International variation in programmes for assessment of children's neurodevelopment in the community: Understanding disparate approaches to evaluation of motor, social, emotional, behavioural and cognitive function.

BACKGROUND: Few areas of medicine demonstrate such international divergence as child development screening and surveillance. Many countries have nationally mandated surveillance policies, but the content of programmes and mechanisms for delivery vary enormously. The cost of programmes is substantial but no economic evaluations have been carried out. We have critically examined the history, underlying philosophy, content and delivery of programmes for child development assessment in five countries with comprehensive publicly funded health services (Denmark, Finland, Norway, Scotland and Sweden). The specific focus of this article is on motor, social, emotional, behavioural and global cognitive functioning including language. FINDINGS: Variations in developmental surveillance programmes are substantially explained by historical factors and gradual evolution although Scotland has undergone radical changes in approach. No elements of universal developmental assessment programmes meet World Health Organization screening criteria, although some assessments are configured as screening activities. The roles of doctors and nurses vary greatly by country as do the timing, content and likely costs of programmes. Inter-professional communication presents challenges to all the studied health services. No programme has evidence for improved health outcomes or cost effectiveness. CONCLUSIONS: Developmental surveillance programmes vary greatly and their structure appears to be driven by historical factors as much as by evidence. Consensus should be reached about which surveillance activities constitute screening, and the predictive validity of these components needs to be established and judged against World Health Organization screening criteria. Costs and consequences of specific programmes should be assessed, and the issue of inter-professional communication about children at remediable developmental risk should be prioritised.

HTA IN CENTRAL-EASTERN-SOUTHERN EUROPE: FINDING ITS WAY TO HEALTH POLICY.

The number of publications on health technology assessment (HTA) from Central, Eastern, and Southern Europe (CESE countries) is still low compared with the north and west of Europe. It is not surprising, as the idea of HTA originated from high-income Western economies and was afterward adopted by the south-eastern part of Europe, which mostly consists of middle-income countries. These CESE countries, with less capacity and experience with HTA processes, must deal with even tougher decisions on financing health technologies than north-western Europe. There may even be a lack of confidence to open discussions on their specific needs for HTA.

IMPLEMENTING HEALTH TECHNOLOGY ASSESSMENT-BASED RECOMMENDATIONS IN FINLAND: MANAGED UPTAKE OF MEDICAL METHODS.

OBJECTIVES: The Managed Uptake of Medical Methods Program (MUMM) started 10 years ago as a joint venture of the Finnish Office for Health Technology Assessment (Finohta) and the twenty hospital districts in Finland. The aim is to offer information on the effectiveness, safety, organizational effects, and costs of new medical methods to support decisions concerning their uptake in secondary care. In this article, we discuss the successes and challenges of implementing the MUMM program. METHODS: A study of awareness and use of five MUMM recommendations for various medical specialties with short-form web-based surveys to hospitals. RESULTS: The recommendations were noticed and considered relevant. In overall assessment they received a mean rating of 8.4 (range: 4 to 10). Two thirds of the respondents thought MUMM recommendations were useful for practice, but only a third had actually used them in decision making. CONCLUSIONS: HTA-based MUMM recommendations were well received by physicians but in practice they are less used than clinical practice guidelines. Short-form electronic surveys were a useful way of gathering information about awareness and implementation. The surveys also functioned as another method of informing key physicians about the recommendations.

Analysis of the costs for the laboratory of flow cytometry screening of urine samples before culture.

Urine culture samples comprise a large proportion of the workload in clinical microbiology laboratories, and most of the urine samples show no growth or insignificant growth. A flow cytometry-based analyzer (Sysmex Corporation, Japan) has been used to screen out negative urine samples prior to culture in the Päijät-Häme district. We applied decision analytic modelling to analyze, from a laboratory perspective, the economic feasibility of the screening method as compared to culture only (conventional method) for diagnosis of urinary tract infection. Our model suggests that the least costly analytical strategy is the conventional method. The incremental cost of screening is €0.29/sample. Although laboratory costs are higher, considerable savings on workload can be achieved. Furthermore, screening has numerous benefits on the treatment process of a patient that well warrant the use of the screening method. We conclude that the incremental cost of screening the samples is worth the expense.

Testing the HTA core model: experiences from two pilot projects.

OBJECTIVES: The aim of this study was to analyze and describe process and outcomes of two pilot assessments based on the HTA Core Model, discuss the applicability of the model, and explore areas of development. METHODS: Data were gathered from HTA Core Model and pilot Core HTA documents, their validation feedback, questionnaires to investigators, meeting minutes, emails, and discussions in the coordinating team meetings in the Finnish Office for Health Technology Assessment (FINOHTA). RESULTS: The elementary structure of the HTA Core Model proved useful in preparing HTAs. Clear scoping and good coordination in timing and distribution of work would probably help improve applicability and avoid duplication of work. CONCLUSIONS: The HTA Core Model can be developed into a platform that enables and encourages true HTA collaboration in terms of distribution of work and maximum utilization of a common pool of structured HTA information for national HTA reports.

