Mita Giacomini

Priority setting for new technologies in medicine: qualitative case study

Abstract Objective: To describe priority setting for new technologies in medicine. Design: Qualitative study using case studies and grounded theory. Setting: Two committees advising on priorities for new technologies in cancer and cardiac care in Ontario, Canada. Participants: The two committees and their 26 members. Main outcome measures: Accounts of priority setting decision making gathered by reviewing documents, interviewing members, and observing meetings. Results: Six interrelated domains were identified for priority setting for new technologies in medicine: the institutions in which the decision are made, the people who make the decisions, the factors they consider, the reasons for the decisions, the process of decision making, and the appeals mechanism for challenging the decisions. Conclusion: These domains constitute a model of priority setting for new technologies in medicine. The next step will be to harmonise this description of how priority setting decisions are made with ethical accounts of how they should be made.

Duty to disclose what? Querying the putative obligation to return research results to participants

Many research ethics guidelines now oblige researchers to offer research participants the results of research in which they participated. This practice is intended to uphold respect for persons and ensure that participants are not treated as mere means to an end. Yet some scholars have begun to question a generalised duty to disclose research results, highlighting the potential harms arising from disclosure and questioning the ethical justification for a duty to disclose, especially with respect to individual results. In support of this view, we argue that current rationales for a duty of disclosure do not form an adequate basis for an ethical imperative. We review policy guidance and scholarly commentary regarding the duty to communicate the results of biomedical, epidemiological and genetic research to research participants and show that there is wide variation in opinion regarding what should be disclosed and under what circumstance. Moreover, we argue that there is fundamental confusion about the notion of “research results,” specifically regarding three core concepts: the distinction between aggregate and individual results, amongst different types of research, and across different degrees of result veracity. Even where policy guidance and scholarly commentary have been most forceful in support of an ethical imperative to disclose research results, ambiguity regarding what is to be disclosed confounds ethical action.

Towards a ``Good'' Death: End-of-Life Narratives Constructed in An Intensive Care Unit

End-of-life decisions regarding the withdrawal and withholding of lifesupporting technology have become commonplace within intensive careunits (ICUs). In this paper, we examine the dialogue between ICU teammembers and families regarding limitation of treatment as a therapeuticnarrative – that is, as a story which frames therapeutic events aswell as the critically ill patients experience in a meaningful andpsychologically comforting way for families and health care providersalike. The key themes of these end-of-life narratives are discussed, aswell as the qualities that the stories share with other narratives ofthe same genre.

Wanted: A New Ethics Field for Health Policy Analysis

Ethics guidance and ethical frameworks are becoming more explicit and prevalent in health policy proposals. However, little attention has been given to evaluating their roles and impacts in the policy arena. Before this can be investigated, fundamental questions must be asked about the nature of ethics in relation to policy, and about the nexus of the fields of applied ethical analysis and health policy analysis. This paper examines the interdisciplinary stretch between bioethics and health policy analysis. In particular, it highlights areas of scholarship where a health policy ethicsspecialization—as distinctive from bioethics—might develop to address health policy concerns. If policy and ethics both ask the same question, that question is: “What is the good, and how do we achieve (create, protect, cultivate) it?” To answer this question, the new field of “health policy ethics” requires development. First, we should develop a full set of ethical principles and complementary ethical theories germane to public policy per se. Second, we must understand better how explicit attention to ethical concerns affects policy dynamics. Third, we require new policy and ethical analytic approaches that contribute to constructive (not obstructive) policy making. Finally, we need indicators of robust, high quality ethical analysis for the purpose public policy making.

