Background: For non-drug technologies, there is often residual uncertainty following systematic review, mainly due to inadequate evidence of efficacy. The unwillingness to make decisions in the presence of uncertainty may lead to passive diffusion and intuitive decision making with or without public pressure. This may affect health system sustainability. There is increasing interest in post-market evaluation through processes that include coverage with evidence development (CED) to address residual uncertainty regarding effectiveness and cost-effectiveness. Global experience of CED has been slow to develop despite their potential contribution to decision making.

Methods: Ontario's field evaluation program to better inform decision making represents a collaboration between physicians, policy decision makers and academic centers. We report results of the first ten CEDs from this program to assess whether they achieved their objective of influencing policy by addressing residual uncertainty following systematic review.

Results: Since 2003, nineteen field evaluation studies to resolve residual uncertainty following systematic review have been completed, ten of which met the criteria of CED and are the focus of this report. There was more than one patient subgroup or intervention in three of the CEDs. This provided the basis for evaluating thirteen outcomes. In each case, the CED addressed the uncertainty and led to a decision based on the systematic review and CED result. The CEDs led to adoption of the technology in six instances, modified adoption in three instances and withdrawal in four instances.

Conclusions: CED makes an important contribution to translating evidence to decision making. Methodologies are needed to increase the scope and reduce timelines for CEDs, such as the use of linked comprehensive and robust data sets and collaborative studies with other jurisdictions. CED before making long-term funding decisions, especially where there is uncertainty of effectiveness, safety or cost-effectiveness, should be increasingly funded by health systems.

Objectives: This study reports the cost-effectiveness of a preventive intervention, consisting of counseling and specific support for the mother–infant relationship, targeted at women at high risk of developing postnatal depression.

Methods: A prospective economic evaluation was conducted alongside a pragmatic randomized controlled trial in which women considered at high risk of developing postnatal depression were allocated randomly to the preventive intervention (n = 74) or to routine primary care (n = 77). The primary outcome measure was the duration of postnatal depression experienced during the first 18 months postpartum. Data on health and social care use by women and their infants up to 18 months postpartum were collected, using a combination of prospective diaries and face-to-face interviews, and then were combined with unit costs (£, year 2000 prices) to obtain a net cost per mother–infant dyad. The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves and net benefit statistics at alternative willingness to pay thresholds held by decision makers for preventing 1 month of postnatal depression.

Results: Women in the preventive intervention group were depressed for an average of 2.21 months (9.57 weeks) during the study period, whereas women in the routine primary care group were depressed for an average of 2.70 months (11.71 weeks). The mean health and social care costs were estimated at £2,396.9 per mother–infant dyad in the preventive intervention group and £2,277.5 per mother–infant dyad in the routine primary care group, providing a mean cost difference of £119.5 (bootstrap 95 percent confidence interval [CI], −535.4, 784.9). At a willingness to pay threshold of £1,000 per month of postnatal depression avoided, the probability that the preventive intervention is cost-effective is .71 and the mean net benefit is £383.4 (bootstrap 95 percent CI, −£863.3–£1,581.5).

Conclusions: The preventive intervention is likely to be cost-effective even at relatively low willingness to pay thresholds for preventing 1 month of postnatal depression during the first 18 months postpartum. Given the negative impact of postnatal depression on later child development, further research is required that investigates the longer-term cost-effectiveness of the preventive intervention in high risk women.

Objectives: To review the scientific evidence on the efficacy, effectiveness, and safety of intra-articular injections of Hylan G-F 20 for the treatment of knee osteoarthritis.

Methods: Systematic review of experimental and observational studies performed in humans up to December 1999. Qualitative and quantitative (meta-analytic) techniques were used for data synthesis.

Results: A single course of intra-articular Hylan G{-}F 20 provides a statistically significant and clinically relevant short-term decrease of the painful symptomatology of knee osteoarthritis and improves joint function. It also seems to delay the need for knee replacement, if results observed in noncontrolled studies are confirmed. Hylan G-F 20 has a comparable efficacy to that of oral NSAID, and a smaller risk of gastrointestinal adverse effects. It seems to be well tolerated and safe, but the short follow-up in most studies limits any extrapolation of the effectiveness and safety over the longer term. There is also scarce evidence on the effect of multiple courses of Hylan G-F 20, and the scientific rigor of both experimental and nonexperimental studies reviewed is somewhat limited.

