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Get With the Guidelines-Stroke is associated with sustained improvement in care for patients hospitalized with acute stroke or transient ischemic attack.

Circulation. 2009 Jan 6;119(1):107-15

Authors: Schwamm LH, Fonarow GC, Reeves MJ, Pan W, Frankel MR, Smith EE, Ellrodt G, Cannon CP, Liang L, Peterson E, Labresh KA

BACKGROUND: Adherence to evidence-based guidelines for treatment of stroke or transient ischemic attack is suboptimal. We sought to establish whether participation in Get With the Guidelines-Stroke was associated with improvements in adherence. METHODS AND RESULTS: This prospective, nonrandomized, national quality improvement program measured adherence to guideline recommendations in 322 847 hospitalized patients discharged with a diagnosis of ischemic stroke or transient ischemic attack. A volunteer sample of 790 US academic and community hospitals participated from 2003 through 2007. The main outcome measures were change in adherence over time to 7 prespecified performance measures and a composite measure (total number of interventions provided in eligible patients divided by total number of care opportunities among eligible patients). Generalized estimating equations were used to identify factors associated with improvement. Participation in Get With the Guidelines-Stroke was associated with improvements in the 7 individual and 1 composite measures from baseline to the fifth year: intravenous thrombolytics (42.09% versus 72.84%), early antithrombotics (91.46% versus 97.04%), deep vein thrombosis prophylaxis (73.79% versus 89.54%), discharge antithrombotics (95.68% versus 98.88%), anticoagulation for atrial fibrillation (95.03% versus 98.39%), lipid treatment for low-density lipoprotein >100 mg/dL (73.63% versus 88.29%), smoking cessation (65.21% versus 93.61%), and composite (83.52% versus 93.97%) (P<0.0001 for all comparisons). Multivariate analysis showed that time in Get With the Guidelines-Stroke was associated with a 1.18-fold yearly increase in the odds of fulfilling care opportunities that was independent of secular trends. CONCLUSIONS: Get With the Guidelines-Stroke participation was associated with increased adherence to all stroke performance measures. Markedly improved stroke care was seen in all hospitals regardless of size, geography, and teaching status.

PMID: 19075103 [PubMed - in process]

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A mixed methods pilot study with a cluster randomized control trial to evaluate the impact of a leadership intervention on guideline implementation in home care nursing.

Implement Sci. 2008 Dec 10;3(1):51

Authors: Gifford WA, Davies B, Graham ID, Lefebre N, Tourangeau A, Woodend K

ABSTRACT: BACKGROUND: Foot ulcers are a significant problem for people with diabetes. Comprehensive assessments of risk factors associated with diabetic foot ulcer are recommended in clinical guidelines to decrease complications such as prolonged healing, gangrene and amputations, and to promote effective management. However, the translation of clinical guidelines into nursing practice remains fragmented and inconsistent, and a recent homecare chart audit showed less than half the recommended risk factors for diabetic foot ulcers were assessed, and peripheral neuropathy (the most significant predictor of complications) was not assessed at all. Strong leadership is consistently described as significant to successfully transfer guidelines into practice. Limited research exists however regarding which leadership behaviours facilitate and support implementation in nursing. The purpose of this pilot study is to evaluate the impact of a leadership intervention in community nursing on implementing recommendations from a clinical guideline on the nursing assessment and management of diabetic foot ulcers. METHODS: Two phase mixed methods design is proposed (ISRCTN 12345678). Phase I: Descriptive qualitative to understand barriers to implementing the guideline recommendations, and to inform the intervention. Phase II: Matched pair cluster randomized controlled trial (n=4 centers) will evaluate differences in outcomes between two implementation strategies. Primary outcome: Nursing assessments of client risk factors, a composite score of 8 items based on Diabetes/Foot Ulcer guideline recommendations. Intervention: In addition to the organization's 'usual' implementation strategy, a 12 week leadership strategy will be offered to managerial and clinical leaders consisting of: a) printed materials, b) one day interactive workshop to develop a leadership action plan tailored to barriers to support implementation; c) three post-workshop teleconferences. DISCUSSION: This study will provide vital information on which leadership strategies are well received to facilitate and support guideline implementation. The anticipated outcomes will provide information to assist with effective management of foot ulcers for people with diabetes. By tracking clinical outcomes associated with guideline implementation, health care administrators will be better informed to influence organizational and policy decision-making to support evidence-based quality care. Findings will be useful to inform the design of future multi-centered trials on various clinical topics to enhance knowledge translation for positive outcomes.

