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[S3-guidelines--sedation in gastrointestinal endoscopy]
Z Gastroenterol. 2008 Nov;46(11):1298-330
Authors: Riphaus A, Wehrmann T, Weber B, Arnold J, Beilenhoff U, Bitter H, von Delius S, Domagk D, Ehlers AF, Faiss S, Hartmann D, Heinrichs W, Hermans ML, Hofmann C, In der Smitten S, Jung M, Kähler G, Kraus M, Martin J, Meining A, Radke J, Rösch T, Seifert H, Sieg A, Wigginghaus B, Kopp I, , , , , , ,
PMID: 19012203 [PubMed - in process]
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Freitag, 12. Dezember 2008
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[Guidelines for long-term oxygen therapy. German society for pneumology and respirator medicine]
Pneumologie. 2008 Dec;62(12):748-56
Authors: Magnussen H, Kirsten AM, Köhler D, Morr H, Sitter H, Worth H
PMID: 19012226 [PubMed - in process]
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Freitag, 12. Dezember 2008
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Patient-reported outcomes: Assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency.
Eur J Cancer. 2008 Nov 13;
Authors: Bottomley A, Jones D, Claassens L
AIMS: Patient-reported outcomes (PROs) have recently gained greater credibility with regulatory bodies aiming to standardise their use and interpretation in RCTs, thereby supporting medicinal product submissions. For this reason, the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) have released guidelines. This review paper provides an overview of the current perspectives and views on these guidelines. METHOD: To evaluate the FDA and EMEA PRO guidelines, 47 expert responses to the FDA guidance were qualitatively reviewed. Two reviewers independently extracted data from these letters and checked these responses to warrant consistency and agreement in the evaluation process. A PubMed literature review was systematically examined to obtain supporting evidence or related articles for both the guidance documents. RESULTS: Generally, there is agreement between regulatory authorities and the research community on the contents of the FDA and EMEA PRO draft guidance. However, disagreements exist on significant philosophical topics (e.g. the FDA focuses more on conceptual models and symptoms than the EMEA) and design topics (e.g. the FDA is more restrictive on issues of recall bias, blinding of oncology trials and degrees of psychometric validation than researchers and the EMEA). This could influence the approval of PRO claims. CONCLUSION: PRO guidance from the EMEA and FDA has been valuable, and has raised the profile and active debate of PROs in oncology. However, our review of the current opinion shows that there are controversial aspects of the guidance. Consequently, greater latitude should be given to how the guidance is interpreted and applied.
PMID: 19013787 [PubMed - as supplied by publisher]
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Freitag, 12. Dezember 2008
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[Have the 2005 guidelines for resuscitation been implemented?]
Ugeskr Laeger. 2008 Nov 17;170(47):3843-7
Authors: Nielsen AM, Isbye DL, Lippert FK
INTRODUCTION: In 2005, new international evidence-based guidelines for cardiopulmonary resuscitation (CPR) were published by the International Liaison Committee on Resuscitation (ILCOR). The aim of these new guidelines is to improve the quality of care and, thereby, the outcome from cardiac arrest. This necessitates that the guidelines are known and implemented in clinical practice. The purpose of this investigation is to elucidate the extent of implementation of Guidelines 2005 (G2005) among doctors on Cardiac Arrest Teams (CAT) one year after the publication. In addition, the date of implementation is examined among medical emergency services and major providers of basic life support (BLS) courses. MATERIAL AND METHODS: A telephone enquiry about CPR among CAT doctors on-duty. Ambulance services and BLS-course providers are contacted by e-mail. RESULTS: Approximately 70% of the doctors were able to answer simple and essential topics on CPR, e.g. compression/ventilation ratio and the number of shocks in a sequence in accordance with G2005. The ambulance service, Falck A/S, implemented G2005 during 2007, while the other ambulance services implemented G2005 within six months after publication. The majority of BLS-course providers implemented the guidelines one year after their publication. CONCLUSION: One year after the publication of G2005, there is limited knowledge of the guidelines among doctors on duty. The study does not give any explanation for the lack of implementation. The barriers to implementation should be clarified, and future guidelines should be accompanied by an active strategy for implementation.
PMID: 19014735 [PubMed - in process]
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Freitag, 12. Dezember 2008
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An educational game for teaching clinical practice guidelines to Internal Medicine residents: development, feasibility and acceptability.
BMC Med Educ. 2008 Nov 18;8(1):50
Authors: Akl EA, Mustafa R, Slomka T, Alawneh A, Vedavalli A, Schunemann HJ
ABSTRACT: BACKGROUND: Adherence to Clinical Practice Guidelines (CPGs) remains suboptimal among internal medicine trainees. Educational games are of growing interest and have the potential to improve adherence to CPGs. The objectives of this study were to develop an educational game to teach CPGs in Internal Medicine residency programs and to evaluate its feasibility and acceptability. METHODS: We developed the Guide-O-Game(c) the format of TV game shows with questions based on recommendations of CPGs. The development of the Guide-O-Game(c) consisted of the creation of a multimedia interactive tool, the development of recommendation-based questions, and the definition of the game’s rules. We evaluated its feasibility through pilot testing and its acceptability through a qualitative process. RESULTS: The multimedia interactive tool uses a Macromedia Flash web application and consists of a manager interface and a user interface. The user interface allows the choice of two game styles. We created so far 16 sets of questions relating to 9 CPGs. The pilot testing proved that the game was feasible. The qualitative evaluation showed that residents considered the game to be acceptable. CONCLUSIONS: We developed an educational game to teach CPGs to Internal Medicine residents that is both feasible and acceptable. Future work should evaluate its impact on educational outcomes.