When research seems like clinical care: a qualitative study of the communication of individual cancer genetic research results

BackgroundResearch ethicists have recently declared a new ethical imperative: that researchers should communicate the results of research to participants. For some analysts, the obligation is restricted to the communication of the general findings or conclusions of the study. However, other analysts extend the obligation to the disclosure of individual research results, especially where these results are perceived to have clinical relevance. Several scholars have advanced cogent critiques of the putative obligation to disclose individual research results. They question whether ethical goals are served by disclosure or violated by non-disclosure, and whether the communication of research results respects ethically salient differences between research practices and clinical care. Empirical data on these questions are limited. Available evidence suggests, on the one hand, growing support for disclosure, and on the other, the potential for significant harm.MethodsThis paper explores the implications of the disclosure of individual research results for the relationship between research and clinical care through analysis of research-based cancer genetic testing in Ontario, Canada in the late 1990s. We analyze a set of 30 interviews with key informants involved with research-based cancer genetic testing before the publicly funded clinical service became available in 2000.ResultsWe advance three insights: First, the communication of individual research results makes research practices seem like clinical services for our respondents. Second, while valuing the way in which research enables a form of clinical access, our respondents experience these quasi-clinical services as inadequate. Finally, our respondents recognize the ways in which their experience with these quasi-clinical services is influenced by research imperatives, but understand and interpret the significance and appropriateness of these influences in different ways.ConclusionOur findings suggest that the hybrid state created through the disclosure of research results about individuals that are perceived to be clinically relevant may produce neither sufficiently adequate clinical care nor sufficiently ethical research practices. These findings raise questions about the extent to which research can, and should, be made to serve clinical purposes, and suggest the need for further deliberation regarding any ethical obligation to communicate individual research results.

Understanding and changing attitudes toward withdrawal and withholding of life support in the intensive care unit

A careful examination of our attitudes toward end-of-life care is critical to our understanding of where change is needed to improve patient outcomes. The objectives of our narrative review are 1) to review why the intensive care unit setting presents particular challenges for the delivery of optimal end-of-life care, 2) to outline how four different research methods can provide insights into our understanding of attitudes about withdrawal of life support, and 3) to suggest seven different approaches to changing prevailing attitudes toward withdrawal of life support in the intensive care unit. To better understand attitudes about end-of-life care in general and withdrawal of life support in particular, we reviewed four different sources of data: 1) decision support tools, 2) qualitative research, 3) surveys, and 4) observational studies. Understanding these attitudes offers valuable insights about strategies that may help to improve the care of dying patients and their families. There are several ways to change attitudes; the approaches we reviewed are 1) promoting social change professionally, 2) legitimizing end-of-life research, 3) determining what families of dying patients need, 4) initiating quality improvement locally, 5) evaluating the benefits and harms of new initiatives, 6) modeling quality end-of-life care for future clinicians, and 7) using narratives. Attitudes toward end-of-life care are influenced by many factors and change slowly. Our attitudes have social and personal origins; they are grounded in values that are collective and community based. Different research methods provide insights into attitudes toward death in the intensive care unit and withdrawal of life support in particular. Understanding these attitudes may offer valuable insights about strategies that should help improve the care for dying patients and their families.

Using practice guidelines to allocate medical technologies. An ethics framework.

Clinical practice guidelines are expanding their scope of authority from clinical decision making to collective policy making, and promise to gain ground as resource allocation tools in coming years. A close examination of how guidelines approach patient selection criteria offers insight into their ethical implications when used as resource allocation or rationing instruments. The purposes of this paper are: a) to examine the structure of allocative reasoning found in clinical guidelines; b) to identify the ethical principles implied and compare how guidelines enact these principles with how explicit systems-level rationing exercises and health policy analyses have approached them; and c) to offer some preliminary suggestions for how these ethical issues might be addressed in the process of guideline development. The resulting framework can be used by guideline developers and users to understand and address some of the ethical issues raised by guidelines for the use of scarce technologies.

Theory-based medicine and the role of evidence: why the emperor needs new clothes, again.

