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Survival rates of extremely preterm infants (gestational age < 26 weeks) in Switzerland: impact of the Swiss guidelines for the care of infants born at the limit of viability.

Arch Dis Child Fetal Neonatal Ed. 2009 Apr 8;

Authors: Fischer N, Steurer MA, Adams M, Berger TM

BACKGROUND: Because ethical decision making in the care of extremely preterm infants varies widely across Europe, the Swiss Society of Neonatology decided to publish its own guidelines on the care of infants born at the limit of viability in 2002. OBJECTIVE: To examine the potential impact of the guidelines on survival rates, short-term complication rates and center-to-center (CTC) outcome differences of extremely preterm infants (22-25 completed weeks). DESIGN: Population-based, retrospective cohort study. SETTING: All 9 level III neonatal intensive care units (NICU) and affiliated pediatric hospitals in Switzerland. PATIENTS: 516 extremely preterm infants born alive between January 1, 2000 and December 31, 2004. MAIN OUTCOME MEASURES: Delivery room (DR) and NICU mortality rates, survival to hospital discharge and incidence of short-term complications in survivors were assessed. To study the impact of the guidelines, two cohorts from two different time periods were compared (years 2000/2001, n=220; years 2003/2004, n=204) whereas patients born in the year of the publication (2002, n=92) were excluded. For CTC comparisons, the entire population (n=516) was analyzed. RESULTS: There was a significant increase in survival rates of extremely preterm infants from 31% to 40% (RR 1.24, 95% CI 1.02,1.50) after the publication of the Swiss guidelines. This improvement was largely explained by significantly improved survival from 42% to 60% (p = 0.01) among infants born at 25 completed weeks because of decreased NICU mortality. Improved survival was not associated with statistically significant changes in the incidence of short-term complications. Despite national guidelines, considerable CTC outcome differences have persisted. CONCLUSIONS: The publication of the Swiss guidelines was followed by significantly improved survival of extremely preterm infants but had no impact on CTC differences.

PMID: 19357122 [PubMed - as supplied by publisher]

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Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline.

Spine. 2009 May 1;34(10):1094-109

Authors: Chou R, Baisden J, Carragee EJ, Resnick DK, Shaffer WO, Loeser JD

STUDY DESIGN: Systematic review. OBJECTIVE: To systematically assess benefits and harms of surgery for nonradicular back pain with common degenerative changes, radiculopathy with herniated lumbar disc, and symptomatic spinal stenosis. SUMMARY OF BACKGROUND DATA: Although back surgery rates continue to increase, there is uncertainty or controversy about utility of back surgery for various conditions. METHODS: Electronic database searches on Ovid MEDLINE and the Cochrane databases were conducted through July 2008 to identify randomized controlled trials and systematic reviews of the above therapies. All relevant studies were methodologically assessed by 2 independent reviewers using criteria developed by the Cochrane Back Review Group (for trials) and Oxman (for systematic reviews). A qualitative synthesis of results was performed using methods adapted from the US Preventive Services Task Force. RESULTS: For nonradicular low back pain with common degenerative changes, we found fair evidence that fusion is no better than intensive rehabilitation with a cognitive-behavioral emphasis for improvement in pain or function, but slightly to moderately superior to standard (nonintensive) nonsurgical therapy. Less than half of patients experience optimal outcomes (defined as no more than sporadic pain, slight restriction of function, and occasional analgesics) following fusion. Clinical benefits of instrumented versus noninstrumented fusion are unclear. For radiculopathy with herniated lumbar disc, we found good evidence that standard open discectomy and microdiscectomy are moderately superior to nonsurgical therapy for improvement in pain and function through 2 to 3 months. For symptomatic spinal stenosis with or without degenerative spondylolisthesis, we found good evidence that decompressive surgery is moderately superior to nonsurgical therapy through 1 to 2 years. For both conditions, patients on average experience improvement either with or without surgery, and benefits associated with surgery decrease with long-term follow-up in some trials. Although there is fair evidence that artificial disc replacement is similarly effective compared to fusion for single level degenerative disc disease and that an interspinous spacer device is superior to nonsurgical therapy for 1- or 2-level spinal stenosis with symptoms relieved with forward flexion, insufficient evidence exists to judge long-term benefits or harms. CONCLUSION: Surgery for radiculopathy with herniated lumbar disc and symptomatic spinal stenosis is associated with short-term benefits compared to nonsurgical therapy, though benefits diminish with long-term follow-up in some trials. For nonradicular back pain with common degenerative changes, fusion is no more effective than intensive rehabilitation, but associated with small to moderate benefits compared to standard nonsurgical therapy.

