This article describes issues that are clinically significant when assessing quality of life of patients whose organ disease can be treated only through transplantation or reliance upon an artificial organ. Emphasis is placed on stresses that affect the family as well as the immediate patient, because, over time, these are inextricably interwoven. The transplant recipient who experiences a “good” medical outcome may perceive that he has little to live for if his family is severely disrupted or broken apart by the strain of the illness. The family of a patient who dies after unremitting complications while being sustained by an artificial organ may experience both relief at the lifting of an unmanageable burden, and continuing guilt that they were unable to provide unconditional love and support to a dying family member.

Emergency preparedness is a continuous quality improvement process through which roles and responsibilities are defined to effectively anticipate, respond to, and recover from the impact of emergencies. This process results in documented plans that provide a backbone structure for developing the core capacities to address health threats. Nevertheless, several barriers can impair an effective preparedness planning, as it needs a 360° perspective to address each component according to the best evidence and practice. Preparedness planning shares common principles with health technology assessment (HTA) as both encompass a multidisciplinary and multistakeholder approach, follow an iterative cycle, adopt a 360° perspective on the impact of intervention measures, and conclude with decision-making support. Our “Perspective” illustrates how each HTA domain can address different component(s) of a preparedness plan that can indeed be seen as a container of multiple HTAs, which can then be used to populate the entire plan itself. This approach can allow one to overcome preparedness barriers, providing an independent, systematic, and robust tool to address the components and ensuring a comprehensive evaluation of their value in the mitigation of the impact of emergencies.

Objective: To assess the influence of physician specialty and the way in which patient data are presented in the treatment recommended for patients with coronary artery disease.

Methods: In a prospective study, 3,628 patients with significant coronary artery disease who had been referred to 1 of 10 heart centers in the Netherlands as possible candidates for either percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft surgery (CABG) were recruited. Within each center, the recommended treatment is determined by a team consisting of cardiologists only, cardiovascular surgeons only, or cardiologists and cardiovascular surgeons (i.e., composite teams). The main outcome measures are the proportions of patients for whom PTCA, CABG, or noninvasive (medical) therapy was recommended.

Results: Composite teams made 71% of recommendations, surgeon-only teams, 12%, and cardiologist-only teams, 17%. Cardiologist-only teams primarily recommended patients to PTCA, surgeon-only teams to CABG, while combined teams made more evenly distributed recommendations (p < .001). Although the patients discussed by the three types of teams were clinically different, the recommendation patterns remained significant after adjusting for these differences (p < .001). For patients with recent myocardial infarction, direct presentation of the case to the team by the referring cardiologist reduced the likelihood that CABG would be recommended.

Conclusions: The treatment recommended to patients with coronary artery disease is affected by the composition of the team providing the recommendation. These findings have important implications for clinical decision making for patients with cardiovascular disease.

Objectives: The aim of this study was to identify individuals with expertise in ethics analysis in Canada, who might contribute to health technology assessment (HTA); to gauge these individuals’ familiarity with, and experience participating in, the production of HTA.

Methods: A contact list was developed using the Canadian Bioethics Society membership list and faculty listings of Canadian universities, bioethics centers, and health agencies. An eighteen-question email survey was distributed to potential respondents to collect data on demographic information, education and work experience in applied ethics, and involvement in HTA.

Results: The survey response rate was 52.8 percent (350/663). Respondents worked primarily in academic institutions (50.4 percent) or hospitals (15.4 percent). Many respondents (83.1 percent) had education, formal training, or work-related experience in practical ethics related to health care, with many having a doctorate (34.5 percent) or master's degree (19.0 percent). One quarter (24.5 percent; n = 87) of respondents indicated they had been involved in an analysis of ethical issues for HTA. Almost two-thirds (65.4 percent; n = 165) of those who had not previously participated in ethics analysis believed they might usefully contribute to an analysis of ethical issues in HTA. Experts who have conducted ethics analysis in HTA had more than twice the odds of having education and training in ethics and a PhD than those who might contribute to ethics analysis.

Conclusion: Many people have contributed to ethics analysis in HTA in Canada, and more are willing to do so. Given the absence of a reliable credential for ethics expertise, HTA producers should exercise caution when enlisting ethics experts.

Formularies are used by payers to optimize access and ensure the appropriate use of medications. Lack of follow-up and re-evaluation can lead to outdated formularies that are not reflective of current evidence. Formulary modernization, an approach to re-align formularies with current evidence has proven successful. The Ontario Drug Policy Research Network (ODPRN) launched a framework for conducting comprehensive drug-class reviews. This commentary describes the individual components of this framework and lessons learned through completion of 12 reviews between 2013 and 2016. We present the ODPRN drug-class review of treatments for chronic hepatitis B as a case example to illustrate the components and impact. The incorporation of foundational health technology assessment components such as economic evaluations and knowledge synthesis with contextualizing evidence such as patient and clinician perspectives (through qualitative studies), real-world evidence (through data analytics), and cross-jurisdictional comparisons (through environmental scans and data analytics), successfully developed jurisdictionally specific policy recommendations grounded in up-to-date evidence. The ODPRN framework for conducting comprehensive drug-class reviews is a robust and feasible approach to conduct formulary modernization. This framework allows for actionable and specific policies which are likely to be considered by decision makers. Adoption of similar frameworks in other jurisdictions may improve uptake of evidence-informed policy recommendations.

