Socioeconomic evaluation is an issue dealt with in the European Commission's research program TIDE. The principles of cost-utility analysis have been examined for usability in the assessment of rehabilitative technologies. A case study, the choice of a type of wheelchair, is described to demonstrate how estimates of utility can be derived and how cost-utility ratios can be used to guide decision making.

Objectives: The health technology assessment (HTA) Core Model® is a tool for defining and standardizing the elements of HTA analyses within several domains for producing structured reports. This study explored the parallels between the Core Model and a national HTA report. Experiences from various European HTA agencies were also investigated to determine the Core Model's adaptability to national reports.

Methods: A comparison between a national report on Genetic Counseling, produced by the Cellule d'expertise médicale Luxembourg, and the Core Model was performed to identify parallels in terms of relevant and comparable assessment elements (AEs). Semi-structured interviews with five representatives from European HTA agencies were performed to assess their user experiences with the Core Model.

Results: The comparative study revealed that 50 percent of the total number (n = 144) of AEs in the Core Model were relevant for the national report. Of these 144 AEs from the Core Model, 34 (24 percent) were covered in the national report. Some AEs were covered only partly. The interviewees emphasized flexibility in using the Core Model and stated that the most important aspects to be evaluated include characteristics of the disease and technology, clinical effectiveness, economic aspects, and safety.

Conclusions: In the present study, the national report covered an acceptable number of AEs of the Core Model. These results need to be interpreted with caution because only one comparison was performed. The Core Model can be used in a flexible manner, applying only those elements that are relevant from the perspective of the technology assessment and specific country context.

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.

The use of electroconvulsive therapy (ECT), controversial since its inception, offers an instructive case study on the challenge of addressing patients' perspectives in the evaluation of health care technology. Despite widespread professional acceptance of ECT, groups of former psychiatric patients have worked through the U.S. legal system to restrict and even ban ECT in the treatment of mental illness. This unusual lay participation in the regulation of health care illustrates how differing conceptions of evidence can affect the evaluation of technology. ECT provides a powerful example of the value of a more complex definition of the significant outcomes of treatment and the growing practice of outcomes assessment, especially as such research is used to shape health policy.

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.

The impact of consensus conferences on physicians was studied in 1985 for the first four conferences Sweden held in 1982–1985. For each conference a main target group was defined as hospital-based physicians in supervisory positions within relevant clinics. Data were collected through a postal survey of all 1,668 members of the four different target groups. The total response rate was 86%. Reported awareness of a particular consensus conference as well as professed knowledge of a single conference statement was high—roughly 90%—for all four conferences. The consensus statement evoked changes in clinical practice according to 7%–10% of the respondents and changes were proportionally higher for physicians in smaller hospitals. Most of the respondents (61%–83%) reported no change, claiming that the consensus statement reflected clinical practices established prior to the conference. The validity of self-reported data is discussed.

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.

Analysis of the septic work-up of 194 neonates at Women's College Hospital, Toronto, showed that the only antepartum condition predicting neonatal sepsis was the mother being on antibiotics. The only postnatal condition predicting sepsis was a maternal postpartum white blood cell count over 11,000. The average cost for tests for a septic work-up in these 194 mother-neonate pairs was $71.48 (Canadian dollars), and the average cost of tests to find a septic case was $1,066.77.

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.

Objectives: The Quebec Trauma Care Continuum (TCC) was initiated in 1991 with the objective of providing accessible, continuous, efficient, and high quality services for all injury cases in the province.

Methods: The TCC design relied on three key components: (i) the designation of a network of acute care and rehabilitation facilities with specific mandates and responsibilities; (ii) the elaboration of transfer protocols, standing agreements, and governing structures to ensure fluid and optimal patient flow; and (iii) the close monitoring of several indicators to facilitate the continuous evaluation and improvement of the network.

Results: Between 1992 and 2002, in-hospital mortality following major trauma decreased from 51.8 percent to 8.6 percent, followed by an additional 24 percent drop between 1999 and 2012. We also observed a 16 percent decrease in average LOS but no change in the incidence of complications or unplanned readmissions. These changes translate into 186 lives saved per year and cost savings, due to shorter LOS, of 6.3 million CD$ per year. The risk-adjusted incidence of in-hospital mortality following major injury between 2006 and 2012 (7 percent) was the lowest of all Canadian provinces.

Conclusions: Strategic transformation of a network's structure and processes, supported by continuous monitoring of validated quality indicators, can lead to significant and sustainable improvements in clinical outcomes. It is hoped that the Quebec trauma story will inspire other jurisdictions and other healthcare sectors.

The importance of patient and public involvement (PPI) is recognized by agencies involved in health technology assessment (HTA) and guideline development. However, a comprehensive overview of the underlying PPI principles, values, strategies, and frameworks is lacking. This scoping review aimed to summarize the available evidence on principles, values, frameworks, and strategies underpinning PPI carried out by agencies involved in HTA and guideline development. A total of twelve records were included, of which four referred to guidelines and eight to HTA. Overall, this review demonstrated a lack of consistency in the definition and application of the concepts of values and principles to PPI in the context of guideline development and HTA. There was significant overlap between values and principles, with some broad themes emerging, such as representation, transparency, relevance, equity, fairness, and reconciling different types of knowledge. Frameworks were typically based on the stages of guideline development or HTA, despite heterogeneity in how stages were labeled and described. Strategies were also mapped to the stages of guideline development and HTA and varied substantially depending on the context and setting. Both strategies and frameworks demonstrated patients and the public can be involved, albeit to a variable extent, throughout the stages of guideline development and HTA. However, frameworks often failed to explicitly link the values and principles with the HTA and guideline development stages through actionable PPI strategies. Further research is warranted to better understand the values, principles, and frameworks underpinning PPI in guideline development and HTA.

