ObjectiveTo evaluate the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ), the revised Bristol Rheumatoid Arthritis Numerical Rating Scales (BRAF-NRS V2) and the Rheumatoid Arthritis Impact of Disease (RAID) scale in six countries.MethodsWe surveyed RA patients in France, Germany, The Netherlands, Spain, Sweden and the UK, including the HAQ, 36-item Short Form Health Survey (SF-36) and potential revisions of the BRAF-NRS coping and Spanish RAID coping items. Factor structure and internal consistency were examined by factor analysis and Cronbach’s α and construct validity by Spearman’s correlation.ResultsA total of 1276 patients participated (76% female, 25% with a disease duration <5 years, median HAQ 1.0). The original BRAF-MDQ four-factor structure and RAID single-factor structure were confirmed in every country with ⩾66% of variation in items explained by each factor and all item factor loadings of 0.71–0.98. Internal consistency for the BRAF-MDQ total and subscales was a Cronbach’s α of 0.75–0.96 and for RAID, 0.93–0.96. Fatigue construct validity was shown for the BRAF-MDQ and BRAF-NRS severity and effect scales, correlated internally with SF-36 vitality and with RAID fatigue (r = 0.63–0.93). Broader construct validity for the BRAFs and RAID was shown by correlation with each other, HAQ and SF-36 domains (r = 0.46–0.82), with similar patterns in individual countries. The revised BRAF-NRS V2 Coping item had stronger validity than the original in all analyses. The revised Spanish RAID coping item performed as well as the original.ConclusionAcross six European countries, the BRAF-MDQ identifies the same four aspects of fatigue, and along with the RAID, shows strong factor structure and internal consistency and moderate–good construct validity. The revised BRAF-NRS V2 shows improved construct validity and replaces the original.

BackgroundPersons with fibromyalgia (FM) suffer from numerous symptoms with various levels of intensity, such as widespread pain, fatigue, cognitive dysfunction, non-restorative sleep, depression, and anxiety among others. The patient’s perspective has been recognised by Outcome Measure in Rheumatology (OMERACT) as a key assessment in FM. For that reason, some patient reported outcomes measures (PROMs) have been developed. PROMs allow the comparison of a specific component of the disease in a patient through time, and also provide the opportunity to health professionals to compare patients between them in clinical trials. However, some PROMs are used over others despite a limited validation process. In addition, different versions of the same PROMs can co-exist, what can lead to uncertainty when selecting the adequate instrument.ObjectivesTo identify the existing PROMs for FM and analyse their psychometric properties.MethodsThe authors performed a comprehensive search in electronic databases (Medline, Embase, and Cochrane) in order to identify validation studies of PROMs for FM. Studies published between January 1990 and November 2017 were included. Generic PROMs and validation of diagnostic criteria and related screening tools were not considered as PROMs and were excluded. Information was gathered based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist manual.ResultsThe electronic search produced 1832 records. After screening, a total of 48 studies containing 16 PROMs for FM were included. The PROMs included address different constructs of the disease, Fibromyalgia Impact Questionnaire (FIQ), Revised Fibromyalgia Impact Questionnaire (FIQR), Combined Index of Symptom Severity, Combined Index of Severity of Fibromyalgia, Comprehensive Rating Scale for Fibromyalgia Symptomatology, Fibromyalgia Assessment Status, Fibromyalgia Bladder Index, Fibromyalgia Burden Assessment, Fibromyalgia Health Assessment Questionnaire, Fibromyalgia Impact Questionnaire+Visual Analogue Scales, Fibromyalgia Participation Questionnaire, Fibromyalgia Sleep Diary, Multidimensional Inventory of Subjective Cognitive Impairment, Multidimensional Patient Reported Outcome Measures Questionnaire, PROMIS Fatigue FM Profile, and Multidimensional daily diary of fatigue-fibromyalgia-17 items. Almost all PROMs have adequate content validity. Three PROMs do not report construct validity; seven do not report reliability, and six do not report internal consistency. Only three PROMs evaluate criterion validity and three responsiveness. The FIQ and the FIQR are the PROMs more widely cross-cultural validated with 18 and 13 adaptations respectively.ConclusionsPROMs for FM have, in general, only partial validation of their psychometric properties. Validation of an instrument is a continuous process in which quality is more important than quantity. Instead of creating new PROMs for FM, future works should focus on completing missing parts of the validation process of existing ones. In addition, cultural a...

