Health care technology assessment is broadly and ambiguously interpreted, diluting its role. It is time to recast the field. We must elucidate it in the contemporary context of health inquiry, explicitly relating it to such pursuits as quality assurance, health services research, effectiveness research, medical informatics, and technological innovation.

Objectives: To compare the cost-effectiveness of generic psychological therapy (counseling) with routinely prescribed antidepressant drugs in a naturalistic general practice setting for a follow-up period of 12 months.

Methods: Economic analysis alongside a randomized clinical trial with patient preference arm. Comparison of depression-related health service costs at 12 months. Cost-effectiveness analysis of bootstrapped trial data using net monetary benefits and acceptability curves.

Results: No significant difference between the mean observed costs of patients randomized to antidepressants or to counseling (£342 vs £302, p = .56 [t test]). If decision makers are not willing to pay more for additional benefits (value placed on extra patient with good outcome, denoted by K, is zero), then we find little difference between the treatment modalities in terms of cost-effectiveness. If decision makers do place value on additional benefit (K > £0), then the antidepressant group becomes more likely to be cost-effective. This likelihood is in excess of 90% where decision makers are prepared to pay an additional £2,000 or more per additional patient with a good global outcome. The mean values for incremental net monetary benefits (INMB) from antidepressants are substantial for higher values of K (INMB = £406 when K = £2,500).

Conclusions: For a small proportion of patients, the counseling intervention (as specified in this trial) is a dominant cost-effective strategy. For a larger proportion of patients, the antidepressant intervention (as specified in this trial) is the dominant cost-effective strategy. For the remaining group of patients, cost-effectiveness depends on the value of K. Since we cannot observe K, acceptability curves are a useful way to inform decision makers.

Objectives: The aim of this study was to assess the accuracy of the English National Horizon Scanning Centre (NHSC) in identifying and filtering pharmaceutical developments using end user and international collaborator databases of emerging technologies as proxies for new drugs of likely significance to health services and/or patients.

Methods: We used the NHSC information system and the list of National Institute for Health and Clinical Excellence (NICE) technology appraisals to estimate the false positive rate for NHSC identification, filtration, and reporting. We assessed the sensitivity of NHSC identification and filtration of pharmaceuticals for NICE technology appraisals from 1999 to the end of December 2010, and for pharmaceuticals entered into the EuroScan International Network database.

Results: We estimate that overall NHSC identification, filtration and reporting had a positive predictive value of 0.39 (95 percent CI, 0.36 to 0.43) and a false positive rate of 60 percent. Using NICE appraisals and EuroScan's database as proxies for pharmaceuticals of significance, we estimate the NHSC sensitivity over the 10-year period at 0.92 (95 percent CI, 0.89 to 0.95) and 0.89 (95 percent CI, 0.82 to 0.96) respectively.

Conclusions: Our results suggest that the NHSC has performed well in terms of sensitivity over the past decade, but that the false positive rate of 60 percent may indicate that the filtration criteria for pharmaceuticals could be tightened for increased efficiency. Future evaluations of EAA systems should include an element of external review and explore the level of accuracy acceptable to funders and customers of such systems.

Objectives: Constructive Technology Assessment (CTA) is a means to guide early implementation of new developments in society, and can be used as an evaluation tool for Coverage with Evidence Development (CED). We used CTA for the introduction of a new diagnostic test in the Netherlands, the 70-gene prognosis signature (MammaPrint®) for node-negative breast cancer patients.

Methods: Studied aspects were (organizational) efficiency, patient-centeredness and diffusion scenarios. Pre-post structured surveys were conducted in fifteen community hospitals concerning changes in logistics and teamwork as a consequence of the introduction of the 70-gene signature. Patient-centeredness was measured by questionnaires and interviews regarding knowledge and psychological impact of the test. Diffusion scenarios, which are commonly applied in industry to anticipate on future development and diffusion of their products, have been applied in this study.

Results: Median implementation-time of the 70-gene signature was 1.2 months. Most changes were seen in pathology processes and adjuvant treatment decisions. Physicians valued the addition of the 70-gene signature information as beneficial for patient management. Patient-centeredness (n = 77, response 78 percent): patients receiving a concordant high-risk and discordant clinical low/high risk-signature showed significantly more negative emotions with respect to receiving both test-results compared with concordant low-risk and discordant clinical high/low risk-signature patients. The first scenario was written in 2004 before the introduction of the 70-gene signature and identified hypothetical developments that could influence diffusion; especially the “what-if” deviation describing a discussion on validity among physicians proved to be realistic.

Conclusions: Differences in speed of implementation and influenced treatment decisions were seen. Impact on patients seems especially related to discordance and its successive communication. In the future, scenario drafting will lead to input for model-based cost-effectiveness analysis. Finally, CTA can be useful as a tool to guide CED by adding monitoring and anticipation on possible developments during early implementation, to the assessment of promising new technologies.

