S3 guidelines for the management of anticoagulation in cutaneous surgery.

BACKGROUND: An increasing number of patients are being treated with anticoagulants and platelet inhibitors. Whenever surgical procedures of the skin are required, questions arise regarding the perioperative management of anticoagulation. METHODS: Development of S3 guidelines following the requirements of the Association of Scientific Medical Societies, systematic literature search and analysis, use of GRADE methodology, structured consensus conference using a nominal group process. RESULTS: During cutaneous surgery, treatment with acetylsalicylic acid (ASA) should be continued if medically necessary. In procedures with a higher risk of bleeding and a positive bleeding history, INR should be determined preoperatively. Surgical procedures of the skin with a higher risk of bleeding should not be performed if the INR is above therapeutic range. Bridging from vitamin K antagonists (VKA) to heparin should not be performed just because of the surgery of the skin. As to direct-acting oral anticoagulants, the last dose should be taken 24 h preoperatively. CONCLUSIONS: The recommendations issued by the German guidelines group are mostly in line with recommendations provided by other guidelines. The American ìChest-Guidelineì recommends continuing VKAs and acetylsalicylic acid during minor dermatologic procedures. In their guidelines, the German College of General Practitioners and Family Physicians considers an INR of 2 to be adequate in surgical procedures on the skin.

Study of perceptions of the extent to which guideline recommendations are binding: a survey of commonly used terminology.

BACKGROUND: Doctors are more likely to implement guidelines in their everyday practice if the recommendations contained in them are understandable. So far, there has been little standardization in the wording of guideline recommendations. It would be important to know how certain terms are understood by guideline users. In this study, doctors were asked in a survey about what they considered to be the level of obligation carried by various formulations that are commonly used in guidelines to recommend particular courses of action. METHODS: An online survey of physicians (mostly dermatologists) was carried out in which they were asked to rate, on a visual analog scale, what they perceived to be the level of obligation of various common formulations for guideline recommendations. RESULTS: The terms "muss" (must) and "darf nicht" (must not) were interpreted as being maximally binding. The two closely related German words "soll" (shall) and "sollte" (should) were considered highly binding, as were negative formulations such as "wird nicht empfohlen" (is not recommended). The perceived level of obligation of "soll" did not differ from that of "sollte" to any detectable extent, nor was there any detectable distinction between the various negative formulations studied. Formulations with the words "wird empfohlen" (is recommended), "kann empfohlen werden" (can be recommended), or other "kann" (can) expressions were considered to be only mildly or moderately binding. In general, there was marked variation in the perceived level of obligation of formulations located in the low and middle ranges. CONCLUSION: These findings suggest that guideline users do not necessarily perceive recommendation strengths as the guideline authors intended. It might be better if positive recommendations came in only two different strengths, while a single recommendation strength might suffice for negative ones. Further studies should shed more light on this question.

Which antipsoriatic drug has the fastest onset of action? Systematic review on the rapidity of the onset of action.

The time necessary for a treatment to become effective is crucial for patients and physicians but has been largely neglected in the reporting and comparison of clinical trials in dermatology. The aim of this systematic review is to determine the time until the onset of action (TOA) of systemic agents approved for moderate-to-severe psoriasis. Primary outcome is the TOA defined as the weighted mean time until 25% of the patients achieved a psoriasis area and severity index (PASI) 75 response. Among the biologics, infliximab has the shortest TOA (3.5 weeks), followed by ustekinumab (high dose 4.6/low dose 5.1 weeks/not weight adapted), adalimumab (4.6 weeks), etanercept (high dose 6.6/low dose 9.5 weeks), and alefacept (high dose 15.4 weeks/low dose: no data). Among the conventional treatments, good data are available for cyclosporine A (CsA; TOA: 6.0 weeks) and limited data are found for methotrexate (MTX; TOA: high dose 3.2/low dose 9.9 weeks). No data are available for fumaric acid esters and retinoids. This systematic review provides clinically relevant information on the onset of action of antipsoriatic agents, although the data currently available allow only a limited assessment. Psoriasis trials should consider including TOA as an additional outcome measure.

Methodological standards in medical reporting.

Published research findings are the basis for health care decisions or further medical research. However, reporting of research methods and findings is often incomplete and of insufficient quality. Poor reporting hampers the assessment of reliability and validity of study results. Strengths and weaknesses of the investigation cannot be completely evaluated and subsequently it can mislead decision making in health care or in further clinical research. Transparent reporting can help minimize misinterpretation of publications. Several guidelines were developed to provide advice for reporting research methods and findings. These reporting guidelines facilitate critical appraisal and interpretation of the studies. The guidelines specify in form of checklists a minimum set of items required for clear and transparent reporting. The checklists focus on design, conduct and analysis of studies in particular issues that might introduce bias into the research. The application of these reporting guidelines is required by many international journals. In this CME article we present guidelines for reporting of randomized controlled trials (CONSORT), observational studies (STROBE) and systematic reviews and meta-analyses (PRISMA, MOOSE).

Management of anticoagulation during dermatosurgical procedures in Germany - results from a cross-sectional study.

