Objectives: The objectives of this study were to identify and qualitatively describe, in a systematic literature review, published studies that collected prostate cancer patients’ health-related quality of life (HRQoL) estimates by using validated, generic instruments.

Methods: Systematic searches of the literature were made using the Medline, Cochrane Library, PsycINFO, and CINAHL electronic databases from 2002 to 2015.

Results: The search identified 2,171 references, of which 237 were obtained for full-text assessment; thirty-three of these articles were deemed relevant and included in the systematic review. An indirect valuation method was used in 73 percent (n = 24) of the studies. The most commonly used HRQoL instrument with an indirect valuation method was the EuroQol (EQ-5D; n = 21), and the second most common was the 15D (n = 5). A direct valuation method was used in 48 percent (n = 16) of the studies. Of these, the Visual Analogue Scale (VAS) was the most often used (n = 10), followed by the Time-Trade-Off (n = 6). HRQoL scores varied in localized and early stage disease between 0.63 and 0.91, and in advanced or metastatic disease stage between 0.50 and 0.87. There was also variance in the HRQoL instruments and study methods used, which explains the large variance in HRQoL scores between the various disease stages.

Conclusions: Although utility and quality-adjusted life-years gained are considered important measures of effectiveness in health care, the number of studies in which utilities of prostate cancer patients have been estimated using generic HRQoL instruments, based on either direct or indirect measurement of HRQoL, is fairly small.

Objectives: The overall objective of this article was to review the theoretical and conceptual dimensions of how the implementation of clinical practice guidelines (CPGs) is likely to affect treatment costs.

Methods: An important limitation of the extant literature on the cost effects of CPGs is that the main focus has been on clinical adaptation. We submit that the process innovation aspects of CPGs require changes in both clinical and organizational dimensions. We identify five organizational factors that are likely to affect the relationship between CPGs and total treatment costs: implementation, coordination, learning, human resources, and information. We review the literature supporting each of these factors.

Results: The net organizational effects of CPGs on costs depends on whether the cost-reducing properties of coordination, learning, and human resource management offset potential cost increases due to implementation and information management.

Conclusions: Studies of the cost effects of clinical practice guidelines should attempt to measure, to the extent possible, the effects of each of these clinical and organizational factors.

Introduction: Hospital-based health technology assessment (HB-HTA) has been introduced to help hospital management in decision making about the adoption of new health technologies (HTs). We reviewed the accuracy of the expected medical impact of HTs assessed at our hospital, as well as the acceptance of this process by clinicians.

Methods: For each HT adopted between 2002 and 2011, a semi-structured interview with the involved clinician was conducted, assessing (i) the perceived utility of the HB-HTA process, (ii) the accuracy of the new HT's expected medical impact as compared with observed patient data from the year 2012, and (iii) the compliance with the indications of the HB-HTA report.

Results: Over the 10-year period, forty HB-HTAs were carried out, of which thirty-four led to acceptance. Twenty-seven of the twenty-eight clinicians involved in these thirty-four HTs accepted the interview and 85 percent acknowledged the utility of the HB-HTA process. Five of the thirty-four HTs were no longer in use. For the twenty-nine remaining HTs, observed patients’ number was as expected in eight, higher in four, lower in fifteen, and not available in two cases. Available average length of stay was 61 percent longer than expected. Two HTs had a higher complication rate and three a lower success rate. Indications evolved in 55 percent of HTs after a few years (seven restrictions, six broadenings, and three other changes).

Conclusions: A HB-HTA process is useful to improve quality in decision making. Follow-up analysis should routinely be performed to adapt HB-HTA reports’ conclusions to practical experience and new scientific evidence.

Objectives: The EUR-ASSESS project was undertaken by a large number of members of European health technology assessment (HTA) agencies and programs with the aim of improving coordination through developments in several areas of HTA. At the conclusion of the project, an independent survey was undertaken to reassess the importance of the original objectives of EUR-ASSESS and determine the impact of the project on the way HTA activities are organized and carried out in Europe.

Methods: A postal questionnaire survey and a series of more in-depth personal interviews.

