Objectives: To compare the cost-effectiveness of alternative methods of screening for retinopathy of prematurity (ROP) in the United Kingdom, including the existing method of indirect ophthalmoscopy by ophthalmologists and digital photographic screening by nurses.

Methods: A decision tree model was used to compare five screening modalities for the UK population of preterm babies, using a health service perspective. Data were taken from published sources, observation at a neonatal intensive care unit (NICU), and expert judgment.

Results: We estimated that use of standard digital cameras by nurses in NICUs would cost more than current methods (£371 compared with £321 per baby screened). However, a specialist nurse visiting units with a portable camera would be cheaper (£172 per baby). These estimates rely on nurses capturing and interpreting the images, with suitable training and supervision. Alternatively, nurses could capture the images then transmit them to a central unit for interpretation by ophthalmologists, although we estimate that this would be rather more expensive (£390 and £201, respectively, for NICU and visiting nurses). Sensitivity analysis was used to examine the robustness of estimates.

Conclusions: It is likely that there is an opportunity to improve the efficiency of the ROP screening program. We estimate that screening by specialist nurses trained in image capture and interpretation using portable digital cameras is a cost-effective alternative to the current program of direct visualization by ophthalmologists. This option would require the development of a suitable portable machine. Direct comparative research is strongly needed to establish the accuracy of the various screening options.

Objectives: This study outlines the needs and current development of the “fourth hurdle” (i.e., requirement of effectiveness and cost-effectiveness data for drug coverage policy decisions) in Hungary, describes the legal background and seeks to address some of the most important questions in this field.

Methods: The study draws on international experiences and discusses five issues that a given jurisdiction needs to consider before introducing the “fourth hurdle” for pharmaceuticals.

Results: The “fourth hurdle” is very relevant in Hungary because many existing drugs are unevaluated and many new, expensive drugs are becoming available. On the other hand, the existing resources for health technology assessment, including economic evaluation, are quite limited. All the five issues are relevant in the Hungarian setting and were helpful in determining exactly how the “fourth hurdle” should be applied.

Conclusions: The most important issue seems to be that the implementation of the “fourth hurdle” needs to be achieved in a way consistent with the limited resources for HTA in Hungary. Specifically this means that, in setting priorities for drugs to evaluate, additional criteria need to be applied. In particular, priority should be given to assessing drugs that have been evaluated in other countries, because this affords the opportunity to adapt existing studies or models to the Hungarian situation.

Objectives: The cost-effectiveness of the Swedish quitline, a nation-wide, free of charge service, is assessed.

Methods: The study was based on data of a sample of 1,131 callers enrolled from February 1, 2000 to November 30, 2001. Outcome was measured as cost per quitter and cost per year of life saved. Cost per quitter was based on a calculation of the total cost of the quitline divided by the number of individuals who reported abstinence after 12 months. The cost per life year saved (LYS) was calculated by the use of data from the literature on average life expectancy for smokers versus quitters, the total cost of the quitline, and the cost of pharmacological treatment.

Results: The number of smokers who used the quitline and reported abstinence after 1 year was 354 (31 percent). The accumulated number of life years saved in the study population was 2,400. The cost per quitter was 1,052–1,360 USD, and the cost per life year saved was 311–401 USD. A sensitivity analysis showed that, for outcomes down to an abstinence rate of 20 percent, the cost per LYS rose modestly, from 311 to 482 USD. Discounting the cost per LYS showed the cost to be 135 USD for 3 percent and 283 USD for 5 percent.

Conclusions: The Swedish quitline is a cost-effective public health intervention compared with other smoking cessation interventions.

This article seeks to comment on the approaches to health technology assessment (HTA) outlined in the four main country studies in this volume. It is written from the perspective of a general practitioner working in an inner city area in the United Kingdom and argues that, from the point of view of the clinician, HTA delivers considerably less than it promises. The problems center on the inevitability of judgment by both politicians and clinicians and the conflicting foundations of these judgments. Within political decision-making, the needs of the population inevitably outweigh the needs of the individual; within clinical decision making, the opposite is the case. Attempting a scientific rationality, HTA struggles with the impossibility of holding the balance between the two. These difficulties are further compounded by the implications of ever-increasing expectations of perfect health and the effects of multinational commercial pressures.