The evidence-based medicine (EBM) movement was established to combat capricious reasoning in clinical care, particularly arguments from authority. Critique of authority and appraisal of evidence remain EBM’s core values and should be revisited in this era of EBM’s maturity and influence. We are now faced with a new form of under-questioned authority: evidence from well-designed and methodologically appraised randomized controlled trials (RCTs). RCT evidence is now prized even when it is incapable of providing meaningful information—in particular, when underlying causal theory is inscrutable. Experimental trial evidence of the effectiveness of remote intercessory prayer provides an illustrative case that highlights systematic scientific blind spots in the institutions of EBM. Medicine—even evidence-based medicine—is theory-based at its core. EBM must cultivate greater capacity to address the crucial role of theory in both the generation and use of experimental evidence.

Decision tools for life support: A review and policy analysis

Objective:To identify, describe, and compare published documents intended to guide decisions about the administration, withholding, or withdrawal of life support in critical care. Design:Review article. Setting and Sources:Publicly available, English-language guidelines or decision tools for life support, identified through systematic literature search. Measurements and Main Results:Forty-nine documents were included and coded for authorship, source, development methodology, format, and positions taken on 12 common life-support issues. Sources were independent academics (n = 21, 43%), professional organizations (n = 19, 44%), and provider organizations. Eighteen documents (37%) described no development method. Twenty-three (47%) were produced collectively (e.g., by committees or consensus conference), 7 (14%) mentioned a literature review, and 2 (4%) were based upon the authors professional experience. Tools differed in format and focus; we characterize three types as decision schemas (involving clinical practice algorithms; n = 7, 14%), decision guides (reviewing legal or professional positions; n = 29, 59%), and decision counsels (more discursive and focusing typically on ethical issues; n = 13, 27%). Tools addressed 12 common life-support issues: advance directives (67%), resource considerations (51%), ICU discharge criteria (27%), ICU admission criteria (16%), whether withholding differs from withdrawing life support (59%), whether nutrition and hydration decisions are different from decisions about other types of life support (61%), euthanasia (49%), double effect (47%), brain death (35%), special considerations for patients in a persistent vegetative state (51%), potential organ donors (12%), and pregnant patients (10%). Positions on these key life-support issues varied. Conclusions:Published tools for guiding life-support decisions vary widely in their genesis, authorship, format, focus, and practicality. They also differ in their attention to, and positions on, key life-support dilemmas. Future research on decision tools should focus on how users interpret and apply the messages in these tools and their impacts on practice, quality of care, participant experiences, and outcomes.

Reconstructing angina: cardiac symptoms are the same in women and men.

clude potassium content on the NFP. One might expect items with high levels of potassium to more often be labeled; however, categories where potassium information was most available had a wide range of potassium content, while some categories with expected high levels of potassium, such as canned whole tomatoes and canned beans, had low potassium information availability. The lack of potassium information on the NFP presents a problem for patients and consumers trying to make informed decisions when purchasing foods, particularly those motivated to minimize their risk of cardiovascular disease and those for whom potassium intake must be restricted. Lack of potassium information is also a problem for researchers and policy makers interested in understanding the overall and potassium-specific nutritional content of the packaged food supply. The New York City Department of Health and Mental Hygiene, along with 35 health authorities and health organizations, has called for a publicly accessible, productspecific nutrition database of packaged food products. The creation of such a database would allow for analyzing nutritional trends, which would inform recommendations to improve nutritional intake. While such a database is valuable with existing NFP information, its public health value would be enhanced if potassium information was consistently available. A limitation of this study is that the NSRI database was originally created to assess changes in sodium concentration; therefore, it includes a wide range of products, but only in food categories with significant potential for sodium reduction (eg, some desserts and beverages are not included). Also, only the top 80% of products sold within each category are represented in the analyses. The FDA is planning to revise the NFP, and potential improvements to its content and format are under consideration. The addition of potassium content and percent daily value to required NFP information could remedy the described deficit in publicly available nutrition information. Providing this important information to consumers, patients, and researchers would allow a more detailed understanding of the food supply, which would complement existing strategies to improve population nutritional intake.