A hospital's quality of care is generally assessed by a review of individual records. This study used unadjusted and risk-adjusted complication rates to measure the quality of care for hospitals that perform coronary artery bypass surgery or angioplasty. Hospitals differed greatly in their complication rates. Only a small percentage of this difference was due to differences in the risks that patients faced.

Objectives: Recently, we developed a diagnostic rule for the diagnosis and treatment of children with meningeal signs. This rule may provide the physician with a rationale to decide on the use of diagnostic and treatment procedures in these children and to improve their care. In this study, we estimated cost savings of the rule compared with current practice.

Methods: Routine care data of 360 children visiting the emergency department of the Sophia Children's Hospital with meningeal signs between 1988 and 1998 were used. Costs of diagnostic tests and treatment were estimated by using financial accounts of an academic and a general pediatric hospital. The number of procedures actually performed and the resulting cost estimates (i.e. unit costs×volume) were compared with the estimated figures after application of the decision rule.

Results: The population of children with meningeal signs comprised 99 with bacterial meningitis (27%), 36 with another serious bacterial infection (10%), and 225 with a self-limiting disease (63%). Application of the rule would reduce lumbar punctures by 12% and hospitalizations for empirical treatment by 15% with the same diagnostic accuracy as current practice. Cost savings were estimated at €292 per patient (relative reduction 10%) and were mainly achieved in the treatment course (€259).

Conclusions: A diagnostic decision rule for children with meningeal signs has the potential to improve the appropriate use of medical resources, to be cost-effective, and to ascertain the absence of bacterial meningitis earlier.

This paper tests the null hypothesis of a zero effect of cesarean section rate on health outcome against the alternative of a positive effect. Using data from 59 hospitals in Sweden from 1988–92, we specify two separate linear regression models for health outcome, one with perinatal mortality, and the other with rate of asphyxia, as dependent variable. We estimate the models by single-year cross-section regressions and as pooled data systems. The null hypothesis cannot be rejected, i.e., we do not find any significant positive effect of cesarean section rate on health outcome. Thus, we conclude that an increase in cesarean section rate does not imply lower perinatal mortality or lower rate of asphyxia. This in turn indicates that the minimum cesarean section rate is optimal.

Objectives: This paper considers the methodological problems that arise in conducting cost analyses in economic evaluations where only observational (rather than experimental) data are available and where the technology being evaluated is diffuse, such that the unit of analysis has to be the institution rather than the patient.

Methods: A case study is reported that concerns the application of computer technology in radiology: picture archiving and communication systems (PACS). A range of different approaches were used to estimate changes in running costs, including time series analyses of routine data and direct observation of resource use.Results:The analysis illustrates some of the difficulties involved in costing the introduction of a diffuse technology. Nevertheless, it provides a firm indication that, overall, the introduction of PACS was found to be associated with a significant increase in hospital costs, suggesting that the initial expectations of financial savings were unduly optimistic.

Conclusions: The research demonstrates that, using multiple methods, it is possible to estimate cost changes within a single hospital. In addition, the paper discusses the nature of the uncertainties in such analyses and possible ways of representing such uncertainty in terms of confidence intervals.

Objective: A basic issue in randomized controlled trials (RCTs) is whether we can safely assume comparability between groups at baseline with respect to all potentially important prognostic factors. In other words, did randomization work sufficiently well? In small trials balanced allocation procedures are employed, whereas in large-scale trials simple randomization will do. The question is: When should balancing be considered?

Methods: We performed a simulation study in which we varied the number of categories in the prognostic factors and the number of patients.

Results: Simulation showed that, in all instances, a balancing procedure almost always led to perfect or almost perfect balance, while the imbalance with simple randomization was larger. To study the effect of balanced and random allocation on subgroup analyses in our OME trial, we compared the quotient of the width of the confidence intervals (CI). The widest CI in random allocation over the 13 hospitals was on average 13% wider than in balanced allocation.

Conclusion: Investigators should always consider balanced allocation, especially in categories with a low number of patients and when subgroup analysis over many categories is requested.

Cost-effectiveness analysis has much conceptual attractiveness in priority setting but is not used to its full potential to assist policy-makers on making choices in health in developed or in developing countries. We call for a shift away from present economic evaluation activities—that tend to produce ad hoc and incomparable economic evaluation studies and, therefore, add little to the compendium of knowledge of cost-effectiveness of health interventions in general—toward a more systematic approach. Research efforts in economic evaluation should build on the foundations of cost-effectiveness research of the past decades to arrive at an informative methodology useful for national policy-makers. This strategy means that governments should steer sectoral cost-effectiveness analysis to obtain systematic and comprehensive information on the economic attractiveness of a set of new and current interventions, using a standardized methodology and capturing interactions between interventions. Without redirecting the focus of economic evaluation research, choosing in health care bears the risk to remain penny-wise but pound-foolish.

