Aktueller Newsletter

Lack of Uniformity in Levels of Evidence and Recommendation Grades in Surgical Oncology Guidelines.

World J Surg. 2012 Apr 28;

Authors: In H, Greenberg CC

PMID: 22543721 [PubMed - as supplied by publisher]

Clinical Practice Guidelines for Assessment and Treatment of Transsexualism. SEEN Identity and Sexual Differentiation Groupd (GIDSEEN).

Endocrinol Nutr. 2012 Apr 26;

Authors: Moreno-Pérez O, Esteva De Antonio I,

Abstract
Transsexual patients can only be diagnosed and treated at functional gender identity Units with provision of high quality care, development of clinical practice guidelines, and interdisciplinary working groups. The therapeutic process has three mainstays: initial psychological diagnostic evaluation and psychotherapy, endocrinological evaluation and hormone therapy, and sex reassignment surgery. Cross-sex hormone therapy is essential for the anatomical and psychological transition process in duly selected patients. Hormones help optimize real-life sex identity, improve quality of life, and limit psychiatric co-morbidities often associated to lack of treatment. Development of this clinical practice guideline addresses the need for implementing a coordinated action protocol for comprehensive health care for transgender people in the National Health System.

PMID: 22542505 [PubMed - as supplied by publisher]

GRADE guidelines 11-making an overall rating of confidence in effect estimates for a single outcome and for all outcomes.

J Clin Epidemiol. 2012 Apr 27;

Authors: Guyatt G, Oxman AD, Sultan S, Brozek J, Glasziou P, Alonso-Coello P, Atkins D, Kunz R, Montori V, Jaeschke R, Rind D, Dahm P, Akl EA, Meerpohl J, Vist G, Berliner E, Norris S, Falck-Ytter Y, Schünemann HJ

Abstract
GRADE requires guideline developers to make an overall rating of confidence in estimates of effect (quality of evidence-high, moderate, low, or very low) for each important or critical outcome. GRADE suggests, for each outcome, the initial separate consideration of five domains of reasons for rating down the confidence in effect estimates, thereby allowing systematic review authors and guideline developers to arrive at an outcome-specific rating of confidence. Although this rating system represents discrete steps on an ordinal scale, it is helpful to view confidence in estimates as a continuum, and the final rating of confidence may differ from that suggested by separate consideration of each domain. An overall rating of confidence in estimates of effect is only relevant in settings when recommendations are being made. In general, it is based on the critical outcome that provides the lowest confidence.

PMID: 22542023 [PubMed - as supplied by publisher]

Evidence-based guidelines for cataract surgery: Guidelines based on data in the European Registry of Quality Outcomes for Cataract and Refractive Surgery database.

J Cataract Refract Surg. 2012 Apr 26;

Authors: Lundström M, Barry P, Henry Y, Rosen P, Stenevi U

Abstract
In March 2008, the European Registry of Quality Outcomes for Cataract and Refractive Surgery (EUREQUO) commenced. This 3-year project was cofunded by the European Union (EU) and the European Society of Cataract & Refractive Surgeons (ESCRS). The ESCRS became the lead partner in the project with 11 national societies as associated partners. The aims of the project were to improve treatment and standards of care for cataract and refractive surgery and to develop evidence-based guidelines for cataract and refractive surgery across Europe. Surgeons from all participating societies contributed to the database, which contained data on 820 000 cataract surgeries in November 2011. The present guidelines are based on data entered from January 1, 2009, to August 28, 2011 (523 921 cataract extractions). The guidelines include only those steps in the cataract surgery process that can be analyzed by the database. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

PMID: 22541829 [PubMed - as supplied by publisher]

Lack of adherence to hypertension treatment guidelines among GPs in southern Sweden - a case report based survey.

BMC Fam Pract. 2012 Apr 26;13(1):34

Authors: Ekesbo RW, Midlöv P, Gerward S, Persson K, Nerbrand C, Johansson L

Abstract
ABSTRACT: BACKGROUND: Despite current guidelines for treatment of hypertension, General Practitioners (GP) fail to correctly adhere to these guidelines. The reasons for this are unclear, but could be related to lack of knowledge in assessing the individual patients cardiovascular risk. Aim: Our aim was to investigate how GPs in southern Sweden adhere to clinical guidelines for treatment of hypertension when major cardiovascular risk factors are taken into consideration. METHOD: A questionnaire with 5 authentic patient cases with hypertension and different cardiovascular risk profiles was sent to a random sample(n=109) of GP's in southern Sweden in order to investigate the attitude towards blood pressure (BP) treatment when major cardiovascular risk factors were present. RESULTS: In general, responding GPs were more focused on the absolute BP target level rather than assessing the entire cardiovascular risk factor profile. Thus, cases with the highest risk of cardiovascular disease were not treated accordingly. However, there are also tendency to over-treatment among the lowest risk groups. Furthermore, the BP level for initiating pharmacological treatment varied widely (systolic BP 140-210 mm Hg). ACE-inhibitors (70%) were the most common first choice of pharmacological treatment. CONCLUSION: In this study, GPs in Southern Sweden were suggesting, for different cases, either under- or overtreatment in relation to current guidelines for treatment of hypertension. On reason may be that they failed to correctly assess individual cardiovascular risk factor profiles.

PMID: 22536853 [PubMed - as supplied by publisher]

[A new evidence and consensus-based German guidelines for diagnosis and treatment of bipolar disorders.]

Nervenarzt. 2012 Apr 27;

Authors: Bauer M

PMID: 22534736 [PubMed - as supplied by publisher]

[Psychiatric care for subjects with bipolar disorder : Results of the new German S3 guidelines.]

Nervenarzt. 2012 Apr 26;

Authors: Brieger P, Bode L, Urban R, Pfennig A

Abstract
Bipolar affective disorders are frequent and have severe consequences. The German S3 guidelines outline the principles of evidence-based treatment of this condition. Based on a partnership with service users and their families accessibility to illness-specific therapy including psychotherapy/psychoeducation, self-help groups for family members and for users are important. Other significant service aspects include assertive outreach and specific rehabilitation (including work). Psychiatric services in Germany remain scattered; therefore there is a need for more coordination.

PMID: 22532326 [PubMed - as supplied by publisher]

Adoption and Implementation of the Original Strict Glycemic Control Guideline is Feasible and Safe in Adult Critically Ill Patients.

Minerva Anestesiol. 2012 Apr 24;

Authors: Schultz MJ, Harmsen RE, Korevaar JC, Abu-Hanna A, van Braam Houckgeest F, van der Sluijs JP, Spronk PE

Abstract
BACKGROUND:Three trials of tight glucose control (TGC) found clinical benefit of normalization of blood glucose levels in the intensive care unit (ICU). Implementation of TGC was imperfect in subsequent trials, since attained blood glucose levels (BGLs) never reached the targets as in the original trials of TGC. We investigated whether implementation of the TGC guideline as used in the original trials of TGC is feasible and safe. METHODS:In this study 3 ICUs adopted and implemented the TGC guideline as used in the original trials of TGC using a multifaceted practice change strategy; 3 ICUs that did not change their blood glucose control guideline served as controls. TGC was practiced by physicians and nurses during the first 12-month (period-2), thereafter exclusively by nurses (period-3). Blood glucose metrics 12-month before (period-1) and 24-month after implementation of the guideline were compared. RESULTS:The analysis included 1,321 in period-1, 1,169 and 1,006 patients in period-2, and -3, respectively, in the intervention ICUs, and 3,110 patients in the control ICUs. After implementation of the new TGC guideline, patients in intervention ICUs had lower median BGLs (105 [IQR: 85 - 130] mg/dl vs. 119 [99 - 150] mg/dl in period-1, P < .001; and vs. 113 [95 - 141] mg/dl in control ICUs, P < .001). The incidence of severe hypoglycemia initially increased, but again decreased when exclusively nurses practiced TGC, and was not associated with increased mortality or morbidity. CONCLUSION:Implementation of the original TGC guideline is feasible and safe. Our study suggests a learning effect over time.

PMID: 22531562 [PubMed - as supplied by publisher]

Rehabilitation after arthroscopic rotator cuff repair: current concepts review and evidence-based guidelines.

Int J Sports Phys Ther. 2012 Apr;7(2):197-218

Authors: van der Meijden OA, Westgard P, Chandler Z, Gaskill TR, Kokmeyer D, Millett PJ

Abstract
PURPOSE: To provide an overview of the characteristics and timing of rotator cuff healing and provide an update on treatments used in rehabilitation of rotator cuff repairs. The authors' protocol of choice, used within a large sports medicine rehabilitation center, is presented and the rationale behind its implementation is discussed.
BACKGROUND: If initial nonsurgical treatment of a rotator cuff tear fails, surgical repair is often the next line of treatment. It is evident that a successful outcome after surgical rotator cuff repair is as much dependent on surgical technique as it is on rehabilitation. To this end, rehabilitation protocols have proven challenging to both the orthopaedic surgeon and the involved physical therapist. Instead of being based on scientific rationale, traditionally most rehabilitation protocols are solely based on clinical experience and expert opinion.
METHODS: A review of currently available literature on rehabilitation after arthroscopic rotator cuff tear repair on PUBMED / MEDLINE and EMBASE databases was performed to illustrate the available evidence behind various postoperative treatment modalities.
RESULTS: There is little high-level scientific evidence available to support or contest current postoperative rotator cuff rehabilitation protocols. Most existing protocols are based on clinical experience with modest incorporation of scientific data.
CONCLUSION: Little scientific evidence is available to guide the timing of postsurgical rotator cuff rehabilitation. To this end, expert opinion and clinical experience remains a large facet of rehabilitation protocols. This review describes a rotator cuff rehabilitation protocol that incorporates currently available scientific literature guiding rehabilitation.

PMID: 22530194 [PubMed - in process]

Evaluation of dietary intake in Danish adults by means of an index based on food-based dietary guidelines.

Food Nutr Res. 2012;56

Authors: Knudsen VK, Fagt S, Trolle E, Matthiessen J, Groth MV, Biltoft-Jensen A, Sørensen MR, Pedersen AN

Abstract
BACKGROUND: Data on dietary intake and physical activity has been collected from a representative sample of the Danish population from 2003-2008.
OBJECTIVES: The aim of the present study was to describe the habitual diet in Denmark and to evaluate the overall diet quality using a diet quality index based on the National Food-Based Dietary Guidelines (FBDG), which consists of seven guidelines regarding diet and one regarding physical activity.
DESIGN: Data from the Danish National Survey of Diet and Physical Activity 2003-2008 (n=3354) were included. The diet quality index was constructed based on five of the seven dietary guidelines. Individuals were categorised according to quartiles of the diet quality index, and food and nutrient intakes were estimated in each of the groups.
RESULTS: Macronutrient distribution did not meet recommendations in any of the groups, as energy from total fat and especially saturated fat was too high. A high intake of high-fat milk products, fat on bread and processed meat contributed to a high intake of total fat and saturated fat, and sugar-sweetened soft drinks contributed to a high intake of added sugars in the group below the lowest quartile of the diet quality index. Individuals above in the highest quartile had higher intakes of 'healthy foods' such as fish, fruit and vegetables, rye bread, and also a higher consumption of water and wine. Overall, intakes of micronutrients were sufficient in all groups.
CONCLUSIONS: The diet quality index is a useful tool in assessing food and nutrient intake in individuals with high vs. low degree of compliance towards the dietary guidelines, and provides a valuable tool in future studies investigating variations in dietary intakes with respect to lifestyle, demographic and regional differences in Denmark.

PMID: 22529769 [PubMed - in process]

Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults: Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society.

Neurology. 2012 Apr 24;78(17):1346-53

Authors: Holland S, Silberstein SD, Freitag F, Dodick DW, Argoff C, Ashman E

Abstract
OBJECTIVE: To provide updated evidence-based recommendations for the preventive treatment of migraine headache. The clinical question addressed was: Are nonsteroidal anti-inflammatory drugs (NSAIDs) or other complementary treatments effective for migraine prevention?
METHODS: The authors analyzed published studies from June 1999 to May 2009 using a structured review process to classify the evidence relative to the efficacy of various medications for migraine prevention.
RESULTS: The author panel reviewed 284 abstracts, which ultimately yielded 49 Class I or Class II articles on migraine prevention; of these 49, 15 were classified as involving nontraditional therapies, NSAIDs, and other complementary therapies that are reviewed herein. Recommendations: Petasites (butterbur) is effective for migraine prevention and should be offered to patients with migraine to reduce the frequency and severity of migraine attacks (Level A). Fenoprofen, ibuprofen, ketoprofen, naproxen, naproxen sodium, MIG-99 (feverfew), magnesium, riboflavin, and subcutaneous histamine are probably effective for migraine prevention (Level B). Treatments considered possibly effective are cyproheptadine, Co-Q10, estrogen, mefenamic acid, and flurbiprofen (Level C). Data are conflicting or inadequate to support or refute use of aspirin, indomethacin, omega-3, or hyperbaric oxygen for migraine prevention. Montelukast is established as probably ineffective for migraine prevention (Level B).

PMID: 22529203 [PubMed - in process]

Evidence-based guideline update: Pharmacologic treatment for episodic migraine prevention in adults: Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society.