The paper outlines the context in which patient's views have been emphasized and the evidence from survey research about the criteria users employ to evaluate health care. Evidence from qualitative research shows that users are ambivalent about modern medicine and are particularly sceptical about the value of drugs and medicine.

This review of the advantages (peaks) and problems (pits) of large data bases to study quality contrasts their suitability with randomized control trials. Researchers need to advise policymakers and others about when statistically significant differences in quality are also politically and socially significant and deserve responsible reactions.

This article describes the findings of an ongoing assessment of prostatectomy that relied on the use of administrative data bases. Examples of the use of claims data for monitoring outcomes and treatment comparisons are provided, as well as a discussion of the strengths and limitations of administrative data for technology assessment.

The growing evidence of the efficacy and effectiveness of dental implants calls for economic evaluations to determine the economic efficiency of this technology for different indications. Such studies must be integrated with the clinical evaluations in order to produce the relevant data. In most cases, dental implants will produce a better outcome than the best alternative technology, but this improvement will only come at greater cost. Cost–benefit evaluations of dental implants must therefore address the difficult task of assessing the value of the improvement in oral health.

This article reviews the developments in HTA in four countries, France, The Netherlands, Sweden, and United Kingdom, in relation to public health. It emphasizes that the majority of assessments made are concerned with individual clinical care rather than with the optimization of health. Possible reasons for the neglect of public health issues are that these are inherently more complex than the assessment of individual procedures or drugs. They are usually multisectoral, politically charged, and often considered mundane and “common sense” and, thus, not requiring evaluation (although when evaluations are done they are often counterintuitive). Unless more emphasis is given to the development and evaluation of public health measures, it is unlikely that there will be any major advances in health status. Possible areas for future assessment should include such issues as smoking, drug and other substance misuse, nutrition, and health inequalities. However, it is unlikely that these major areas of concern will be included in the future unless the methods of choice for priorities of development and assessment are changed to include measures that improve health status rather than only clinical services.

Objectives: To examine the feasibility of retrieving missing outcome data for summary meta-analyses using an example dealing with the effects of aerobic exercise on lipids and lipoproteins in adults.

Methods: Missing lipid and/or lipoprotein data from a currently developed meta-analytic data base were requested by means of electronic mail from 39 of 174 (22.4 percent) eligible studies. Binary logistic regression was used to examine whether year of publication and country were significant predictors for whether data would be provided.

Results: Of the thirty-nine studies from which data were requested, usable data were received for thirteen (33.3 percent) of the studies. The addition of these previously missing data decreased the percentage of eligible studies that would have had to be excluded by 33.5 percent (from 22.4 percent to 14.9 percent). Neither year of publication nor country in which the study was conducted (United States versus other) were significant predictors of whether missing data would be provided or not (p>.05).

Conclusions: Moderate success was achieved in the acquisition of missing outcome data dealing with the effects of aerobic exercise on lipids and lipoproteins in adults. However, whether this level of response is true in other areas of research needs to be determined by additional research.

Objectives: The aim of this study was to assess the cost-effectiveness of drotrecogin alfa (activated) compared with best supportive care in a UK cohort of adult intensive-care patients with severe sepsis.

Methods: A systematic review of evidence on the clinical- and cost-effectiveness of drotrecogin alfa (activated) was undertaken, and a decision-analytic model was developed to estimate the cost-effectiveness of treatment in the United Kingdom. Trial data from the Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study have been synthesized with other data, including UK data on severe sepsis, to estimate the costs and consequences of treatment over time.

Results: For patients with severe sepsis and multiple organ dysfunction, the estimates of cost per life year and cost per quality-adjusted life year (QALY) are £4,931 and £8,228, respectively. For patients with severe sepsis alone, the cost per life-year and cost per QALY are £5,495 and £9,161, respectively.

Conclusions: Whereas the therapeutic cost for drotrecogin alfa (activated) appears high (at around £5,000 per patient) and the potential impact on the provider budget is considerable, drotrecogin alfa (activated) is clinically effective, represents a cost-effective use of resources, and is a significant advance in the treatment of severe sepsis in patients requiring intensive care.

Objectives: The aim of this study was to identify risk points in the different stages of the smart infusion pump implementation process to prioritize improvement measures.

Methods: Failure modes and effects analysis (FMEA) in the pediatric intensive care unit (PICU) of a General and Teaching Hospital. A multidisciplinary team was comprised of two intensive care pediatricians, two clinical pharmacists and the PICU nurse manager. FMEA was carried out before implementing CareFusion infusion smart pumps and eighteen months after to identify risk points during three different stages of the implementation process: creating a drug library; using the technology during clinical practice and analyzing the data stored using Guardrails® CQI v4.1 Event Reporter software.

