Published in 2017

Emollients and moisturisers for eczema

van Zuuren, E. J., Fedorowicz, Z., Christensen, R., Lavrijsen, A. & Arents, B. WM. 6 feb. 2017 I : Cochrane Database of Systematic Reviews. 2, s. CD012119

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Eczema is a chronic skin disease characterised by dry skin, intense itching, inflammatory skin lesions, and a considerable impact on quality of life. Moisturisation is an integral part of treatment, but it is unclear if moisturisers are effective.

OBJECTIVES: To assess the effects of moisturisers for eczema.

SEARCH METHODS: We searched the following databases to December 2015: Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, the GREAT database. We searched five trials registers and checked references of included and excluded studies for further relevant trials.

SELECTION CRITERIA: Randomised controlled trials in people with eczema.

DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures.

MAIN RESULTS: We included 77 studies (6603 participants, mean age: 18.6 years, mean duration: 6.7 weeks). We assessed 36 studies as at a high risk of bias, 34 at unclear risk, and seven at low risk. Twenty-four studies assessed our primary outcome 'participant-assessed disease severity', 13 assessed 'satisfaction', and 41 assessed 'adverse events'. Secondary outcomes included investigator-assessed disease severity (addressed in 65 studies), skin barrier function (29), flare prevention (16), quality of life (10), and corticosteroid use (eight). Adverse events reporting was limited (smarting, stinging, pruritus, erythema, folliculitis).Six studies evaluated moisturiser versus no moisturiser. 'Participant-assessed disease severity' and 'satisfaction' were not assessed. Moisturiser use yielded lower SCORAD than no moisturiser (three studies, 276 participants, mean difference (MD) -2.42, 95% confidence interval (CI) -4.55 to -0.28), but the minimal important difference (MID) (8.7) was unmet. There were fewer flares with moisturisers (two studies, 87 participants, RR 0.40, 95% CI 0.23 to 0.70), time to flare was prolonged (median: 180 versus 30 days), and less topical corticosteroids were needed (two studies, 222 participants, MD -9.30 g, 95% CI -15.3 to -3.27). There was no statistically significant difference in adverse events (one study, 173 participants, risk ratio (RR) 15.34, 95% CI 0.90 to 261.64). Evidence for these outcomes was low quality.With Atopiclair (three studies), 174/232 participants experienced improvement in participant-assessed disease severity versus 27/158 allocated to vehicle (RR 4.51, 95% CI 2.19 to 9.29). Atopiclair decreased itching (four studies, 396 participants, MD -2.65, 95% CI -4.21 to -1.09) and achieved more frequent satisfaction (two studies, 248 participants, RR 2.14, 95% CI 1.58 to 2.89), fewer flares (three studies, 397 participants, RR 0.18, 95% CI 0.11 to 0.31), and lower EASI (four studies, 426 participants, MD -4.0, 95% CI -5.42 to -2.57), but MID (6.6) was unmet. The number of participants reporting adverse events was not statistically different (four studies, 430 participants, RR 1.03, 95% CI 0.79 to 1.33). Evidence for these outcomes was moderate quality.Participants reported skin improvement more frequently with urea-containing cream than placebo (one study, 129 participants, RR 1.28, 95% CI 1.06 to 1.53; low-quality evidence), with equal satisfaction between the two groups (one study, 38 participants, low-quality evidence). Urea-containing cream improved dryness (investigator-assessed) more frequently (one study, 128 participants, RR 1.40, 95% CI 1.14 to 1.71; moderate-quality evidence) with fewer flares (one study, 44 participants, RR 0.47, 95% CI 0.24 to 0.92; low-quality evidence), but more participants in this group reported adverse events (one study, 129 participants, RR 1.65, 95% CI 1.16 to 2.34; moderate-quality evidence).Three studies assessed glycerol-containing moisturiser versus vehicle or placebo. More participants in the glycerol group noticed skin improvement (one study, 134 participants, RR 1.22, 95% CI 1.01 to 1.48; moderate-quality evidence), and this group saw improved investigator-assessed SCORAD (one study, 249 participants, MD -2.20, 95% CI -3.44 to -0.96; high-quality evidence), but MID was unmet. Participant satisfaction was not addressed. The number of participants reporting adverse events was not statistically significant (two studies, 385 participants, RR 0.90, 95% CI 0.68 to 1.19; moderate-quality evidence).Four studies investigated oat-containing moisturisers versus no treatment or vehicle. No significant differences between groups were reported for participant-assessed disease severity (one study, 50 participants, RR 1.11, 95% CI 0.84 to 1.46; low-quality evidence), satisfaction (one study, 50 participants, RR 1.06, 95% CI 0.74 to 1.52; very low-quality evidence), and investigator-assessed disease severity (three studies, 272 participants, standardised mean difference (SMD) -0.23, 95% CI -0.66 to 0.21; low-quality evidence). In the oat group, there were fewer flares (one study, 43 participants, RR 0.31, 95% CI 0.12 to 0.7; low-quality evidence) and less topical corticosteroids needed (two studies, 222 participants, MD -9.30g, 95% CI 15.3 to -3.27; low-quality evidence), but more adverse events were reported (one study, 173 participants; Peto odds ratio (OR) 7.26, 95% CI 1.76 to 29.92; low-quality evidence).All moisturisers above were compared to placebo, vehicle, or no moisturiser. Participants considered moisturisers more effective in reducing eczema (five studies, 572 participants, RR 2.46, 95% CI 1.16 to 5.23; low-quality evidence) and itch (seven studies, 749 participants, SMD -1.10, 95% CI -1.83 to -0.38) than control. Participants in both treatment arms reported comparable satisfaction (three studies, 296 participants, RR 1.35, 95% CI 0.77 to 2.26; low-quality evidence). Moisturisers led to lower investigator-assessed disease severity (12 studies, 1281 participants, SMD -1.04, 95% CI -1.57 to -0.51; high-quality evidence) and fewer flares (six studies, 607 participants, RR 0.33, 95% CI 0.17 to 0.62; moderate-quality evidence), but there was no difference in adverse events (10 studies, 1275 participants, RR 1.03, 95% CI 0.82 to 1.30; moderate-quality evidence).Topical active treatment combined with moisturiser was more effective than active treatment alone in reducing investigator-assessed disease severity (three studies, 192 participants, SMD -0.87, 95% CI -1.17 to -0.57; moderate-quality evidence) and flares (one study, 105 participants, RR 0.43, 95% CI 0.20 to 0.93), and was preferred by participants (both low-quality evidence). There was no statistically significant difference in number of adverse events (one study, 125 participants, RR 0.39, 95% CI 0.13 to 1.19; very low-quality evidence). Participant-assessed disease severity was not addressed.

