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Guidelines for Submitting Adverse Event Reports for Publication.

Therapie. 2009 Juillet-Aout;64(4):289-294

Authors: Kelly W, Arellano F, Barnes J, Bergman U, Edwards R, Fernandez A, Freedman S, Goldsmith D, Huang K, Jones J, McLeay R, Moore N, Stather R, Trenque T, Troutman W, van Puijenbroek E, Williams F, Wise R

Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation and reporting of suspected drug or other medical product adverse events.

PMID: 19804709 [PubMed - as supplied by publisher]

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Overview of evaluation and treatment guidelines for epilepsy.

Curr Treat Options Neurol. 2009 Jul;11(4):273-84

Authors: Stern JM

Choosing the most appropriate treatment for a patient with epilepsy depends on complicated and critical decisions. The number of treatment options has become large, and evidence of effectiveness for each treatment continues to expand. To address this problem, numerous guidelines have been produced by several societies and organizations. However, the guidelines do not always agree in their recommendations, mostly because of differing methods reflecting distinct purposes, but these differences are useful because they highlight both what is incontrovertible and what is unknown. Overall, the evidence needed to choose an antiepileptic drug (AED) wisely is incomplete, and no individual AED or group of AEDs is universally preferred as first-line therapy. Initial treatment should be based in part on the seizure-type diagnosis because the AEDs differ in their efficacy for various seizure types. The AEDs also differ in their safety, tolerability, and potential for pharmacologic interactions. These issues and the patient's general medical history are additional factors to be used when selecting an AED. The failure of AEDs to completely control seizures should lead to consideration of epilepsy surgery, especially for patients with mesial temporal lobe epilepsy. However, there is no consensus regarding how many AEDs should be tried before the condition is deemed pharmacoresistant. Vagus nerve stimulation and the ketogenic diet are alternative treatments for patients with pharmacoresistant epilepsy who do not have epilepsy surgery or who have unsuccessful surgery.

PMID: 19523353 [PubMed - in process]

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The ESPEN clinical practice guidelines on Parenteral Nutrition: Present status and perspectives for future research.

Clin Nutr. 2009 Jun 12;

Authors: Bozzetti F, Forbes A

The ESPEN Guidelines on Parenteral Nutrition (PN) reflect current scientific knowledge in the field of clinical nutrition in adults. They summarize the indications for PN and its anticipated outcomes in respect of the underlying disease, nutritional status and quality of life. They are companion documents to the ESPEN Guidelines on Enteral Nutrition and follow the same general format. They address the influence of the underlying disease on the patient's nutritional status, and that of malnutrition on the outcome of the disease. Contraindications to and complications of PN are considered, together with comparative analyses of the roles of the parenteral and enteral routes in different illness states. The quality and strength of the supporting literature has been graded according to the criteria of the Scottish Intercollegiate Guidelines Network (SIGN) and the Agency for Health Care Policy and Research. Hence, meta-analysis of randomised clinical trials (level of evidence Ia) or at least one randomised clinical trial (level of evidence Ib) translate to a Grade A recommendation. Levels of evidence IIa, IIb and III are attributed respectively to: at least one well-designed controlled trial without randomisation; at least one other type of well-designed, quasi-experimental study; or well-designed non-experimental descriptive studies such as comparative studies, correlation studies, case-control studies; each of these sustains a Grade B recommendation. Grade C recommendations reflect expert opinion and/or the clinical experience of respected authorities (level of evidence IV). Each of the 11 sets of PN Guidelines was devised by an international working group, the total faculty comprising no fewer than 87 experts from 16 European/Mediterranean countries, each group's contributions being co-ordinated by a designated chairman. Once each guideline had been approved by all the members of the relevant working group, this version was reviewed by at least two independent external reviewers (one selected from ESPEN's Education and Clinical Practice Committee, and at least one from outside the ESPEN committee structure). Following this review each guideline was hosted in draft form on the public pages of the ESPEN website for at least one month to permit the receipt of comments or suggestions from any interested party. At this point the Guidelines were reviewed and revised again by the original working group chairman and submitted to the Clinical Nutrition editorial process. At least 3 further reviewers were selected by the Journal's editorial office for each guideline, in line with the normal selection process. Final revisions were performed by the Chairmen of the working groups, and by ourselves as commissioning editors of the whole project. More than 300 evidence-based recommendations are now presented. Fewer than one sixth of the recommendations are Grade A, and disappointingly, but unsurprisingly, more than 50% are Grade C. The need for more and better controlled trials in the field remains apparent.

