Published in 2019

INTRODUCTION: The Global Burden of Disease 2010 study ranked osteoarthritis (OA) as a leading cause of years lived with disability. With an ageing population, increasing body weight and sedentary lifestyle, a substantial increase especially in knee OA (KOA) is expected. Management strategies for KOA include non-pharmacological, pharmacological and surgical interventions. Meanwhile, over-the-counter pain medications have been discredited as they are associated with several risks with long-term usage. By consequence, the use of exercise and all sorts of complementary and alternative medicine (CAM) for joint pain has increased. The available self-management strategies are plenty, but there is no overview of their use at a population level and whether they are used along with doctors' prescriptions or replace these. The aim of this study is to estimate the population incidence of developing knee symptoms and analyse the association between (and impact of) the use of self-reported preventive measures and knee symptoms.

METHODS AND ANALYSIS: This prospective cohort study pragmatically recruits individuals from the municipality of Frederiksberg, Denmark. All citizens aged 60-69 years old will be contacted annually for 10 years and asked to participate in a web-based survey. The major outcomes are self-reported knee symptoms and their association with use of various management strategies, including use of non-pharmacological treatments and CAM. Secondary outcomes include the influence of treatments on use of healthcare system and surgical procedures. Descriptive and analytic statistics (eg, logistic regression) will be used to provide summaries about the sample and observations made and the associations between self-management and development of knee symptoms.

ETHICS AND DISSEMINATION: This study can be implemented without permission from the Health Research Ethics Committee. Permission has been obtained from the Danish Data Protection Agency. Study findings will be disseminated in peer-reviewed journals and presented at relevant conferences.

TRIAL REGISTRATION NUMBER: NCT03472300.

Originalsprog Engelsk
Tidsskrift BMJ Open
Vol/bind 9
Udgave nummer 9
Sider (fra-til) e028087
ISSN 2044-6055
DOI
Status Udgivet - 4 sep. 2019

Bibliografisk note

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials

Orbai, A-M., Holland, R., Leung, Y. Y., Tillett, W., Goel, N., Christensen, R., McHugh, N., Gossec, L., de Wit, M., Højgaard, P., Coates, L. C., Mease, P. J., Birt, J., Fallon, L., FitzGerald, O., Ogdie, A., Shea, B., Strand, V., Duffin, K. C., Tugwell, P., Beaton, D. & Gladman, D. D., aug. 2019, I : Journal of Rheumatology. 46, 8, s. 990-995 6 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT) psoriatic arthritis (PsA) working group is developing a Core Outcome Measurement Set for PsA clinical trials [randomized controlled trials (RCT) and longitudinal observational studies (LOS)] using the OMERACT Filter 2.1 instrument selection algorithm. Our objective was to assess the Psoriatic Arthritis Impact of Disease questionnaire (PsAID12) for the measurement of the core domain PsA-specific health-related quality of life (HRQOL).

METHODS: PsAID12 measurement property evidence gathered in a systematic literature review, and additional analyses conducted in LOS, were used to inform a consensus process. Analyses that had not been published were independently reviewed by the OMERACT technical advisory group. Data and process were presented, discussed in breakout groups, and voted on at the OMERACT conference (Terrigal, Australia, May 2018).

RESULTS: PsAID12 fulfilled the green (good to go) OMERACT standards for domain match, feasibility, reliability, and construct/longitudinal construct validity. Discrimination and thresholds of meaning were amber (caution but good enough to go forward). The overall working group recommendation was amber/provisional endorsement of PsAID12 for measuring PsA-specific HRQOL in RCT and LOS. Of 96 participants who voted at the PsA OMERACT workshop, 87.5% (84) voted "yes" to endorse this recommendation; 14 of the 96 were patient research partners (PRP) and 93% of them (13) voted "yes"; 82 participants were not PRP and 87% of them (71) voted "yes."

