Introduction: Clinical practice guidelines (CPGs) are an important source of justification for clinical decisions in modern evidence-based practice. Yet, we have given little attention to how they argue their evidence. In particular, how do CPGs argue for treatment with long-term medications that are increasingly prescribed to older patients? Approach and rationale: I selected six disease-specific guidelines recommending treatment with five of the medication classes most commonly prescribed for seniors in Ontario, Canada. I considered the stated aims (...) of these CPGs and the techniques employed towards those aims. Finally, I reconstructed and logically analysed the arguments supporting recommendations for pharmacotherapy. Analysis: The primary function of CPGs is rhetorical, or persuasive, and their means of persuasion include both a display of their credibility and their argumentation. Arguments supporting pharmacotherapy recommendations for the target population follow a common inductive pattern: statistical generalization from randomized controlled trial (RCT) and meta-analysis evidence. Two of the CPGs also argue their treatment recommendations for older patients in this style, while three fail to justify pharmacotherapy specifically for the older population. Discussion: The arguments analysed lack the auxiliary assumptions that would warrant making a generalization about the clinical effectiveness of medications for the older population. Guidelines reason using simple induction, while ignoring important inferential gaps. Future guidelines should aspire to be well-reasoned rather than simply evidence-based; argue from a plurality of evidence; be wary of hasty inductions; appropriately limit the scope of their recommendations; and avoid making law-like, prescriptive generalizations. (shrink)

The reliability of clinical practice guidelines has been disputed because guideline panel members are often burdened with financial conflicts of interest. Current recommendations for COI regulation advise not only detailed declaration but also active management of conflicts. To continuously assess COI declaration and management in German guidelines we established the public database LeitlinienWatch. We analyzed all German guidelines at the highest methodological level that included recommendations for pharmacological therapy according to five criteria: declaration and assessment of COI, (...) composition of the guideline development group, independence of the coordinators and lead authors, imposed abstentions because of COI and public external review. Each criterion was assessed using predefined outcome categories. Most guidelines contained a detailed declaration of COI. However, none of the guidelines provided full transparency of COI assessment results. The guideline group was composed of a majority of participants with COI in 55% of the guidelines, no guideline was free of participants with COI. Only 9% of guidelines had coordinators and lead authors without any financial COI. Most guidelines did not provide a rule for abstentions for participants with COI. In 21% of guidelines there was a rule, but abstentions were either not practiced or not documented, whereas in 7% partial abstentions and in 2% complete abstentions were documented. Two thirds of the guideline drafts were not externally reviewed via a public website. COI are usually documented in detail in German guidelines of the highest methodological level. However, considerable improvement is needed regarding active management of COI, including recruitment of independent experts for guideline projects, abstention from voting for participants with COI and external review of the guideline draft. We assume that the publicly available ratings on GuidelineWatch will improve the handling of conflicts of interest in guideline development. (shrink)

Flawed clinical practice guidelines may compromise patient care. Commercial conflicts of interest on panels that write treatment guidelines are particularly problematic, because panelists may have conflicting agendas that influence guideline recommendations. Historically, there has been no legal remedy for conflicts of interest on guidelines panels. However, in May 2008, the Attorney General of Connecticut concluded a ground-breaking antitrust investigation into the development of Lyme disease treatment guidelines by one of the largest medical societies in the United States, (...) the Infectious Diseases Society of America (IDSA). Although the investigation found significant flaws in the IDSA guidelines development process, the subsequent review of the guidelines mandated by the settlement was compromised by a lack of impartiality at various stages of the IDSA review process. This article will examine the interplay between the recent calls for guidelines reform, the ethical canons of medicine, and due process considerations under antitrust laws as they apply to the formulation of the IDSA Lyme disease treatment guidelines. The article will also discuss pitfalls in the implementation of the IDSA antitrust settlement that should be avoided in the future. (shrink)

Conflicts of interest affect recommendations in clinical guidelines and disclosure of such conflicts is important. However, not all conflicts of interest are disclosed. Using a public available disclosure list we determined the prevalence and underreporting of conflicts of interest among authors of clinical guidelines on drug treatments.

