Purpose: The aim of this study was to identify and analyze the characteristics of leadership and management associated with a successful Lean thinking adaptation in healthcare.

Design: A systematic literature review was undertaken using electronic databases: PubMed, PubMed Systematic Review, ABI/INFORM, Business Source Complete, Emerald, JBI, and Cinahl. Inclusion criteria were: (i) a description of Lean management or leadership in health care, (ii) a reference to Lean thinking, (iii) a peer-reviewed original research article or a literature review, and (iv) a full text article available in English. Among the 1,754 peer-reviewed articles identified, nine original articles and three systematic reviews met the inclusion criteria. Data on informants, methods, and settings were extracted and collated. Content analysis was used to conduct a review of the nine original studies describing and analyzing the success factors of Lean adaptation. The characteristics of leadership and management were analyzed by using the concept of a managerial windshield that divides leadership and management into four ontological dimensions: activities, style, focus, and purpose, each with typical developmental stages of skills and capabilities. The current study has some limitations: some papers from the journals not indexed in the searched databases may have been overlooked and the literature searches were carried out only for a 5-year period.

Findings: Considering the results using the windshield concept emphasizes the philosophy, principles, and tools of Lean thinking. Lean leadership and management factors in health care were mainly conceptualized as skills and capabilities such as problem solving, making changes occur, empowering, communicating, coaching, supporting, facilitating, being democratic, organizational learning, and organizational success, all of which represented middle-stage or advanced managerial skills and capabilities.

Practical Implications: A conceptual analysis of systematically reviewed studies of Lean leadership and management point to certain traits as being typical when adapting Lean thinking to health care. The concept of a managerial windshield is useful when categorizing and analyzing essential managerial skills and capabilities for Lean implementation. Findings are beneficial when learning and educating the skills required for Lean transformation in healthcare organizations.

Deliberative processes are a well-established part of health technology assessment (HTA) programs in a number of high- and middle-income countries, and serve to combine complex sets of evidence, perspectives, and values to support open, transparent, and accountable decision making. Nevertheless, there is little documentation and research to inform the development of effective and efficient deliberative processes, and to evaluate their quality. This article summarizes the 2020 HTAi Global Policy Forum (GPF) discussion on deliberative processes in HTA.

Through a combination of small and large group discussion and successive rounds of polling, the GPF members reached strong agreement on three core principles for deliberative processes in HTA: transparency, inclusivity, and impartiality. In addition, discussions revealed other important principles, such as respect, reviewability, consistency, and reasonableness, that may supplement the core set. A number of associated supporting actions for each of the principles are also described in order to make each principle realizable in a given HTA setting. The relative importance of the principles and actions are context-sensitive and must be considered in light of the political, legislative, and operational factors that may influence the functioning of any particular HTA environment within which the deliberative process is situated. The paper ends with suggested concrete next steps that HTA agencies, researchers, and stakeholders might take to move the field forward. The proposed principles and actions, and the next steps, provide a springboard for further research and better documentation of important aspects of deliberation that have historically been infrequently studied.

Objectives: The aim of this study was to determine the insulin-delivery system and the attributes of insulin therapy that best meet patients' preferences, and to estimate patients' willingness-to-pay (WTP) for them.

Methods: This was a cross-sectional discrete choice experiment (DCE) study involving 378 Canadian patients with type 1 or type 2 diabetes. Patients were asked to choose between two hypothetical insulin treatment options made up of different combinations of the attribute levels. Regression coefficients derived using conditional logit models were used to calculate patients' WTP. Stratification of the sample was performed to evaluate WTP by predefined subgroups.

Results: A total of 274 patients successfully completed the survey. Overall, patients were willing to pay the most for better blood glucose control followed by weight gain. Surprisingly, route of insulin administration was the least important attribute overall. Segmented models indicated that insulin naïve diabetics were willing to pay significantly more for both oral and inhaled short-acting insulin compared with insulin users. Surprisingly, type 1 diabetics were willing to pay $C11.53 for subcutaneous short-acting insulin, while type 2 diabetics were willing to pay $C47.23 to avoid subcutaneous short-acting insulin (p < .05). These findings support the hypothesis of a psychological barrier to initiating insulin therapy, but once that this barrier has been overcome, they accommodate and accept injectable therapy as a treatment option.