Results: EUR-ASSESS was generally considered successful in achieving its aims, particularly in creating an informal network of people and organizations, improving the understanding of the work of others, improving the ability to focus the objectives of HTA, facilitating the sharing of experience and mutual learning opportunities, exchanging ideas on research agendas, and developing a common language. However, significant differences emerged in the expectations of different actors in European HTA, and in their perceptions of the impact of the project. These reflect the wide diversity of approaches existing in Europe.

Conclusions: Health technology assessment in Europe is changing its nature from a set of national or local initiatives with relatively limited impact to a truly European movement with strong links and coordination between its individual components. Important lessons can be learned from the experience of EUR-ASSESS, particularly in the light of an increasing commitment of the European Commission to play a role in the development of technology assessment.

Greater access to web-based information on health-care interventions might result in greater participation by patients in care and self-care decisions, but only improve health outcomes if the indicated actions produce the intended benefits. Unbiased research on benefits and harms of health information can provide a basis for evidence-based patient information systems.

Objectives: To evaluate the quality of the information content on bone-mineral density (BMD) testing posted on consumer health websites (CHWS).

Methods: Five popular engines (Yahoo, MSN, AOL, Lycos, and Go.com) were used to search for patient information on bone densitometry. The fifteen websites that supplied relevant content and were identified by three of the five search engines were selected in order of popularity of the search engine and primacy of placement. Six BMD reports from health technology assessment (HTA) organizations were used as a standard of scientific quality. These were identified from the HTA Database at York University United Kingdom and published between 1996 and 2001. Content was extracted from both document types, and these sets were compared independently by two reviewers.

Results: The majority of CHWS identified by popular search engines do not disclose the limited capacity of BMD to discriminate between low-risk individuals and those who will suffer future fractures. CHWS generally present BMD testing as quick, painless, noninvasive, and as being recommended, based on risk factors that are widespread among the general public. BMD testing information is prominently paired on CHWS sites with information on osteoporosis, with an emphasis on “silent disease” and the devastating consequences of advanced disease. Sponsors of CHWS sites are frequently either providers of BMD testing or companion drugs, and consequently in a position of conflict of interest with regard to decisions to undergo BMD testing. HTA organizations have no documented conflict of interest, nor do they invoke emotional arguments. Their approach is to emphasize the effects of testing on populations, on the basis of referenced research findings.

Conclusions: Content analysis demonstrates the omissions and divergence of information on BMD testing available to consumers on the Internet, as compared with HTA reports. The content of HTA reports has undergone rigorous systematic and peer review; therefore, their findings may be useful to consumers. This information is not generally accessible to patients using the most popular Internet search engines. Inaccurate and incomplete information may cause harm by deflecting patients from optimal decisions.

Background: Clearly the benefits of a treatment must not be outweighed by the adverse effects. If researchers fail to incorporate adverse effects adequately in models, this could limit the validity of the results obtained. In the worst case, interventions that are cost-effective may be shown not to be. The aim of this research was to review current practice when incorporating adverse effects in economic models.

Methods: A survey of HTA reports commissioned by the National Institute for Health Research (NIHR) Health Technology Assessment programme, published between 2004 and 2007 was conducted. All reports which investigated the clinical and cost-effectiveness of a health technology using a systematic review and an economic model framework were included.

Results: A total of eighty reports met the inclusion criteria. Of the models including adverse effects (43/80), 67 percent used a clinical adverse effects parameter, 79 percent a cost of adverse effects parameter, 86 percent used one of these, and 60 percent used both. Of the thirty-seven models that did not include adverse effects, eighteen justified this omission, most commonly lack of data; nineteen appeared to make no explicit consideration of adverse effects in the model.

Conclusions: In many cases, poor reporting made it difficult to ascertain if there had been any consideration of adverse effects. We suggest that the findings of this survey support a call for much clearer and explicit reporting of adverse effects, or their exclusion, in decision models and for explicit recognition in future guidelines that “all relevant outcomes” should include some consideration of adverse events.

Objectives: The aim of this study was to assess viewpoints of end-users concerning the purchasing process of high-risk medical devices and to discuss the relevance of health technology assessments (HTAs) at the hospital level and other potential areas for improvement of purchasing processes.

Methods: We used a cross-sectional study and assessed the attitudes and thoughts of orthopedic specialists. The study took place between June and October 2015 in Mexico.