The HTA core model: a novel method for producing and reporting health technology assessments.

OBJECTIVES: The aim of this study was to develop and test a generic framework to enable international collaboration for producing and sharing results of health technology assessments (HTAs). METHODS: Ten international teams constructed the HTA Core Model, dividing information contained in a comprehensive HTA into standardized pieces, the assessment elements. Each element contains a generic issue that is translated into practical research questions while performing an assessment. Elements were described in detail in element cards. Two pilot assessments, designated as Core HTAs were also produced. The Model and Core HTAs were both validated. Guidance on the use of the HTA Core Model was compiled into a Handbook. RESULTS: The HTA Core Model considers health technologies through nine domains. Two applications of the Model were developed, one for medical and surgical interventions and another for diagnostic technologies. Two Core HTAs were produced in parallel with developing the model, providing the first real-life testing of the Model and input for further development. The results of formal validation and public feedback were primarily positive. Development needs were also identified and considered. An online Handbook is available. CONCLUSIONS: The HTA Core Model is a novel approach to HTA. It enables effective international production and sharing of HTA results in a structured format. The face validity of the Model was confirmed during the project, but further testing and refining are needed to ensure optimal usefulness and user-friendliness. Core HTAs are intended to serve as a basis for local HTA reports. Core HTAs do not contain recommendations on technology use.

European network for health technology assessment, EUnetHTA: planning, development, and implementation of a sustainable European network for health technology assessment.

OBJECTIVES: The European network on Health Technology Assessment (EUnetHTA) aimed to produce tangible and practical results to be used in the various phases of health technology assessment and to establish a framework and processes to support this. This article presents the background, objectives, and organization of EUnetHTA, which involved a total of sixty-four partner organizations. METHODS: Establishing an effective and sustainable structure for a transnational network involved many managerial, policy, and methodological tools, according to the objective of each task or Work Package. Transparency in organization, financial transactions, and decision making was a key principle in the management of the Project as was the commitment to appropriately involve stakeholders. RESULTS: EUnetHTA activities resulted in a clear management and governance structure, efficient partnership, and transnational cooperation. The Project developed a model for sustainable continuation of the EUnetHTA Collaboration. CONCLUSIONS: The EUnetHTA Project achieved its goals by producing a suite of practical tools, a strong network, and plans for continuing the work in a sustainable EUnetHTA Collaboration that facilitates and promotes the use of HTA at national and regional levels. Responsiveness to political developments in Europe should be balanced with maintaining a high level of ambition to promote independent, evidence-based information and well-tested tools for best practice based on a strong network of HTA institutions.

Health technology assessment in Finland.

Since the 1990s, health policy makers in Finland have been supportive of evidence-based medicine and approaches to implement its results. The Finnish Office for Health Technology Assessment (Finohta) has grown from a small start in 1995 to a medium-sized health technology assessment (HTA) agency, with special responsibility in providing assessments to underpin national policies in screening. External evaluations enhanced the rapid growth. In the Finnish environment, decision making on health technologies is extremely decentralized, so Finohta has developed some practical tools for implementing HTA findings. The Managed Uptake of Medical Methods program links the hospital districts to agree on introduction of technologies. The Ohtanen database provides Finnish-language summaries of major assessments made in other countries.

Ethical analysis to improve decision-making on health technologies.

Health technology assessment (HTA) is the multidisciplinary study of the implications of the development, diffusion and use of health technologies. It supports health-policy decisions by providing a joint knowledge base for decision-makers. To increase its policy relevance, HTA tries to extend beyond effectiveness and costs to also considering the social, organizational and ethical implications of technologies. However, a commonly accepted method for analysing the ethical aspects of health technologies is lacking. This paper describes a model for ethical analysis of health technology that is easy and flexible to use in different organizational settings and cultures. The model is part of the EUnetHTA project, which focuses on the transferability of HTAs between countries. The EUnetHTA ethics model is based on the insight that the whole HTA process is value laden. It is not sufficient to only analyse the ethical consequences of a technology, but also the ethical issues of the whole HTA process must be considered. Selection of assessment topics, methods and outcomes is essentially a value-laden decision. Health technologies may challenge moral or cultural values and beliefs, and their implementation may also have significant impact on people other than the patient. These are essential considerations for health policy. The ethics model is structured around key ethical questions rather than philosophical theories, to be applicable to different cultures and usable by non-philosophers. Integrating ethical considerations into HTA can improve the relevance of technology assessments for health care and health policy in both developed and developing countries.

Hypertension guideline implementation: experiences of Finnish primary care nurses.

