OBJECTIVE: To examine height changes in middle-aged northern European women in relation to overall and cardiovascular mortality.

DESIGN: Population-based cohort studies with longitudinally measured heights and register-based mortality.

SETTING: Sweden and Denmark.

PARTICIPANTS: Population-based samples of 2406 Swedish and Danish women born on selected years in 1908-1952, recruited to baseline examinations at ages 30-60, and re-examined 10-13 years later.

MAIN OUTCOME MEASURE: Total and cardiovascular disease (CVD) specific mortality during 17-19 years of follow-up after last height measure.

RESULTS: For each 1 cm height loss during 10-13 years, the HR (95% CI) for total mortality was 1.14 (1.05 to 1.23) in Swedish women and 1.21 (1.09 to 1.35) in Danish women, independent of key covariates. Low height and high leisure time physical activity at baseline were protective of height loss, independent of age. Considering total mortality, the HR for major height loss, defined as height loss greater than 2 cm, were 1.74 (1.32 to 2.29) in Swedish women and 1.80 (1.27 to 2.54) in Danish women. Pooled analyses indicated that height loss was monotonically associated with an increased mortality, confirming a significant effect above 2 cm height loss. For cause-specific mortality, major height loss was associated with a HR of 2.31 (1.09 to 4.87) for stroke mortality, 2.14 (1.47 to 3.12) for total CVD mortality and 1.71 (1.28 to 2.29) for mortality due to causes other than CVD.

CONCLUSION: Height loss is a marker for excess mortality in northern European women. Specifically the hazard of CVD mortality is increased in women with height loss during middle age, and the results suggest that the strongest cause-specific endpoint may be stroke mortality. The present findings suggest attention to height loss in early and mid-adulthood to identify women at high risk of CVD, and that regular physical activity may prevent early onset height loss.

BACKGROUND: Low-dose naltrexone (LDN) is used widely as an off-label treatment for pain despite limited evidence for its effectiveness. A few small trials with a high risk of bias have investigated the effect of LDN on pain associated with fibromyalgia in women, but larger and more methodologically robust studies are needed. The primary aim of this randomized controlled trial is to investigate if 12 weeks of LDN treatment is superior to placebo in reducing the average pain intensity during the last 7 days in women with fibromyalgia.

METHODS: A single-center, permuted block randomized, double-blind, placebo-controlled, parallel-group trial will be performed in Denmark. Randomization comprises 100 women aged 18-64 years diagnosed with fibromyalgia who will be treated with either LDN or placebo for 12 weeks including a 4-week titration phase. The primary outcome is change in average pain intensity (during the last 7 days) from baseline to 12 weeks. Secondary outcomes are other fibromyalgia-related symptoms, i.e., tenderness, fatigue, sleep disturbance, stiffness, memory problems, depression, anxiety and measures of global assessment, physical function, impact of fibromyalgia, pain distribution, and health-related quality of life. Intention-to-treat analysis will be performed, and the number of responders with a more than 15%, 30%, and 50% improvement of pain after 12 weeks will be calculated for the LDN and placebo groups. Exploratory outcomes include measures of pain sensitivity, muscle performance, and biomarkers.

DISCUSSION: This study will contribute with high-level evidence on the efficacy of low-dose naltrexone for the treatment of pain in women with fibromyalgia. Secondary outcomes include both disease-specific and generic components investigating whether LDN influences other symptoms than pain. Explorative outcomes are included to provide greater insight into the mechanism of action of LDN and possibly a better understanding of the underlying pathology in fibromyalgia.

TRIAL REGISTRATION: EudraCT 2019-000702-30. Registered on 12 July 2019. ClinicalTrials.gov NCT04270877. Registered on 17 February 2020.

INTRODUCTION The multi-organ disease Lyme borreliosis can cause mainly large joint arthritis. No guideline exists describing how to diagnose Lyme arthritis (LA). The incidence of LA in Denmark remains unknown, but it is considered to be low. The primary aim of this study was to quantify the number of Borrelia burgdorferi serological tests requested from primary and secondary care; secondly, to examine how often LA is diagnosed. METHODS this was a register-based study including B. burgdorferi serological tests analysed at the department of clinical microbiology at Hvidovre and Herlev Hospitals during a two-year period. The results of the tests were categorised into primary and secondary care. A medical record review was made covering all newly referred rheumatological patients with B. burgdorferi serological tests analysed the Department of Clinical Microbiology, Hvidovre Hospital. A model was set up to diagnose LA. RESULTS Most tests were requested by primary care. A total of 146 rheumatology patients were tested for B. burgdorferi of whom 118 were newly referred. Using our model to diagnose LA, we found that three patients had possible LA, whereas one had likely LA, but none were given a final LA diagnosis. Overdiagnosis was not common among rheumatologists. CONCLUSION. The number of requested B. burgdorferi serological tests was highest in primary care. A clear guideline describing how to diagnose LA is needed in primary and secondary care alike.

BACKGROUND: Structural damage is as an important outcome in the Psoriatic Arthritis (PsA) Core Domain Set and its assessment is recommended at least once in the development of a new drug.

OBJECTIVES: To conduct a systematic review (SR) to identify studies addressing the measurement properties of radiographic outcome instruments for structural damage in PsA and appraise the evidence through the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Framework Instrument Selection Algorithm (OFISA).

METHODS: A SR was conducted using search strategies in EMBASE and MEDLINE to identify full-text English studies which aimed to develop or assess the measurement properties of radiographic outcome instruments in PsA. Determination of eligibility and data extraction was performed independently by two reviewers with input from a third to achieve consensus. Two reviewers assessed the methodology and results of eligible studies and synthesized the evidence using OMERACT methodology.

RESULTS: Twelve articles evaluating radiographic instruments were included. The articles assessed nine peripheral (hands, wrists and/or feet) and six axial (spinal and/or sacroiliac joints) radiographic instruments. The peripheral radiographic instruments with some evidence for reliability, cross-sectional construct validity and longitudinal construct validity were the Ratingen and modified Sharp van der Heijde scores. No instruments had evidence for clinical trial discrimination or thresholds of meaning. There was limited evidence for the measurement properties of all identified axial instruments.

CONCLUSION: There are significant knowledge gaps in the responsiveness of peripheral radiographic instruments. Axial radiographic instruments require further validation, and the need to generate novel instruments and utilise other imaging modalities should be considered.