BackgroundWeight loss is a commonly recommended treatment for gout, but the magnitude of effect to expect has to our knowledge not previously been evaluated in a systematic review.ObjectivesThe aim of this systematic review was to determine the benefits and harms associated with weight loss in overweight patients with gout.MethodsBased on a pre-defined protocol (CRD42016037937), we searched six databases for longitudinal studies, quantitatively reporting the effect of weight loss in overweight gout patients. Risk of bias was assessed using the ROBINS-I tool. The quality of the evidence was assessed using GRADE.ResultsFrom 3,991 potentially eligible studies, 10 were included (incl. one RCT). Interventions included diet with/without physical activity, bariatric surgery, diuretics, metformin, or no intervention. Due to clinical heterogeneity of the included studies, data are presented for each study and synthesised separately. The effect on serum uric acid (sUA) ranged from -168 to 30 μmol/L, and 0% to 60% patients achieved sUA normalisation (i.e. sUA <360 μmol/L). Six out of eight studies (75%) showed beneficial effects on gout attacks. A dose-response relationship was indicated in two studies for sUA, sUA normalisation and gout attacks. At short term (<3 months) after bariatric surgery, one study showed temporary increase in sUA, and another showed temporary increased number of gout attacks. Other possible harmful effects, measured by proxies such as withdrawals due to adverse events and serious adverse events, were poorly reported.ConclusionsThe available evidence is in favour of weight loss for overweight gout patients, with low, moderate and low quality of evidence for an effect on sUA, sUA normalisation, and gout attacks, respectively. At short term, temporary increased sUA and gout attacks may occur after bariatric surgery. There is an urgent need to initiate rigorous prospective studies (preferably RCTs) to provide more trustworthy estimates of benefits and harms of weight loss in overweight gout patients.References Richette P, Doherty M, Pascual E, et al. 2016 updated EULAR evidence-based recommendations for the management of gout. Ann Rheum Dis 2016:1–14, doi: 10.1136/annrheumdis-2016-209707. Disclosure of InterestNone declared

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BackgroundThe 20-item BRAF-MDQ was developed in the UK to measure RA fatigue, with a total score and 4 distinct subscales reflecting different fatigue concepts; there are 35 translations. If the translations adequately capture these concepts, then their internal factor structure should be similar; if not this would indicate important cultural differences in fatigue perception, requiring country-specific scoring. Criterion and construct validity have not yet been examined outside the UK.ObjectivesTo test the internal structure, criterion and construct validity of the BRAF-MDQ in France (F), Germany (G), Netherlands (N), Spain (Sp), Sweden (Sw) and UK.Methods100-200 RA patients in each country completed the BRAF-MDQ (sufficient for reliable factor analysis by country), the RA Impact of Disease (RAID) and the SF-36. BRAF-MDQ internal factor structure was tested by confirmatory factor analysis of the original 4 factors; internal consistency by Cronbach's alpha; criterion validity by Spearman's correlation with RAID and SF-36 vitality subscale; and construct validity by correlation with the remaining 7 SF-36 domains.Results1276 patients participated (F 206, G 216, N 317, Sp 157, Sw 170, UK 210). Overall, 76% were female; 10% <40 yrs old and 50% ≥60 yrs; 25.5% disease duration <5 yrs, with no major differences between countries. Overall mean BRAF-MDQ (0-70) was 26.04 (SD 16.18, range 0-70), country range 22.02 (G) to 34.19 (UK).The original 4-factor structure was upheld in each country with all items loading >0.7: Physical fatigue factor 0.749-0.910, Living with fatigue 0.705-0.899, Cognitive fatigue 0.797-0.959 and Emotional fatigue 0.793-0.919. The factor structure was upheld in 476/480 further tests comprising the 4 factors tested in 20 randomly selected subsets of 50% of patients per country (bootstrapping).Internal consistency was strong in all 6 countries for the total BRAF-MDQ: Cronbach's alpha 0.932-0.954. Subscales were also internally consistent in all 6 countries: Physical 0.75-0.791; Living 0.918-0.943; Cognition 0.912-0.955, Emotion 0.852-0.893.Criterion validity was shown in the toal sample and all 6 countries by high correlations amongst the BRAF subscales (0.367-0.986); high correlations of the total BRAF with the BRAF subscales (r=0.815–0.928); and of the total BRAF and subscales with both the RAID fatigue item (0.512-0.878) and SF-36 Vitality item (-0.501 to -0.830).Construct validity was shown in all 6 countries and in the total sample by appropriate correlations between the total BRAF, subscales and the remaining 7 SF-36 health domains: r=-0.223 (Sw, Emotion with Physical Function) to -0.760.ConclusionsThe BRAF-MDQ has an internal factor structure that holds across 6 EU countries, supporting its conceptual validity internationally. It has evidence for internal consistency, criterion and construct validity in 6 countries, further supporting its increasingly widespread use.Disclosure of InterestNone declared