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PubMed1990

The National Cholesterol Education program: guidelines and commentaries.

There is overwhelming evidence that atherosclerosis is caused by elevated cholesterol levels and that the process can be prevented, arrested, and even reversed by altering the cholesterol fractions. The National Cholesterol Education program established guidelines for the management of hypercholesterolemia. Classification of cholesterol values are: Desirable 200 mg./dl, Borderline high 200-239 mg./dl high risk 240 mg./dl and above. Total cholesterol is used for case finding and screening, but LDL cholesterol is the key index for decisions requiring treatment. Classification of LDL levels is as follows: High risk 160 mg/.dl and over, Borderline 130 to 159 mg./dl, Acceptable 130 mg./dl and below. Secondary and familiar disorders should be identified. Dietary therapy is the cornerstone of cholesterol reducing interventions. Steps one and two diets are described, with limitations of saturated fats to 10% of total calories and cholesterol to 300 mg./daily in step one; step two diet limits saturated fats to 7% of total calories-and cholesterol to 200 mg./daily. Pharmacotherapy is based on 5 groups of hypolipidemics agents: A--Resins (cholestyramine and colestipol) B--Nicotinic acid C--Probucol D--Fibric acids (gemfibrozil) E--Reductase inhibitors (lovastatin). Some areas of criticism and controversies regarding the guidelines are discussed and identified.

Humans↗
PubMed1999

[The Cologne Guidelines Conference: computer-assisted clinical practice guidelines in clinical diagnosis].

Eighteen clinical practice guidelines on interdisciplinary diagnostic issues were developed at the University Hospital of Cologne, Germany. The guideline committee is organized and directed by the quality control program, which also includes the local Cochrane initiative and a wide range of organizational topics. During guideline development, questions of differential diagnosis were addressed to the same extent as the organizational and financial realization. Broad consideration was given to medicolegal implications, but need for interspecialty cooperation was judged to be more critical and even more relevant in this regard. Guidelines were primarily developed as algorithms and translated to text versions secondarily. Critical steps in the decision tree were supported by rated literature and recommendations weighte by criteria as used in evidence-based medicine. For implementation, guidelines were presented to colleagues in a series of short lectures, as print versions containing all literature used in the developing process, and in hypertext format, which is accessible via intranet. Three levels of presentation were chosen in the html-version: algorithm, decision, and information. The former is due to orientation in the guideline, the second displays the binary question, and the latter makes the scientific background available, together with literature and links for more information. Efforts to check effectiveness are currently been made, questions of efficiency will be addressed in future.

Algorithms↗
PubMed2001

Medical quality assessment by scoring adherence to guideline intentions.

Quality assessment of clinician actions and patient outcomes is a central problem in guideline- or standards-based medical care. In this paper we describe an approach for evaluating and consistently scoring clinician adherence to medical guidelines using the intentions of guideline authors. We present the Quality Indicator Language (QUIL) that may be used to formally specify quality constraints on physician behavior and patient outcomes derived from medical guidelines. We present a modeling and scoring methodology for consistently evaluating multi-step and multi-choice guideline plans based on guideline intentions and their revisions.

Algorithms↗
PubMed2000

[Methodological standards of the evidence-based approach of clinical guidelines development in Germany. Consensus between the scientific community, self-governed bodies and practice].

The most appropriate method of clinical guidelines development has been the subject of controversial debates in Germany during the last few years. The German Guidelines Clearinghouse at the Society for Quality in Medicine (Cologne) provided a discussion forum where clinicians, methodologists, the Association of the Scientific Medical Societies, and the corporate self-governed bodies (the health insurances, physicians' associations, and the hospital associations) agreed on the most important methods of an evidence-based approach for guidelines development. It was generally agreed that rigorous methodological standards should be followed to ensure both the scientific quality and the consensus quality in the development or revision of clinical practice guidelines. The agreement draws on the following topics: Scientifically valid guidelines: (1) are based on a comprehensive and systematic review of the best available evidence, (2) derive the recommendations from the best available evidence, and (3) demonstrate explicitly how the recommendations are linked to the evidence. The quality of consensus is ensured through (1) the participation of all relevant stakeholders in the guideline panel and (2) the application of formal consensus development methods. This type of an "evidence-based consensus guideline" is assumed to possess the highest level of scientific and political legitimacy.

Evidence-Based Medicine↗
PubMed2006

Improving the use of research evidence in guideline development: 11. Incorporating considerations of cost-effectiveness, affordability and resource implications.