PMID: 19523723 [PubMed - as supplied by publisher]

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Improved diagnosis and treatment of soft tissue sarcoma patients after implementation of national guidelines: A population-based study.

Eur J Surg Oncol. 2009 Jun 12;

Authors: Jansen-Landheer ML, Krijnen P, Oostindiër MJ, Kloosterman-Boele WM, Noordijk EM, Nooij MA, Steup WH, Taminiau AH, Vree R, Hogendoorn PC, Tollenaar RA, Gelderblom H

AIM: The majority of clinicians, radiologists and pathologists have limited experience with soft tissue sarcomas. In 2004, national guidelines were established in The Netherlands to improve the quality of diagnosis and treatment of these rare tumours. This study evaluates the compliance with the guidelines over time. PATIENTS: Population-based series of 119 operated patients with a soft tissue sarcoma (STS) diagnosed in 1998-1999 (79 before implementation of new guidelines) and in 2006 (40 after implementation). METHODS: Coded information regarding patient and tumour characteristics as well as (the results of) pathology review was collected from the medical patient file by two experienced data-managers. RESULTS: Diagnostic imaging of the tumour was performed according to the guidelines in 75-100% depending on the site of the tumour (abdominal versus non-abdominal) as well as the time of diagnosis. Adherence to the guidelines with respect to invasive diagnostic procedures in patients with non-abdominal STS improved over time. A pre-operative histological diagnosis was obtained in 42% of the patients in 1998-1999 and in 72% of the patients in 2006 (p<0.001). The guidelines for reporting on pathology were increasingly adhered to. In 2006, (nearly) all pathology reports mentioned tumour size, morphology, tumour grade, resection margins and radicality. This represents a major improvement compared to the pathology reports in 1998-1999, where these aspects were not mentioned in 14-40% of the cases. The proportion of prospective pathology reviews by (a member of) the expert panel increased from 60% in 1998-1999 to 90% in 2006 (p=0.001). DISCUSSION: The compliance with the guidelines has been optimised by the increased attention to this group of patients. Most important factors have been the reporting of the results of the first evaluation and (discussions about) the centralisation of treatment. Further improvements could be reached by the prospective web based registry monitoring logistic aspects as well as parameters useful for the evaluation of the quality of care.

PMID: 19525085 [PubMed - as supplied by publisher]

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2008 SOR guidelines for the prevention and treatment of thrombosis associated with central venous catheters in patients with cancer: report from the working group.

Ann Oncol. 2009 Jun 12;

Authors: Debourdeau P, Kassab Chahmi D, Le Gal G, Kriegel I, Desruennes E, Douard MC, Elalamy I, Meyer G, Mismetti P, Pavic M, Scrobohaci ML, Lévesque H, Renaudin JM, Farge D,

BACKGROUND: In view of the lack of recommendations on central venous catheter (CVC)-associated thrombosis in cancer patients, we established guidelines according to the well-standardized Standards, Options and Recommendations methodology. Material and methods: A literature review (1990-2007) on CVC-associated thrombosis was carried out. The guidelines were developed on the basis of the corresponding levels of evidence derived from analysis of the 36 of 175 publications selected. They were then peer reviewed by 65 independent experts. RESULTS: For the prevention of CVC-associated thrombosis, the distal tip of the CVC should be placed at the junction between the superior cava vein and right atrium; anticoagulants are not recommended. Treatment of CVC-associated thrombosis should be based on the prolonged use of low-molecular weight heparins. Maintenance of the catheter is justified if it is mandatory, functional, in the right position, and not infected, with a favorable clinical evolution under close monitoring; anticoagulant treatment should then be continued as long as the catheter is present. CONCLUSIONS: Several rigorous studies do not support the use of anticoagulants for the prevention of CVC-associated thrombosis. Treatment of CVC-associated thrombosis relies on the same principles as those applied in the treatment of established thrombosis in cancer patients.