CONCLUSION: At OMERACT 2018, PsAID12 was the first patient-reported outcome measure provisionally endorsed as a core outcome measure for disease-specific HRQOL in PsA clinical trials. PsAID12 discrimination and improvement thresholds will be studied in future RCT.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 46
Udgave nummer 8
Sider (fra-til) 990-995
Antal sider 6
ISSN 0315-162X
DOI
Status Udgivet - aug. 2019

PURPOSE: The primary objective was to examine the reliability of the Copenhagen Achilles length measure (CALM) in patients with an Achilles tendon rupture and secondary to examine the reliability of Achilles tendon resting angle (ATRA) and Achilles tendon length measure (ATLM).

METHOD: The study was executed as a cross-sectional study on two different groups: one focused on CALM and the other on ATRA/ATLM. CALM was performed on 56 patients at four timepoints during the first year after injury, whereas ATRA/ATLM were carried out on 28 patients. Intra- and inter-rater reliabilities were determined using the intra-class correlation coefficient (ICC), the standard error of the measurement (SEM), and the minimal detectable change (MDC).

RESULTS: For CALM, all measurements, both for injured and non-injured sides as well as for elongation, indicated excellent relative reliability (ICC ≥ 0.75). During the four timepoints, the inter-rater absolute reliability had an SEM that ranged between 0.3 and 0.8 cm (1-4 SEM%) for injured and non-injured sides and 0.3-0.6 cm (18-29 SEM%) for elongation. On an individual level, the inter-rater absolute reliability had an MDC ranging between 0.8 and 2.2 cm (4-11 MDC%) for injured and non-injured sides and 0.8-1.7 cm (47-81 MDC%) for elongation. In the case of ATRA, relative reliability was excellent (ICC ≥ 0.75), and for ATLM, it was fair to excellent (ICC 0.58-0.79). ATRA presented a lower measurement error than ATLM.

CONCLUSION: Copenhagen Achilles length measure showed excellent relative reliability, but had a significant measurement error at four timepoints the first year following an Achilles tendon rupture.

LEVEL OF EVIDENCE: II.

Originalsprog Engelsk
Tidsskrift Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA
ISSN 0942-2056
DOI
Status E-pub ahead of print - 20 aug. 2019

Response to: 'Mandatory, cost-driven switching from originator etanercept to its biosimilar SB4: possible fallout on non-medical switching' by Cantini and Benucci

Glintborg, B., Loft, A. G., Omerovic, E., Hendricks, O., Linauskas, A., Espesen, J., Danebod, K., Jensen, D. V., Nordin, H., Dalgaard, E. B., Chrysidis, S., Kristensen, S., Raun, J. L., Lindegaard, H., Manilo, N., Jakobsen, S. H., Hansen, I. M. J., Dalsgaard Pedersen, D., Sørensen, I. J., Andersen, L. S., Grydehøj, J., Mehnert, F., Krogh, N. S. & Hetland, M. L., 2019, I : Annals of the Rheumatic Diseases.

Publikation: Bidrag til tidsskriftKommentar/debatForskningpeer review

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
ISSN 0003-4967
DOI
Status E-pub ahead of print - 2019

Road traffic noise and markers of adiposity in the Danish nurse cohort: A cross sectional study

Cramer, J., Therming Jørgensen, J., Sørensen, M., Backalarz, C., Laursen, J. E., Ketzel, M., Hertel, O., Jensen, S. S., Simonsen, M. K., Bräuner, E. V. & Andersen, Z. J., 1 maj 2019, I : Environmental Research. s. 502-510 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background: Studies have suggested that traffic noise is associated with markers of obesity. We investigated the association of exposure to road traffic noise with body mass index (BMI) and waist circumference in the Danish Nurse Cohort. Methods: We used data on 15,501 female nurses (aged >44 years) from the nationwide Danish Nurse Cohort who, in 1999, reported information on self-measured height, weight and waist circumference, together with information on socioeconomic status, lifestyle, work and health. Road traffic noise at the most exposed façade of the residence was estimated using Nord2000 as the annual mean of a weighted 24 h average (L
den
). We used multiple linear regression models to examine associations of road traffic noise levels in 1999 (1-year mean) with BMI and waist circumference, adjusting for potential confounders, and evaluated effect-modification by degree of urbanization, air pollution levels, night shift work, job strain, sedative use, sleep aid use, and family history of obesity. Results: We did not observe associations between road traffic noise (per 10 dB increase in the 1-year mean L
den
) and BMI (kg/m
2
) (beta: 0.00; 95% confidence interval CI: −0.07, 0.07) or waist circumference (cm) (−0.09; −0.31, 0.13) in the fully adjusted model. We found significant effect modification of job strain and degree of urbanization on the associations between L
den
and both BMI and waist circumference. Job strained nurses were associated with a 0.41 BMI-point increase, (0.06–0.76) and a 1.00 cm increase in waist circumference (0.00–2.00). Nurses living in urban areas had a statistically significant positive association of L
den
with BMI (0.26; 0.11–0.42), whilst no association was found for nurses living in suburban and rural areas. Conclusion: Our results suggest that road traffic noise exposure in nurses with particular susceptibilities, such as those with job strain, or living in urban areas may lead to increased BMI, a marker of adiposity.

