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Scientific evidence underlying the ACC/AHA clinical practice guidelines.

JAMA. 2009 Feb 25;301(8):831-41

Authors: Tricoci P, Allen JM, Kramer JM, Califf RM, Smith SC

CONTEXT: The joint cardiovascular practice guidelines of the American College of Cardiology (ACC) and the American Heart Association (AHA) have become important documents for guiding cardiology practice and establishing benchmarks for quality of care. OBJECTIVE: To describe the evolution of recommendations in ACC/AHA cardiovascular guidelines and the distribution of recommendations across classes of recommendations and levels of evidence. DATA SOURCES AND STUDY SELECTION: Data from all ACC/AHA practice guidelines issued from 1984 to September 2008 were abstracted by personnel in the ACC Science and Quality Division. Fifty-three guidelines on 22 topics, including a total of 7196 recommendations, were abstracted. DATA EXTRACTION: The number of recommendations and the distribution of classes of recommendation (I, II, and III) and levels of evidence (A, B, and C) were determined. The subset of guidelines that were current as of September 2008 was evaluated to describe changes in recommendations between the first and current versions as well as patterns in levels of evidence used in the current versions. RESULTS: Among guidelines with at least 1 revision or update by September 2008, the number of recommendations increased from 1330 to 1973 (+48%) from the first to the current version, with the largest increase observed in use of class II recommendations. Considering the 16 current guidelines reporting levels of evidence, only 314 recommendations of 2711 total are classified as level of evidence A (median, 11%), whereas 1246 (median, 48%) are level of evidence C. Level of evidence significantly varies across categories of guidelines (disease, intervention, or diagnostic) and across individual guidelines. Recommendations with level of evidence A are mostly concentrated in class I, but only 245 of 1305 class I recommendations have level of evidence A (median, 19%). CONCLUSIONS: Recommendations issued in current ACC/AHA clinical practice guidelines are largely developed from lower levels of evidence or expert opinion. The proportion of recommendations for which there is no conclusive evidence is also growing. These findings highlight the need to improve the process of writing guidelines and to expand the evidence base from which clinical practice guidelines are derived.

PMID: 19244190 [PubMed - indexed for MEDLINE]

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Identifying the effective evidence sources to use in developing Clinical Guidelines for Acute Stroke Management: lived experiences of the search specialist and project manager.

Health Info Libr J. 2009 Mar;26(1):47-55

Authors: Parkhill A, Hill K

Background: The Australian National Stroke Foundation appointed a search specialist to find the best available evidence for the second edition of its Clinical Guidelines for Acute Stroke Management. Objective: To identify the relative effectiveness of differing evidence sources for the guideline update. Methods: We searched and reviewed references from five valid evidence sources for clinical and economic questions: (i) electronic databases; (ii) reference lists of relevant systematic reviews, guidelines, and/or primary studies; (iii) table of contents of a number of key journals for the last 6 months; (iv) internet/grey literature; and (v) experts. Reference sources were recorded, quantified, and analysed. Results: In the clinical portion of the guidelines document, there was a greater use of previous knowledge and sources other than electronic databases for evidence, while there was a greater use of electronic databases for the economic section. Conclusions: The results confirmed that searchers need to be aware of the context and range of sources for evidence searches. For best available evidence, searchers cannot rely solely on electronic databases and need to encompass many different media and sources.

PMID: 19245643 [PubMed - in process]

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European best practice guidelines for cystic fibrosis neonatal screening.

