Diffusion of minimally invasive therapy in Europe

This paper considers the diffusion of the 10 cases presented in this issue. Most of the cases have diffused relatively slowly. This slow diffusion can be explained by a number of factors, including budgetary restraints, financial incentives, physician conservatism, and lack of appropriate training. A consistent thread in the cases is the argument that evidence of effectiveness is not convincing. The article considers whether further diffusion of each innovation can be justified from existing evidence. This information is important for policy purposes. Policies might be developed to encourage or to discourage any potentially important innovation.     

The impact of the UK NHS purchaser-provider split on the 'rational' introduction of new medical technologies

This article uses evidence from case studies of the introduction of three new medical technologies to explore the impact of the UK NHS purchaser--provider split on the diffusion of new medical technologies. A desirable policy objective is assumed to be the 'rational' diffusion of medical technologies according to evidence that they are clinically and cost effective. Theoretical mechanisms are identified through which diffusion could be controlled, and the case studies are used to explore the extent to which rational technology diffusion occurs in practice in the NHS. They illustrate the influence of purchasers and providers on the introduction and early use of new technologies and explore the extent to which research about clinical and cost effectiveness is used to inform decisions about technology adoption. The results demonstrate the limited influence of purchasers and the short term clinical and organisational objectives pursued by providers in relation to technology adoption. It is suggested that initiatives to promote rational technology diffusion might be most effective if they are focused on decision making in providers, and if they aim to balance the influence on decisions of administrative and financial information about the technologies with more systematic use of research about clinical and cost effectiveness.     

The development of minimally invasive therapy in the United Kingdom

The diffusion of minimally invasive therapy (MIT) must be understood against the background of sweeping changes in the organisation and funding of the National Health Service (NHS) in the UK. The separation of purchasers from providers of health care makes national policy, in theory, less important, as local developments are supposed to drive the process of needs assessment and resource allocation. Within this climate new technologies increasingly have to prove their cost-effectiveness. Yet the country case study illustrates that such studies lack established methodologies and wide application. One of the key barriers to diffusion lies within the profession itself, where resistance to paradigmatic change is the strongest force against innovation. The partnership between innovative clinicians and forward-looking managers is important if diffusion of new procedures is to be secured. The discussion of the 10 examples will highlight some of these important issues.     

Diffusion of laparoscopic technologies in Denmark

It has been predicted that minimally invasive therapy will have dramatic consequences for the specialty of general surgery, as demonstrated by the diffusion of laparoscopic cholecystectomy. To investigate the determinants of the diffusion in Denmark of five laparoscopic technologies (cholecystectomy, appendicectomy, surgery for colon cancer, surgery for inguinal hernia and fundoplication), questionnaires on seventeen factors' influence on the adoption (stimulating or impeding) were sent to fifty-nine hospitals. Fifty hospitals (85%) responded. Overall, 98% adopted laparoscopic cholecystectomy in Denmark between 1991 and 1995, whereas the remainder of the technologies were adopted by 7-65% of hospitals performing these operations. Large and specialized hospitals were the earliest adopters. The factors, nature of technology (minimally invasive versus conventional), training (appropriate training courses), competition (between specialties and between hospitals) and media attention have stimulated the diffusion, whereas three budget factors (budget for investment, budget for operation and public regulation) usually had an impeding effect. Stimulating factors prevail for all laparoscopic technologies indicating that some guidance of the adoption and use of new health technologies might be necessary. In Denmark, one of the suggested health policies to secure timely guidance is the establishment of an early warning system.     

Reflections on the social epidemiologic dimension of health technology assessment

Certain key parameters such as safety, efficacy, effectiveness, and cost effectiveness have long been established as key in HTA analysis. Equally important, however, are sociolegal and epidemiologic perspectives. A comprehensive analytic framework will consider the implications of using a technology in the context of societal norms, cultural values, and social institutions and relations. The methodology in which this expanded framework has been developed is termed 'Strategic HTA' to denote its power for the decision-making process. In addition to systematic reviews of published evidence, it incorporates analyses of the influence of dominant social relations on technological development and diffusion. This essay discusses the social epidemiologic aspects of health technology assessment, which includes factors such as sex and gender. It seeks to show how it is possible to bring data from wide-ranging disciplinary perspectives within the parameters of a single scientific inquiry; to draw from them scientifically defensible conclusions; and thereby to realize a deeper understanding of technology impact within a health care system. Armed with such an understanding, policy officials will be better prepared to resolve the competitive clamor of stakeholder voices, and to make the most "equitable" use of the available resources.     

