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)

To achieve lower medical spending with as little reduction as possible in good outcomes, practitioners and policy makers alike have been experimenting with the use of practice guidelines. These guidelines both recommend certain types of therapies and proscribe others in the treatment of patients with particular conditions. This paper explores the question of whether guidelines which do reduce total resource costs of medical care to a population will be feasible and produce “acceptable” results. The definition of (...) acceptable is part of the policy problem, so it will be left open for a while, but the question of which outcomes match with which levels of resource cost will form the positive basis for the normative judgment of “acceptability.”. (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)

Discussions about the role of practice guidelines and the strength of the evidence on which they are based should begin with a set of more basic questions: What is the function of such guidelines and what forces shape their use?At least two forces can be seen behind the press for guidelines. On the one hand, guidelines can be used to improve the quality of care by raising the general level of practice to meet at (...) least the standards set by experts. At the other, they become vehicles for cost containment.By international standards, the United States spends a disproportionate share of its gross domestic product on health care. The majority of spending increases are traceable to the growth in technology. Whether couched as a concern that resources could be better used to provide other parts of the population with more effective health care or as a general concern that money spent on health might be better used for other social goods, a notion exists that less is better. (shrink)

This article critically looks at the challenges that are incumbent in the deployment of married soldiers who work for the South African National Defence Force. The SANDF previously deployed soldiers outside the borders of South Africa for a period of 6 months or less. But currently, the SANDF has a deployment period of 12 months. This period is twice that of the earlier period, which means that soldiers and their families have to spend 12 months apart from one another. This (...) has an adverse effect on the marriages of soldiers and makes the SANDF appear as an uncaring institute because its military operations tend to impact family lives. Using a qualitative research approach, this article explores the emic experiences of married soldiers who were deployed, and concludes by suggesting some pastoral guidelines that may prove useful for a multi-professional team handling the issues of deployment. (shrink)

This article investigates and provides guidelines to the negative impact of mahadi on the Basotho youth before they may marry. It is important to note that marriage is one of the main parts of the life cycle amongst the Basotho and not only joins a man and a woman together, but is also considered to unite the members of the respective families of the married couple into one family. This union of two families comes into effect when the process (...) of negotiation of the mahadi is initiated. The negotiation for mahadi is, in other words, the first stage of bonding two families together. In the hope of gaining a better understanding and results, the writer searched for a qualitative method to conduct the research. (shrink)

In response to increasing use of practice guidelines in medicine, physicians have focused their attention on how these guidelines can restrict their medical practices. However, guidelines not only restrict physician discretion, but they also limit the treatment options available to patients. As a result, treatments which patients consider beneficial may not be recommended; for example, some hysterectomies for abnormal uterine bleeding, and cataract surgery in patients with dementia. When guidelines are used to determine which medical (...) treatments a health care organization or insurer will cover, these recommendations become restrictions. Thus far, guidelines have been developed without adequate attention to the impact that their restrictive use has on diverse patient values.Two significant tensions in current medical ethics relate to the inclusion of patient values in practice guidelines. First, a tension exists between the traditional paternalistic model of care, in which the physician judges unilaterally which treatments will benefit the patient, and the more recent autonomy model, in which the physician elicits the individual patient's health values to determine which treatments will be beneficial. (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)

With both the cost and quality of health care under scrutiny, many in the health care industry have turned to outcomes research and practice guidelines for answers. But many physicians have resisted, claiming their clinical judgment is a better guide. Both camps may be right.

Practice guidelines are an increasingly relevant feature of health insurance. One hundred and seventy-eight million people in the United States have some form of private health insurance coverage; coverage for 150 million of them is employment-related. Traditionally, this coverage was provided by employers purchasing a group contract under which an insurance carrier provided indemnity coverage for employees—that is, the insurance company paid all usual, customary, and reasonable charges incurred by an employee for medical care, subject in some cases (...) to an annual deductible and to a percentage of covered expenses, co-paid by the employee, for each service. In recent years, however, employers in greater numbers have switched to so-called self-insurance plans in which employees’ health care claims are paid directly by the employer. (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)

The microbiota-gut-brain axis field is at an exciting stage, but the most recent developments in microbiota research still have to find their way into MGB studies. Here we outline the standards for microbiome data generation, the appropriate statistical techniques, and the covariates that should be included in MGB studies to optimize discovery and translation to clinical applications.

