Stefanie Deckert

The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials.

The lack of core outcome sets for atopic eczema (AE) is a major obstacle for advancing evidence-based treatment. The global Harmonising Outcome Measures for Eczema (HOME) initiative has already defined clinical signs, symptoms, quality of life, and long-term control of flares as core outcome domains for AE trials. This article deals with the standardization of measurement instruments to assess clinical signs of AE. To resolve the current lack of standardization of the assessment of clinical signs of AE, we followed a structured process of systematic reviews and international consensus sessions to identify 1 core outcome measurement instrument for assessment of clinical signs in all future AE trials. Systematic reviews indicated that from 16 different instruments identified to assess clinical signs of AE, only the Eczema Area and Severity Index (EASI) and the objective Scoring Atopic Dermatitis (SCORAD) index were identified as extensively validated. The EASI has adequate validity, responsiveness, internal consistency, and intraobserver reliability. The objective SCORAD index has adequate validity, responsiveness, and interobserver reliability but unclear intraobserver reliability to measure clinical signs of AE. In an international consensus study, patients, physicians, nurses, methodologists, and pharmaceutical industry representatives agreed that the EASI is the preferred core instrument to measure clinical signs in all future AE trials. All stakeholders involved in designing, reporting, and using clinical trials on AE are asked to comply with this consensus to enable better evidence-based decision making, clearer scientific communication, and improved patient care.

Nonallergic comorbidities of atopic eczema: an overview of systematic reviews

The aims of this overview are to synthesize the current evidence of published systematic reviews (SRs) on nonallergic comorbidities of atopic eczema (AE). EMBASE and MEDLINE were searched for SRs published from inception to November 2012. SRs were selected independently based on predefined inclusion criteria. Methodological quality of SRs included was assessed by two independent reviewers using the Revised Assessment of Multiple Systematic Reviews (R‐AMSTAR) checklist. Nine SRs met all inclusion criteria. Six reviews addressing the association between AE and cancer suggest a decreased risk of glioma, meningioma, and acute lymphoblastic leukemia in patients with current or previous AE. One SR reported a consistent positive association of AE with attention‐deficit hyperactivity disorder (ADHD). Diabetes mellitus type 1 and multiple sclerosis (MS) were not significantly related to AE in reviews based on cross‐sectional and case–control studies. Patients with AE appear to be at decreased risk of brain tumors. The relationship of AE with Th1‐ and Th17‐mediated (auto‐)inflammatory conditions such as diabetes mellitus type 1 and MS should be clarified in prospective observational studies. Children with AE are at increased risk of ADHD. SRs on the risk of depression and Th17‐mediated disorders such as inflammatory bowel disease of patients with AE are missing.

Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME)

This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6–7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient‐reported symptoms, long‐term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting participants (31 of whom were dermatologists). Significant progress was made on the domain of clinical signs. Without reference to any named scales, it was agreed that the intensity and extent of erythema, excoriation, oedema/papulation and lichenification should be included in the core outcome measure for the scale to have content validity. The group then discussed a systematic review of all scales measuring the clinical signs of eczema and their measurement properties, followed by a consensus vote on which scale to recommend for inclusion in the core outcome set. Research into the remaining three domains was presented, followed by discussions. The symptoms group and quality of life groups need to systematically identify all available tools and rate the quality of the tools. A definition of long‐term control is needed before progress can be made towards recommending a core outcome measure.

The role of psychosocial working conditions on burnout and its core component emotional exhaustion – a systematic review

AimsTo analyze the association between psychosocial working conditions and burnout and its core component emotional exhaustion, a systematic literature review was undertaken including cohort studies, case–control studies, and randomized controlled trials.MethodsThe literature search in Medline and PsycInfo was based on a defined search string and strict exclusion and inclusion criteria. Evaluation of the 5,599 initially identified search hits by two independent reviewers and a detailed quality assessment resulted in six methodologically adequate cohort studies considering the relationship between psychosocial working conditions and burnout (one study) as well as the burnout core component emotional exhaustion (five studies).ResultsThe results of our systematic review point to a relationship between psychosocial working conditions and the development of emotional exhaustion/burnout. Particularly high job demands seem to play a role in the development of emotional exhaustion. However, strong intercorrelations between workplace factors, as a matter of principle, make the identification of a single psychosocial workplace factor (being associated with an especially high or low risk of burnout) difficult.ConclusionsMultidimensional approaches including reduction of work demands, enhancement of decision latitude and improving the social climate might be promising for preventing burnout and emotional exhaustion. However, methodologically adequate intervention studies are urgently needed to prove the effectiveness of workplace interventions.

