Objectives: This investigation was undertaken to study the costs of a Case Method Learning (CML) -supported lipid-lowering strategy in secondary prevention of coronary artery disease (CAD) in primary care.

Methods: This prospective randomized controlled trial in primary care with an additional external specialist control group in Södertälje, Stockholm County, Sweden, included 255 consecutive patients with CAD. Guidelines were mailed to all general practitioners (GPs; n=54) and presented at a common lecture. GPs who were randomized to the intervention group participated in recurrent CML dialogues at their primary health-care centers during a 2-year period. A locally well-known cardiologist served as a facilitator. Assessment of low-density lipoprotein (LDL) cholesterol was performed at baseline and after 2 years. Analysis according to intention-to-treat—intervention and control groups (n=88)—was based on group affiliation at baseline. The marginal cost of lipid lowering comprised increased cost of lipid-lowering drugs in the intervention group compared with the primary care control group, cost of attendance of the GP's in the intervention group, and cost of time for preparation, travel, and seminars of the facilitator. Costs are as of 2002 with an exchange rate 1 US$=9.5 SEK (Swedish Crowns).

Results: Patients in the primary care intervention group had their LDL cholesterol reduced by 0.5 (confidence interval [CI], 0.1–0.9) mmol/L compared with the primary care control group (p<.05). No change occurred in controls. LDL cholesterol in the external specialist control group decreased by 0.6 (CI, 0.4–0.8) mmol/L. The cost of the educational intervention represented only 2 percent of the drug cost. The cost of lipid lowering in the intervention group, including the cost of the educational intervention, was actually lower than that of patients treated at the specialist clinic—106 US$ per mmol decrease in LDL cholesterol in the intervention group and 153 US$ per mmol decrease in LDL cholesterol in the specialist group. EuroQol 5D Index, which gives an estimate of global health-related quality of life, was 0.80 (CI, 0.75–0.85) in the present cohort.

Conclusions: The additional cost of CML was only 2 percent of the drug cost. Assuming the same gain in life expectancy per millimole decrease in LDL cholesterol as in the 4S-study gives a cost per gained quality-adjusted life year of US$ 24,000. This finding indicates that the CML-supported lipid-lowering strategy is cost-effective. The low cost of CML in primary care should probably warrant its use in the improvement of the quality of care in other major chronic diseases.

Objectives: The aim of this study was to identify and characterize studies that have used quality-adjusted life-years (QALYs) based on measurements of patients’ health-related quality of life (HRQoL) as an indicator of effectiveness of screening programs.

Methods: Systematic search of the literature until March 2010, using several electronic databases. Initial screening of articles based on abstracts, and evaluation of full-text articles were done by at least two of the authors.

Results: The search identified 1,610 articles. Based on review of abstracts, 431 full-text articles were obtained for closer inspection and, of these, 81 reported QALYs based on patient-derived data using a valid HRQoL assessment. The most frequently used method to assess HRQoL was Time Trade-Off (55 percent) followed by EQ-5D (26 percent). The most frequently studied medical conditions were malignant diseases (23 percent) followed by cardiovascular diseases (19 percent). All studies employed some kind of modeling with the Markov model being the most prevalent type (65 percent). Majority of the articles (59 percent) concluded that the screening program studied was cost-effective.

Conclusions: The use of QALYs in the evaluation of screening programs has expanded during the last few years. However, only a minority of studies have used HRQoL data derived from patients, using direct or indirect valuation. Further investigation and harmonization of the methodology in evaluation of screening programs is needed to ensure better comparability across different screening programs.

Objectives: This research integrates existing literature on information technology (IT) in hospitals, and proposes and validates a comprehensive IT capacities assessment tool in these settings.

Methods: A comprehensive literature review was conducted on Medline until September 2006 to identify studies that used specific IT measures in hospitals. The results were mapped and used as a basis for the development of the proposed instrument, which was tested through a survey of Canadian healthcare organizations (N = 221).