PMID: 19525362 [PubMed - as supplied by publisher]

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ST Elevation Myocardial Infarction Guidelines Today: A Systematic Review Exploring Updated ACC/AHA STEMI Guidelines and Their Applications.

Am J Ther. 2009 Jun 13;

Authors: Loomba RS, Arora R

With new study findings becoming available, the American College of Cardiology (ACC) and the American Heart Association (AHA) have made additions and revisions to their guidelines for treating patients with ST elevation myocardial infarctions (STEMI). It is important for clinicians to be familiar with these changes so that they may be applied and assist in the treatment of patients. Electronic searches on databases such as PubMed, Cochrane Library, and Medline were conducted using specific keywords pertaining to the ACC/AHA guidelines and the specific topics discussed in these guidelines to find randomized controlled trials, meta-analyses, and systematic reviews. Additional studies were then found via hand search for referenced sources. All sources were then stratified on quality and relevance. The ACC/AHA have made several additions and revisions to the 2004 STEMI guidelines. These include recommendations focusing on reperfusion and antithrombotic therapy, ancillary anticoagulation, fibrinolytic therapy, and primary percutaneous intervention (PCI). Goal times for interventions such as fibrinolytic therapy and PCI are also set forth in new guidelines, which stress prompt response to STEMI for better outcomes. Changes deal with all aspects of care such as care provided by emergency medical systems (EMS) en route to the hospital, in-hospital fibrinolysis and PCI, post-hospitalization measures, and secondary prevention. It is of great importance that clinicians who deal with STEMI become familiar with the latest guidelines so that the quality of care they provide is of the highest caliber and that patients experience the highest quality of life after STEMI treatment.

PMID: 19531937 [PubMed - as supplied by publisher]

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Evaluation of AAP guidelines for cholesterol screening in youth: Project HeartBeat!

Am J Prev Med. 2009 Jul;37(1 Suppl):S71-7

Authors: Eissa MA, Wen E, Mihalopoulos NL, Grunbaum JA, Labarthe DR

BACKGROUND: The American Academy of Pediatrics (AAP) criterion for screening for hypercholesterolemia in children is family history of hypercholesterolemia or cardiovascular disease or BMI > or =85th percentile. This paper aims to determine the sensitivity, specificity, and positive predictive value (PPV) of dyslipidemia screening using AAP criteria along with either family history or BMI. METHODS: Height, weight, plasma total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides, and family history were obtained for 678 children aged 8, 11, and 14 years, enrolled from 1991 to 1993 in Project HeartBeat!. Sensitivity, specificity, and PPV screening of each lipid component using family history alone, BMI > or =85th percentile alone, or family history and/or BMI > or =85th percentile, were calculated using 2008 AAP criteria (total cholesterol, LDL-C, and triglycerides > or =90th percentile; HDL-C <10th percentile). RESULTS: Sensitivity of detecting abnormal total cholesterol, LDL-C, HDL-C, and triglycerides using family history alone ranged from 38% to 43% and significantly increased to 54%-66% using family history and/or BMI. Specificity significantly decreased from approximately 65% to 52%, and there were no notable changes in PPV. In black children, cholesterol screening using the BMI > or =85th percentile criterion had higher sensitivity than when using the family history criterion. In nonblacks, family history and/or BMI > or =85th percentile had greater sensitivity than family history alone. CONCLUSIONS: When the BMI screening criterion was used along with the family history criterion, sensitivity increased, specificity decreased, and PPV changed trivially for detection of dyslipidemia. Despite increased screening sensitivity by adding the BMI criterion, a clinically significant number of children still may be misclassified.

PMID: 19524159 [PubMed - in process]

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Nurses' experiences of guideline implementation: a focus group study.