PMID: 19077199 [PubMed - as supplied by publisher]

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Acute coronary syndrome emergency treatment strategies: Improved treatment and reduced mortality in patients with acute coronary syndrome using guideline-based critical care pathways.

Am Heart J. 2009 Jan;157(1):61-8

Authors: Corbelli JC, Janicke DM, Cziraky MJ, Hoy TA, Corbelli JA

BACKGROUND: An acute coronary syndrome (ACS) emergency treatment strategies (ACSETS) critical care pathway (CCP), embedding guideline-based treatment, was evaluated in a 4-hospital system in Buffalo, NY, for its impact on ACS drug utilization, length of stay, and mortality. METHODS: The study used an observational design comparing pre- (n = 1,240) and post- (n = 1,709) ACSETS implementation cohorts followed over 1 year. Both myocardial infarction (MI) (59%) and unstable angina (UA) (41%) patients were studied. Multivariate regression analysis was used to analyze possible differences in major end points. RESULTS: Appropriate ACS medication use was significantly higher in the ACSETS group in the first 24 hours and at discharge. In a subgroup of managed care health insurance patients (n = 884 ), prescription refills for statins, beta-blockers, angiotensin-converting enzyme inhibitors, and clopidogrel were significantly greater in the ACSETS group up to and including 7 months after discharge, although at 7 months, actual refill rate was poor (30%-50%) for both groups. Length of stay was significantly reduced (HR 0.82 [0.72-0.90]). Inpatient mortality was not significantly reduced. One-year adjusted mortality was reduced significantly compared to non-ACSETS in the MI group (by 19%) (HR 0.81 [0.66-0.99]) but not in the UA group (HR 1.13 [0.71-1.79]). CONCLUSIONS: ACSETS contributes to the proof of concept of critical care pathway (CCP) improvement of ACS care, as revealed by increased acute and chronic evidence-based use of medication, decreased length of stay, and, in the case of MI patients, decreased adjusted 1-year mortality. One-year mortality benefit was observed in MI but not UA patients.

PMID: 19081398 [PubMed - in process]

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[Practice guideline for breast cancer rehabilitation from the perspective of the rehabilitation centres: findings of a user survey on acceptance and practicability of the pilot version.]

Rehabilitation (Stuttg). 2008 Dec;47(6):334-42

Authors: Winnefeld M, Brüggemann S

BACKGROUND: The pilot phase of the rehabilitation guideline for patients with breast cancer of the German Pension Fund was accompanied by a user survey. This survey allowed oncological rehabilitation centres to comment on the guideline and to suggest changes. METHODS: In the autumn of 2007 a total of 57 oncological rehabilitation centres treating a minimum of 50 patients with breast cancer (ICD-10: C50) annually were contacted with a written survey. The questionnaire was accompanied by an overview of performance data according to the KTL (Classification of Therapeutic Procedures) from 2006 allowing to determine the degree of adherence to the guideline’s requirements. RESULTS: Between 75% and 95% of the respondents agree that the rehabilitation guideline for breast cancer fulfils the quality attributes “scientific foundation (evidence)”, “relevance for day-to-day work”, “up-to-dateness”, and “inter- and multidisciplinary development”. 65% consider the guideline’s comprehensiveness as “adequate” and structure and clarity as “rather to very structured”. The individual chapters and treatment modules are “rather to very comprehensible” for 68% to 100%. Further information is needed especially with regard to “methodological overview”, “information on the guideline’s integration into the Pension Insurance’s quality assurance programme”, “scope” and “minimum percentage of patients requiring such treatment”. Between 70% and 85% consider the KTL codes suggested to sufficiently represent the therapeutic contents of the treatment modules. 20% to 68% agree with the guideline’s requirements regarding the “minimum percentage of patients requiring such treatment”. In 7 of a total of 15 treatment modules the requirements are considered “adequate”. The main reasons for insufficient adherence to the guideline’s requirements are coding problems, as well as a high treatment volume and shortage of staff. The implementation of the guideline for the rehabilitation of patients with breast cancer raises positive and negative expectations. DISCUSSION: The discussion centers around the normative standards regarding the minimum percentage of patients requiring such treatment that is considered too high in many modules. However, suggestions to alter the treatment requirements are at times quite heterogeneous. Coding problems should not be overrated as the performance data so far available date back to a period prior to introduction of the new KTL 2007. CONCLUSION: At the end of the pilot phase the guideline will be revised where necessary, taking the rehabilitation centres’ feedback into account. The Pension Insurance considers the guideline for the rehabilitation of patients with breast cancer an important addition to the quality assurance programme. According to the survey’s results the guideline is generally accepted and realisable.

