To determine whether patients are less likely to receive an inappropriate procedure in countries that devote fewer resources to health care than does the United States, we studied how appropriately coronary angiography and coronary artery bypass surgery were performed in the Trent region of the United Kingdom. The medical records of 320 patients who underwent coronary angiography and 319 who underwent coronary artery bypass surgery in 1987 and 1988 were randomly selected for review. Despite the United Kingdom's more limited use of coronary angiography and coronary artery bypass surgery, a substantial proportion were still performed for less than appropriate reasons, by both U.S. and U.K. criteria. Merely reducing the rate of use of these procedures will not be sufficient to eliminate such inappropriate use.

A desirable element of cost-effectiveness analysis (CEA) modeling is a systematic way to relate uncertainty about input parameters to uncertainty in the computational results of the CEA model. Use of Bayesian statistical estimation and Monte Carlo simulation provides a natural way to compute a posterior probability distribution for each CEA result. We demonstrate this approach by reanalyzing a previously published CEA evaluating the incremental cost-effectiveness of tissue plasminogen activator compared to streptokinase for thrombolysis in acute myocardial infarction patients using data from the GUSTO trial and other auxiliary data sources. We illustrate Bayesian estimation for proportions, mean costs, and mean quality-of-life weights. The computations are performed using the Bayesian analysis software WinBUGS, distributed by the MRC Biostatistics Unit, Cambridge, England.

Objectives: Ethical analysis can highlight important ethical issues related to implementing a technology, values inherent in the technology itself, and value-decisions underlying the health technology assessment (HTA) process. Ethical analysis is a well-acknowledged part of HTA, yet seldom included in practice. One reason for this is lack of knowledge about the properties and differences between the methods available. This study compares different methods for ethical analysis within HTA.

Methods: Ethical issues related to bariatric (obesity) surgery were independently evaluated using axiological, casuist, principlist, and EUnetHTA models for ethical analysis within HTA. The methods and results are presented and compared.

Results: Despite varying theoretical underpinnings and practical approaches, the four methods identified similar themes: personal responsibility, self-infliction, discrimination, justice, public funding, and stakeholder involvement. The axiological and EUnetHTA models identified a wider range of arguments, whereas casuistry and principlism concentrated more on analyzing a narrower set of arguments deemed more important.

Conclusions: Different methods can be successfully used for conducting ethical analysis within HTA. Although our study does not show that different methods in ethics always produce similar results, it supports the view that different methods of ethics can yield relevantly similar results. This suggests that the key conclusions of ethical analyses within HTA can be transferable between methods and countries. The systematic and transparent use of some method of ethics appears more important than the choice of the exact method.

Objectives: The current digital revolution is particularly relevant for interactions of healthcare providers with patients and the community as a whole. The growing public acceptance and distribution of new communication tools such as smart mobile phones provide the prerequisite for information and communication technology (ICT) -assisted healthcare applications. The present study aimed at identifying specifications and perceptions of different interest groups regarding future demands of ICT-supported doctor–patient communication in Austria.

Methods: German-speaking Austrian healthcare experts (n = 73; 74 percent males; mean age, 43.9 years; SD 9.4) representing medical professionals, patient advocates, and administrative personnel participated in a 2-round online Delphi process. Participants evaluated scenario-based benefits and obstacles for possible prospect introduction as well as degree of innovation, desirability, and estimated implementation dates of two medical care-related future set ups.

Results: Panelists expected the future ICT-supported doctor–patient dialogue to especially improve the three factors doctors–patient relationship, patients’ knowledge, and quality of social health care. However, lack of acceptance by doctors, data security, and monetary aspects were considered as the three most relevant barriers for ICT implementation. Furthermore, inter-group comparison regarding desirability of future scenarios showed that medical professionals tended to be more skeptical about health-related technological innovations (p < .001).

Conclusions: The findings of this survey revealed different expectations among interest groups. Thus, we suggest building taskforces and using workshops for establishing a dialogue between stakeholders to positively shape the future of ICT-supported collaboration and communication between doctors and patients.

Objectives: To describe the number of trials and participants in a typical systematic review from The Cochrane Database of Systematic Reviews.

Methods: The number of trials in 1,000 Cochrane systematic reviews in issue 1, 2001 of The Cochrane Database of Systematic Reviews was counted for three categories of trial: included trials, ongoing trials, and trials awaiting assessment for inclusion. (The term trial is used in this paper, although a small number of Cochrane reviews include studies that are not trials.) The total number of participants in included trials was extracted from a sample of reviews.

Results: A total of 9,778 trials were included in the Cochrane reviews. There were a further 356 ongoing trials and 1,138 trials awaiting assessment for inclusion. A typical review contained six included trials. Forty percent of the reviews listed ongoing trials and/or trials awaiting assessment for inclusion. Based on a sample of 258 reviews, the median number of participants per review was 945 (interquartile range, 313 to 2,511) per review and 118 (interquartile range, 60 to 241) per trial.