J Clin Nurs. 2009 Jun 17;

Authors: Alanen S, Välimäki M, Kaila M,

Aims. The aim of the study was to address the following questions: What kind of experiences do primary care nurses have of guideline implementation? What do nurses think are the most important factors affecting the adoption of guidelines? Background. The implementation of clinical guidelines seems to be dependent on multiple context-specific factors. This study sets out to explore the experiences of primary care nurses concerning guideline implementation. Design. Qualitative interview. Methods. Data were generated by four focus group interviews involving nurses working in out-patient services in primary health centres in Finland. Purposive sampling was used to select health centres. Inductive content analysis was used to identify themes emerging from the data. Results. Four main groups of factors were identified from the analysis of data: (i) factors related to the organisation, (ii) factors related to nurses, (iii) factors related to the anticipated consequences and (iv) factors related to the patient group. Nurses' awareness and acceptance of guidelines and the anticipated positive consequences facilitate the implementation of guidelines. Organisational support, especially the adapting of guidelines to local circumstances, seems to be crucial for successful implementation. Conclusions. Clinical guidelines can be promising tools in enhancing evidence-based nursing practice, as nurses see them as practical work tools in patient care and so are willing to adopt them. However, support from management and physicians is needed to ensure the successful implementation of guidelines into nursing practices. Relevance to clinical practice. Based on the findings of this study and previous knowledge of guideline implementation some practical recommendations are suggested. Select the most relevant guidelines to clinical practice, organise the adaptation of guidelines to local circumstances, inform all practitioners involved in treatment and give clear instructions for the adoption of the guidelines.

PMID: 19538563 [PubMed - as supplied by publisher]

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Adherence to K/DOQI bone metabolism guidelines.

J Ren Nutr. 2009 Jul;19(4):334-42

Authors: Smith DH, Johnson ES, Thorp ML, Yang X

OBJECTIVE: Guidelines for the treatment of patients with chronic kidney disease recommend laboratory testing of markers of bone metabolism, including intact parathyroid hormone, calcium, and phosphorus. The authors sought to evaluate the concordance of contemporary clinical practice with treatment recommendations. Trends were evaluated (2002 to 2005) in testing for bone metabolism in patients with chronic kidney disease, and the relation between bone metabolism markers, severity of chronic kidney disease, and cardiovascular hospitalizations were examined. DESIGN: Retrospective cohort. SETTING: Large United States health-maintenance organization. PATIENTS: Chronic kidney disease. RESULTS: Little variation was found in testing rates over time. Testing frequency was positively correlated with severity of kidney disease, referral to nephrology, and test type (annual testing was most likely for intact parathyroid hormone, and least likely for calcium). Patients with higher intact parathyroid hormone values had a greater risk of cardiovascular-related hospitalization; after adjusting for potential confounders, those with an intact parathyroid hormone value of 200 and greater had a relative risk of 2.16 (95% confidence interval, 1.09 to 4.29). CONCLUSIONS: This study supports the hypothesized association between disorders of bone metabolism and cardiovascular disease, but it does not address whether increased testing for disorders of bone metabolism will improve outcomes for patients with chronic kidney disease. Nor does our analysis imply that controlling parathyroid hormone will prevent cardiovascular hospitalizations. Future studies should more fully explore those critical clinical questions.

PMID: 19539186 [PubMed - in process]

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Assessment factors for extrapolation from short-time to chronic exposure-Are the REACH guidelines adequate?

Toxicol Lett. 2009 Jun 18;

Authors: Malkiewicz K, Hansson SO, Rudén C

Due to the relative scarcity of long-term toxicity data, assessment factors for extrapolation from relatively short to chronic exposures have an important role in the risk assessment of chemicals. A recent REACH guidance document includes recommended default assessment factors that cover subacute-subchronic, subchronic-chronic, and subacute-chronic extrapolations. The recommended assessment factors are smaller than in most previous proposals, since they are calibrated to achieve central estimates (50th percentile of the target distribution) rather than a higher percentile such as the 95th, as has been more common. These assessment factors are nevertheless presented as representing a "widely agreed level of conservatism", a statement that may lead to misunderstandings of what is achieved by using them in a risk assessment. Assessment factors have been based on evidence from animal studies with different designs, in particular with focus on different endpoints. Our re-analysis of experimental data shows that using mortality as an endpoint leads to smaller assessment factors than if the factors are derived from corresponding ratios for non-lethal toxicity.

PMID: 19540321 [PubMed - as supplied by publisher]

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