Conclusions: By understanding and addressing patients' preferences for insulin therapy, diabetes educators can use this information to find an optimal treatment approach for each individual patient, which may ultimately lead to improved control, through improved compliance, and better diabetes outcomes.

Objectives: Rare diseases are often heterogeneous in their progression and response to treatment, with only a small population for study. This provides challenges for evidence generation to support HTA, so novel research methods are required.

Methods: Discussion with an expert panel was augmented with references and case studies to explore robust approaches for HTA evidence generation for rare disease treatments.

Results: Traditional RCTs can be modified using sequential, three-stage or adaptive designs to gain more power from a small patient population or to focus trial design. However, such designs need to maintain important design aspects such as randomization and blinding and be analyzed to take account of the multiple analyses performed. N-of-1 trials use within-patient randomization to test repeat periods of treatment and control until a response is clear. Such trials could be particularly valuable for rare diseases and when prospectively planned across several patients and analyzed using Bayesian techniques, a population effect can be estimated that might be of value to HTA. When the optimal outcome is unclear in a rare disease, disease specific patient reported outcomes can elucidate impacts on patients’ functioning and wellbeing. Likewise, qualitative research can be used to elicit patients’ perspectives, with just a small number of patients.

Conclusions: International consensus is needed on ways to improve evidence collection and assessment of technologies for rare diseases, which recognize the value of novel study designs and analyses in a setting where the outcomes and effects of importance are yet to be agreed.

Objectives: The aim of this study was to assess the evidence that reuse of medical devices marketed for single use only (SUDs) is safe, effective and cost-effective, and to consider the use and health services impact of this practice in Canada.

Methods: A systematic review was performed of studies that reported clinical or economic outcomes following reuse of SUDs in humans. Direct costs of adverse health events associated with SUD reuse and indications of budget impact were obtained using data for devices for laparoscopic cholecystectomy and coronary angioplasty. Legal and ethical issues were reviewed, drawing on material relevant to Canada. Data on current reuse of SUDs were obtained through a survey of Canadian acute care hospitals.

Results: Studies of variable quality suggested that SUD reuse could be safe and effective, and would give cost savings, if there were no adverse events. Eliminating reuse of SUDs for laparoscopic cholecystectomy and coronary angioplasty would add less than 0.1 percent to costs of the procedures over 1 year. Adverse health events associated with device reuse create liability risks; patients should be informed of any known or foreseeable risks of reuse. Most of the 28 percent (111/398) of acute hospitals that reprocess SUDs do so in-house. Some do not have a written policy or an incident reporting mechanism.

Conclusions: There is insufficient evidence to establish the safety, efficacy and cost-effectiveness of reusing SUDs. Legal and ethical issues require attention to minimize liability and maintain patient safety and trust. Some hospitals that reprocess SUDs do not have adequate documentation. These findings do not support the reuse of SUDs in Canadian hospitals.

Objective: To review published data regarding the accuracy and effectiveness of three screening tests: mammography, prostate-specific antigen (PSA), and prenatal ultrasound.

Methods: Published evidence regarding the accuracy and effectiveness of the three tests was collected by computerized literature search and supplemented by manual review of relevant bibliographies.

Results: Screening mammograms lower breast cancer mortality by about 20%. Most data come from women aged 50–64 years; women aged 40–49 years may also benefit, but the absolute risk reduction is lower. Up to 1,500 to 2,500 women must undergo screening to prevent one death from breast cancer. Mammograms miss approximately 12% to 37% of cancers, generate false-positive results, and cause anxiety while abnormal results are evaluated. PSA screening can detect 80% to 85% of prostate cancers but has a high false-positive rate. There is little direct evidence that early detection reduces morbidity or mortality. Indirect evidence includes a trend toward earlier stage tumors and steadily declining mortality rates in geographic areas where PSA screening has become common. Potential harms include the morbidity associated with evaluating abnormal results, and complications from treatment (e.g., impotence, incontinence). The overall balance of benefits and harms remains uncertain in the absence of better evidence. Prenatal ultrasound may reduce perinatal mortality, primarily through elective abortions for congenital anomalies, but does not appear to lower live birth rates. Although ultrasound has no proven effect on neonatal morbidity, it provides more accurate estimates of gestational age that prevent unnecessary inductions for post-term pregnancy. Screening detects multiple gestations, congenital anomalies, and intrauterine growth retardation, but direct health benefits from having this knowledge are unproved. Ultrasound has both positive and negative psychological effects on parents. The scans do not appear to harm childhood development.