Conclusion: This report is a descriptive study of the number of trials and participants in a typical Cochrane review from The Cochrane Library, issue 1, 2001.

Objectives: The study determined whether the results of recently completed systematic reviews evaluating the effectiveness of public health interventions were used in the development of new provincial policies for public health practice.

Methods: This telephone survey included all members from five review groups who updated the Ontario Mandatory Health Programs and Services guidelines for Public Health in 2000. Independent variables included characteristics of the systematic reviews, organization, and the individual. Outcomes included the use of the reviews in developing new policies and the extent to which the reviews led to new recommendations for practice. Descriptive summaries as well as multiple linear regression were conducted.

Results: Eighty-five percent of decision-makers agreed to participate in the study. Ninety-six percent of respondents reported that the systematic reviews played a part in developing the new guidelines, while 47 percent indicated that the reviews contributed a great deal to the development of new recommendations for practice. The multiple linear regression model explained 42 percent of the variation in use of the reviews for developing new recommendations for practice. Significant predictor variables included the importance of the reviews in comparison to other sources of information and relevance of the reviews to the policy decisions.

Conclusion: Public health decision-makers in Ontario have very positive perceptions of the usefulness of systematic reviews in policy development. Therefore, ongoing efforts to promote the usefulness and relevance of systematic reviews to public health decision-makers should remain a priority for health services researchers.

Bayesian statistics provide effective techniques for analyzing data and translating the results to inform decision making. This paper provides an elementary tutorial overview of the WinBUGS software for performing Bayesian statistical analysis. Background information on the computational methods used by the software is provided. Two examples drawn from the field of medical decision making are presented to illustrate the features and functionality of the software.

Objectives: Health technology assessment (HTA) carried out for policy decision making has well-established principles unlike hospital-based HTA (HB-HTA), which differs from the former in the context characteristics and ways of operation. This study proposes principles for good practices in HB-HTA units.

Methods: A framework for good practice criteria was built inspired by the EFQM excellence business model and information from six literature reviews, 107 face-to-face interviews, forty case studies, large-scale survey, focus group, Delphi survey, as well as local and international validation. In total, 385 people from twenty countries have participated in defining the principles for good practices in HB-HTA units.

Results: Fifteen guiding principles for good practices in HB-HTA units are grouped in four dimensions. Dimension 1 deals with principles of the assessment process aimed at providing contextualized information for hospital decision makers. Dimension 2 describes leadership, strategy and partnerships of HB-HTA units which govern and facilitate the assessment process. Dimension 3 focuses on adequate resources that ensure the operation of HB-HTA units. Dimension 4 deals with measuring the short- and long-term impact of the overall performance of HB-HTA units. Finally, nine core guiding principles were selected as essential requirements for HB-HTA units based on the expertise of the HB-HTA units participating in the project.

Conclusions: Guiding principles for good practices set up a benchmark for HB-HTA because they represent the ideal performance of HB-HTA units; nevertheless, when performing HTA at hospital level, context also matters; therefore, they should be adapted to ensure their applicability in the local context.

Background: Home hemodialysis offers potential advantages over hospital hemodialysis, including the opportunity for more frequent and/or longer dialysis sessions. Expanding home hemodialysis services may help cope with the increasing numbers of people requiring hemodialysis.

Methods: We sought comparative studies or systematic reviews of home versus hospital/satellite unit hemodialysis for people with end-stage renal failure (ESRF). Outcomes included quality of life and survival. We searched MEDLINE, EMBASE, HealthSTAR, CINAHL, PREMEDLINE, and BIOSIS. Two reviewers independently extracted data and assessed the quality of the studies included.

Results: Twenty-seven studies of variable quality were included. People on home hemodialysis generally experienced a better quality of life and lived longer than those on hospital hemodialysis. Their partners, however, found home hemodialysis more stressful. Four studies using a Cox proportional hazards model to compare home with hospital hemodialysis reported a lower mortality risk for home hemodialysis. Of two studies using a Cox model to compare home with satellite unit hemodialysis, one reported a similar mortality risk, whereas the other reported a lower mortality risk for home hemodialysis.

Conclusions: Home hemodialysis was generally associated with better outcomes than hospital hemodialysis and (more modestly so) satellite unit hemodialysis, in terms of quality of life, survival, and other measures of effectiveness. People on home hemodialysis, however, are a highly selected group. Home hemodialysis also provides the opportunity for more frequent and/or longer dialysis sessions than would otherwise be possible. It is difficult to disentangle the true effects of home hemodialysis from such influencing factors.

Despite their potential utility, clinicians are skeptical about claims data as a substrate for clinical research. Clinicians' concerns are centered on two issues—the quality of the data and the fairness of comparisons that are made. To increase the impact of claims data research on clinical practice, several strategies should be pursued.

