically designed experiment with the aim of answering some precisely framed question,” including random allocation of the subjects in the trial (4).

There are three phenomena unique to medical research. First, unlike most historic events and their time- and culture-specific relationships, determination of the efficacy of medical care cuts across national and cultural boundaries in the Western world. Second, most of the study methods currently used to determine whether a specific medical intervention works have a long tradition, usually stretching back over centuries. Third, it is difficult to predict whether, and how readily, research results will be incorporated into medical practice.

In Connecticut there was considerable variation by town of residence in the proportions of patients diagnosed in 1985–1988 receiving transurethral resection only, prostatectomy, and irradiation (without surgery) for local-stage prostate cancer and receiving endocrine surgery for late-stage prostate cancer. Age and socioeconomic variables were examined as predictors of this variation.

Recent health reports, including the 1993 World Development Report, have emphasized the importance of integrating the needs of the population into technology assessment. This paper reviews previous approaches to technology assessment and identifies the missing link between technology and its impact on the physical, emotional, and social needs of the community, namely needs-based technology assessment. It stresses the key role played by issues of equity and community values in making technology decisions. A number of models for needs-based technology assessment are described.

When new medical technologies enter the market, there is often uncertainty about the added value for the patient and for society, hampering well-considered decision making about reimbursement. Current Belgian legislation already offered opportunities for the managed uptake of possibly innovative emerging implants. However, it has also some shortcomings such as the lack of a clear research design, rendering the scientific evaluation of clinical effectiveness, cost-effectiveness, and patient or organizational issues more difficult. Against this background, a new procedure was elaborated by the Belgian health insurance institute and the Belgian Health Care Knowledge Centre.

Objectives: To compare the cost-effectiveness of endoscopy and empirical proton pump inhibition (PPI) therapy for management of dyspepsia in primary care.

Methods: A randomized controlled trial, including prospective collection of economic resource data, was conducted in general practice from June 2000 to August 2002, Aarhus County, Denmark. We randomly assigned 368 dyspeptic patients from thirty-two general practices to treatment with omeprazol 40 mg for 2 weeks (n=184) or endoscopy (n=184). The study adopted a societal perspective, and the year of costing was 2006. Outcome measures: days free of dyspeptic symptoms and proportion of patients with dyspepsia after 1 year based on patients' and general practitioners' (GPs) assessment. Costs were estimated from patient and GP questionnaires and from medical records.

Results: The incremental cost-effectiveness (CE) ratio for 1 day free of dyspeptic symptoms using the endoscopy strategy was €/day 154 compared with the PPI strategy. The incremental CE ratio for one person free of dyspeptic symptoms after 1 year using the endoscopy strategy was €13,905 based on the patients' evaluation, and the incremental CE ratio for one person free of predominant symptoms after 1 year was €5,990 according to the GPs' evaluation. The PPI strategy was both cheaper and more effective than the endoscopy strategy when reflux was the predominant symptom.

Conclusions: A strategy using empirical antisecretory PPI therapy should be recommended if the alternative is an endoscopy strategy for managing dyspeptic patients in general practice, especially if reflux was the predominant symptom.

Objectives: To explore and test methods for the operation of a national Early Warning System (EWS) in Denmark and to support decision making by the Danish Centre for Evaluation and Health Technology Assessment on this issue.

Methods: On the basis of literature reviews, information from members of EuroScan, and supported by clinical experts and stakeholders, existing methods were adapted and new methods were developed as part of a feasibility study.

Results: Approximately 200 technologies in 30 specialties were identified on the basis of information by EuroScan. A new instrument was developed to distinguish between important and unimportant technologies (filtering). Clinical experts in six specialties applied the instrument to sixty-two technologies in their respective fields, of which nine (15%) were judged potentially important for the Danish health care system. For priority setting, adapting a Dutch instrument to the Danish context was discussed. In principle, the instrument was acceptable, but several changes were proposed, for example, relating to the decentralized structure of the Danish health care system. For early assessment, the format and methods applied by SBU and Canadian Coordinating Office for Health Technology Assessment (CCOHTA) were compared and applied to pharmaceuticals (glitazones in treatment of type 2 diabetes mellitus) and a procedure (embolization of uterine fibromas). Given the main target group of the Danish EWS, local decision makers, the CCOHTA format was preferred.

Conclusions: The findings of the study have laid the foundation for an EWS using appropriate methods adapted to local circumstances. On the basis of the findings, a decision was made to start an EWS.