PMID: 19085794 [PubMed - in process]

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Evaluation and Management of Adult Hypoglycemic Disorders: An Endocrine Society Clinical Practice Guideline.

J Clin Endocrinol Metab. 2008 Dec 16;

Authors: Cryer PE, Axelrod L, Grossman AB, Heller SR, Montori VM, Seaquist ER, Service FJ

Objective: To provide guidelines for the evaluation and management of adults with hypoglycemic disorders including those with diabetes mellitus. Evidence: Using the recommendations of the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) group, the quality of evidence is graded very low ( plus sign in circle OOO), low ( plus sign in circle plus sign in circle OO), moderate ( plus sign in circle plus sign in circle plus sign in circle O) or high ( plus sign in circle plus sign in circle plus sign in circle plus sign in circle). Summary of Recommendations: We recommend evaluation and management of hypoglycemia only in patients in whom Whipple's triad - symptoms, signs, or both consistent with hypoglycemia, a low plasma glucose concentration, and resolution of those symptoms or signs after the plasma glucose concentration is raised - is documented. In patients with hypoglycemia without diabetes mellitus we recommend the following strategy: First, pursue clinical clues to potential hypoglycemic etiologies - drugs, critical illnesses, hormone deficiencies, nonislet cell tumors. In the absence of these causes, the differential diagnosis narrows to accidental, surreptitious, or even malicious hypoglycemia or endogenous hyperinsulinism. In patients suspected of having endogenous hyperinsulinism, measure plasma glucose, insulin, C-peptide, proinsulin, beta-hydroxybutyrate, and circulating oral hypoglycemic agents during an episode of hypoglycemia and measure insulin antibodies. Insulin or insulin secretagogue treatment of diabetes mellitus is the most common cause of hypoglycemia. We recommend the practice of hypoglycemia risk factor reduction-addressing the issue of hypoglycemia, applying the principles of intensive glycemic therapy, and considering both the conventional risk factors and those indicative of compromised defenses against falling plasma glucose concentrations - in persons with diabetes.

PMID: 19088155 [PubMed - as supplied by publisher]

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Effect of evidence-based feeding guidelines on mortality of critically ill adults: a cluster randomized controlled trial.