Neurology. 2012 Apr 24;78(17):1337-45

Authors: Silberstein SD, Holland S, Freitag F, Dodick DW, Argoff C, Ashman E

Abstract
OBJECTIVE: To provide updated evidence-based recommendations for the preventive treatment of migraine headache. The clinical question addressed was: What pharmacologic therapies are proven effective for migraine prevention? METHODS: The authors analyzed published studies from June 1999 to May 2009 using a structured review process to classify the evidence relative to the efficacy of various medications available in the United States for migraine prevention. Results and Recommendations: The author panel reviewed 284 abstracts, which ultimately yielded 29 Class I or Class II articles that are reviewed herein. Divalproex sodium, sodium valproate, topiramate, metoprolol, propranolol, and timolol are effective for migraine prevention and should be offered to patients with migraine to reduce migraine attack frequency and severity (Level A). Frovatriptan is effective for prevention of menstrual migraine (Level A). Lamotrigine is ineffective for migraine prevention (Level A).

PMID: 22529202 [PubMed - in process]

Guidelines for the Evaluation and Management of Status Epilepticus.

Neurocrit Care. 2012 Apr 24;

Authors: Brophy GM, Bell R, Claassen J, Alldredge B, Bleck TP, Glauser T, Laroche SM, Riviello JJ, Shutter L, Sperling MR, Treiman DM, Vespa PM,

Abstract
Status epilepticus (SE) treatment strategies vary substantially from one institution to another due to the lack of data to support one treatment over another. To provide guidance for the acute treatment of SE in critically ill patients, the Neurocritical Care Society organized a writing committee to evaluate the literature and develop an evidence-based and expert consensus practice guideline. Literature searches were conducted using PubMed and studies meeting the criteria established by the writing committee were evaluated. Recommendations were developed based on the literature using standardized assessment methods from the American Heart Association and Grading of Recommendations Assessment, Development, and Evaluation systems, as well as expert opinion when sufficient data were lacking.

PMID: 22528274 [PubMed - as supplied by publisher]

[Quality of reporting in studies on bipolar disorders : Implications for the development of guidelines.]

Nervenarzt. 2012 Apr 14;

Authors: Soltmann B, Pfennig A, Weikert B, Bauer M, Strech D

Abstract
BACKGROUND: Selective publishing as well as inadequate reporting of clinical trials entail a risk of bias in clinical decision making. Therefore the CONSORT statement was introduced to improve the quality of reporting of randomized controlled trials (RCT). This study aimed to assess the quality of reporting of RCTs on pharmacological treatment of bipolar disorder in relation to publication period and endorsement of publication guidelines. METHODS: In the context of the development of the German evidence and consensus-based S3 guidelines for diagnosis and therapy of bipolar disorders a systematic literature search was carried out to identify all RCTs published between 2000 and 2010 relevant to the pharmacological treatment of bipolar disorders. An adapted checklist based on the CONSORT statement was used to assess the quality of reporting. RESULTS: A total of 134 RCTs were included in this analysis. Of the 72 checklist items, 43% were generally reported adequately (reported in  ≥ 75% of all trials) and 25% inadequately (reported in  < 25% of all trials). Reporting was generally poor for randomization, effect size (reported in 22%) and number needed to treat (NNT 16%). No consistent trend could be shown for improvement in quality of reporting over time or for journals that do or do not endorse the URM (uniform requirements for manuscripts submitted to biomedical journals). CONCLUSIONS: Clinical investigators as well as editors and reviewers should be further encouraged to follow publication guidelines otherwise trials have to be downgraded or excluded from systematic evaluations.

PMID: 22528061 [PubMed - as supplied by publisher]

Design and methodology of the COACH-2 (Comparative study on guideline adherence and patient compliance in heart failure patients) study: HF clinics versus primary care in stable patients on optimal therapy.

Neth Heart J. 2012 Apr 24;

Authors: Luttik ML, Brons M, Jaarsma T, Hillege HL, Hoes A, de Jong R, Linssen G, Lok DJ, Berger M, van Veldhuisen DJ

Abstract
BACKGROUND: Since the number of heart failure (HF) patients is still growing and long-term treatment of HF patients is necessary, it is important to initiate effective ways for structural involvement of primary care services in HF management programs. However, evidence on whether and when patients can be referred back to be managed in primary care is lacking. AIM: To determine whether long-term patient management in primary care, after initial optimisation of pharmacological and non-pharmacological treatment in a specialised HF clinic, is equally effective as long-term management in a specialised HF clinic in terms of guideline adherence and patient compliance. METHOD: The study is designed as a randomised, controlled, non-inferiority trial. Two-hundred patients will be randomly assigned to be managed and followed in primary care or in a HFclinic. Patients are eligible to participate if they are (1) clinically stable, (2) optimally up-titrated on medication (according to ESC guidelines) and, (3) have received optimal education and counselling on pre-specified issues regarding HF and its treatment. Furthermore, close cooperation between secondary and primary care in terms of back referral to or consultation of the HF clinic will be provided.The primary outcome will be prescriber adherence and patient compliance with medication after 12 months. Secondary outcomes measures will be readmission rate, mortality, quality of life and patient compliance with other lifestyle changes. EXPECTED RESULTS: The results of the study will add to the understanding of the role of primary care and HF clinics in the long-term follow-up of HF patients.

PMID: 22527916 [PubMed - as supplied by publisher]

Diagnosis, treatment and prevention of ankle sprains: an evidence-based clinical guideline.

Br J Sports Med. 2012 Apr 20;

Authors: Kerkhoffs GM, van den Bekerom M, Elders LA, van Beek PA, Hullegie WA, Bloemers GM, de Heus EM, Loogman MC, Rosenbrand KC, Kuipers T, Hoogstraten JW, Dekker R, Ten Duis HJ, van Dijk CN, van Tulder MW, van der Wees PJ, de Bie RA

Abstract
Ankle injuries are a huge medical and socioeconomic problem. Many people have a traumatic injury of the ankle, most of which are a result of sports. Total costs of treatment and work absenteeism due to ankle injuries are high. The prevention of recurrences can result in large savings on medical costs. A multidisciplinary clinical practice guideline was developed with the aim to prevent further health impairment of patients with acute lateral ankle ligament injuries by giving recommendations with respect to improved diagnostic and therapeutic opportunities. The recommendations are based on evidence from published scientific research, which was extensively discussed by the guideline committee. This clinical guideline is helpful for healthcare providers who are involved in the management of patients with ankle injuries.

PMID: 22522586 [PubMed - as supplied by publisher]

Editorial ethical guidelines: what about the evaluation of the benefits to humans?

Lab Anim. 2012 Apr;46(2):176

Authors: Pfister R, Gyger M, Bugnon P, Desbaillets I, Fellay JM, Illgen-Wilcke B, Kohler I, Zeller W,

PMID: 22517993 [PubMed - as supplied by publisher]

Implementation of the new American Cancer Society process for creating cancer screening guidelines.

Cancer Cytopathol. 2012 Apr 19;

Authors: Byers T

PMID: 22517634 [PubMed - as supplied by publisher]

Guidelines for preventing catheter infection: assessment of knowledge and practice among paediatric and neonatal intensive care healthcare workers.

J Hosp Infect. 2012 Apr 17;

Authors: Guembe M, Bustinza A, Sánchez Luna M, Carrillo-Álvarez A, Pérez Sheriff V, Bouza E,

Abstract
We analysed knowledge of and adherence to guidelines for the prevention of catheter-related infection (CRI) among Spanish healthcare workers (HCWs) from paediatric and neonatal intensive care units by distributing 357 questionnaires to 31 Spanish hospitals. The overall mean scores for individual knowledge and daily practice were 5.61 and 5.78, respectively. Our results reveal room for improvement in Spanish HCWs' knowledge of prevention of CRI. Continuing education programmes and implementation of care bundles must be introduced to improve prevention and management of CRI.

PMID: 22516169 [PubMed - as supplied by publisher]

The application of modified guidelines for epistaxis management: Our experience in 30 patients before and 32 patients after audit.

Clin Otolaryngol. 2012 Apr;37(2):151-5

Authors: Javed F, Foxton C, Daudia A

PMID: 22515713 [PubMed - in process]

Expert validation of fit-for-purpose guidelines for designing programmes of assessment.

BMC Med Educ. 2012 Apr 17;12(1):20

Authors: Dijkstra J, Galbraith R, Hodges BD, McAvoy PA, McCrorie P, Southgate LJ, Van der Vleuten CP, Wass V, Schuwirth LW

Abstract
ABSTRACT: BACKGROUND: An assessment programme, a purposeful mix of assessment activities, is necessary to achieve a complete picture of assessee competence. High quality assessment programmes exist, however, design requirements for such programmes are still unclear. We developed guidelines for design based on an earlier developed framework which identified areas to be covered. A fitness-for-purpose approach defining quality was adopted to develop and validate guidelines. METHOD: First, in a brainstorm, ideas were generated, followed by structured interviews with 9 international assessment experts. Then, guidelines were fine-tuned through analysis of the interviews. Finally, validation was based on expert consensus via member checking. RESULTS: In total 72 guidelines were developed and in this paper the most salient guidelines are discussed. The guidelines are related and grouped per layer of the framework. Some guidelines were so generic that these are applicable in any design consideration. These are: the principle of proportionality, rationales should underpin each decisions, and requirement of expertise. Logically, many guidelines focus on practical aspects of assessment. Some guidelines were found to be clear and concrete, others were less straightforward and were phrased more as issues for contemplation. CONCLUSIONS: The set of guidelines is comprehensive and not bound to a specific context or educational approach. From the fitness-for-purpose principle, guidelines are eclectic, requiring expertise judgement to use them appropriately in different contexts. Further validation studies to test practicality are required.

PMID: 22510502 [PubMed - as supplied by publisher]

The impact of adherence to screening guidelines and of diabetes clinics referral on morbidity and mortality in diabetes.

PLoS One. 2012;7(4):e33839

Authors: Giorda C, Picariello R, Nada E, Tartaglino B, Marafetti L, Costa G, Gnavi R

Abstract
Despite the heightened awareness of diabetes as a major health problem, evidence on the impact of assistance and organizational factors, as well as of adherence to recommended care guidelines, on morbidity and mortality in diabetes is scanty. We identified diabetic residents in Torino, Italy, as of 1st January 2002, using multiple independent data sources. We collected data on several laboratory tests and specialist medical examinations to compare primary versus specialty care management of diabetes and the fulfillment of a quality-of-care indicator based on existing screening guidelines (GCI). Then, we performed regression analyses to identify associations of these factors with mortality and cardiovascular morbidity over a 4 year- follow-up. Patients with the lowest degree of quality of care (i.e. only cared for by primary care and with no fulfillment of GCI) had worse RRs for all-cause (1.72 [95% CI 1.57-1.89]), cardiovascular (1.74 [95% CI 1.50-2.01]) and cancer (1.35 [95% CI 1.14-1.61]) mortality, compared with those with the highest quality of care. They also showed increased RRs for incidence of major cardiovascular events up to 2.03 (95% CI 1.26-3.28) for lower extremity amputations. Receiving specialist care itself increased survival, but was far more effective when combined with the fulfillment of GCI. Throughout the whole set of analysis, implementation of guidelines emerged as a strong modifier of prognosis. We conclude that management of diabetic patients with a pathway based on both primary and specialist care is associated with a favorable impact on all-cause mortality and CV incidence, provided that guidelines are implemented.

PMID: 22509263 [PubMed - in process]

Guidelines and pharmacopoeial standards for pharmaceutical impurities: Overview and critical assessment.

Regul Toxicol Pharmacol. 2012 Apr 7;

Authors: Snodin DJ, McCrossen SD

Abstract
ICH/regional guidances and agency scrutiny provide the regulatory framework for safety assessment and control of impurities in small-molecule drug substances and drug products. We provide a critical assessment of the principal impurity guidances and, in particular, focus on deficiencies in the derivation of the threshold of toxicological concern (TTC) as applied to genotoxic impurities and the many toxicological anomalies generated by following the current guidelines on impurities. In terms of pharmacopoeial standards, we aim to highlight the fact that strictly controlling numerous impurities, especially those that are minor structural variants of the active substance, is likely to produce minimal improvements in drug safety. It is believed that, wherever possible, there is a need to simplify and rebalance the current impurity paradigm, moving away from standards derived largely from batch analytical data towards structure-based qualification thresholds and risk assessments using readily available safety data. Such changes should also lead to a minimization of in vivo testing for toxicological qualification purposes. Recent improvements in analytical techniques and performance have enabled the detection of ever smaller amounts of impurities with increased confidence. The temptation to translate this information directly to the regulatory sphere without any kind of safety evaluation should be resisted.

PMID: 22507740 [PubMed - as supplied by publisher]

Squamous Cell Carcinomas of the Head and Neck in Fanconi Anemia: Risk, Prevention, Therapy, and the Need for Guidelines.

