Objectives: The International Network of Agencies for Health Technology Assessment (INAHTA) has been tracking activities associated with the clinical use of positron emission tomography (PET) in its members' healthcare systems since 1997 and published its first Joint Project report on PET in 1999. Part 1 of this Joint Project report presents survey results on diffusion, assessment activities, and policy for clinical use related to PET among INAHTA members since 1999.

Methods: INAHTA members were surveyed in 2003–2004.

Results: Twenty-seven INAHTA agencies (69 percent response rate) from nineteen countries responded to the survey. Dedicated PET systems are the most universally installed systems to date. Mobile scanners and modified gamma cameras are used occasionally as lower cost alternatives, and interest in PET–computed tomography hybrid models is rising despite limited assessment of impact on service planning. PET was used and assessed most commonly for managing patients with cancer. All respondents reported having some form of public funding for clinical PET frequently linked to data collection for the purpose of gathering evidence to refine clinical use and guide resource allocation toward indications that maximize clinical and cost-effectiveness.

Conclusions: The use of HTA within a continuous quality improvement framework can help optimize scarce resources for evaluation and use of high cost diagnostic technologies such as PET, particularly where potential clinical or cost-effectiveness is considerable but conclusive evidence is lacking.

Objectives: Since 1997, members of the International Network of Agencies for Health Technology Assessment (INAHTA) have collaborated on a Joint Project to track the diffusion, evaluation, and clinical policy of positron emission tomography (PET). Part 2 of this updated Joint Project report summarizes HTA-based strategies for directing the clinical use of PET and a discussion on the value of HTA in managing the diffusion of high cost diagnostic technologies, which were presented at an INAHTA-sponsored workshop at the Health Technology Assessment International Annual Meeting in 2004 on strategies for managing high cost diagnostic technologies.

Methods: A summary of the workshop proceedings is presented.

Conclusions: Sharing assessment work, universal agreement in assessment conclusions, stakeholder input, and modeling techniques help manage the uncertainty in the evidence base while targeting clinical use of PET toward the most promising indications. Emphasis on HTA findings, linkage between financing of clinical PET and outcome evaluation, and targeted dissemination of scientific findings empower providers to reduce unnecessary utilization and contain costs within a quality improvement framework. Above all, a trustworthy source of HTA information and a process that is conducive to using scientific evidence as the basis for decision making are essential for managing the diffusion of complex and costly diagnostic technologies in patient care.

Objectives: The objective of this study is to analyze statistically the possible determinants and implications of including or not including recommendations in health technology assessments (HTAs).

Methods: A sample of 433 HTAs published by eleven leading institutions or agencies in nine countries was reviewed and analyzed statistically by multiple logistic regression.

Results: The extent of policy and research recommendations in HTAs varies greatly from country to country. The content and scope of HTAs have some impact on recommendations. Extensive assessment of economic and organizational aspects increases the likelihood of including policy recommendations. Extensive assessment of technological and patient aspects increases the likelihood of including research recommendations, whereas extensive focus on economic aspects is negatively related to research recommendations. The most striking result is that the use of external partners for assessment increases the likelihood of including research recommendations in HTAs but not policy recommendations.

Conclusions: HTA commissioners, agencies, institutions, and funding authorities need to be aware of the consequences of the choices they make in advance of assessing health technologies. Outsourcing HTA to external partners suggests a greater likelihood of being told that “more research is needed.” The scope and content of HTAs has an impact on the type of recommendations, and country-specific preferences are strong predictors of recommendations in HTAs.

Objectives: The objective of this study is to assess the impact of CEDIT (French Committee for the Assessment and Dissemination of Technological Innovations) recommendations on the introduction of technological innovations within the AP-HP (Assistance Publique–Hôpitaux de Paris), the French hospital network to which this body is attached.

Methods: In 2002, a study based on semidirective interviews of fourteen people affected by these recommendations and a case study relating to thirteen recommendations issued between 1995 and 1998 were conducted.

Results: The CEDIT is very scientifically reputable among interviewees. There is generally widespread interest for the recommendations. They are used as decision-making tools by administrative staff and as negotiating instruments by doctors in their dealings with management. Based on the case study, ten of thirteen recommendations had an impact on the introduction of the technology in health establishments. One recommendation appears not to have had an impact. Furthermore, the impact of two technologies was impossible to assess.

Conclusions: This study highlights the significant impact of recommendations arising from a structure that is attached to a hospital network and the good match between CEDIT's objectives and its assignments.