Why did some Danish counties introduce breast cancer screening and others not? An exploratory study of four selected counties

OBJECTIVES: Of the fourteen counties and two municipalities that until recently were responsible for healthcare provision in Denmark, five introduced mammography screening (MS) programs. The objective of this research is to explain this decision-making variation and to gain insight into priority setting processes in health-care provision at the county level in Denmark. METHODS: Literature on priority setting in health care was used to derive seven explanatory factors for comparing decision making on MS between four selected counties, of which two had implemented MS. The relative importance of each explanatory factor in each county was determined by analyzing policy documents, supplemented with interviews of selected stakeholders. The results were combined and compared at the county level. RESULTS: Evidence of effectiveness of MS was considered satisfactory and ethical issues related to MS were perceived relatively unproblematic only in those counties that introduced MS. Lack of resources, that is, radiologists, was an additional important factor for counties not implementing MS. Local opinion leaders have played a stimulating role, whereas advisory policy documents at the central government level and even legislation have had a minor impact. CONCLUSIONS: The four counties have based their decision making on the introduction of MS on different combinations of a limited number of factors that have been differentially weighted. The pattern of relevant factors in both counties not introducing MS is rather similar. The study elucidates the role of complementary factors to evidence in decision making. Of interest, recent public sector reforms have resulted in the decision to have MS implemented nationwide.     

Minimally invasive therapy in Denmark

Minimally invasive therapy (MIT) is beginning to have impacts on health care in Denmark, although diffusion has been delayed compared to diffusion in other European countries. Now policy makers are beginning to appreciate the potential advantages in terms of closing hospitals and shifting treatment to the out-patient setting, and diffusion will probably go faster in the future. Denmark does not have a system for technology assessment, neither central nor regional, and there is no early warning mechanism to survey international developments. This implies lack of possibilities for the planning of diffusion, training, and criteria for treatment.     

Assessment of biotechnology drugs: what are the issues?

Biotechnology is increasingly regarded as an important reservoir for the development of new and innovative, but generally expensive, pharmaceuticals. At the same time, concerns about cost containment have triggered a keen interest in evaluating and comparing the values of diverse health care interventions. In this paper we studied the process of assessment and diffusion of biotechnology drugs by studying three cases, i.e. nebacumab, colony stimulating factors and recombinant human growth hormone. These cases are evaluated in a standardised format, concerning safety, efficacy, cost-effectiveness and ethical, legal and social issues. Many factors that determine the fate of a biotechnology drug seemed to be similar to those of 'classical' drugs. The definition and measurement of clinically relevant outcomes has been identified as a key factor in the assessment process. Another important issue is the relatively small population for the primary indications of biotechnology drugs and the subsequent process of broadening of indications. Paradoxically, the current trend towards evidence-based medicine means that we will increasingly have to make decisions based on 'incomplete' knowledge'.     

Overcoming barriers to health service access: influencing the demand side

Evidence suggests that demand-side barriers may be as important as supply factors in deterring patients from obtaining treatment. Yet relatively little attention is given, either by policy makers or researchers, to ways of minimizing their effect. These barriers are likely to be more important for the poor and other vulnerable groups, where the costs of access, lack of information and cultural barriers impede them from benefiting from public spending. Demand barriers present in low- and middle-income countries and evidence on the effectiveness of interventions to overcome these obstacles are reviewed. Demand barriers are also shown to be important in richer countries, particularly among vulnerable groups. This suggests that while barriers are plentiful, there is a dearth of evidence on ways to reduce them. Where evidence does exist, the data and methodology for evaluating effectiveness and cost-effectiveness is insufficient. An increased focus on obtaining robust evidence on effective interventions could yield high returns. The likely nature of the interventions means that pragmatic policy routes that go beyond the traditional boundaries of the public health sector are required for implementing the findings.     

SUPPORT Tools for evidence-informed Policymaking in health 11: Finding and using evidence about local conditions

Background

Little is known about the process of knowledge translation in low- and middle-income countries. We studied policymaking processes in Mozambique, South Africa and Zimbabwe to understand the factors affecting the use of research evidence in national policy development, with a particular focus on the findings from randomized control trials (RCTs). We examined two cases: the use of magnesium sulphate (MgSO₄) in the treatment of eclampsia in pregnancy (a clinical case); and the use of insecticide treated bed nets and indoor residual household spraying for malaria vector control (a public health case).