Klin Padiatr. 2012 Apr 13;

Authors: Scheckenbach K, Wagenmann M, Freund M, Schipper J, Hanenberg H

Abstract
Fanconi anemia (FA) is a rare recessive DNA repair disorder that is clinically characterized by congenital malformations, progressive bone marrow failure, and increased incidence of malignancies, especially acute myeloid leukemia and squamous cell carcinomas of the head and neck (HNSCCs) and the anogenital regions. On a cellular level, typical features of the disorder are a high degree of genomic instability and an increased sensitivity to bi-functionally alkylating agents. So far, germ-line defects in 15 different FA genes have been identified. Some of these FA genes are also established as tumor susceptibility genes for familiar cancers.In recent years, the prevention and therapy of HNSCCs in FA patients has become more important as the percentage of patients surviving into adulthood is rising. HNSCCs appear in very young FA patients without common risk factors. Since cisplatin-based chemotherapy in combination with radiotherapy, essential parts of the standard treatment approach for sporadic HNSCCs, cannot be used in FA patients due to therapy-associated toxicities and mortalities even with reduced dosing, surgery is the most important treatment option for HNSCCs, in FA patients and requires an early and efficient detection of malignant lesions. So far, no uniform treatment protocol for the management of HNSCCs in FA patients exists. Therefore, we propose that the information on affected FA patients should be collected worldwide, practical therapeutic guidelines developed and national treatment centers established.

PMID: 22504776 [PubMed - as supplied by publisher]

Newly Diagnosed Immune Thrombozytopenia - German Guideline Concerning Initial Diagnosis and Therapy.

Klin Padiatr. 2012 Apr 13;

Authors: Eberl W, Dickerhoff R

Abstract
Newly diagnosed immune thrombocytopenia occurs in 3-5/100 000 children < 14 y per year. Bleeding symptoms do not correlate with platelet count. Diagnostic approach includes history, clinical examination and analysis of blood count with blood smear by experienced hematologist. Additional investigations are only necessary in atypical cases and cases with additional symptoms or inadequate response to therapy. The decision to treat ITP should be made cautiously and not entirely be based on the platelet count. Decisions based on clinical symptoms and progress of the illness are more reasonable. There is no evidence, that therapy at the time of diagnosis influences the further course and can avoid intracerebral hemorrhage.

PMID: 22504770 [PubMed - as supplied by publisher]

The report of male gender and retinopathy status improves the current consensus guidelines for the screening of myocardial ischemia in asymptomatic type 2 diabetic patients.

Nutr Metab Cardiovasc Dis. 2012 Apr 12;

Authors: Cosson E, Nguyen MT, Chanu B, Balta S, Takbou K, Valensi P

Abstract
BACKGROUND AND AIMS: American Diabetes Association (ADA), French-speaking Societies for diabetes & cardiology (ALFEDIAM-SFC) and Cardiac Radionuclide Imaging (CRI) have proposed guidelines for the screening of silent myocardial ischemia (SMI). The aim of the study was to evaluate their diagnostic values and how to improve them. METHODS AND RESULTS: 731 consecutive type 2 diabetic patients with ≥1 additional risk factor were screened between 1992 and 2006 for SMI by stress myocardial scintigraphy and for silent coronary artery disease (CAD) by coronary angiography. A total of 215 (29.4%) patients had SMI, and 79 of them had CAD. ADA (Odds Ratio 1.7 [95% Confidence Interval: 1.2-2.5]; p < 0.05), ALFEDIAM-SFC (OR 1.5 [1.0-2.5], p < 0.05) and CRI criteria (OR 2.0 [1.4-2.8], p < 0.01) predicted SMI. Considering the presence of male gender and retinopathy added to the prediction of SMI allowed by ADA criteria (c statistic: area under the curve AROC 0.651 [0.605-0.697] versus 0.582 [0.534-0.630]), p < 0.01 and ALFEDIAM-SFC criteria (AROC 0.672 [0.620-0.719] versus 0.620 [0.571-0.670], p < 0.05). CRI prediction of SMI was improved by considering the presence of macroproteinuria and retinopathy (AROC 0.621 [0.575-0.667] versus 0.594 [0.548-0.641], p < 0.01). Severe retinopathy (OR 3.4 [1.2-9.4], p < 0.05), smoking habits (OR 2.1 [1.1-4.2], p < 0.05) and triglyceride levels (OR 1.3 [1.0-1.6], p < 0.05) were independent predictors of CAD in the patients with SMI. CONCLUSION: Current guidelines criteria are able to predict SMI but prediction may be improved by considering male gender and the presence of retinopathy. CAD is more frequent in the patients with SMI who are current smokers, have severe retinopathy and higher triglyceride levels.

PMID: 22502874 [PubMed - as supplied by publisher]

Guidelines for prospective authors to submit acceptable manuscripts to the Journal of the Acoustical Society of America.

J Acoust Soc Am. 2012 Apr;131(4):3432

Authors: Wu SF, Xiang N

Abstract
The Editor-In-Chief of the Journal of the Acoustical Society of America (JASA) has recently compiled a list of problems in the manuscripts submitted to JASA that often lead to an outright rejection by the Associate Editors handling their review. These problems often occur during submission and writing of a manuscript. They include selecting a title, listing the authors, composing an abstract, defining the scope of work, presenting the background and significance of the research, reporting and discussing the major discovery, ideas and results, showing the work and results that have been published by others in other journals already, drawing concise conclusions, citing references, displaying equations, figures, tables, etc. Last but not the least is the English writing that should be grammatically correct and easy to understand by someone with a similar background. This talk gives a quick overview of these potential problems, which are frequently shown in the manuscripts submitted by authors overseas. The goal of this talk is to provide helpful suggestions and guidelines to the prospective authors whose native language is not English to submit manuscripts that can pass the initial screening and ultimately get published in JASA. Disguised examples of some problematic manuscripts are discussed and analyzed.

PMID: 22502021 [PubMed - in process]

SURVEILLANCE GUIDELINES BASED ON RECURRENCE PATTERNS AFTER RADICAL CYSTECTOMY FOR BLADDER CANCER: THE CANADIAN BLADDER CANCER NETWORK EXPERIENCE.

BJU Int. 2012 Apr 13;

Authors: Daneshmand S

PMID: 22500693 [PubMed - as supplied by publisher]

Surveillance guidelines based on recurrence patterns after radical cystectomy for bladder cancer: the Canadian Bladder Cancer Network experience.

BJU Int. 2012 Apr 13;

Authors: Yafi FA, Aprikian AG, Fradet Y, Chin JL, Izawa J, Rendon R, Estey E, Fairey A, Cagiannos I, Lacombe L, Lattouf JB, Bell D, Saad F, Drachenberg D, Kassouf W

Abstract
Study Type - Prognosis (cohort) Level of Evidence 2a What's known on the subject? and What does the study add? Radical cystectomy with pelvic lymph node dissection is recognized as the standard of care for carcinoma invading bladder muscle and for refractory non-muscle-invasive bladder cancer. Owing to high recurrence and progression rates, a two-pronged strict surveillance regimen, consisting of both functional and oncological follow-up, has been advocated. It is also well recognized that more aggressive tumours with extravesical disease and node-positive disease recur more frequently and have worse outcomes. This study adds to the scant body of literature available regarding surveillance strategies after radical cystectomy for bladder cancer. In the absence of any solid evidence supporting the role of strict surveillance regimens, this extensive examination of recurrence patterns in a large multi-institutional project lends further support to the continued use of risk-stratified follow-up and emphasizes the need for earlier strict surveillance in patients with extravesical and node-positive disease. OBJECTIVES: •  To review our data on recurrence patterns after radical cystectomy (RC) for bladder cancer (BC). •  To establish appropriate surveillance protocols. PATIENTS AND METHODS: •  We collected and pooled data from a database of 2287 patients who had undergone RC for BC between 1998 and 2008 in eight different Canadian academic centres. •  Of the 2287 patients, 1890 had complete recurrence information and form the basis of the present study. RESULTS: •  A total of 825 patients (43.6%) developed recurrence. •  According to location, 48.6% of recurrent tumours were distant, 25.2% pelvic, 14.5% retroperitoneal and 11.8% to multiple regions such as pelvic and retroperitoneal or pelvic and distant. •  The median (range) time to recurrence for the entire population was 10.1 (1-192) months with 90 and 97% of all recurrences within 2 and 5 years of RC, respectively. •  According to stage, pTxN+ tumours were more likely to recur than ≥pT3N0 tumours and ≤pT2N0 tumours (5-yr RFS 25% vs. 44% vs. 66% respectively, P < 0.001). Similarly, pTxN+ tumours had a shorter median time to recurrence (9 months, range 1-72 months) than ≥pT3N0 tumours (10 months, range 1-70 months) or ≤pT2N0 tumours (14 months, range 1-192 months, P < 0.001). CONCLUSIONS: •  Differences in recurrence patterns after RC suggest the need for varied follow-up protocols for each group. •  We propose a stage-based protocol for surveillance of patients with BC treated with RC that captures most recurrences while limiting over-investigation.

PMID: 22500588 [PubMed - as supplied by publisher]

[Budget impact analysis of antiretroviral therapy. A reflection based on the GESIDA guidelines.]

Gac Sanit. 2012 Apr 10;

Authors:

Abstract
OBJECTIVE: The latest version of the Spanish clinical practice guidelines on antiretroviral therapy (ART) in HIV-infected adults, developed by the Spanish AIDS Study Group (GESIDA) and the National AIDS Plan, recommends initiating ART early in certain circumstances. The aim of this study was to estimate the budget impact of this recommendation by using the data from the VACH cohort. METHODS: We considered a scenario in which all naïve asymptomatic patients would initiate ART if they had <500 lymphocytes, or a CD4/μL count >500/μL if they were older than 55 years, or had high viral load, liver disease, chronic kidney disease or high cardiovascular risk. The study was designed as a cost analysis in terms of annual pharmaceutical expenditure. The only costs included were those relating to the ART combinations analyzed. To estimate these costs, we assumed that this guideline had a penetration of 80%, an adherence of 95% and 12% dropouts. RESULTS: A total of 12,500 patients were reviewed. Of these, 1,127 (10%) had not initiated ART; CD4 lymphocyte count was 350-500 in 294 (26.1%) and > 500 in 685 (60.8%). If the new clinical practice guideline were applied, 45.2% of naïve patients (95% CI: 42.4%-48.2%) would be advised to start ART. Carrying out this recommendation in hospitals of the VACH cohort would require an additional annual investment of € 3,270,975 and would increase the overall cost of antiretroviral drugs by 3%. CONCLUSIONS: In the framework of health economics, incorporating economic impact estimates - such as those performed in this study - into clinical practice guidelines would be advisable to increase their feasibility.

PMID: 22498716 [PubMed - as supplied by publisher]

Chronic solvent-induced encephalopathy: European consensus of neuropsychological assessment. Characteristics and guidelines.

Neurotoxicology. 2012 Apr 4;

Authors: van Valen E, van Thriel C, Akila R, Nilson LN, Bast-Pettersen R, Sainio M, van Dijk F, van der Laan G, Verberk M, Wekking E

Abstract
INTRODUCTION: The presence of neuropsychological impairment is a hallmark of chronic solvent-induced encephalopathy (CSE), and using clinical neuropsychological procedures to generate a valid assessment of the condition is crucial for its diagnosis. The goals of this consensus document are to provide updated knowledge of the neuropsychological characteristics of CSE and to provide internationally acceptable guidelines for using neuropsychological assessments in the process of diagnosing patients who are suspected of having CSE. MATERIALS AND METHODS: A European working group that was composed of experts in the field of the clinical diagnosis of CSE met at several round-table meetings and prepared this report. The first section of the consensus paper addresses a review of the relevant literature that was published between 1985 and March 2012. The second section addresses recommendations for the clinical neuropsychological assessment of patients who are suspected of having CSE. RESULTS: The literature review indicates that the most common neuropsychological impairments in CSE patients are within the domains of attention, particularly the speed of information processing, memory, and motor performance. It appears that the influence of CSE on memory processes mainly involves immediate recall and generally involves verbal, visual and visuospatial material. In the second section, six recommendations are presented regarding important functional domains for the neuropsychological diagnostic process of CSE that relate to the evaluation of neuropsychological impairment, the assessment and evaluation of symptoms, differential diagnostic considerations, the reliability and validity of neuropsychological test results, and the retesting of patients. DISCUSSION AND CONCLUSIONS: These recommendations will contribute to the improvement of the process for accurately diagnosing CSE, better counselling for CSE patients, the comparability of epidemiological data between countries, and finally, by raising awareness, these recommendations will contribute to combating the adverse health effects of occupational exposure to solvents.

PMID: 22498091 [PubMed - as supplied by publisher]

Guidelines for evaluating and managing children born with disorders of sexual development.

Pediatr Ann. 2012 Apr 1;41(4):e1-7

Authors: Douglas G, Axelrad ME, Brandt ML, Crabtree E, Dietrich JE, French S, Gunn S, Karaviti L, Lopez ME, Macias CG, McCullough LB, Suresh D, Austin E, Reid Sutton V

Abstract
Children born with disorders of sexual differentiation (DSD) pose numerous challenges for the parents, family, and treating physicians. The pediatrician is usually the first medical contact for newborns with DSD or for toddlers and children who present with DSD at a later time.Several years ago, we formed a Gender Medicine Team (GMT) at Baylor College of Medicine and Texas Children's Hospital (TCH) to explore and evaluate the most appropriate management strategies, which had long been a matter of concern and contention. Subsequently, the GMT, composed of experts in the fields of endocrinology, ethics, genetics, gynecology, psychology, pediatric surgery, and urology, formed a Task Force to evaluate the information available from our own experiences and from reviews of the literature. Utilizing the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) system to assess the evidence and recommendations, the Task Force developed a consensus statement for clinical management of DSD and for making appropriate sex assignments.

