Hindrik Vondeling

Cost effectiveness of physiotherapy, manual therapy, and general practitioner care for neck pain: economic evaluation alongside a randomised controlled trial

Abstract Objective: To evaluate the cost effectiveness of physiotherapy, manual therapy, and care by a general practitioner for patients with neck pain. Design: Economic evaluation alongside a randomised controlled trial. Setting: Primary care. Participants: 183 patients with neck pain for at least two weeks recruited by 42 general practitioners and randomly allocated to manual therapy (n=60, spinal mobilisation), physiotherapy (n=59, mainly exercise), or general practitioner care (n=64, counselling, education, and drugs). Main outcome measures: Clinical outcomes were perceived recovery, intensity of pain, functional disability, and quality of life. Direct and indirect costs were measured by means of cost diaries that were kept by patients for one year. Differences in mean costs between groups, cost effectiveness, and cost utility ratios were evaluated by applying non-parametric bootstrapping techniques. Results: The manual therapy group showed a faster improvement than the physiotherapy group and the general practitioner care group up to 26 weeks, but differences were negligible by follow up at 52 weeks. The total costs of manual therapy (€447; £273;

Selection of new health technologies for assessment aimed at informing decision making: A survey among horizon scanning systems.

402) were around one third of the costs of physiotherapy (€1297) and general practitioner care (€1379). These differences were significant: P<0.01 for manual therapy versus physiotherapy and manual therapy versus general practitioner care and P=0.55 for general practitioner care versus physiotherapy. The cost effectiveness ratios and the cost utility ratios showed that manual therapy was less costly and more effective than physiotherapy or general practitioner care. Conclusions: Manual therapy (spinal mobilisation) is more effective and less costly for treating neck pain than physiotherapy or care by a general practitioner. What is already known on this topic The cost of treating neck pain is considerable Many conservative interventions are available, such as prescription drugs, yet their cost effectiveness has not been evaluated No randomised trials of conservative treatment for neck pain have so far included an economic evaluation What this study adds Manual therapy is more effective and less costly than physiotherapy or care by a general practitioner for treating neck pain Patients undergoing manual therapy recovered more quickly than those undergoing the other interventions

PRE-MARKET CLINICAL EVALUATIONS OF INNOVATIVE HIGH-RISK MEDICAL DEVICES IN EUROPE

OBJECTIVES Uncertainty is pervasive in decision making on new health technologies; therefore, some countries have put systems in place to support decision makers with timely information. An important, but as yet undocumented, determinant of the potential value for decision making of these so-called horizon scanning systems (HSSs) is how the most significant health technologies are selected. METHODS All thirteen member organizations of EuroScan, a collaborative network for HSSs, were surveyed and interviewed on how they prioritize technologies for assessment. RESULTS The majority of HSSs directly serves a customer. Some customers actively request early assessments of new health technologies, thereby diminishing the need for priority setting for the HSSs. All systems express a concern to miss an important technology and/or to select an unimportant technology. Almost all HSSs use explicit selection criteria, but these criteria hardly ever are operationalized. The number of criteria used varies, but costs and health benefit of the technology are always taken into account. The process of reaching a final decision is implicit, undocumented in all but one system, and is based on agreement by consensus. CONCLUSIONS The process of making the final decision on which technologies to assess can be improved by applying existing criteria more consistently and transparently. Current practice does not safeguard against missing an important technology. This finding is probably most important to act upon for systems with customers that do not actively request assessment of specific technologies.

The Contribution of Health Technology Assessment, Health Needs Assessment, and Health Impact Assessment to the Assessment and Translation of Technologies in the Field of Public Health Genomics

OBJECTIVES High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. METHODS The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. RESULTS In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. CONCLUSIONS For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.

MAPPING OF HEALTH TECHNOLOGY ASSESSMENT IN SELECTED COUNTRIES

The European Union has named genomics as one of the promising research fields for the development of new health technologies. Major concerns with regard to these fields are, on the one hand, the rather slow and limited translation of new knowledge and, on the other hand, missing insights into the impact on public health and health care practice of those technologies that are actually introduced. This paper aims to give an overview of the major assessment instruments in public health [health technology assessment (HTA), health needs assessment (HNA) and health impact assessment (HIA)] which could contribute to the systematic translation and assessment of genomic health applications by focussing at population level and on public health policy making. It is shown to what extent HTA, HNA and HIA contribute to translational research by using the continuum of translational research (T1–T4) in genomic medicine as an analytic framework. The selected assessment methodologies predominantly cover 2 to 4 phases within the T1–T4 system. HTA delivers the most complete set of methodologies when assessing health applications. HNA can be used to prioritize areas where genomic health applications are needed or to identify infrastructural needs. HIA delivers information on the impact of technologies in a wider scope and promotes informed decision making. HTA, HNA and HIA provide a partly overlapping and partly unique set of methodologies and infrastructure for the translation and assessment of genomic health applications. They are broad in scope and go beyond the continuum of T1–T4 translational research regarding policy translation.