AUTHORS' CONCLUSIONS: Most moisturisers showed some beneficial effects, producing better results when used with active treatment, prolonging time to flare, and reducing the number of flares and amount of topical corticosteroids needed to achieve similar reductions in eczema severity. We did not find reliable evidence that one moisturiser is better than another.

Originalsprog Engelsk
Tidsskrift Cochrane Database of Systematic Reviews
Vol/bind 2
Sider (fra-til) CD012119
ISSN 1361-6137
DOI
Status Udgivet - 6 feb. 2017

EQ-5D utility, response and drug survival in rheumatoid arthritis patients on biologic monotherapy: A prospective observational study of patients registered in the south Swedish SSATG registry

Jørgensen, T. S., Turesson, C., Kapetanovic, M. C., Englund, M., Turkiewicz, A., Christensen, R., Bliddal, H., Geborek, P. & Kristensen, L. E. 2017 I : P L o S One. 12, 2, s. e0169946

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: Biologic agents have dramatically changed treatment of rheumatoid arthritis (RA). To date only scarce head-to-head data exist especially when the biological therapies are given as monotherapy without concomitant disease modifying drugs (DMARDs). Thus the objective of the current study is to evaluate treatment response of all available biological therapies with special focus on utility (EQ-5D-3L) and drug survival of biologic DMARDs (bDMARDs) prescribed as monotherapy in RA patients in southern Sweden.

MATERIALS AND METHODS: All RA patients registered in a regional database as initiating bDMARD as monotherapy, i.e. without concomitant conventional synthetic DMARDs (csDMARDs), from 1st of January 2006 through 31st of December 2012, were included. Patients were followed from initiation of the first dose of bDMARD monotherapy treatment until withdrawal from treatment, loss of follow-up or 31st of December 2012. Descriptive statistics for utility (EQ-5D-3L), effectiveness, and drug survival of bDMARD monotherapy were calculated.