Health technology assessment needs to relate to contemporary questions which concern public health-care systems: how to keep people healthy, how to focus on the needs of those with chronic disabilities and integrate care between the hospital and the community, how to encourage and audit effective teamwork, and how to establish a consensus about what is effective and affordable. Clinicians have an ethical responsibility to practice efficiently and economically, for profligacy in the care of one patient may mean that another is treated inadequately. For similar reasons, clinicians need to play a full role in the management of services. Advice from health technology assessment is vital and needs to be accurate, relevant, timely, clear, and accessible. As well as being concerned about what works, we need also to eliminate from practice what does not. Regular audit and appraisal of practice against the evidence base should be useful in this respect. Alternative approaches to management, such as the provision of care as opposed to aggressive treatments, need to be evaluated, and health technology assessment needs to consider how services are delivered, not just specific treatments.

Objectives: To explore and test methods for the operation of a national Early Warning System (EWS) in Denmark and to support decision making by the Danish Centre for Evaluation and Health Technology Assessment on this issue.

Methods: On the basis of literature reviews, information from members of EuroScan, and supported by clinical experts and stakeholders, existing methods were adapted and new methods were developed as part of a feasibility study.

Results: Approximately 200 technologies in 30 specialties were identified on the basis of information by EuroScan. A new instrument was developed to distinguish between important and unimportant technologies (filtering). Clinical experts in six specialties applied the instrument to sixty-two technologies in their respective fields, of which nine (15%) were judged potentially important for the Danish health care system. For priority setting, adapting a Dutch instrument to the Danish context was discussed. In principle, the instrument was acceptable, but several changes were proposed, for example, relating to the decentralized structure of the Danish health care system. For early assessment, the format and methods applied by SBU and Canadian Coordinating Office for Health Technology Assessment (CCOHTA) were compared and applied to pharmaceuticals (glitazones in treatment of type 2 diabetes mellitus) and a procedure (embolization of uterine fibromas). Given the main target group of the Danish EWS, local decision makers, the CCOHTA format was preferred.

Conclusions: The findings of the study have laid the foundation for an EWS using appropriate methods adapted to local circumstances. On the basis of the findings, a decision was made to start an EWS.

Objectives:To compare the six-year outcome of a multidisciplinary rehabilitation program with continued care within primary care in terms of health-related quality of life and cost-effectiveness. Furthermore, predictors of total costs to society were examined.

Methods:A prospective, matched, controlled, six-year follow-up was designed. The study included 236 patients (42 men, 194 women) nineteen to sixty-one years of age with prolonged musculoskeletal disorders. The intervention comprised a four-week multidisciplinary rehabilitation and an active one-year follow-up based on a bio-psycho-social approach. The control group received continued care within primary care. The main outcome measures were quality of life measured using the Nottingham Health Profile, motivation identified by an interview and patient-specific total costs to society. Differences in mean costs between groups and cost-effectiveness were evaluated by applying nonparametric bootstrapping techniques.

Results: Total costs per treated patient in the rehabilitation group and the control group were £43,464 (SD=31,093) and £44,123 (SD=33,333), respectively (p=.896). Multidisciplinary rehabilitation improved quality of life somewhat more cost-effectively. Motivation was revealed as a predictor of total costs.

Conclusion: In the long-run, the evaluated multidisciplinary rehabilitation improved the highly motivated patients' quality of life most cost-effectively. The latently motivated patients may require rehabilitation, which is less intensive and with a longer duration, to improve their health in a whole-person perspective. The burden of prolonged musculoskeletal disorders to society was reaffirmed. Motivation could be a predictor of total costs, a factor which has to be taken into account in the examination procedure.