On 23 September 2002, the Belgian law on euthanasia came into force. This makes Belgium the second country in the world to have an Act on euthanasia. Even though there is currently legal regulation of euthanasia in Belgium, very little is known about how this legal regulation could be translated into care for patients who request euthanasia.

The author of this paper discusses why the issue of financial conflicts of interest in psychiatry has important public health implications for women and why FCOI complicate the informed consent process. For example, when psychiatric diagnostic and treatment guidelines are unduly influenced by industry, informed consent becomes a critical issue, because women may be assigned diagnostic labels that are not valid and may also be receiving imbalanced or even inaccurate information about their mental health treatment options. However, mere disclosure of (...) industry relationships is an insufficient solution. Following Ells, the author offers a more robust account of autonomy, inspired by Foucault, to strengthen informed consent practices. In addition to addressing power relations, this Foucauldian account of autonomy emphasizes the relational and dialogical aspect of the physician–patient relationship. (shrink)

Researchers, investigative journalists, community physicians, ethicists, and policy makers have voiced strong concerns about the integrity of medicine. Specifically, questions have been raised about the ways in which financial conflicts of interest (FCOI) in the biomedical field may be compromising the integrity of the scientific research process and thus compromising patient care by disseminating imbalanced or even inaccurate information (Angell 2004). Indeed, many of us are no longer surprised when we read about settlements made by pharmaceutical companies—some totaling hundreds of (...) millions of dollars—for withholding information on adverse side effects, overstating the efficacy of medications, or for aggressive .. (shrink)

Are clinical practice guidelines a means for improving the quality of health care? For saving money in the health care system? For solving the malpractice problem? For making the health care system work better for all? Or, are they a recipe for disaster? This overview sets out conceptual, definitional, and practical aspects of clinical practice guidelines as a broad framework for reflecting on the issue of what guidelines are and why they count. It draws mainly on (...) work done since 1990 at the Institute of Medicine and focuses on five questions. First, what are guidelines, and who develops them? Second, what criteria or principles should be used to create good guidelines? Third, what problems or pitfalls exist in developing and disseminating guidelines? Fourth, in what ways can guidelines help improve medical care, and in what ways will they not be as practical or useful, particularly with respect to quality of care? Finally, what ethical context might guide deliberations on this topic? (shrink)

In 2001, leaders with palliative care convened to discuss the standardization of palliative care and formed the National Consensus Project for Quality Palliative Care. In 2004, the National Consensus Project for Quality Palliative Care produced the first edition of Clinical Guidelines for Quality Palliative Care. The Guidelines were developed by leaders in the field who examined other national and international standards with the intent to promote consistent, accessible, comprehensive, optimal palliative care through the health care spectrum. Within the guidelines (...) there are eight domains to the provision of palliative care. This article focuses on the last, but very significant Domain 8—Ethical and Legal Aspects of Care. (shrink)

Are clinical practice guidelines a means for improving the quality of health care? For saving money in the health care system? For solving the malpractice problem? For making the health care system work better for all? Or, are they a recipe for disaster? This overview sets out conceptual, definitional, and practical aspects of clinical practice guidelines as a broad framework for reflecting on the issue of what guidelines are and why they count. It draws mainly on (...) work done since 1990 at the Institute of Medicine and focuses on five questions. First, what are guidelines, and who develops them? Second, what criteria or principles should be used to create good guidelines? Third, what problems or pitfalls exist in developing and disseminating guidelines? Fourth, in what ways can guidelines help improve medical care, and in what ways will they not be as practical or useful, particularly with respect to quality of care? Finally, what ethical context might guide deliberations on this topic? (shrink)

There is a dilemma in modern medicine, and, as a general family practitioner, this dilemma has great impact on me as a professional with a responsibility to my patients, and on the treatments I prescribe. Every day we receive a lot of updated information about relevant issues in treatment of various conditions we encounter in our daily practice. There is a great deal of interesting, serious research; however, frequently results and conclusions are very different and at times, contradictory. It (...) is extremely difficult to evaluate updated research information, and to understand trends in current medicine. Our responsibility to our patients is to find a solution for this problem. (shrink)