RESULTS: During the study period, a total of 554 patients were registered in SSATG as initiating bDMARD monotherapy. Most of the patients were women (81%), with a mean age of 57 years. The average disease duration was more than 12 years, and on average the patients had previously been treated with approximately four different csDMARDs. Fifty-five percent of the patients were initiating their first bDMARD, 26% their second, and 19% their third or more. At baseline the average EQ-5D-3L was 0.34. Most patients had moderate to high disease activity, with a mean DAS28 of 5.0, and were substantially disabled, with an average HAQ score of 1.4. At 6 months´ follow-up, the EQ-5D-3L in patients still on the biologic drug had increased by mean 0.23 (SD 0.4) with no differences between type of bDMARD (p = 0.49). The mean change in EQ-5D-3L ranged from 0.11 (rituximab and infliximab) to 0.42 (tocilizumab). Although the changes were numerically different, no distinct pattern favored any particular bDMARD for EQ-5D-3L (p = 0.49) or other clinical outcomes. Overall, DAS28 defined remission and low disease activity were achieved in 20% and 43% of patients, respectively. Drug survival rates were statistically significantly different between bDMARDs (p = 0.01), with the highest rates observed for rituximab, followed by etanercept. After failing first course of anti-TNF, patients switching to another mode of action had significantly higher drug survival than those switching to a second course of anti-TNF therapy (p = 0.02).

CONCLUSIONS: Utility (EQ-5D-3L) increased after 6 months of all bDMARD treatments in monotherapy, indicating improvement of patients' quality of life. After failure of anti-TNF treatment in monotherapy, switching to another mode of action may be associated with better drug survival than starting a second TNF-inhibitor.

Originalsprog Engelsk
Tidsskrift P L o S One
Vol/bind 12
Tidsskriftsnummer 2
Sider (fra-til) e0169946
ISSN 1932-6203
DOI
Status Udgivet - 2017

Erratum to: Ethnic Differences in Persistence with COPD Medications: a Register-Based Study

Hu, Y., Cantarero-Arévalo, L., Frølich, A. & Jacobsen, R. dec. 2017 I : Journal of racial and ethnic health disparities. 4, 6, s. 1253

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Originalsprog Engelsk
Tidsskrift Journal of racial and ethnic health disparities
Vol/bind 4
Tidsskriftsnummer 6
Sider (fra-til) 1253
ISSN 2196-8837
DOI
Status Udgivet - dec. 2017

Erratum to: Ethnic Inequalities in COPD Outcomes: a Register-Based Study in Copenhagen, Denmark

Hu, Y., Cantarero-Arévalo, L., Frølich, A. & Jacobsen, R. 2 feb. 2017

Publikation: AndetAndet bidragForskning

Originalsprog Engelsk
Publikationsdato 2 feb. 2017
DOI
Status Udgivet - 2 feb. 2017
Navn Journal of racial and ethnic health disparities
ISSN 2196-8837

Ethnic Differences in Persistence with COPD Medications: a Register-Based Study

Hu, Y., Cantarero-Arévalo, L., Frølich, A. & Jacobsen, R. dec. 2017 I : Journal of racial and ethnic health disparities. 4, 6, s. 1246-1252 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Long-acting bronchodilators (LABDs) are recommended as a first-line maintenance therapy in patients with moderate or severe chronic obstructive pulmonary disease (COPD). The aim of the study was to explore potential ethnic differences in persistence with LABD in COPD patients.

METHODS: A cohort of COPD patients diagnosed in 2003-2007 in Copenhagen, Denmark, was followed for 2 years in the Danish national registers. According to the number of the LABD medications dispensed, individuals were categorized into three therapy groups: monotherapy, drug combination therapy, and multiple drug therapy. Persistence was defined as the period from the first prescription date to the date of discontinuation. Treatment was considered discontinued if the interval between the two prescriptions was longer than the number of days of cumulative medication supply according to defined daily doses plus 7 days.

RESULTS: In total, 1129 incident COPD patients using LABDs were included; 6.7% had other than Danish ethnic background. Survival analyses showed that in the cases where LABD medication combination presented COPD maintenance therapy, ethnic background was associated with the higher risk of the therapy discontinuation: HR = 1.40, 95% CI = 1.03-1.90, p = 0.03. There were no ethnic differences in persistence in the monotherapy or multiple therapy groups.

CONCLUSIONS: COPD patients with other than Danish ethnic background discontinued COPD maintenance therapy more often than ethnic Danes. Attention to the barriers of persistent COPD medication use in COPD patients from ethnic minorities should be payed to facilitate better COPD management.

