Exploring Human Values in the Design of a Web-Based QoL-Instrument for People with Mental Health Problems: A Value Sensitive Design Approach.

Quality of life (QoL) is an important outcome measure in mental health care. Currently, QoL is mainly measured with paper and pencil questionnaires. To contribute to the evaluation of treatment, and to enhance substantiated policy decisions in the allocation of resources, a web-based, personalized, patient-friendly and easy to administer QoL instrument has been developed: the QoL-ME. While human values play a significant role in shaping future use practices of technologies, it is important to anticipate on them during the design of the QoL-instrument. The value sensitive design (VSD) approach offers a theory and method for addressing these values in a systematic and principled manner in the design of technologies. While the VSD approach has been applied in the field of somatic care, we extended the VSD approach to the field of mental healthcare with the aim to enable developers of the QoL-instrument to reflect on important human values and anticipate potential value conflicts in its design. We therefore explored how VSD can be used by investigating the human values that are relevant for the design of the QoL-ME. Our exploration reveals that the values autonomy, efficiency, empowerment, universal usability, privacy, redifinition of roles, (redistribution) of responsibilites, reliability, solidarity, surveillance and trust are at stake for the future users of the technology. However, we argue that theoretical reflections on the potential ethical impact of a technology in the design phase can only go so far. To be able to comprehensively evaluate the usability the VSD approach, a supplementary study of the use practices of the technology is needed.

Reframing professional boundaries in healthcare: a systematic review of facilitators and barriers to task reallocation from the domain of medicine to the nursing domain.

AIM: To explore the main facilitators and barriers to task reallocation. BACKGROUND: One of the innovative approaches to dealing with the anticipated shortage of physicians is to reallocate tasks from the professional domain of medicine to the nursing domain. Various (cost-)effectiveness studies demonstrate that nurse practitioners can deliver as high quality care as physicians and can achieve as good outcomes. However, these studies do not examine what factors may facilitate or hinder such task reallocation. METHOD: A systematic literature review of PubMed and Web of Knowledge supplemented with a snowball research method. The principles of thematic analysis were followed. RESULTS: The 13 identified relevant papers address a broad spectrum of task reallocation (delegation, substitution and complementary care). Thematic analysis revealed four categories of facilitators and barriers: (1) knowledge and capabilities, (2) professional boundaries, (3) organisational environment, and (4) institutional environment. CONCLUSION: Introducing nurse practitioners in healthcare requires organisational redesign and the reframing of professional boundaries. Especially the facilitators and barriers in the analytical themes of 'professional boundaries' and 'organisational environment' should be considered when reallocating tasks. If not, these factors might hamper the cost-effectiveness of task reallocation in practice.

Finding legitimacy for the role of budget impact in drug reimbursement decisions.

OBJECTIVES: Research has shown that effectiveness, cost-effectiveness, and severity of illness each play a role in drug reimbursement decisions. However, the role of budget impact in such decisions is less obvious. Policy makers almost always demand a budget impact estimate yet seem reluctant to formally include budget impact as a rationing criterion. Health economists even reject budget impact as a legitimate criterion. For these reasons, it is important to examine its use in rationing decisions, and rationales underlying its use. METHODS: We trace several rationales supporting the use of budget impact through a literature review, supplemented by semistructured interviews with eleven key stakeholders involved in drug reimbursement decisions in the Netherlands. RESULTS: Budget impact arguments are used in certain instances, although policy makers appear uncomfortable with its use because well described rationales still are lacking. In addition, we identify the following rationales to support budget impact as a rationing criterion: opportunity costs, loss aversion, uncertainty and equal opportunity. CONCLUSIONS: Budget impact plays a role in drug reimbursement decisions and has rationales to support its use. However, policy makers do not easily admit that they consider budget impact and are even reluctant to explicitly use budget impact as a formal criterion. A debate would strengthen the theoretical foundation of budget impact as a legitimate criterion in the context of drug reimbursement decisions. Such discussion of budget impact's role will also enhance policy-makers' accountability.

Role of budget impact in drug reimbursement decisions.