JAMA. 2008 Dec 17;300(23):2731-41

Authors: Doig GS, Simpson F, Finfer S, Delaney A, Davies AR, Mitchell I, Dobb G,

CONTEXT: Evidence demonstrates that providing nutritional support to intensive care unit (ICU) patients within 24 hours of ICU admission reduces mortality. However, early feeding is not universally practiced. Changing practice in complex multidisciplinary environments is difficult. Evidence supporting whether guidelines can improve ICU feeding practices and patient outcomes is contradictory. OBJECTIVE: To determine whether evidence-based feeding guidelines, implemented using a multifaceted practice change strategy, improve feeding practices and reduce mortality in ICU patients. DESIGN, SETTING, AND PATIENTS: Cluster randomized trial in ICUs of 27 community and tertiary hospitals in Australia and New Zealand. Between November 2003 and May 2004, 1118 critically ill adult patients expected to remain in the ICU longer than 2 days were enrolled. All participants completed the study. INTERVENTIONS: Intensive care units were randomly assigned to guideline or control groups. Guideline ICUs developed an evidence-based guideline using Browman's Clinical Practice Guideline Development Cycle. A practice-change strategy composed of 18 specific interventions, leveraged by educational outreach visits, was implemented in guideline ICUs. MAIN OUTCOME MEASURES: Hospital discharge mortality. Secondary outcomes included ICU and hospital length of stay, organ dysfunction, and feeding process measures. RESULTS: Guideline and control ICUs enrolled 561 and 557 patients, respectively. Guideline ICUs fed patients earlier (0.75 vs 1.37 mean days to enteral nutrition start; difference, -0.62 [95% confidence interval {CI}, -0.82 to -0.36]; P < .001 and 1.04 vs 1.40 mean days to parenteral nutrition start; difference, -0.35 [95% CI, -0.61 to -0.01]; P = .04) and achieved caloric goals more often (6.10 vs 5.02 mean days per 10 fed patient-days; difference, 1.07 [95% CI, 0.12 to 2.22]; P = .03). Guideline and control ICUs did not differ with regard to hospital discharge mortality (28.9% vs 27.4%; difference, 1.4% [95% CI, -6.3% to 12.0%]; P = .75) or to hospital length of stay (24.2 vs 24.3 days; difference, -0.08 [95% CI, -3.8 to 4.4]; P = .97) or ICU length of stay (9.1 vs 9.9 days; difference, -0.86 [95% CI, -2.6 to 1.3]; P = .42). CONCLUSIONS: Using a multifaceted practice change strategy, ICUs successfully developed and introduced an evidence-based nutritional support guideline that promoted earlier feeding and greater nutritional adequacy. However, use of the guideline did not improve clinical outcomes. Trial Registration anzctr.org.au Identifier: ACTRN12608000407392.

PMID: 19088351 [PubMed - indexed for MEDLINE]

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Implementing nutrition guidelines in the critical care setting: a worthwhile and achievable goal?

JAMA. 2008 Dec 17;300(23):2798-9

Authors: Jones NE, Heyland DK

PMID: 19088358 [PubMed - indexed for MEDLINE]

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Meeting the 60-min physical activity guideline: effect of operationalization.

Med Sci Sports Exerc. 2009 Jan;41(1):81-6

Authors: De Vries SI, Hopman-Rock M, Bakker I, Van Mechelen W

PURPOSE: To investigate the effect of guideline operationalization in terms of intensity threshold, bout duration, and days on the proportion of children meeting the health-related 60-min physical activity guideline using a subjective and an objective assessment method. METHODS: Five hundred and twenty-one children (6-11 yr) completed a physical activity diary for at least 4 d. A subsample of 51 children simultaneously wore an ActiGraph (ActiGraph, Pensacola, FL) accelerometer. Time spent above moderate-intensity thresholds of 3 and 5 METs, respectively, for continuous bouts of at least 1, 5, and 10 min was calculated. For each intensity threshold and bout duration, the proportion of children meeting the 60-min guideline was calculated. A distinction was made between meeting the 60-min threshold on each assessment day and meeting this threshold on average across all assessment days. RESULTS: The proportion of children meeting the 60-min guideline differed considerably by guideline operationalization and assessment method. It ranged from 3% to 86% using the diary and from 0% to 100% using the ActiGraph. Overall, a higher proportion of children met the guideline when the 3-MET intensity threshold was used compared with the 5-MET threshold and when a shorter bout duration was used compared with a longer bout duration. More children met the guideline on average across all assessment days compared with the guideline on each assessment day. In general, boys were found to be more active than girls, independent of guideline operationalization and assessment method. CONCLUSION: Meeting the 60-min guideline highly depends on guideline operationalization and assessment method. Consensus about how the guideline should be operationalized is needed to monitor the extent to which populations of children meet the guideline and to simplify comparison between studies.