PMID: 22494213 [PubMed - in process]

Michigan oncology practices showed varying adherence rates to practice guidelines, but quality interventions improved care.

Health Aff (Millwood). 2012 Apr;31(4):718-28

Authors: Blayney DW, Severson J, Martin CJ, Kadlubek P, Ruane T, Harrison K

Abstract
Despite improvements in care for patients with cancer, and in their survival rates, it is not clear that best practices are uniformly delivered to patients. We measured the quality of outpatient cancer care, using validated quality measures, in a consortium of thirty-six outpatient oncology practices in Michigan. We discovered that throughout the measurement period, for breast and colorectal cancer care, there was a more than 85 percent rate of adherence to quality care processes. For end-of-life care processes, the adherence rate was 73 percent, and for symptom and toxicity management care processes, adherence was 56 percent. In particular, we found variations in care around the fundamental oncologic task of management of cancer pain. To address quality gaps, we developed interventions to improve adherence to treatment guidelines, improve pain management, and incorporate palliative care into oncology practice. We concluded that statewide consortia that assume much of the cost burden of quality improvement activities can bring together oncology providers and payers to measure quality and design interventions to improve care.

PMID: 22492888 [PubMed - in process]

Adherence to treatment guidelines and survival in patients with early-stage breast cancer by age at diagnosis.

Br J Surg. 2012 Jun;99(6):813-20

Authors: van de Water W, Bastiaannet E, Dekkers OM, de Craen AJ, Westendorp RG, Voogd AC, van de Velde CJ, Liefers GJ

Abstract
BACKGROUND: Elderly patients with breast cancer are under-represented in clinical studies. It is not known whether treatment guidelines, based on clinical trials, can be extrapolated to this population. The aim of this study was to assess adherence to treatment guidelines by age at diagnosis, and to examine age-specific survival in relation to adherence to guidelines.
METHODS: Patients with early-stage breast cancer aged either less than 65 years, or 75 years or more, diagnosed between 2005 and 2008, were identified from the Netherlands Cancer Registry. Adherence to treatment guidelines for breast and axillary surgery, radiotherapy, chemotherapy and endocrine therapy was determined. Non-adherence to the guidelines was defined as overtreatment or undertreatment. The primary endpoint was overall survival, assessed by means of an instrumental variable, the comprehensive cancer centre region.
RESULTS: Some 24 959 patients younger than 65 years and 6561 patients aged 75 years or more were included in the analysis. Median follow-up was 2·8 years. Compared with patients younger than 65 years, those aged at least 75 years were less frequently treated in concordance with guidelines: 62·0 per cent (15 487 patients) versus 55·6 per cent (3647 patients) (P < 0·001). In both age groups, most patients received at least three of five treatment modalities in concordance with guidelines: 98·8 per cent (24 652 patients) and 93·8 per cent (6152 patients) respectively. Analysis of survival using the instrumental variable showed that adherence to guidelines was not associated with overall survival in patients younger than 65 years (P = 0·601) or those aged at least 75 years (P = 0·190).
CONCLUSION: Adherence to treatment guidelines was affected by age at diagnosis. However, adherence to the guidelines was not associated with overall survival in either age group. Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

PMID: 22492310 [PubMed - in process]

[Auditory processing and perception disorders: proposed treatment and management : Guidelines of the German Society for Phoniatry and Pedaudiology].

HNO. 2012 Apr;60(4):359-68

Authors: Schönweiler R, Nickisch A, Am Zehnhoff-Dinnesen A

PMID: 22491883 [PubMed - in process]

Evidence and Insights in the NCCN Guidelines.

J Natl Compr Canc Netw. 2012 Apr 1;10(4):427-9

Authors: McClure JS

PMID: 22491042 [PubMed - in process]

British Dietetic Association evidence-based guidelines for the dietary management of irritable bowel syndrome in adults.

J Hum Nutr Diet. 2012 Apr 10;

Authors: McKenzie YA, Alder A, Anderson W, Wills A, Goddard L, Gulia P, Jankovich E, Mutch P, Reeves LB, Singer A, Lomer MC,

Abstract
McKenzie Y.A., Alder A., Anderson W., Wills A., Goddard L., Gulia P., Jankovich E., Mutch P., Reeves L.B., Singer A. & Lomer M.C.E. (2012) Evidence-based practice guidelines for the dietary management of irritable bowel syndrome in adults. J Hum Nutr Diet. ABSTRACT: Background:  Irritable bowel syndrome (IBS) is a chronic debilitating functional gastrointestinal disorder. Diet and lifestyle changes are important management strategies. The aim of these guidelines is to systematically review key aspects of the dietary management of IBS, with the aim of providing evidence-based guidelines for use by registered dietitians. Methods:  Questions relating to diet and IBS symptom management were developed by a guideline development group. These included the role of milk and lactose, nonstarch polysaccharides (NSP), fermentable carbohydrates in abdominal bloating, probiotics and empirical or elimination diets. A comprehensive literature search was conducted and relevant studies from January 1985 to November 2009 were identified using the electronic database search engines: Cinahl, Cochrane Library, Embase, Medline, Scopus and Web of Science. Evidence statements, recommendations, good practice points and research recommendations were developed. Results:  Thirty studies were critically appraised. A dietetic care pathway was produced following a logical sequence of treatment and formed the basis of these guidelines. Three lines of dietary management were identified. First line: Clinical and dietary assessment, healthy eating and lifestyle management with some general advice on lactose and NSP. Second line: Advanced dietary interventions to improve symptoms based on NSP, fermentable carbohydrates and probiotics. Third line: Elimination and empirical diets. Research recommendations were also identified relating to the need for adequately powered and well designed randomised controlled trials. Conclusions:  These guidelines provide evidence-based details of how to achieve the successful dietary management of IBS.

PMID: 22489905 [PubMed - as supplied by publisher]

Factors influencing intracranial pressure monitoring guideline compliance and outcome after severe traumatic brain injury.

Crit Care Med. 2012 Apr 6;

Authors: Biersteker HA, Andriessen TM, Horn J, Franschman G, van der Naalt J, Hoedemaekers CW, Lingsma HF, Haitsma I, Vos PE

Abstract
OBJECTIVE:: To determine adherence to Brain Trauma Foundation guidelines for intracranial pressure monitoring after severe traumatic brain injury, to investigate if characteristics of patients treated according to guidelines (ICP+) differ from those who were not (ICP-), and whether guideline compliance is related to 6-month outcome. DESIGN:: Observational multicenter study. PATIENTS:: Consecutive severe traumatic brain injury patients (≥16 yrs, n = 265) meeting criteria for intracranial pressure monitoring. MEASUREMENTS AND MAIN RESULTS:: Data on demographics, injury severity, computed tomography findings, and patient management were registered. The Glasgow Outcome Scale Extended was dichotomized into death (Glasgow Outcome Scale Extended = 1) and unfavorable outcome (Glasgow Outcome Scale Extended 1-4). Guideline compliance was 46%. Differences between the monitored and nonmonitored patients included a younger age (median 44 vs. 53 yrs), more abnormal pupillary reactions (52% vs. 32%), and more intracranial pathology (subarachnoid hemorrhage 62% vs. 44%; intraparenchymal lesions 65% vs. 46%) in the ICP+ group. Patients with a total intracranial lesion volume of ~150 mL and a midline shift of ~12 mm were most likely to receive an intracranial pressure monitor and probabilities decreased with smaller and larger lesions and shifts. Furthermore, compliance was low in patients with no (Traumatic Coma Databank I -10%) visible intracranial pathology. Differences in case-mix resulted in higher a priori probabilities of dying (median 0.51 vs. 0.35, p<.001) and unfavorable outcome (median 0.79 vs. 0.63, p<.001) in the ICP+ group. After correction for baseline and clinical characteristics with a propensity score, intracranial pressure monitoring guideline compliance was not associated with mortality (odds ratio 0.93, 95% confidence interval 0.47-1.85, p = .83) nor with unfavorable outcome (odds ratio 1.81, 95% confidence interval 0.88-3.73, p = .11). CONCLUSIONS:: Guideline noncompliance was most prominent in patients with minor or very large computed tomography abnormalities. Intracranial pressure monitoring was not associated with 6-month outcome, but multiple baseline differences between monitored and nonmonitored patients underline the complex nature of examining the effect of intracranial pressure monitoring in observational studies.

PMID: 22488001 [PubMed - as supplied by publisher]

The process of continuous journal improvement: New author guidelines for statistical and analytical reporting in VACCINE.

Vaccine. 2012 Apr 19;30(19):2915-7

Authors: Oberg AL, Poland GA

PMID: 22482869 [PubMed - in process]

Current Status of Preventive Cardiology Training Among United States Cardiology Fellowships and Comparison to Training Guidelines.

Am J Cardiol. 2012 Apr 4;

Authors: Pack QR, Keteyian SJ, McBride PE, Weaver WD, Kim HE

Abstract
We evaluated preventive cardiology education in United States cardiology fellowship programs and their adherence to Core Cardiovascular Training Symposium training guidelines, which recommend 1 month of training, faculty with expertise, and clinical experience in cardiac rehabilitation, lipid disorder management, and diabetes management as a part of the prevention curricula. We sent an anonymous survey to United States cardiology program directors and their chief fellow. The survey assessed the program curricula, rotation structure, faculty expertise, obstacles, and recommended improvements. The results revealed that 24% of surveyed programs met the Core Cardiovascular Training Symposium guidelines with a dedicated 1-month rotation in preventive cardiology, 24% had no formalized training in preventive cardiology, and 30% had no faculty with expertise in preventive cardiology, which correlated with fewer rotations in prevention than those with specialized faculty (p = 0.009). Fellows rotated though the following experiences (% of programs): cardiac rehabilitation, 71%; lipid management, 37%; hypertension, 15%; diabetes, 7%; weight management/obesity, 6%; cardiac nutrition, 6%; and smoking cessation, 5%. The program directors cited "lack of time" as the greatest obstacle to providing preventive cardiology training and the chief fellows reported "lack of a developed curriculum" (p = 0.01). The most recommended improvement was for the American College of Cardiology to develop a web-based curriculum/module. In conclusion, most surveyed United States cardiology training programs currently do not adhere to basic preventive cardiovascular medicine Core Cardiovascular Training Symposium recommendations. Additional attention to developing curricular content and structure, including the creation of an American College of Cardiology on-line knowledge module might improve fellowship training in preventive cardiology.

PMID: 22482864 [PubMed - as supplied by publisher]

Impact of adherence to the GOLD guidelines on symptom prevalence, lung function decline and exacerbation rate in the Swiss COPD cohort.

Swiss Med Wkly. 2012;142:0

Authors: Jochmann A, Scherr A, Jochmann D, Miedinger D, Schafroth T, Chhajed P, Tamm M, Leuppi J

Abstract
PRINCIPLES: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines aim to optimise chronic obstructive pulmonary disease (COPD) diagnosis and treatment. However, little is known about the extent to which general practitioners' (GP) adherence to GOLD guidelines improves patient outcomes.
METHODS: In this questionnaire-based study, COPD patients were screened and enrolled; exacerbation history was recorded, and demographic, spirometric and management data were collected for 12 months. Spirometry was performed at least every 6 months according to American Thoracic Society guidelines. Based on these data, patients were grouped into GOLD COPD severity classifications. Data were expressed as the difference between baseline and month 12.
RESULTS: Among 139 GPs, 454 patients were analysed regarding baseline and 12 month data. There was no significant change in distribution of GOLD COPD severity grades, lung function or guideline adherence. Chronic cough and sputum production were significantly reduced (p <0.001; p <0.020), as was exacerbation rate (p = 0.041). Factors associated with exacerbations were male sex, asthma and cerebrovascular insult as a co-morbidity. Exacerbation rate was significantly reduced in patients treated with combination therapy (long-acting β2-agonist (LABA)+ inhaled corticosteroids (ICS); p = 0.0178) and long-acting anticholinergics (LAAC; p = 0.0011). Patients treated per guidelines had no advantage in lung function, estimation of symptom prevalence or, most importantly, exacerbation rate.
CONCLUSIONS: While there was no improvement in adherence to GOLD guidelines, disease severity was not affected detrimentally, suggesting that guideline adherence does not seem to impact symptom prevalence, exacerbation rate or lung function decline after one year of follow up.

PMID: 22481636 [PubMed - in process]

Adherence to Clinical Guidelines Improves Patient Outcomes in Australian Audit of Stroke Rehabilitation Practice.