The costs and benefits of vaccinating troops on United Nations tours in Yugoslavia against hepatitis A were compared. The marginal cost of one case of hepatitis A avoided by vaccination was calculated and compared with the marginal cost of achieving the same outcome by passive immunization. The cost-benefit ratio (medium estimate) for troops at low risk of contracting hepatitis A was 0.01 and for those at high risk was 0.03.

Vaccinating troops against hepatitis A for a single deployment appears to be an inefficient procedure, especially in troops at low risk. However, in professional troops from countries of low hepatitis A endemicity who are likely to be involved in several operational deployments, vaccination becomes more efficient the more times the same troops are deployed.

Objectives: Decision analysis is commonly used to perform economic evaluations of new pharmaceuticals. The outcomes of such studies are often reported as an incremental cost per quality-adjusted life year (QALY) gained with the new agent. Decision analysis can also be used in the context of estimating drug cost before market entry. The current study used neurokinin-1 (NK-1) receptor antagonists, a new class of antiemetics for cancer patients, as an example to illustrate the process using an incremental cost of $Can20,000 per QALY gained as the target threshold.

Methods: A decision model was developed to simulate the control of acute and delayed emesis after cisplatin-based chemotherapy. The model compared standard therapy with granisetron and dexamethasone to the same protocol with the addition of an NK-1 before chemotherapy and continued twice daily for five days. The rates of complete emesis control were abstracted from a double-blind randomized trial. Costs of standard antiemetics and therapy for breakthrough vomiting were obtained from hospital sources. Utility estimates characterized as quality-adjusted emesis-free days were determined by interviewing twenty-five oncology nurses and pharmacists by using the Time Trade-Off technique. These data were then used to estimate the unit cost of the new antiemetic using a target threshold of $Can20,000 per QALY gained.

Results: A cost of $Can6.60 per NK-1 dose would generate an incremental cost of $Can20,000 per QALY. The sensitivity analysis on the unit cost identified a range from $Can4.80 to $Can10.00 per dose. For the recommended five days of therapy, the total cost should be $Can66.00 ($Can48.00–$Can100.00) for optimal economic efficiency relative to Canada's publicly funded health-care system.

Conclusions: The use of decision modeling for estimating drug cost before product launch is a powerful technique to ensure value for money. Such information can be of value to both drug manufacturers and formulary committees, because it would facilitate negotiations for optimal pricing in a given jurisdiction.

This article analyzes the use of antibiotics in Danish general practice. We observed considerable variation in the prescription of antibiotics among general practitioners (GPs). Internationally, Denmark has a low consumption of antibiotics. The use of antibiotics was closely associated with GPs' use of drugs, other than antibiotics, and to some extent with use of microbiological diagnostic tests. These findings provide evidence for the assumption that the consumption of antibiotics can be decreased further, which stresses the need for a restrictive policy concerning antibiotics.

Objectives: The objectives of this study is to review the set of criteria of the Institute of Medicine (IOM) for priority-setting in research with addition of new criteria if necessary, and to develop and evaluate the reliability and validity of the final priority score.

Methods: Based on the evaluation of 199 research topics, forty-five experts identified additional criteria for priority-setting, rated their relevance, and ranked and weighted them in a three-round modified Delphi technique. A final priority score was developed and evaluated. Internal consistency, test–retest and inter-rater reliability were assessed. Correlation with experts’ overall qualitative topic ratings were assessed as an approximation to validity.

Results: All seven original IOM criteria were considered relevant and two new criteria were added (“potential for translation into practice”, and “need for knowledge”). Final ranks and relative weights differed from those of the original IOM criteria: “research impact on health outcomes” was considered the most important criterion (4.23), as opposed to “burden of disease” (3.92). Cronbach's alpha (0.75) and test–retest stability (interclass correlation coefficient = 0.66) for the final set of criteria were acceptable. The area under the receiver operating characteristic curve for overall assessment of priority was 0.66.

Conclusions: A reliable instrument for prioritizing topics in clinical and health services research has been developed. Further evaluation of its validity and impact on selecting research topics is required.

Objectives: Implantable cardioverter defibrillator (ICD) therapy reduces the risk of sudden death in patients with ischemic cardiomyopathy, but their novelty and cost may represent barriers to utilization. The objective of this study was to examine the influence of age, gender, place of residence, and socioeconomic status on rates of ICD implantation for the primary prevention of death.

