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PubMed1999

Implication of evidence-based medicine in prescription guidelines taught to French medical students: current status in the cardiovascular field.

OBJECTIVES: To study how satisfactory the contents of introductory courses in cardiovascular therapeutics, given to medical students in France, are with respect to the concepts of evidence-based medicine. METHODS: Medical school lecturers were asked to provide written course material used as part of medical school courses. Best-available evidence was classified as existent (including two therapeutic subclasses: indicated and contraindicated), and nonexistent. Four scores (from 0 to 10) were given, according to conformity with best-available evidence, and citation of randomized clinical trials (RCT), meta-analyses and therapeutic objectives. RESULTS: Thirty-four written documents were obtained from 43 faculties. Although the score (mean +/- SEM) of conformity with best-available evidence was 5.43 +/- 0.28 for the existent best-available evidence class, the corresponding scores for the citation of RCT, meta-analyses, and therapeutic objectives were, respectively, 1 +/- 0.2, 0.16 +/- 0.07, and 2.7 +/- 0.3. The four scores were highest when the best-available evidence belonged to the indicated class, intermediate when best-available evidence was nonexistent, and lowest for the contraindicated class (P < .05). These scores were significantly higher when the printed material was intended for specialists. CONCLUSION: Despite some limitations, the extent of agreement with the best-available evidence is only moderate. Pathophysiologic reasoning is largely preferred to justify the choice of therapeutics recommended to medical students.

Analysis of Variance↗

PubMedDate not supplied

WIC providers' perspectives on offering smoking cessation interventions.

PURPOSE: To examine the perspectives of WIC clinic providers on offering smoking cessation interventions for pregnant women. STUDY DESIGN AND METHODS: Four focus groups consisting of WIC nurses, dietitians, and social workers (N = 25) were conducted at WIC clinics in eastern Iowa. Researchers developed discussion guidelines to determine how WIC providers currently approached pregnant women who smoke cigarettes and what they considered barriers to providing effective smoking cessation interventions. Code mapping was used to analyze focus group discussions. RESULTS: Factors influencing the ability of WIC staff to provide a smoking cessation intervention for pregnant women included available time, clinic priorities, staff approaches to clients, and staff training. In addition, providers expressed concerns about educational materials for clients as well as additional client issues that prevented smoking cessation. The absence of mechanisms to track clinic outcomes related to smoking cessation was also noted. CLINICAL IMPLICATIONS: WIC providers have time limitations that may necessitate minimal or low-intensity interventions for smoking cessation, but did not know that such approaches are actually effective. WIC providers require more education about the entire issue of smoking cessation in order to become more proactive in their attempts to help pregnant women quit. Training that enhances self-efficacy and understanding of the impact of smoking on mothers, infants, and children should be initiated to motivate staff to intervene. Another strategy to motivate WIC staff in this regard could be tracking clinic outcomes in helping women to quit smoking or prevent relapse.

Attitude of Health Personnel↗

PubMed2001

Dose discrepancies between the Physicians' Desk Reference and the medical literature, and their possible role in the high incidence of dose-related adverse drug events.

BACKGROUND: Adverse drug events (ADEs) are a major cause of morbidity and mortality, and even minor ADEs may adversely affect patients' compliance with treatment. Because most ADEs are dose-related phenomena, adjusting drug dosages to account for individual patients' needs and tolerances is fundamental to good therapeutics. OBJECTIVE: To determine whether the Physicians' Desk Reference (PDR), the leading source of drug information for physicians, provides the full range of effective drug doses, especially the lowest, least ADE-prone doses of medications, for physicians to consider in treating patients. METHODS: Review of dosage guidelines and dose-response information in the PDR. Comparison with dose-response data obtained from articles listed in MEDLINE from 1966 to 2000. RESULTS: For many types of medications, physicians are frequently advised to use the lowest effective doses of drugs, especially initially. Yet, effective low doses determined in prerelease studies or in postrelease work are often omitted from the PDR, even when they have been recommended by expert panels. CONCLUSIONS: Optimal therapeutics depends on the availability of comprehensive information. However, the PDR contains only the limited dose information from package inserts. Because the PDR was originally developed as a promotional device, there is no mechanism by which all clinically relevant dose-response data or important postrelease discoveries are regularly and rapidly incorporated into it. Thus, a gap exists in the availability of current and comprehensive dose information for physicians. This article provides information on lower, effective doses for 48 major medications, with an extensive reference list-a compilation of low-dose information not previously published, to our knowledge, in the medical literature. Physicians must have a readily accessible source of current and complete dose-response information to individualize drug therapy and minimize the risks of ADEs.

