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The Harmonising Outcome Measures for Eczema (HOME) initiative is a multidisciplinary, evidence-based international group developing a core outcome set for atopic eczema trials. HOME has previously recommended four essential domains to be measured; signs, symptoms, quality of life and long-term control, with Eczema Area and Severity Index (EASI) and Patient-Oriented Eczema Measure (POEM) as the instruments to measures signs and symptoms, respectively. The aim of the current study was to define the domain of long-term control, and achieve consensus on what instrument(s) should be used to measure it. Two qualitative studies were conducted by the long-term control working group: online focus groups involving patients and carers, and an online qualitative survey of the HOME membership. These were analysed thematically and combined to provide evidence on what long-term control of atopic eczema means to patients, carers and clinicians. A face-to-face consensus meeting (HOME V) was held on 12-14 June 2017 in Nantes, France, involving moderated small interactive groups and whole-group discussions with anonymous voting. The HOME roadmap and COSMIN and COMET guidelines on outcome measurement instrument selection were followed. Discussions and voting on the definition of long-term control and the face validity and feasibility of different ways of measuring long-term control were informed by these two international qualitative studies and other published evidence (systematic reviews and validation studies). Focus groups involving 99 patients and carers were conducted in the U.K., the U.S.A., the Netherlands, France, Sweden and Japan. The HOME survey included 62 responses, mainly clinicians, representing 16 countries. Patients, carers and clinicians considered long-term control to involve several related concepts: level of disease activity, impact on daily life, and treatment required (such as reducing treatment or using only maintenance treatment). Issues highlighted to consider when measuring long-term control included capturing the perspective of patients, carers and clini-cians, burden of data collection, interpretability and including an objective assessment. The consensus meeting in Nantes was attended by 81 participants from 13 countries. There was consensus (91% of participants voted in favour) that the long-term-control domain consists of repeated measures of the agreed core domains [clinician-reported signs, patient-reported symptoms (including itch intensity) and quality of life] plus a patient global assessment. Pending further discussions, the existing recommended instruments for signs and symptoms (EASI and POEM) should be used. HOME recommends that long-term control of atopic eczema is captured in trials by repeated measures of the existing core domains plus a patient global assessment. Further work is required on the timing of assessments and to determine the patient global assessment instrument.

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.

OBJECTIVES: In 2011 an ACR/EULAR collaboration developed new remission definitions for RA. In the present study, we evaluated the prevalence and predictive validity of these new ACR/EULAR remission criteria in 4 different European early rheumatoid arthritis cohorts. METHODS: Data from a tot al of 722 patients with early RA were analysed. Presence of remission at 6 months, as defined by one of the 4 proposed ACR/EULAR remission definitions was used to predict good functional and radiological outcome between 1 and 2 years of follow-up. RESULTS: Remission rates at 6 months ranged from 2-17% (Boolean definition) between the four cohorts. The level of HAQ and radiological damage varied between cohorts. Patients in remission at 6 months have an increased likelihood of long-term good outcome in terms of HAQ stability, but not radiographic stability. The performance of the practice definitions of remission was highly similar to the trial definitions. CRP status seems to add little information to the classification of remission in early RA. CONCLUSIONS: In clinical practice, a minority of patients with early RA achieves remission in the first 6 months of treatment. Remission at 6 months is predictive for good HAQ outcome between year 1 and 2 after inclusion, but not radiographic stability.