PMID: 19017400 [PubMed - as supplied by publisher]
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Freitag, 12. Dezember 2008
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Could the National Institute for Health and Clinical Excellence guidelines on urodynamics in urinary incontinence put some women at risk of a bad outcome from stress incontinence surgery?
BJU Int. 2008 Nov 18;
Authors: Agur W, Housami F, Drake M, Abrams P
OBJECTIVE To evaluate the potential impact of the UK National Institute for Health and Clinical Excellence (NICE) recommendation that preoperative urodynamics are not necessary for women with ‘pure symptoms of stress urinary incontinence’ (SUI), by using data from a population of women referred with lower urinary tract symptoms. PATIENTS AND METHODS In a retrospective study of 6276 women with UI, from an electronic database at a tertiary referral centre, information was collected and entered into a urodynamics computer database at the time of history taking and before conducting the tests. The database was used to identify women aged 18-80 years who had multichannel cystometry for UI over a 17-year period (1 January 1990 to 31 December 2006). To apply the NICE criterion of a ‘clearly defined clinical diagnosis of pure SUI’, strict selection criteria were used to identify patients with pure SUI. The reliability of the patients’ history in predicting ‘pure’ urodynamic SUI in patients with ‘pure’ SUI was investigated. The correspondence of the symptomatic diagnosis of pure SUI with the urodynamic findings was assessed, and sensitivity, specificity, positive and negative predictive values were calculated using contingency tables. RESULTS Only 324 (5.2%) women had pure SUI; moreover, a quarter of those with pure SUI symptoms ultimately had urodynamic diagnoses other than urodynamic SUI, that could affect the outcome of continence surgery. CONCLUSION These findings indicate that only a small group of women fulfil the NICE criteria of pure SUI. These strict criteria do not ensure that all women with potentially important urodynamic findings are evaluated accordingly. Therefore, we suggest that this NICE recommendation was unwise and, furthermore, was not based on properly acquired expert opinion.
PMID: 19021606 [PubMed - as supplied by publisher]
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Clinical practice guideline improves the treatment of sickle cell disease vasoocclusive pain.
Pediatr Blood Cancer. 2008 Nov 20;
Authors: Morrissey LK, Shea JO, Kalish LA, Weiner DL, Branowicki P, Heeney MM
BACKGROUND: Pain is the most common complication of sickle cell disease requiring emergency department (ED) visits and hospitalization. A Clinical Practice Guideline (CPG) to manage acute sickle cell pain offers clinicians a standardized approach for the provision of evidence-based, cost-effective care. After CPG implementation, monitoring of pre-established indicators is a strategy to evaluate progress toward meeting the goal of providing rapid, effective pain relief for patients with acute sickle cell pain. METHODS: A retrospective chart review of patients with sickle cell disease admitted through the ED at Children’s Hospital Boston with the primary diagnosis of vaso-occlusive pain was performed for a period before and after implementation of the CPG. Endpoints measured were: use of a validated pain scale, time from ED triage to first dose of analgesic, use of adequate weight-based analgesic dosing, frequency and location of PCA initiation, and time from ED triage to patient controlled analgesia (PCA) initiation. RESULTS: Two hundred sixty three sickle cell pain admissions in 93 unique subjects were analyzed, 51 pre-CPG and 212 post-CPG. Statistically significant improvements in use of pain scale, appropriate weight-based analgesic dosing, utilization of PCA, and time to initiation of PCA were observed. There was not a statistically significant improvement in the percentage of subjects who received their 1st dose of analgesic within 1 hr; however the median time to first analgesic was reduced significantly from 80 to 65 min (P = 0.003). CONCLUSIONS: Implementation of a CPG to manage acute sickle cell pain in the ED improves the ability to deliver timely, effective analgesia to this patient population. Establishing and monitoring internal benchmarks provides a means for ongoing evaluation of the pre-established goals for patient care. Pediatr Blood Cancer (c) 2008 Wiley-Liss, Inc.
PMID: 19023890 [PubMed - as supplied by publisher]
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Freitag, 12. Dezember 2008
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Re: Gunnar Aus, Christopher Chapple, Tomas Hanûs, et al. The European Association of Urology (EAU) Guidelines Methodology: A Critical Evaluation. Eur Urol. In press. 10.1016/j.eururo.2008.07.012.
Eur Urol. 2008 Nov 21;
Authors: Dahm P, Yeung L, Schünemann H
PMID: 19028007 [PubMed - as supplied by publisher]
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