Methods Report: European S3‐Guidelines on the systemic treatment of psoriasis vulgaris – update 2015 – EDF in cooperation with EADV and IPC

• DOI: 10.1111/jdv.13353
• Publication Date: 2015-10-16T04:08:57Z
• Authors: A. Nast; A. Jacobs; S. Rosumeck; R.N. Werner
• Keywords: Venereology; Critical appraisal

Anja Jacobs Alexander Nast Stefanie Rosumeck Ricardo Niklas Werner This document is the methods report to 'Update of evidence and consensus-based European S3-Guidelines systemic treatment psoriasis vulgaris'. The first edition these guidelines has been published in Journal Academy Dermatology Venereology.1 Please use following reference when citing guidelines: A, Gisondi P, Ormerod AD, Saiag Smith C, Spuls PI, Arenberger Bachelez H, Barker J, Dauden E, de Jong Feist Jobling R, Kemeny L, Maccarone M, Mrowietz U, Papp KA, Paul Reich K, S, Talme T, Thio HB, van Kerkhof RN, Yawalkar N. on vulgaris - Update 2015 Short version EDF cooperation with EADV IPC. J Eur Acad Dermatol Venereol 2015; 29: 2277–2294. were developed taking into account quality criteria for as suggested by Appraisal Guidelines Research Evaluation (AGREE II) Instrument.2 For planning elaboration underlying systematic literature review interventions vulgaris, methodology Cochrane Handbook Systematic Reviews Interventions3 GRADE working group4 was adapted. These evidence- contain recommendations that assist clinicians care patients specific clinical conditions. are based best available their development followed a pre-specified, standardized process. Nevertheless, do not replace clinicians' knowledge skills, since never encompass therapy specifications all medical decision-making situations, deviation from may be justified or inevitable situations. Safety aspects considered within represent comprehensive assessment safety information included interventions. They limited those chosen evaluation trials. Readers must carefully check determine whether (e.g. regarding dose, dosing regimens, contraindications drug interactions) complete, correct, up-to-date appropriate. intended adapted national regional circumstances (regulatory approval availability treatments, health provider insurance systems). Thus, societies associated Forum (EDF) Association Venereology (EADV) will responsible adoption implementation level. Aim update guidelines' 2009.5 primary goal professionals choice optimal individual patient. targeted at involved psoriasis, primarily dermatologists general practitioners (GP). guidelines, efficacy treatments summarized. Based evidence, formulated consented an expert panel structured consensus Division Evidence Medicine (dEBM) Department Dermatology, Allergology, Charité – Universitätsmedizin Berlin, Germany coordinated process including organization process, conduction vulgaris. Members dEBM participated moderated conference, but entitled vote recommendations. group rheumatologist. officially nominated (EDF), International Psoriasis Council (IPC). members selected virtue experience and/or research expertise field previous work 2009. An international patient nominate representatives affected could identified, thus participation difficult realize. Patient UK Italy each part group. had same voting rights other internal too. Furthermore one chapter, namely 'Severity assessment/Quality life Patients perspective' which integrated main chapter 'introduction vulgaris' written representatives. reported outcomes such DLQI scores relevant outcome studies reporting endpoints review. invited take external comment drafted document. A steering project composed who have experiences development. selection interventions, subgroups full list supplied beginning this page 2. kindly supported EDF. financial support did influence receive incentives reimbursement Assessment synthesis done independently industrial interest. Key questions answered accordance Recommendations exclusively according assessment. declaration potential conflicts interest (COI) Committee Medical Editors6 required At formalized member asked his her declaration. COI discussed. see any substantial there no further comments remarks. person presented Appendix 4.1. key guidelines.1, 5 steps preparation performed via electronic mail contacts decided options evaluation: Although fumaric acid esters licensed only Germany, it known they used several countries off-label medication UK7) therefore evidence-based biological agent efalizumab8 lost its marked authorization psoriasis. Alefacept Switzerland US only, currently being distributed more. Both medications excluded guidelines. Furthermore, exclude phototherapy due high number up feasible during (time costs). Combinations more than two considered. Studies combination therapies if compared monotherapy evaluate benefit comparison monotherapy. fact certain does necessarily imply appropriate efficacy, well outcomes. Beside parameters, seem importance patient.9, 10 According methodology, rate respect relevance decisions concerning scale 1 9 representing irrelevant critical Mean values ratings experts served rank grading evidence. mean score 7–9 rated decision, 4–6 important decision making, 1–3 indicated respective importance.11 Only Table shows assigned rating importance. reasons feasibility ensure comparability, induction week 16 after start whatever closest time point, however, earlier 8.12 long-term therapy, results 24 thereafter. To review, least Outcomes events per case dichotomous (the reported) change continuous standard reported). Eligible inclusion initial RCTs (including placebo controlled head-to-head trials) participants diagnosis independent publication type. minimal evaluated study arm duration 8 weeks. Publication language restricted. 