There are three known criteria that underlie drug reimbursement decisions: therapeutic value, cost-effectiveness, and burden of disease. However, evidence from recent reimbursement decisions in several jurisdictions points to residual, unexplained variables, among which is budget impact. Budget impact refers to the total costs that drug reimbursement and use entail with respect to one part of the health care system, pharmaceutical care, or to the entire health care system, taking into account the possible reallocation of resources across budgets or sectors of the health care system. The economic and equity rationale for carrying out budget impact analyses is opportunity cost, or benefits forgone, measured in terms of utility or equitable distribution, by using resources in one way rather than another. In other words, by choosing to draw down the budget in one way, decision makers forgo other opportunities to use the same resources. Under a set of unrealistic assumptions, cost-effectiveness analysis accounts for opportunity cost while conveying to the decision maker the price of maximizing health gains, subject to a budget or resource constraint. However, the underlying assumptions are implausible, particularly in the context of pharmaceutical care. Moreover, budget impact analysis is more useful to the decision maker than cost-effectiveness analysis if the objective is not to maximize health gains subject to a budget or resource constraint, but to reduce variance in health gains. With respect to equitable distribution, budget impact analyses lay bare the individuals or groups who lose out - those who bear the opportunity cost of spending resources in accordance with one decision rule rather than another.

The increasingly complex fourth hurdle for pharmaceuticals.

There are three known criteria that underlie drug reimbursement decisions: therapeutic value, cost effectiveness and burden of disease. However, evidence from recent reimbursement decisions in several jurisdictions points to residual unexplained variables, one of which may be budget impact. An economic rationale for carrying out budget impact analyses is opportunity cost, measured by the economic benefits foregone by using resources in one way rather than another. Under certain assumptions, cost-effectiveness analysis accounts for opportunity cost while conveying to the decision maker the price of maximising health gains, subject to a budget constraint. However, the underlying assumptions are implausible, particularly in the context of pharmaceutical care. Although drugs that are cost effective may lead to unambiguous health gains among patient groups for whom the drugs are indicated, the opportunity costs could conceivably lead to a reduction in aggregate health gains, or failure to meet different kinds of equity considerations. The pertinent policy question is where to find the resources to fund new innovations, such as cost-effective pharmaceuticals, or drugs targeting severe diseases. It may be a matter of redeployment of resources across healthcare sectors, cancelling the funding of (older) pharmaceuticals that are less cost effective, or delisting drugs that are cost effective but target less burdensome conditions.

Conditional reimbursement within the Dutch drug policy.

In The Netherlands, conditional reimbursement is considered to be a promising approach to achieving more effective and efficient pharmaceutical care. Because of its formal status and nationwide regulation, conditional reimbursement may allow governments to better control medical decision-making. To evaluate the effects of conditional reimbursement on medicine use and its performance as a policy tool, we compared observed volumes of medicine use with expected volumes. In addition, we mapped the annual growth by analysing trends in the volumes of use of all conditionally reimbursed drugs; starting with the year the drug entered the market (using macro-level data). Next we explored five cases in depth (using micro-level data) in order to explore what fraction of individual prescriptions met the requirements. We also performed qualitative research (document analysis, interviews (N=65)) in order to obtain the stakeholders' perspectives on how the measure functions, as well as to interpret the case studies data further. The findings suggest that conditional reimbursement may be an effective policy instrument, but that several changes are needed to optimize its impact. These changes are predominantly related to transparency (e.g. conditions are set following clear procedures and criteria), legitimacy (conditions should be consistent with criteria for prioritization), feasibility of procedures to control appropriate use, and timely and appropriate commitment of the stakeholders.

Inequalities in oncology care: Economic consequences of high cost drugs.

The expenditures for hospital drugs are continuously increasing, and grow much faster than the global hospital budgets do. This explosive growth is caused mainly by a few so-called 'expensive drugs' of which the oncolytics form the main part. The global budgets should stimulate more effective provision of care ('technical efficiency'), however the room for technical efficiency is decreasing. Hospitals thus have to make impossible choices, so that eventually equal access can no longer be guaranteed. If no other policies are applied, health care goals will no longer be met. This paper tries to map the contours of the current problem and its possible solutions. It is time governments take up their responsibility and take back control.