Originalsprog Engelsk
Tidsskrift Journal of racial and ethnic health disparities
Vol/bind 4
Tidsskriftsnummer 6
Sider (fra-til) 1246-1252
Antal sider 7
ISSN 2196-8837
DOI
Status Udgivet - dec. 2017

EULAR recommendations for management of fibromyalgia

Macfarlane, G. J., Kronisch, C., Atzeni, F., Häuser, W., Choy, E. H., Amris, K., Branco, J. C., Dincer, F., Leino-Arjas, P., Longley, K., McCarthy, G., Makri, S., Perrot, S., Sarzi Puttini, P., Taylor, A. & Jones, G. T. 5 maj 2017 I : Annals of the Rheumatic Diseases. 76, 12, s. e54

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 76
Tidsskriftsnummer 12
Sider (fra-til) e54
ISSN 0003-4967
DOI
Status Udgivet - 5 maj 2017

EULAR revised recommendations for the management of fibromyalgia

Macfarlane, G. J., Kronisch, C., Dean, L. E., Atzeni, F., Häuser, W., Fluß, E., Choy, E., Kosek, E., Amris, K., Branco, J. C., Dincer, F., Leino-Arjas, P., Longley, K., McCarthy, G. M., Makri, S., Perrot, S., Sarzi-Puttini, P., Taylor, J. A. & Jones, G. T. feb. 2017 I : Annals of the Rheumatic Diseases. 76, 2, s. 318-328 11 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: The original European League Against Rheumatism recommendations for managing fibromyalgia assessed evidence up to 2005. The paucity of studies meant that most recommendations were 'expert opinion'.

METHODS: A multidisciplinary group from 12 countries assessed evidence with a focus on systematic reviews and meta-analyses concerned with pharmacological/non-pharmacological management for fibromyalgia. A review, in May 2015, identified eligible publications and key outcomes assessed were pain, fatigue, sleep and daily functioning. The Grading of Recommendations Assessment, Development and Evaluation system was used for making recommendations.

RESULTS: 2979 titles were identified: from these 275 full papers were selected for review and 107 reviews (and/or meta-analyses) evaluated as eligible. Based on meta-analyses, the only 'strong for' therapy-based recommendation in the guidelines was exercise. Based on expert opinion, a graduated approach, the following four main stages are suggested underpinned by shared decision-making with patients. Initial management should involve patient education and focus on non-pharmacological therapies. In case of non-response, further therapies (all of which were evaluated as 'weak for' based on meta-analyses) should be tailored to the specific needs of the individual and may involve psychological therapies (for mood disorders and unhelpful coping strategies), pharmacotherapy (for severe pain or sleep disturbance) and/or a multimodal rehabilitation programme (for severe disability).

CONCLUSIONS: These recommendations are underpinned by high-quality reviews and meta-analyses. The size of effect for most treatments is relatively modest. We propose research priorities clarifying who will benefit from specific interventions, their effect in combination and organisation of healthcare systems to optimise outcome.

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 76
Tidsskriftsnummer 2
Sider (fra-til) 318-328
Antal sider 11
ISSN 0003-4967
DOI
Status Udgivet - feb. 2017

First Line Biological Treatment in Ankylosing Spondylitis, Prescription Rates, Baseline Demographics and Disease Activity. a Collaboration between Biological Registers in the Five Nordic Counties

Glintborg, B., Lindström, U., Aaltonen, K., Kristianslund, E. K., Gudbjornsson, B., Chatzidionysiou, K., Askling, J., Nordström, D., Hetland, M. L., Guiseppe, D. D., Dreyer, L., Jørgensen, T. S., Kristensen, L. E., Eklund, K., Grondal, G., Ernestam, S., Joensuu, J., Kvien, T. K., Lie, E., Fagerli, K. M., Geirsson, A. J., Jonsson, H. & Jacobsson, L. T. H. 2017 I : Arthritis & Rheumatology. 69, S10, 1541

Publikation: Bidrag til tidsskriftKonferenceabstrakt i tidsskriftForskningpeer review

Originalsprog Engelsk
Artikelnummer 1541
Tidsskrift Arthritis & Rheumatology
Vol/bind 69
Tidsskriftsnummer S10
ISSN 1537-2960
Status Udgivet - 2017