PMID: 19363455 [PubMed - in process]

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Nonsurgical interventional therapies for low back pain: a review of the evidence for an american pain society clinical practice guideline.

Spine. 2009 May 1;34(10):1078-93

Authors: Chou R, Atlas SJ, Stanos SP, Rosenquist RW

STUDY DESIGN: Systematic review. OBJECTIVE: To systematically assess benefits and harms of nonsurgical interventional therapies for low back and radicular pain. SUMMARY OF BACKGROUND DATA: Although use of certain interventional therapies is common or increasing, there is also uncertainty or controversy about their efficacy. METHODS: Electronic database searches on Ovid MEDLINE and the Cochrane databases were conducted through July 2008 to identify randomized controlled trials and systematic reviews of local injections, botulinum toxin injection, prolotherapy, epidural steroid injection, facet joint injection, therapeutic medial branch block, sacroiliac joint injection, intradiscal steroid injection, chemonucleolysis, radiofrequency denervation, intradiscal electrothermal therapy, percutaneous intradiscal radiofrequency thermocoagulation, Coblation nucleoplasty, and spinal cord stimulation. All relevant studies were methodologically assessed by 2 independent reviewers using criteria developed by the Cochrane Back Review Group (for trials) and by Oxman (for systematic reviews). A qualitative synthesis of results was performed using methods adapted from the US Preventive Services Task Force. RESULTS: For sciatica or prolapsed lumbar disc with radiculopathy, we found good evidence that chemonucleolysis is moderately superior to placebo injection but inferior to surgery, and fair evidence that epidural steroid injection is moderately effective for short-term (but not long-term) symptom relief. We found fair evidence that spinal cord stimulation is moderately effective for failed back surgery syndrome with persistent radiculopathy, though device-related complications are common. We found good or fair evidence that prolotherapy, facet joint injection, intradiscal steroid injection, and percutaneous intradiscal radiofrequency thermocoagulation are not effective. Insufficient evidence exists to reliably evaluate other interventional therapies. CONCLUSION: Few nonsurgical interventional therapies for low back pain have been shown to be effective in randomized, placebo-controlled trials.

PMID: 19363456 [PubMed - in process]

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Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society.

Spine. 2009 May 1;34(10):1066-77

Authors: Chou R, Loeser JD, Owens DK, Rosenquist RW, Atlas SJ, Baisden J, Carragee EJ, Grabois M, Murphy DR, Resnick DK, Stanos SP, Shaffer WO, Wall EM,

STUDY DESIGN: Clinical practice guideline. OBJECTIVE: To develop evidence-based recommendations on use of interventional diagnostic tests and therapies, surgeries, and interdisciplinary rehabilitation for low back pain of any duration, with or without leg pain. SUMMARY OF BACKGROUND DATA: Management of patients with persistent and disabling low back pain remains a clinical challenge. A number of interventional diagnostic tests and therapies and surgery are available and their use is increasing, but in some cases their utility remains uncertain or controversial. Interdisciplinary rehabilitation has also been proposed as a potentially effective noninvasive intervention for persistent and disabling low back pain. METHODS: A multidisciplinary panel was convened by the American Pain Society. Its recommendations were based on a systematic review that focused on evidence from randomized controlled trials. Recommendations were graded using methods adapted from the US Preventive Services Task Force and the Grading of Recommendations, Assessment, Development, and Evaluation Working Group. RESULTS: Investigators reviewed 3348 abstracts. A total of 161 randomized trials were deemed relevant to the recommendations in this guideline. The panel developed a total of 8 recommendations. CONCLUSION: Recommendations on use of interventional diagnostic tests and therapies, surgery, and interdisciplinary rehabilitation are presented. Due to important trade-offs between potential benefits, harms, costs, and burdens of alternative therapies, shared decision-making is an important component of a number of the recommendations.

