Background: The aim of this study was to explore the impact of sex and disease classification on outcomes in axial spondyloarthritis (axSpA) patients, including both radiographic (r-) axSpA and non-radiographic (nr-) axSpA, in males and females, respectively. Methods: AxSpA patients were consecutively recruited from two rheumatology outpatient university clinics. We explored how sex and axSpA disease classification affected patient-reported outcome measures (PROMs). General linear models were used to investigate if there was an association between the continuous variables and each of the main effects of interest (sex and axSpA classification), as well as the possible interaction between them. Categorical outcome measures were analyzed with the use of logistic regression with the same fixed effects. We analyzed the relationship between tender point count (TPC) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The prevalence of extra-articular manifestations (EAMs) and the Charlson Comorbidity Index (CCI) were determined. Results: According to the protocol, a total of 100 outpatients with axSpA were enrolled (r-axSpA males 30, r-axSpA females 10, nr-axSpA males 25, nr-axSpA females 35). The BASDAI scores appeared higher among nr-axSpA females (median [Q
₁; Q
₃], 47 [21; 60]) compared with the combined median for the 3 other subgroups 25 [12; 25]. Female sex was associated with a higher number of tender point count (TPC, P < 0.001). TPC and BASDAI were correlated for female nr-axSpA patients (r = 0.44, P = 0.008) and male nr-axSpA patients (r = 0.56, P = 0.003). Being classified as nr-axSpA was associated with a lower SF-36 Mental Component Summary (median for the 4 subgroups: nr-axSpa females 46.7, nr-axSpA males 52.3 vs. r-axSpA males 56.9 and r-axSpA females 50.4). EAMs were frequent (up to 50%). The CCI was low in all 4 subgroups, and no difference in the CCI between the subgroups was observed (P = 0.14). However, male sex had a significant impact on the CCI (P = 0.03). Conclusions: In summary, patients with r-axSpA, regardless of sex, appeared less affected on most PROMs compared with nr-axSpA patients. However, female sex was associated with a higher number of TPC. TPC could possibly confound disease activity outcomes such as BASDAI, and one can consider different thresholds for defining high disease activity depending on the patient's sex. Trial registration: The trial is registered and approved by the Region of Southern Denmark's Ethics Committee (S-20150219). Registered 19 February 2015.

OBJECTIVE: To update the 1997 OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) core domain set for clinical trials in hip and/or knee osteoarthritis (OA).

METHODS: An initial review of the COMET database of core outcome sets (COS) was undertaken to identify all domains reported in previous COS including individuals with hip and/or knee OA. These were presented during 5 patient and health professionals/researcher meetings in 3 continents (Europe, Australasia, North America). A 3-round international Delphi survey was then undertaken among patients, healthcare professionals, researchers, and industry representatives to gain consensus on key domains to be included in a core domain set for hip and/or knee OA. Findings were presented and discussed in small groups at OMERACT 2018, where consensus was obtained in the final plenary.

RESULTS: Four previous COS were identified. Using these, and the patient and health professionals/researcher meetings, 50 potential domains formed the Delphi survey. There were 426 individuals from 25 different countries who contributed to the Delphi exercise. OMERACT 2018 delegates (n = 129) voted on candidate domains. Six domains gained agreement as mandatory to be measured and reported in all hip and/or knee OA clinical trials: pain, physical function, quality of life, and patient's global assessment of the target joint, in addition to the mandated core domain of adverse events including mortality. Joint structure was agreed as mandatory in specific circumstances, i.e., depending on the intervention.

CONCLUSION: The updated core domain set for hip and/or knee OA has been agreed upon. Work will commence to determine which outcome measurement instrument should be recommended to cover each core domain.

The World Health Organization (WHO) recommends reducing free sugars to less than 10% of total energy intake (TEI) due to their potential implications in weight gain and dental caries. Our objectives were to (1) estimate the intake of total, added, and free sugars, (2) define the main sugar sources, and (3) evaluate the adherence to sugar guidelines. The first national nutrition survey 2014-2015 included non-institutional adults aged 18-75 years. Diet was assessed with two non-consecutive 24-hour dietary recalls in 2057 participants. Added and free sugar content was systematically estimated by two dietitians using available information from the manufacturer and/or standard recipe/composition. Usual daily intake distributions were modeled and weighted for sampling design, non-response, weekdays, and seasons. Total, added, and free sugar intake was respectively 107 g (±44), 53 g (±36), and 65 g (±40), representing 19%, 9%, and 11% of TEI. Sugar consumption was higher among younger adults and lower among people living in the Italian-speaking region. The three main food sources of free sugars were: (1) sweet products (47% of total free sugars), in particular sweet spreads (15%) and cakes/cookies (11%); (2) beverages (29%), mainly fruit and vegetable juices (13%), and sugar-sweetened beverages (12%, but 20% in younger adults); and (3) dairy products (9%), with yogurt accounting for 6%. Respectively, 44% of women and 45% of men had free sugar intake below 10% of TEI. Of people aged between 18-29, 30-64, and 65-75 years, 36%, 45%, and 53% had free sugar intake below 10% of TEI, respectively. The prevalence of Swiss people with free sugar intake that was <5% of the TEI was 8%. Adherence to the WHO recommendations guidelines was generally low in Switzerland, particularly among young adults, and in line with other high-income countries.

