Cochrane Reviews and Dermatological Trials Outcome Concordance: Why Core Outcome Sets Could Make Trial Results More Usable.

Evidence-based health care requires that relevant outcomes for patients are included in clinical trials investigating treatment effects, allowing subsequent systematic reviews to summarize all relevant evidence to guide clinical practice. Currently, no gold standard of outcome choice for dermatology trials and reviews exists. We systematically assessed concordance between efficacy outcomes in a random sample of 10 Cochrane Skin systematic reviews and the 220 dermatology trials included. Reviews did not include 742 (68%) of the 1,086 trial outcomes. Of the 60 outcomes the reviews sought, 17 (28%) were not reported in any trial, while 12 were assessed in <50% of trials. For 11 of 23 (48%) primary review outcomes, meta-analysis was impossible, because trial outcomes were absent or unclear. This small overlap of review/trial outcomes could suggest that trials are not measuring the outcomes perceived to be the most important by patients, clinicians, systematic reviewers, and trialists. The lack of standardized outcome measures, poor reporting of outcomes in trials, and low concordance of outcomes between reviews and primary studies could be improved by the development and implementation of Core Outcome Sets. These are an agreed-upon minimum set of key outcomes, for specified conditions, to be reported in all trials.

Developing a core outcome domain set to assessing effectiveness of interdisciplinary multimodal pain therapy: the VAPAIN consensus statement on core outcome domains.

Interdisciplinary multimodal pain therapy (IMPT) is a biopsychosocial treatment approach for patients with chronic pain that comprises at least psychological and physiotherapeutic interventions. Core outcome sets (COSs) are currently developed in different medical fields to standardize and improve the selection of outcome domains, and measurement instruments in clinical trials, to make trial results meaningful, to pool trial results, and to allow indirect comparison between interventions. The objective of this study was to develop a COS of patient-relevant outcome domains for chronic pain in IMPT clinical trials. An international, multiprofessional panel (patient representatives [n = 5], physicians specialized in pain medicine [n = 5], physiotherapists [n = 5], clinical psychologists [n = 5], and methodological researchers [n = 5]) was recruited for a 3-stage consensus study, which consisted of a mixed-method approach comprising an exploratory systematic review, a preparing online survey to identify important outcome domains, a face-to-face consensus meeting to agree on COS domains, and a second online survey (Delphi) establishing agreement on definitions for the domains included. The panel agreed on the following 8 domains to be included into the COS for IMPT: pain intensity, pain frequency, physical activity, emotional wellbeing, satisfaction with social roles and activities, productivity (paid and unpaid, at home and at work, inclusive presentism and absenteeism), health-related quality of life, and patient's perception of treatment goal achievement. The complexity of chronic pain in a biopsychosocial context is reflected in the current recommendation and includes physical, mental, and social outcomes. In a subsequent step, measurement instruments will be identified via systematic reviews.

[Epidemiology and prediction of the risk of falling in patients in acute care settings: Analysis of routine data from a university hospital]. / Epidemiologie und Vorhersage des Sturzrisikos von Patienten in der akutstationären Versorgung: Analyse von Routinedaten eines Universitätsklinikums.

BACKGROUND: Falls are a relevant issue of inpatient treatment. Epidemiological analysis concerning incidence, risk factors for falls and the quality of risk assessments are missing. METHODS: In a routine data-based cross-sectional study all patients hospitalized in the University Hospital Dresden, Germany, during 2012 and 2013 were analyzed according to fall incidence and risk factors (items of Dresden fall risk assessment [Dresden-FRA], age, sex, severity of disease, and length of stay. Fall risk and associated risk factors were determined using descriptive methods and logistic regression models. In addition, the quality of the fall risk assessment was evaluated. RESULTS: The risk of falling during the observation period was 1.6 %. Differences exist between the medical disciplines (risk of falling 0.1 % to 9.8 %). The fall rate was 2.9/1,000 days of treatment. Higher age, longer inpatient stay, and a higher level of disease severity were significant predictors of falls. Less serious consequences of falls were more frequently documented (84 %) than consequences of falls requiring treatment (16 %). All nine items of the Dresden-FRA were significant risk factors. The sensitivity and specificity of the Dresden-FRA were 69.9 % and 71.4 %, respectively. CONCLUSION: Patients at an older age and with more severe disease have a higher risk of falling. The validated assessment of the individual risk of falling is an important tool of medical quality management and risk management. The present study can help to raise awareness about the quality of risk assessments, to further improve fall risk assessment, and to increase patient safety in acute care.