Originalsprog Engelsk
Tidsskrift Environmental Research
Sider (fra-til) 502-510
Antal sider 9
ISSN 0013-9351
DOI
Status Udgivet - 1 maj 2019

Secular trends in the incidence and prevalence of gout in Denmark from 1995 to 2015: a nationwide register-based study

Zobbe, K., Prieto-Alhambra, D., Cordtz, R., Højgaard, P., Hindrup, J. S., Kristensen, L. E. & Dreyer, L., 1 maj 2019, I : Rheumatology (Oxford, England). 58, 5, s. 836-839 4 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To investigate temporal trends in the incidence and prevalence of gout in the adult Danish population.

METHODS: Using the nationwide Danish National Patient Registry, we calculated the number of incident gout patients (per 100 000 person-years) within each 1 year period from 1995 to 2015 and the prevalence of gout in 2000 and 2015. Further, we calculated age- and gender-specific incidence rates of gout from 1995 to 2015.

RESULTS: We identified a total of 45 685 incident gout patients (72.9% males) with a mean age of 65 years (s.d. 16) at diagnosis. In both genders, an increase in age-standardized incidence rates was observed from 32.3/100 000 (95% CI 30.7, 33.9) in 1995 to 57.5/100 000 (95% CI 55.6, 59.5) in 2015 (P < 0.001). Similar trends were observed for 8950 cases diagnosed in rheumatology departments. We likewise observed an increase in the prevalence of gout from 0.29% (95% CI 0.29, 0.30) in 2000 to 0.68% (95% CI 0.68, 0.69) in 2015.

CONCLUSIONS: The annual incidence rate of gout increased by almost 80% in Denmark between 1995 and 2015. The prevalence increased by nearly 130% between 2000 and 2015. Reasons for this are unknown but may include an increase in risk factors (e.g. obesity, diabetes mellitus), longer life expectancy and increased awareness of the disease among patients and/or health professionals.

Originalsprog Engelsk
Tidsskrift Rheumatology (Oxford, England)
Vol/bind 58
Udgave nummer 5
Sider (fra-til) 836-839
Antal sider 4
ISSN 1462-0324
DOI
Status Udgivet - 1 maj 2019

Bibliografisk note

© The Author(s) 2018. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

BACKGROUND: Reduction in gadolinium (Gd) contrast agents is wanted due to the uncertainty of the potential side effects.

PURPOSE: To investigate whether it is possible to reduce the contrast dose from conventional double dose to single dose when increasing the field strength from 1.5-T to 3-T for separating early cartilage degeneration from healthy cartilage, assessed by delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC).

MATERIAL AND METHODS: Nine patients with knee osteoarthritis (OA), Kellgren-Lawrence grade (KLG) 1-4, were recruited from an ongoing weight loss cohort study. dGEMRIC was performed at 3-T using single (0.1 mmoI/kg) and double (0.2 mmoI/kg) doses of intravenous (i.v.) Gd-DTPA2-. Regions of interest (ROls) were drawn around the posterior weight-bearing femoral knee cartilage in lateral and medial compartments. In five medial compartments ROIs could not be drawn due to severe degeneration of cartilage. T1-relaxation times were compared to previously published values from 1.5-T and to non-contrast values from 3-T.