AIMS: To investigate whether intensive lifestyle intervention induce partial or complete type 2 diabetes (T2D) remission.

MATERIALS AND METHODS: In a secondary analysis of a randomized, assessor-blinded, single-center trial, patients with non-insulin dependent T2D (duration<10 years), were randomly assigned (2:1, stratified by sex, from April 2015 to August 2016) to a lifestyle intervention group (n=64) or a standard care group (n=34). The primary outcome was partial or complete T2D remission defined as non-diabetic glycemia with no glucose-lowering medications at the outcome assessments at both 12- and 24-months from baseline. All participants received standard care with a standardized, blinded, target-driven medical therapy during the initial 12-months. The lifestyle intervention moreover included 5-6 weekly aerobic and combined aerobic and strength training sessions (30-60 min) and individual dietary plans aiming for BMI ≤ 25 kg/m2 . No intervention was provided during the 12 months follow-up period.

RESULTS: Among 98 randomized participants, 93 (mean [SD] age, 54.6 [8.9] years; 46 [43%] women; mean [SD] baseline HbA1c 49.3 [9.3] mmol/mol) completed follow-up. At follow-up, 23%(14) in the intervention and 7%(2) in the standard care group met the criteria for any T2D remission (odds ratio (OR) [95% CI] 4.4 [0.8 to 21.4], p=0.08). Assuming participants lost-to-follow-up (N=5) had relapsed, the OR [95% CI] for T2D remission was 4.4 [1.0 to 19.8] (p=0.048).

CONCLUSIONS: The statistically non-significant three-fold increased remission rate of T2D in the lifestyle intervention group calls for further large-scale studies to understand how to implement sustainable lifestyle interventions in T2D.

STUDY REGISTRATION: ClinicalTrials.gov registration (NCT02417012). This article is protected by copyright. All rights reserved.

OBJECTIVE: To assess the uptake of the OMERACT-OARSI (Outcome Measures in Rheumatology- Osteoarthritis Research Society International) core outcome set (COS) domains in hip and/or knee osteoarthritis (OA) trials.

METHODS: There were 382 trials of hip and/or knee OA identified from the ClinicalTrial.gov registry from 1997 to 2017. Frequency of COS adoption was assessed by year and per 5-yearly phases.

RESULTS: COS adoption decreased from 61% between 1997 and 2001 to 38% between 2012 and 2016. Pain (95%) and physical function (86%) were most consistently adopted. Patient's global assessment (48%) was the principal missing domain.

CONCLUSION: Limited adoption of the COS domains indicates that further consideration to improve uptake is required.

BACKGROUND AND AIMS: Obesity is an increasing problem in patients after total knee replacement. The aim of this study was to investigate whether a weight loss intervention before primary total knee replacement would improve quality of life, knee function, mobility, and body composition 1 year after surgery.

MATERIAL AND METHODS: Patients scheduled for total knee replacement due to osteoarthritis of the knee and obesity were randomized to a control group receiving standard care or to an intervention group receiving 8-week low-energy diet before total knee replacement. Patient-reported quality of life, 6-Min Walk Test, and body composition by dual-energy X-ray absorptiometry were assessed before intervention for the diet group, and within 1 week preoperatively for both groups, and the changes in outcome from baseline to 1 year after total knee replacement were compared between groups. The number of participants was lower than planned, which might introduce a type-2 error and underestimate the trend for a better outcome after weight loss.

RESULTS: The analyses are based on a total of 76 patients, 38 in each group. This study showed major improvement in both study groups in quality of life and knee function, though no statistically significant differences between the groups were observed 1 year after total knee replacement. The average weight loss after 8-week preoperative intervention was 10.7 kg and consisted of a 6.7 kg reduction in fat mass. One year after total knee replacement, the participants in the diet group managed to maintain the weight reduction, whereas there was no change in the control group.

CONCLUSION: The results suggest that it is feasible and safe to implement an intensive weight loss program shortly before total knee replacement. The preoperative intervention resulted in a 10% body weight loss, improved body composition, lower cardiovascular risk factors, and sustained s-leptin.

Magnetic resonance imaging (MRI) has an established role in the assessment of degenerative musculoskeletal conditions. However, conventional supine MRI findings often correlate poorly with clinical findings. Some patients experience accentuated back pain in the weight-bearing position. Therefore, supine MRI may underestimate the severity of degenerative spine findings. To try and improve the clinical validity of spine imaging, axial loading devices have been used with conventional supine MR imaging to simulate loading of the upright spine. More recently, upright weight-bearing MRI systems (0.25-0.6 T) were introduced, allowing images to be obtained in the standing or seated weight-bearing position and even during upright flexion or extension, rotation, or bending. Some scanners even enable capturing of real-time spinal movement. This review addresses the technical aspects and potential challenges of weight-bearing MRI, both in clinical practice and research.