Conclusions: Whereas there is good quality scientific evidence showing that Hylan G-F 20 is a safe and well-tolerated therapy providing a short-term decrease of the pain symptoms while improving joint function, the delay of the need for knee replacement as well as the durability of the effect over the longer term have only been demonstrated in noncontrolled clinical series. The available evidence is not sufficient to reach firm conclusions on the effect of multiple courses of intra-articular injections of Hylan G-F 20 on health outcomes.

Objectives: Clinical trials have demonstrated that fecal occult blood screening for colorectal cancer can significantly reduce mortality. However, to be deemed a priority from a public health policy perspective, any new program must prove itself to be cost-effective. The objective of this study was to assess the cost-effectiveness of screening for colorectal cancer using a fecal occult blood screening test, the Hemoccult-II, in a cohort of 100,000 asymptomatic individuals 50–74 years of age.

Methods: A decision analysis model using a Markov approach simulates the trajectory of the cohort allocated either to screening or no screening over a 20-year period through several health states. Clinical and economic data used in the model came from the Burgundy trial, French population-based studies, and Registry data.

Results: Modeling biennial screening versus the absence of screening over a 20-year period resulted in a 17.7 percent mortality reduction and a discounted incremental cost-effectiveness ratio of 3,357 € per life-year gained among individuals 50–74 years of age. Sensitivity analyses performed on epidemiological and economic data showed the strong impact on the results of colonoscopy cost, of compliance to screening, and of specificity of the screening test.

Conclusions: Cost-effectiveness estimates and sensitivity analyses suggest that biennial screening for colorectal cancer with fecal occult blood test could be recommended from the age of 50 until 74. Our findings support the attempts to introduce large-scale population screening programs.

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.

Breast cancer is the second leading cause of death by cancer among women in the United States. The total cost of illness for breast cancer has been estimated to be $3.8 billion, of which $1.8 billion represents medical care costs. It has been estimated that breast cancer detected early is considerably less expensive than when the tumor is discovered at a later stage. Mass screening using mammography can improve early detection by as much as 15–35%. Cost-effectiveness studies have estimated that the costs of breast cancer screening range between $13,200 and $28,000 per year of life saved. The cost-effectiveness of breast cancer screening in the 40–49-year-old age group is controversial. Mass screening for breast cancer will probably increase total health care costs, but when all economic costs are included, screening appears to be more cost-effective than not screening.

Objectives: To assess the clinical-effectiveness and cost-effectiveness of pegylated interferon alfa (2a and 2b) combined with ribavirin in previously untreated patients with moderate to severe chronic hepatitis C, compared with the current standard treatment, which is nonpegylated interferon alfa combined with ribavirin.

Methods: Systematic review and economic evaluation. A sensitive search strategy was applied to several electronic bibliographic databases. Relevant studies were critically appraised and meta-analyzed. A hypothetical cohort of 1,000 patients entered a Markov model and were followed up for a more than 30-year period to predict natural history, duration spent in each health state, and treatment costs.

Results: Two fully published Phase III randomized controlled trials were included. Methodological quality was generally good. Dual therapy with pegylated interferon was significantly more effective than nonpegylated dual therapy with a pooled sustained virological response rate (SVR) of 55 percent (95 percent confidence interval [CI], 52–58 percent) compared with 46 percent (95 percent CI, 43–49 percent). The pooled relative risk of remaining infected was 0.83 (95 percent CI, 0.76–0.91 percent). Genotype was the strongest predictor of outcome, with SVRs in patients with the more responsive genotypes 2 and 3 reaching up to 80 percent. The incremental cost per quality-adjusted life year (QALY) for pegylated dual therapy compared with nonpegylated dual therapy was £12,123. The cost per QALY remained under £30,000 for most patient subgroups and in sensitivity analyses.

