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PubMed1998

Snyder v. American Association of Blood Banks: a re-examination of liability for medical practice guideline promulgators.

Medical practice guidelines are playing an increasingly important role in both the medical and the legal context. As tools for the health practitioner, it is thought that medical practice guidelines may contribute to an increase in the quality of patient care and cost-effectiveness. In the legal setting, guidelines may improve the functioning of the medical malpractice system by creating more rational, predictable standards of care. The development and promulgation of medical practice guidelines, while increasing, are still evolving. A number of concerns, especially in the areas of physician autonomy, physician control, and ethics, as well as efficacy, need to be resolved. The use of such guidelines as the legal standard of care in malpractice cases evokes similar concerns, along with fears that the use of guidelines at trial may either lower the standard of care, or, conversely, raise the standard of care to levels that are difficult to meet. Adding to this controversy is the recent case of Snyder v. American Association of Blood Banks (1996), in which the New Jersey Supreme Court upheld a jury finding that the American Association of Blood Banks (AABB) was liable to a plaintiff who contracted AIDS from an HIV-tainted transfusion, for negligent failure to adopt guidelines requiring blood testing for surrogate markers. This opinion is significant as the first to find a duty of care running from a medical guideline promulgator to a third person, the injured patient. The opinion is examined in depth and within the context of other relevant case law. The impact the opinion will have is difficult to gauge. The somewhat unique facts of the case, as well as the court's unusually stinging critique of the defendant, AABB, and its motivations informing its response to the concerns about blood contamination, may limit its value as precedent. However, precedent does exist in analogous non-medical cases for promulgator liability. The pros and cons of promulgator liability are weighed. While closer regulation of guideline development and promulgation or promulgator immunity may be warranted, it is premature to consider either seriously until the impact of the Snyder opinion can be appreciated.

Blood Banks↗
PubMed1994

Clinical practice guidelines: from methodological to practical issues.

The main goal of clinical practice guidelines is to help clinical decision by practitioners, who can not integrate in their daily practice all the published data concerning new technologies and knowledge. Guidelines also have growing applications in the ethical, legal, socio-economic, public policy and health care funding fields. This article describes the various methodologies that have been proposed to develop guidelines. These methods rely to varying degrees on formal methods of analysis of scientific evidence and expert opinions. Then a step by step process is described, that should ensure a rigorous, feasible and explicit guideline development and lead to valid and applicable recommendations. In order for guidelines to be used, they have to be efficiently implemented. Respective efficiency and justification of educational and coercive methods of implementation are discussed.

Clinical Competence↗
PubMedDate not supplied

A method for estimating the cost-effectiveness of incorporating patient preferences into practice guidelines.

Many clinical practice guidelines fail to account for the preferences of the individual patient. Approaches that seek to include the preferences of the individual patient in the decision-making process (e.g., interactive videodisks for patient education), however, may incur substantial incremental costs. Developers of clinical practice guidelines must therefore determine whether it is appropriate to make their guidelines flexible with regard to patient preferences. The authors present a formal method for determining the cost-effectiveness of incorporating the preferences of individual patients into clinical practice guidelines. Based on utilities assessed from 37 patients, they apply the method in the setting of mild hypertension. In this example, they estimate that the cost-effectiveness ratio for individualized utility assessment is $48,565 per quality-adjusted year of life, a ratio that compares favorably with other health interventions that are promoted actively. This approach, which can be applied to any clinical domain, offers a formal method for determining whether the incorporation of individual patient preferences is important clinically and is justified economically.

Adult↗
PubMed1997

The use of clinical practice guidelines (CPGs) to evaluate practice and control costs in ventriculoperitoneal shunt management.

BACKGROUND: As a step toward maximizing the quality and cost-effectiveness of neurosurgical care, we designed clinical practice guidelines (CPGs) for the management of VP shunt malfunctions and infections at a tertiary care pediatric teaching institution. The detailed CPGs determine the use of radiographic studies, laboratory tests, and invasive procedures in the management of this problem. One purpose of the CPGs is to provide clear clinical guidelines for the medical trainee, thereby reducing variability in care and unnecessary utilization of resources. METHODS: The CPGs were developed in stages over a 2-year period. The practice patterns in our institution for the management of shunt malfunctions and infections were articulated. They were compared with those published in the neurosurgical literature, and areas of clinical decision-making variability were identified. Preliminary guidelines were formulated, and data regarding patient care were prospectively collected. Based on this data, final CPGs were formulated and implemented. Total and itemized hospital charges for patients managed according to the CPGs were compared with those for patients in the 3 years before CPG implementation. RESULTS: CPG-managed patients had generally lower total and itemized charges as compared with control patients. Decreased charges per hospital day and charges for shunt films in the CPG group were statistically significant. CONCLUSIONS: The process by which the CPGs were developed and implemented, as well as the CPGs themselves, are described. We also present the clinical, demographic, and financial data that were prospectively collected for all patients managed within the CPGs over an initial 1-year period and compare it with data obtained for control groups of shunt malfunction patients admitted during the 3 years before implementation of the CPGs. We find a trend toward reduction of charges after implementation of the CPG.