J Cyst Fibros. 2009 Feb 24;

Authors: Castellani C, Southern KW, Brownlee K, Dankert Roelse J, Duff A, Farrell M, Mehta A, Munck A, Pollitt R, Sermet-Gaudelus I, Wilcken B, Ballmann M, Corbetta C, de Monestrol I, Farrell P, Feilcke M, Férec C, Gartner S, Gaskin K, Hammermann J, Kashirskaya N, Loeber G, Macek M, Mehta G, Reiman A, Rizzotti P, Sammon A, Sands D, Smyth A, Sommerburg O, Torresani T, Travert G, Vernooij A, Elborn S

There is wide agreement on the benefits of NBS for CF in terms of lowered disease severity, decreased burden of care, and reduced costs. Risks are mainly associated with disclosure of carrier status and diagnostic uncertainty. When starting a NBS programme for CF it is important to take precautions in order to minimise avoidable risks and maximise benefits. In Europe more than 25 screening programmes have been developed, with quite marked variation in protocol design. However, given the wide geographic, ethnic, and economic variations, complete harmonisation of protocols is not appropriate. There is little evidence to support the use of IRT alone as a second tier, without involving DNA mutation analysis. However, if IRT/DNA testing does not lead to the desired specificity/sensitivity ratio in a population, a screening programme based on IRT/IRT may be used. Sweat chloride concentration remains the gold standard for discriminating between NBS false and true positives, but age-related changes in sweat chloride should be taken into account. CF phenotypes associated with less severe disease often have intermediate or normal sweat chloride concentrations. Programmes should include arrangements for counselling and management of infants where the diagnosis is not clear-cut. All newborns identified by NBS should be managed according to internationally accepted guidelines. CF centre care and the availability of necessary medication are essential prerequisites before the introduction of NBS programmes. Clear explanation to families of the process of screening and of implications of normal and abnormal results is central to the success of CF NBS programmes. Effective communication is especially important when parents are told that their child is affected or is a carrier. When establishing a NBS programme for CF, attention should be given to ensuring timely and appropriate processing of results, to minimise potential stress for families.

PMID: 19246252 [PubMed - as supplied by publisher]

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The EMEA Guideline on First-in-Human Clinical Trials and Its Impact on Pharmaceutical Development.

Toxicol Pathol. 2009 Feb 26;

Authors: Mitlon MN, Horvath CJ

PMID: 19246571 [PubMed - as supplied by publisher]

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Comparison of ICD-10 Diagnostic Guidelines and Research Criteria for Enduring Personality Change after Catastrophic Experience.

Psychopathology. 2009 Feb 27;42(2):113-118

Authors: Beltran RO, Silove D, Llewellyn GM

Enduring personality change after catastrophic experience (EPCACE) is a diagnostic category included in the International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10), as one of the adult personality disorders. Preliminary investigation suggests there is considerable endorsement in principle for this new category amongst experts in the field of intentional human trauma, yet many aspects of the diagnosis remain contentious. EPCACE is described in 2 sets of ICD-10 criteria: the Diagnostic Criteria for Research (DCR) and the Clinical Description and Diagnostic Guidelines (CDDG). Studies have found that the use of the DCR and CDDG for some disorders has created issues related to lack of compatibility and agreement between these 2 versions. This article examines the similarities and differences between the DCR and CDDG for EPCACE. Using background literature to inform our analysis, this article highlights issues related to the stressor criterion, symptom criteria, impairment criterion, criterion related to exclusion of personal vulnerability and early psychiatric history, symptom duration and relationship of post-traumatic-stress disorder with EPCACE. The similarities and differences between the research criteria and diagnostic guidelines of EPCACE are consistent with concerns already identified in the literature for other disorders. This presents a challenge to the way in which diagnostic criteria are conceptualized and stated.

PMID: 19246954 [PubMed - as supplied by publisher]

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Implementing KDOQI CKD definition and staging guidelines in Southern California Kaiser Permanente.

