Integrating clinical and economic evidence in clinical guidelines: More needed than ever!

RATIONALE, AIMS, AND OBJECTIVES: In recent years, several expensive new health technologies have been introduced. The availability of those technologies intensifies the discussion regarding the affordability of these technologies at different decision-making levels. On the meso level, both hospitals and clinicians are facing budget constraints resulting in a tension to balance between different patients' interests. As such, it is crucial to make optimal use of the available resources. Different strategies are in place to deal with this problem, but decisions on a macro level on what to fund or not can limit the role and freedom of clinicians in their decisions on a micro level. At the same time, without central guidance regarding such decisions, micro level decisions may lead to inequities and undesirable treatment variation between clinicians and hospitals. The challenge is to find instruments that can balance both levels of decision making. DISCUSSION: Clinicians are becoming increasingly aware that their decisions to spend more resources (like time and budget) on 1 particular patient group reduce the resources available to other patients. Involving clinicians in thinking about the optimal use of limited resources, also in an attempt to bridge the world of economic reasoning and clinical practice, is crucial therefore. We argue that clinical guidelines may prove a clear vehicle for this by including both clinical and economic evidence to support the recommendations made. The development of such guidelines requires cooperation of clinicians, and health economists are cooperating with each other. CONCLUSION: The development of clinical guidelines which combine economic and clinical evidence should be stimulated, to balance central guidance and uniformity while maintaining necessary decentralized freedom. This is an opportunity to combine the reality of budgets and opportunity costs with clinical practice. Missing this opportunity risks either variation and inequity or central and necessarily crude measures.

"Too much medicine": Insights and explanations from economic theory and research.

Increasing attention has been paid in recent years to the problem of "too much medicine", whereby patients receive unnecessary investigations and treatments providing them with little or no benefit, but which expose them to risks of harm. Despite this phenomenon potentially constituting an inefficient use of health care resources, it has received limited direct attention from health economists. This paper considers "too much medicine" as a form of overconsumption, drawing on research from health economics, behavioural economics and ecological economics to identify possible explanations for and drivers of overconsumption. We define overconsumption of health care as a situation in which individuals consume in a way that undermines their own well-being. Extensive health economics research since the 1960s has provided clear evidence that physicians do not act as perfect agents for patients, and there are perverse incentives for them to provide unnecessary services under various circumstances. There is strong evidence of the existence of supplier-induced demand, and of the impact of various forms of financial incentives on clinical practice. The behavioural economics evidence provides rich insights on why clinical practice may depart from an "evidence-based" approach. Moreover, behavioural findings on health professionals' strategies for dealing with uncertainty, and for avoiding potential regret, provide powerful explanations of why overuse and overtreatment may frequently appear to be the "rational" choice in clinical decision-making, even when they cause harm. The ecological economics literature suggests that status or positional competition can, via the principal-agent relationship in health care, provide a further force driving overconsumption. This novel synthesis of economic perspectives suggests important scope for interdisciplinary collaboration; signals potentially important issues for health technology assessment and health technology management policies; and suggests that cultural change might be required to achieve significant shifts in clinical behaviour.

[Challenges of an integrative and personalised health care for health economics and the insurance system]. / Herausforderungen einer integrativen und personalisierten Gesundheitsversorgung für die Gesundheitsökonomie und das Versicherungssystem.

OBJECTIVES: "Stratifying medicine" is a topic of increasing importance in the public health system. There are several questions related to "stratifying medicine". This paper reconsiders definitions, opportunities and risks related to "stratifying medicine" as well as the main challenges of "stratifying medicine" from the perspective of a public health insurance. DEFINITION: The application of the term and the definition are important points to discuss. Terms such as "stratified medicine", "personalised medicine" or "individualised medicine" are used. The Techniker Krankenkasse prefers "stratifying medicine", because it usually means a medicine that tailors therapy to specific groups of patients by biomarkers. OPPORTUNITIES AND RISKS: "Stratifying medicine" is associated with various hopes, e. g., the avoidance of ineffective therapies and early detection of diseases. But "stratifying medicine" also carries risks, such as an increase in the number of cases by treatment of disease risks, a duty for health and the weakening of the criteria of evidence-based medicine. CHALLENGES: The complexity of "stratifying medicine" is a big challenge for all involved parties in the health system. A lot of interrelations are still not completely understood. So the statutory health insurance faces the challenge of making innovative therapy concepts accessible in a timely manner to all insured on the one hand but on the other hand also to protect the community from harmful therapies. Information and advice to patients related to "stratifying medicine" is of particular importance. The equitable distribution of fees for diagnosis and counselling presents a particular challenge. The solidarity principle of public health insurance may be challenged by social and ethical issues of "stratifying medicine". CONCLUSION: "Stratifying medicine" offers great potential to improve medical care. However, false hopes must be avoided. Providers and payers should measure chances and risks of "stratifying medicine" together for the welfare of the patients.