Boston↗
PubMed2006

Application of The APA Practice Guidelines on Suicide to Clinical Practice.

This article presents charts from The American Psychiatric Association Practice Guideline for the Assessment and Treatment of Patients with Suicidal Behaviors, part of the Practice Guidelines for the Treatment of Psychiatric Disorders Compendium, and a summary of the assessment information in a format that can be used in routine clinical practice. Four steps in the assessment process are presented: the use of a thorough psychiatric examination to obtain information about the patient's current presentation, history, diagnosis, and to recognize suicide risk factors therein; the necessity of asking very specific questions about suicidal ideation, intent, plans, and attempts; the process of making an estimation of the patient's level of suicide risk is explained; and the use of modifiable risk and protective factors as the basis for treatment planning is demonstrated. Case reports are used to clarify use of each step in this process.

Adult↗
PubMed2006

ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society.

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Algorithms↗
PubMed2001

ACC/AHA/ESC Guidelines for the Management of Patients With Atrial Fibrillation: Executive Summary A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation) Developed in Collaboration With the North American Society of Pacing and Electrophysiology.

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Aged↗
PubMedDate not supplied

KDOQI clinical practice guidelines and clinical practice recommendations--2006 updates.

In scanning through the KDOQI guidelines for this article, I applaud the Work Group members as there is an emphasis placed on timely education of the patient, their family members, close friends, and/or primary care providers for both HD and PD. We have all seen in our practice setting, how critical education is for our patients. Studies have shown that timely patient education as CKD advances can both improve outcomes and reduce cost. These guidelines certainly emphasize the importance of advocating for education of patients with CKD. We know that we as nephrology nurses are crucial for educating the patient with CKD, the patient with ESRD, family members, and caregivers and for re-enforcing their education.

Evidence-Based Medicine↗
PubMed2000

A clinical practice guideline for treating tobacco use and dependence: A US Public Health Service report. The Tobacco Use and Dependence Clinical Practice Guideline Panel, Staff, and Consortium Representatives.

OBJECTIVE: To summarize the recently published US Public Health Service report Treating Tobacco Use and Dependence: A Clinical Practice Guideline, which provides recommendations for brief clinical interventions, intensive clinical interventions, and system changes to promote the treatment of tobacco dependence. PARTICIPANTS: An independent panel of 18 scientists, clinicians, consumers, and methodologists selected by the US Agency for Healthcare Research and Quality. A consortium of 7 governmental and nonprofit organizations sponsored the update. EVIDENCE: Approximately 6000 English-language, peer-reviewed articles and abstracts, published between 1975 and 1999, were reviewed for data that addressed assessment and treatment of tobacco dependence. This literature served as the basis for more than 50 meta-analyses. CONSENSUS PROCESS: One panel meeting and numerous conference calls and staff meetings were held to evaluate meta-analytic and other results, to synthesize the results, and to develop recommendations. The updated guideline was then externally reviewed by more than 70 experts and revised. CONCLUSIONS: This evidence-based, updated guideline provides specific recommendations regarding brief and intensive tobacco cessation interventions as well as system-level changes designed to promote the assessment and treatment of tobacco use. Brief clinical approaches for patients willing and unwilling to quit are described. Major conclusions and recommendations include: (1) Tobacco dependence is a chronic condition that warrants repeated treatment until long-term or permanent abstinence is achieved. (2) Effective treatments for tobacco dependence exist and all tobacco users should be offered those treatments. (3) Clinicians and health care delivery systems must institutionalize the consistent identification, documentation, and treatment of every tobacco user at every visit. (4) Brief tobacco dependence treatment is effective, and every tobacco user should be offered at least brief treatment. (5) There is a strong dose-response relationship between the intensity of tobacco dependence counseling and its effectiveness. (6) Three types of counseling were found to be especially effective-practical counseling, social support as part of treatment, and social support arranged outside of treatment. (7) Five first-line pharmacotherapies for tobacco dependence-sustained-release bupropion hydrochloride, nicotine gum, nicotine inhaler, nicotine nasal spray, and nicotine patch-are effective, and at least 1 of these medications should be prescribed in the absence of contraindications. (8) Tobacco dependence treatments are cost-effective relative to other medical and disease prevention interventions; as such, all health insurance plans should include as a reimbursed benefit the counseling and pharmacotherapeutic treatments identified as effective in the updated guideline. JAMA. 2000;283:3244-3254

Cost-Benefit Analysis↗