Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis:protocol for a multicentre randomised controlled trial

INTRODUCTION: Cardiovascular morbidity is a major burden in patients with rheumatoid arthritis (RA). In this study, we compare the effect of a targeted, intensified, multifactorial intervention with that of conventional treatment of modifiable risk factors for cardiovascular disease (CVD) in patients with early RA fulfilling the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) criteria. METHODS AND ANALYSIS: The study is a prospective, randomised, open label trial with blinded end point assessment and balanced randomisation (1:1) conducted in 10 outpatient clinics in Denmark. The primary end point after 5 years of follow-up is a composite of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularisation. Secondary outcomes are: the proportion of patients achieving low-density lipoprotein cholesterol <2.5 mmol/L, glycated haemoglobin <48 mmol/mol, blood pressure <140/90 mm  Hg for patients without diabetes and <130/80 mm Hg for patients with diabetes and normoalbuminuria (urinary albumin creatinine ratio <30 mg/g) after 1 year of follow-up and the proportion of patients in each treatment group achieving low RA disease activity after 1 year, defined as a disease activity score C-reactive protein (DAS28-CRP) <3.2 and a DAS28-CRP score <2.6 after 12, 24 and 60 months. Furthermore, all hospitalisations for acute and elective reasons will be adjudicated by the event committee after 12, 24 and 60 months. Three hundred treatment-naive patients with early RA will be randomly assigned (1:1) to receive either conventional treatment administered and monitored by their general practitioner according to national guidelines (control group) or a stepwise implementation administered and monitored in a quarterly rheumatological nurse-administered set-up of behaviour modification and pharmacological therapy targeting (1) hyperlipidaemia, (2) hypertension, (3) hyperglycaemia and (4) microalbuminuria (intervention group). ETHICS AND DISSEMINATION: This protocol is approved by the local ethics committee (DK-S-2014007) and The Danish Health and Medicines Authority. Dissemination will occur through presentations at National and International conferences and publications in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT0224625

Development and validation of a brief, descriptive Danish pain questionnaire (BDDPQ).

BACKGROUND: A new pain questionnaire should be simple, be documented to have discriminative function, and be related to previously used questionnaires. METHODS: Word meaning was validated by using bilingual Danish medical students and asking them to translate words taken from the Danish version of the McGill pain questionnaire into English. Evaluative word value was estimated using a visual analog scale (VAS). Discriminative function was assessed by having patients with one of six painful conditions (postherpetic neuralgia, phantom limb pain, rheumatoid arthritis, ankle fracture, appendicitis, or labor pain) complete the questionnaire. RESULTS: We were not able to find Danish words that were reliably back-translated to the English words 'splitting' or 'gnawing'. A simple three-word set of evaluative terms had good separation when rated on a VAS scale ('let' 17.5+/-6.5 mm; 'moderat' 42.7+/-8.6 mm; and 'staerk' 74.9+/-9.7 mm). The questionnaire was able to discriminate among the six painful conditions with 77% accuracy by just using the descriptive words. The accuracy of the questionnaire increased to 96% with the addition of evaluative terms (for pain at rest and with activity), chronicity (acute vs. chronic), and location of the pain. CONCLUSIONS: A Danish pain questionnaire that subjects and patients can self-administer has been developed and validated relative to the words used in the English McGill Pain questionnaire. The discriminative ability of the questionnaire among some common painful conditions has been tested and documented. The questionnaire may be of use in patient care and research