Conclusions: Pegylated interferon is clinically effective, represents good value for the money, and is a significant advance in the treatment of this insidious disease.

Objectives: Health technology financing is often based on randomized controlled trials (RCTs), which are often the same ones used for licensing. Because they are designed to show the best possible results, typically Phase III studies are conducted under ideal and highly controlled conditions. Consequently, it is not surprising that technologies do not always perform in real life in the same way as controlled conditions. Because financing (and price paid) decisions can be made with overestimated results, health authorities need to ask whether health systems achieve the results they expect when they choose to pay for a technology. The optimal way to answer this question is to assess the performance of financed technologies in real-world settings. Health technology performance assessment (HTpA) refers to the systematic evaluation of the properties, effects, and/or impact of a health intervention or health technology in the real world to provide information for investment/disinvestment decisions and clinical guideline updates. The objective is to describe the development and principal aspects of the Guideline for HTpA commissioned by the Brazilian Ministry of Health.

Methods: Our methods used include extensive literature review, refinement with experts across countries, and public consultation.

Results: A comprehensive guideline was developed, which has been adopted by the Brazilian government.

Conclusion: We believe the guideline, with its particular focus on disinvestment, along with the creation of a specific program for HTpA, will allow the institutionalization and continuous improvement of the scientific methods to use real-world evidence to optimize available resources not only in Brazil but across countries.

Objectives: Coverage decisions are decisions by third party payers about whether and how much to pay for technologies or services, and under what conditions. Given their complexity, a systematic and transparent approach is needed. The DECIDE (Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence) Project, a GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group initiative funded by the European Union, has developed GRADE Evidence to Decision (EtD) framework for different types of decisions, including coverage ones.

Methods: We used an iterative approach, including brainstorming to generate ideas, consultation with stakeholders, user testing, and pilot testing of the framework.

Results: The general structure of the EtD includes formulation of the question, an assessment using twelve criteria, and conclusions. Criteria that are relevant for coverage decisions are similar to those for clinical recommendations from a population perspective. Important differences between the two include the decision-making processes, accountability, and the nature of the judgments that need to be made for some criteria. Although cost-effectiveness is a key consideration when making coverage decisions, it may not be the determining factor. Strength of recommendation is not directly linked to the type of coverage decisions, but when there are important uncertainties, it may be possible to cover an intervention for a subgroup, in the context of research, with price negotiation, or with restrictions.

Conclusions: The EtD provides a systematic and transparent approach for making coverage decisions. It helps ensure consideration of key criteria that determine whether a technology or service should be covered and that judgments are informed by the best available evidence.

Objectives: Approximately 10–15 percent of individuals with diabetes mellitus develop foot ulcers, which precede 85 percent of amputations. Increased oxygen, through the use of hyperbaric oxygen therapy (HBOT), has been suggested to encourage ulcer healing thus reducing the risk of amputation. The objective of this systematic review is to evaluate the efficacy of systemic HBOT for nonhealing ulcers of the lower limb in diabetes patients.

Methods: A systematic search, using controlled and keyword terms focusing on “HBOT” and “lower limb diabetic ulcers,” was conducted. Databases searched included Medline, EMBASE, CINAHL, PubMed, Wiley's Cochrane Library, and Biosis. Randomized controlled trials (RCTs) and observational studies were included. Pooled estimates of outcomes were determined when appropriate.

Results: Of the 654 citations identified, 157 articles underwent full-text review. Data were abstracted from twelve publications (six RCTs and six comparative observational studies). Pooled analysis of the RCT and observational data showed that treatment with HBOT reduced the risk of major amputation by 60 percent (p = .29) and 61 percent (p = .003) compared with standard wound care, respectively. The RCT data revealed that the relative risk of having an unhealed wound following HBOT was 0.54 (p = .10) and 0.24 (p < .0001) based on observational data.

Conclusions: Due to the limited RCT evidence, it is not possible to conclusively establish the benefits and harms of treating diabetic lower limb ulcers with HBOT. No significant effects on amputation rates were found in the RCT evidence and in the high quality studies, no difference was found.