PMID: 19092704 [PubMed - in process]

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[Adherence to national guidelines for lipid management in a department of endocrinology.]

Ann Endocrinol (Paris). 2008 Dec 16;

Authors: Chiche F, Giral P, Bourdillon F, Bruckert E

Objectives.- National guidelines for lipid management have been updated in March 2005 by the French Health Products Safety Agency (Afssaps). The objective of this study was to assess clinical practices based on these recommendations in a department of endocrinology specialized in the management of dyslipidemic patients. Materials and methods.- A sample of patients was independently selected among those referred to our outpatient clinic for assessment of hyperlipidemia. We analyzed retrospectively whether the management of dyslipidemia in these patients was consistent with national guidelines. Results.- We included 62 patients. At admission, 61% of patients had a lipid-lowering treatment that was consistent with the guidelines and a LDL-cholesterol value below the target level. At discharge, the lipid-lowering treatment was modified in 27% of patients. The changes were consistent with Afssaps guidelines in 79% of patients. Cases of non-compliance with the guidelines were explained by a lower threshold of LDL-cholesterol target in patients with carotid plaques and no changes because LDL-cholesterol was just above the LDL-cholesterol target. Conclusion.- Lipid management was consistent with Afssaps guidelines in a majority of patients. However, this study emphasized unresolved problems in lipid management, such as the question of integrating arterial status in the therapeutic decision.

PMID: 19095217 [PubMed - as supplied by publisher]

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New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).

Eur J Cancer. 2009 Jan;45(2):228-47

Authors: Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J

BACKGROUND: Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics: both tumour shrinkage (objective response) and disease progression are useful endpoints in clinical trials. Since RECIST was published in 2000, many investigators, cooperative groups, industry and government authorities have adopted these criteria in the assessment of treatment outcomes. However, a number of questions and issues have arisen which have led to the development of a revised RECIST guideline (version 1.1). Evidence for changes, summarised in separate papers in this special issue, has come from assessment of a large data warehouse (>6500 patients), simulation studies and literature reviews. HIGHLIGHTS OF REVISED RECIST 1.1: Major changes include: Number of lesions to be assessed: based on evidence from numerous trial databases merged into a data warehouse for analysis purposes, the number of lesions required to assess tumour burden for response determination has been reduced from a maximum of 10 to a maximum of five total (and from five to two per organ, maximum). Assessment of pathological lymph nodes is now incorporated: nodes with a short axis of 15 mm are considered measurable and assessable as target lesions. The short axis measurement should be included in the sum of lesions in calculation of tumour response. Nodes that shrink to <10mm short axis are considered normal. Confirmation of response is required for trials with response primary endpoint but is no longer required in randomised studies since the control arm serves as appropriate means of interpretation of data. Disease progression is clarified in several aspects: in addition to the previous definition of progression in target disease of 20% increase in sum, a 5mm absolute increase is now required as well to guard against over calling PD when the total sum is very small. Furthermore, there is guidance offered on what constitutes 'unequivocal progression' of non-measurable/non-target disease, a source of confusion in the original RECIST guideline. Finally, a section on detection of new lesions, including the interpretation of FDG-PET scan assessment is included. Imaging guidance: the revised RECIST includes a new imaging appendix with updated recommendations on the optimal anatomical assessment of lesions. FUTURE WORK: A key question considered by the RECIST Working Group in developing RECIST 1.1 was whether it was appropriate to move from anatomic unidimensional assessment of tumour burden to either volumetric anatomical assessment or to functional assessment with PET or MRI. It was concluded that, at present, there is not sufficient standardisation or evidence to abandon anatomical assessment of tumour burden. The only exception to this is in the use of FDG-PET imaging as an adjunct to determination of progression. As is detailed in the final paper in this special issue, the use of these promising newer approaches requires appropriate clinical validation studies.

PMID: 19097774 [PubMed - in process]

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