The social production of an enterprise clinic: nurses, clinical pathway guidelines and contemporary healthcare practicesIn this paper I critically engage with the forming of contemporary nursing practice with/in an ‘enterprise clinic’ in order to discuss the practical potential of developing a mode of reflective practice that is a critical ontology of self. Critical engagement in the paper is secured through a ‘troubling’ of the relationship between the contemporary practices of both the self and governance, without the reduction (...) of one to the other. The paper draws on my doctoral study in which I combined the techniques of ethnography and discourse analysis in order to critically examine registered nurses’ employment of clinical pathway guidelines through an analysis of the political technologies through which that engagement was constituted. This critical purchase was applied because of the influence of the contemporary ‘problematisation’ of healthcare provision in western society on the formation and deployment of the professional identities of nurses. (shrink)

The idea that physicians should accept recommendations from learned colleagues on how to practice medicine is probably as old as medicine itself, but beginning around 1990, it took on new urgency in the face of rising health care costs, widespread, unjustifiable variation in practice patterns, concerns about medical errors and quality of care, and what some perceived to be perverse effects of the malpractice system. One solution put forward was practice guidelines, which the Institute of Medicine defined (...) as systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. (shrink)

BackgroundStructured, systematic methods to formulate consensus recommendations, such as the Delphi process or nominal group technique, among others, provide the opportunity to harness the knowledge of experts to support clinical decision making in areas of uncertainty. They are widely used in biomedical research, in particular where disease characteristics or resource limitations mean that high-quality evidence generation is difficult. However, poor reporting of methods used to reach a consensus – for example, not clearly explaining the definition of consensus, or not (...) stating how consensus group panellists were selected – can potentially undermine confidence in this type of research and hinder reproducibility. Our objective is therefore to systematically develop a reporting guideline to help the biomedical research and clinical practice community describe the methods or techniques used to reach consensus in a complete, transparent, and consistent manner.MethodsThe ACCORD project will take place in five stages and follow the EQUATOR Network guidance for the development of reporting guidelines. In Stage 1, a multidisciplinary Steering Committee has been established to lead and coordinate the guideline development process. In Stage 2, a systematic literature review will identify evidence on the quality of the reporting of consensus methodology, to obtain potential items for a reporting checklist. In Stage 3, Delphi methodology will be used to reach consensus regarding the checklist items, first among the Steering Committee, and then among a broader Delphi panel comprising participants with a range of expertise, including patient representatives. In Stage 4, the reporting guideline will be finalised in a consensus meeting, along with the production of an Explanation and Elaboration document. In Stage 5, we plan to publish the reporting guideline and E&E document in open-access journals, supported by presentations at appropriate events. Dissemination of the reporting guideline, including a website linked to social media channels, is crucial for the document to be implemented in practice.DiscussionThe ACCORD reporting guideline will provide a set of minimum items that should be reported about methods used to achieve consensus, including approaches ranging from simple unstructured opinion gatherings to highly structured processes. (shrink)

A clinical scenario is described where an anaesthetist is concerned about the seemingly high risk/benefit ratio relating to laparoscopic versus standard inguinal hernia operations. Some options for further action by the anaesthetist are introduced. The remainder of the paper explores the question of who can legitimately assess the acceptability of risk/benefit ratios, and defends the use of practice guidelines at the expense of so called clinical freedom. It is argued that respect for persons is not breached by (...) limiting the treatment options offered to patients to those therapies which have a ‘reasonable’ risk/benefit ratio. This ‘reasonableness’ is context dependent, and should be properly decided by those with expertise in the field. (shrink)

