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

This is the report from the fifth meeting of the Harmonising Outcome Measures for Eczema initiative (HOME V). The meeting was held on 12–14 June 2017 in Nantes, France, with 81 participants. The main aims of the meeting were (i) to achieve consensus over the definition of the core domain of long-term control and how to measure it and (ii) to prioritize future areas of research for the measurement of the core domain of quality of life (QoL) in children. Moderated whole-group and small-group consensus discussions were informed by presentations of qualitative studies, systematic reviews and validation studies. Small-group allocations were performed a priori to ensure that each group included different stakeholders from a variety of geographical regions. Anonymous whole-group voting was carried out using handheld electronic voting pads according to predefined consensus rules. It was agreed by consensus that the long-term control domain should include signs, symptoms, quality of life and a patient global instrument. The group agreed that itch intensity should be measured when assessing long-term control of eczema in addition to the frequency of itch captured by the symptoms domain. There was no recommendation of an instrument for the core outcome domain of quality of life in children, but existing instruments were assessed for face validity and feasibility, and future work that will facilitate the recommendation of an instrument was agreed upon. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international group working together to develop a core outcome set (COS) for clinical trials in eczema (synonymous with atopic eczema and atopic dermatitis). HOME is coordinated from the Centre of Evidence Based Dermatology, University of Nottingham, U.K. Participation in HOME is open to anyone with an interest in outcomes for eczema. A COS is the agreed upon minimum set of instruments that should be included in all clinical trials for a particular condition. Use of a COS does not preclude using other instruments; other domains and instruments can also be included to meet the specific requirements of individual trials. COS initiatives are active across many fields of medicine and should enable better synthesis of trial data and reduce selective outcome reporting bias. The HOME initiative follows the best current guidance on developing a COS. Four core domains have been identified: clinician-reported signs; patient-reported symptoms; quality of life; and long-term control. The core outcome measurement instruments for clinician-reported signs and patient-reported symptoms have been established: the Eczema Area and Severity Index (EASI) for measuring clinician reported signs was agreed on at the HOME III meeting, and the Patient-Oriented Eczema Measure (POEM) was chosen to measure patient-reported symptoms at the HOME IV meeting. This is a report from the fifth consensus meeting of the HOME initiative (HOME V), which was held on 12–14 June 2017 in Nantes, France. The local organizers were Sebastien Barbarot and Jean-Francois Stalder of Nantes University Hospital, France

Use of routine hospital morbidity data together with weight and height of patients to predict in-hospital complications following total joint replacement

Extent: 8p. The electronic version of this article is the complete one and can be found online at: http://www.biomedcentral.com/1472-6963/12/380BackgroundRoutinely collected data such as hospital morbidity data (HMD) are increasingly used in studying clinical outcomes among patients undergoing total joint replacement (TJR). These data are readily available and cover large populations. However, since these data were not originally collected for the purpose of health research, a rigorous assessment of their quality is required. We assessed the accuracy of the diagnosis of obesity in HMD and evaluated whether the augmentation of HMD with actual weight and height of patients could improve their ability to predict major in-hospital complications following total joint replacement in men.MethodsThe electronic records of 857 participants in the Health In Men Study (HIMS) who had had TJR were linked with Western Australia HMD. HMD-recorded diagnosis of obesity was validated using the actual weight and height obtained from HIMS. In-hospital major complications were modelled using multivariable logistic regressions that either included the actual weight and height or HMD-recorded obesity. Model discrimination was calculated using area under ROC curve.ResultsThe HMD failed to detect 70% of the obese patients. Only 64 patients (7.5%) were recorded in HMD as obese although 216 (25%) were obese [BMI: ≥30kg/m2] (sensitivity: 0.2, positive predictive value: 0.7). Overall, 174 patients (20%) developed an in-hospital major complication which was significantly higher in the overweight and obese comparing with patients with normal weight. HMD-recorded obesity was not independently associated with major complications, whereas a dose-response relationship between weight and these complications was observed (P=0.004). Using the actual weight and height of the participants instead of HMD-recorded diagnosis of obesity improved model discrimination by 9%, with areas under ROC curve of: 0.69, 95% CI: 0.64-0.73 for the model with HMD-recorded obesity compared with 0.75, 95% CI: 0.70-0.79 for the model with actual weight and height, PConclusionBody weight is an important risk factor for in-hospital complications in patients undergoing TJR. HMD systems do not include weight and height as variables whose recording is mandatory. Augmenting HMD with patients' weight and height may improve prediction of major complications following TJR. Our study suggests making these variables mandatory in any hospital morbidity data system.George Mnatzaganian, Philip Ryan, Paul E Norman, David C Davidson and Janet E Hille