The dramatic decrease in dental caries among children in the United States has been well documented and widely reported. In the early 1970s, only approximately 28% of children were free of dental caries; by 1980, this figure increased to 36.6% (53). The most recent national survey results reported by the National Institute of Dental Research found approximately 50% of all school children to be free of caries (50).

Objectives: The research question was whether training level of admitting physicians and referrals from practitioners in primary health care (PHC) are risk factors for emergency readmission within 30 days to internal medicine.

Methods: This report is a prospective multicenter study carried out during 1 month in 1997 in seven departments of internal medicine in the County of Stockholm, Sweden. Two of the units were at university hospitals, three at county hospitals and two in district hospitals. The study area is metropolitan–suburban with 1,762,924 residents. Data were analyzed by multiple logistic regression.

Results: A total of 5,131 admissions, thereby 408 unplanned readmissions (8 percent) were registered (69.8 percent of 7,348 true inpatient episodes). The risk of emergency readmission increased with patient's age and independently 1.40 times (95 percent confidence interval [CI], 1.13–1.74) when residents decided on hospitalization. Congestive heart failure as primary or comorbid condition was the main reason for unplanned readmission. Referrals from PHC were associated with risk decrease (odds ratio, 0.53; 95 percent CI, 0.38–0.73).

Conclusion: The causes of unplanned hospital readmissions are mixed. Patient contact with primary health care appears to reduce the recurrence. In addition to the diagnoses of cardiac failure, training level of admitting physicians in emergency departments was an independent risk factor for early readmission. Our conclusion is that it is cost-effective to have all decisions on admission to hospital care confirmed by senior doctors. Inappropriate selection of patients to inpatient care contributes to poor patient outcomes and reduces cost-effectiveness and quality of care.

Multiple myeloma is a disorder of the bone marrow that is associated with bone pain and osteolytic lesions. These complications can lead to the development of pathologic fractures and severe patient morbidity. However, the results of a recent randomized trial in patients with multiple myeloma demonstrated that single 90 mg monthly doses of pamidronate as an adjunct to chemotherapy reduced the incidence of skeletal-related events and improved patients' quality of life. A cost-benefit analysis using an ex-ante insurance willingness-to-pay (WTP) approach was conducted from a Canadian societal perspective to estimate the net cost or benefit of prophylactic pamidronate therapy for patients with multiple myeloma. This included direct costs for drug administration and hospital savings secondary to avoiding skeletal-related events. One hundred Canadian taxpayers were then interviewed to ascertain their maximum WTP for the benefits of pamidronate. The WTP survey instrument was simple to administer and easily understood by participants. Respondents stated that they would be willing to pay an average of Can $3,364 (95% CI: $2,096, $4,632) as an income tax increase to be paid over their lifetime for the value offered by the product. The benefit was then subtracted from the overall cost of nine monthly doses of pamidronate ($4,153) producing a net societal cost of $789 per patient (95% CI: (−$479, $2,057). The administration of monthly pamidronate therapy in multiple myeloma patients produces a situation of cost neutrality (societal benefits = costs). Additional clinical trials to identify high-risk patient subgroups that would most benefit from the drug are needed.

Our goal in formulating the proposed principles was to stimulate discussion of HTA program goals and procedures to enhance the rigor, validity, and usefulness of HTA. The thoughtful and constructive comments by David Banta, David Hailey, and Duncan Neuhauser are an excellent beginning to what we hope will be an extended and interactive process. We appreciate the opportunity to respond to some of their comments, suggestions, and critiques.

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.

Switzerland has a mixed public and private healthcare system. All citizens are enrolled in compulsory basic health insurance. A 1996 law allows people to choose among different sickness funds and managed care plans. The federal government is empowered to act on important health issues, but the 26 cantons have prime responsibility in health care and social welfare. They have their own laws on health care, hygiene, hospitals, and social welfare. These laws are not harmonized. The system is complex, with a mix of public (mainly hospitals) and private (mainly doctors' offices) providers. The health services are decentralized. Ambulatory care was traditionally provided in doctors' offices, but the last decade has seen the development of centers for day surgery, group practices, and managed care plans. Decisions on placement, location, and extension of services are decentralized. The payment system is very complex. Current trends include global budgets, cost analyses, and prices related to patient categories. However, coverage policy is developed centrally and includes both traditionally established services and new technologies. New technologies are added to the list only after evaluation by the Federal Coverage Committee. The coverage process integrates health technology assessment (HTA). Coverage can be granted in stages, including limited coverage and temporary coverage. Technologies and coverage can be reevaluated on the basis of registries or assessment information. The structure of the Swiss healthcare system does not lend itself to the establishment of a national HTA program. However, recent moves include the development of a coordinating mechanism for HTA in Switzerland.

A sociological approach to medical technology assessment is outlined in this paper, first in general and then with specific reference to controversies surrounding the use of prostate-specific antigen (PSA) testing to population screening for prostate cancer.