GRADE Equity Guidelines 3: Health equity considerations in rating the certainty of synthesized evidence

Welch, V. A., Akl, E. A., Pottie, K., Ansari, M. T., Briel, M., Christensen, R., Dans, A., Dans, L., Eslava-Schmalbach, J. H., Guyatt, G., Hultcrantz, M., Jull, J., Katikireddi, S. V., Lang, E., Matovinovic, E., Meerpohl, J., Morton, R., Mosdøl, A., Murad, M. H., Petkovic, J., Schunemann, H. J., Sharaf, R., Shea, B., Singh, J. A., Solà, I., Stanev, R., Stein, A. T., Thabane, L., Tonia, T., Tristan, M., Vitols, S., Watine, J. & Tugwell, P. 4 apr. 2017 I : Journal of Clinical Epidemiology.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: The aim of this paper is to describe a conceptual framework for how to consider health equity in the GRADE (Grading Recommendations Assessment and Development Evidence) guideline development process.

STUDY DESIGN AND SETTING: Consensus-based guidance developed by the GRADE working group members and other methodologists.

RESULTS: We developed consensus-based guidance to help address health equity when rating the certainty of synthesized evidence (i.e., quality of evidence). When health inequity is determined to be a concern by stakeholders, we propose five methods for explicitly assessing health equity: 1) Include health equity as an outcome; 2) Consider patient-important outcomes relevant to health equity; 3) Assess differences in the relative effect size of the treatment; 4) Assess differences in baseline risk and the differing impacts on absolute effects; and 5) Assess indirectness of evidence to disadvantaged populations and/or settings.

CONCLUSION: The most important priority for research on health inequity and guidelines is to identify and document examples where health equity has been considered explicitly in guidelines. Although there is a weak scientific evidence base for assessing health equity, this should not discourage the explicit consideration of how guidelines and recommendations affect the most vulnerable members of society.

Originalsprog Engelsk
Tidsskrift Journal of Clinical Epidemiology
ISSN 0895-4356
DOI
Status Udgivet - 4 apr. 2017

Hair dyeing, hair washing and hair cortisol concentrations among women from the healthy start study

Kristensen, S. K., Larsen, S. C., Olsen, N. J., Fahrenkrug, J. & Heitmann, B. L. mar. 2017 I : Psychoneuroendocrinology. 77, s. 182-185 4 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Hair cortisol concentration (HCC) has been suggested as a promising marker for chronic stress. However, studies investigating the influence of hair dyeing and hair washing frequency on HCC have shown inconsistent results.

OBJECTIVE: To examine associations between HCC and hair dyeing status or weekly hair washing frequency among women.

METHODS: This cross-sectional study was based on data from 266 mothers participating in the Healthy Start intervention study. HCC was measured in the proximal end of the hair (1-2cm closest to the scalp) while hair dyeing status, frequency of hair washing and covariates were reported by the women. Linear regression analyses were applied to assess the associations between HCC and hair dyeing or weekly frequency of hair washing.

RESULTS: No statistically significant difference (p=0.91) in HCC was found between women who dyed hair (adjusted mean: 137pg/mg [95% CI: 122,153]) and women with natural hair color (adjusted mean: 139pg/mg [95% CI: 123,155]). Frequency of hair washing was not associated with HCC (β: -3.7 [95% CI: -9.0, 1.5; P=0.20]).

CONCLUSIONS: This study of 266 Danish women provides no evidence in support of an association between HCC and hair dyeing status or hair washing frequency.

Originalsprog Engelsk
Tidsskrift Psychoneuroendocrinology
Vol/bind 77
Sider (fra-til) 182-185
Antal sider 4
ISSN 0306-4530
DOI
Status Udgivet - mar. 2017

Hand bone loss in early rheumatoid arthritis during a methotrexate-based treat-to-target strategy with or without adalimumab-a substudy of the optimized treatment algorithm in early RA (OPERA) trial

Ørnbjerg, L. M., Østergaard, M., Jensen, T., Hørslev-Petersen, K., Stengaard-Pedersen, K., Junker, P., Ellingsen, T., Ahlquist, P., Lindegaard, H., Linauskas, A., Schlemmer, A., Dam, M. Y., Hansen, I., Lottenburger, T., Ammitzbøll, C. G., Jørgensen, A., Krintel, S. B., Raun, J., Hetland, M. L., Slot, O., Nielsen, L. K., Skjødt, H., Majgaard, O., Lorenzen, T., Horn, H. C., Kowalski, M., Johansen, I. L., Pedersen, P. M., Manilo, N. & Bliddal, H. 1 apr. 2017 I : Clinical rheumatology. 36, 4, s. 781-789