RESULTS: Mean dGEMRIC T1-relaxation time in the lateral compartment was 769 ms for single dose vs. 561 ms for double dose ( P < 0.0001); and 685 ms for single dose vs. 454 ms for double dose ( P = 0.004) in the medial compartment.

CONCLUSION: We found a dose-response relationship between single and double doses of Gd-DTPA2- using 3-T in knee OA patients, similar to the findings at 1.5-T. Compared to the T1-relaxation time at 3-T without contrast (1240 ms), this further separation between OA and normal cartilage indicates that "single dose" dGEMRIC could be sufficient for cartilage health assessment at 3-T.

Originalsprog Engelsk
Tidsskrift Acta Radiologica
Vol/bind 60
Udgave nummer 6
Sider (fra-til) 749-754
Antal sider 6
ISSN 0284-1851
DOI
Status Udgivet - jun. 2019

GOALS: It is unclear whether social inequality exists for mortality after stroke. Results of studies on the relation between socioeconomic position (SEP) and mortality after stroke have been inconsistent and inconclusive.

MATERIAL AND METHODS: We studied the association between SEP expressed by income and the risk of death after stroke by merging data on incident stroke from Danish registries with nationwide coverage. We identified all incident cases of stroke hospitalized in Denmark 2003-2012 (n = 60503). Patients were followed up to 9years after stroke (median 2.6 years). Adjusting for age and sex we studied all-cause death and cause-specific death by stroke, cardiac disease, cancer, and other diseases certified by death records and stratified by income.

RESULTS: Of the patients 20,953 (34.6%) had died within follow-up: Death by stroke 8018 (13.2%); cardiac disease 4250 (7.0%); cancer 3060 (5.0%); other diseases 5625 (9.2%). Long-term mortality rates were inversely related to income for all causes of death. The difference in mortality between the lowest and the highest income group at 5years after stroke was 15.5% (relative) and 5.7% (absolute). Differences in short-term mortality (1-month to 1-year) between income groups were small and clinically insignificant.

CONCLUSIONS: Social inequality in mortality after stroke expressed by income was pronounced for long-term mortality while not for short-term mortality. It seems that social inequality is expressed in a greater risk among stroke patients with low income for the advent of new diseases subsequently leading to death rather than in their ability to survive the incident stroke.

Originalsprog Engelsk
Tidsskrift Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
ISSN 1052-3057
DOI
Status Udgivet - 28 mar. 2019

Bibliografisk note

Copyright © 2019 Elsevier Inc. All rights reserved.

OBJECTIVE: To evaluate the 18-month post-intervention efficacy following a four-month individually tailored, behavioral intervention on daily sitting time in patients with rheumatoid arthritis (RA). The four-month post-intervention results showed that patients in the intervention reduced their daily sitting time, improved patient-reported outcomes and total cholesterol levels compared to the control group.

METHODS: In an observer-blinded randomized trial, 150 RA patients were included. During four months, the intervention group (n=75) received three motivational counselling sessions and tailored text messages aimed at increasing light-intensity physical activity through reduction of sedentary behavior. The control group (n=75) maintained usual lifestyle. Primary outcome was change from baseline to 18 months post intervention in objectively measured daily sitting time (ActivPAL). Secondary outcomes included changes in clinical patient-reported outcomes and cardio-metabolic biomarkers. A mixed effect repeated measures ANCOVA model in the intention-to-treat population was applied.

RESULTS: At 22-months follow-up from baseline, 12 participants were lost to follow-up. Compared to baseline, sitting time in the intervention group decreased 1.10 h/day, whereas it increased by 1.32 h/day in the control group; between-group difference of -2.43 h/day (95%CI: -2.99;-1.86; p<0.0001) favoring the intervention group. For most secondary outcomes between-group differences favored the intervention: VAS-pain: -15.51 mm (-23.42;-7.60), VAS-fatigue: -12.30 mm (-20.71;-3.88), physical function: -0.39 HAQ-units (-0.53;-0.26), total cholesterol: -0.86 (-1.03;-0.68), triglyceride: -0.26 (-0.43;-0.09) and average glucose: -1.15 (-1.39;-0.91) mmol/l.