Adverse Drug Reaction Reporting Systems↗

PubMed2003

General principals of management: education.

Asthma education is an essential part of the treatment of this disease. Health care professionals must establish a partnership with the patient with asthma and the patient's family to devise a plan of care with which the patient voluntarily will comply. The partnership with the patient begins at the first encounter and continues throughout the therapeutic relationship. Each member of the health care team can be instrumental in reinforcing the crucial information the patient must know to be an informed participant in his or her care. Nursing professionals are in a particularly advantageous position to foster this partnership because of their patient-focused outlook and the quality of time spent with patients. When the partnership is based on mutual trust and cooperation, the clinician can direct asthma care that is consistent with current expert guidelines. Educational interventions should be meaningful to the patient, learner centered to incorporate the patient's needs, and sensitive to the patient's cultural influences. The patient and his or her significant social and family support should be actively involved. The clinician should be alert to the patient's readiness to learn and tailor the message to suit the setting in which it is delivered. The patient should receive information that allows his or her participation in goal setting for treatment. Essentials to be included are the significance of the diagnosis, basics about inflammation as the primary cause of symptoms, the difference between controllers and relievers, how to use the medications and monitoring devices, how to reach the provider, and the need for continuous ongoing interaction with the clinician. Goals set in the partnership are objectified in the asthma action plan or guided self-management plan. The success of the treatment can be assessed from the patient's improved asthma control and reduced reliance on emergency treatment. Every health care provider is a potential wealth of patient education. Every patient encounter is an opportunity to reinforce knowledge and proficiency in asthma management. Nursing professionals can play a fundamental and crucial role in asthma education by maintaining the focus of the medical treatment on the priorities in asthma care--the learning needs and goals of the patient.

Asthma↗

PubMed1997

[Isotretinoin (Roaccutane) in women of childbearing age: failure of following prescription guidelines].

BACKGROUND: Despite prominent warnings, pregnancies continue to be reported in women exposed to isotretinoin. PATIENTS AND METHODS: We report results of the analysis of 318 questions asked to pharacovigilance structures in France from 1987 to 1995 because of an exposition to isotretinoin during the risk period and of a prospective inquiry concerning isotretinoin prescription in women conducted among pharmacists. RESULTS: These 318 pregnancies began during the month after Roaccutane withdrawal (n = 104, 33 p. 100), during Roaccutane treatment (n = 163, 51 p. 100) or before Roaccutane treatment (n = 51, 16 p. 100). Of the 267 women with pregnancies conceived during treatment with isotretinoin (n = 104) or during the month after its discontinuation (n = 163), contraception was not prescribed in 28 (15 p. 100) or prescribed but with poor compliance in 109 (60 p. 100). Pregnancy was terminated voluntarily in 199 women (81 p. 100). In the 173 women who were interviewed in pharmacies, 49 (28 p. 100) did not use contraception and among them contraception was prescribed in only 59 p. 100. Only 14 p. 100 had received full information about isotretinoin and pregnancy. The teratogenic effects of isotretinoin were known by 98 p. 100 of the women and the need of contraception during treatment and for one month after discontinuation by 70 p. 100. DISCUSSION: Insufficient compliance with warnings is the main reason for pregnancies in women receiving isotretinoin therapy. A pregnancy prevention program is needed before prescription to ensure comprehension and to obtain informed consent of patients.

