Objectives: This study explores the factors that enhance or reduce the prospects for public involvement in the activities of health technology assessment (HTA) agencies.

Methods: The analytical framework for this study is based on the work of John W. Kingdon, which provides a comprehensive synthesis of the factors influencing governments and public organizations' agenda. The study draws insights from forty-two semistructured telephone interviews with informants involved in international HTA networks and/or in HTA agencies in Canada, Denmark, and the United Kingdom.

Results: This exploratory study suggests that the HTA community is moving toward greater public involvement. However, the HTA community remains cautious and ambivalent about the technical feasibility of public involvement, its acceptability to policy makers and practitioners, and its impacts on HTA agencies' resources and procedures.

Conclusions: The study stresses the importance of conducting rigorous and compelling evaluations to inform HTA agencies' decision to adopt, or reject, public involvement practices.

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.

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.

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.

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.

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.

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.

Swedish antenatal care is staffed by midwives working within the primary health care system, but with close collaboration with the hospital. The compliance to the program both from staff and mothers is very high, with 13.2 visits on average. There is a regional variation both in the number of visits and in the use of routine tests.

Objective: The objective was to develop an economic prioritization model to assist those involved in the selection and prioritization of health technology assessment topics and commissioning of HTA projects.

Methods: The model used decision analytic techniques to estimate the expected costs and benefits of the health care interventions that were the focus of the HTA question(s) considered by the NHS Health Technology Assessment Programme in England. Initial estimation of the value for money of HTA was conducted for several topics considered in 1997 and 1998.

Results: The results indicate that, using information routinely available in the literature and from the vignettes, it was not possible to estimate the absolute value of HTA with any certainty for this stage of the prioritization process. Overall, the results were uncertain for 65% of the HTA questions or topics analyzed. The relative costs of the interventions or technologies compared to existing costs of care and likely levels of utilization were critical factors in most of the analyses. The probability that the technology was effective with the HTA and the impact of the HTA on utilization rates were also key determinants of expected costs and benefits.

Conclusions: The main conclusion was that it is feasible to conduct ex ante assessments of the value for money of HTA for specific topics. However, substantial work is required to ensure that the methods used are valid, reliable, consistent, and an efficient use of valuable research time.

Objectives: Based on a prevalent framework in the information systems field, this study proposes and describes an integrated model for evaluating picture archiving and communication system (PACS) success from multiple users' perspectives.

Methods: Our study details the validation process of the proposed model at a large tertiary-care teaching hospital in Canada. Both qualitative and quantitative data were collected to assess the psychometric properties of the measurement instrument and test the research hypotheses.

Results: Our findings clearly reveal that radiologists, technologists, and clinicians have different views regarding the factors influencing PACS success. For instance, the results for radiologists show that their concern with efficiency and productivity is best guaranteed by a system that is reliable and easy to use. Furthermore, that only perceived system usefulness influenced clinicians' satisfaction with PACS is a reflection of the primary impact that technology has on their work, namely, the ability to have instant access to images from any point in the hospital. Even though, overall, all three groups view the adoption of PACS positively, the mean scores indicate that radiologists and technologists seem to be more satisfied and their expectations to be met at a higher level than clinicians.

Conclusions: We believe the measurement instruments developed in this study can be used as a diagnostic tool by project managers interested in better understanding the extent to which different groups of stakeholders perceive the deployment of PACS as being successful and how factors influencing perceptions of PACS success vary across user types.

Objectives: There is little specific guidance on performing an early cost-effectiveness analysis (CEA) of medical tests. We developed a framework with general steps and applied it to two cases.

Methods: Step 1 is to narrow down the scope of analysis by defining the test's application, target population, outcome measures, and investigating current test strategies and test strategies if the new test were available. Step 2 is to collect evidence on the current test strategy. Step 3 is to develop a conceptual model of the current and new test strategies. Step 4 is to conduct the early-CEA by evaluating the potential (cost-)effectiveness of the new test in clinical practice. Step 5 involves a decision about the further development of the test.