Arch Phys Med Rehabil. 2012 Apr 3;

Authors: Hubbard IJ, Harris D, Kilkenny MF, Faux SG, Pollack MR, Cadilhac DA

Abstract
Hubbard IJ, Harris D, Kilkenny MF, Faux SG, Pollack MR, Cadilhac DA. Adherence to clinical guidelines improves patient outcomes in Australian audit of stroke rehabilitation practice. OBJECTIVE: To study the correlation between adherence to recommended management and good recovery outcomes in an Australian cohort of inpatients receiving rehabilitation. DESIGN: Processes of care were audited and included those recommended in the Australian Clinical Guidelines for Stroke Rehabilitation and Recovery. SETTING: National audit data from 68 rehabilitation units were used, with each hospital contributing up to 40 consecutive cases. PARTICIPANTS: Not applicable. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Discharged home or an increase of greater than or equal to 22 in FIM scores between admission and discharge. Multivariable logistic regression models controlling for patient clustering were used to assess the associations between adherence to recommended management and recovery outcomes (dependent variables). RESULTS: Hospitals contributed 2119 patients (median age 75y, 53% men). We found that rehabilitation units providing evidence-based management (eg, treatment for sensorimotor impairment 38%, hypertonicity 56%, mobility 94%, and home assessments 71%) were more likely to provide better recovery outcomes for people with stroke. A discharge FIM score of 100 was clinically relevant and was strongly correlated with whether or not a patient was discharged home. We found very good correlation between admission and discharge FIM scores in stroke rehabilitation. CONCLUSIONS: This is one of the first study comparing adherence to recommended management in Australian rehabilitation units and stroke recovery outcomes based on national audit data. Novel findings include the significance of an FIM score between 80 and 100 and the clinical significance of various management processes.

PMID: 22480546 [PubMed - as supplied by publisher]

Guideliner microcatheter to improve back-up support during a complex coronary stenting procedure through a tortuous left internal mammary graft.

J Invasive Cardiol. 2012 Apr;24(4):E77-9

Authors: Park CI, Noble S, Bonvini RF

Abstract
Back-up support during percutaneous coronary interventions (PCI) is one of the keys for successful intervention. Extra back-up support guiding catheters, deep intubation, buddy wires, and other more complex techniques are usually used to improve this support. Left anterior descending (LAD) artery PCI through the left internal mammary artery (LIMA) are rarely performed because many operators feel reluctant to instrument a disease-free LIMA graft risking iatrogenic complications by passing wire, balloons, and stents to the diseased distal LAD. Improving back-up support during LIMA-LAD PCIs is often challenging because in this particular setting the distance between the LAD lesion and the guiding catheter is exceedingly long. We report a case of a challenging PCI of the LAD through a patent and disease-free LIMA graft. After multiple failed attempts to cross the LAD lesion with conventional stent deployment techniques, we successfully finished the stenting procedure using the Guideliner microcatheter (Vascular Solutions) as a guiding extension through the LIMA graft. With this case, we illustrate that this microcatheter dramatically improves the back-up support, allowing stent deployment also in very difficult settings as in tortuous LIMA grafts.

PMID: 22477763 [PubMed - in process]

SIE, SIES, GITMO evidence-based guidelines on novel agents (thalidomide, bortezomib, and lenalidomide) in the treatment of multiple myeloma.

Ann Hematol. 2012 Apr 4;

Authors: Barosi G, Merlini G, Billio A, Boccadoro M, Corradini P, Marchetti M, Massaia M, Tosi P, Palumbo A, Cavo M, Tura S

Abstract
In this project, we produced drug-specific recommendations targeting the use of new agents for multiple myeloma (MM). We used the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) system which separates the judgments on quality of evidence from the judgment about strength of recommendations. We recommended thalidomide and bortezomib in MM patients candidates to autologous stem cell transplantation (ASCT) (weak positive). We did not recommend novel agents as maintenance therapy after ASCT (weak negative). In patients not candidate to ASCT, thalidomide or bortezomib (strong positive) associated with melphalan and prednisone were recommended. In these patients, no specific course of action could be recommended as for maintenance therapy. In patients who are refractory or relapsing after first-line therapy, we recommended bortezomib and pegylated liposomal doxorubicin, or lenalidomide and dexamethasone combinations (weak positive).

PMID: 22476884 [PubMed - as supplied by publisher]

Best Practice Guidelines on Surgical Response in Disasters and Humanitarian Emergencies: Report of the 2011 Humanitarian Action Summit Working Group on Surgical Issues within the Humanitarian Space.

Prehosp Disaster Med. 2012 Apr 4;:1-8

Authors: Chackungal S, Nickerson JW, Knowlton LM, Black L, Burkle FM, Casey K, Crandell D, Demey D, Giacomo LD, Dohlman L, Goldstein J, Gosney JE, Ikeda K, Linden A, Mullaly CM, O'Connell C, Redmond AD, Richards A, Rufsvold R, Santos AL, Skelton T, McQueen K

Abstract
The provision of surgery within humanitarian crises is complex, requiring coordination and cooperation among all stakeholders. During the 2011 Humanitarian Action Summit best practice guidelines were proposed to provide greater accountability and standardization in surgical humanitarian relief efforts. Surgical humanitarian relief planning should occur early and include team selection and preparation, appropriate disaster-specific anticipatory planning, needs assessment, and an awareness of local resources and limitations of cross-cultural project management. Accurate medical record keeping and timely follow-up is important for a transient surgical population. Integration with local health systems is essential and will help facilitate longer term surgical health system strengthening.

PMID: 22475370 [PubMed - as supplied by publisher]

Appropriate chemotherapy dosing for obese adult patients with cancer: american society of clinical oncology clinical practice guideline.

J Clin Oncol. 2012 May 1;30(13):1553-61

Authors: Griggs JJ, Mangu PB, Anderson H, Balaban EP, Dignam JJ, Hryniuk WM, Morrison VA, Pini TM, Runowicz CD, Rosner GL, Shayne M, Sparreboom A, Sucheston LE, Lyman GH

Abstract
PURPOSE To provide recommendations for appropriate cytotoxic chemotherapy dosing for obese adult patients with cancer. METHODS The American Society of Clinical Oncology convened a Panel of experts in medical and gynecologic oncology, clinical pharmacology, pharmacokinetics and pharmacogenetics, and biostatistics and a patient representative. MEDLINE searches identified studies published in English between 1996 and 2010, and a systematic review of the literature was conducted. A majority of studies involved breast, ovarian, colon, and lung cancers. This guideline does not address dosing for novel targeted agents. Results Practice pattern studies demonstrate that up to 40% of obese patients receive limited chemotherapy doses that are not based on actual body weight. Concerns about toxicity or overdosing in obese patients with cancer, based on the use of actual body weight, are unfounded. Recommendations The Panel recommends that full weight-based cytotoxic chemotherapy doses be used to treat obese patients with cancer, particularly when the goal of treatment is cure. There is no evidence that short- or long-term toxicity is increased among obese patients receiving full weight-based doses. Most data indicate that myelosuppression is the same or less pronounced among the obese than the non-obese who are administered full weight-based doses. Clinicians should respond to all treatment-related toxicities in obese patients in the same ways they do for non-obese patients. The use of fixed-dose chemotherapy is rarely justified, but the Panel does recommend fixed dosing for a few select agents. The Panel recommends further research into the role of pharmacokinetics and pharmacogenetics to guide appropriate dosing of obese patients with cancer.

PMID: 22473167 [PubMed - in process]

The guideline implementability research and application network (GIRAnet): an international collaborative to support knowledge exchange: study protocol.

Implement Sci. 2012;7(1):26

Authors: Gagliardi AR, Brouwers MC, Bhattacharyya OK

Abstract
UNLABELLED: ABSTRACT:
BACKGROUND: Modifying the format and content of guidelines may facilitate their use and lead to improved quality of care. We reviewed the medical literature to identify features desired by different users and associated with guideline use to develop a framework of implementability and found that most guidelines do not contain these elements. Further research is needed to develop and evaluate implementability tools.
METHODS: We are launching the Guideline Implementability Research and Application Network (GIRAnet) to enable the development and testing of implementability tools in three domains: Resource Implications, Implementation, and Evaluation. Partners include the Guidelines International Network (G-I-N) and its member guideline developers, implementers, and researchers. In phase one, international guidelines will be examined to identify and describe exemplar tools. Indication-specific and generic tools will populate a searchable repository. In phase two, qualitative analysis of cognitive interviews will be used to understand how developers can best integrate implementability tools in guidelines and how health professionals use them for interpreting and applying guidelines. In phase three, a small-scale pilot test will assess the impact of implementability tools based on quantitative analysis of chart-based behavioural outcomes and qualitative analysis of interviews with participants. The findings will be used to plan a more comprehensive future evaluation of implementability tools.
DISCUSSION: Infrastructure funding to establish GIRAnet will be leveraged with the in-kind contributions of collaborating national and international guideline developers to advance our knowledge of implementation practice and science. Needs assessment and evaluation of GIRAnet will provide a greater understanding of how to develop and sustain such knowledge-exchange networks. Ultimately, by facilitating use of guidelines, this research may lead to improved delivery and outcomes of patient care.

PMID: 22471937 [PubMed - in process]

Prescribing and guidelines: both must improve to combat antimicrobial resistance.

Eur Respir J. 2012 Apr;39(4):1050

Authors: Thomas M, Price DB, Chisholm A

PMID: 22467732 [PubMed - in process]

[Short Version S3 Guideline Sedation for Gastrointestinal Endoscopy und medicolegal implications].

Z Gastroenterol. 2012 Apr;50(4):407-10

Authors: Riphaus A, Bitter H

Abstract
With the publication of the first German S3 guideline on sedation for gastrointestinal endoscopy, the topic sedation has recently attracted the interest not only of physicians and medical assistants but also of the general public. It remains the topic of many, often controversial, discussions. This discussion arises mainly because of the fact that with the guideline - although giving a structured survey of the already existing requirements on structural as well as personnel qualifications - more emphasis is placed on the necessary personnel resources, standards for adequate patient information on the sedation, and risk stratification for the patient with the publication of the guideline.

PMID: 22467544 [PubMed - in process]

Spontaneous occlusion of the circle of Willis in children: pediatric moyamoya summary with proposed evidence-based practice guidelines.

J Neurosurg Pediatr. 2012 Apr;9(4):353-60

Authors: Smith ER, Scott RM

Abstract
Moyamoya is a progressive arteriopathy of unknown origin affecting the branches of the internal carotid artery (ICA). The arteriopathy can present as an isolated medical condition, affecting both sides of the brain ("moyamoya disease") or can be unilateral or found in association with systemic disorders ("moyamoya syndrome"). The ischemia resulting from luminal narrowing predisposes children to transient ischemic attacks and stroke-the primary presentations of affected patients. Although it is rare-affecting 1 in 1 million children in the US-moyamoya is implicated in 6% of all childhood strokes. Diagnosis is defined by characteristic findings on arteriograms, including stenosis of the branches of the ICA and a pathognomonic spray of small collateral vessels in this region, descriptively likened to a "puff of smoke" ("moyamoya" in Japanese). Treatment is predicated on restoration of cerebral blood flow by surgical revascularization. The rarity of this disorder has limited research and the development of evidence-based clinical management. While acknowledging these limitations, in this article the authors aim to summarize current studies of pediatric moyamoya, with the objective of providing a framework for construction of evidence-based guidelines for treatment. The compilation of current data in these guidelines should serve as a resource to aid pediatric neurosurgeons in their role as advocates for providing appropriate care to affected children.

PMID: 22462697 [PubMed - in process]

The process of reconciliation: evaluation of guidelines for translating quality-of-life questionnaires.

Expert Rev Pharmacoecon Outcomes Res. 2012 Apr;12(2):189-197

Authors: Koller M, Kantzer V, Mear I, Zarzar K, Martin M, Greimel E, Bottomley A, Arnott M, Kuliś D,

Abstract
Reconciliation refers to the process through which two or more independent forward translations are merged into one single translation. This critical step in the translation process is difficult to formalize. The purpose of this review is to analyze how reconciliation is specified in leading guidelines for the translation of quality-of-life questionnaires and other patient-reported outcome forms with regard to the number and qualifications of individuals involved, the processes followed, as well as the criteria applied. In general, relatively little attention has been paid to characterizing the process in detail. Based on these findings, we specify criteria to be followed.

PMID: 22458620 [PubMed - as supplied by publisher]

Acute coronary syndromes: considerations for improved acceptance and implementation of management guidelines.

Expert Rev Cardiovasc Ther. 2012 Apr;10(4):489-503

Authors: Van de Werf F, Ardissino D, Bueno H, Collet JP, Gershlick A, Kolh P, Kristensen SD, Silber S, Verheugt F, Wojakowski W

Abstract
The management of acute coronary syndrome in Europe is covered by various European Society of Cardiology guidelines, which although valuable, are complex and may not always provide clear guidance in everyday clinical practice. Consequently, implementation of the guideline recommendations is frequently suboptimal. To complicate matters further, a wealth of new data from large trials examining novel anti-thrombotic agents will become or are already available, necessitating guideline updates. This article summarizes the gaps between current guideline-recommended treatment of acute coronary syndrome and daily practice as dictated by the evidence base, including recent trials. Reasons for the suboptimal implementation of the current European Society of Cardiology guidelines and possible solutions to making these more practice oriented are presented.

PMID: 22458581 [PubMed - in process]

[Anemia in the elderly : Urgent need for guidelines].