Am J Kidney Dis. 2009 Mar;53(3 Suppl 3):S86-99

Authors: Rutkowski M, Mann W, Derose S, Selevan D, Pascual N, Diesto J, Crooks P

We outline the experience of Southern California Kaiser Permanente, a large integrated health maintenance organization, in implementing the chronic kidney disease (CKD) definition and staging guidelines of the Kidney Disease Outcomes Quality Initiative (KDOQI) from 2002 to 2008, including estimated glomerular filtration rate (eGFR) implementation, algorithm for GFR range assignment and reassignment, and practical modifications of CKD staging for population management. We departed from the KDOQI CKD definition and staging as follows: for stages 1 to 2, we required "macroproteinuria" rather than "microalbuminuria" as the marker of kidney damage; for stage 3, we included individuals with macroproteinuria, diabetes mellitus based on diabetic registry, or eGFR + 1/2 age less than 85; and for stage 5, we included only individuals not receiving renal replacement therapy. In an adult population of 2.5 million members, we identified 2.9% (72,005) for CKD population management (0.1%, 0.2%, 1.7%, 0.15%, and 0.01% with stages 1, 2, 3, 4, and 5, respectively). Outpatient visits with a nephrologist in the past 12 months for the prevalent CKD population increased modestly from 2003 to 2008 from 20% to 24%. Nephrologists see a higher risk subset, including 77% of patients with stages 4 to 5, 45% of prevalent patients with CKD stages 1 to 5 with the last urine protein level greater than approximately 1 g, and 21% of patients with stage 3 in the past 12 months, but only 4% of patients with eGFR of 30 to 59 mL/min/1.73 m(2) not meeting our criteria for stage 3. Primary care providers see the majority of patients with stages 1 to 5 in the course of a year (85%) and are aware of kidney disease (79% coded for kidney disease). Other quality indicators during the 12-month window include the following: for patients with prevalent CKD stages 1 to 5, a total of 56% with last blood pressure greater than 129/79 mm Hg, 21% missing qualitative proteinuria, 16% missing angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, 11% missing low-density lipoprotein cholesterol, 40% with low-density lipoprotein cholesterol level greater than 100 mg/dL, 50% of patients with diabetes with hemoglobin A(1c) level of 7% or greater; for prevalent patients with CKD stages 3 to 5, a total of 14% missing hemoglobin level and 13% with hemoglobin level less than 11 mg/dL; and for prevalent patients with CKD stages 4 to 5, a total of 2.5 hospital d/patient and 62% not attending instructional classes for modalities of renal replacement therapy. Optimal start of end-stage renal disease therapy, defined as the proportion of patients with stages 4 to 5 who either started peritoneal dialysis therapy directly, started hemodialysis therapy using an arteriovenous fistula, or received a preemptive renal transplant, was 54%. Comprehensive CKD care is possible within a large health maintenance organization, but with substantial opportunity for improvement remaining.

PMID: 19231766 [PubMed - in process]

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Blood pressure paradox in patients with non-ST-segment elevation acute coronary syndromes: results from 139,194 patients in the Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the American College of Cardiology/American Heart Association Guidelines (CRUSADE) quality improvement initiative.

Am Heart J. 2009 Mar;157(3):525-31

Authors: Bangalore S, Messerli FH, Ou FS, Tamis-Holland J, Palazzo A, Roe MT, Hong MK, Peterson ED,

BACKGROUND: The relationship between systolic blood pressure (BP) and the risk of cardiovascular events is complex. In patients with chronic coronary artery disease, a J-shaped relationship has been shown, such that there is an increased risk of events both at high and low BP. The current coronary artery disease risk prediction models, however, considers a linear relationship between presenting BP and outcomes in patients presenting with acute coronary syndromes. METHODS: We evaluated 139,194 patients with non-ST-segment elevation acute coronary syndromes in the Can Rapid risk stratification of Unstable anigina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA guidelines (CRUSADE) quality improvement initiative. The presenting systolic BP was summarized as 10-unit increments. Primary outcome was a composite of in-hospital events all-cause mortality, reinfarction, and stroke. Secondary outcomes were each of these outcomes considered separately. RESULTS: From the cohort of 139,194 patients, 9,566 (6.87%) patients had a primary outcome (death/reinfarction or stroke) of which 5,910 (4.25%) patients died, 3,724 (2.68%) patients had reinfarction, and 1,079 (0.78%) patients had a stroke during hospitalization. There was an inverse association between presenting systolic BP and the risk of primary outcome, all-cause mortality, and reinfarction such that there was an exponential increase in the risk with lower presenting systolic BP even after controlling for baseline variables. However, there was no clear relationship between stroke and lower presenting systolic BP. CONCLUSIONS: In contrast to longitudinal impacts, there is a BP paradox on acute outcomes such that a lower presenting BP is associated with increased risk of in-hospital cardiovascular events. These associations should be considered in acute coronary syndrome prognostic models.