Abnormalities, Drug-Induced↗

PubMed2006

Guidelines for management of home parenteral support in adult chronic intestinal failure patients.

Management of home parenteral support in adult benign but chronic intestinal failure patients requires a nutrition support team using disease-specific pathways. Education of patients to ensure they self manage home parenteral nutrition (HPN) is cornerstone to obtain minimal rate of technical complications and improvement in quality of life. Nutritive mixtures, compounded by pharmacists in single "all-in-one" bags, must be tailored according to the nutritional and intestinal status of individual patients with definition of macronutrients and water-electrolyte needs, respectively. Each PN cycle should be complete in essential nutrients to be nutritionally efficient and should have sufficient amounts of amino acids, dextrose, water, minerals, and micronutrients to avoid deficiency. When the nutritional goal is achieved, a minimum number of PN cycles per week should be implemented, guided ideally by digestive balance(s) (In-Out) of macronutrients and minerals of individual patients. Indeed, HPN is, in most cases, a complementary nonexclusive mode of nutritional support. In short gut patients--who represent 75% of chronic intestinal failure patients--encouraging enteral feeding decrease PN delivery and the risk of metabolic liver disease associated with HPN. In short gut patients with no severe renal impairment, blood citrulline dosage, in association with the remnant anatomy, is a tool to delineate transient from permanent intestinal failure. The latter group includes candidates for trophic gut factors and rehabilitative or reconstructive surgery, including intestinal transplantation. Thus, outcome improvement for intestinal failure patients needs intestinal failure teams having expertise in all medical and surgical aspects of this field.

Adult↗

PubMed2002

[Well-informed on health matters--how well? The German 'Clearinghouse for Patient Information'--objective, background and methods].

OBJECTIVE: Health information for lay people in print or electronic form are internationally recognised as useful tools and as necessary in the decision-making process of individuals. The effectiveness of offered patient information depends on quality and accessibility. Because much of the available health information is significantly deficient, the Agency for Quality in Medicine developed a programme for assessing the quality of specialised health and medical information for all non-medically trained persons. The German 'Clearinghouse for Patient Information' project is an adjunct to the already established German 'Clearinghouse for Clinical Guidelines'. METHOD: The basis for quality improvement for specialised medical information consists 1. in the determination of demands on quality for patient information published in the German language, 2. development of a standardised instrument for assessing the quality of specialised medical information by non-medically trained persons, 3. establishment of an Internet portal for evaluated and rated material, and 4. the establishment and organisation of relevant partnerships with information providers and users of health and medical information. The principle building block to rate medical information for lay people are the DISCERN criteria for good patient information. The results of the quality rating of specialised medical information are made available to the public with emphasis on promoting transparency of the assessment and rating processes used. RESULTS: The Internet-based patient information service of the Agency for Quality in Medicine (www.patienten-information.de 19.06.02) has currently a selection of approximately 800 information items covering fifty disease topics with fully or partially evaluated and rated information. Partnerships to appropriate information providers and users are already established and have been tested in special single projects. CONCLUSION: To advance the process of quality improvement for medical information for non-medical and lay persons, it is essential to develop and to intensify the cooperation with stake holders and partners at different levels. Only through close cooperation with others it is possible to create a basis to continuously develop and improve the information quality assessment instrument further. In addition, effective strategies need to be developed to disseminate these endeavours to patients and consumers of health information in a user-friendly and transparent way.

Evidence-Based Medicine↗

PubMed2003

A structured literature review to determine the use of the American Society for Therapeutic Radiology and Oncology consensus definition of biochemical failure.