Methods

We used a qualitative case-study methodology to explore the policy making process. We carried out key informants interviews with a range of research and policy stakeholders in each country, reviewed documents and developed timelines of key events. Using an iterative approach, we undertook a thematic analysis of the data.

Findings

Prior experience of particular interventions, local champions, stakeholders and international networks, and the involvement of researchers in policy development were important in knowledge translation for both case studies. Key differences across the two case studies included the nature of the evidence, with clear evidence of efficacy for MgSO₄ and ongoing debate regarding the efficacy of bed nets compared with spraying; local researcher involvement in international evidence production, which was stronger for MgSO₄ than for malaria vector control; and a long-standing culture of evidence-based health care within obstetrics. Other differences were the importance of bureaucratic processes for clinical regulatory approval of MgSO₄, and regional networks and political interests for malaria control. In contrast to treatment policies for eclampsia, a diverse group of stakeholders with varied interests, differing in their use and interpretation of evidence, was involved in malaria policy decisions in the three countries.

Conclusion

Translating research knowledge into policy is a complex and context sensitive process. Researchers aiming to enhance knowledge translation need to be aware of factors influencing the demand for different types of research; interact and work closely with key policy stakeholders, networks and local champions; and acknowledge the roles of important interest groups.     

Systematic reviews of economic evaluations: utility or futility?

Systematic reviews of studies of effectiveness are the centrepiece of evidence‐based medicine and policy making. Increasingly, systematic reviews of economic evaluations are also an expected input into much evidence‐based policy making, with some health economists even calling for ‘an economics approach to systematic review’. This paper questions the value of conducting systematic reviews of economic evaluations to inform decision making in health care. It argues that the value of systematic reviews of economic evaluations is usually undermined by three things. Firstly, compared with effectiveness studies, there is a much wider range of factors that limit the generalisability of cost–effectiveness results, over time and between health systems and service settings, including the context‐dependency of resource use and opportunity costs, and different decision contexts and budget constraints. Secondly, because economic evaluations are more explicitly intended to be decision‐informing, the requirements for generalisability take primacy, and considerations of internal validity become more secondary. Thirdly, since one of the two main forms of economic evaluation – decision analytic modelling – is itself a well‐developed method of evidence synthesis, in most cases the need for a comprehensive systematic review of previous economic evaluations of a particular health technology or policy choice is unwarranted. I conclude that apparent ‘meta‐analytic expectations’ for clear and widely applicable cost–effectiveness conclusions from systematic reviews of economic evaluations are optimistic and generally futile. For more useful insights and knowledge from previous economic studies in evidence‐based policy making, a more limited range of reasons for conducting systematic reviews of health economic studies is proposed. Copyright © 2009 John Wiley & Sons, Ltd.     

Safe Motherhood interventions in low-income countries: an economic justification and evidence of cost effectiveness

It is estimated that 1600 women die world-wide each day as a result of problems during pregnancy or childbirth. A large proportion of these deaths is preventable. This article examines the economic case for investing in safe motherhood interventions, and reviews key evidence of the cost effectiveness of safe motherhood interventions. According to one study, antenatal and maternal services comprise two of the six most cost effective sets of health interventions in low-income countries. However, little detailed evidence exists regarding the relative cost effectiveness of antenatal care, post-abortion care and essential obstetric care. Despite this there is clear evidence that interventions such as substituting manual vacuum aspiration for dilatation and curettage can result in significant savings both for health facilities and patients. The paper estimates first that 26% of maternal deaths are avoidable through antenatal/community-based interventions, costing around 30% of the WHO Mother Baby Package; and secondly that access to quality essential obstetric care can prevent a further 48% of maternal deaths, consuming 24% of total Mother Baby Package costs. Further work on the cost effectiveness of safe motherhood interventions would provide useful information for policy makers concerned with reducing maternal mortality in the most efficient manner possible.     

Are the best available clinical effectiveness data used in economic evaluations of drug therapies?