PMID: 19249424 [PubMed - in process]

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European guidelines for the certification of professionals in sleep medicine: report of the task force of the European Sleep Research Society.

J Sleep Res. 2009 Mar;18(1):136-41

Authors: Pevernagie D, Stanley N, Berg S, Krieger J, Amici R, Bassetti C, Billiard M, Cirignotta F, Garcia-Borreguero D, Tobler I, Fischer J,

In recent years, sleep medicine has evolved into a full-grown discipline, featuring a multidisciplinary approach to diagnosis and treatment of patients with sleep disorders. Sleep medicine cuts across the boundaries of different conventional disciplines and is therefore open to medical and non-medical professionals with different specialty backgrounds. The aim of the current paper is to introduce a qualification for those professionals whose main occupation is to practice sleep medicine in the setting of a sleep medicine centre. The drafting of guidelines dealing with requirements for such qualification was entrusted to a task force by the European Sleep Research Society. The guidelines are the result of a progressive consensus procedure in which standards were defined for education, training, and evaluation. The final step along this pathway is a theoretical and practical examination, providing proof of proficiency in the field of sleep medicine. This paper describes the object of specific competences, the scope of sleep medicine, and the qualification procedures that pertain to three professional categories: medical specialists, non-medical professionals with a university master degree (such as psychologists and biologists), and nurses and technologists. Indices of preceding practical experience and theoretical knowledge are presented in Appendices 1 and 2. These guidelines are a European standard. They may be adapted in the future according to new scientific insights. National certification programs that comply with these guidelines may be subject to homologation by the ESRS.

PMID: 19250180 [PubMed - in process]

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Use and misuse of the consolidated standards of reporting trials (CONSORT) guidelines to assess research findings: Comment on Coyne, Stefanek, and Palmer (2007).

Psychol Bull. 2009 Mar;135(2):173-8

Authors: Kraemer HC, Kuchler T, Spiegel D

Comments on the article titled Psychotherapy and survival in cancer: The conflict between hope and evidence by J. C. Coyne, M. Stefanek, and S. C. Palmer.The basic principles underlying randomized clinical trials have been known for more than 50 years. The Consolidated Standards of Reporting Trials (CONSORT) guidelines, published in 1996 and based on those principles, are a valuable guide to what needs to be reported from any trial within word-limit constraints, but they do not provide guidelines to the decisions that have to be made to generate a trial with credible results. Using these guidelines as do J. C. Coyne, M. Stefanek, and S. C. Palmer (2007) is a misinterpretation of their purpose. Furthermore, Coyne et al. misrepresented the methods and findings of studies of the effects of psychosocial intervention on cancer survival. These errors are systematically reviewed. The results of these questionable analyses led Coyne et al. to recommend stopping research in an area that may be highly productive. Recent developments in the field are summarized. It is a mistaken and dangerous conclusion to declare this or other areas of scientific research off limits. (PsycINFO Database Record (c) 2009 APA, all rights reserved).

PMID: 19254073 [PubMed - in process]

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Misinterpretation of Evidence Synthesis and ASIPP Guidelines by Chou.

Pain Med. 2009 Feb 25;

Authors: Boswell M, Abdi S, Manchikanti L

PMID: 19254340 [PubMed - as supplied by publisher]

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