OBJECTIVES: The American Society for Therapeutic Radiology and Oncology consensus definition (ACD) of biochemical failure after radiotherapy for prostate cancer requires three consecutive prostate-specific antigen increases from a nadir value. The members of the Consensus Panel recognized that the timing and frequency of prostate-specific antigen determinations could affect the comparability among different reports if this definition was used. For this reason, the Consensus Panel members recommended three guidelines for studies presented for publication (publication guidelines [PGs]). The present analysis examined the extent to which the ACD has been used in the peer-reviewed published literature and how frequently the PGs have been followed. METHODS: A structured literature review of 10 relevant journals was done. The inclusion criteria for the literature review required publication in calendar year 1999 or 2000; treatment with external beam radiotherapy and/or brachytherapy for previously untreated, nonmetastatic prostate cancer; and the use of a prostate-specific antigen-defined disease-free endpoint. A standardized checklist was created and completed by both of the authors. We independently reviewed each publication to determine whether the ACD of biochemical failure was used and whether the PGs were followed. Discrepancies between us were resolved by joint review of each publication in question to achieve a consensus. RESULTS: Fifty-seven articles met the inclusion criteria. The median number of patients in the articles reviewed was 302 (range 22 to 2222). The ACD was followed in 37 (64.9%) of 57 articles. None of the reviewed articles followed all three PGs. In five articles (8.7%), two of the three PGs were followed. The vast majority of the articles reviewed (52 of 57, 91.3%) followed one or none of the PGs recommended by the Consensus Panel. CONCLUSIONS: The ACD was used in two thirds of peer-reviewed published articles. The PGs were followed much less frequently. Consistent standards of reporting have not been uniformly applied to peer-reviewed manuscripts.

Brachytherapy↗

PubMed2005

Cardiac rehabilitation services in Denmark: still room for expansion.

AIM: European cardiologists agree that cardiac rehabilitation (CR) should be offered as an integrated part of cardiac care, and CR guidelines have been published. The authors aimed to ascertain the potential for expanding CR coverage at hospitals in Denmark. METHOD: A cross-sectional questionnaire study was conducted among all hospitals receiving acute cardiac patients (n = 67). The response rate was 79%, with no differences according to catchment area, number of beds, or geographical location. The hospitals were classified as having full CR if all core components (physical training, psychosocial support, dietary counselling, smoking cessation, and pharmaceutical risk factor management) were available during each of three phases: (I) in hospital; (II) outpatient; and (II) community-based services. RESULTS: Many hospitals offered one or more of the CR components during phases I and II: physical training (77%; 77%), psychosocial support (89%; 79%), dietary counselling (85%; 89%), smoking cessation (94%; 68%), and clinical control by a physician (100%; 93%). The content varied greatly. Full phase I CR was offered at 57% (95% confidence interval (95% CI): 44-70%) of the hospitals and 47% (95% CI: 34-60%) offered full phase II CR. Phase III CR was very rare (2% (95% CI: 0-6%). The numbers of patients receiving CR was not registered. CONCLUSION: Marked progress was made in the 1990s in implementing CR; nevertheless, the services are far from fully expanded. Denmark has great potential for improving CR services, as do most other European countries. CR activities need to be registered at Danish hospitals.

Cardiology Service, Hospital↗

PubMedDate not supplied

Unmet needs in the treatment of allergic asthma: potential role of novel biologic therapies.