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

This study aims to investigate 1-year hand bone loss (HBL1-year) in early rheumatoid arthritis (RA) patients treated with a methotrexate (MTX) and intra-articular triamcinolone treat-to-target strategy +/- adalimumab and to determine if HBL6months is associated with radiographic progression after 2 years. In a clinical trial (OPERA) of 180 treatment-naive early RA patients, bone mineral density (BMD) was estimated from hand radiographs with digital X-ray radiogrammetry (DXR) at baseline, after 6 (n = 90) and 12 months (n = 70) of follow-up. Baseline and 2-year radiographs were scored according to the Sharp/van der Heijde method. Baseline characteristics and HBL6months (0-6 months changes in DXR-BMD) were investigated as predictors of structural damage by univariate linear (∆ total Sharp/van der Heijde score (TSS) as dependent variable) and logistic (+/-radiographic progression (∆TSS >0) as dependent variable) regression analyses. Variables with p < 0.10 were included in multivariable models. In 70 patients with available HBL1-year data, HBL1-year was median (interquartile range (IQR)) -1.9 (-3.3; -0.26 mg/cm(2)) in the MTX + placebo group and -1.8 (-3.6; 0.06) mg/cm(2) in the MTX + adalimumab group, p = 0.98, Wilcoxon signed-rank. Increased HBL (compared to general population reference values) was found in 26/37 and 23/33 patients in the MTX + placebo and MTX + adalimumab groups, chi-squared = 0.99. In 90 patients with HBL6months data and 2-year radiographic data, HBL6months was independently associated with ∆TSS after 2 years (β = -0.086 (95% confidence interval = -0.15; -0.025) TSS unit/mg/cm(2) increase, p = 0.006) but not with presence of radiographic progression (∆TSS >0) (OR 0.96 (0.92-1.0), p = 0.10). In early RA patients treated with a methotrexate-based treat-to-target strategy, the majority of patients had increased HBL1-year, irrespective of adalimumab; HBL6months was independently associated with ∆TSS after 2 years.

Originalsprog Engelsk
Tidsskrift Clinical rheumatology
Vol/bind 36
Tidsskriftsnummer 4
Sider (fra-til) 781-789
ISSN 0770-3198
DOI
Status Udgivet - 1 apr. 2017

Harms associated with taking nalmefene for substance use and impulse control disorders: A systematic review and meta-analysis of randomised controlled trials

Johansen, K. G. V., Tarp, S., Astrup, A., Lund, H., Pagsberg, A. K. & Christensen, R. 29 aug. 2017 I : P L o S One. 12, 8, s. 1-14 14 s., e0183821

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

IMPORTANCE: Nalmefene is a newly approved drug for alcohol use disorder, but the risk of harms has not been evaluated from empirical trial evidence.

OBJECTIVE: To assess the harm of nalmefene administered to individuals diagnosed with substance use or impulse control disorders by performing a systematic review and meta-analysis of randomised controlled trials.

DATA SOURCES: A search was performed in Cochrane Central Register of Controlled Trials (CENTRAL, 2014), MEDLINE via PubMed (1950), EMBASE via Ovid (1974), and Clinicaltrials.gov through December 2014.

STUDY SELECTION: This study included only randomised controlled trials with placebo or active controls that administered nalmefene to adult individuals for treating impulse control and/or substance use disorders. Both published and unpublished randomised controlled trials were eligible for inclusion.

DATA EXTRACTION AND SYNTHESIS: Internal validity was assessed using the Cochrane risk-of-bias tool. Published information from the trials was supplemented by contact between reviewers and industry sponsor. Data were combined using two meta-approaches in fixed effects models; Peto Odds Ratios and risk differences were reported with 95% confidence intervals (95%CIs).

MAIN OUTCOMES AND MEASURES: Number of patients with serious adverse events, including specific psychiatric serious adverse events and withdrawals due to adverse events.

