Perceived barriers to guidelines in peritoneal dialysis.

Nephrol Dial Transplant. 2011 May;26(5):1683-9

Authors: Allen N, Schwartz D, Sood AR, Mendelssohn D, Verrelli M, Tanna G, Schiff J, Komenda P, Rigatto C, Sood MM

Background. Little is known regarding barriers to guideline adherence in the nephrology community. We set out to identify perceived barriers to evidence-based medicine (EBM) and measurement of continuous quality indicators (CQI) in an international cohort of peritoneal dialysis (PD) practitioners.

PMID: 20959345 [PubMed - in process]

An exploration of nurses’ perceptions regarding the implementation of a best practice guideline on the assessment and management of foot ulcers for people with diabetes.

Appl Nurs Res. 2011 May;24(2):88-93

Authors: Ritchie L, Prentice D

The aim of this qualitative study was to explore nurses’ perceptions regarding the implementation of a best practice guideline (BPG) on the assessment and management of foot ulcers for people with diabetes. Fourteen nurses from a community care setting and three hemodialysis units participated in five focus groups and one individual interview. The findings focus on key points regarding the impact of BPG implementation in the areas of patient outcomes, nursing practice, and interdisciplinary teamwork.

PMID: 20974071 [PubMed - in process]

Outcome for Gram-negative bacteraemia when following restrictive empirical antibiotic guidelines.

QJM. 2011 May;104(5):411-9

Authors: Enoch DA, Phillimore N, Mlangeni DA, Salihu HM, Sismey A, Aliyu SH, Karas JA

Introduction: Restrictions in prescribing broad spectrum antimicrobials have been part of a strategy to reduce Clostridium difficile cases in the UK in recent years. However, there has been little work on assessing the safety of alternative antimicrobial agents.

PMID: 21115461 [PubMed - in process]

Grading quality of evidence and strength of recommendations in clinical practice guidelines part 3 of 3. The GRADE approach to developing recommendations.

Allergy. 2011 May;66(5):588-95

Authors: Bro?ek JL, Akl EA, Compalati E, Kreis J, Terracciano L, Fiocchi A, Ueffing E, Andrews J, Alonso-Coello P, Meerpohl JJ, Lang DM, Jaeschke R, Williams JW, Phillips B, Lethaby A, Bossuyt P, Glasziou P, Helfand M, Watine J, Afilalo M, Welch V, Montedori A, Abraha I, Horvath AR, Bousquet J, Guyatt GH, Schünemann HJ,

This is the third and last article in the series about the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to grading the quality of evidence and the strength of recommendations in clinical practice guidelines and its application in the field of allergy. We describe the factors that influence the strength of recommendations about the use of diagnostic, preventive and therapeutic interventions: the balance of desirable and undesirable consequences, the quality of a body of evidence related to a decision, patients’ values and preferences, and considerations of resource use. We provide examples from two recently developed guidelines in the field of allergy that applied the GRADE approach. The main advantages of this approach are the focus on patient important outcomes, explicit consideration of patients’ values and preferences, the systematic approach to collecting the evidence, the clear separation of the concepts of quality of evidence and strength of recommendations, and transparent reporting of the decision process. The focus on transparency facilitates understanding and implementation and should empower patients, clinicians and other health care professionals to make informed choices.

PMID: 21241318 [PubMed - in process]

Guidelines and recommendations for assessment of somatosensory function in oro-facial pain conditions–a taskforce report.

J Oral Rehabil. 2011 May;38(5):366-94

Authors: Svensson P, Baad-Hansen L, Pigg M, List T, Eliav E, Ettlin D, Michelotti A, Tsukiyama Y, Matsuka Y, Jääskeläinen SK, Essick G, Greenspan JD, Drangsholt M

The goals of an international taskforce on somatosensory testing established by the Special Interest Group of Oro-facial Pain (SIG-OFP) under the International Association for the Study of Pain (IASP) were to (i) review the literature concerning assessment of somatosensory function in the oro-facial region in terms of techniques and test performance, (ii) provide guidelines for comprehensive and screening examination procedures, and (iii) give recommendations for future development of somatosensory testing specifically in the oro-facial region. Numerous qualitative and quantitative psychophysical techniques have been proposed and used in the description of oro-facial somatosensory function. The selection of technique includes time considerations because the most reliable and accurate methods require multiple repetitions of stimuli. Multiple-stimulus modalities (mechanical, thermal, electrical, chemical) have been applied to study oro-facial somatosensory function. A battery of different test stimuli is needed to obtain comprehensive information about the functional integrity of the various types of afferent nerve fibres. Based on the available literature, the German Neuropathic Pain Network test battery appears suitable for the study of somatosensory function within the oro-facial area as it is based on a wide variety of both qualitative and quantitative assessments of all cutaneous somatosensory modalities. Furthermore, these protocols have been thoroughly described and tested on multiple sites including the facial skin and intra-oral mucosa. Standardisation of both comprehensive and screening examination techniques is likely to improve the diagnostic accuracy and facilitate the understanding of neural mechanisms and somatosensory changes in different oro-facial pain conditions and may help to guide management.