Methods: We conducted a population-based retrospective cohort study involving the entire province of Ontario, Canada. Patients were eligible if they had survived following hospitalization for heart failure from 1 January 1993, to 31 March 2004, and previously sustained an acute coronary syndrome within 5 years. Patients with an existing ICD or a documented history of cardiac arrest were excluded, as were patients who died in the hospital. Primary outcome was ICD implantation.

Results: We identified 48,426 patients hospitalized for heart failure who survived to hospital discharge. Of these, 440 received an ICD, with a gradual 30-fold increase in implantation rates over the study period (.12–3.9 percent). ICD recipients were more likely to be men (odds ratio [OR] = 4.14; 95 percent confidence interval [CI], 3.24–5.30), younger than 75 years of age (OR = 3.19; 95 percent CI, 2.57–3.96), reside in a metropolitan area (OR = 1.42; 95 percent CI, 1.04–1.9), and live in a higher socioeconomic neighborhood (OR = 1.32; 95 percent CI, 1.08–1.61).

Conclusions: Among patients with heart failure and a previous myocardial infarction, ICD use is increasing in Ontario. However, the application of this technology is characterized by major sociodemographic inequities. The causes and consequences of the pronounced age and gender discrepancies, in particular, warrant further investigation.

Objectives: Despite recent development of health technology assessment (HTA) methods, there are still methodological gaps for the assessment of complex health technologies. The INTEGRATE-HTA guidance for effectiveness, economic, ethical, socio-cultural, and legal aspects, deals with challenges when assessing complex technologies, such as heterogeneous study designs, multiple stakeholder perspectives, and unpredictable outcomes. The objective of this article is to outline this guidance and describe the added value of integrating these assessment aspects.

Methods: Different methods were used to develop the various parts of the guidance, but all draw on existing, published knowledge and were supported by stakeholder involvement. The guidance was modified after application in a case study and in response to feedback from internal and external reviewers.

Results: The guidance consists of five parts, addressing five core aspects of HTA, all presenting stepwise approaches based on the assessment of complexity, context, and stakeholder involvement. The guidance on effectiveness, health economics and ethics aspects focus on helping users choose appropriate, or further develop, existing methods. The recommendations are based on existing methods’ applicability for dealing with problems arising with complex interventions. The guidance offers new frameworks to identify socio-cultural and legal issues, along with overviews of relevant methods and sources.

Conclusions: The INTEGRATE-HTA guidance outlines a wide range of methods and facilitates appropriate choices among them. The guidance enables understanding of how complexity matters for HTA and brings together assessments from disciplines, such as epidemiology, economics, ethics, law, and social theory. This indicates relevance for a broad range of technologies.

Objectives: Since 2002, the treatment with cholinesterase inhibitors (CHEIs) for Alzheimer's disease (AD) has been paid for by the public health system of the Brazilian Ministry of Health for any patient that fulfills clinical criteria established by an evidence-based guideline developed and published by the Ministry. The aim of this study was to evaluate compliance of prescription patterns to the national guideline for use of CHEIs’ in the southern Brazilian state of Rio Grande do Sul.

Methods: We created a regional expert-committee reference center to review all prescriptions of CHEIs and to send feedback to physicians whenever prescriptions without compliance to the guideline were noted. One thousand three hundred ninety-nine (1,399) CHEI prescriptions presented to the public health system from 2005 to 2007 were evaluated by an expert team of neurologists and psychiatrists. Clinical history, performance on mental status screening by Mini Mental State Examination (MMSE), Clinical Dementia Rating scale (CDR), laboratory results, and neuroimaging findings were evaluated in relation to the adherence to the national guideline's recommendations. If the prescription was rejected because of lack of adherence to the criteria of the guideline, a written response was sent by the expert committee to physicians concerning the request.

Results: The majority of the requests (n = 1,044; 75 percent) did not meet the AD guideline's criteria, either for diagnosis or for treatment, and were not granted. A diagnostic mistake was evident in 64.3 percent of cases. Findings of vascular or Parkinson's dementia or severe AD were the main reasons for rejection. Rivastigmine was the most prescribed cholinesterase inhibitor, used in 86 percent of cases. Of note was the reduction in the number of CHEIs prescriptions in the years following this intervention.

Conclusions: The public health strategy of using expert-review of prescriptions and their compliance to national guideline revealed a low rate of rational use of CHEIs for dementia. Such a strategy is relevant for protecting patients from unproven medical interventions and for reducing waste of resources.

Objectives: The aim of this study was to evaluate the direct costs of type 2 diabetes mellitus patients treated in a Brazilian public hospital.

Methods: This was an exploratory retrospective cost-of-illness study with quantitative approach, using medical records of patients treated in a public hospital (2012–14), with at least one consultation over a period of 12 months. Data on patient's profile, exams, number of consultations, medications, hospitalizations, and comorbidities were collected. The cost per patient per year (pppy) was calculated as well as the costs related to glycated hemoglobin (HbA1c) values, using thresholds of 7 and 8 percent.