Objectives: Evaluating the impact of recommendations based upon health technology assessment (HTA) represents a challenge for both HTA agencies and healthcare policy makers. This research sought to understand factors affecting the uptake of HTA recommendations to support decision making with respect to the introduction of three health technologies.

Methods: Using a multidimensional framework, based upon a combination of theoretical models, a case study was conducted. A total of twenty-eight semistructured interviews were done with physicians from fifteen hospitals and other stakeholders in Catalonia. Interview content was analyzed iteratively and classified according to theoretical dimensions and contextual factors.

Results: At the sociopolitical level, factors related to the organization and financing of the health system were found to affect the utilization of HTA recommendations. At the healthcare organization level, existing collaborations between the hospital and the HTA agency favored the integration of recommendations into practices. Formalism in the organization also influenced the utilization of HTA recommendations. At the professional level, the high degree of autonomy of specialists, the importance of peers and collegial control, and the definition of professional roles and responsibilities influenced physicians' willingness to integrate HTA recommendations into their practice.

Conclusions: This study offers a comprehensive framework to understand the complex dynamics that affect adoption of health technologies in organizational and professional practices. The findings suggest some avenues to promote the integration of HTA recommendations into practices and, thus, increase the utilization of scientific evidence to support decision making in health care.

Objectives: Uncertainty is pervasive in decision making on new health technologies; therefore, some countries have put systems in place to support decision makers with timely information. An important, but as yet undocumented, determinant of the potential value for decision making of these so-called horizon scanning systems (HSSs) is how the most significant health technologies are selected.

Methods: All thirteen member organizations of EuroScan, a collaborative network for HSSs, were surveyed and interviewed on how they prioritize technologies for assessment.

Results: The majority of HSSs directly serves a customer. Some customers actively request early assessments of new health technologies, thereby diminishing the need for priority setting for the HSSs. All systems express a concern to miss an important technology and/or to select an unimportant technology. Almost all HSSs use explicit selection criteria, but these criteria hardly ever are operationalized. The number of criteria used varies, but costs and health benefit of the technology are always taken into account. The process of reaching a final decision is implicit, undocumented in all but one system, and is based on agreement by consensus.

Conclusions: The process of making the final decision on which technologies to assess can be improved by applying existing criteria more consistently and transparently. Current practice does not safeguard against missing an important technology. This finding is probably most important to act upon for systems with customers that do not actively request assessment of specific technologies.

Objectives: This study describes the diffusion of advanced diagnostic devices in India and assess implications for efficiency in resource use and equity.

Methods: Commodity-level import statistics, household survey data, and interviews with medical device sellers are used to assess the spread of diagnostic devices. Published qualitative evidence, case studies of diagnostic service providers, and cross-country analyses are used to identify the reasons underlying the spread of medical devices in India. Case studies of public and private providers and data from 150 hospitals in one Indian state are used to assess efficiency in resource use and the distributive impacts of diagnostic devices.

Results: High-end medical device inflows rose during the 1990s, with both supply- and demand-side factors influencing this trend. Although our results suggest that the overall quantity of advanced diagnostics in India is not excessive, there is some evidence of inefficiency in public facilities and possibly unethical practices in private diagnostic facilities. The unequal geographical distribution of magnetic resonance imaging facilities, coupled with inefficient use of medical devices in public facilities suggests inequality in access.

Conclusions: The study points to major regulatory gaps and health system inefficiencies and suggests ways in which these gaps can be addressed.

Objectives: The objective of this study is to apply a Markov model to compare cost-effectiveness of total knee replacement (TKR) using computer-assisted surgery (CAS) with that of TKR using a conventional manual method in the absence of formal clinical trial evidence.

Methods: A structured search was carried out to identify evidence relating to the clinical outcome, cost, and effectiveness of TKR. Nine Markov states were identified based on the progress of the disease after TKR. Effectiveness was expressed by quality-adjusted life years (QALYs). The simulation was carried out initially for 120 cycles of a month each, starting with 1,000 TKRs. A discount rate of 3.5 percent was used for both cost and effectiveness in the incremental cost-effectiveness analysis. Then, a probabilistic sensitivity analysis was carried out using a Monte Carlo approach with 10,000 iterations.