CONCLUSION: Eighteen months after intervention, patients in the intervention group were still significantly less sedentary than controls. Findings suggest that a behavioral approach is beneficial for promoting long-term physical activity and health in patients with RA.

Originalsprog Engelsk
Tidsskrift Arthritis Care & Research
ISSN 2151-464X
DOI
Status E-pub ahead of print - 10 sep. 2019

Bibliografisk note

© 2019, American College of Rheumatology.

The Association between ADL Ability and Quality of Life among People with Advanced Cancer

Brekke, M. F., la Cour, K., Brandt, Å., Peoples, H. & Wæhrens, E. E., 2019, I : Occupational therapy international. 2019, s. 2629673

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background: Occupational therapy and occupational science are founded on the theoretical core assumption that occupation and quality of life (QoL) are closely related. However, such theoretical core assumptions must be supported through empirically based research.

Objective: To investigate the association between QoL and occupation, here self-reported and observed ADL abilities as a part of occupation, among people with advanced cancer, including determining whether self-reported or observed ADL ability had the stronger association with QoL.

Methods: The study was nested in a cross-sectional study. The association between ADL ability and QoL among 108 people with advanced cancer was investigated using the ADL Interview (ADL-I), the Assessment of Motor and Process Skills (AMPS), and the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30).

Results and Conclusions: Results showed that high observed ADL motor ability was associated with high QoL. In contrast, observed ADL process ability and self-reported ADL ability were not significantly associated with QoL. Oppositely expected, observed ADL ability had a stronger association with QoL than self-reported ADL ability. Thereby, the study to some extent contributes knowledge confirming the theoretical core assumptions about the relation between occupation, here performance of ADL, and QoL.

Originalsprog Engelsk
Tidsskrift Occupational therapy international
Vol/bind 2019
Sider (fra-til) 2629673
ISSN 0966-7903
DOI
Status Udgivet - 2019

The association between having assistive devices and activities of daily living ability and health-related quality of life: An exploratory cross-sectional study among people with advanced cancer

Funch, A., Kruse, N. B., la Cour, K., Peoples, H., Waehrens, E. E. & Brandt, Å., maj 2019, I : European Journal of Cancer Care Online. 28, 3, s. e13002

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To explore whether people with advanced cancer who had assistive devices had higher or lower ADL ability and/or HRQoL than people with advanced cancer who did not have assistive devices.

METHODS: A cross-sectional study of 164 participants with advanced cancer. Self-reported ADL ability and HRQoL were assessed using the ADL-Interview and the EORTC QLQ-C30. Data regarding assistive devices were collected using a study-specific questionnaire. Data were analysed using multiple linear regression. The regression coefficients (B) were presented in crude form and adjusted for potential confounding variables (age, gender, cohabiting, receiving help, physical functioning, fatigue and pain). p-Values (p) < 0.05 were considered statistically significant.

RESULTS: Having assistive devices was associated with lower ADL ability (B = -0.923, p = <0.0001), but this association was not significant after adjustment where it was found that physical functioning was a confounder positively associated with ADL ability (B = 0.030, p = <0.0001). No significant association was found between having assistive devices and HRQoL. Both fatigue (B = -0.336, p = <0.0001) and pain (B = -0.124, p = 0.010) were negatively associated with HRQoL.

CONCLUSION: The participants had the same ADL ability and HRQoL regardless of them having assistive devices. Interventions addressing physical functioning or fatigue and pain might contribute to enhancing ADL ability and HRQoL among people with advanced cancer.

Originalsprog Engelsk
Tidsskrift European Journal of Cancer Care Online
Vol/bind 28
Udgave nummer 3
Sider (fra-til) e13002
ISSN 1365-2354
DOI
Status Udgivet - maj 2019

Bibliografisk note

© 2019 John Wiley & Sons Ltd.

OBJECTIVE: To evaluate the benefit of adding occupational therapy or physiotherapy interventions to a standard rehabilitation programme targeted for chronic widespread pain.

DESIGN: Randomized active-controlled non-blinded trial.

SUBJECTS: Women with chronic widespread pain recruited in a tertiary outpatient clinic.