80% need fulfil above mentioned population criteria. As version,1, search existing reviews using databases Library, Medline, Medline In-Process Embase September 12th 2013. Start date particular inception database. Automatic e-mail alerts four new hits entire strategy received monthly October 2014. Detailed strategies different (see 4.2). Titles abstracts individually checked eligibility assessors (AJ, SR). Full texts potentially similarly In disagreement screening texts, third assessor (AN) conflict solved discussion (Fig. 1). Data collection SR), data extraction form (Microsoft® Excel worksheet, 2). All then transferred Review Manager file.13 Risk ratios 95% CI differences calculated comparison. missing derivation (SD), SD error confidence interval available. No imputation comparisons without measure variance meta-analysis. effect estimates pooled meta-analysis random effects model (Review 5.2). We numerous multi-arm our analyses. If multiple meta-analysis, we split shared three groups smaller sample size avoid double-counting would create unit-of-analysis error. both arms because provide either direction magnitude relative effect3. Limited treatment. Most 'loose' period. identified 24. include group, calculate 'placebo response'. original 'lost' arms, long-time imputed response. Placebo PASI75, PASI90 PGA 'clear/almost clear'. Identified provided 3. method until onset action (TOA 25 PASI 75 [w] TOA 25% [w]) described elsewhere.9 assessed slightly faster comparator difference > 0.5 weeks; week. bias tool.3 summarized system recommended (Grading Assessment, Development Evaluation) Using profiler,14 profiles comparison, chapters 3.3.1). question categorized categories, 'very low' 'high'.15 4 summarizes levels approach grade group.15 criteria, applied decrease increase question, intervention outcome: risk tool3 assess limitations domains assessed: sequence generation, allocation concealment, incomplete data, selective reporting, blinding personnel, sources bias. Overall depended contributing studies. downgrading ('serious limitations') 2 points ('very serious possible.16 addition downgraded data. point ('important inconsistency'), heterogeneous effect. were: widely varying across studies, overlap intervals (CI), large I² (I² statistical test quantifying variation estimate between studies).17 Inconsistency performed. When populations recruited subgroup make recommendation expected (due significant studied target population), overall ('some') ('major uncertainty about directness').18 Here, downgraded, characteristics baseline match predefined consist mild psoriasis). criterion determining precision width position (CI)19: imprecision very wide, crossed threshold (defined line ± 0.25) difference. reduction PASI, 0.5*SD control secondary analysis (i.e. TOA) twice, degree estimable. effect, point.20 Due low trials formal testing visual characterization funnel plots) Rating generally observational non-randomized trials.21 restricted randomized trials, upgrading SR) aspect. Comments justify downgrading. short text summarizing summary findings table (dichotomous outcomes)22 (continuous outcomes).23 finding tables basis developing subchapters systematically opinions. topicals UV focus guideline, mentioning them subpopulation, where highly treatments. Prior draft guideline circulated Delphi technique drafts drugs special alternative suggestions collected required. During conference 9th 10th Amsterdam, Netherlands, nominal agree upon recommendations.24 Nast, MD, certified moderator German Scientific Societies (AWMF). simplify identification recommendations, highlighted throughout (grey boxes). ambiguity, classify strength recommendation. approach, five strengths differentiated: strong against intervention, weak recommendation.25 (high/moderate/low/very low), balance undesirable desirable consideration costs preferences.25, 26 expressed wording symbols (Table 5). recommendation, terms percentage agreement measured documented. Three defined distinguished. 'strong consensus' aimed at. cases lower achieved, 'consensus' (75–94% agreement) 'weak (50–74% agreement). sections 'Instructions use' 'Lab control' discussed whole text. Before publication, underwent extensive Internal accomplished confirm (kick-off conference), prior preliminary completed changes before publication. disseminated EADV, UEMS addition, interested free participate accessible online open 27th January through 23rd February (using platform www.crocodoc.com). Each 'editorial change', 'forwarded authors consideration' 'rejected reasoning)'. responses dEBM. result re-voted issues modified technique. (i) blood count monitoring esters, (ii) instruction woman childbearing age etanercept (iii) definition 'second line' footnote ustekinumab. re-voting, final phase piloted own practices encouraged practicability second system. adaption (http://www.euroderm.org/index.php/edf-guidelines). awareness necessity among physicians, adhesion success should pursued increasing amount publications, continually updated reflect recent state After December 31st, 2019, expire. Should occur meantime (such withdrawal licensing) expire earlier. cases, issue needed initiate update.