Results: Computer-assisted TKR was a long-term cost-effective technology, but the QALYs gained were small. After the first 2 years, the incremental cost per QALY of computer-assisted TKR was dominant because of cheaper and more QALYs. The incremental cost-effectiveness ratio (ICER) was sensitive to the “effect of CAS,” to the CAS extra cost, and to the utility of the state “Normal health after primary TKR,” but it was not sensitive to utilities of other Markov states. Both probabilistic and deterministic analyses produced similar cumulative serious or minor complication rates and complex or simple revision rates. They also produced similar ICERs.

Conclusions: Compared with conventional TKR, computer-assisted TKR is a cost-saving technology in the long-term and may offer small additional QALYs. The “effect of CAS” is to reduce revision rates and complications through more accurate and precise alignment, and although the conclusions from the model, even when allowing for a full probabilistic analysis of uncertainty, are clear, the “effect of CAS” on the rate of revisions awaits long-term clinical evidence.

Objectives: Although measuring the utilization of ambulatory and home-based healthcare resources is an essential component of economic analyses, very little methodological attention has been devoted to the development and evaluation of resource costing tools. This study evaluated a newly developed tool, the Ambulatory and Home Care Record (AHCR), which comprehensively evaluates costs incurred by the health system and care recipients and their unpaid caregivers.

Methods: The level of agreement between self-reports from 110 cystic fibrosis care recipients and administrative data was assessed for four categories of health services: home-based visits with healthcare professionals, ambulatory visits with healthcare professionals, laboratory and diagnostic tests, and prescription medications.

Results: Agreement between care recipients' reports on the AHCR and administrative data ranged from moderate (kappa=0.41; 95 percent confidence interval, 0.16–0.61) for physician specialist visits to perfect (kappa=1.0) for physiotherapy visits.

Conclusions: By evaluating and standardizing a resource and costing tool, such as the AHCR, economic evaluations may be improved and comparisons of the resource implications for different services and for diverse populations are possible.

Objectives: The objective of this study was to analyze preferences for activities comprised in comprehensive cardiac rehabilitation programs among former cardiac patients from three different hospitals in Copenhagen County, Denmark.

Methods: A discrete choice experiment was applied to elicit the preferences for the offer of participation in various cardiac rehabilitation program activities: smoking cessation course, physical exercise program, personal meetings with cardiac nurse, group meetings managed by cardiac nurses, and nutritional counseling guidance. The questionnaire was sent to 742 former cardiac patients. We had a response rate of 69 percent.

Results: We found that preferences differed with respect to gender and age and that the offer of participation in cardiac rehabilitation activities was not highly valued by older patients, in particular among older men.

Conclusions: The discrete choice experiment proved a valuable instrument for the measurement of preferences for cardiac rehabilitation. The study provides important information on patients' preferences for cardiac rehabilitation for healthcare professionals and decision makers.

Objectives: The aim of the study was to evaluate the validity of the systematic reviews as a source of best evidence and to present and interpret the evidence of the systematic reviews on effectiveness of surgery and percutaneous interventions for stable coronary artery disease.

Methods: Electronic databases were searched without language restriction from January 1966 to March 2004. The databases used included the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials, DARE, the Health Technology Assessment Database, MEDLINE(R), MEDLINE(R) In-Process & Other Non-Indexed Citations. We included systematic reviews of randomized clinical trials on patients with stable coronary heart disease undergoing percutaneous coronary intervention or coronary artery bypass surgery in comparison with medical treatment or a comparison between invasive techniques. At least one of the following outcomes had to be reported: death, myocardial infarction, angina pectoris, revascularization. The methodological quality was assessed using a modified version of the scale devised by Oxman and Guyatt (1991). A standardized data-extraction form was used. The method used to evaluate clinical relevance was carried out with updated method guidelines from the Cochrane Back Research Group. Quantitative synthesis of the effectiveness data is presented.

Results: We found nineteen systematic reviews. The median score of validity was 13 points (range, 6–17 points), with a maximum of 18 points. vCoronary artery bypass surgery gives better relief of angina, and the need for repeated procedures is reduced after bypass surgery compared with percutaneous interventions. There is inconsistent evidence as to whether bypass surgery improves survival compared with percutaneous intervention. A smaller need for repeated procedures exists after bare metal stent and even more so after drug-eluting stent placement than after percutaneous intervention without stent placement. However, according to the current evidence, these treatment alternatives do not differ in terms of mortality or myocardial infarction.

Conclusions: We found some high-quality systematic reviews. There was evidence on the potential of invasive treatments to provide symptomatic relief. Surgery seems to provide a longer-lasting effect than percutaneous interventions with bare metal stents or without stents. Evidence in favor of drug-eluting stents so far is based on short-term follow-up and mostly on patients with single-vessel disease.