Results: A total of seventeen studies provided indicators of clinical and administrative IT capacities in hospitals. Based on the mapping of these indicators, a comprehensive IT capacities assessment instrument was developed including thirty-four items exploring computerized processes, thirteen items assessing contemporary technologies, and eleven items investigating internal and external information sharing. A time frame was inserted in the tool to reflect “plans for” versus “current” implementation of IT; in the latter, the extent of current use of computerized processes and technologies was measured on a (1–7) scale. Overall, the survey yielded a total of 106 responses (52.2 percent response rate), and the results demonstrated a good level of reliability and validity of the instrument.

Conclusions: This study unifies existing work in this area, and presents the psychometric properties of an IT capacities assessment tool in hospitals. By developing scores for capturing IT capacities in hospitals, it is possible to further address important research questions related to the determinants and impacts of IT sophistication in these settings.

Objectives: The aim of this study was to briefly describe the current state of early awareness and alert (EAA) activities and systems in four Latin-American countries (Argentina, Brazil, Colombia, and Mexico).

Methods: Key informants were selected and completed an open questionnaire that included the following domains: current state of EAA activities and systems in each country, potential role for EAA systems in the health system, and future EAA projects that are currently being considered.

Results: In all four countries, health technology assessment (HTA) processes are used to prioritize the use of health resources, albeit at varying degrees and with different mechanisms and methodologies. EAA activities are still limited and there are virtually no institutions or units with specific functions explicitly devoted to EAA activity. However, most countries have developed some initial forms of EAA systems. Being in its initial stages there is no clear differentiation between these early awareness activities and other HTA functions, and no specific methodologies or processes are used to anticipate the emergence of new technologies. Consequently, early evaluation of technologies generally occurs in a reactive manner, after they have been introduced in the market and under the pressure of different stakeholders.

Conclusions: There is growing awareness that the early identification and assessment of emerging technologies should be an integral part of HTA and the decision-making process. Many initiatives are currently focusing on building partnerships between the various regulatory bodies involved in the incorporation of technologies at national levels. It is reasonable to foresee that EAA activities will continue to develop and expand in the region.

There has been tremendous technological innovation in the healthcare sector, but it has also raised serious ethical and social concerns. The COVID-19 pandemic has only magnified these existing challenges. Hence, addressing these challenges becomes imperative in the “new normal.” In this context, this article uses a narrative synthesis approach to discuss the linkages of health technology, innovation, and policy to identify the challenges of this complex interaction by applying the principles of pragmatism and historicity to the existing literature. Moreover, the existing scientific mechanisms in the form of health technology assessment (HTA) and responsible innovation in health (RIH) are described to address these challenges. Using inductive epistemology, the linkages between HTA and RIH within a health innovation ecosystem framework are discussed for the future application of an integrated approach to address societal challenges. The proposed integrated approach of HTA and RIH is a work in progress and conceptualized as transdisciplinary, flexible, and adaptive, which is expected to facilitate future discussion, research, and policy action.

Objectives: The role of biomedical engineers (BMEs) has changed widely over the years, from managing a group of technicians to the planning of large installations and the management of medical technology countrywide. As the technology has advanced, the competence of BMEs has been challenged because it is no longer possible to be an expert in every component of the technology involved in running a hospital. Our approach has been to form a network of professionals that are experts in different fields related to medical technology, where work is coordinated to provide high quality services at the planning and execution stages of projects related to medical technology.

Methods: A study of the procedures involved in the procurement of medical technology has been carried out over the years. These experiences have been compared with several case studies where the approach to problem solving in this area has been multidisciplinary. Planning and execution phases of projects involving medical technology management have been identified.

Results: After several instances of collaboration among experts from different fields, a network for management of healthcare technology has been formed at our institution that incorporates the experience from different departments that were dealing separately with projects involving medical technology.