Objectives: The Human Genome Project has led to a multitude of new potential screening targets on the level of human DNA. The aim of this systematic review is to critically summarize the evidence from health economic evaluations of genetic screening in the literature.

Methods: Based on an extensive explorative search, an appropriate algorithm for a systematic database search was developed. Twenty-one health economic evaluations were identified and appraised using published quality criteria.

Results: Genetic screening for eight conditions has been found to be investigated by health economic evaluation: hereditary breast and ovarian cancer, familial adenomatous polyposis (FAP) colorectal cancer, hereditary nonpolyposis colorectal carcinoma (HNPCC), retinoblastoma, familial hypercholesterolemia, hereditary hemochromatosis, insulin-dependent diabetes mellitus, and cystic fibrosis. Results range from dominated to cost-saving. Population-wide genetic screening may be considered cost-effective with limited quality of evidence only for three conditions. The methodology of the studies was of varying quality. Cost-effectiveness was primarily influenced by mutation prevalence, genetic test costs, mortality risk, effectiveness of treatment, age at screening, and discount rate.

Conclusions: Health economic evidence on genetic screening is limited: Only few conditions have properly been evaluated. Based on the existing evidence, healthcare decision makers should consider the introduction of selective genetic screening for FAP and HNPCC. As genetic test costs are declining, the existing evaluations may warrant updating. Especially in the case of hereditary hemochromatosis, genetic population screening may be about to turn from a dominated to a cost-effective or even cost-saving intervention.

The International Network of Agencies for Health Technology Assessment (INAHTA) spans the globe as a network of 50 publicly-funded health technology assessment (HTA) agencies supporting health system decision making for 1.4 billion people in thirty countries. Agency members are non-profit HTA organizations that are part of, or directly support, regional or national governments. Recently, INAHTA surveyed its members to gather perspectives from agency leadership on the most important issues in HTA today. This paper describes the top 10 challenges identified by INAHTA members. Addressing these challenges requires a call for action from INAHTA member agencies and the many other actors involved in the HTA ecosystem. In opening this call for action, INAHTA will lead the way; however, a comprehensive undertaking from all players is needed to effectively address these challenges and to continue to evolve HTA in its role as a strong and effective contributor to health systems.

Objectives: To examine differences in the ethical judgments made by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs).

Methods: We did a review of the literature and included any study that attempted to compare the ethical judgments made by different RECs or IRBs when reviewing one or more protocol.

Results: There were twenty-six articles reporting such discrepancies across Europe, within the United Kingdom, Spain, and United States. Of these studies, there were only five reports of some RECs approving while others rejecting the same protocol. All studies, however, reported differences in the clarifications and revisions asked of researchers regarding consent, recruitment, risks and benefits, compensation arrangements, and scientific issues.

Conclusions: The studies were generally anecdotal reports of researchers trying to do research. New rules requiring a single ethical opinion for multi-site research at least in European Member States may simply conceal problematic issues in REC decision making. In the last analysis, we should expect a certain degree of variation and differences if we are to keep a committee system of review, although there is a pressing need to investigate the way in which RECs make these judgments. In particular, we need to identify the source of any aberrations, distortions, or confusions that could arbitrarily affect these judgments. Furthermore, local conditions remain important ethical considerations and should not be sidelined in pursuit of greater “consistency.”

Objectives: Many hospitals in New Zealand have been using clinical priority assessment criteria (CPAC) to select and prioritize patients for access to publicly funded elective surgery. CPAC usually consist of clinical, patient-experienced, and social measures. The objective of this study was to determine how robust patient rankings were and the extent to which the patients selected were those who benefited the most from surgery.

Methods: Patients prioritized for cataract (n = 101), prostate (n = 103), and hip or knee joint replacement (n = 137) surgery according to CPAC were assessed using the EQ-5D, SF-12, and condition-related patient-experienced health status measures before and after treatment. Correlations between the rankings of patients on the CPACs and the alternative instruments were explored.

Results: For each surgery group, the CPAC ranking of patients was not strongly correlated with rankings obtained using their before-treatment EQ-5D (valued) profiles or the SF-12, although there was some correlation with rankings according to the condition-related measures. Improvements in the health status of patients who were operated on, as measured by the change in their EQ-5D values, were poorly correlated with equivalent changes on the SF-12 and condition-related measures. Patients' baseline health status according to the CPAC, the EQ-5D, and the SF-12 patient-experienced measures was only slightly related to the magnitude of benefit following surgery. The strongest predictors of improvement in health status were the baseline condition-related measures.

Conclusions: The current method of prioritizing patients in New Zealand requires reconsideration, although a gold standard method for prioritization is not immediately apparent from these results.