Objectives: The objectives of this study were to identify, in a systematic literature review, published studies having used quality-adjusted life years (QALYs) based on actual measurements of patients' health-related quality of life (HRQoL) and to determine which HRQoL instruments have been used to calculate QALYs. Furthermore, the aims were to characterize studies with regard to medical specialty, intervention studied, results obtained, quality, country of origin, QALY gain observed, and interpretation of results regarding cost-effectiveness.

Methods: Systematic searches of the literature were made using the MEDLINE, Embase, CINAHL, SCI, and Cochrane Library electronic databases. Initial screening of identified articles was based on abstracts read independently by two of the authors; full-text articles were again evaluated by two authors, who made the final decision on which articles should be included.

Results: The search identified 3,882 articles; 624 were obtained for closer review. Of the reviewed full-text articles, seventy reported QALYs based on actual before–after measurements using a valid HRQoL instrument. The most frequently used instrument was EuroQol HRQoL instrument (EQ-5D, 47.5 percent). Other instruments used were Health Utilities Index (HUI, 8.8 percent), the Rosser–Kind Index (6.3 percent), Quality of Well-Being (QWB, 6.3 percent), Short Form-6D (SF-6D, 5.0 percent), and 15D (2.5 percent). The rest (23.8 percent) used a direct valuation method: Time Trade-Off (10.0 percent), Standard Gamble (5.0 percent), visual analogue scale (5.0 percent), or rating scale (3.8 percent). The most frequently studied medical specialties were orthopedics (15.5 percent), pulmonary diseases (12.7 percent), and cardiology (9.9 percent). Ninety percent of the studies came from four countries: United Kingdom, United States, Canada, the Netherlands. Approximately half of the papers were methodologically high quality randomized trials. Forty-nine percent of the studied interventions were viewed by the authors of the original studies as being cost-effective; only 13 percent of interventions were deemed not to be cost-effective.

Conclusions: Although QALYs gained are considered an important measure of effectiveness of health care, the number of studies in which QALYs are based on actual measurements of patients' HRQoL is still fairly limited.

Objectives: The objective of this study is to describe the frequency of inappropriate empirical antibiotic therapy in secondary intra-abdominal infection and to identify the possible relationship between inappropriateness and some clinical outcomes.

Methods: A retrospective descriptive multicenter study was conducted using hospital secondary databases developed at two university hospitals located in northeast Spain. Participants were patients 18 years of age or older who were diagnosed with community-acquired intra-abdominal infections between January 1, 1998, and December 31, 2000, identified through computerized patient records using ICD-9 codes. Appropriateness of empirical treatment was defined according to the recommendations of the literature. The clinical outcome of each patient was classified as one of the following: (i) resolved with initial therapy, (ii) required second-line antibiotics, (iii) required re-operation, or (iv) in-hospital death. The Fisher's exact test or the Chi-squared test for categorical variables and the t-test or Mann–Whitney test for continuous variables were used for comparing groups. Conditional logistic and linear regression analyses were also applied.

Results: Of 376 cases, 51 cases (13.6 percent, 95 percent confidence interval, 10–17 percent) received inappropriate empirical antibiotic therapy according to the scientific literature. Inappropriate initial empirical treatment was significantly associated with the need for a second line of antibiotics (p<.001), although not with re-operation, mortality, or length of hospitalization.

Conclusions: Approximately 14 percent of the patients received inappropriate empirical antibiotic treatment. Worse clinical outcomes consistently were observed in the group of patients receiving inappropriate empirical treatment. The appropriateness of antibiotic treatment for a given infection, in light of the availability of clearly defined clinical guidelines is an easily evaluated aspect of the quality of care.

Objectives: The relatively high cost of information technology systems may be a barrier to hospitals thinking of adopting this technology. The experiences of early adopters may facilitate decision making for hospitals less able to risk their limited resources. This study identifies the costs to design, develop, implement, and operate an innovative informatics-based registry and disease management system (POPMAN) to manage type 2 diabetes in a primary care setting.

Methods: The various cost components of POPMAN were systematically identified and collected.

Results: POPMAN cost $450,000 to develop and operate over 3.5 years (1999–2003). Approximately $250,000 of these costs are one-time expenditures or sunk costs. Annual operating costs are expected to range from $90,000 to $110,000 translating to approximately $90 per patient for a 1,200 patient registry.