Conclusions: This network has led us to propose this approach to solve medical technology management projects, where the strengths of each subgroup complement each other. This structure will lead to a more integrated approach to healthcare technology management and will ensure higher quality solutions.

Objectives: Effective formulary management in healthcare institutions safeguards rational drug use and optimizes health outcomes. We implemented a formulary management program integrating the principles of health technology assessment (HTA) to improve the safe, appropriate, and cost-effective use of medicine in Singapore.

Methods: A 3-year formulary management program was initiated in 2011 in five public healthcare institutions. This program was managed by a project team comprising HTA researchers. The project team worked with institutional pharmacy and therapeutics (P&T) committees to: (i) develop tools for formulary drug review and decision making; (ii) enhance the HTA knowledge and skills of formulary pharmacists and members of P&T committees; (iii) devise a prioritization framework to overcome resource constraints and time pressure; and (iv) conceptualize and implement a framework to review existing formulary.

Results: Tools that facilitate drug request submission, drug review, and decision making were developed for formulary drug inclusion. A systematic framework to review existing formulary was also developed and tested in selected institutions. A competency development plan was rolled out over 2 years to enhance formulary pharmacists’ proficiency in systematic literature search and review, meta-analysis, and pharmacoeconomic evaluation. The plan comprised training workshops and on-the-job knowledge transfer between the project team and institutional formulary pharmacists through collaborating on selected drug reviews. A resource guide that consolidated the tools and templates was published to encourage the adoption of best practices in formulary management.

Conclusions: Based on the concepts of HTA, we implemented an evidence-based approach to optimize formulary management.

Objectives: The aim of this study was to assess effect of adult diapers on health-related quality of life (HRQOL) and the independent level of performing activities of daily living (ADLs) in people with urinary or fecal incontinence. Psychological consequences of patients’ caregivers were also measured.

Methods: This quasi-experimental study was conducted at two rehabilitation centers in Thailand. People aged 15 years or greater with chronic urinary or fecal incontinence were eligible. Study participants received adult diapers for 10 weeks after recruitment. Thai EuroQol Five Dimensions (EQ-5D) and the Barthel Index were measured at baseline and weeks 2, 6, and 10 to evaluate HRQOL and the independent level of performing ADLs, respectively. The Braden Scale was used to assess the risk of having pressure ulcers. Mean differences in the Thai EQ-5D, the Barthel Index, and the Braden Scale, before and after receiving adult diapers, were estimated using a multilevel linear regression model.

Results: There were ninety patients and forty-eight caregivers who took part in this study. HRQOL and independent level of performing ADLs had improved significantly by week 10 after receiving adult diapers with mean differences of 0.102 (95% confidence interval [CI], 0.046–0.158) and 4.40 (95% CI, 1.74–7.07), respectively. The risk of having pressure ulcers had significantly decreased by 67 percent (95% CI, 16 percent–78 percent) by week 10 after receiving adult diapers.

Conclusions: The results indicate a significant improvement of HRQOL and the independent level of performing ADLs among incontinent patients after receiving adult diapers. These results were used to inform the development of the health benefits package under the Universal Health Coverage Scheme in Thailand.

Objectives: The aim of this study was to investigate originator pharmaceutical companies’ practices in relation to health technology assessment (HTA) and the views and perceptions of their executives on the importance of HTA in pricing and reimbursement of medicines in Greece.

Methods: A qualitative study was performed, using individual semi-structured interviews based on an interview schedule with open-ended questions. The target population was market access departments’ executives of originator pharmaceutical companies. Our target sample consisted of sixteen executives, of whom ten agreed to participate. Saturation point was reached after eight interviews. Data were audio recorded, transcribed verbatim, and analyzed using content analysis.

Results: Participants considered HTA as a very important complementary tool for decision making in health policy, particularly in the field of pharmaceuticals and medical devices. They believed that, in Greece, HTA could be institutionalized for the reimbursement mechanism of medicines under certain conditions relating to current health policy-making attitudes and conditions pertaining in the country. They considered that there are many constraints which must be overcome as well as opportunities to be exploited.