OBJECTIVE: To provide a review of the current status of the treatment of asthma and introduce new and developing forms of therapy by means of a review of published literature on asthma and publications on new and emerging therapies. Increased public awareness of asthma, improved patient and provider education, implementation of national treatment guidelines, and availability of safe and effective therapies have combined to provide an effective response to the increase in asthma prevalence. However, the number of persons with poorly controlled asthma and asthma-related complications remains unacceptably high. This is particularly true for the relatively small cohort of patients with moderateto- severe asthma that is poorly controlled with inhaled corticosteroids and other standard-of-care medications. Consequently, these patients often experience frequent exacerbations, leading to a disproportionate consumption of asthma health care resources and a poor quality of life. The National Committee on Quality Assurance suggests that the negative impact of asthma can be minimized if health care providers implement aggressive asthma management programs that include patient education and appropriate medications. Newer therapies such as injectable anti-IgE may provide a benefit for many patients. SUMMARY: Currently available asthma medications have been proven to be generally safe and effective for most asthma patients. However, the subset of patients with difficult-to-treat asthma who experience frequent exacerbations requiring emergency department visits or hospitalizations may benefit from novel therapies designed to target specific mechanisms underlying airway inflammation. CONCLUSIONS: New therapies may help in the treatment of patients whose asthma is not controlled. These include anti-immunoglobulin E (IgE) antibodies, cytokine modulators, and DNA vaccinations. Future research will determine if these targeted biologic therapies are a cost-effective means to improve the clinical and economic outcomes of asthma management.

Antibodies, Monoclonal↗

PubMed2002

Compliance with National Cholesterol Education Program dietary and lifestyle guidelines among older women with self-reported hypercholesterolemia. The Women's Health Initiative.

PURPOSE: Dietary therapy remains the first line of treatment for patients with high blood cholesterol levels. Among free-living persons, compliance with National Cholesterol Education Program (NCEP) dietary recommendations is uncertain. SUBJECTS AND METHODS: We performed a cross-sectional, baseline analysis of 91,627 postmenopausal women enrolled in the Women's Health Initiative Observational Study. Among women with self-reported hypercholesterolemia, we ascertained factors associated with compliance with National Cholesterol Education Program dietary recommendations, defined for the Step II diet as <or=30% of total calories from fat, <7% of calories from saturated fat, and daily dietary cholesterol <200 mg. RESULTS: Of the 13,777 participants who reported having high cholesterol levels requiring drug therapy, only 20% reported total fat, saturated fat, and dietary cholesterol consumption consistent with Step II dietary goals. Factors associated with Step II dietary compliance included having a college degree (odds ratio [OR] = 1.26; 95% confidence interval [CI]: 1.14 to 1.40), a prior cardiovascular event (OR = 1.48; 95% CI: 1.28 to 1.70), and consumption of five or more daily servings of fruits or vegetables (OR = 3.0; 95% CI: 2.7 to 3.3). Being married, smoking, a sedentary lifestyle, and a higher body mass index were all associated with reduced compliance (all P <0.0001). In the subsample in which plasma lipid levels were measured, dietary compliance was associated with higher levels of low-density lipoprotein cholesterol (P = 0.02). CONCLUSION: Since the inception of the NCEP in 1985, health care providers, public health programs, and patients have not successfully implemented the dietary recommendations.

Age Factors↗

PubMed2006

Antidepressant discontinuation syndrome: consensus panel recommendations for clinical management and additional research.

OBJECTIVE: Currently, no evidence-based guidelines exist for the management of serotonin reuptake inhibitor (SRI) discontinuation syndrome. This article summarizes recommendations with respect to future research as well as clinical management recommendations for SRI discontinuation syndrome. PARTICIPANTS: In April 2004, a panel of physicians convened in New York City to discuss recommendations for clinical management of and additional research on SRI discontinuation syndrome. EVIDENCE: Previous guidance for management of SRI discontinuation syndrome was proposed in 1997 in a consensus meeting also chaired by Alan F. Schatzberg. A literature search of the PubMed database was conducted to identify articles on SRI discontinuation syndrome that have been published since 1997. CONSENSUS PROCESS: The 2004 panel reviewed important preclinical and clinical studies, discussed prospective investigation of this syndrome in clinical trials, and suggested the establishment of a research network to collect data in naturalistic settings. The panel also reviewed the management recommendations published in 1997 and subsequently updated the recommendations, taking into account the latest clinical data as well as the personal experience of its members with patients. CONCLUSIONS: Additional preclinical and clinical studies are necessary to further elucidate the underlying biological mechanisms of SRI discontinuation syndrome and to identify the patient populations and agents that are most affected by this phenomenon. Management strategies include gradual tapering of doses and should emphasize clinical monitoring and patient education.