Z Gerontol Geriatr. 2012 Apr;45(3):182-5

Authors: Röhrig G, Schulz RJ

Abstract
The prevalence of anemia in the elderly is high and can reach among independent community-dwelling persons > 20% and among hospitalized geriatric patients up to 40%. Anemia in the elderly has numerous causes rather than being clearly age related. Although it is widely acknowledged that anemia influences morbidity and mortality in geriatric patients in a negative manner, guidelines concerning diagnostics and therapeutic steps do not exist in Germany. We present a work-up of guidelines of German (AWMF) and international (G-I-N, NGC) specialists' societies dealing with the subject "anemia." Regarding the demographic changes with a growing population of geriatric patients with anemia, the development of a national (German) guideline for an ethically acceptable and cost-effective management of anemia in the elderly is necessary.

PMID: 22454096 [PubMed - in process]

Identifying best practice guidelines for debriefing in surgery: a tri-continental study.

Am J Surg. 2012 Apr;203(4):523-9

Authors: Ahmed M, Sevdalis N, Paige J, Paragi-Gururaja R, Nestel D, Arora S

Abstract
BACKGROUND: Changes in surgical training have decreased opportunities for experiential learning in the operating room (OR). With this decrease, a commensurate increase in debriefing-dependent simulation-based activities has occurred. Effective debriefing could optimize learning from both simulated and real clinical encounters.
METHODS: Thirty-three semistructured interviews with surgeons, anesthesiologists, and OR nurses from the United Kingdom, United States, and Australia identified the goals of debriefing, core components of an effective debrief, and solutions to its effective implementation. Interviews were audiotaped, transcribed, and coded using emergent theme analysis.
RESULTS: Core components of an effective debrief include having the appropriate approach, establishing a learning environment, learner engagement, managing learner reaction, reflection, analysis, diagnosis, and application to real clinical practice. Solutions to enhance practice involve promotion of a debriefing culture within the surgical community with protected time to conduct a structured debriefing.
CONCLUSIONS: A need exists to enhance surgical training through regular structured debriefing. Identifying the key components of an effective debrief is a first step toward improving practice and embedding a debriefing culture within the OR.

PMID: 22450027 [PubMed - in process]

Evidence lacking on anticoagulation therapy practices, guidelines say.

Am J Health Syst Pharm. 2012 Apr 1;69(7):538-9

Authors: Traynor K

PMID: 22441778 [PubMed - in process]

Neonatal outcomes after implementation of guidelines limiting elective delivery before 39 weeks of gestation.

Obstet Gynecol. 2012 Apr;119(4):870; author reply 870-1

Authors: Tita AT, Owen J

PMID: 22433357 [PubMed - in process]

[Guideline to prevent claims due to medical malpractice, on how to act when they do occur and how to defend oneself through the courts].

Rev Clin Esp. 2012 Apr;212(4):198-205

Authors: Bruguera M, Arimany J, Bruguera R, Barberia E, Ferrer F, Sala J, Pujol Robinat A, Medallo Muñiz J

Abstract
Claims due to presumed medical malpractice are increasing in all developed countries and many of them have no basis. To prevent legal complaints, the physicians should know the reasons why complaints are made by their patients and adopt the adequate preventive measures. In the case of a complaint, it is essential to follow the guidelines that allow for adequate legal defense and the action of the physician before the judge that inspires confidence and credibility. The risk of the claims can be reduced with adequate information to the patient, the following of the clinical guidelines, control of the risk factors and adoption of verification lists in each invasive procedure. In case of complication or serious adverse effect, explanations should be given to the patient and family and it should be reported to the facility where one works and to the insurance company. If the physician received a claim, he/she should report it to the insurance compare so that it can name a lawyer responsible for the legal defense who will advise the physician regarding the appearance in court before the judge.

PMID: 22397887 [PubMed - in process]

Clinical pharmacogenetics implementation consortium guidelines for HLA-B genotype and abacavir dosing.

Clin Pharmacol Ther. 2012 Apr;91(4):734-8

Authors: Martin MA, Klein TE, Dong BJ, Pirmohamed M, Haas DW, Kroetz DL

Abstract
Human leukocyte antigen B (HLA-B) is responsible for presenting peptides to immune cells and plays a critical role in normal immune recognition of pathogens. A variant allele, HLA-B*57:01, is associated with increased risk of a hypersensitivity reaction to the anti-HIV drug abacavir. In the absence of genetic prescreening, hypersensitivity affects ~6% of patients and can be life-threatening with repeated dosing. We provide recommendations (updated periodically at http://www.pharmkgb.org) for the use of abacavir based on HLA-B genotype.

PMID: 22378157 [PubMed - in process]

Adherence to HIV treatment guidelines for comorbid disease assessment and initiation of antiretroviral therapy.

J Acquir Immune Defic Syndr. 2012 Apr 15;59(5):478-88

Authors: Bloch M, Hoy J, Cunningham N, Roth N, Bailey M, Pierce A, Watson J, Carr A

Abstract
BACKGROUND: There are limited data on adherence to HIV treatment guidelines. We assessed adherence to US Department of Health and Human Services guidelines with Australian Commentary for adults initiating antiretroviral therapy (ART).
METHODS: Data were recorded regarding "when to start", "what to start" and pre-ART comorbid disease assessment for consecutive adults initiating ART at primary care and hospital clinics in Sydney and Melbourne from 2004 through 2008. Independent predictors of adherence to guidelines were calculated by stepwise logistic regression.
RESULTS: For the 500 subjects (95.9% male, mean 40.2 years, median CD4 count 270 cells/μL) "when to start" adherence was 87.6%, and was less likely with initiation in a clinical trial [0.25 (95% CI: 0.13 to 0.49); P < 0.0001] and previous, short-term nontherapeutic antiretroviral exposure [0.08 (0.03 to 0.25); P < 0.0001]. "What to start" adherence was 69.0% for guideline-"preferred" regimens (85.8% for guideline-"preferred" or "alternative" regimens) and more likely with ART initiated in 2008 versus pre-2008 [OR: 2.69 (1.64 to 4.61); P = 0.0001]. Median comorbid disease assessment adherence was 56.8%, ranging from 25.6% for urinalysis to 99.2% for white blood cell count, and was more likely in patients with AIDS, and initiating ART in hospital or in a clinical trial. Hospital clinics were more likely to perform antiretroviral resistance testing (71.2% vs. 46.4%, P < 0.0001), to use "preferred" ART regimens (76.8% vs. 62.2%, P = 0.0002) but less likely to promote healthy diet and lifestyle (63.4% vs. 36.4%, P < 0.0001).
CONCLUSIONS: "When to start" and "what to start" guidelines have been largely adhered to in Australia, but pre-ART comorbid disease assessment requires greater attention.

PMID: 22367456 [PubMed - indexed for MEDLINE]

System Accuracy Evaluation for Blood Glucose Measurements Should Be Performed in Accordance with ISO 15197:2003 and CLSI-Approved Guideline EP7-A2.

Diabetes Technol Ther. 2012 Apr;14(4):379-80

Authors: Hinzmann R, Tran CT

PMID: 22335617 [PubMed - in process]

Short term impact of guidelines on vancomycin dosing and therapeutic drug monitoring.

Int J Clin Pharm. 2012 Apr;34(2):282-5

Authors: Swartling M, Gupta R, Dudas V, Guglielmo BJ

Abstract
Background After medical center implementation of 2009 ASHP/IDSA guidelines, we evaluated the appropriateness of vancomycin dosing and TDM. Objective Our primary objectives were to assess short term effects on (1) appropriateness of initial vancomycin dosing, (2) appropriateness of sampling of plasma levels, before and after implementation of guidelines. Method The study was conducted in two phases, pre-guideline and post-guideline implementation. The interventions included (1) Nurses and phlebotomist education regarding the appropriate timing of vancomycin sampling, (2) A nomogram for appropriate initial dosing that was distributed to medical staff. Patient demographics, dosing and timing of sampling were collected in eligible patients and assessed for appropriateness. Results The appropriateness of the prescribed dose increased from 51% (128/253) of patients during the pre period to 78% (155/200) (p < 0.0001) during the post period. Similarly, overall appropriateness of sampling of vancomycin troughs at steady state improved from 36% (63/173) pre to 55% (106/191) (p < 0.03) post. Specifically, the appropriate timing of troughs (within 30 min of the next dose) increased from 37% (64/173) during the pre period to 78% (149/191) during the post period (p < 0.0001). Conclusion Adoption of the guidelines with associated training resulted in significant short term improvement in vancomycin dosing and TDM.

PMID: 22331444 [PubMed - in process]

The use of design-based stereology to evaluate volumes and numbers in the liver: a review with practical guidelines.

J Anat. 2012 Apr;220(4):303-17

Authors: Marcos R, Monteiro RA, Rocha E

Abstract
Stereology offers a number of tools for the analysis of sections in microscopy (which usually provide only two-dimensional information) for the purpose of estimating geometric quantities, such as volume, surface area, length or number of particles (cells or other structures). The use of these tools enables recovery of the three-dimensional information that is inherent in biological tissues. This review uses the liver as a paradigm for summarizing the most commonly used state-of-the-art methods for quantitation in design-based stereology. Because it is often relevant to distinguish hyperplasia and hypertrophy in liver responses, we also focus on potential pitfalls in the sampling and processing of liver specimens for stereological purposes, and assess the existing methods for volume and number estimation. With respect to volume, we considered whole liver volume (V), volume density (V(V)) and so-called local volumes, including the number-weighted volume (V(N)) and the volume-weighted volume (V(V)). For number, we considered the total number (N) and the numerical density (N(V)). If correctly applied, current stereological methods guarantee that no bias is introduced in the estimates, which will be therefore accurate; additionally, methods can be tuned for obtaining precise quantitative estimates that can reveal subtle changes in the volume or number of selected hepatic cells. These methods have already detailed the effects of some substances and specific diets on the liver, and should be routinely included in the toolbox of liver research.

PMID: 22296163 [PubMed - in process]

A review of the use of the dermatology life quality index as a criterion in clinical guidelines and health technology assessments in psoriasis and chronic hand eczema.

Dermatol Clin. 2012 Apr;30(2):237-44, viii

Authors: Basra MK, Chowdhury MM, Smith EV, Freemantle N, Piguet V

Abstract
The Dermatology Life Quality Index (DLQI) is an easy and practical way of quantifying the impact of skin disease. The role of DLQI in treatment guidelines and its emergence as an eligibility and response criterion in health technology appraisal are discussed. This review analyzes the current available literature on the clinical use of the DLQI, with particular reference to its relationship with disease severity and as a criterion in the assessment of health technology. The need for future studies of chronic hand eczema to incorporate DLQI to document quality-of-life outcomes with new treatments is also discussed.

PMID: 22284138 [PubMed - in process]

[Changing the treatment goal at the end of life: effects of a guideline at a hospital].

Dtsch Med Wochenschr. 2012 Apr;137(16):829-33

Authors: Jox RJ, Winkler EC, Borasio GD

Abstract
Background and objective: Deciding about treatment goals at the end of life is a frequent and difficult challenge to medical staff. As more health care institutions issue ethico-legal guidelines to their staff the effects of such a guideline should be investigated in a pilot project.Participants and methods: Prospective evaluation study using the pre-post method. Physicians and nurses working in ten intensive care units of a university medical center in Germany answered a specially designed questionnaire before and one year after issuance of the guideline.Results: 197 analyzable answers were obtained from the first (pre-guideline) and 251 from the second (post-guideline) survey (54 % and 58 % response rate, respectively). Initially the clinicians expressed their need for guidelines, advice on ethical problems, and continuing education. One year after introduction of the guideline one third of the clinicians was familiar with the guideline's content and another third was aware of its existence. 90% of those who knew the document welcomed it. Explanation of the legal aspects was seen as its most useful element. The pre- and post-guideline comparison demonstrated that uncertainty in decision making and fear of legal consequences were reduced, while knowledge of legal aspects and the value given to advance directives increased. The residents had derived the greatest benefit.Conclusion: By promoting the knowledge of legal aspects and ethical considerations, guidelines given to medical staff can lead to more certainty when making in end of life decision.

PMID: 22278719 [PubMed - in process]

Dental Trauma Guide: a source of evidence-based treatment guidelines for dental trauma.

Dent Traumatol. 2012 Apr;28(2):142-7

Authors: Andreasen JO, Lauridsen E, Gerds TA, Ahrensburg SS

Abstract
Diagnosis and treatment for traumatic dental injuries are very complex owing to the multiple trauma entities represented by six luxation types and nine fracture types affecting both the primary and the permanent dentition. When it is further considered that fracture and luxation injuries are often combined, the result is that more than 100 trauma scenarios exist, when the two dentitions are combined. Each of these trauma scenarios has a specific treatment demand and prospect for healing. With such a complexity in diagnosis and treatment, it is obvious that even experienced practitioners may have problems in selecting proper treatment for some of these trauma types. To remedy this situation, an Internet-based knowledge base consisting of 4000 dental trauma cases with long-term follow up is now available to the public and the professions on the Internet using the address http://www.DentalTraumaGuide.org. It is the aspiration that the use of this Guide may lead the practitioner to offer an evidence-based diagnosis and treatment.

PMID: 22272918 [PubMed - in process]

Impact of a region wide antimicrobial stewardship guideline on urinary tract infection prescription patterns.