To examine the validity of the additive quality-adjusted lite year model used to evaluate a multiphase health state, data from a pilot study of mammography were used to determine whether the values assigned to a multiphase postmastectomy health state could be estimated from a combination of the independently rated constituent health state values. The results suggest that they cannot.

Objectives: The aim of this study was to evaluate the cost-effectiveness of four risk-lowering interventions (smoking cessation, antihypertensives, aspirin, and statins) in primary prevention of cardiovascular disease.

Methods: Using data from the Framingham Heart Study and the Framingham Offspring study, we built life tables to model the benefits of the selected interventions. Participants were classified by age and level of risk of coronary heart disease. The effects of risk reduction are obtained as numbers of death averted and life-years saved within a 10-year period. Estimates of risk reduction by the interventions were obtained from meta-analyses and costs from Dutch sources.

Results: The most cost-effective is smoking cessation therapy, representing savings in all situations. Aspirin is the second most cost-effective (€2,263 to €16,949 per year of life saved) followed by antihypertensives. Statins are the least cost-effective (€73,971 to €190,276 per year of life saved).

Conclusions: A cost-effective strategy should offer smoking cessation for smokers and aspirin for moderate and high levels of risk among men 45 years of age and older. Statin therapy is the most expensive option in primary prevention at levels of 10-year coronary heart disease risk below 30 percent and should not constitute the first choice of treatment in these populations.

Objectives: Values are intrinsic to the use of health technology assessments (HTAs) in health policy, but neglecting value assumptions in HTA makes their results appear more robust or normatively neutral than may be the case. Results of a 2003 survey by the International Network of Agencies for Health Technology Assessment (INAHTA) revealed the existence of disparate methods for making values and ethical issues explicit when conducting HTA.

Methods: An Ethics Working Group, with representation from sixteen agencies, was established to develop a framework for addressing ethical issues in HTA. Using an iterative approach, with email exchanges and face-to-face workshops, a report on Handling Ethical Issues was produced.

Results: This study describes the development process and the agreed upon framework for reflexive ethical analysis that aims to uncover and explore the ethical implications of technologies through an integrated, context-sensitive approach and situates the proposed framework within previous work in the development of ethics analysis in HTA.

Conclusions: It is important that methodological approaches to address ethical reflection in HTA be integrative and context sensitive. The question-based approach described and recommended here is meant to elicit this type of reflection in a way that can be used by HTA agencies. The questions proposed are considered only as a starting point for handling ethics issues, but their use would represent a significant improvement over much of the existing practice.

Objectives: Individual patient data (IPD) meta-analyses have been proposed as a major improvement in meta-analytic methods to study subgroup effects. Subgroup effects of conventional and IPD meta-analyses using identical data have not been compared. Our objective is to compare such subgroup effects using the data of six trials (n = 1,643) on the effectiveness of antibiotics in children with acute otitis media (AOM).

Methods: Effects (relative risks, risk differences [RD], and their confidence intervals [CI]) of antibiotics in subgroups of children with AOM resulting from (i) conventional meta-analysis using summary statistics derived from published data (CMA), (ii) two-stage approach to IPD meta-analysis using summary statistics derived from IPD (IPDMA-2), and (iii) one-stage approach to IPD meta-analysis where IPD is pooled into a single data set (IPDMA-1) were compared.

Results: In the conventional meta-analysis, only two of the six studies were included, because only these reported on relevant subgroup effects. The conventional meta-analysis showed larger (age < 2 years) or smaller (age ≥ 2 years) subgroup effects and wider CIs than both IPD meta-analyses (age < 2 years: RDCMA -21 percent, RDIPDMA-1 -16 percent, RDIPDMA-2 -15 percent; age ≥2 years: RDCMA -5 percent, RDIPDMA-1 -11 percent, RDIPDMA-2 -11 percent). The most important reason for these discrepant results is that the two studies included in the conventional meta-analysis reported outcomes that were different both from each other and from the IPD meta-analyses.

Conclusions: This empirical example shows that conventional meta-analyses do not allow proper subgroup analyses, whereas IPD meta-analyses produce more accurate subgroup effects. We also found no differences between the one- and two-stage meta-analytic approaches.

There are marked geographical variations in rates of medical and surgical intervention at every level of aggregation and in every aspect of medical practice. These data raise a range of important theoretical, methodological, and policy issues. Much the same pattern of variation characterizes the prescription and consumption of therapeutic drugs. Data from a survey of general practice in New Zealand confirm the existence of extensive variability in prescribing. Multilevel techniques are deployed to isolate the specific interpractitioner element in this variability. Controlling for patient, diagnostic, and practitioner variables improves the predictive power of the model but does not reduce the extent of interpractitioner variability in prescribing rates. The existence of such variability raises questions about the role of clinical uncertainty and professional autonomy in the promotion of rational therapeutics in medical practice.