Results: We collected data from 187 orthopedic surgeons. Involvement of orthopedic specialists in purchasing was reported by 86 percent. However, clinical practice was perceived as negatively influenced by purchasing outcomes by 92 percent. The problems were described as: material failure; effectiveness of medical devices; obsolete medical device technology; incomplete provision of implant / instrument sets; delayed provision of implants and instruments.

Conclusions: To prevent sub-standard outcomes of purchasing decisions, this study and the current literature suggest that technologies should be assessed during the purchasing process, end-users should be adequately involved, and decisions should be based on multiple criteria including clinical impact in the short-term (e.g., primary stability of implant) and long-term (e.g., survival of implant). The focus on Mexico is particularly novel and provides insights into a health system where HTA is mainly present at the macro level and can be used for the listing of medical device technologies in the standard list. This study concludes that Mexican stakeholders of the purchasing process underestimate the contribution of HTAs at the level of purchasing decisions. HTA in Mexico has improved over the past years but still requires more advancement.

The purpose of this study was to determine how horizon-scanning organizations can encourage the implementation of recommendations contained in their early warning messages about emerging health technologies. We reviewed the conclusions of the EUR-ASSESS Project Subgroup report on dissemination and impact, an overview of systematic reviews of interventions to promote implementation of research findings by health care professionals, and various Cochrane Effective Practice and Organisation of Care Group protocols and reviews. The evidence on the effectiveness of different implementation strategies aimed at distinct target groups is of variable quality. There is some evidence from rigorous study designs on the effectiveness of strategies designed to influence the behavior of health care professionals; the quality of the evidence relating to policy makers and the general public is more limited. Horizon-scanning organizations can improve the likelihood of their recommendations being acted upon by developing active implementation strategies based on the best available evidence, establishing links with key groups, and directing early warning messages at specific target audiences. Given the relative lack of good quality evidence, it is important that implementation strategies be rigorously evaluated to determine their effectiveness.

Recent advances in genetic identification and characterization of a number or hereditary disorders have led to increased possibilities for genetic testing and screening. The context and methods of screening are important given that identification of otherwise healthy persons as being presymptomatic or at increased risk for genetic diseases may have serious consequences for their future lifestyle, employment, and insurability. This article examines general principles for genetic screening, including goals, delivery issues, and professional and lay responses to screening and counseling, and recommends areas in which social psychological research on screening is needed.

Orphan drug products generally are used in treating or preventing rare diseases. The small number of patients available for study may create special problems in the evaluation of these products. This paper examines some of the special problems that are associated with the design and implementation of studies to evaluate the safety and efficacy of orphan drugs. The U.S. Food and Drug Administration (FDA) has not established special criteria for evaluating orphan drugs per se, but the FDA has been flexible in evaluating drug products that present special problems, especially when these products are for treatment of serious of life-threatening illnesses. The FDA and other U.S. governmental agencies also have taken steps to promote the development and availability of drugs for rare diseases, including making these products available to patients who are in need, even before the drugs have full FDA marketing approval.

There is a wide panorama of disorders in the newborn infant where neonatal intensive care has been proven effective in reducing mortality. Although modern neonatal intensive care can be very costly, shortand simple interventions for support and resuscitation still can be highly beneficial. In reviewing the field of neonatal intensive careduring the 1980s, it becomes evident that a major challenge for the future will be to apply physiological principles of great and provenvaluefor the newborn baby to more simple devices. Only thereby canthe technology of neonatal care defined as a complex of actions–not only equipment and techniques–become justified for future generations.

The intensive care unit (ICU), one of the great achievements of modern medicine, is both a set of technologies and a space with a special function. This essay traces the evolution of the ICU's crucial technologies, and how the space bearing this name was carved out in the hospital. Ethical, legal, and social developments, an important part of this story, are incorporated in it.

Patterns of the diffusion of laparoscopic cholecystectomy in Canadian hospitals were determined by a telephone survey of 153 randomly selected hospitals over two years. Results were analyzed by region, hospital size, and type of hospital. Laparoscopic cholecystectomy has diffused very quickly compared with other technologies, before any comprehensive evaluation to consider its potential impact could take place.

