Marta Redondo

Translating patient reported outcome measures: methodological issues explored using cognitive interviewing with three rheumatoid arthritis measures in six European languages

OBJECTIVE Cross-cultural translation of patient-reported outcome measures (PROMs) is a lengthy process, often performed professionally. Cognitive interviewing assesses patient comprehension of PROMs. The objective was to evaluate the usefulness of cognitive interviewing to assess translations and compare professional (full) with non-professional (simplified) translation processes. METHODS A full protocol used for the Bristol RA Fatigue Multi-dimensional Questionnaire and Numerical Rating Scale (BRAF-MDQ, BRAF-NRS) was compared with a simplified protocol used for the RA Impact of Disease scale (RAID). RA patients in the UK, France, the Netherlands, Germany, Spain and Sweden completed the PROMs during cognitive interviewing (BRAFs in the UK were omitted as these were performed during development). Transcripts were deductively analysed for understanding, information retrieval, judgement and response options. Usefulness of cognitive interviewing was assessed by the nature of problems identified, and translation processes by percentage of consistently problematic items (⩾40% patients per country with similar concerns). RESULTS Sixty patients participated (72% women). For the BRAFs (full protocol) one problematic item was identified (of 23 items × 5 languages, 1/115 = 0.9%). For the RAID (simplified protocol) two problematic items were identified (of 7 items × 6 languages, 2/42 = 4.8%), of which one was revised (Dutch). Coping questions were problematic in both PROMs. CONCLUSION Conceptual and cultural challenges though rare were important, as identified by formal evaluation, demonstrating that cognitive interviewing is crucial in PROM translations. Proportionately fewer problematic items were found for the full than for the simplified translation procedure, suggesting that while both are acceptable, professional PROM translation might be preferable. Coping may be a particularly challenging notion cross-culturally.

Negative affect in systemic sclerosis

Abstract Negative affect appears frequently in rheumatic diseases, but studies about their importance and prevalence in systemic sclerosis patients are scarce, and the results are inconclusive separately. We conducted a comprehensive search on April 2013 of PubMed, Medline, and PsycINFO databases to identify original research studies published. A total of 48 studies were included in this systematic review. We found negative emotions have very high levels in these patients, compared to both healthy population other chronic rheumatic patients assessed with the same instruments and cutoffs. Depression has been, of the three negative emotions that we approach to in this review, the most widely studied in systemic sclerosis, followed by anxiety. Despite the fact that anger is a common emotion in these diseases is poorly studied. Methodologic issues limited the ability to draw strong conclusions from studies of predictors. Disease-specific symptoms (swollen joints, gastrointestinal and respiratory symptoms and digital ulcers) and factors related to physical appearance were associated with negative emotions. Interdisciplinary care and biopsychosocial approach would have a great benefit in the clinical management of these patients.

The revised Bristol Rheumatoid Arthritis Fatigue measures and the Rheumatoid Arthritis Impact of Disease scale : validation in six countries

Abstract Objective To 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. Methods We 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. Results A 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. Conclusion Across 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.

FRI0367 Fatigue is an Internationally Valid Concept: The Bristol RA Fatigue Multi-Dimensional Questionnaire (BRAF-MDQ) in 6 EU Countries

Background The 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. Objectives To 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. Methods 100-200 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 Cronbachs alpha; criterion validity by Spearmans correlation with RAID and SF-36 vitality subscale; and construct validity by correlation with the remaining 7 SF-36 domains. Results 1276 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: Cronbachs 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. Conclusions The 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 Interest None declared

Expert recommendations on the psychological needs of patients with rheumatoid arthritis

ObjectiveTo establish feasible and practical recommendations for the management of the psychological needs of patients with rheumatoid arthritis (RA) from the moment of diagnosis through the course of the disease.MethodsA nominal group meeting was held with an RA expert team including rheumatologists and psychologists, at which a guided discussion addressed the most important psychological and emotional needs in RA. Based on the comments collected, and a literature review, a matrix document of recommendations for telematics discussion was prepared, as well as a Delphi survey to test agreement with these recommendations. Agreement was defined if at least 80% of participants voted ≥ 7 (from 1, totally disagree to 10, totally agree). For each recommendation, the level of evidence and grading of recommendations was established following the Oxford criteria, and the degree of agreement through the Delphi.ResultsThirteen recommendations were established, addressing several key processes: (1) identification of psychological problems and needs in patients with RA, and a guideline for their management in daily practice; (2) communication with patients; (3) referral criteria to mental health professionals.ConclusionsThese recommendations are intended to help health care professionals openly address the psychological aspects of patients in daily practice to follow and treat them properly.