This paper describes the development and testing of a European version of the Appropriateness Evaulation Protocol (AEP). It stemmed from the original U.S. version and the multiple adaptations and modifications made previously and separately by researchers in European countries. The group was particularly concerned with developing a common list of reasons for inappropriate admissions and days of stay, since the principal goal was to enable an understanding of inappropriate hospital use and potential solutions within local health and social care systems. Developing a common EU-AEP included several steps. First, each national instrument was translated from the national language to English. These back translations were compared with each other and with the US-AEP. A working group analyzed the content of the lists of reasons published in the literature and proposed a novel conceptual approach. On the basis of workshop discussions, a draft of a common European version was circulated to each participant for agreement. In the EU-AEP, the clinical criteria for the appropriateness of admission include 10 related to patient condition and five to clinical services. The criteria for the appropriateness of days of care include 10 covering medical services, six for life support/nursing services, and eight related to patient condition. The proposed core list of reasons of inappropriateness distinguish clearly between two concepts: a) the level of care required by the patient; and b) the reason why this level of care was not used. The first list would thus refer to the nature of resources and facilities required, while the second would focus more on the efficient organization of those resources. A validated European tool to assess inappropriate hospital admissions and hospital days of stay and their causes might be used to assess the need for resources for inpatient care as well as for outpatient care. Assessing the reasons for inadequacies might lead also to the examination of organizational questions. Finally, a common tool allows comparisons between countries concerning the frequency of inappropriate admissions and days of stay and their reasons in relation to the different organizations of health care across Europe.

Since the early days of medical computing, medical computer researchers have envisioned how computers could benefit medical research and practice and have deplored the inability of medicine to take full advantage of the computer's power. They, and others, have analyzed the causes for the medical computing “lag.” These analyses identify a wide range of difficulties that the introduction of computers into medicine faced, and continues to face.

In the last two decades a number of health status index models have been developed for assessing the value of health outcomes in terms of quality-adjusted life years. The models can be tested by comparing their implications with direct observations of how societies think resources should be distributed across patient groups. This paper reviews empirical evidence of this kind from various countries and summarizes the evidence in three rules of thumb for selecting values for health states. Nine different models are judged relative to these rules of thumb. Eight of the models underestimate the strength of social preferences for treating the severely ill before the less severely ill. The ninth has a strong bias against states associated with emotional distress. As a consequence, none of the models can be seen as sufficient stand-alone instruments for valuing health outcomes. Instead, the models may be seen as complementary and adjustable parts of a tool kit that should also include the rules of thumb suggested in this paper.

The most reliable information on any type of medical intervention is provided by the results of randomized clinical trials (RCTs). In response to increasing pressure to make effective use of limited resources, increasing numbers of health professionals rely on the medical literature, in particular reports of RCTs. However, RCTs may be influenced by a number of factors that introduce bias during the conduct, analysis, and reporting of the trial. Trials may be described as random, when in fact only quasi-random means of treatment allocation have been used; patients may be selectively removed from the analysis; and the report may restrict presentation to or give undue emphasis to only the analyses that yield positive results. The implications of such bias are discussed with particular reference to the effect that they may have on reviews and meta-analyses.

Objectives: The present study evaluated the cost-effectiveness of a behavioral graded exercise therapy (GET) program compared with usual care (UC) in terms of the performance of daily activities by patients with chronic shoulder complaints in primary care.

Methods: A total of 176 patients were randomly assigned either to GET (n=87) or to UC (n=89). Clinical outcomes (main complaints, shoulder disability [SDQ] and generic health-related quality of life [EQ-5D], and costs [intervention costs, direct health care costs, direct non–health-related costs, and indirect costs]) were assessed during the 12-week treatment period and at 52 weeks of follow-up.