Maximisation in extra-welfarism: A critique of the current position in health economics.

This paper explores critically the use of 'maximisation' as a decision rule within extra-welfarism. Although extra-welfarism in theory focuses on a broader evaluative space than that of utility, in practice there is a narrowing to a focus on health alone; this clear disjoint is one of the factors that makes discussion of extra-welfarism difficult. In this paper we focus on the reality of extra-welfarism as currently practiced (that is, as health maximisation). The paper questions whether a change (from welfarism to extra-welfarism) of the evaluative space from utility to health, automatically implies a change in the rule for decision making from utility maximisation to health maximisation. Both theoretical and empirical grounds are considered. It is reasoned here that the separation of efficiency and equity associated with welfarism is no longer possible within a health evaluative space. Thus any maximisation of health is instead aligned with Bentham's felicific calculus, and implies the acceptance of an ethical basis of utilitarianism. Empirical grounds for maximisation, based on the views of members of society, do not seem to support such a utilitarian ethical basis for the production and distribution of health. This leaves health economists very much relying on perceptions of decision makers' values in their support of health maximisation.

The individual in mainstream health economics: a case of Persona Non-grata.

This paper is motivated by Davis' [14] theory of the individual in economics. Davis' analysis is applied to health economics, where the individual is conceived as a utility maximiser, although capable of regarding others' welfare through interdependent utility functions. Nonetheless, this provides a restrictive and flawed account, engendering a narrow and abstract conception of care grounded in Paretian value and Cartesian analytical frames. Instead, a richer account of the socially embedded individual is advocated, which employs collective intentionality analysis. This provides a sound foundation for research into an approach to health policy that promotes health as a basic human right.

Supplier-induced demand: reconsidering the theories and new Australian evidence.

This paper reconsiders the evidence and several of the key arguments associated with the theory of supplier-induced demand (SID). It proposes a new theory to explain how ethical behaviour is consistent with SID. The purpose of a theory of demand and one criterion for the evaluation of a theory is the provision of a plausible explanation for the observed variability in service use. We argue that Australian data are not easily explained by orthodox possible explanation. We also argue that, having revisited the theory of SID, the agency relationship between doctors and patients arises not simply because of asymmetrical information but from an asymmetrical ability and willingness to exercise judgement in the face of uncertainty. It is also argued that the incomplete demand shift that must occur following an increase in the doctor supply is readily explained by the dynamics of market adjustment when market information is incomplete and there is non-collusive professional (and ethical) behaviour by doctors. Empirical evidence of SID from six Australian data sets is presented and discussed. It is argued that these are more easily explained by SID than by conventional demand side variables. We conclude that once the uncertainty of medical decision making and the complexity of medical judgements are taken into account, SID is a more plausible theory of patient and doctor behaviour than the orthodox model of demand and supply. More importantly, SID provides a satisfactory explanation of the observed pattern and change in the demand for Australian medical services, which are not easily explained in the absence of SID.

The relationship between paediatricians and commerce.

The interaction between doctors and commerce, particularly the pharmaceutical industry, has recently been subject to increasing scrutiny. Doctors are now exposed to mounting influence from industry as it spends large amounts of money on marketing, is heavily involved with continuing medical education and sponsors a major proportion of research. Conflicts of interest may exist on both sides of the relationship: doctors can be manipulated and companies need to be profitable. Paediatricians are just as open to this influence as are other members of the medical profession. There is evidence that clinical practice is altered by interaction with industry, although doctors appear to deny the likelihood of being influenced. There are significant concerns over the increasing involvement of the pharmaceutical industry with research, although the regulation of the industry continues to be strengthened and the process of research is becoming more transparent. Disclosure of conflicts of interest involving authorship is now common practice and should extend to all facets of the relationship. However, collaboration continues to be necessary in order to develop new therapies, maximise research and particularly in paediatrics, to test medications in children. Paediatricians need to be aware of the sources of influence and understand current guidelines so that interactions with industry continue to be appropriate.

Clinical trials, genetic add-ons, and the question of benefit-sharing.

Discussion of benefit-sharing has become common in the sphere of human genetic research. Roughly, this term means that individuals or organisations who could reap financial rewards from research into human genetics have some obligation to share the benefits of this research, perhaps with the people who made the research possible in the first place, or with humankind more broadly. This idea has met with some acceptance, finding its way into policy recommendations and statements of several prominent groups. However, the issue of benefit-sharing is generally raised in the context of large-scale population-based genetic studies. Other sources of human DNA are often ignored. In particular, little attention has been paid to the increasingly common practice of collecting genetic samples as add-ons to clinical drug trials. Generally such trials do not specify a use for these samples, which are collected for purposes of potential future research. We argue that if a case for benefit-sharing can be made for genetic studies in general, it can be made for add-on studies as well. We suggest some ways in which benefit-sharing might be implemented for genetic add-on studies.