BACKGROUND: Treatment with antiplatelet drugs (APD) and vitamin K antagonists (VKA) can be a challenge during the management of dermatosurgical interventions. METHODS: We performed a cross-sectional study on the perioperative management of APD and VKA in dermatological private practices and clinics in Germany, using anonymized, standardized questionnaires. RESULTS: 233 responses were evaluated (response rate 37 %). Skin biopsies are performed in 82.7 % of offices and in 90.8 % of clinics despite treatment with VKA. Small excisions are done in 62.5 % of offices and 76.9 % of clinics during treatment with VKA, for large excision this applies to 11.9 % of offices and 33.8 % of clinics. Low-dose treatment with APD (#100 mg) does not hinder 80.4 % of private practices and 89.2 % of clinics to perform small excisions as well as 36.3 % and 53.8 %, respectively, to perform large excisions. Of private practitioners 67.3 % and 83.1 % of clinic-based dermato-surgeons do not consider high-dose APD a contraindication for small excisions, and 25.0 % and 41.5 %, respectively, for large excisions. Most frequently switching to heparin is performed 6-8 days prior to surgery and switching back 0-2 days after surgery. CONCLUSIONS: Large differences in the perioperative management of anticoagulant therapy during dermatosurgical procedures have been identified. Further studies and guidelines should be developed.

[Using new media for online consensus conferences and open external review of guidelines - results of two pilot studies]. / Nutzung von Neuen Medien für Online-Konsensuskonferenzen sowie offene Online-Kommentierung von Leitlinien - Ergebnisse zweier Pilotprojekte.

The development of guidelines almost always requires considerable time and financial resources. An important task is therefore to identify and evaluate online methods that facilitate guideline work. ONLINE CONSENSUS CONFERENCE: During the development of the S2k guideline for the management of staphylococcus aureus infections an online consensus conference was held using an online tool provided by the Deutsche Forschungsnetz in combination with a telephone conference. During the 2-hour meeting, no technical difficulties occurred. A survey among the participants showed that this format had a high rate of acceptance. ONLINE REVIEW: During the development of the update of the German S3-Guidelines for the therapy of psoriasis an external open review was performed. An online platform allowing direct visible commenting was chosen. During the five week period of commenting, 26 users added 160 comments. After the review process, the comments were assessed by the editors and the original authors. The selected instrument provides a suitable means for online commenting of guidelines and facilitates the revision of the text.

Effect of biofeedback and deep oscillation on Raynaud's phenomenon secondary to systemic sclerosis: results of a controlled prospective randomized clinical trial.

Our aim was to evaluate the effect of deep oscillation and biofeedback on Raynaud's phenomenon (RP) secondary to systemic sclerosis (SSc). A prospective randomized study was performed in SSc patients receiving either deep oscillation (n = 10) or biofeedback (n = 8) thrice a week for 4 weeks, or patients were randomized into the waiting group untreated for vasculopathy (n = 10) in time of running the study interventions. Biofeedback resulted in an improvement of RP as determined by score reduction of visual analogue scale compared with patients of the control group (P < 0.05), whereas deep oscillation revealed a tendency for improvement (P = 0.055). The study underlines the beneficial role of physiotherapy for the treatment of SSc-related RP.

[S3-guidelines for the treatment of psoriasis vulgaris--methods report]. / S3-Leitlinie zur Therapie der Psoriasis vulgaris--Methodenreport.

BACKGROUND: This methods report summarizes the methodology used to update the German Psoriasis Guidelines. METHODS: The guidelines were developed following the recommendations of the Association of the Scientific Medical Societies in Germany. Medline, Cochrane Library and Embase were searched to generate new evidence. In addition, the results from the literature search from the EU Psoriasis Guidelines were used. The recommendations were discussed during a consensus conference using nominal group technique and were voted on during the Delphi procedure. An extensive internal and external review (open) was performed. RESULTS: Due to changes in drug licensing efalizumab was excluded from the guidelines and adalimumab and ustekinumab were added. 97 new studies were included to serve as a basis for the recommendations. The level of evidence improved for calcineurin inhibitors from level 4 to level 2/3 and for MTX and systemic retinoids from level 3 to level 2. A lack of evidence still exists for coal tar (level of evidence 4). All other described interventions have a level of evidence of 2 or 1. CONCLUSIONS: The field of psoriasis therapy is in constant transition. A lack of head to head trials makes direct comparisons still a challenging task. Continuous updating will be necessary to respond to the further changes expected in the field of psoriasis.

Disclosure of potential conflicts of interest in dermatological guidelines in Germany - an analysis - status quo and quo vadis.

BACKGROUND: In order to ensure the reliability of clinical practice guidelines it is essential to consider potential conflicts of interest with regard to its development. METHODS: All valid dermatological practice guidelines, which were developed by the German Dermatologic Society (DDG) or the Professional Association of German Dermatologists (BVDD), were recorded. Details about financing and conflicts of interest were systematically evaluated by two independent appraisers according to Domain 6 of the guidelines evaluation instruments AGREE and AGREE II. RESULTS: 38 practice guidelines of the DDG/BVDD were identified. Data about financing of the guidelines are included in 12 of 38 guidelines (32 %) only. Conflicts of interest are stated in no more than 7 of the 38 guidelines (18 %). Wherever a connection with the pharmaceutical industry was stated, no further information on how possible conflicts of interests were dealt with was found. CONCLUSIONS: In current guidelines details on the financing as well as the disclosures of potential conflicts of interest are stated insufficiently. Here an optimization is necessary. Furthermore strategies for handling conflicts of interest need to be developed. One possibility is a specific discussion on this issue at the beginning and during the process of the guidelines work. Furthermore in case of potential conflicts of interest a solution as e. g. abstention from voting on specific questions needs to be developed.