The process of technology assessment is evolving. The process of policy development for technology is the least understood in the cycle of technology assessment. The process of policy development, which should involve extensive consultation and a broad-based research and evaluation program, is often fraught with difficulties and can cause further analysis or the assessment process to come grinding to a halt. This article reviews some social, political, and ethical issues and the role of civil society in influencing the technology assessment process for new reproductive technologies in Canada. It is written from the perspective of one of the Deputy Directors of Research and Evaluation for the Royal Commission on New Reproductive Technologies and highlights the strengths and difficulties of technology assessment when civil society and technology assessment come face to face. A brief update by a policy analyst in Health Canada on the current situation of legislation on new reproductive technologies has been provided and is included at the end of this article.

Objectives: We conducted a meta-analysis of recently published randomized controlled trials (RCTs) to identify the most effective and safe etanercept dosing regimen and duration of therapy for the treatment of patients with ankylosing spondylitis (AS).

Methods: We systematically reviewed PubMed, Embase, Cochrane Library, and Web of Science databases for RCTs. The proportion of patients attaining 20 percent improvement (according to the Spondyloarthritis International Society response criteria [ASAS 20]) was evaluated as a primary outcome. Secondary outcomes included 50 percent increase in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50) used for evaluating efficacy, as well as the BASDAI/Bath Ankylosing Spondylitis Functional Index (BASFI) scores and adverse events.

Results: ASAS 20 indicated that the efficacy of etanercept did not differ amongst dosing regimens (25 mg twice-weekly versus 50 mg once-weekly: relative risk [RR], 2.18, 95 percent confidence interval [CI], 1.78–2.67 versus RR, 2.00, 95 percent CI, 1.70–2.37). The ASAS 20 reported subgroup differences among treatment durations of less than 12 weeks (RR, 2.70; 95 percent CI, 2.09–3.49); 12 weeks (RR, 1.74; 95 percent CI, 1.37–2.22); and more than 12 weeks (RR, 2.56; 95 percent CI, 1.88–3.48). Other outcomes included BASDAI, BASDAI 50, and BASFI. Drug safety differed according to the treatment regimen and duration.

Conclusion: Our meta-analysis found that there was no significant efficacy difference between 50 mg once-weekly and 25 mg twice-weekly dosing for the treatment of AS, and a dosing duration of less than 12 weeks was more effective for treating AS patients.

Objectives: The aim of this study was to describe and analyze the introduction of health technology (HTA) in Romania.

Methods: Based on a review of the literature and legislative documents and personal experiences and observations, the authors describe, evaluate, and explain the background and evolution of the HTA system.

Results: Initiatives to introduce HTA in Romania date from the early 1990s, but real steps were taken only in 2012 when the European Union Directive 2011/24/ on the application of patients’ rights in cross-border health care had to be passed into Romanian law.

The main developments consist of: the establishment of a national competent authority, the development of a methodology for the rapid assessment of drugs, setting HTA as the main tool for compiling the list of medicines to be covered by the NHIF, and capacity building initiatives. One early result of HTA implementation was an updated list of reimbursed drugs, allowing Romanian patients access to new, innovative medicines.

Conclusions: In Romania, HTA become an issue for all stakeholders: decision makers are interested in cost-containment, patients in obtaining the best care, and producers in receiving acceptable reimbursement remains on the health policy agenda. Further steps are envisaged, especially for international collaboration, which is considered an important factor for HTA development in Romania.

Evaluations of telemedicine have sought to assess various measures of effectiveness (e.g., diagnostic accuracy), efficiency (e.g., cost), and engagement (e.g., patient satisfaction) to determine its success. Few studies, however, have looked at evaluating the organizational impact of telemedicine, which involves technology and process changes that affect the way that it is used and accepted by patients and clinicians alike. This study reviews and discusses the conceptual issues in telemedicine research and proposes a fresh approach for evaluating telemedicine. First, we advance a patient pathway perspective, as most of the existing studies view telemedicine as a support to a singular rather than multiple aspects of a health care process. Second, to conceptualize patient pathways and understand how telemedicine impacts upon them, we propose simulation as a tool to enhance understanding of the traditional and telemedicine patient pathway.

Objectives: In a resource-constrained reality, physicians are facing polar demands—those of healthcare managements to adopt cost-conscious behaviors and those of ethical standards that obligate physicians to consider only their patients' best interests. In our study, we aimed to determine the attitudes, practices, and knowledge of healthcare costs among Israeli physicians.

Methods: A questionnaire was developed and mailed to a representative sample of physicians in Israel. The overall response rate was 51 percent. The study reviewed self-reported levels of cost consciousness in practice, attitudes, obstacles related to cost containment, and knowledge of the costs of medical resources.