Antidepressive Agents↗

PubMed2002

Bronchial asthma and self-management education: implementation of Guidelines by an interdisciplinary programme in health network.

UNLABELLED: Asthma is a chronic disease generating very high costs even for Switzerland. Self-management education (SME) is effective and recommended as an integral part of management in the most recent guidelines on asthma treatment. Its aim is to reduce morbidity [hospitalisations (H), lost workdays (LW), emergency consultations (EC)] and improve quality of life (QOL) in these patients. METHOD: Integrated programme with educational platforms (two-language booklet), SME in 66 patients (30 m, 36 f) with interdisciplinary quality team (pneumologists, primary care physicians, pharmacists, specialised nursing staff), QOL questionnaire. Measurement of morbidity parameters 12 months before and after SME. Measurement of QOL before and 12 months after SME. RESULTS: Hospitalisations fell from 35 to 8%*, EC from 88 to 53%*. and LW from 39 to 14%* (*p <0.001). Overall, SME resulted in a health cost saving of CHF 202,510 in terms of LW and CHF 131,200 in terms of days in hospital, i.e. a total of CHF 333,710. Costs saved per patient were CHF 5,056 per year. QOL improved with the following scores: overall QOL 4.5 +/- 0.9 to 5.2 +/- 0.9*; activities 4.5 +/- 0.9 to 5.2 +/- 0.9*; symptoms 4.2 +/- 1.1 to 5.2 +/- 1.1*; emotions 4.9 +/- 1.1 to 5.6 +/- 1*; environment 4.5 +/- 1.4 to 4.9 +/- 1.3* (*p <0.001). CONCLUSION: SME by interdisciplinary health network is effective. It brings a steep fall in costs for asthma treatment by cutting back hospitalisations and lost workdays and by improving the asthmatics' quality of life. It should be recognised and better supported by the health system.

Adolescent↗

PubMed2006

Improving blood pressure control through provider education, provider alerts, and patient education: a cluster randomized trial.

BACKGROUND: Inadequate blood pressure control is a persistent gap in quality care. OBJECTIVE: To evaluate provider and patient interventions to improve blood pressure control. DESIGN: Cluster randomized, controlled trial. SETTING: 2 hospital-based and 8 community-based clinics in the Veterans Affairs Tennessee Valley Healthcare System. PATIENTS: 1341 veterans with essential hypertension cared for by 182 providers. Eligible patients had 2 or more blood pressure measurements greater than 140/90 mm Hg in a 6-month period and were taking a single antihypertensive agent. INTERVENTION: Providers who cared for eligible patients were randomly assigned to receive an e-mail with a Web-based link to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7) guidelines (provider education); provider education and a patient-specific hypertension computerized alert (provider education and alert); or provider education, hypertension alert, and patient education, in which patients were sent a letter advocating drug adherence, lifestyle modification, and conversations with providers (patient education). MEASUREMENTS: Proportion of patients with a systolic blood pressure less than 140 mm Hg at 6 months; intensification of antihypertensive medication. RESULTS: Mean baseline blood pressure was 157/83 mm Hg with no differences between groups (P = 0.105). Six-month follow-up data were available for 975 patients (73%). Patients of providers who were randomly assigned to the patient education group had better blood pressure control (138/75 mm Hg) than those in the provider education and alert or provider education alone groups (146/76 mm Hg and 145/78 mm Hg, respectively). More patients in the patient education group had a systolic blood pressure of 140 mm Hg or less compared with those in the provider education or provider education and alert groups (adjusted relative risk for the patient education group compared with the provider education alone group, 1.31 [95% CI, 1.06 to 1.62]; P = 0.012). LIMITATIONS: Follow-up blood pressure measurements were missing for 27% of study patients. The study could not detect a mechanism by which patient education improved blood pressure control. CONCLUSIONS: A multifactorial intervention including patient education improved blood pressure control compared with provider education alone.