METHODS: Participants were randomized to a two-week, group-based standard rehabilitation programme followed by 16 weeks of group-based occupational therapy (Group BOT, n = 43) or 16 weeks of group-based physiotherapy (Group BPT, n = 42). Group A only received the two-week rehabilitation programme acting as comparator (n = 96).

OUTCOMES: Primary outcomes were the Assessment of Motor and Process Skills and Short Form-36 (SF36) Mental Component Summary score.

RESULTS: Mean changes in motor and process ability measures were clinically and statistically insignificant and without differences across the three groups assessed 88 weeks from baseline. Motor ability measures: -0.006 (95% confidence interval (CI): -0.244 to 0.233) in Group BOT; -0.045 (95% CI: -0.291 to 0.202) in Group BPT; and -0.017 (95% CI: -0.248 to 0.213) in Group A, P = 0.903. Process ability measures: 0.087 (95% CI: -0.056 to 0.231) in Group BOT; 0.075 (95% CI: -0.075 to 0.226) in Group BPT; and 0.072 (95% CI: -0.067 to 0.211) in Group A, P = 0.924. Mean changes in patient-reported outcomes were likewise small; clinically and statistically insignificant; and independent of group allocation, except for the SF36 mental component summary score in the BPT group: 8.58 (95% CI: 1.75 to 15.41).

CONCLUSION: Participants were on average stable in observation-based measures of functional ability and patient-reported outcomes, except in overall mental well-being, favouring the enhanced intervention. Efficacy of additional interventions on functional ability remains uncertain.

Originalsprog Engelsk
Tidsskrift Clinical Rehabilitation
Vol/bind 33
Udgave nummer 8
Sider (fra-til) 1367-1381
Antal sider 15
ISSN 0269-2155
DOI
Status Udgivet - aug. 2019

The Importance of the World Health Organization Sugar Guidelines for Dental Health and Obesity Prevention

Breda, J., Jewell, J. & Keller, A., 2019, I : Caries Research. 53, 2, s. 149-152 4 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

The World Health Organization (WHO) recommends a reduced intake of free sugars throughout the life course (strong recommendation) with a reduction of free sugars intake to less than 10% of the total energy intake (strong recommendation) and preferably below 5% of the total energy intake (conditional recommendation) in both adults and children. Available data clearly show that people already consume significantly more sugar than they should, increasing the risk for dental caries, overweight and obesity. The WHO recommendations are intended for use by the policy makers as a benchmark for assessing intake of sugars by populations and as a driving force for policy change. To create a favorable environment, enabling the overall amount of free sugar intake to be as low as possible and to reduce the frequency of consumption of sugar-rich foods, a range of public health interventions is advised.

Originalsprog Engelsk
Tidsskrift Caries Research
Vol/bind 53
Udgave nummer 2
Sider (fra-til) 149-152
Antal sider 4
ISSN 0008-6568
DOI
Status Udgivet - 2019

Bibliografisk note

The Author(s). Published by S. Karger AG, Basel.

The NoHoW protocol: a multicentre 2×2 factorial randomised controlled trial investigating an evidence-based digital toolkit for weight loss maintenance in European adults

Scott, S. E., Duarte, C., Encantado, J., Evans, E. H., Harjumaa, M., Heitmann, B. L., Horgan, G. W., Larsen, S. C., Marques, M. M., Mattila, E., Matos, M., Mikkelsen, M-L., Palmeira, A. L., Pearson, B., Ramsey, L., Sainsbury, K., Santos, I., Sniehotta, F., Stalker, C., Teixeira, P. J. & Stubbs, R. J., 30 sep. 2019, I : BMJ Open. 9, 9, s. e029425

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION: Obesity and associated diseases place a severe burden on healthcare systems. Behavioural interventions for weight loss (WL) are successful in the short term but often result in weight regain over time. Self-regulation of eating and activity behaviours may significantly enhance weight loss maintenance (WLM) and may be effectively augmented by contextual behavioural approaches to emotion regulation. The NoHoW trial tests the efficacy of a theoretically informed, evidence-based digital toolkit using a mobile-enabled website, activity trackers and Wi-Fi scales for WLM aiming to target (1) self-regulation and motivation, and (2) emotion regulation in adults who achieved clinically significant (≥5%) WL in the previous 12 months (initial body mass index (BMI) ≥25 kg/m2).