PMID: 19363457 [PubMed - in process]

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Impact of a multifaceted intervention on cholesterol management in primary care practices: guideline adherence for heart health randomized trial.

Arch Intern Med. 2009 Apr 13;169(7):678-86

Authors: Bertoni AG, Bonds DE, Chen H, Hogan P, Crago L, Rosenberger E, Barham AH, Clinch CR, Goff DC

BACKGROUND: Physician adherence to National Cholesterol Education Program clinical practice guidelines has been poor. METHODS: We recruited 68 primary care family and internal medicine practices; 66 were randomly allocated to a study arm; 5 practices withdrew, resulting in 29 receiving the Third Adult Treatment Panel (ATP III) intervention and 32 receiving an alternative intervention focused on the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-7). The ATP III providers received a personal digital assistant providing the Framingham risk scores and ATP III-recommended treatment. All practices received copies of each clinical practice guideline, an introductory lecture, 1 performance feedback report, and 4 visits for intervention-specific academic detailing. Data were abstracted at 61 practices from random samples of medical records of patients treated from June 1, 2001, through May 31, 2003 (baseline), and from May 1, 2004, through April 30, 2006 (follow-up). The proportion screened with subsequent appropriate decision making (primary outcome) was calculated. Generalized estimating equations were used to compare results by arm, accounting for clustering of patients within practices. RESULTS: We examined 5057 baseline and 3821 follow-up medical records. The screening rate for lipid levels increased from 43.6% to 49.0% (ATP III practices) and from 40.1% to 50.8% (control practices) (net difference, -5.3% [P = .22]). Appropriate management of lipid levels decreased slightly (73.4% to 72.3%) in ATP III practices and more markedly (79.7% to 68.9%) in control practices. The net change in appropriate management favored the intervention (+9.7%; 95% confidence interval [CI], 2.8%-16.6% [P < .01]). Appropriate drug prescription within 4 months decreased in both arms (38.8% to 24.8% in ATP III practices and 45.3% to 24.1% in control practices; net change, +7.2% [P = .37]) Overtreatment declined from 6.6% to 3.9% in ATP III and rose from 4.2% to 6.4% in control practices (net change, -4.9% [P = .01]). CONCLUSIONS: A multifactor intervention including personal digital assistant-based decision support may improve primary care physician adherence to the ATP III guidelines. Trial Registration clinicaltrials.gov Identifier: NCT00224848.

PMID: 19364997 [PubMed - indexed for MEDLINE]

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Evidence-based nutrition guidelines for critically ill adults.

JAMA. 2009 Apr 15;301(15):1543; author reply 1543-4

Authors: Finucane TE

PMID: 19366773 [PubMed - indexed for MEDLINE]

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Guidelines for the provision and assessment of nutrition support therapy in the adult critically ill patient: Society of Critical Care Medicine and American Society for Parenteral and Enteral Nutrition: Executive Summary.

Crit Care Med. 2009 May;37(5):1757-61

Authors: Martindale RG, McClave SA, Vanek VW, McCarthy M, Roberts P, Taylor B, Ochoa JB, Napolitano L, Cresci G, ,

PMID: 19373044 [PubMed - indexed for MEDLINE]

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A parallel guideline development and formalization strategy to improve the quality of clinical practice guidelines.