Adult↗

PubMed1997

Improving care for minority children with asthma: professional education in public health clinics.

OBJECTIVE: Recent studies have shown that lack of continuing primary care for asthma is associated with increased levels of morbidity in low-income minority children. Although effective preventive therapy is available, many African-American and Latino children receive episodic treatment for asthma that does not follow current guidelines for care. To see if access, continuity, and quality of care could be improved in pediatric clinics serving low-income children in New York City, we trained staff in New York City Bureau of Child Health clinics to provide continuing, preventive care for asthma. METHODS: We evaluated the impact of the intervention over a 2-year period in a controlled study of 22 clinics. Training for intervention clinic staff was based on National Asthma Education and Prevention Program guidelines for the diagnosis and management of asthma, and included screening to identify new cases and health education to improve family management. The intervention included strong administrative support by the Bureau of Child Health to promote staff behavior change. We hypothesized that after the intervention, clinics that received the intervention would, compared with control clinics, have increased numbers of children with asthma receiving continuing care in the clinics and increased staff use of new pharmacologic and educational treatment methods. RESULTS: In both the first and second follow-up years, the intervention clinics had greater positive changes than control clinics on measures of access, continuity, and quality of care. For second year follow-up data these include: for access, greater rate of new asthma patients (40/1000 vs 16/1000; P < .01); for continuity, greater percentage of asthma patients returning for treatment 2 years in a row (42% vs 12%; P < .001) and greater annual frequency of scheduled visits for asthma per patient (1.85 vs .88; P < .001); and for quality, greater percentage of patients receiving inhaled beta agonists (52% vs 15%; P < .001) and inhaled antiinflammatory drugs (25% vs 2%; P < .001), and greater percentages of parents who reported receiving patient education on 12 topics from Bureau of Child Health physicians (71% vs 58%; P < .01) and nurses (61% vs 44%; P < .05). CONCLUSION: We conclude that the intervention substantially increased the Bureau of Child Health staff's ability to identify children with asthma, involve them in continuing care, and provide them with state-of-the-art care for asthma.

Black or African American↗

PubMed2005

Recent National Cholesterol Education Program Adult Treatment Panel III update: adjustments and options.

In the summer of 2004, an evidence-based update of the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) guidelines for management of hypercholesterolemia was published. This detailed assessment of 5 major clinical trials, published since the ATP III report in 2001, was designed to provide guidance for physicians in decision making for patients at high risk and very high risk. We have tried to summarize this assessment by suggesting the following to clinicians: (1) Calculate global risk of coronary artery disease (CAD) to determine an overall strategy for cholesterol management. (2) Emphasize the benefits of diet, exercise, and weight control or therapeutic lifestyle change, especially in those with lifestyle risk factors. (3) Use 3-hydroxy-3-methyglutaryl coenzyme A reductase inhibitors (statins) as first-line drugs to reduce risk of CAD and stroke in those at moderate to high risk. (4) If statins are prescribed, use moderate doses that reduce plasma levels of low-density lipoprotein (LDL) cholesterol by > or = 30% to 40%. (5) Strongly consider statin therapy in those with diabetes (with the exception of severe hypertriglyceridemia). (6) Consider LDL cholesterol-lowering drug therapy for lipids in older patients at risk. (7) Consider adding either a fibrate or nicotinic acid in high-risk patients with elevated plasma triglyceride values or low levels of plasma high-density lipoprotein cholesterol after statin therapy has achieved the LDL cholesterol goal. (8) Continue to treat those at low risk in similar fashion as before. This update is to inform current physician judgment in this area. Further clinical trial data that may modify or extend these recommendations are eagerly awaited.