There is convincing evidence for the known and unambiguously accepted beneficial effects of glucocorticoids at low dosages. However, the implementation of existing recommendations and guidelines on the management of glucocorticoid therapy in rheumatic diseases is lagging behind. As a first step to improve implementation, we aimed at defining conditions under which long-term glucocorticoid therapy may have an acceptably low level of harm. A multidisciplinary European League Against Rheumatism task force group of experts including patients with rheumatic diseases was assembled. After a systematic literature search, breakout groups critically reviewed the evidence on the four most worrisome adverse effects of glucocorticoid therapy (osteoporosis, hyperglycaemia/diabetes mellitus, cardiovascular diseases and infections) and presented their results to the other group members following a structured questionnaire for final discussion and consensus finding. Robust evidence on the risk of harm of long-term glucocorticoid therapy was often lacking since relevant study results were often either missing, contradictory or carried a high risk of bias. The group agreed that the risk of harm is low for the majority of patients at long-term dosages of ≤5 mg prednisone equivalent per day, whereas at dosages of >10 mg/day the risk of harm is elevated. At dosages between >5 and ≤10 mg/day, patient-specific characteristics (protective and risk factors) determine the risk of harm. The level of harm of glucocorticoids depends on both dose and patient-specific parameters. General and glucocorticoid-associated risk factors and protective factors such as a healthy lifestyle should be taken into account when evaluating the actual and future risk.

The Cohort Hip and Cohort Knee (CHECK) study included participants with early symptomatic osteoarthritis (OA) of the hip or knee and evaluated clinical, radiographic and biochemical variables in order to establish the course, prognosis and underlying mechanisms of early symptomatic osteoarthritis. A total of 1002 participants aged 45-65 years, with symptomatic OA characterized by pain of knee and/ or hip, entered the cohort in the period October 2002 to September 2005. They were included at or within 6 months of their first visit to the general practitioner for these symptoms. An overview of measures that are included in the study can be found on the website www.check-research.com]. On the basis of their presenting symptoms, participants were divided into two groups. Participants with mild symptoms visited the research centre at years 0, 2, 5, 8 and 10 (variable visiting group) and participants with more serious symptoms visited the research centre each year (annual visiting group). After 7 years, only 105 participants (10%) had dropped out; their baseline characteristics did not differ significantly from those of other participants. CHECK is a valuable source of information on early symptomatic OA, that allows the examination of high-quality data on clinical, radiographic and biochemical variables. The CHECK steering group welcomes collaboration with national and international colleagues. Requests for collaboration or access to data can be sent to [checkreu@umcutrecht.nl].

Purpose: The computerized Animated Activity Questionnaire (AAQ) for assessing activity limitations in hip and knee osteoarthritis (HKOA) consists of video animations from which patients can choose the animation that best matches their own performance. The AAQ has demonstrated good validity and reliability. Application of the AAQ in international studies, requires good cross-cultural validity, i.e., minimal Differential Item Functioning (DIF) across countries. The aim of this study was to evaluate cross-cultural validity. Methods: Patients in 7 European countries patients completed the AAQ on a computer. Ordinal logistic regression analysis was used to evaluate DIF across languages (Dutch versus 6 other languages). DIF is defined as follows: If a patient in a country has the same level of activity limitation as a patient in the Netherlands (the reference country in which the AAQ is developed), they should score the same on each item of the AAQ. If there is a statistical significant difference between countries, there is DIF. We used frequently described criteria in literature to assess DIF between countries. Criteria for non-uniform DIF were set as a statistical significance (p

This dissertation consists of two parts. The first part is the result of thorough historical research into the development and content of the discussion of Hannah Arendt’s book ‘Eichmann in Jerusalem’ between 1963 and 1967, in three countries: the US, West Germany and France. This part corrects and enhances the historiography of the controversy on several important points. The second part looks specifically at the participation of fifteen historian-reviewers in the debate. These fifteen texts were analysed with help of the pragma-dialectical argumentation theory and method. The first result of this is a structured presentation of the precise differences of opinion between Arendt and the fifteen reviewers, and of the arguments that keep recurring in their discussion. Secondly, these textual analyses provide insight into the procedural problems that can occur in a heated discussion of the Holocaust, as well as the ways that discussants attempt to overcome these obstacles. These results are starting points for further research into the problematic nature of so-called Holocaust controversies, especially for research into the participation of historians in these notoriously difficult discussions.