Conclusions: Decisions in pharmaceutical policy should be scientifically substantiated and HTA should be institutionalized primarily for reimbursement decisions. Development of guidelines for conducting pharmaco-economic evaluation, change in health policy goals, recording of cost and epidemiological data, and broader participation of all stakeholders in HTA decision-making processes are suggested as prerequisites for a successful implementation of HTA in Greece.

In recognition of patients’ roles using, and contributing to, a publicly funded health system, the Canadian Agency for Drugs and Technologies in Health (CADTH) created a Patient and Community Advisory Committee. Twelve members bring lived experiences of chronic illness, progressive illness, mental illness, trauma, traveling long distances for treatment, and caregiving to an ill child, parent, or spouse. Members contribute their own insights and ideas but do not represent specific organizations or viewpoints. This paper explores how CADTH determined the committee's role, whether to have individuals or organizations as members, and how to recruit for diversity. The creation of this committee is changing how CADTH engages with patients.

Objectives: Assessment of willingness to pay (WTP) by contingent valuation (CV) and choice experiments (CE) is increasingly performed in economic evaluation of health care. However, the question of whether the methods for measuring WTP are acceptable to decision makers and scientists has remained largely unacknowledged. The aim of this study was to learn more about decision makers' and scientists' opinion concerning these methods.

Methods: An expert group developed a questionnaire consisting of key items that may influence the opinion about CV and CE according to the constructs “attitude toward behavior,” “subjective norm,” and “behavioral intention” as defined by the Theory of Reasoned Action by Ajzen and Fishbein. In a survey, seventy-seven decision makers representing key institutions in the German healthcare system and forty-two scientists in health economics completed the questionnaire.

Results: Scientists and decision makers in particular did not show a high intention to use methods for measuring WTP. Skepticism regarding precision of the methods and subjects' capability to imagine paying an amount of money for a certain health commodity were stated along with the assertion that the hypothetical decision-making scenario was rather a distant reality. Nevertheless, the majority of scientists and decision makers did not state rejection of the methods.

Conclusions: Increasing the probability of using methods for measuring WTP in health care, the hypothetical scenarios should be made more realistic and payment vehicles should be used to help patients relate payment to a real health benefit. Moreover, an intensive discussion on the potential usefulness of CV/CE without excluding ethical concerns in comparison to existing alternatives has to be resumed.

Prognostic factors were analyzed among women with ovarian cancer. Stage, histologic subtype and grade, age, performance status, residual tumor size, and platinum-based chemotherapy were factors that significantly influenced the survival rate. Based on these findings, we performed maximal cytoreductive surgery and gave dose-intensified platinum-based chemotherapy to patients with advanced disease and were able to improve survival rate significantly.

A review of 39 articles found no consensus on indication for laparoscopic assisted vaginal hysterectomy (LAVH) compared with traditional approaches. Since only three randomized trials comparing LAVH with traditional methods exist, the scientific basis for surgical choice is lacking. Uncontrolled studies indicated that outcomes following LAVH were not superior to vaginal hysterectomy and costs were significantly higher.

Health technology assessment (HTA) agencies are considering adopting a lifecycle approach to assessments to address uncertainties in the evidence base at launch and to revisit the clinical and economic value of therapies in a dynamic clinical landscape. For reassessments of therapies post launch, HTA agencies are looking to real-world evidence (RWE) to enhance the clinical and economic evidence base, though challenges and concerns in using RWE in decision-making exists. Stakeholders are embarking on demonstration projects to address the challenges and concerns and to further define when and how RWE can be used in HTA decision making. The Institute for Clinical and Economic Review piloted a 24-month observational RWE reassessment. Key learnings from this pilot include identifying the benefits and challenges with using RWE in reassessments and considerations on prioritizing and selecting topics relevant for RWE updates.