Results: Several actions for improvement were taken. These included carrying out periodical reviews of the drug library, developing support documents, and including a training profile in the system so that alarms set off by real programming errors could be distinguished from those caused by incorrect use of the system. Eighteen months after the implementation, these measures had helped to reduce the likelihood of each risk point occurring and increase the likelihood of their detection.

Conclusions: Carrying out an FMEA made it possible to detect risk points in the use of smart pumps, take action to improve the tool, and adapt it to the PICU. Providing user training and support tools and continuously monitoring results helped to improve the usefulness of the drug library, increased users’ compliance with the drug library, and decreased the number of unnecessary alarms.

Objectives: The suitability of general HTA methodology for medical devices is gaining interest as a topic of scientific discourse. Given the broad range of medical devices, there might be differences between groups of devices that impact both the necessity and the methods of their assessment. Our aim is to develop a taxonomy that provides researchers and policy makers with an orientation tool on how to approach the assessment of different types of medical devices.

Methods: Several classifications for medical devices based on varying rationales for different regulatory and reporting purposes were analyzed in detail to develop a comprehensive taxonomic model.

Results: The taxonomy is based on relevant aspects of existing classification schemes incorporating elements of risk and functionality. Its 9 × 6 matrix distinguishes between the diagnostic or therapeutic nature of devices and considers whether the medical device is directly used by patients, constitutes part of a specific procedure, or can be used for a variety of procedures. We considered the relevance of different device categories in regard to HTA to be considerably variable, ranging from high to low.

Conclusions: Existing medical device classifications cannot be used for HTA as they are based on different underlying logics. The developed taxonomy combines different device classification schemes used for different purposes. It aims at providing decision makers with a tool enabling them to consider device characteristics in detail across more than one dimension. The placement of device groups in the matrix can provide decision support on the necessity of conducting a full HTA.

Background: Walking is a good way to meet physical activity guidelines. We examined the effectiveness of walking in groups compared with walking alone or inactive controls in physically healthy adults on physical activity and quality of life. (PROSPERO CRD42016033752).

Methods: We searched Medline, Embase, Cinahl, Web of Knowledge Science Citation Index, and Cochrane CENTRAL until March 2016, for any comparative studies, in physically healthy adults, of walking in groups compared with inactive controls or walking alone, reporting any measure of physical activity. We searched references from recent relevant systematic reviews. Two reviewers checked study eligibility and independently extracted data. Disagreements were resolved through discussion. Quality was assessed using likelihood of selection, performance, attrition, and detection biases. Meta-analysis was conducted using Review Manager 5.3.

Results: From 1,404 citations, 18 studies were included in qualitative synthesis and 10 in meta-analyses. Fourteen compared group walking to inactive controls and four to walking alone. Eight reported more than one measure of physical activity, none reported according to current guidelines. Group walking compared with inactive controls increased follow-up physical activity (9 randomized controlled trials, standardized mean difference [SMD] 0.58 [95 percent confidence interval {CI}, 0.34–0.82] to SMD 0.43 [95 percent CI, 0.20–0.66]). Compared with walking alone, studies were too few and too heterogeneous to conduct meta-analysis, but the trend was improved physical activity at follow-up for group walking participants. Seven (all inactive control) reported quality-of-life: five showed statistically significantly improved scores.

Discussion: Better evidence may encourage government policy to promote walking in groups. Standardized physical activity outcomes need to be reported in research.

The major aim of this study was to estimate and compare the patient-borne costs of lifelong subcutaneous gamma globulin therapy at the hospital and at home. Thirty patients were included and the data were collected with a questionnaire. The introduction of self-therapy at home reduced the total yearly costs by approximately 50% and the out-of-pocket expenses for the palients by 85%.

Objectives: To assess the cost-effectiveness of alternative initial strategies in the management of uninvestigated dyspepsia in adult patients presenting to a primary care physician in Canada.

Methods: Clinical decision-making was modeled based on outcomes data from the literature and expert opinion. Costs were obtained from official reimbursement lists, and a detailed microcosting analysis of a gastroscopy. Costs were analysed over a one-year period after initial presentation, including consideration of a single relapse of symptoms. The main outcome was a symptomatic cure. The seven management strategies based on different initial tests were endoscopy, double-contrast barium meal, empirical eradication therapy, empirical antisecretory treatment, urea breath test (UBT), laboratory serology, and sequential testing (laboratory serology followed, if Helicobacter pylori positive, by UBT).