Objectives: We assess the cost-effectiveness of smoking relapse prevention interventions designed to keep quitters from resuming the use of cigarettes. Because relapse prevention is complementary to smoking cessation efforts, the appropriate test of its cost-effectiveness is whether it reduces the incremental cost-effectiveness ratio (ICER) of smoking cessation. The major goal of the study is to carry out such a test.

Methods: Data from a randomized trial that ascertained the effectiveness of alternative modes of smoking relapse prevention are combined with ICER estimates of smoking cessation to assess whether relapse prevention is cost-effective.

Results: The trial produced convincing evidence that relapse prevention yields statistically significant reductions in the proportion of quitters who are smoking at 24 months postquit. The intervention effects are substantial enough to raise the denominator terms of the smoking cessation ICER and, thereby, offset the amount relapse prevention adds to cost numerator terms. In this sense, smoking relapse prevention tends to pay for itself.

Conclusions: Smoking relapse prevention is a highly cost-effective addition to current efforts to curb cigarette consumption. Complementary health interventions of this sort should be assessed by different methods than those commonly found in the cost-effectiveness literature.

Objectives: Assess the degree to which research project findings were published and explore factors that influenced publication.

Methods: Questionnaire to project leaders. Classification of publications and findings. Chi-squared; univariate and multivariate Cox regression analyses.

Results: Forty percent of projects published in peer-reviewed journal; highly statistically significant relationships between publication in peer-reviewed journals and (1) projects in Responsive/Fellowships streams (p=.045); and (2) projects awarded >£22,713 (p=.02); influence of study findings not statistically significant.

Conclusions: Funders should consider the significant number of studies that did not result in publication and the higher rate of publication in peer-reviewed journals from some programs.

Health technology assessment (HTA) involves values and judgments, but there have been few attempts to seek the views of members of the public or to ensure that they have access to the results. Patients and citizens can make an important contribution to HTA by determining priorities for assessment, designing and conducting assessments and appraisals, receiving and using the findings, and engaging in debates about policy priorities and rationing. Those responsible for HTA should make greater efforts to involve the public and ensure that the findings are accessible to patients for use when making treatment choices.

Objectives: The aim of the study reported here was to investigate whether the use of magnetic resonance imaging (MRI) impacts on the clinical management of patients presenting with chronic knee problems, reduces costs, and improves patient outcome.

Methods: A single-center randomized controlled trial was conducted. Patients attending with knee problems in whom surgery was being considered were randomized either to investigation using an MRI scan or to investigation using arthroscopy. The study investigated benefits in terms of avoidance of surgery and patient health-related quality of life (using SF-36 and EQ-5D). Costs were assessed from the perspectives of the National Health Service and patients. All analyses were by intention to treat.

Results: The trial recruited 118 patients. No statistically significant differences were found between groups in terms of health outcome. However, the use of MRI was associated with a positive diagnostic/therapeutic impact: a significantly smaller proportion of patients in the MRI group underwent surgery (MRI=0.41, No-MRI=0.71; p value=.001). There was a similar mean overall cost for both groups.

Conclusions: The use of MRI in patients with chronic knee problems, in whom surgery was being considered, did not increase costs overall, was not associated with worse outcomes, and avoided surgery in a significant proportion of patients.

Objectives: Reported is the importance of properly reflecting uncertainty associated with prognostic model estimates when calculating the survival benefit of a treatment or technology, using liver transplantation as an example.

Methods: Monte Carlo simulation techniques were used to account for the uncertainty of prognostic model estimates using the standard errors of the regression coefficients and their correlations. These methods were applied to patients with primary biliary cirrhosis undergoing liver transplantation using a prognostic model from a historic cohort who did not undergo transplantation. The survival gain over 4 years from transplantation was estimated.