RATIONALE, AIMS AND OBJECTIVES: Evidence-based guidelines on hypertension have been developed in many western countries. Yet, there is little evidence of their impact on the clinical practices of primary care nurses. METHOD: We assessed the style of implementation and adoption of the national Hypertension Guideline (HT Guideline) in 32 Finnish health centres classified in a previous study as 'disseminators' (n = 13) or 'implementers' (n = 19). A postal questionnaire was sent to all nurses (n = 409) working in the outpatient services in these health centres. Additionally, senior nursing officers were telephoned to enquire if the implementation of the HT Guideline had led to a new division of labour between nurses and doctors. RESULTS: Questionnaires were returned from 327 nurses (80.0%), while all senior nursing officers (n = 32) were contacted. The majority of nurses were of the opinion that the HT Guideline has been adopted into clinical practice. The recommendations in the HT Guideline were adopted in clinical practice with varying success, and slightly more often in implementer health centres than in disseminator health centres. Nurses in implementer health centres more often agreed that multiple channels had been used in the implementation (P < 0.001). According to senior nursing officers the implementation of the HT Guideline had led to a new division of labour between nurses and doctors in about a half of the health centres, clearly more often in implementer health centres (P < 0.001). CONCLUSIONS: The HT Guideline was well adopted into clinical practice in Finland. The implementation of the HT Guideline had an impact on clinical practices, and on creating a new division of labour between nurses and doctors.

Screening for fetal abnormalities: from a health technology assessment report to a national statute.

OBJECTIVES: Previously in Finland, each municipality selected which methods to use in screening for fetal abnormalities. This resulted in practice variation and inequity. The national health technology assessment (HTA) office Finohta compared the methods and time frames available when screening for chromosomal and structural abnormalities. The assessment identified a need to discuss several value-laden questions before policy decisions could be taken. METHODS: The National Screening Committee (NSC) at the Ministry of Health and Social Affairs (MOH) formulated a statement based on the HTA report to inform policy makers. This article describes the steps in the policy process. RESULTS: The national screening committee organized an open forum to discuss the ethically relevant aspects of fetal screening, and a lengthy public discussion highlighted the viewpoints of various stakeholders. Based on the assessment, public discussion, and several committee meetings that heard further experts, the NSC formulated a conclusion based on equity of access. This also offered options for families unwilling to terminate a pregnancy due to fetal abnormality. The MOH sent the conclusion to a comment round, and the proposal was accepted with minor adjustments. The Ministry decided to unify the regulation of all public screening programs by one statute. The policy process lasted three years, and the methods to screen for fetal abnormalities will be unified after a further 3 years. CONCLUSIONS: The assessment of screening programs for fetal abnormalities reached beyond its original mandate. The process of examining values behind screening resulted in a program that respects the differing objectives and ethical values of pregnant families, and to national legislation on screening programs.

Cost-effectiveness analysis of guidelines for antihypertensive care in Finland.

BACKGROUND: Hypertension is one of the major causes of disease burden affecting the Finnish population. Over the last decade, evidence-based care has emerged to complement other approaches to antihypertensive care, often without health economic assessment of its costs and effects. This study looks at the extent to which changes proposed by the 2002 Finnish evidence-based Current Care Guidelines concerning the prevention, diagnosis, and treatment of hypertension (the ACCG scenario) can be considered cost-effective when compared to modelled prior clinical practice (the PCP scenario). METHODS: A decision analytic model compares the ACCG and PCP scenarios using information synthesised from a set of national registers covering prescription drug reimbursements, morbidity, and mortality with data from two national surveys concerning health and functional capacity. Statistical methods are used to estimate model parameters from Finnish data. We model the potential impact of the different treatment strategies under the ACCG and PCP scenarios, such as lifestyle counselling and drug therapy, for subgroups stratified by age, gender, and blood pressure. The model provides estimates of the differences in major health-related outcomes in the form of life-years and costs as calculated from a 'public health care system' perspective. Cost-effectiveness analysis results are presented for subgroups and for the target population as a whole. RESULTS: The impact of the use of the ACCG scenario in subgroups (aged 40-80) without concomitant cardiovascular and related diseases is mainly positive. Generally, costs and life-years decrease in unison in the lowest blood pressure group, while in the highest blood pressure group costs and life-years increase together and in the other groups the ACCG scenario is less expensive and produces more life-years. When the costs and effects for subgroups are combined using standard decision analytic aggregation methods, the ACCG scenario is cost-saving and more effective. CONCLUSION: The ACCG scenario is likely to reduce costs and increase life-years compared to the PCP scenario in many subgroups. If the estimated trade-offs between the subgroups in terms of outcomes and costs are acceptable to decision-makers, then widespread implementation of the ACCG scenario is expected to reduce overall costs and be accompanied by positive outcomes overall.

Prioritizing guideline topics: development and evaluation of a practical tool.