Results: In patients under age 45, endoscopy, double-contrast barium meal, and sequential testing were not cost-effective approaches. UBT was the most effective and most costly strategy costing $8,238 per additional patient cure compared with laboratory serology. In patients over age 45, UBT was again the most effective and most costly strategy, but endoscopy was the most reliable in detecting gastric cancers. Clinical variables that impacted these findings were the probability of symptomatic relapse in patients with nonulcer dyspepsia (NUD) after successful versus failed H. pylori eradication, the probability of finding a duodenal ulcer (DU) in a young dyspeptic patient, the specificity of UBT, and the prevalence of H. pylori in patients with DU.

Conclusions: A “test-and-treat” approach was favored, with UBT being the most effective but most costly initial test in adult dyspeptics under age 45. The choice of the most cost-effective approach is dependent on the benefits of H. pylori eradication in patients with NUD. In patients over age 45, UBT is the most effective and most costly, but endoscopy results in the early detection of most gastric cancers.The authors are indebted to the other members of the UBTAN Group, including Drs. Phil Sherman, Alan Thomson, and Sander Veldhuyzen van Zanten. The authors also thank Paul Sinclair, Eileen Grace, and Lawrence Joseph for their much valued comments and opinions.AB and CAF are research scholars of the Fonds de la Recherche en Santé du Québec. This work was supported in part by an “at arms length” grant from AstraZeneca Canada.

A controversial issue in cost-effectiveness analysis is the discounting of gained life-years. What has not been realized, however, is that the different methods used for discounting this measurement provide fundamentally different results. The method used is seldom explicitly stated. In the present article the four main methods for the discounting of gained life-years are reviewed and compared. The conclusion is that if we wish to continue comparing results, researchers must employ the same methodology.

Health outcome assessment may be used for a variety of purposes: to evaluate the effectiveness of medical practices: to assess the quality of services provided; to educate providers, purchasers, and users of health services about the sequelae of treated and untreated disease; to guide reimbursement and regulatory policy; and to characterize the health status of a population. This article focuses on the use of health outcomes to evaluate the effectiveness of medical practices and to assess the quality of services provided.

Objectives: The aim of this study was to describe the history of health technology assessment (HTA) in France.

Methods: The approach was a descriptive review done by people who have been very much involved in this history.

Results: The interest in HTA and evaluation as a tool for health decision making goes back to the 1970s in France. During the 1980s, there were several attempts to develop a national HTA agency, which finally came to fruition with the development of the Agence Nationale de l'Evaluation Medicale (ANDEM) in 1989. ANDEM's main success, perhaps, was in making HTA known in France by developing its own assessments, writing and validating appropriate methodologies for assessing medical technology and medical practices, and by organizing in France the development of programs of consensus development conferences, which the ANDEM either organized itself or supported and validated. In the mid-1990s, the mandate of ANDEM was extended to hospital accreditation and the agency's name was changed to Agence Nationale d'Accreditation et d'Evaluation en Sante (ANAES). Finally, in 2005, the National Authority for Health (HAS) was formed to consolidate efforts to centralize the programs of HTA, aiming at helping decision making regarding reimbursement and pricing, in one agency and to define the optimal use of health technology in France.

Conclusions: HTA has become a strong influence in the healthcare system in France. These developments may be considered rather typical of the approach to public policy questions in France, where regulation is more in use than in other countries (at least in the healthcare field). At the same time, this approach has made lobbying and other attempts to influence decisions common as well, so one might say that HTA is more politicized than in some other countries in Europe.

Objectives: Evaluation is crucial for integration of e-Health/m-Health into healthcare systems and health technology assessment (HTA) could offer sound methodological basis for these evaluations. Aim of this study was to look for HTA reports on e-Health/m-Health technologies and to analyze their transparency, consistency and thoroughness, with the goal to detect areas that need improvement.

Methods: PubMed, ISI-WOS, and University of York – Centre for Reviews and Dissemination–electronic databases were searched to identify reports on e-Health/m-Health technologies, published up until April 1, 2016. The International Network of Agencies for Health Technology Assessment (INAHTA) checklist was used to evaluate transparency and consistency of included reports. Thoroughness was assessed by checking the presence of domains suggested by the European network for Health Technology Assessment (EUnetHTA) HTA Core Model.

Results: Twenty-eight reports published between 1999 and 2015 were included. Most were delivered by non-European countries (71.4 percent) and only 35.7 percent were classified as full reports. All the HTA reports defined the scope of research whereas more than 80 percent provided author details, summary, discussed findings, and conclusion. On the contrary, policy and research questions were clearly defined in around 30 percent and 50 percent of reports. With respect to the EUnetHTA Core Model, around 70 percent of reports dealt with effectiveness and economic evaluation, more than 50 percent described health problem and approximately 40 percent organizational and social aspects.

Conclusions: E-Health/m-Health technologies are increasingly present in the field of HTA. Yet, our review identified several missing elements. Most of the reports failed to respond to relevant assessment components, especially ethical, social and organizational implications.