Conclusions: Even for the most established screening tests, the appropriateness of routine testing depends on subjective value judgments about the quality of supporting evidence and about the trade-offs between benefits and harms. Individuals, clinicians, policy makers, and governments must weigh the evidence in light of these values and the constraints imposed by available resources.

Cost-effectiveness analysis compared four treatments of end-stage renal disease in Brazil: continuous ambulatory peritoneal dialysis (CAPD), in-center hemodialysis (HD), cadaver donor transplantation (CD-Tx), and living related donor transplantation (LR-Tx). After 2 years, the costs per year of survival were CAPD, $12,134; HO, $10,065; CO-Tx, $6,978; and LR-Tx, $3,022. The HD cost was lower than CAPO partially because of the reuse of hemodialyzers in Brazil. Although less cost-effective, both dialysis treatments yielded more years of survival after 2 years. This analysis reveals a trade-off between cost per year of survival and years of survival.

Objectives: The aim of this study was to describe the developing health technology assessment (HTA) activities in Brazil, both historically and in the present day.

Methods: This report is a descriptive analysis based on personal experiences of the authors and on selected literature.

Results: Interest in HTA in Brazil began in the mid-1980s. Several seminars and consultations were held, often with invited foreign participants. A cadre of people with knowledge and expertise in HTA was gradually developed. In 2003, several policies were developed by the federal government of Brazil to encourage HTA and base clinical, management, and policy decisions on HTA. During the past 5 years, institutional development has been rapid in government, private companies (mainly prepaid health plans), academia, and research institutes. Further policy changes are needed to maximize the impact of these developments. Nevertheless, although the growing network of HTA programs will have a considerable impact on Brazilian health care, further institutional development could stimulate this change.

Conclusions: It would be desirable if the Federal Ministry of Health of Brazil were to proceed to develop a national agency for HTA.

Objectives: There is widespread commitment—at least in principle—to “evidence-informed” clinical practice and policy development in health care. The intention is that only “appropriate” care ought to be delivered at public expense. Although the rationale for an appropriateness agenda is widely endorsed, and methods have been proposed for addressing it, few published studies exist of contemporary policy initiatives which have actually led to successful disinvestment. Our objective was to explore whether the direct involvement of policy stakeholders could advance appropriateness and disinvestment.

Methods: Several collaborative engagements with policy stakeholders were undertaken to adapt and combine conceptual and empirical material related to appropriateness and disinvestment from the literature to create tools and processes for use in Canada and the province of Ontario in particular.

Results: By combining inputs from the literature with colloquial evidence from policy stakeholders, a definition of appropriateness was developed and, importantly, endorsed by all the provincial and territorial ministers of health in Canada. Second, a reassessment framework was successfully implemented for identifying priorities for selective disinvestment.

Conclusions: When scientific evidence was combined with colloquial evidence from policy stakeholders, progress was made on the design and successful implementation of policies for appropriateness and disinvestment.

Objectives: Research has shown that effectiveness, cost-effectiveness, and severity of illness each play a role in drug reimbursement decisions. However, the role of budget impact in such decisions is less obvious. Policy makers almost always demand a budget impact estimate yet seem reluctant to formally include budget impact as a rationing criterion. Health economists even reject budget impact as a legitimate criterion. For these reasons, it is important to examine its use in rationing decisions, and rationales underlying its use.

Methods: We trace several rationales supporting the use of budget impact through a literature review, supplemented by semistructured interviews with eleven key stakeholders involved in drug reimbursement decisions in the Netherlands.

Results: Budget impact arguments are used in certain instances, although policy makers appear uncomfortable with its use because well described rationales still are lacking. In addition, we identify the following rationales to support budget impact as a rationing criterion: opportunity costs, loss aversion, uncertainty and equal opportunity.

Conclusions: Budget impact plays a role in drug reimbursement decisions and has rationales to support its use. However, policy makers do not easily admit that they consider budget impact and are even reluctant to explicitly use budget impact as a formal criterion. A debate would strengthen the theoretical foundation of budget impact as a legitimate criterion in the context of drug reimbursement decisions. Such discussion of budget impact's role will also enhance policy-makers' accountability.

Objectives: The frequency and consequences of major bleeding associated with anticoagulant prophylaxis for prevention of venous thromboembolism is examined.