A clinical scenario is described where an anaesthetist is concerned about the seemingly high risk/benefit ratio relating to laparoscopic versus standard inguinal hernia operations. Some options for further action by the anaesthetist are introduced. The remainder of the paper explores the question of who can legitimately assess the acceptability of risk/benefit ratios, and defends the use of practice guidelines at the expense of so called clinical freedom. It is argued that respect for persons is not breached by (...) limiting the treatment options offered to patients to those therapies which have a ‘reasonable’ risk/benefit ratio. This ‘reasonableness’ is context dependent, and should be properly decided by those with expertise in the field. (shrink)

A clinical scenario is described where an anaesthetist is concerned about the seemingly high risk/benefit ratio relating to laparoscopic versus standard inguinal hernia operations. Some options for further action by the anaesthetist are introduced. The remainder of the paper explores the question of who can legitimately assess the acceptability of risk/benefit ratios, and defends the use of practice guidelines at the expense of so called clinical freedom. It is argued that respect for persons is not breached by (...) limiting the treatment options offered to patients to those therapies which have a ‘reasonable’ risk/benefit ratio. This ‘reasonableness’ is context dependent, and should be properly decided by those with expertise in the field. (shrink)

Over the last decade, standards for when and how to undertake a wide range of medical interventions have poured forth from medical specialty groups, commercial and nonprofit organizations, and state and federal panels. Known by a variety of names—from practice parameters to clinical guidelines—and intended for a range of purposes—from diminishing the incidence of maloccurences in hospitals to cutting the costs of health care—these guidelines share one important feature: the intention of decreasing the range of variation in medical (...) practice. Such standardization immediately appeals to anyone interested in improving the quality of health care and, in particular, reducing inappropriate medical interventions, in light of the difficulties for a conscientious physician today in adhering to the best standard of practice when faced with ever increasing medical knowledge and the growing number and complexity of diagnostic, preventive, and therapeutic interventions. (shrink)

Over the last decade, standards for when and how to undertake a wide range of medical interventions have poured forth from medical specialty groups, commercial and nonprofit organizations, and state and federal panels. Known by a variety of names—from practice parameters to clinical guidelines—and intended for a range of purposes—from diminishing the incidence of maloccurences in hospitals to cutting the costs of health care—these guidelines share one important feature: the intention of decreasing the range of variation in medical (...) practice. Such standardization immediately appeals to anyone interested in improving the quality of health care and, in particular, reducing inappropriate medical interventions, in light of the difficulties for a conscientious physician today in adhering to the best standard of practice when faced with ever increasing medical knowledge and the growing number and complexity of diagnostic, preventive, and therapeutic interventions. (shrink)

Die rasanten technischen Fortschritte in der Genomforschung ermöglichen heute schon die Sequenzierung des einzelnen menschlichen Genoms in wenigen Tagen und zu vertretbaren Kosten. In der Krebsforschung ermöglicht die genetische Sequenzanalyse, zunehmend die Defekte zu identifizieren, die für das Tumorwachstum bei jedem einzelnen Patienten verantwortlich sind. Auf dieser Basis können zielgerichteter Therapien entwickelt werden. Diese Forschung wirft jedoch auch neue, ethische Fragen auf. Diesen normativen Fragen widmet sich in Heidelberg das interdisziplinäre EURAT Projekt mit dem Ziel, ethisch und rechtlich informierte Lösungen (...) zu formulieren und zu etablieren.Dieser Beitrag gibt zum einen einen Überblick über die ethischen und klinischen Fragen, die für den Aufklärungs- und Einwilligungsprozess in die biobankbasierte Genomforschung relevant sind. Zum anderen wird als organisationsethische Antwort auf die Frage, wie eine Forschungsinstitution den verantwortungsvollen Umgang mit genetischen Informationen in Biobanken über die verschiedenen Berufsgruppen und beteiligten Institute hinweg sichern kann, ein Verhaltenskodex vorgestellt. Eine gut begründete, informierte Zustimmung und ein Verhaltenskodex sind beides Elemente einer „Best Practice Leitlinie“ und sollen den verantwortlichen Umgang aller beteiligten Mitarbeiter mit sensiblen genetischen Daten prägen. (shrink)