OBJECTIVES: Use of evidence on clinical effectiveness that is of poor quality or is biased in favour of the therapy under study is a concern in economic evaluations and may contribute to a mistrust of pharmacoeconomic studies. This study aimed to determine whether the authors of economic evaluations use the best available evidence for clinical effectiveness. METHODS: One hundred economic evaluations of drug therapies (published in 2001-2003) were sampled randomly from the National Health Service Economic Evaluation Database, and the source of clinical evidence was identified. For each therapy, alternative, high quality sources of clinical effectiveness data were sought by searching the Database of Abstracts of Reviews of Effects and Health Technology Assessment databases. The magnitude and direction of the effect size in the different sources of evidence were compared. RESULTS: Relevant systematic reviews were found for only 32 of the 100 economic evaluations in the sample. In three cases these reviews had been identified by the authors of the economic evaluations and two of these cases were used in the evaluation. Comparisons were possible in 21 cases. The clinical effects reported in all 21 comparisons were similar in direction but differed in magnitude. Compared to the systematic reviews, the authors of economic evaluations used evidence that was more favourable in five cases, less favourable in four cases, and similar in 12 cases. Six of the economic evaluations and corresponding systematic reviews did not present measures of effectiveness in a manner that allowed comparison. CONCLUSIONS: Authors of economic evaluations have not made sufficient use of the evidence available from systematic reviews of clinical effectiveness. The central role of economic evaluations in health policy makes it essential that improvements in economic methods are accompanied by a structured search for the highest quality information on clinical effectiveness.     

Evidence based primary care? A multi‐tier,multiple stakeholder perspective from Chile

A new challenge in health policy is the implementation of evidence-based practice. It is useful to look at international experiences which go beyond the conventional USA and UK examples. Health sector restructuring in Chile has as its goals: using evidence-based decision-making to reduce variations of practice, contain costs and increase the effectiveness of clinical practice. A key area of change is within primary health care. But how does the implementation of evidence-based health care proceed in reality? In order to understand this, it was decided to assess the policy environment using stakeholder analysis. METHODS: Fifteen stakeholders from the public health sector were interviewed in depth using a snowball strategy for sampling. Material relating to perceptions, thoughts and aspirations about evidence-based innovations in primary health care was collected. Content analysis of the material produced a matrix of criteria and indicators of operational power. RESULTS: Concepts of evidence and effectiveness are different according to the role of each stakeholder in the health system. Most innovations proposed by government are related to management and stakeholders considered them as not being evidence-based. Informal mechanisms of decision-making predominated over the formal. Political issues are more important than formal evidence. All stakeholders felt they had power to define policy criteria but not to implement them. Implementation difficulties are related to how the system is organized and the culture within each organization. Most stakeholders indicated the need for human resources with appropriate knowledge and personal skills in order to implement these changes. These findings reveal again the importance of human factors within organizations. Policy-making should consider such processual aspects in order to implement changes in practices in Chilean health care system more effectively.     

How are policy makers using evidence? Models of research utilisation and local NHS policy making

STUDY OBJECTIVE: This paper is based on a qualitative study that aimed to identify factors that facilitate or impede evidence-based policy making at a local level in the UK National Health Service (NHS). It considers how models of research utilisation drawn from the social sciences map onto empirical evidence from this study. DESIGN: A literature review and case studies of social research projects that were initiated by NHS health authority managers or GP fundholders in one region of the NHS. In depth interviews and document analysis were used. SETTING: One NHS region in England. PARTICIPANTS: Policy makers, GPs and researchers working on each of the social research projects selected as case studies. MAIN RESULTS: The direct influence of research evidence on decision making was tempered by factors such as financial constraints, shifting timescales and decision makers' own experiential knowledge. Research was more likely to impact on policy in indirect ways, including shaping policy debate and mediating dialogue between service providers and users. CONCLUSIONS: The study highlights the role of sustained dialogue between researchers and the users of research in improving the utilisation of research-based evidence in the policy process.     