Results: Ignoring the uncertainty in the prognostic model, the estimated survival benefit of liver transplantation was 16.7 months (95 percent confidence interval [CI], 13.5 to 20.1), and was statistically significant (p<.001). After adjusting for model uncertainty using the standard errors of the regression coefficients, the estimated survival benefit was 17.5 months (95 percent CI, −3.9 to 38.5) and was no longer statistically significant. An additional adjustment for the correlation between regression coefficients widened the 95 percent confidence interval slightly: the estimated survival benefit was 17.0 months (95 percent CI: −4.6 to 38.6).

Conclusions: It is important that the precision of regression coefficients is available for users of published prognostic models. Ignoring this additional information substantially underestimates uncertainty, which can then impact misleadingly on policy decisions.

This article presents the pharmaceutical industry's perspective on health technology assessment (HTA) with specific comments on the HTA systems in England and Wales, France, The Netherlands, and Sweden. The comments are focused on the following main themes: (i) The contributions of the HTA system to overall efficiency in the health-care system, (ii) HTA as a cost-driver for industry, patients, government, and society, and (iii) The various implementation barriers that currently exist for a successful implementation of HTA results.

Objectives: To assess the impact of the availability of drug-eluting stents (DES) in April 2002 in Emilia-Romagna (a four-million resident Italian region), on the rate of use of revascularization procedures. DES are expected to influence the rate of use of coronary artery bypass graft (CABG) and percutaneous coronary interventions (PCI). However, to date, little empirical information is available on the actual impact of this innovation on clinical practice.

Methods: A time series regression analysis of the monthly number of procedures (PCI and CABG) performed between January 1998 and March 2003.

Results: DES availability was associated with statistically significant changes in the use of revascularization procedures, although the size of the effect was always small or moderate. PCI increased only by 0.36 more procedures per month (approximately four per year), whereas more evident was the concurrent reduction of isolated CABG (4.15 fewer per month, that is fifty fewer per year). Overall, considering all the surgical revascularizations (i.e., CAGB both isolated and associated with other interventions), there was a reduction of 2.52 procedures per month (thirty less per year).

Conclusions: Despite DES being at a very early stage of their diffusion process, our results indicate that they are already having an impact, although moderate, on the use of revascularization procedures. If these findings will be confirmed, they will have a substantial influence on the patterns of care for patients with coronary artery disease and relevant policy implications for health services.

Objectives: Summary physical health scores for the Short Form (SF) measures are computing using positive weights for physical items and negative weights for mental health items. Mental health summary scores use positive weights for mental items and negative weights for physical. The RAND Health Status Inventory (HSI) measures do not use negative weights. Do these different approaches to scoring matter? The objective was to compare summary scores using both the SF and RAND-HSI.

Methods: SF-36 and the Health Utilities Index Mark 3 (HUI3) were administered to a cohort of patients waiting for elective total hip arthroplasty (THA). SF-12 and HUI3 were administered to a cohort of high-risk primary-care patients. Summary scores were generated and compared. Single-attribute utility scores for emotion in HUI3 were also computed. Canadian and US norms for SF, RAND-HSI, and HUI3 were used to interpret results.

Results: For THA patients, mean physical health scores were 28 and 36 for SF and RAND-HSI. Mean mental health scores were 55 and 42. For the primary-care patients, the scores were 34 and 36 for physical and 46 and 40 for mental health.

Conclusions: SF and RAND-HSI provided somewhat similar summary scores in the THA study. However, SF and RAND-HSI mental health scores differed in the primary-care patient cohort and results from HUI3 corroborate the mental health deficits identified by the RAND-HSI. It may be wise for investigators to use both SF and RAND-HSI scoring systems.

Objectives: The observed posterior probability distributions regarding the benefits of surgery for otitis media with effusion (OME) with expected probability distributions, using Bayes' theorem are compared.

Methods: Postal questionnaires were used to assess prior and posterior probability distributions among ear-nose-throat (ENT) surgeons in the Netherlands.

Results: In their prior probability estimates, ENT surgeons were quite optimistic with respect to the effectiveness of tube insertion in the treatment of OME. The trial showed no meaningful benefit of tubes on hearing and language development. Posterior probabilities calculated on the basis of prior probability estimates and trial results differed widely from those, elicited empirically 1 year after completion of the trial and dissemination of the results.