Methods: We conducted a systematic review and meta-analysis of controlled trials that reported rates of major bleeding after pharmaceutical thromboprophylaxis in patients undergoing major orthopedic surgery. Thromboprophylactic agents were divided into four groups:warfarin/other coumarin derivatives (WARF), unfractionated heparin (UFH), low molecular weight heparin (LMWH), and pentasaccharide (PS). Meta-analysis was conducted comparing LMWH with each of WARF, UFH, and PS. The frequency of re-operation due to major bleeding was reviewed and combined with published costs to estimate the mean cost of managing major bleeding events in these patients.

Results: Twenty-one studies including 20,523 patients met inclusion criteria for the meta-analysis. No evidence of significant between-trial heterogeneity in risk ratios was found. Combined (fixed effects) relative risks (RR) of major bleeding compared with LMWH were WARF – RR 0.59 (95 percent confidence interval [CI], 0.44–0.80); UFH – RR 1.52 (95 percent CI, 1.04–2.23); PS – RR 1.52 (95 percent CI, 1.11–2.09). Seventy-one studies including 32,433 patients were included in the review of consequences of major bleeding. We estimated that the average cost of major bleeding is $113 per patient receiving thromboprophylaxis.

Conclusions: LMWH results in fewer major bleeding episodes than UFH and PS but more than WARF. These events are costly and clinically important.

Despite the perception of many people that lasers represent the cutting edge of high-technology medicine, this form of medical technology has been subject to relatively little rigorous evaluation. This dearth of research relates particularly to economic evaluation, where there have been few attempts to justify the high cost of laser equipment. This paper details an economic evaluation of the use of laser technology as a secondary adjunct to angioplasty to treat peripheral arterial occlusions. Using data from a range of sources, including a published randomized trial, a cost-utility model is developed to estimate the costs and benefits of the laser, relative to standard angioplasty. The best available data indicate a cost-effective role for the laser, but important areas of uncertainty exist, including the laser's secondary recanalization rate, which has been estimated on the basis of limited numbers of patients. This uncertainty suggests that further research is required before widespread diffusion of the laser for use in this clinical context.

This article considers technology assessment (TA) to be a comprehensive form of policy research. Technology assessment must then have a relation to policy-making; in the area of health care, TA must relate to such political decisions as resource allocation. Since policies are determined politically, i.e., by factors such as power and influence, technology assessment is, or should be, part of a political process. Technology assessment seems to be developing predominantly as a technical and professional activity, carried out in centers with no relation to the policy-making process. While the impact of technology on health, as well as such broader impacts as those on financial costs, is a key concern, political considerations and political decision-making must always be an important dimension in health care TA.

This article reviews the methods of economic evaluation of health technology. The different forms of evaluation are outlined and the importance of assessing costs and benefits at the margin stressed. The approaches used by economists to analyze priorities for health technologies are discussed and a number of key managerial and policy issues identified. It is concluded that, while further methodological improvements can be made, a clear methodology for economic evaluation of health technologies has been established. However, attention needs to be paid to the timeliness and relevance of economic evaluation in order to ensure its maximum impact

Objectives: A set of fifteen key principles (KP) has been recently proposed to guide decisions on the structure of HTA programs, the methods of HTA, the processes for conducting HTA and the use of HTA findings in decision-making. The objective of this research is to explore whether these KPs are relevant and useful in Latin America (LA), and to what extent they are being applied.

Methods: A Web-based survey was sent to 11,792 HTA researchers and users in LA to explore the perceived relevance of each KP, its current level of application and the gap between these two.

Results: We received 1,142 responses from nineteen LA countries (9.7 percent response rate). The subgroup of KP related to Methods and to the Use of HTA received the higher mean scores in the relevance scale (9.00 and 8.94). Level of current application scored low in all KP (3.2 to 4.9). Higher gaps were observed in principles related to the use of HTA in decision making and to the processes for conducting HTA. Countries with more developed HTA showed higher scores in the degree of current application (5.3 versus 3.4, p < .01) and lower gaps (3.84 versus 5.21, p < .01). Researchers, compared with research users, scored the relevance of the KPs higher.

Conclusions: KPs seem to be very relevant to most HTA researchers and users in LA. However, the current level of application was considered uniformly poor. Higher gaps were observed in KPs related to the link between HTA and decision making, highlighting one of the major challenges for the countries in the region.