Conclusions: The cost of POPMAN is comparable to the costs of other quality-improving interventions for patients with diabetes. Modifications to POPMAN for adaptation to other chronic diseases or to interface with new electronic medical record systems will require additional investment but should not be as high as initial development costs. POPMAN provides a means of tracking progress against negotiated quality targets, allowing hospitals to negotiate pay for performance incentives with insurers that may exceed the annual operating cost of POPMAN. As a result, the quality of care of patients with diabetes through use of POPMAN could be improved at a minimal net cost to hospitals.

Objectives: Industrial management principles could be used to improve the quality and efficiency of health care. In this study, we have evaluated the effects of a process management approach to trauma patient care. The major objective was to reduce the waiting times and increase the efficiency of the hospital.

Methods: Urgent surgery care was analyzed as an overall process. The process development followed the Plan-Do-Check-Act (PDCA) cycle and was based on statistical analysis of certain performance metrics. Data were collected from hospital databases and by personnel interviews. To develop the process, the anesthesia induction was performed outside the operating room, better process guidance was developed, and patient flow was reorganized. The transition time for these changes was 1 year (2002 to 2003).

Results: Waiting times decreased by 20.5 percent (p<.05), nonoperative times in the operating room were reduced by 23.1 percent (p<.001), and efficiency was increased by 9.7 percent (p<.001) after reengineering of the care process. Overtime hours decreased by 30.9 percent.

Conclusions: Managing urgent surgical care as a process can improve the productivity and quality of care without a need to increase personnel resources. The focus should be on reducing waiting times and waste times.

Objectives: In cost-minimization studies, it is important to establish noninferiority in the clinical effect of the treatments under investigation. The relationship between the proportion of patients reaching the end point in a study, equivalence limit (δ), and power is investigated in the context of cost-minimization studies with dichotomous clinical end points. Two formulations of the null-hypothesis, absolute and relative formulations of δ, will be explored.

Methods: Sensitivity analysis was performed, in which the effect of the predicted proportions and δ on the power in a noninferiority setting was investigated. The patterns found are discussed in terms of the practical relevance within the cost-minimization framework.

Results: Sensitivity analyses show different patterns of results for both null-hypotheses. The differences in these results originate from the way δ is expressed. By expressing δ as absolute difference, power grows quite fast when sample proportions are smaller than expected. In the case of a proportional δ at small sample proportions, the power to establish noninferiority remains low.

Conclusions: To obtain valid results from a cost-minimization study, care has to be taken to adapt the correct methodology for noninferiority testing in clinical outcomes. Defining δ in terms of absolute differences between treatments can lead to obscured results. Although conservative, the expression of δ as a proportion of the effectiveness of the treatment as usual is found to be closer to clinical practice. The inflated δ, resulting from smaller clinical effects than expected when absolute formulation is applied, thus can be avoided.

Objectives: The mode of contact and response levels of authors who had been asked to provide missing or incomplete data for a systematic review on diet and exercise interventions for weight loss was examined.

Methods: We contacted authors by electronic mail, letter, or both. Survival analyses were performed with the Kaplan–Meier method to determine differences in the proportion of responders over time among the different modes of contact and to determine whether response rates differed between authors from the United States and those from other countries. Logistic regression was used to determine whether the number of items requested and publication date influenced the likelihood of response.

Results: Two hundred forty-one (39.9 percent) studies had missing or incomplete data (e.g., sample size, age, caloric restriction, exercise amount, and so on). We were unable to locate ninety-five authors (39.4 percent). Of the remaining authors, forty-six authors (31.5 percent) responded to information requests. Time to respond differed by contact method (p<.05): e-mail (3 ± 3 days), letter (27 ± 30 days), and both (13 ±12 days). Response rates from U.S. authors did not differ from those of other countries.

Conclusions: Our study suggests poor success in the acquisition of essential information. Given considerable time and resources, weight loss studies require improved reporting standards to minimize the relatively unsuccessful attempt to contact authors for important and necessary information.

We should be careful when making claims that a given individual had a major impact on a given field. After all, much research is undertaken in teams and good ideas are quickly transferred and developed. There are, however, several reasons to suggest that Alan Williams made a major impact and that the field may have developed differently had he never become a health economist. I give five reasons below.

The Journal has lost a loyal friend and trusted advisor when former board member Bernard S. Bloom, PhD, died at his home in Society Hill, Pennsylvania. A gifted economist, Bernie's contribution to the healthcare field was immeasurable and left an indelible impression on students and peers alike.