广西学校细菌性肠道传染病疫情特点及其影响因素分析

目的了解广西近年发生于学校的细菌性肠道传染病爆发疫情的流行病学特点及影响处理效果的因素,为预防与控制学校肠道传染病的流行提供依据。方法收集广西2001-2004年各级疾病预防控制机构对学校爆发疫情的调查处理报告和资料,对资料进行流行病学描述并进行多因素逐步回归分析。结果64起爆发疫情中伤寒副伤寒35起、细菌性痢疾15起、感染性腹泻14起,共报告病例5 795例。疫情多发于乡镇和城乡结合部的寄宿学校(82.81%),以春、秋季节尤其是秋季开学为高发,传播途径以水型为主(65.63%)。多因素逐步回归分析,首例与疫情报告时间间隔、病例隔离措施、病种和传播途径影响疫情处理效果。结论农村学校以水型传播为主的细菌性肠道传染病是当前广西学校卫生工作的突出问题;疫情报告是否及时、病例隔离措施是否落实是影响疫情处理效果的关键因素。     

Surgical treatment of hepatocellular carcinoma

Surgical treatment of hepatocellular carcinoma. The therapy of hepatocellular carcinoma (HCC) has got nowadays an important problem of medicine. The five year survival time has increased in the consequences of the last 25 year medical activities. The development of liver surgery, the introduction of aggressive surgical strategy, the prognosis of the disease and the special indication of the operation have had important factors in bettering of the results. The size and number of the tumor, the tumor-free region of the tissue resected, capsule building, and the venous infiltration are the most important factors influencing the survival time. The repeated resection in case of newly developed HCC has got also a result with 19-20 per cent of five year survival time. In cases of non resectable tumors the a la carte chemotherapy, radiofrequency, TACE for down staging produce an opportunity in 10-20% of tumors being resectable. The new combined surgical-oncologic-intervention strategies involve the two step and repeated interventions, the minimal invasive technique (MIT), the TACE and the a la carte chemotherapy. Liver transplantation can be carried out exclusively in tumors less than 3 cm and in those having no more than 3 metastases.     

Case-control vaccine effectiveness studies: Preparation,design, and enrollment of cases and controls

Case-control studies are commonly used to evaluate effectiveness of licensed vaccines after deployment in public health programs. Such studies can provide policy-relevant data on vaccine performance under ‘real world’ conditions, contributing to the evidence base to support and sustain introduction of new vaccines. However, case-control studies do not measure the impact of vaccine introduction on disease at a population level, and are subject to bias and confounding, which may lead to inaccurate results that can misinform policy decisions. In 2012, a group of experts met to review recent experience with case-control studies evaluating the effectiveness of several vaccines; here we summarize the recommendations of that group regarding best practices for planning, design and enrollment of cases and controls. Rigorous planning and preparation should focus on understanding the study context including healthcare-seeking and vaccination practices. Case-control vaccine effectiveness studies are best carried out soon after vaccine introduction because high coverage creates strong potential for confounding. Endpoints specific to the vaccine target are preferable to non-specific clinical syndromes since the proportion of non-specific outcomes preventable through vaccination may vary over time and place, leading to potentially confusing results. Controls should be representative of the source population from which cases arise, and are generally recruited from the community or health facilities where cases are enrolled. Matching of controls to cases for potential confounding factors is commonly used, although should be reserved for a limited number of key variables believed to be linked to both vaccination and disease. Case-control vaccine effectiveness studies can provide information useful to guide policy decisions and vaccine development, however rigorous preparation and design is essential.     

When Does FDAMA Section 114 Apply? Ten Case Studies

BackgroundSection 114 of the Food and Drug Administration Modernization Act of 1997 regulates the promotion of health economic information by pharmaceutical companies to US health plans. Greater clarity is important given demands by payers and other stakeholders for evidence of value.ObjectivesTo develop hypothetical case studies of health economic promotions to examine legal and policy implications.MethodsWe constructed for pedagogical purposes 10 categories of potential health economic promotions. We generated hypothetical case studies for each category, including questions about whether each might be allowable under Section 114. The case studies were developed around the following categories: 1) costing out on-label clinical end points; 2) promotion of a costing exercise to physicians working in an accountable care organization setting; 3) burden-of-illness claims; 4) economic analysis of a formulary restriction policy; 5) extrapolations to doses, populations, or settings not covered in trials; 6) adherence claims; 7) “utilization of care” as a secondary end point in randomized clinical trials; 8) costing out a competitor drug’s adverse event; 9) economic analysis of comparative effectiveness claims using an indirect treatment comparison; and 10) extrapolating from surrogate to long-term outcomes in an economic model.DiscussionMost cases seem to fall into a gray zone given haziness around what constitutes “competent and reliable evidence” and “directly relate[d]” to an approved indication. In practice, it is difficult to know what the section allows given the imprecision of the statute and lack of guidance about its scope.ConclusionIdeally, future guidance will provide clarity and flexibility.