METHODS AND ANALYSIS: The study is an 18-month, 3-centre, 2×2 factorial single-blind, randomised controlled trial, which recruited 1627 participants achieving ≥5% WL between March 2017 and March 2018. Participants are randomly allocated to one of four arms: (1) self-monitoring only (self-weighing and activity tracker), (2) self-regulation and motivation, (3) emotion regulation or (4) combined self-regulation, motivation and emotion regulation. Participants attend four clinical investigation days at 0, 6, 12 and 18 months and are instructed to use the digital toolkit for 18 weeks during the first 6 months and at their discretion for the remaining 12 months. The primary outcome is change in weight (kg) at 12 months from baseline. Secondary outcomes are body composition (eg, bioimpedance analysis), health biomarkers (glycated haemoglobin, lipids, blood pressure, hair cortisol), dietary intake, physical activity, sleep, motivational, self-regulatory, emotion regulatory moderators/mediators of WLM, engagement, user experience, acceptability and cost-effectiveness of the interventions.

ETHICS AND DISSEMINATION: Ethical approval was granted by Institutional Ethics Committees at the Universities of Leeds (17-0082; 27 February 2017), Lisbon (17/2016; 20 February 2017) and Capital Region of Denmark (H-16030495, 8 March 2017). Results will be published in scientific journals.

TRIAL REGISTRATION NUMBER: ISRCTN88405328.

Originalsprog Engelsk
Tidsskrift BMJ Open
Vol/bind 9
Udgave nummer 9
Sider (fra-til) e029425
ISSN 2044-6055
DOI
Status Udgivet - 30 sep. 2019

Bibliografisk note

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

The OMERACT-OARSI Core Domain Set for Measurement in Clinical Trials of Hip and/or Knee Osteoarthritis

Smith, T. O., Hawker, G. A., Hunter, D. J., March, L. M., Boers, M., Shea, B. J., Christensen, R., Guillemin, F., Terwee, C. B., Williamson, P. R., Dodd, S., Roos, E. M., Loeser, R. F., Schnitzer, T. J., Kloppenburg, M., Neogi, T., Ladel, C. H., Kalsi, G., Kaiser, U., Buttel, T. W., Ashford, A. E., Mobasheri, A., Arden, N. K., Tennant, A., Hochberg, M. C., de Wit, M., Tugwell, P. & Conaghan, P. G., aug. 2019, I : Journal of Rheumatology. 46, 8, s. 981-989 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 46
Udgave nummer 8
Sider (fra-til) 981-989
Antal sider 9
ISSN 0315-162X
DOI
Status Udgivet - aug. 2019

Total, Added, and Free Sugar Consumption and Adherence to Guidelines in Switzerland: Results from the First National Nutrition Survey menuCH

Chatelan, A., Gaillard, P., Kruseman, M. & Keller, A., 19 maj 2019, I : Nutrients. 11, 5

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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.

Originalsprog Engelsk
Tidsskrift Nutrients
Vol/bind 11
Udgave nummer 5
ISSN 2072-6643
DOI
Status Udgivet - 19 maj 2019

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.

Originalsprog Engelsk
Tidsskrift Diabetes, Obesity and Metabolism
ISSN 1462-8902
DOI
Status E-pub ahead of print - 5 jun. 2019

Bibliografisk note

This article is protected by copyright. All rights reserved.