Results: Forty-two percent of the physicians reported high levels of cost consciousness in their daily practice; 70 percent reported greater current cost consciousness in comparison to 5 years ago; 76 percent of the responses legitimized institutional demands for cost containment. Although 83 percent of the physicians that responded expressed the belief that economic thinking was inherently the role of management, only 39 percent thought it was part of the physician's role. It was found that predominant predictors of agreement to cost consciousness concepts were employment by a community health plan, a managerial position, participation in health economics seminars, and male gender.

Conclusions: Cost consciousness among physicians is related to a broad array of parameters. Interventions must emphasize the benefits of evidence-based medicine as an anchor for both cost containment and quality care, as well as providing assistance to physicians in accepting economic decision-making as part of their professional role.

Objectives: Learning effects may have considerable influence on the performance of new health technologies, thereby on cost-effectiveness and ultimately on resource allocation. In the area of radiotherapy, equipment is becoming increasingly costly and the analysis of learning effects is complex given that sequential treatments are necessary, with multiple sessions for each patient. Our study aimed at analyzing learning effects in radiotherapy at an early stage of innovation.

Methods: We used multilevel analysis to separate out the different learning effects of the new technique. Statistical analysis of observational data collected in a French National prospective survey was performed using an individual growth model. Intrapatient learning was modeled at level 1, and two types of interpatient learning were considered at level 2, regarding possible influences of professional experience on (i) the duration of each patient's first session in a given setting and (ii) the rate of change of session duration over time for a given patient. Conventional radiotherapy was also considered for comparison.

Results: Our results demonstrate a substantial type-1 interpatient learning effect and an even higher intrapatient learning effect. No type-2 interpatient learning was at work: professional experience did not impact intrapatient learning. Moreover, some intrapatient learning was also reported with conventional radiotherapy and was not significantly modified by innovation. Session duration was in any case strongly influenced by disease.

Conclusions: Because professionals highly underestimated the learning phenomenon, assessment of learning cannot be based on professional statements and it requires careful analysis of observational data.

Objectives: Health Technology Assessment (HTA) is a relatively new concept in Latin America (LA). The objectives of this exploratory study were to identify HTA programs in LA, review HTA documents produced by those programs, and assess the extent to which HTA aims are being achieved.

Methods: An electronic search through two databases was performed to identify HTA programs in LA. A content analysis was performed on HTA documents (n = 236) produced by six programs between January 2000 and March 2007. Results were analyzed by comparing document content with the main goals of HTA.

Results: The number of HTA documents increased incrementally during the study period. The documents produced were mostly short HTA documents (82 percent) that assessed technologies such as drugs (31 percent), diagnostic and/or screening technologies (18 percent), or medical procedures (18 percent). Two-thirds (66 percent) of all HTA documents addressed issues related to clinical effectiveness and economic evaluations. Ethical, social, and/or legal issues were rarely addressed (<1 percent). The two groups most often targeted for dissemination of HTA information were third-party payers (55 percent) or government policy makers (41 percent).

Conclusions: This study showed that while HTA programs in LA have attempted to address the main goals of HTA, they have done so through the production of short documents that focus on practical high-technology areas of importance to two specific target groups. Clinical and economic considerations still take precedence over ethical, social, and/or legal issues. Thus, an integrated conceptual framework in LA is wanting.

Background: Non small cell lung cancer (NSCLC) diagnosis and treatment is a highly complex process, requiring managerial skills merged with clinical knowledge and experience. Integrated care pathways (ICPs) might be a good strategy to overview and improve patient's management. The aim of this study was to review the ICPs of NSCLC patients in a University Hospital and to identify areas of quality improvement.

Materials and Methods: The electronic medical records of 169 NSCLC patients visited at the University Hospital were retrospectively reviewed. Quality of care (QoC) has been measured trough fifteen indicators, selected according main international Guidelines and approved by the multi-disciplinary team for thoracic malignancies. Results have been compared with those of a similar retrospective study conducted at the same hospital in 2008.

Results: A total of 146 patients were considered eligible. Eight of fifteen indicators were not in line with the benchmarks. We compared the results obtained in the two separate periods. Moreover, we process some proposal to be discussed with the general management of the hospital, aimed to redesign NSCLC care pathways.

Conclusions: ICPs confirm to be feasible and to be an effective tool in real life. The periodic measurement of QoC indicators is necessary to ensure clinical governance of patients pathways.

Respiratory insufficiency has previously been a frequent cause of neonatal death, especially in preterm infants. As late as in 1967, Silverman and associates (66) found that in infants with hyaline membrane disease (HMD), mechanical ventilation with a body-enclosing negative pressure respirator did not improve survival. Before 1970, the mortality among infants who required respiratory therapy was high (20;46;70). At the end of the 1960s and the beginning of the 1970s, several new methods were introduced to improve ventilation of newborn infants. Kirby and coworkers (41) introduced intermittent mandatory ventilation as a way of weaning from mechanical ventilation. In a series of studies, Reynolds and coworkers evaluated the effects of different peak airway pressures, respiratory frequencies, and inspiratory:expiratory ratios on arterial blood gases and right to left shunts (32;58;59;60).