Timing of adoption of laparoscopic cholecystectomy in Denmark and in The Netherlands: a comparative study

OBJECTIVES The aim of this study was to develop and apply an instrument to map the level of health technology assessment (HTA) development at country level in selected countries. We examined middle-income countries (Argentina, Brazil, India, Indonesia, Malaysia, Mexico, and Russia) and countries well-known for their comprehensive HTA programs (Australia, Canada, and United Kingdom). METHODS A review of relevant key documents regarding the HTA process was performed to develop the instrument which was then reviewed by selected HTAi members and revised. We identified and collected relevant information to map the level of HTA in the selected countries. This was supplemented by information from a structured survey among HTA experts in the selected countries (response rate: 65/385). RESULTS Mapping of HTA in a country can be done by focusing on the level of institutionalization and the HTA process (identification, priority setting, assessment, appraisal, reporting, dissemination, and implementation in policy and practice). Although HTA is most advanced in industrialized countries, there is a growing community in middle-income countries that uses HTA. For example, Brazil is rapidly developing effective HTA programs. India and Russia are at the very beginning of introducing HTA. The other middle-income countries show intermediate levels of HTA development compared with the reference countries. CONCLUSIONS This study presents a set of indicators for documenting the current level and trends in HTA at country level. The findings can be used as a baseline measurement for future monitoring and evaluation. This will allow a variety of stakeholders to assess the development of HTA in their country, help inform strategies, and justify expenditure for HTA.

“The future should not take us by surprise”: Preparation of an early warning system in Denmark

Laparoscopic cholecystectomy (LC) has diffused rapidly in most industrialised countries. The aim of this study has been to analyse the impact of different hospital characteristics on the hospital adoption of LC in Denmark and The Netherlands. Data on the timing of the adoption of LC and hospital characteristics (hospital size, teaching status and location) were retrieved in both countries. Proportional hazard regression was used to analyse different multivariate models. A total of 59 Danish and 109 Dutch hospitals adopting LC were identified. The multivariate analyses showed that increased hospital size was associated with relatively early adoption of LC in Denmark. Neither this nor other hospital characteristics influenced the timing of adoption in The Netherlands. As in other countries studied, hospital size is identified as an important factor in hospital adoption, whereas teaching status and location play a more limited role. The study shows that a multivariate method, such as the proportional hazard regression, can be used to elucidate differences among countries of the impact of different factors on the adoption of medium-ticket technologies like LC. Such multinational comparisons provide valuable information for health policy and planning.

Cost Effectiveness and Cost Utility of Acetylcysteine versus Dimethyl Sulfoxide for Reflex Sympathetic Dystrophy

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.

Cost-Utility Analysis of Intensive Blood Glucose Control with Metformin versus Usual Care in Overweight Type 2 Diabetes Mellitus Patients in Beijing, P.R. China

AbstractObjective: To determine the cost effectiveness and cost utility of acetylcysteine versus dimethyl sulfoxide (DMSO) for patients with reflex sympathetic dystrophy (RSD), from a societal viewpoint. Design: An economic evaluation was conducted alongside a double-dummy, double-blind, randomised, controlled trial. Patients were followed for 1 year. The primary outcome measure was the Impairment-level Sum Score (ISS). Utilities were determined by the EuroQOL instrument (EQ-5D). Both cost-effectiveness and cost-utility analyses were performed. Differences in mean direct, indirect and total costs were estimated. Corresponding 95% confidence intervals were calculated by bootstrapping techniques. Results: Both groups (DMSO, n = 64; acetylcysteine, n = 67) showed relevant improvement; no differences in effects were found. Only the total direct costs were significantly lower in the DMSO group for the period of 0–52 weeks. The incremental cost-effectiveness ratios showed that, in general, DMSO generated fewer costs and more effects compared with acetylcysteine. Post-hoc subgroup analyses on cost effectiveness suggested that patients with warm RSD could be best treated with DMSO and patients with cold RSD with acetylcysteine. These results were based on small subsamples. Conclusion: In general, DMSO is the preferred treatment for patients with RSD.

Strategies for successful evaluation and policy-making toward health care technology on the move : The case of medical lasers

OBJECTIVE The UKPDS 34 and 51 showed that intensive blood glucose control with metformin is cost-saving and increases life expectancy in overweight type 2 diabetic patients in the United Kingdom. Diabetes is becoming an important health problem in urban China. This study addresses the effects and costs of intensive blood glucose control in this setting, aimed at supporting decision-making on the allocation of scarce resources. METHODS A decision analytic model was developed to estimate the costs and effectiveness of intensive blood glucose control in overweight type 2 diabetes patients in Beijing, compared with usual care in accordance with clinical practice. The analysis was carried out from a health-care perspective. RESULTS The base-case analysis (3% discount rate) shows that the average incremental costs of 11 years of intensive treatment with metformin are 126.6 K RMB (16.4 K US