RATIONALE, AIMS AND OBJECTIVES: A clear process for selecting and adopting clinical practice guidelines in the new topic areas is needed. The aim of this study is to design and develop a practical tool to assess guideline topics that have been suggested to the organization responsible for producing guidelines. METHODS: We carried out an iterative development, feasibility and validation study of a guideline topic prioritization tool. The setting included the guideline producer organization and the tax-funded health care system. In the first stage of the tool development, participants were researchers, members of the Current Care Board and experts from health care organizations. In the second stage, the evaluation was done internally within the project by three independent reviewers. The main outcome measures were responses to an evaluation questionnaire, qualitative process feedback and analysis of the performance of the instrument on a random set of guidelines. RESULTS: Evaluations by three independent reviewers revealed good agreement and face validity with respect to its feasibility as a planning tool at the guideline board level. Feedback from board members suggested that the instrument is useful in prioritizing guideline topics. CONCLUSION: This instrument was accepted for use by the Board. Further developments are needed to ensure feedback and acceptability of the instrument by those proposing topics.

Ethical evaluation in health technology assessment reports: an eclectic approach.

OBJECTIVES: Ethical evaluation has become an important part of health technology assessment (HTA), but so far no generally accepted method for doing this exists. This article explains the eclectic approach developed at the Finnish HTA office. METHODS: Each HTA report is produced in cooperation with the methodological and clinical experts from various levels of healthcare organizations. An open framework for ethical evaluation when assessing different types of interventions is used to identify all possible stakeholders for each particular intervention. The ethical consequences for each party are identified during the entire process of the HTA project. RESULTS: The results of an ethical evaluation in four different HTA projects (two on screening, one on surgical intervention, and one in rehabilitation) show that an open framework is useful for opening discussion and understanding the scope of each ethical evaluation. Both content and methodological experts have found the process to be useful in capturing the broad consequences of implementing a new method. CONCLUSIONS: Ethical evaluation is a continuous process that considers the prevalent morals, values, and behavioral models of the society. An in-depth ethical evaluation helps the decision-makers to realize the consequences that implementing a new method has on individual citizens, the healthcare system, and society.

Cost-effectiveness of implementing national guidelines in the treatment of acute otitis media in children.

OBJECTIVES: Acute otitis media (AOM) is one of the most common diseases of childhood, representing a major disease burden on the society. New evidence-based guidelines for AOM, focusing on children under 7 years of age, were introduced in Finland in 1999. The aim of this study was to evaluate the cost-effectiveness of implementing those guidelines in Finland. METHODS: A 5-year prospective trial was conducted in thirty community primary healthcare centers in Finland. All AOM patients between 0 and 6 years of age visiting the study health centers for the first time, for this episode of illness, during 1 week in November 1998 (n = 579) and November 2002 (n = 369) were included in this study. The outcome measure was the percentage of symptom-free patients. RESULTS: The mean direct cost of an AOM episode per patient stayed almost the same after implementing the guidelines, euro152 in 1998 and euro150 in 2002. After implementing the guidelines, the percentage of symptom-free patients was 10 percentage points higher than before the guidelines. The treatment after the implementation of the guidelines, thus, was a dominant strategy. CONCLUSIONS: Implementing the guidelines to the treatment of AOM in children was associated with extra health benefits at slightly lower direct costs and, thus, is a dominant strategy. The focus of this study was on the short-term effects of the treatment; including long-term effects in the analysis might affect the results.

Overview of systematic reviews on invasive treatment of stable coronary artery disease.

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. Coronary 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.

Expanding screening for rare metabolic disease in the newborn: an analysis of costs, effect and ethical consequences for decision-making in Finland.

AIM: Currently, the only metabolic disorder that newborns are screened for in Finland is congenital hypothyroidism. A proposal to start a pilot study on screening for other rare metabolic diseases using tandem mass spectrometry prompted a health technology assessment project on the effect and costs of expanded newborn screening programme options. METHOD: A modelling study using data from current published studies, healthcare registers and expert opinion. RESULTS: The annual running cost of screening 56,000 newborns for the chosen five disorders (congenital adrenal hyperplasia, medium-chain acyl-CoA dehydrogenase deficiency [MCADD], long chain 3-hydroxyacyl-CoA dehydrogenase deficiency [LCHADD], phenylketonuria [PKU] and glutaric aciduria type 1 [GA 1]) was estimated to be euros 2.5 million or euros 45 per newborn when starting costs were included. The costs per quality-adjusted life year (QALY) gained are a maximum of euros 25,500. Prevention of severe handicap in one newborn would reduce the costs to a maximum of euros 18,000 per QALY gained. CONCLUSIONS: Expanding the Finnish neonatal screening programme would require a new organization. The cost-effectiveness, resources, ethics and equity need to be considered when deciding in favour of or against starting a new screening programme.