Cholesterol, LDL↗

PubMed2003

Guidelines for lowering lipids to reduce coronary artery disease risk: a comparison of rosuvastatin with atorvastatin, pravastatin, and simvastatin for achieving lipid-lowering goals.

Both the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III and the Second Joint Task Force of European Societies guidelines have established low-density lipoprotein (LDL) cholesterol goals for lipid-lowering treatment to reduce the risk of coronary artery disease. Data from 3 trials that compared rosuvastatin 10 mg (n = 389) with atorvastatin 10 mg (n = 393) and 2 trials that compared rosuvastatin 10 mg (n = 226) with pravastatin 20 mg (n = 252) and simvastatin 20 mg (n = 249) were pooled separately to compare the achievement of LDL cholesterol goals over 12 weeks of treatment in hypercholesterolemic patients. Noncomparative pooling of rosuvastatin 10 mg results from all 5 trials (n = 615) showed that 80% achieved NCEP ATP III goals and 81% achieved the European goal of <3.0 mmol/L. Compared with atorvastatin 10 mg, significantly more patients treated with rosuvastatin 10 mg achieved their ATP III (76% vs 53%) and European (82% vs 51%) goals (p <0.001). Also, in comparisons with simvastatin 20 mg and pravastatin 20 mg, 86% of patients treated with rosuvastatin 10 mg achieved ATP III goals, compared with 64% of simvastatin-treated patients and 49% of pravastatin-treated patients (p <0.001). The proportions of patients who achieved the European goal were 80%, 48%, and 16% for rosuvastatin 10 mg, simvastatin 20 mg, and pravastatin 20 mg, respectively, in this comparison (all p <0.001). A total of 71% of patients treated with rosuvastatin 10 mg who had triglyceride levels > or =200 mg/dL met both their LDL cholesterol and their non-high-density lipoprotein cholesterol goals.

Adult↗

PubMed2003

The breathlessness, cough, and sputum scale: the development of empirically based guidelines for interpretation.

BACKGROUND: A patient report of respiratory symptoms in COPD is essential to successfully monitoring disease, adjusting treatment, and evaluating outcomes. OBJECTIVE: To develop empirically based guidelines for interpreting mean changes in symptom scores using the Breathlessness, Cough, and Sputum Scale (BCSS). METHODS: Analyses were performed on data from three multinational trials (n = 2,971). Mean changes in BCSS score with treatment were examined by physician and patient ratings of treatment efficacy, juxtaposed with percentage change in symptoms, statistical effect size (ES), DeltaFEV(1), and change in St. George Respiratory Questionnaire (SGRQ) score. BCSS scores during an exacerbation were examined relative to changes in peak expiratory flow and rescue medication use. RESULTS: Mean baseline BCSS total score was 5.2 +/- 2 (+/- SD); 90% of scores were between 2 and 9. Highly efficacious treatment (n = 257; physician rating) was associated with a DeltaBCSS total score of - 1.3 +/- 1.8, representing a 24% improvement (ES = 0.7), and corresponding to a 10% improvement in FEV(1) and DeltaSGRQ score total of - 10.3 +/- 13.8. Similar changes in BCSS score were observed during recovery from an exacerbation (n = 713; - 1.3 +/- 1.8). Mean change with moderately efficacious treatment (n = 965) was - 0.7 +/- 1.8, a 13% improvement (ES = 0.3) corresponding to DeltaSGRQ total score of - 6.8 +/- 12.6. Mildly efficacious treatment (n = 891) was associated with a change of - 0.35, a 7% improvement (ES = 0.18), with a DeltaFEV(1) <1% and DeltaSGRQ total score of - 2.6 +/- 11.7. CONCLUSIONS: Patient-reported daily symptom data are sensitive to change and useful for both observational studies and controlled clinical trials of patients with COPD. A mean DeltaBCSS total score > 1.0 represents substantial symptomatic improvement, changes of approximately 0.6 can be interpreted as moderate, and changes of 0.3 can be considered small.

Clinical Trials as Topic↗