Effects of Volatile Anesthetics on Mortality and Postoperative Pulmonary and Other Complications in Patients Undergoing Surgery: A Systematic Review and Meta-analysis

Background:It is not known whether modern volatile anesthetics are associated with less mortality and postoperative pulmonary or other complications in patients undergoing general anesthesia for surgery. Methods:A systematic literature review was conducted for randomized controlled trials fulfilling following criteria: (1) population: adult patients undergoing general anesthesia for surgery; (2) intervention: patients receiving sevoflurane, desflurane, or isoflurane; (3) comparison: volatile anesthetics versus total IV anesthesia or volatile anesthetics; (4) reporting on: (a) mortality (primary outcome) and (b) postoperative pulmonary or other complications; (5) study design: randomized controlled trials. The authors pooled treatment effects following Peto odds ratio (OR) meta-analysis and network meta-analysis methods. Results:Sixty-eight randomized controlled trials with 7,104 patients were retained for analysis. In cardiac surgery, volatile anesthetics were associated with reduced mortality (OR = 0.55; 95% CI, 0.35 to 0.85; P = 0.007), less pulmonary (OR = 0.71; 95% CI, 0.52 to 0.98; P = 0.038), and other complications (OR = 0.74; 95% CI, 0.58 to 0.95; P = 0.020). In noncardiac surgery, volatile anesthetics were not associated with reduced mortality (OR = 1.31; 95% CI, 0.83 to 2.05, P = 0.242) or lower incidences of pulmonary (OR = 0.67; 95% CI, 0.42 to 1.05; P = 0.081) and other complications (OR = 0.70; 95% CI, 0.46 to 1.05; P = 0.092). Conclusions:In cardiac, but not in noncardiac, surgery, when compared to total IV anesthesia, general anesthesia with volatile anesthetics was associated with major benefits in outcome, including reduced mortality, as well as lower incidence of pulmonary and other complications. Further studies are warranted to address the impact of volatile anesthetics on outcome in noncardiac surgery.

Albumin versus crystalloid solutions in patients with the acute respiratory distress syndrome: a systematic review and meta-analysis.

IntroductionIn patients with acute respiratory distress syndrome (ARDS) fluid therapy might be necessary. The aim of this systematic review and meta-analysis is to determine the effects of colloid therapy compared to crystalloids on mortality and oxygenation in adults with ARDS.MethodsRandomized controlled trials (RCTs) were identified through a systematic literature search of MEDLINE, EMBASE, CENTRAL and LILACS. Articles published up to 15th February 2013 were independently screened, abstracted, and assessed (Cochrane Risk of Bias Tool) to provide evidence-based therapy recommendations. RCTs were eligible if they compared colloid versus crystalloid therapy on lung function, inflammation, damage or mortality in adults with ARDS. Primary outcome parameters were respiratory mechanics, gas exchange lung inflammation and damage as well as hospital mortality. Kidney function, need for renal replacement therapy, hemodynamic stabilization and intensive care unit (ICU) length of stay served as secondary outcomes.ResultsA total of 3 RCTs out of 4130 potential trials found in the databases were selected for qualitative and quantitative analysis totaling 206 patients who received either albumin or saline. Overall risk of bias was unclear to high in the identified trials. Calculated pooled risk of death was not statistically significant (albumin 34 of 100 (34.0%) versus 40 of 104 (38.5%), relative risk (RR) = 0.89, 95% confidence interval (CI) 0.62 to 1.28, P = 0.539). Weighted mean difference (WMD) in PaO2/FiO2 (mmHg) improved in the first 48 hours (WMD = 62, 95% CI 47 to 77, P <0.001, I2 = 0%) after therapy start and remained stable after 7 days (WMD = 20, 95% CI 4 to 36, P = 0.017, I2 = 0%).ConclusionsThere is a high need for RCTs investigating the effects of colloids in ARDS patients. Based on the findings of this review, colloid therapy with albumin improved oxygenation but did not affect mortality.