Results: Results showed that GET was more effective than UC in restoring daily activities as assessed by the main complaints instrument after the 12-week treatment period (p=.049; mean difference, 7.5; confidence interval [CI], 0.0–15.0). These effects lasted for at least 52 weeks (p=.025; mean difference 9.2; CI, 1.2–17.3). No statistically significant differences were found on the SDQ or EQ5D. GET significantly reduced direct health care costs (p=.000) and direct non–health care costs (p=.029). Nevertheless, total costs during the 1-year follow-up period were significantly higher (p=.001; GET=€530 versus UC=€377) due to the higher costs of the intervention. Incremental cost-effectiveness ratios for the main complaints (0–100), SDQ (0–100), and EQ-5D (−1.0–1.0) were €17, €74, and €5,278 per unit of improvement, respectively.

Conclusions: GET proved to be more effective in the short- and long-term and reduces direct health care costs and direct non–health care costs but is associated with higher costs of the intervention itself.

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.

Objectives: To provide an overview of the development of health technology assessment (HTA) in Germany since the 1990s.

Methods: Analysis of key documents (e.g. literature, laws, and other official documentation) and personal experiences.

Results: Health technology assessment (HTA) entered the political agenda in Germany only in the mid-1990s, basically as the result of a top-down approach toward more efficiency in health care, but with a strong impetus of an evidence-based medicine movement. Accordingly, HTA became part of several healthcare reform laws since 1997, which led to the establishment of the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG) in 2004. This tandem construction aims at using evidence in decision-making processes for coverage and other decisions.

Conclusions: These developments have led to a considerable impact of HTA in Germany. In addition, a broad spectrum of activities at universities and in other organizations, such as the German Institute for Medical Documentation and Information (DIMDI), can be observed that contribute to both teaching and research in HTA. German researchers in the field of HTA are actively involved in international projects, such as EUNetHTA, and contribute to scientific conferences and journals.

Background: Despite the mandate to examine the medical, ethical, and economic implications of the development and use of health technology, health technology assessment (HTA) reports often emphasize the epidemiologic and economic aspects, and omit ethical considerations. This study examines both whether and how ethical issues are incorporated into HTA.

Objectives: We aim to (i) review a set of Canadian HTA reports for ethics content, (ii) describe the strategies used to incorporate ethically relevant information into HTA, and (iii) determine the presence of implicit ethical issues in a sample of HTA reports.

Methods: Descriptive and qualitative content analysis of 608 HTA reports produced by six Canadian HTA agencies from January 1997 to December 2006.

Results: We found that (i) a minority (17 percent) of Canadian HTA reports addressed ethical issues, (ii) secondary research predominates while primary analysis is rare, (iii) implicit ethical issues are present in HTA reports that do not purport to address ethics.

Conclusions: Canadian HTA reports rarely explicitly, and then only superficially, address ethics, though implicit ethical issues abound.

Objectives: Recent policy recommendations for cervical screening include liquid-based cytology. This new approach could improve laboratory throughput, reducing the waiting time for test results. New guidelines also standardize the interval for screening, with women aged 25–50 offered screening every 3 years and women aged 50–64 every 5 years. Quantitative evidence on the preferences of women for alternative screening programs is limited; this study, therefore, elicits such preferences.

Methods: A postal questionnaire using a discrete choice experiment was mailed to 2,000 women in the Tayside Health Board region of Scotland.

Results: A response rate of 44 percent from those women who had previously had a smear was achieved. Women had a significant positive preference for reductions in recall rates and waiting time for results. Women preferred more frequent screening, particularly those aged 50+. Expected reductions in the chance of recall from the conventional Pap smear to the new liquid-based cytology were associated with a willingness to pay of £41. Women aged 50+ would be willing to pay £42 to increase the frequency of screening from every 5 to every 3 years. Service characteristics did not influence screening participation.

Conclusions: Guidance to move to liquid-based cytology will meet women's preferences for fewer repeat cervical smears and should reduce waiting time for results. However, proposals to increase screening intervals for those aged 50+ are inconsistent with the preferences for this age group. From a policy perspective, our study results suggest that the changes in attributes of the service such as unsatisfactory smear rates and frequency of screening, will improve service efficiency without affecting participation rates.