THU0593 Validity of The Bristol RA Fatigue Multi-Dimensional Questionnaire (BRAF-MDQ) and Rheumatoid Arthritis Impact of Disease (RAID) Scale across 6 European Countries

Background The BRAF-MDQ1,2 and RAID3 are patient-reported outcome measures derived from the patient perspective. The 20 item BRAF-MDQ has 4 factors (physical, cognitive, emotional fatigue, living with fatigue) and the 7 item RAID is uni-dimensional. The BRAF-MDQ properties have not been tested outside the UK, nor the validity of the new Swedish RAID examined. Objectives To test the structure, construct and criterion validity of the BRAF-MDQ and the RAID in 6 EU countries. Methods Survey of RA clinic patients in clinics in France, Germany, Netherlands, Spain, Sweden and UK (F, G, N, Sp, Sw, UK), using BRAF-MDQ, RAID and SF-36. Factor structure examined by Confirmatory Factor Analysis and internal consistency by Cronbachs Alpha. Criterion validity for the BRAF-MDQ evaluated by internal Spearmans correlations, and for BRAF-MDQ and RAID fatigue item by correlation with each other and SF-36 Vitality subscale. Construct validity of BRAF-MDQ and RAID evaluated by Spearmans Correlation with each other, HAQ, and SF-36 domains. Analysis conducted overall and by individual country and for BRAF-MDQ by total and subscales. Results 1276 patients participated: F 206, G 216, N 317, Sp 157, Sw 170, UK 210. Disease duration <5 yrs for 25%, 76% female, median HAQ 1.0 (IQR 0.375–1.5). Mean total BRAF-MDQ was 26/70 (SD 26) with subscales physical fatigue 11.38/22 (SD 5.77), living with fatigue 6.46/21 (SD 5.4), cognitive 4.28/15 (SD 8.7) and emotional fatigue 3.41/12 (SD 3.22). Mean RAID was 4.15/10 (SD 2.31). Confirmatory factor analysis: BRAF-MDQ original UK 4 factor structure was confirmed in each country, demonstrating one factor for each set of variables, with high factor loadings (0.71–0.96). Bootstrapping (4 sets of analyses on 20 random samples of 50% of patients/country), found the structure held true in at least 19/20 sets per country. RAID single factor structure was confirmed in all countries (0.75–0.95). Internal consistency ranged from 0.75–0.96 for the BRAF-MDQ (total and subscales) and the RAID ranged from 0.93–0.96 (overall and by country). Criterion validity overall and by country: The BRAF-MDQ correlated internally and with the SF-36 Vitality and RAID fatigue items (0.6–0.93). Construct validity: BRAF-MDQ and RAID correlatied with each other, the HAQ, and remaining 8 SF36 domains (0.46–0.86). Conclusions The BRAF-MDQ and RAID demonstrate strong, consistent factor structure and internal consistency, with moderate-good criterion and construct validity across 6 EU countries, reflecting their robust methods of development. This indicates no specific country scoring is necessary, and strengthens the case for measuring both fatigue and impact in multi-country studies. References Nicklin et al, Arth Care Res 2010:62:1552–8. Nicklin et al, Arth Care Res 2010:62:1559–6. Gossec et al, Ann Rheum Dis 2009;68:1680–5 Acknowledgement EULAR project grant EP1009 Disclosure of Interest None declared

SAT0647-HPR Patient Personality Influences The Prescription of Treatment for Rheumatoid Arthritis

Background Individualized treatment of rheumatoid arthritis (RA) based on genetic and serologic factors is increasingly accepted. In addition, patients are more actively involved in the management of their disease. However, personality has received little attention with respect to perception of the need and adherence to treatment. Objectives Our objective was to evaluate the influence of personality on the intensity of RA treatment. Methods We performed a cross-sectional study in two hospitals with early arthritis clinics where sociodemographic, clinical, and therapeutic variables are systematically recorded. Patients completed Eysenck Personality Questionnaire, Multidimensional Health Locus of Control, Pain-Related Self-Statement Scale and Pain-Related Control Scale. Aggressive treatment was considered if patients received more than two DMARDs or biological agents during the first year of follow-up. Multivariate logistic regression analysis was performed to determine predictors of aggressive treatment. Results 176 RA patients were included (80% women, disease begin median age 55 years). Treatment was considered aggressive in 57.9% of the sample. Scores were high in extraversion in 50.8% of patients, neuroticism in 29.5%, and psychoticism in 14.7%.Neuroticism was the only factor associated with aggressive treatment, which was less probable (p=0.04, OR =0.40). Neuroticism also decreased the possibility of receiving a combination of biologics and DMARDs (p=0.04, OR =0.28). Conclusions Patients with high scores on neuroticism are more worried, obsessive and hypochondriac, leading them to reject more aggressive therapy. It is important educate patients about their disease so that they will accept more aggressive approaches in clear cases of poor outcome. Disclosure of Interest None declared