Safety and efficacy of thrombolysis in telestroke: A systematic review and meta-analysis

Objective: The aim of this systematic review and meta-analysis was to evaluate the safety and efficacy of IV thrombolysis (IVT) with tissue plasminogen activator (tPA) delivered through telestroke networks in patients with acute ischemic stroke. Methods: We conducted a systematic review and meta-analysis according to PRISMA guidelines. Literature searches on MEDLINE, Embase, and CENTRAL databases covered prospective randomized controlled and nonrandomized studies comparing telemedicine-guided IVT to IVT administered at stroke centers and were published from the earliest date available until April 1, 2015. Outcomes of interest were symptomatic intracerebral hemorrhage, mortality, and functional independence (modified Rankin Scale scores 0–1) at 3 months. Random-effects meta-analysis was used to compute pooled effect estimates and the I2 statistic to assess heterogeneity. Results: Of 529 records identified, 7 studies totaling 1,863 patients fulfilled our eligibility criteria. Among these, thrombolysis was largely restricted to the 3-hour time window. Symptomatic intracerebral hemorrhage rates were similar between patients subjected to telemedicine-guided IVT and those receiving tPA at stroke centers (risk ratio [RR] = 1.01, 95% confidence interval [CI] 0.37–2.80; p = 0.978) with low evidence of heterogeneity (I2 = 37%; p = 0.189). There was no difference in mortality (RR = 1.04, 95% CI 0.74–1.48; p = 0.806) or in functional independence (RR = 1.11, 95% CI 0.78–1.57; p = 0.565) at 3 months between telemedicine-guided and stroke center thrombolysis. No heterogeneity was identified (I2 = 0%, p = 0.964 and I2 = 52%, p = 0.123, respectively). Conclusions: Our findings indicate that IV tPA delivery through telestroke networks is safe and effective in the 3-hour time window. Lack of prospective trials, however, emphasizes the need to further substantiate these findings in the 3- to 4.5-hour time window. PROSPERO registration information: URL: http://www.crd.york.ac.uk/PROSPERO. Unique identifier: CRD42015017232.

Systematic review of the effect of the psychosocial working environment on cognition and dementia

The high incidence of cognitive impairment in the ageing population, together with the challenges it imposes to health systems, raises the question of what affect working life has on cognitive abilities. The study, therefore, reviews recent work on the longitudinal impact of psychosocial work conditions on cognitive functioning and on dementia. Relevant articles were identified by a systematic literature search in PubMed and PsycINFO using a standardised search string and specific inclusion and exclusion criteria. We included articles reporting longitudinal effects that were investigated in cohort studies, case–control studies or randomised controlled trials in the working population. Two independent reviewers evaluated the studies in three subsequent phases: (i) title–abstract screening, (ii) full-text screening and (iii) checklist-based quality assessment.Methodical evaluation of the identified articles resulted in 17 studies of adequate quality. We found evidence for a protective effect of high job control and high work complexity with people and data on the risk of cognitive decline and dementia. Moreover, cognitively demanding work conditions seem to be associated with a decreased risk of cognitive deterioration in old age.Psychosocial work conditions can have an impact on cognitive functioning and even on the risk of dementia. As the world of work is undergoing fundamental changes, such as accelerated technological advances and an ageing working population, optimising work conditions is essential in order to promote and maintain cognitive abilities into old age.

A systematic review of the outcomes reported in multimodal pain therapy for chronic pain

There are no recommendations provided for the outcome domains of chronic pain that should be explicitly considered in each clinical trial to describe the efficacy and effectiveness of multimodal pain therapy (MPT). Our aims were to summarize all reported outcome domains in studies assessing the effects of MPT for chronic pain, and to subsequently inform a consensus‐based development of a core outcome set of domains in this field.

Core outcome set to assess effectiveness in multimodal pain therapy – preliminary results of an interdisciplinary online survey

Background For multimodal pain therapy (MPT), a bio-psycho-social therapy approach for patients suffering from chronic pain, a core outcome set (COS) is currently lacking. Following the recommendations from initiatives such as Outcome Measures in Rheumatology (OMERACT) and Harmonizing Outcome Measures for Eczema (HOME), the study “Validation and Application of a patient relevant core set of outcome domains to assess multimodal PAIN therapy” (VAPAIN) aims to develop an accepted and valid COS for MPT.