Int J Clin Pharm. 2012 Apr;34(2):325-9

Authors: Slekovec C, Leroy J, Vernaz-Hegi N, Faller JP, Sekri D, Hoen B, Talon D, Bertrand X

Abstract
Background Fluoroquinolones are frequently prescribed for non complicated urinary tract infection treatments and have a negative ecological impact. We aimed to substitute them by antibiotics with narrower activity spectrum in order to preserve fluoroquinolone activity in complicated hospital infections. Objective To assess the impact of a multi-modal approach that combines the dispatching of antibiotic prescription guidelines and voluntary attendance at educational sessions on general practitioners' (GP) antibiotic prescription habits. Setting This study was led in Franche-Comté, a French eastern region, where GPs were given a guideline recommending a restricted use of fluoroquinolones for urinary tract infections. Method Segmented regression analysis of interrupted time series was used to assess changes in antibiotic prescription. Main outcome measure: The antibiotic prescription data of nitrofurantoin, fosfomycin-trometamol and fluoroquinolones for women aged 15-65 years were obtained from the regional agency of health insurance. Results Twenty months after intervention, the number of nitrofurantoin and fosfomycintrometamol prescriptions increased by 36.8% (95% CI: 30.6-42.2) and 28.5% (95% CI: 22.9-35.4), respectively, while that of norfloxacin decreased by 9.1% (95% CI: -15.3 to -3.5). Conclusion This study suggests that the dispatch of the guideline on urinary tract infection had a moderate impact on antibiotic prescriptions.

PMID: 22252772 [PubMed - in process]

Impact of the European Paediatric Life Support Course on knowledge of Resuscitation Guidelines among Austrian emergency care providers.

Minerva Anestesiol. 2012 Apr;78(4):434-41

Authors: Schebesta K, Rössler B, Kimberger O, Hüpfl M

Abstract
BACKGROUND: Even though anaesthetists do not resuscitate children on a daily basis, they need to perform paediatric life support regularly due to their different duties. As the knowledge of international guidelines varies widely, highly standardized European Paediatric Life Support (EPLS) courses have been introduced to improve standards of care. This national survey among Austrian anaesthetists and EPLS course participants evaluated the impact of this course at the end of the guideline period 2005-2010.
METHODS: After approval by the institutional review board an online survey about paediatric resuscitation guidelines was sent to EPLS course participants of the guideline period 2005 (EPLS group) and members of the Austrian Society of Anaesthesia, Resuscitation and Intensive Care (ÖGARI) two weeks before publication of the resuscitations guidelines 2010. Respondents without an EPLS course were assigned to the non-EPLS group.
RESULTS: Of 333 respondents 247 finished the survey. One hundred eighty five persons were assigned to EPLS group and 62 to the non-EPLS group. Members of the EPLS group performed significantly better than the non-EPLS group (76±19% correct answers EPLS group vs. 63±18% correct answers non-EPLS group, p<0.0001). Furthermore, the EPLS group performed better than anesthetists with regular resuscitation training and or resuscitation experience but without an EPLS course.
CONCLUSION: The attendance of an EPLS course within the guideline period 2005 significantly increased the theoretical knowledge of paediatric resuscitation guidelines.

PMID: 22240622 [PubMed - in process]

Sub-optimal achievement of guideline-derived lipid goals in management of diabetes patients with atherosclerotic cardiovascular disease, despite high use of evidence-based therapies.

Diab Vasc Dis Res. 2012 Apr;9(2):138-45

Authors: Deguzman PB, Akosah KO, Simpson AG, Barbieri KE, Megginson GC, Goldberg RI, Beller GA

Abstract
Guidelines recommend aggressive goals for lipid and blood pressure reduction for high risk patients with diabetes mellitus and atherosclerotic coronary disease. However, it remains unclear how many patients achieve treatment goals versus the number of people merely placed on treatment. We conducted an observational study in an academic cardiology clinic. A total of 926 patients with atherosclerotic cardiovascular disease and concomitant diabetes mellitus met criteria. Mean age was 68.4 ± 10.2, 65.6% were male, and 86.8% were Caucasian. By the last visit a high percentage of patients were receiving recommended medications. Mean LDL-cholesterol achieved was 80.4 mg/dl with 40.9% reaching ≤ 70 mg/dl, and 61.7% reaching SBP ≤ 130 mmHg. Many patients with diabetes mellitus and atherosclerotic cardiovascular disease are prescribed recommended medications; however, few achieve guidelines-specified therapeutic goals for LDL-cholesterol and blood pressure. Studies evaluating performance improvement should include percentage of patients reaching treatment goals. Mechanisms underlying the treatment gap need to be identified and addressed.

PMID: 22234950 [PubMed - in process]

Bending the prescription opioid dosing and mortality curves: impact of the Washington State opioid dosing guideline.

Am J Ind Med. 2012 Apr;55(4):325-31

Authors: Franklin GM, Mai J, Turner J, Sullivan M, Wickizer T, Fulton-Kehoe D

Abstract
BACKGROUND: Opioid use and dosing for patients with chronic non-cancer pain have dramatically increased over the past decade, resulting in a national epidemic of mortality associated with unintentional overdose, and increased risk of disability among injured workers. We assessed changes in opioid dosing patterns and opioid-related mortality in the Washington State (WA) workers' compensation system following implementation of a specific WA opioid dosing guideline in April, 2007.
METHODS: Using detailed computerized billing data from WA workers' compensation, we report overall prevalence of opioid prescriptions, average morphine-equivalent dose (MED)/day, and proportion of workers on disability compensation receiving opioids and high-dose (≥120 mg/day MED) opioids over the past decade. We also report the trend of unintentional opioid deaths during the same time period.
RESULTS: Compared to before 2007, there has been a substantial decline in both the MED/day of long-acting DEA Schedule II opioids (by 27%) and the proportion of workers on doses ≥120 md/day MED (by 35%). There was a 50% decrease from 2009 to 2010 in the number of deaths.
CONCLUSIONS: The introduction in WA of an opioid dosing guideline appears to be associated temporally with a decline in the mean dose for long-acting opioids, percent of claimants receiving opioid doses ≥120 mg MED per day, and number of opioid-related deaths among injured workers.

PMID: 22213274 [PubMed - in process]

Triple-negative breast cancer: the impact of guideline-adherent adjuvant treatment on survival-a retrospective multi-centre cohort study.

Breast Cancer Res Treat. 2012 Apr;132(3):1073-80

Authors: Schwentner L, Wolters R, Koretz K, Wischnewsky MB, Kreienberg R, Rottscholl R, Wöckel A

Abstract
Triple-negative breast cancer (TNBC) (ER-/PGR-/erb-2-) constitutes an aggressive subtype in breast cancer because it is accompanied by a significant decrease in overall survival (OAS) and recurrence-free survival (RFS) compared with hormone receptor positive breast cancers. This retrospective cohort study investigates the following issues: (1) Is there an impact of guideline-adherent treatment on RFS and OAS in TNBC? (2) Which adjuvant treatment has the most important impact on RFS and OAS in TNBC? This German retrospective multi-centre cohort study included 3,658 patients with primary breast cancer recruited from 2000 to 2005. The definition of guideline adherence was based on the German national S3 guideline for diagnosis and treatment of breast cancer (2004). A total of 371 patients (10.1%) had TNBC. Compared with HR+/erb-2- breast cancer (P = 0.001; HR = 1.75; 95% CI: 1.27-2.40), the recurrence rate of TNBC was significantly higher (P < 0.001; HR = 2.86; 95% CI: 2.17-3.76). Furthermore, the 5-year RFS and OAS was significantly lower in TNBC (RFS: 74.8% [95% CI: 68.8-80.8%] vs. 86.5% [95% CI: 84.6-88.4%] [log-rank P = 0.0001]) (OAS: 75.8% [95% CI: 69.9-81.8%] vs. 86.0% [95% CI: 84.1-87.9%] [log-rank P = 0.0001]). The most important parameters predicting RFS and OAS in TNBC after receiving guideline-conform chemotherapy are guideline-adherent surgery, radiotherapy, nodal status and grading. Overall, 66.8% TNBC were found with one or more (18%) guideline violations, which subsequently impaired OAS and RFS. The most important impact on OAS and RFS in TNBC patients was because of guideline violations (GV) concerning adjuvant radiotherapy and GV concerning adjuvant chemotherapy. Patients with TNBC primarily have a worse prognosis in terms of RFS and OAS than patients of a primarily non-TNBC phenotype. There is a strong association between guideline-adherent adjuvant treatment and improved survival outcome in TNBC. The outcome significantly decreases with the number of guideline violations.

PMID: 22205141 [PubMed - in process]

Implementation of pharmacotherapy guidelines in heart failure: experience from the German Competence Network Heart Failure.

Clin Res Cardiol. 2012 Apr;101(4):263-72

Authors: Zugck C, Franke J, Gelbrich G, Frankenstein L, Scheffold T, Pankuweit S, Duengen HD, Regitz-Zagrosek V, Pieske B, Neumann T, Rauchhaus M, Angermann CE, Katus HA, Ertl GE, Störk S

Abstract
AIM: To evaluate the implementation of current pharmacotherapy guidelines of heart failure and to identify factors associated with high pharmacotherapy guideline adherence in heart failure patients.
METHODS AND RESULTS: We pooled data from seven studies performed in the context of the German Competence Network Heart Failure selecting patients with chronic systolic heart failure and left ventricular ejection fraction (LVEF) <45% (n = 2,682). The quality of pharmacotherapy was evaluated by calculating the guideline adherence indicator (GAI), which considers three (GAI-3) or five (GAI-5) of the recommended heart failure substance classes and accounts for respective contraindications. GAI-3 was categorized as perfect (GAI = 100%: 71% of the cohort), medium (GAI = 50-99%: 22%), and poor adherence (GAI <50%: 7%). In ordinal regression, the following factors were positively associated with perfect adherence: history of revascularization (odds ratio 1.59, 95% confidence interval 1.27-1.98), prior ICD implantation (2.29, 1.76-2.98), and LV ejection fraction <30% (1.45, 1.19-1.76), whereas age (per 10 years; 0.82, 0.77-0.89), NYHA III/IV (0.15, 0.12-0.18), unknown duration of heart failure (0.69, 0.53-0.89), and antidepressant medication (0.61, 0.42-0.88) were negatively associated with perfect adherence. Better GAI-3 at baseline predicted favorable changes of LV ejection fraction and end-diastolic diameter after 1 year. One-year mortality risk was closely related to GAI-3 in both groups of NYHA functional class I/II (excellent vs. poor GAI-3: 7.2 vs. 14.5%, log rank = 0.004) and class III/IV (13.5 vs. 21.5%, log rank = 0.005).
CONCLUSIONS: This large pooled analysis showed that a high level of guideline adherence is achievable in the context of clinical studies. Those receiving and tolerating optimal pharmacotherapy experience a better prognosis. Nevertheless, the implementation of heart failure medication needs further improvement in female and elderly patients, especially those in NYHA functional class >II and patients with LVEF ≥30%.

PMID: 22139085 [PubMed - in process]

Adherence to available clinical practice guidelines for initiation of antihypertensive medication in patients with or without diabetes mellitus and other comorbidities in taiwan.

J Clin Pharmacol. 2012 Apr;52(4):576-85

Authors: Chou CC, Lin WS, Kao TW, Chang YW, Chen WL

Abstract
The aim of the study is to explore the prescribing trends for antihypertensive medications in newly diagnosed hypertensive subjects with different comorbidities with or without diabetes in Taiwan. Factors for prescribing angiotensin receptor blockers (ARBs) are also investigated. The study design is a secondary data analysis of Taiwanese population from the National Health Insurance, from 1997, to 2004. A total of 3 218 187 patients were included in the statistical analysis; there were 2 963 861 cases without diabetes and 254 326 with diabetes. From 1998 to 2004, in both arms, there were significant trends for increasing ARB use (ρ = 0.964, P < .001). Patients with preexisting diabetes were more likely to be prescribed ARBs than those without preexisting diabetes (OR = 1.68; 95% CI, 1.65-1.70). A similar situation was noted for patients with the comorbidities of cerebrovascular accident (OR = 1.61), congestive heart failure (OR = 2.20), coronary artery disease (OR = 1.63), and chronic kidney disease (OR = 2.23). Although diuretics were not the most commonly prescribed antihypertensive for nondiabetics during the study period, physicians' prescribing practices were within the range of published clinical practice guidelines for hypertension management. Further comprehensive studies are needed to explore the impact of prescription patterns, especially ARBs, on the allocation of health care resources and therapeutic efficacy in Taiwan.

PMID: 22021568 [PubMed - in process]

The value of population pharmacokinetics and simulation for postmarketing safety evaluation of dosing guidelines for drugs with a narrow therapeutic index: buflomedil as a case study.