The news reminds us almost daily that the truth is apparently not highly valued by many in business. This paper develops two prescriptive standards — the Expectation and Reputation guidelines — that may help businesspeople avoid violating clearly accepted truth standards. The guidelines also assist in determining whether truth is required in circumstances where honesty seems in conflict with the practical demands of business. A discussion of why, when and how these guidelines may be applied to facilitate (...) truth-telling by business organizations follows, along with illustrative examples. (shrink)

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)

Publishing has become, in several respects, more challenging in recent years. Academics are faced with evolving ethics that appear to be more stringent in a bid to reduce scientific fraud, the emergence of science watchdogs that are now scrutinizing the published literature with critical eyes to hold academics, editors and publishers more accountable, and a barrage of checks and balances that are required between when a paper is submitted and eventually accepted, to ensure quality control. Scientists are often under increasing (...) pressure to produce papers in an increasingly stringent publishing environment. In such a climate, timing is everything, as is the efficiency of the process. Academics appreciate that rejections are part of the fabric of attempting to get a paper published, but they expect the reason to be clear, based on careful evaluation of their work, and not on superficial or unsubstantiated excuses. A desk rejection occurs when a paper gets rejected even before it has entered the peer review process. This paper examines the features of some desk rejections and offers some guidelines that would make desk rejections valid, fair and ethical. Academics who publish are under constant pressure to do so quickly, but effectively. They are dependent on the editors’ good judgment and the publisher’s procedures. Unfair, unsubstantiated, or tardy desk rejections disadvantage academics, and editors and publishers must be held accountable for wasting their time, resources, and patience. (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)

Decision making capacity (DMC) is a fundamental concept grounding the principle of respect for autonomy and the practice of obtaining informed consent. DMC must be determined and documented every time a patient undergoes a hospital procedure and for routine care when there is reason to believe decision making ability is compromised. In this paper we explore a path toward ethically informed development and implementation of a hospital policy related to DMC assessment. We begin with a review of the context (...) of DMC assessment before discussing some considerations relevant to policy creation by healthcare ethics committees. The discussion concludes in a presentation of a typology of capacity assessment policies, which draws upon a sampling of currently used hospital policies to illustrate relevant ethical considerations. (shrink)

ABSTRACT Isobel Ross rightly points out that providing information is not enough to guarantee that patients will choose the best course of action. She argues that to adequately protect patients’interests, we need practice guidelines to‘ensure that dangerous and unnecessarily risky procedures are excluded from practice’. What constitutes an‘unnecessarily risky procedure’is to be determined by a group of reasonable doctors. At one point, Ross suggests that such guidelines are‘presumptive’rather than ‘absolute’. But this is really a concession to (...) patient variability. She intends that certain procedures are ruled out on paternalistic grounds. I will argue that practice guidelines are desirable but should not determine practice. We should not rule out procedures on paternalistic grounds. (shrink)

ABSTRACTIn this article, we discuss the benefits of Bayesian statistics and how to utilize them in studies of moral education. To demonstrate concrete examples of the applications of Bayesian statistics to studies of moral education, we reanalyzed two data sets previously collected: one small data set collected from a moral educational intervention experiment, and one big data set from a large-scale Defining Issues Test-2 survey. The results suggest that Bayesian analysis of data sets collected from moral educational studies can provide (...) additional useful statistical information, particularly that associated with the strength of evidence supporting alternative hypotheses, which has not been provided by the classical frequentist approach focusing on P-values. Finally, we introduce several practical guidelines pertaining to how to utilize Bayesian statistics, including the utilization of newly developed free statistical software, Jeffrey’s Amazing Statistics Program, and thresholding based on Bayes Factors, to scholars in the field of moral education. (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.

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)