PMID: 21241350 [PubMed - in process]

One should not just read what one believes: the nearly irresolvable issue of producing truly objective, evidence-based guidelines for the management of differentiated thyroid cancer.

Eur J Nucl Med Mol Imaging. 2011 May;38(5):793-8

Authors: Dietlein M, Verburg FA, Luster M, Reiners C, Pitoia F, Schicha H

PMID: 21243355 [PubMed - in process]

Screening and therapeutic management of lipoprotein(a) excess: Review of the epidemiological evidence, guidelines and recommendations.

Clin Chim Acta. 2011 May 12;412(11-12):797-801

Authors: Lippi G, Franchini M, Targher G

Lipoprotein(a) (Lp(a)) is a low density lipoprotein-like particle in which apolipoprotein B100 is covalently linked to the unique apolipoprotein(a). There is a mounting body of evidence suggesting a role of Lp(a) in the development and progression of several vascular diseases, such as coronary heart disease, ischemic stroke, abdominal aortic aneurysm and venous thromboembolism, so that prominent scientific societies have recently endorsed guidelines and recommendations that increasingly encourage the screening and the therapeutic management of Lp(a) excess. In this article, we review the epidemiologic evidence, guidelines and recommendations concerning the relationship between increased plasma Lp(a) levels and risk of cardiovascular disease or venous thromboembolism by systematically retrieving the most relevant articles from electronic databases. Although uncertainty still remains regarding the opportunity to screen for hyperlipoproteinemia(a), it seems inopportune as yet to measure plasma Lp(a) levels in asymptomatic persons, while its measurement might be of clinical significance in selected categories of patients at intermediate or high cardiovascular risk. The measurement of Lp(a) should be performed by using immunometric, harmonized and size-insensitive techniques and results reported in total lipoprotein mass rather than in traditional units. It is uncertain if Lp(a) genotyping or phenotyping add any additional information for the cardiovascular disease risk stratification. Although the optimal therapeutic management of Lp(a) excess is still controversial, a general agreement exists that very high Lp(a) levels should be lowered in patients with multiple cardiovascular risk factors, preferably with nicotinic acid therapy (e.g., 1.0-3.0g/day).

PMID: 21256836 [PubMed - in process]

An analysis of the impact of FDA’s guidelines for addressing cardiovascular risk of drugs for type 2 diabetes on clinical development.

Contemp Clin Trials. 2011 May;32(3):324-32

Authors: Viereck C, Boudes P

We examined the impact of FDA’s 2008 guidelines for addressing cardiovascular risks of new therapies for type 2 diabetes on clinical trials. We focused on the new class of incretin-modulating drugs, exenatide, sitagliptin, saxagliptin and liraglutide, which were approved in 2005-2010. We contrasted these findings with those from 2 different groups: 1. diabetes drugs approved in the same timeframe but with a non-incretin mechanism of action (colesevelam HCl and bromocriptine mesylate) and 2. diabetes drugs with NDAs delayed and not yet approved within the same time frame (vildagliptin, alogliptin, insulin inhalation powder, and exenatide long acting release). The new guidelines have had an important impact on clinical development. Review time has increased over 2-fold. The increase is seen even if a drug with the same mechanism of action has been already approved. Whereas exenatide (approved in 2005) required 10 months of regulatory review, the approval of liraglutide in 2010 required more than twice as long (21 months). In contrast, the marketing authorization of liraglutide in the EU required 14 months. Additionally, the manufacturer of vildagliptin announced in June 2008, 30 months after the NDA was filed, that a re-submission to meet FDA’s demands was not planned. The drug however received marketing authorization in the EU in 2007. The number of randomized patients and patient-years in NDAs increased more than 2.5 and 4 fold, respectively since the guidelines. The significant cost increases and negative publicity because of rare adverse reactions will adversely affect future clinical research in type 2 diabetes and not address its burgeoning health care impact.

PMID: 21266202 [PubMed - in process]

Twin pregnancies: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF).