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the 11th of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on incorporating considerations of cost-effectiveness, affordability and resource implications in guidelines and recommendations. METHODS: We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: When is it important to incorporate cost-effectiveness, resource implications and affordability considerations in WHO guidelines (which topics)? For cost-effectiveness:The need for cost/effectiveness information should be dictated by the specific question, of which several may be addressed in a single guideline. It is proposed that the indications for undertaking a cost-effectiveness analysis (CEA) could be a starting point for determining which recommendation(s) in the guideline would benefit from such analysis. For resource implications/affordability:The resource implications of each individual recommendation need to be considered when implementation issues are being discussed. How can cost-effectiveness, resource implications and affordability be explicitly taken into account in WHO guidelines? For cost-effectiveness: composite function If data are available, the ideal time to consider cost-effectiveness is during the evidence gathering and synthesizing stage. However, because of the inconsistent availability of CEAs and the procedural difficulty associated with adjusting results from different CEAs to make them comparable, it is also possible for cost-effectiveness to be considered during the stage of developing recommendations. composite function Depending on the quantity and quality and relevance of the data available, such data can be considered in a qualitative way or in a quantitative way, ranging from a listing of the costs to a modelling exercise. At the very least, a qualitative approach like a commentary outlining the economic issues that need to be considered is necessary. If a quantitative approach is to be used, the full model should be transparent and comprehensive. For resource implications/affordability: composite function Resource implications, including health system changes, for each recommendation in a WHO guideline should be explored. At the minimum, a qualitative description that can serve as a gross indicator of the amount of resources needed, relative to current practice, should be provided. How does one provide guidance in contextualizing guideline recommendations at the country level based on considerations of cost-effectiveness, resource implications and affordability? All models should be made available and ideally are designed to allow for analysts to make changes in key parameters and reapply results in their own country. In the global guidelines, scenarios and extensive sensitivity/uncertainty analysis can be applied.Resource implications for WHO. From the above, it is clear that guidelines development groups will need a health economist. There is need to ensure that this is included in the budget for guidelines and that there is in-house support for this as well.

Journal Article↗
PubMed2000

Dutch hospital drug formularies: pharmacotherapeutic variation and conservatism, but concurrence with national pharmacotherapeutic guidelines.

AIMS: This research examines current hospital drug formularies (HDFs) of all Dutch general hospitals. It assesses the extent to which they recommend the same drugs, the breadth of their coverage in terms of therapeutic areas, drug groups incorporated and individuals drugs included, and their extent of conservatism by considering the year of introduction of the drugs included within groups. Furthermore, it considers the extent to which their recommendations concur and comply with those of national pharmacotherapeutic guidelines and the WHO Essential Drugs List (EDL). METHODS: Seventy-eight (81%) out of all 96 current Dutch HDFs were received of which 62 were suitable for study. Differences between HDFs and eventual associations with hospital characteristics were researched by statistical testing and case-control studies. To evaluate HDFs' concurrence with national guidelines and compliance with the WHO EDL, nine drug groups were studied in detail: benzodiazepines, calcium channel blockers, beta-adrenoceptor blocking agents, ACE-inhibitors, angiotensin-II inhibitors, NSAIDs, H2-receptor antagonists, 5HT3-antagonists, and H+-pump inhibitors. Concurrence and compliance with national guidelines and the WHO EDL was defined as inclusion of recommended drugs. Non-concurrence was defined as inclusion of nonrecommended drugs. RESULTS: The total number of indications addressed and drug groups incorporated within HDFs varied from 28 to 72 (median 56) and from 30 to 123 (median 97), respectively. The total number of individual drug entities (pharmacological substances) included ranged from 239 to 658 (median 430) and the total number of drug products, including all different dosage forms, from 412 to 1121 (median 655). Within drug groups, drug entities first marketed were most frequently included. Teaching hospitals were most likely to include recently marketed drugs. Depending on the drug group, HDFs' concurrence and compliance with national guidelines and the WHO EDL ranged from 35% to 100%. CONCLUSIONS: Findings indicate that Dutch HDFs are rather uniform in the indications addressed and the drug groups incorporated. However, the number of individual drug entities and drug products included within groups varies considerably. Furthermore, Dutch HDFs are considered rather conservative, as older drugs are favoured over more recent drugs. Generally, with some drug exceptions, Dutch HDFs concur and comply with recommendations in national pharmacotherapeutic guidelines and with the WHO EDL over 90%.

Chemistry, Pharmaceutical↗