Conclusions: ENT surgeons did not adjust their opinion about the benefits of surgical treatment of glue ears to the extent that they should have done according to Bayes' theorem. Users of the results of Bayesian analyses, notably policy-makers, should realize that Bayes' theorem is prescriptive and not necessarily descriptively correct. Health policy decisions should not be based on the untested assumption that health-care professionals use new evidence to adjust their subjective beliefs in a Bayesian manner.

Objectives: This study aims to describe a cycle of development leading to sustainable methods for involving consumers in the management of a program commissioning health technology assessment.

Methods: Staff time was dedicated to developing procedures for recruiting and briefing consumers to participate in prioritizing, commissioning, and reporting research. Resources and support were developed in light of early feedback from consumers and those working with them. These were piloted and amended before being used routinely.

Results: Over 4 years, procedures and resources have been developed to support six consumers attending seven to eight prioritization meetings a year; thirty to forty-five consumers each year commenting on research need for particular topics; thirty consumers a year commenting on research proposals, and twenty a year commenting on research reports. The procedures include clear job descriptions, induction and development days, clear briefing materials, payment for substantial tasks, and regularly seeking feedback to improve procedures.

Conclusions: Explicit, inclusive, and reproducible methods for supporting consumer involvement that satisfy National Health Service policy recommendations for involving consumers in research require dedicated staff time to support a cycle of organizational development.

Objectives: To study the impact on public health in terms of utility of various proportions of first-eye and second-eye cataract surgery.

Methods: A model was used to study the impact on a population of a fixed cataract surgical rate (9,250 operations/1,000,000 people) with varying proportions of first-eye and second-eye cataract operations. The study population was the County of Blekinge with a known incidence of previous cataract surgery. The prevalence of cataract, the estimated need for cataract surgery, and the utility values were taken from the literature. The population was grouped by disability stage of cataract and previous cataract surgery in accordance with prevalence studies and data from a large national database on cataract surgery and patients' self-assessed visual function. The mortality rate was taken from real data for the study population.

Results: Given a fixed cataract surgical rate over a period of five years, a high percentage of second-eye cataract surgery (42 percent) resulted in a mean utility of 0.82239 in the population forty years of age and older and the corresponding number for a low percentage of second-eye cataract surgery (25 percent) was 0.82253. A high percentage of second-eye surgeries resulted in 421 more individuals who were well compared with a low percentage of second-eye surgeries. On the other hand, a low percentage of second-eye surgeries resulted in 152 fewer individuals with disability and 118 fewer individuals with dependence compared with a high percentage of second-eye surgeries.

Conclusions: A high frequency of first-eye cataract surgeries instead of second-eye surgeries affects more individuals and means an optimized improvement of utility in a population. This should be recommended if the cataract surgical rate is very insufficient. If the cataract surgical rate is high, more second-eye surgeries should be performed to optimize quality of life to as many as possible.

The longer you can look back, the better you can look forward

—Sir Winston Churchill

Objectives: To compare the hospitalization day price, and the hospitalization costs 100 years ago with the present situation.

Methods: Municipal and hospital archives of two cities, Maastricht in The Netherlands and Tongeren in Belgium, were studied systematically for reports of costs. These were compared with the present accounts.

Results: Starting from the second part of the nineteenth century, an official day price was calculated each year by averaging the total hospital expenditures by the total number of hospitalization days. Of all expenditures, nutrition accounted for nearly 50% of expenses. Differences with the current situation are striking. Nowadays, the day price is a negotiated tariff. Management and salaries make up more than 70% of the present expenditures.

Conclusions: Hospitalization day prices have been used for approximately 150 years to determine hospitalization costs. Since then, the total hospital expenditures and the relative cost components have changed considerably. Compared with the spending power of people, the cost of one day in the hospital increased substantially.