Eur J Obstet Gynecol Reprod Biol. 2011 May;156(1):12-7

Authors: Vayssière C, Benoist G, Blondel B, Deruelle P, Favre R, Gallot D, Jabert P, Lemery D, Picone O, Pons JC, Puech F, Quarello E, Salomon L, Schmitz T, Senat MV, Sentilhes L, Simon A, Stirneman J, Vendittelli F, Winer N, Ville Y

The rate of twin deliveries in 2008 was 15.6 per 1000 in France, an increase of approximately 80% since the beginning of the 1970s. It is recommended that chorionicity be diagnosed as early as possible in twin pregnancies (Professional Consensus). The most relevant signs (close to 100%) are the number of gestational sacs between 7 and 10 weeks and the presence of a lambda sign between 11 and 14 weeks (Professional Consensus). In twin pregnancies, nuchal translucency is the best parameter for evaluating the risk of aneuploidy (Level B). The routine use of serum markers during the first or the second trimester is not recommended (Professional Consensus). In the case of a choice about sampling methods, chorionic villus sampling is recommended over amniocentesis (Professional Consensus). Monthly follow-up by a gynaecologist-obstetrician in an appropriate facility is recommended for dichorionic pregnancies (Professional Consensus). A monthly ultrasound examination including an estimation of fetal weight and umbilical artery Doppler is recommended (Professional Consensus). It is recommended to plan delivery of uncomplicated dichorionic diamniotic twin pregnancies from 38 weeks and before 40 weeks (Level C). Monthly prenatal consultations and twice-monthly ultrasound are recommended for monochorionic twins (Professional Consensus). It is reasonable to consider delivery from 36 weeks but before 38 weeks+6 days, with intensified monitoring during that time (Professional Consensus). Prenatal care of monochorionic pregnancies must be provided by a physician working in close collaboration with a facility experienced in the management of this type of pregnancy and its complications (Professional Consensus). The increased risk of maternal complications and the high rate of medical interventions justify the immediate and permanent availability of a gynaecologist-obstetrician with experience in the vaginal delivery of twins (Professional Consensus). It is recommended that the maternity ward where delivery takes place have rapid access to blood products (Professional Consensus). Only obstetric history (history of preterm delivery) (Level C) and transvaginal ultrasound measurement of cervical length (Level B) are predictive factors for preterm delivery. No study has shown that the identification by transvaginal sonography (TVS) of a group at risk of preterm delivery makes it possible to reduce the frequency of such deliveries in asymptomatic patients carrying twins (Professional Consensus). It is important to recognize signs of TTTS early to improve the management of these pregnancies (Professional Consensus). Treatment and counseling must be performed in a center that can offer fetoscopic laser coagulation of placental anastomoses (Professional Consensus). This laser treatment is the first-line treatment (Level B). In the absence of complications after laser treatment, planned delivery is recommended from 34 weeks and no later than 37 weeks (Professional Consensus). For delivery, it is desirable for women with a twin pregnancy to have epidural analgesia (Professional Consensus). The studies about the question of mode of delivery have methodological limitations and lack of power. Active management of the delivery of the second twin is recommended to reduce the interval between the births of the two twins (Level C). In the case of non-cephalic presentation, total breech extraction, preceded by internal version manoeuvres if the twin’s position is transverse, is associated with the lowest cesarean rates for second twins (Level C). In the case of high and not yet engaged cephalic presentation and if the team is appropriately trained, version by internal manoeuvres followed by total breech extraction is to be preferred to a combination of resumption of pushing, oxytocin perfusion, and artificial rupture of the membranes, because the former strategy appears to be associated with fewer cesareans for the second twin (Level C).

PMID: 21277672 [PubMed - in process]

Evidence-based guidelines for the pharmacological treatment of schizophrenia: recommendations from the British Association for Psychopharmacology.

J Psychopharmacol. 2011 May;25(5):567-620

Authors: Barnes TR,

These guidelines from the British Association for Psychopharmacology address the scope and targets of pharmacological treatment for schizophrenia. A consensus meeting, involving experts in schizophrenia and its treatment, reviewed key areas and considered the strength of evidence and clinical implications. The guidelines were drawn up after extensive feedback from the participants and interested parties, and cover the pharmacological management and treatment of schizophrenia across the various stages of the illness, including first-episode, relapse prevention, and illness that has proved refractory to standard treatment. The practice recommendations presented are based on the available evidence to date, and seek to clarify which interventions are of proven benefit. It is hoped that the recommendations will help to inform clinical decision making for practitioners, and perhaps also serve as a source of information for patients and carers. They are accompanied by a more detailed qualitative review of the available evidence. The strength of supporting evidence for each recommendation is rated.

PMID: 21292923 [PubMed - as supplied by publisher]