Results: Data of 726 patients were collected with mean age of 62 ± 11 years (68.3 percent female). A total of 67.1 percent presented HbA1c > 7 percent and 44.9 percent > 8 percent. The median cost of diabetes was United States dollar (USD) 197 pppy. The median costs of medication were USD 152.49 pppy, while costs of exams and consultations were USD 40.57 pppy and 8.70 pppy, respectively. Thirty-eight patients (4 percent) were hospitalized and presented a median cost of 3,656 per patient per hospitalization with a cost equivalent to 53.1 percent of total expenses. Total costs of patients with HbA1c ≤ 7 percent were lower for this group and also costs of medications and consultations, whereas for patients with HbA1c ≤ 8 percent, only total costs and costs of medications were lower when compared with HbA1c > 8 percent patients.

Conclusions: Medications and hospitalizations were the major contributor of diabetes expenses. Preventing T2DM, or reducing its complications through adequate control, may help avoid the substantial costs related to this disease.

Several studies have been carried out regarding different interventions in an effort to improve levels of physical activity in people with an intellectual disability (ID). Studies have been carried out regarding physical activity interventions (1), educational interventions (2), and multimodal interventions (3). New technologies are currently being used to carry out changes in daily habits and to promote health in different pathologies but not in people with an ID (4;5). Due to the poor maintenance of physical activity that we have found in people with ID, the objective of the present study is to determine the maintenance of levels of physical activity, quality of life, self-efficacy, and social support in this population through an intervention with an application in their smartphones.

Objectives: Current health technology assessment (HTA) is not well equipped to assess complex technologies as insufficient attention is being paid to the diversity in patient characteristics and preferences, context, and implementation. Strategies to integrate these and several other aspects, such as ethical considerations, in a comprehensive assessment are missing. The aim of the European research project INTEGRATE-HTA was to develop a model for an integrated HTA of complex technologies.

Methods: A multi-method, four-stage approach guided the development of the INTEGRATE-HTA Model: (i) definition of the different dimensions of information to be integrated, (ii) literature review of existing methods for integration, (iii) adjustment of concepts and methods for assessing distinct aspects of complex technologies in the frame of an integrated process, and (iv) application of the model in a case study and subsequent revisions.

Results: The INTEGRATE-HTA Model consists of five steps, each involving stakeholders: (i) definition of the technology and the objective of the HTA; (ii) development of a logic model to provide a structured overview of the technology and the system in which it is embedded; (iii) evidence assessment on effectiveness, economic, ethical, legal, and socio-cultural aspects, taking variability of participants, context, implementation issues, and their interactions into account; (iv) populating the logic model with the data generated in step 3; (v) structured process of decision-making.

Conclusions: The INTEGRATE-HTA Model provides a structured process for integrated HTAs of complex technologies. Stakeholder involvement in all steps is essential as a means of ensuring relevance and meaningful interpretation of the evidence.

All evaluation exercises involve ethical values, as they require some conception of the “good life.” Evaluation of health technologies is no exception. Because there is no consensus about what is a good life, we have to devise decision-making procedures in which citizens with different opinions are heard and treated fairly (1). The purpose of health technology assessment (HTA) is to offer useful input into this process so as to increase the quality of the deliberations and of the resulting decisions. How to bring ethical values into this process?

Objectives: Strengthening efforts toward better collaboration plays a pivotal role in the assessment of medical devices to reduce overlap and save resources. This study explored the level of duplication in health technology assessments (HTA) of medical devices in Europe and their respective timing in order to identify areas for better collaboration.

Methods: An analysis of European HTA reports of medical devices regarding overlaps in topics and timing in relation to market authorization was performed. We conducted a systematic search in the ADVANCE, Centre for Reviews and Dissemination, Syngerus, and POP databases, complemented by hand searching, to identify HTA reports published between 01/2003 and 07/2016 for a preselected cohort group of ten technologies. We analyzed the number of annual assessments per technology and evaluated activity patterns and timing in undertaking the HTA of the different institutes in Europe.

Results: The results revealed the amount of duplication in the European HTA production: the number of reports per technology ranged from minimum seven to maximum twenty-two over a time-span of 13.5 years. HTA institutes perform assessments at a similar time range within 5 to 10 years following market authorization. The timing of the initial assessment in relation to the granting of the CE-mark varies according to the particular technology.

Conclusion: The findings suggest that efficient collaboration may help to save scarce resources and time of HTA institutes in Europe. Efficient collaboration as such needs to shift the focus beyond the time span of 1 year, and build on each's others work from previous assessments.