The long-term health sequelae for women from assisted reproductive technology (ART) have not been studied extensively. There are a number of reasons that women's health may be compromised after ART procedures, including the consequences of the increased incidence of multiple births, operative deliveries, and preterm infants, the possible adverse effects of the drug regimens used for ovarian stimulation, and the instrumentation involved in ART procedures. In this paper we review the existing literature in these areas. It emphasizes the effects of the drugs used for ovarian stimulation, and in particular the incidence of cancer among women who have undergone ART. The review indicates that there is cause for concern about the long-term effects on women from ART treatments. It highlights the lack of research undertaken in almost all areas related to women's long-term health after ART. In the area of ART and cancer, it draws attention to the lack of conclusive evidence in relation to the posited association between fertility treatments and cancer, resulting from the limited number of very large studies and the need for longer follow-up periods. We make a number of recommendations regarding further research that is needed to address the current shortcomings in the published literature.

Health technology assessment (HTA) agencies vary in their use of quantitative patient preference data (PP) and the extent to which they have formalized this use in their guidelines. Based on the authors' knowledge of the literature, we identified six different PP “use cases” that integrate PP into HTA in five different ways: through endpoint selection, clinical benefit rating, predicting uptake, input into economic evaluation, and a means to weight all HTA criteria. Five types of insight are distinguished across the use cases: understanding what matters to patients, predicting patient choices, estimating the utility generated by treatment benefits, estimating the willingness to pay for treatment benefits, and informing distributional considerations. Summarizing the literature on these use cases, we recommend circumstances in which PP can add value to HTA and the further research and guidance that is required to support the integration of PP in HTA. Where HTA places more emphasis on clinical outcomes, novel endpoints are available; or where there are already many treatment options, PP can add value by helping decision makers to understand what matters to patients. Where uptake is uncertain, PP can be used to estimate uptake probability. Where indication-specific utility functions are required or where existing utility measures fail to capture the value of treatments, PP can be used to generate or supplement existing utility estimates. Where patients are paying out of pocket, PP can be used to estimate willingness to pay.

Objectives: Made available since 2002, transcatheter aortic valve implantation (TAVI) is a minimally invasive new intervention which can provide significant survival improvement to patients with aortic stenosis. However, TAVI is expensive and currently not reimbursed by many governments. Some governments and institutions have been conducting health technology assessments (HTAs) to inform their reimbursement decisions. The aim of the present study is to review HTAs that have relied on a cost-effectiveness analysis to inform reimbursement decisions of TAVI.

Methods: A systematic literature review was conducted among published literature as well as reports released by HTA agencies. Predetermined inclusion and exclusion criteria, following the Preferred Reporting System for Systematic Reviews and Meta-Analysis guidelines, were used to select relevant HTAs. The selected papers were assessed against the Consolidated Health Economic Evaluation Reporting Standards.

Results: HTAs on TAVI from three countries were available for this review: Canada, Belgium, and the United Kingdom. All three HTAs used the Placement of Aortic Transcatheter Valve (PARTNER) trial data with Markov models to estimate the incremental cost effectiveness ratio. The three HTAs recommended conditional reimbursement for TAVI for otherwise inoperable patients. The HTAs did not use clear methods to estimate the health-related utility which ultimately affected their cost-effectiveness results. The UK HTA showed the best value for money (US$20,416 per quality-adjusted life-year).

Conclusion: All studies found TAVI to be more costly and less effective for high-risk patients suitable for surgery, whereas TAVI was consistently found to be cost effective for otherwise inoperable patients.

Increasingly, health technology assessment (HTA) is used to aid decisions on the reimbursement of pharmaceuticals or recommendations for their use. The pharmaceutical industry seeks to work in partnership with HTA agencies; however, this presents a number of challenges. Clinical trials will need to include appropriate measures that capture economic and patient benefits as well as relevant clinical endpoints, and the industry will want to seek international harmonization of the many guidelines for economic evaluation. The problem of demonstrating cost-effectiveness of a product before it is available for use must be addressed, possibly by conditional reimbursement to allow collection of real world evidence. It is also important that reimbursement decision makers minimize bias, play fair, and adhere to the written rules they issue. If the industry fairly demonstrates the value of a product using the best available evidence, HTA agencies should be transparent in the rationale for their recommendations.