Uptake of the OMERACT-OARSI Hip and Knee Osteoarthritis Core Outcome Set: Review of Randomized Controlled Trials from 1997 to 2017

Smith, T. O., Mansfield, M., Hawker, G. A., Hunter, D. J., March, L. M., Boers, M., Shea, B. J., Christensen, R., Guillemin, F., Terwee, C. B., Williamson, P. R., Roos, E. M., Loeser, R. F., Schnitzer, T. J., Kloppenburg, M., Neogi, T., Ladel, C. H., Kalsi, G., Kaiser, U., Buttel, T. W., Ashford, A. E., Mobasheri, A., Arden, N. K., Tennant, A., Hochberg, M. C., de Wit, M., Tugwell, P. & Conaghan, P. G., aug. 2019, I : Journal of Rheumatology. 46, 8, s. 976-980 5 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 46
Udgave nummer 8
Sider (fra-til) 976-980
Antal sider 5
ISSN 0315-162X
DOI
Status Udgivet - aug. 2019

Vitamin D in early life and later risk of multiple sclerosis-A systematic review, meta-analysis

Ismailova, K., Poudel, P., Parlesak, A., Frederiksen, P. & Heitmann, B. L., 2019, I : PLoS One. 14, 8, s. e0221645

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

The study examined results from previous studies of early life vitamin D exposure and risk of MS in adulthood, including studies on season or month of birth and of migration. A systematic review was conducted using PubMed and Web of Science databases as well as checking references cited in articles. The quality of studies was assessed using the Newcastle-Ottawa scale and the AMSTAR score. Twenty-eight studies were selected for analysis. Of these, six population studies investigated early life vitamin D exposure and risk of MS, and three found inverse while the remaining found no associations. A consistent seasonal tendency for MS seemed evident from 11/15 studies, finding a reduced occurrence of MS for Northern hemisphere children who were born late autumn, and late fall for children born in the Southern hemisphere. This was also confirmed by pooled analysis of 6/15 studies. Results of the migration studies showed an increased risk of MS if migration from high to low-MS-risk areas had occurred after age 15 years, while risk of MS was reduced for those migrating earlier in life (<15years). A similar, but inverse risk pattern was observed among migrants from low to high-MS-risk areas. One study found an increased risk of MS in the second generation of migrants when migrating from low to high-MS-risk areas. An association between early life vitamin D and later risk of MS seems possible, however evidence is still insufficient to conclude that low vitamin D exposure in early life increases the risk of MS in adulthood. PROSPERO register number: CRD 42016043229.

Originalsprog Engelsk
Tidsskrift PLoS One
Vol/bind 14
Udgave nummer 8
Sider (fra-til) e0221645
ISSN 1932-6203
DOI
Status Udgivet - 2019

Published in 2018

2018 update of the EULAR recommendations for the management of Behçet's syndrome

Hatemi, G., Christensen, R., Bang, D., Bodaghi, B., Celik, A. F., Fortune, F., Gaudric, J., Gul, A., Kötter, I., Leccese, P., Mahr, A., Moots, R., Ozguler, Y., Richter, J., Saadoun, D., Salvarani, C., Scuderi, F., Sfikakis, P. P., Siva, A., Stanford, M., Tugal-Tutkun, I., West, R., Yurdakul, S., Olivieri, I. & Yazici, H., jun. 2018, I : Annals of the Rheumatic Diseases. 77, 6, s. 808-818 11 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Several new treatment modalities with different mechanisms of action have been studied in patients with Behçet's syndrome (BS). The aim of the current effort was to update the recommendations in the light of these new data under the auspices of the European League Against Rheumatism (EULAR) Standing Committee for Clinical Affairs. A task force was formed that included BS experts from different specialties including internal medicine, rheumatology, ophthalmology, dermatology, neurology, gastroenterology, oral health medicine and vascular surgery, along with a methodologist, a health professional, two patients and two fellows in charge of the systematic literature search. Research questions were determined using a Delphi approach. EULAR standardised operating procedures was used as the framework. Results of the systematic literature review were presented to the task force during a meeting. The former recommendations were modified or new recommendations were formed after thorough discussions followed by voting. The recommendations on the medical management of mucocutaneous, joint, eye, vascular, neurological and gastrointestinal involvement of BS were modified; five overarching principles and a new recommendation about the surgical management of vascular involvement were added. These updated, evidence-based recommendations are intended to help physicians caring for patients with BS. They also attempt to highlight the shortcomings of the available clinical research with the aim of proposing an agenda for further research priorities.

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 77
Udgave nummer 6
Sider (fra-til) 808-818
Antal sider 11
ISSN 0003-4967
DOI
Status Udgivet - jun. 2018

Pages