Fundam Clin Pharmacol. 2012 Apr;26(2):279-85

Authors: Bourguignon L, Ducher M, Matanza D, Bleyzac N, Uhart M, Odouard E, Maire P, Goutelle S

Abstract
Population pharmacokinetics and simulation techniques currently play an important role in new drug development. This paper illustrates the potential value of those methods in postmarketing safety assessment, using buflomedil in elderly patients as an example. We retrospectively assessed the risk of buflomedil overdosing associated with the latest dosing recommendations of the French Drug Agency (AFSSAPS). First, buflomedil concentrations measured in 24 elderly patients were analysed with a nonparametric population approach. Then, the pharmacokinetic model was used to perform a 1000-patient Monte Carlo simulation for the two recommended buflomedil dosage regimens. The maximum concentrations calculated after 10 days of therapy were compared with levels observed in reported cases of toxicity to assess the probability of overdosing. A three-compartment model best fit concentration data. Population predictions showed little bias (-0.14 mg/L) and good precision (8.73 mg(2) /L(2)). Overall results of the simulation study showed that the application of the two recommended dosage regimens of buflomedil was associated with overdosing (C(max) > 10 mg/L) and potential toxicity in 2.9% of geriatric patients. In patients with mild renal impairment, who may receive the higher-dosage regimen by therapeutic error, the probability of overdosing was 6.2%. Despite specific dosing recommendations in case of renal impairment, this study shows that the use of buflomedil could be associated with significant risk of overdosing in geriatric patients. Such results might have enhanced decision-making when buflomedil safety was reassessed by AFSSAPS in 2006. The retrospective case of buflomedil illustrates how these methods may be valuable in postmarketing safety evaluation of potentially toxic drugs.

PMID: 22004557 [PubMed - in process]

Implementation of flow cytometry in the diagnostic work-up of myelodysplastic syndromes in a multicenter approach: report from the Dutch Working Party on Flow Cytometry in MDS.

Leuk Res. 2012 Apr;36(4):422-30

Authors: Westers TM, van der Velden VH, Alhan C, Bekkema R, Bijkerk A, Brooimans RA, Cali C, Dräger AM, de Haas V, Homburg C, de Jong A, Kuiper-Kramer PE, Leenders M, Lommerse I, te Marvelde JG, van der Molen-Sinke JK, Moshaver B, Mulder AB, Preijers FW, Schindhelm RK, van der Sluijs A, van Wering ER, Westra AH, van de Loosdrecht AA,

Abstract
Flow cytometry (FC) is recognized as an important tool in the diagnosis of myelodysplastic syndromes (MDS) especially when standard criteria fail. A working group within the Dutch Society of Cytometry aimed to implement FC in the diagnostic work-up of MDS. Hereto, guidelines for data acquisition, analysis and interpretation were formulated. Based on discussions on analyses of list mode data files and fresh MDS bone marrow samples and recent literature, the guidelines were modified. Over the years (2005-2011), the concordance between the participating centers increased indicating that the proposed guidelines contributed to a more objective, standardized FC analysis, thereby ratifying the implementation of FC in MDS.

PMID: 21982641 [PubMed - indexed for MEDLINE]

Survival of patients with bilateral versus unilateral breast cancer and impact of guideline adherent adjuvant treatment: a multi-centre cohort study of 5292 patients.

Breast. 2012 Apr;21(2):171-7

Authors: Schwentner L, Wolters R, Wischnewsky M, Kreienberg R, Wöckel A

Abstract
This retrospective multi-centre study is focussed on recurrence free and overall survival of bilateral breast cancer (BBC) versus unilateral breast cancer (UBC). The impact of BBC on survival is stratified to guideline adherence, according to the German national S3-guideline. Another aim of the study is to identify the influence of various guideline violations in adjuvant treatment on survival of BBC patients. 229 (4.3%) patients had BBC and 5063 (95.7%) had UBC. There is a significant association between BBC/UBC and recurrence free (RFS: p < 0.001) and overall survival (OAS: p = 0.003). Only 15.7% of patients with BBC are treated 100% guideline adherent (index- + contralateral tumour). 31.0% (30.5%) were guideline adherent with respect to the index (contralateral) tumour. The outcome decreases significantly with the number of guideline violations. There was no significant difference in RFS and OAS between BBC and UBC after adjusting for tumour size, nodal status, grading and if guideline adherent treatment was applied. CONCLUSION: 1. Patients with BBC have primarily a worse prognosis in terms of RFS and OAS than patients with primarily UBC. 2. There is a strong association between guideline adherence and RFS/OAS of patients with BBC or UBC. The outcome decreases with the number of guideline violations. 3. If guideline adherent treatment was applied (for both tumours in case of BBC) there was no significant difference in RFS and OAS between BBC and UBC after adjusting for tumour size, nodal status, grading.

PMID: 21945313 [PubMed - in process]

A population-based assessment of the National Comprehensive Cancer Network practice guideline indications for pelvic lymph node dissection at radical prostatectomy.

BJU Int. 2012 Apr;109(8):1177-82

Authors: Abdollah F, Schmitges J, Sun M, Shariat SF, Briganti A, Abdo A, Tian Z, Perrotte P, Montorsi F, Karakiewicz PI

Abstract
Study Type - Therapy (cohort) Level of Evidence  2b What's known on the subject? and What does the study add? The National Comprehensive Cancer Network guidelines recommend pelvic lymph node dissection in patients with a nomogram-predicted lymph node invasion risk of 2% or more. We set out to examine the validity of this recommendation. OBJECTIVES •  To examine the ability of the threshold recommended by the National Comprehensive Cancer Network (NCCN) in correctly predicting histologically-confirmed lymph node invasion (LNI). •  The 2010 NCCN practice guidelines for prostate cancer recommend a pelvic lymph node dissection (PLND) at radical prostatectomy in all individuals with a nomogram predicted LNI risk of ≥2%. PATIENTS AND METHODS •  We assessed 20 877 patients who were treated with radical prostatectomy and PLND between 2004 and 2006, within the Surveillance, Epidemiology and End Results database. •  The 2% nomogram threshold, as well as other threshold values (range 1-10%) were tested. •  Finally, we externally validated the NCCN guideline nomogram. RESULTS •  Overall, 2.5% of patients had LNI. •  The use of the 2% threshold would allow the avoidance of 23% of PLNDs, at the cost of missing 1.7% of patients with LNI. Conversely, the use of a 3% threshold would allow the avoidance of 58% of PLNDs, at the cost of missing 15% of patients with LNI vs 72% and 26%, respectively, for the 4% threshold. •  Overall, the accuracy of the NCCN guideline nomogram quantified according to the receiver-operator characteristics-derived area under the curve was 82%. CONCLUSIONS •  In a population-based sample, the NCCN guideline nomogram is highly accurate. •  However, the 2% threshold will permit the avoidance of only 23% of PLNDs, instead of the 48% intended by the NCCN guidelines. •  The use of a 3% threshold may allow a lower rate of PLND overtreatment, although it will miss more patients with LNI.

PMID: 21880105 [PubMed - in process]

Primary care guidelines for geriatric assessment : A structured, comparative analysis.

Z Gerontol Geriatr. 2012 Apr;45(3):224-230

Authors: Frese T, Franke M, Keyser M, Rurik I, Sandholzer H

Abstract
A structured geriatric assessment (GA) improves the quality of health care; however, the quality of GA guidelines has hardly been investigated. Eight guidelines were identified by systematically searching guideline databases, web sites of guideline developers, and PubMed. The methodological quality was assessed by two appraisers using the German Guideline Evaluation Instrument (DELBI). Guideline content was extracted; organizational and medical recommendations were compared. The methodological appraisal revealed a broad range of quality. The domains "Scope and purpose" and "Clarity and presentation" showed good results. The domains "Applicability" and "Editorial independence" had results that were not as good. Medical recommendations agreed to a great extent. GA should be delivered continuously for all older people in their homes by one responsible assessor. In cooperation with relatives, patient-centered therapy goals should be defined. Differences were identified in profession, instruments, aims, and "tailoring." The quality of primary care guidelines for GA may be improved. Details of organization of a GA require further research.

PMID: 21805190 [PubMed - as supplied by publisher]

Implementation of a Guideline for Low Back Pain Management in Primary Care: A Cost-Effectiveness Analysis.

Spine (Phila Pa 1976). 2012 Apr 15;37(8):701-710

Authors: Becker A, Held H, Redaelli M, Chenot JF, Leonhardt C, Keller S, Baum E, Pfingsten M, Hildebrandt J, Basler HD, Kochen MM, Donner-Banzhoff N, Strauch K

Abstract
STUDY DESIGN.: Cost-effectiveness analysis alongside a cluster randomized controlled trial. OBJECTIVE.: To study the cost-effectiveness of 2 low back pain guideline implementation (GI) strategies. SUMMARY OF BACKGROUND DATA.: Several evidence-based guidelines on management of low back pain have been published. However, there is still no consensus on the effective implementation strategy. Especially studies on the economic impact of different implementation strategies are lacking. METHODS.: This analysis was performed alongside a cluster randomized controlled trial on the effectiveness of 2 GI strategies (physician education alone [GI] or physician education in combination with motivational counseling [MC] by practice nurses)--both compared with the postal dissemination of the guideline (control group, C). Sociodemographic data, pain characteristics, and cost data were collected by interview at baseline and after 6 and 12 months. low back pain-related health care costs were valued for 2004 from the societal perspective. RESULTS.: For the cost analysis, 1322 patients from 126 general practices were included. Both interventions showed lower direct and indirect costs as well as better patient outcomes during follow-up compared with controls. In addition, both intervention arms showed superiority of cost-effectiveness to C. The effects attenuated when adjusting for differences of health care utilization prior to patient recruitment and for clustering of data. CONCLUSION.: Trends in cost-effectiveness are visible but need to be confirmed in future studies. Researchers performing cost-evaluation studies should test for baseline imbalances of health care utilization data instead of judging on the randomization success by reviewing non-cost parameters like clinical data alone.

PMID: 21738095 [PubMed - as supplied by publisher]

Managing peripheral venous catheters: an investigation on the efficacy of a strategy for the implementation of evidence-based guidelines.

J Eval Clin Pract. 2012 Apr;18(2):414-9

Authors: Frigerio S, Di Giulio P, Gregori D, Gavetti D, Ballali S, Bagnato S, Guidi G, Foltran F, Renga G

Abstract
RATIONALE, AIMS AND OBJECTIVES: Until now, the evaluation of the effectiveness of guideline implementation in nursing and allied health professions has received relatively little attention. The aims of this study were (i) to describe the development process of guidelines concerning the management of peripheral venous catheters (PVCs) implemented in an Italian hospital; and (ii) to evaluate the effectiveness of guideline dissemination in terms of both clinical outcomes (signs of infection) and process outcomes (measures of appropriateness of PVC management).
METHODS: An observational study was conducted before and after the adoption of a new protocol in the CTO-CRF-Maria Adelaide Hospital. Data from 306 PVCs (153 before and 153 after) were collected. For each PVC, a wide range of outcome measures was collected, including: data on fixation system type of dressing; visibility of the insertion site; registration of the insertion date; duration of catheter insertion; presence of connectors, taps and needles; and signs of infection. The effect of guideline implementation was evaluated using a logistic regression model to adjust for the confounding variable represented by the nurses' average years of working experience.
RESULTS: The risk of using inappropriate dressing was significantly reduced [odds ratio (OR) 0.43; 95% confidence interval (CI) 0.27-0.70], while the use of transparent dressing increased (OR 2.39; 95% CI 1.46-3.89).
CONCLUSION: Our study shows significant improvement in practices relevant to the correct management of PVCs 2 months after guideline implementation. A second survey (after a minimum of 6 months) is necessary to assess persistence of improvement in clinical practices.

PMID: 21114722 [PubMed - in process]

A systematic approach for uptake of evidence on sex-specific issues in guidelines--a pilot study.

J Eval Clin Pract. 2012 Apr;18(2):369-77

Authors: Keuken D, Bindels P, Klazinga N, Haafkens J

Abstract
RATIONALE, AIMS AND OBJECTIVES: Increasing evidence indicates that sex-specific issues may have impact on prevention, diagnosis, or treatment. These issues are not systematically considered during the development of Dutch clinical practice guidelines. The aim of this study is to identify how members of guideline development groups discuss sex-specific evidence, and whether and how the outcomes of these discussions are reflected in the guideline.
METHODS: Six guideline development committees (GDCs) were studied. Each committee was supported by a staff member from the guideline organization who was trained and received feedback to facilitate uptake of evidence on sex differences in the process of guideline development. Non-participant observation and transcription of audio recordings from 22 GDC meetings were performed. Content analysis of meeting transcripts and guidelines were studied to analyse characteristics of discussion episodes on sex-specific research data-based issues (subject matter, initiator and group approach towards the topic and themes) and whether or not conclusions on evidence were reflected in the final guideline text.
RESULTS: Of the 87 identified discussion episodes, 68 dealt with sex-specific research evidence potentially relevant to guidelines. Respectively 51%, 28% and 21% of the latter episodes were initiated by committee members, staff members and chairpersons. Group approaches towards the subject matter were generally positive. Data from 60% of those episodes were reflected in the final guideline text. Sex-specific data on reproductive issues were more often discussed and reflected in guideline texts than data on other health issues. Discussion episodes on sex-specific evidence initiated by chairpersons were most often reflected in the guidelines.
CONCLUSIONS: This pilot study indicates that GDCs regularly focused on sex-specific issues. The participation of a trained staff member contributed to this.

PMID: 21091853 [PubMed - in process]