Results: The first case illustrated the impact of varying the test performance on the headroom (maximum possible price) of an add-on test for patients with an intermediate-risk of having rheumatoid arthritis. Analyses showed that the headroom is particularly dependent on test performance. The second case estimated the minimum performance of a confirmatory imaging test to predict individual stroke risk. Different combinations of sensitivity and specificity were found to be cost-effective; if these combinations are attainable, the medical test developer can feel more confident about the value of further development of the test.

Conclusions: A well-designed early-CEA methodology can improve the ability to develop (cost-)effective medical tests in an efficient manner. Early-CEAs should continuously integrate insights and evidence that arise through feedback, which may convince developers to return to earlier steps.

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.

Background: Decision analytic models, as used in economic evaluations, require data on several clinical parameters. The gold standard approach is to conduct a systematic review of the relevant clinical literature, although reviews of economic evaluations indicate that this is rarely done. Technology appraisals for the National Institute for Health and Clinical Excellence (NICE), which are fully funded, represent the best case scenario for the close integration of economic evaluations and systematic reviews. The objective of this study was to assess the extent to which the systematic review of the clinical literature informs the economic evaluation in NICE technology appraisals.

Methods: All NICE technology assessment reports (TARs) published between January 2003 and July 2006 were considered. Data were abstracted on the TAR topics, the primary measure of clinical effectiveness, the approach to pooling in the clinical review, the measure of economic benefit and the use, or non-use, of the systematic review in the economic evaluation.

Results: Forty-one TARs were published in the period studied, all of which contained a systematic review. Most of the economic evaluations (85 percent) were cost-utility analyses, reflecting NICE's guidelines for economic evaluation. In seventeen cases, the clinical data were not pooled in the review, owing to heterogeneity in the clinical data or the limited number of studies. In these cases, the economists used alternative approaches for estimating the key effectiveness parameter in the model. The results of the review (when pooled) were always used when the primary clinical effectiveness measure corresponded with the measure of economic benefit (e.g., survival). However, because preference-based quality of life measures are rarely included in clinical trials, the results of the systematic review were never directly used in the cost-utility analyses. Nevertheless, the outputs of the systematic review were used when the data were useful in estimating components of the quality-adjusted life-year (QALY) (e.g., the life-years gained, or the frequencies of health states to which QALYs could be assigned). Problems occurred mainly when the clinical data were not pooled, or when the measure of clinical benefit could not be converted into health states to which QALYs could be assigned.

Conclusions: Economic evaluations can benefit from systematic reviews of the clinical literature. However, such reviews are not a panacea for conducting a good economic evaluation. Much of the relevant data for estimating QALYs are not contained in such reviews and the chosen method for summarizing the clinical data may inhibit the assessment of economic benefit. Problems would be reduced if those undertaking the technology assessments discussed the data requirements for the economic model at an early stage.

It is difficult to study the epidemiology of ICUs, as they lack a uniform nomenclature and/or classification. The organization and distribution of intensive care medicine depend on the size and function of the hospital. The patients in ICUs are predominantly men, with a high proportion of elderly patients (≥70 years) constituting 25–30% of the total. Case-mix, severity of illness and outcome differ from one unit to another, and can be compared only if the patients are classified with a common classification system. Most survivors of intensive care seem to return to normal or near normal functional level within one year. Compared to Western Europe, the United States has more ICU beds and a nearly ten times higher admission rate to intensive care. These variations can be seen as a result of a fundamental difference in the attitudes toward withdrawing or withholding life support.

We analyze what is known and unknown about the contribution of the pharmacist as patient educator, physician consultant, and agent to affect patient outcomes in ambulatory settings. The need for pharmacist services is discussed, as are the theoretical underpinnings and quality of the scientific evidence to support their efficacy. The analysis is conducted in the context of a shift in pharmacists' roles from product to patient orientation as well as recent U.S. legislation mandating enhanced pharmacists' roles via drug utilization review for all Medicaid patients. We conclude with a research and action agenda, calling for stronger research designs in evaluating pharmacists' interventions. The shifting paradigm in the pharmacy profession, coupled with the implementation of the Omnibus Budget Reconciliation Act of 1990, provide unique opportunities for rigorous evaluations of pharmacists as agents of change for rational drug therapy.