Int J Med Inform. 2009 Apr 16;

Authors: Goud R, Hasman A, Strijbis AM, Peek N

PURPOSE: Clinical practice guidelines often contain ambiguities, inconsistencies, and logical errors that hamper implementation of these guidelines in practice. As guideline formalization is useful to verify the logical structure, consistency, and completeness of guidelines, several authors have argued that the formalization of guidelines concurrent with their development may improve their quality. However, experiences with such a parallel guideline development and formalization approach have not yet been reported. The goal of this study was to develop such a strategy and evaluate its application in practice. METHODS: Existing methodologies for guideline development and guideline formalization were analyzed and used as a basis to develop a strategy in which guideline formalization is performed concurrently with guideline development. The developed strategy was applied in the development of a clinical practice guideline for cardiac rehabilitation. RESULTS: A parallel guideline development and formalization strategy was developed that intertwines the processes of guideline development and guideline formalization. Central assets are early involvement of guideline formalization specialists and formalization tools, cooperation between guideline authors and guideline formalization specialists in the development of clinical algorithms, access to domain knowledge when formalization identifies inconsistencies or omissions, and formal verification of the guideline model prior to guideline dissemination. This strategy was applied in the development of a guideline for cardiac rehabilitation and helped to identify several vague and inconsistent recommendations and impracticabilities in the narrative guidelines that could be resolved before publication. In addition, the strategy ensured consistency between the narrative and formalized guideline. CONCLUSIONS: Based on our experience, formalizing a guideline concurrent with its development is feasible in practice and we recommend applying such a strategy as it can be beneficial to the quality of and consistency between the guideline’s narrative and formalized version.

PMID: 19375977 [PubMed - as supplied by publisher]

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Treatment of Metastatic Breast Cancer: A Large Observational Study on Adherence to French Prescribing Guidelines and Financial Cost of the Anti-HER2 Antibody Trastuzumab.

Am J Clin Oncol. 2009 Apr 17;

Authors: Poncet B, Colin C, Bachelot T, Jaisson-Hot I, Derain L, Magaud L, Fournel-Federico C, Mousseau M, Tigaud JD, Jacquin JP, Trillet-Lenoir V

OBJECTIVE:: This observational study aimed at analyzing adherence to prescribing guidelines of anti-HER2 monoclonal antibody trastuzumab treatment for metastatic breast cancer. Efficacy and costs were also evaluated. METHODS:: The adherence to the trastuzumab treatment plan was analyzed according to both the French postlicensing guidelines published in 2001 and clinical guidelines from the regional cancer network in a cohort of 131 consecutive patients. RESULTS:: The level of appropriateness to the molecular target was very high (92% of the patients showed a positive HER2 status, defined as HER2 3+ confirmed by immunohistochemistry or 2+ confirmed by fluorescent in situ hybridization). The treatment plan was made according to the French postlicensing guidelines in 41 patients (31.3%) and to the regional clinical guidelines for 109 patients (83.2%). The main reason for the difference was the type of molecules authorized for combination to trastuzumab. The median overall survival of the studied population was 18.6 months and the median progression-free survival rate was 7.7 months. Up to death or end of the study, the overall cost for the treatment of breast cancer with trastuzumab per patient and per year was &OV0556;47,832. CONCLUSION:: This quite low adherence of clinicians to the French postlicensing guidelines is in contrast with the high level of adherence to the regional clinical guidelines. The reason is that the latter are less rigid about previously received treatments and enlarge the potential associated cytotoxics to vinorelbine. This supports the French National Cancer Institute decision to get expert clinicians involved together with the French agency for sanitary security of health products and the high health authority in a common elaboration of guidelines.

PMID: 19381078 [PubMed - as supplied by publisher]

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Beyond the guidelines: where evidence ends and the frontier begins.

Curr Opin Cardiol. 2009 May;24(3):221-2

Authors: Feldman DS

PMID: 19384092 [PubMed - in process]

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