FRI0190 Cognitive Interviewing is Crucial in Translating Patient Reported Outcome Measures (PROMS): an International Study in 6 Countries

Background International studies necessitate validated translations and adaptations of PROMs. However, the exact technique to translate and validate a PROM is not well defined. The full procedure can be complex and costly: the Bristol Rheumatoid Arthritis Fatigue Multi-dimensional Questionnaire and Numerical Rating Scales (BRAF-MDQ; BRAF-NRS)1 were translated by professional PROM translators using an extensive protocol. A simplified procedure can also be used as was the case for the Rheumatoid Arthritis Impact of Disease Score (RAID) - translated by the clinician developers, using a brief protocol.2 Objectives To compare the full versus simplified procedures used for these 2 questionnaires, in 5 languages, using formal cognitive interviewing (CI).3 Methods In each language (Dutch, English, French, German, Spanish, Swedish), 10 patients per country completed all 3 PROMS, using CI (verbalising their thoughts and audio-taped). Each item was analysed for Understanding, Retrieval (of information), Judgement and Response (options). The steering committee interpreted all the data; a cut-off for “difficult item” was set at 30% ie if >3/10 patients in a country had difficulties with an item. The number of difficult items was compared across the questionnaires. The difficult items were rephrased where appropriate. Results As planned, 60 patients participated, of whom 50 assessed all 3 questionnaires (BRAFs not assessed in English, RAID not assessed in Swedish): 72% women; 17% aged <39 yrs, 50% aged 40-59, 33% aged >60. (a) After the extensive translation process (BRAFs), the number of difficult items identified by CI were: BRAF-MDQ, 0 difficult items identified out of 20 questions and 5 languages (0%); and BRAF-NRS had 1 difficult item out of 3 questions and 5 languages (6.7%). Specifically, Dutch patients were confused by the BRAF-NRS Coping response option, which is reverse scored (high = good) compared to the other NRS. Overall percentage of difficult items for the BRAFs was 0.87% (1 item of 23 x 5 languages, or 1 in 115). (b) After the simplified translation process (RAID questionnaire) 2 difficult items out of 7 questions and 6 languages were identified (4.7% or 2 in 42). The difficult questions were Question 2 (functional disability) in Spanish and Q5 (physical wellbeing) in Dutch. For one item, the initial translation was widely different from the original version indicating a real translation error. Conclusions More difficult items were found for the RAID questionnaire, which had been translated using a simplified procedure, than for the BRAFs (professionally translated). The data thus suggest that while both translation methods are possible, professional PROM translation might be preferable. These problems were only identified by formal evaluation, demonstrating that cognitive interviewing is crucial in PROM translations. References Nicklin et al. Arth Care Res 2010. Gossec et al. ARD 2009. Drennen J. J Adv Nurs 2003. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.2451

AB0829-HPR Influence of ra patient personality for more aggressive therapies

Background Actually, patients with rheumatoid arthritis (RA) play a more active role in relation to his illness, and the choice of treatment. The patient’s personality can be an important part in this process. Few studies associate medical characteristics of the patient with prognosis and treatment. However, for the evaluation of RA using self-administered questionnaires (eg HAQ) or the patient’s own assessment (DAS28), which are being influenced by patient characteristics such as personality. Objectives To evaluate the influence of personality factors in the type of treatment that patients receive. Methods Multicenter study of a cohort of patients with RA, with a crossover design. We selected patients diagnosed RA of recent onset in two hospitals, with a maximum follow-up of 18 months. All patients who consented completed a form that included general sociodemographic variables, the Eysenck Personality Questionnaire (EPQ-A), Locus of Control Health-related questionnaire (MHLC), and Beliefs and Self-statements about Pain questionnaire (PRCS / PRSS). Also collected measures of disease activity (DAS28 and CRP in the first year after diagnosis). Aggressive treatment was considered to have received more than two DMARDs, or Biological, during follow up. A descriptive analysis of the variables associated with more aggressive treatment and a logistic regression analysis to determine personality variables associated with treatment, adjusting for sociodemographic and clinical characteristics were performed. Results A total of 176 RA patients were included in the study. 80% of the sample was women. The mean age was 55.7 ± 13.2 years. The 48.8% of the sample received aggressive treatment. The 50.89% of patients had high scores on extraversion, and 28.7% scored high in neuroticism. We do not found significant differences in age and sex related to aggressive treatment. We performed a multivariate logistic regression analysis, finding that the personality trait of neuroticism is the only predictor of receiving more aggressive treatment (p = 0.01, OR = 0.34). Conclusions Patients with high scores on neuroticism are more worried, anxious and / or depressed, affecting their assessment of the disease and may influence the increased demand for therapeutic resources. Disclosure of Interest None Declared