RESULTS: Of 20 potentially relevant studies, 15 randomised controlled trials met the inclusion criteria, and 8 of these provided data enabling the meta-analysis. Overall, serious adverse events did not occur more often in the nalmefene group than in the placebo group (Peto Odds Ratio = 0.97 [95% CI 0.64-1.44]; P = 0.86). Risk of psychiatric serious adverse events was slightly elevated, albeit not at a statistically significant level (Peto Odds Ratio = 1.32 [95% CI 0.62, 2.83]; P = 0.47). Withdrawals due to adverse events were significantly more likely to occur with nalmefene compared to placebo (Peto Odds Ratio = 3.22 [95% CI 2.46-4.22]; P<0.001).

CONCLUSIONS AND RELEVANCE: The three-fold increased risk of withdrawal from treatment on nalmefene due to adverse events is a matter of safety concern. The nature of these adverse events cannot be elucidated further without access to individual patients data.

Originalsprog Engelsk
Artikelnummer e0183821
Tidsskrift P L o S One
Vol/bind 12
Tidsskriftsnummer 8
Sider (fra-til) 1-14
Antal sider 14
ISSN 1932-6203
DOI
Status Udgivet - 29 aug. 2017

Health Equity Considerations for Developing and Reporting Patient-reported Outcomes in Clinical Trials: A Report from the OMERACT Equity Special Interest Group

Petkovic, J., Barton, J. L., Flurey, C., Goel, N., Bartels, C. M., Barnabe, C., de Wit, M. P. T., Lyddiatt, A., Lacaille, D., Welch, V., Boonen, A., Shea, B., Christensen, R., Maxwell, L. J., Campbell, W., Jull, J., Toupin-April, K., Singh, J. A., Goldsmith, C. H., Sreih, A. G., Pohl, C., Hofstetter, C., Beaton, D. E., Buchbinder, R., Guillemin, F. & Tugwell, P. S. nov. 2017 I : Journal of Rheumatology. 44, 11, s. 1727-1733 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: Despite advances integrating patient-centered outcomes into rheumatologic studies, concerns remain regarding their representativeness across diverse patient groups and how this affects equity. The Outcome Measures in Rheumatology (OMERACT) Equity Working Group aims to determine whether and how to address equity issues within the core outcome sets of domains and instruments.

METHODS: We surveyed current and previous OMERACT meeting attendees and members of the Campbell and Cochrane Equity Group regarding whether to address equity issues within the OMERACT Filter 2.0 Core Outcome Sets and how to assess the appropriateness of domains, instruments, and measurement properties among diverse patients. At OMERACT 2016, results of the survey and a narrative review of differential psychosocial effects of rheumatoid arthritis (i.e., on men) were presented to stimulate discussion and develop a research agenda.

RESULTS: We proposed 6 moments for which an equity lens could be added to the development, selection, or testing of patient-reported outcome measures (PROM): (1) recruitment, (2) domain selection, (3) feasibility in diverse settings, (4) instrument validity, (5) thresholds of meaning, and (6) consideration of statistical power of subgroup analyses for outcome reporting.

CONCLUSION: There is a need to (1) conduct a systematic review to assess how equity and population characteristics have been considered in PROM development and whether these differences influence the ranking of importance of outcome domains or a patient's response to questionnaire items, and (2) conduct the same survey described above with patients representing groups experiencing health inequities.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 44
Tidsskriftsnummer 11
Sider (fra-til) 1727-1733
Antal sider 7
ISSN 0315-162X
DOI
Status Udgivet - nov. 2017

AIMS AND OBJECTIVES: To describe how group-based multidisciplinary rehabilitation for patients with fibromyalgia can influence patients' self-efficacy and ability to cope with their illness.

BACKGROUND: Multidisciplinary rehabilitation is recommended in the management of fibromyalgia. Self-efficacy is said to influence and predict adaptive coping behaviours and functioning. However, knowledge is lacking on how rehabilitation programmes may influence self-efficacy and ability to cope, from the patients' perspective.

DESIGN: Grounded theory study of semi-structured focus group interviews.

METHODS: Participants (n = 17) were included in four focus groups that had completed a two-week multidisciplinary rehabilitation programme together. Interviews were conducted four weeks after each group had completed the programme. The analysis was conducted constant comparatively applying open, axial and selective coding.

RESULTS: Categories (in italics) were derived from data in which the explanatory core category was identified: Learning to accept and live with pain as a life condition, and linked to three categories mutually influencing each other: Increased self-acceptance of living with the illness, experiencing acceptance from others and developing new coping strategies. Thus, patients benefitted from multidisciplinary rehabilitation with stronger self-efficacy and expectations to their future coping. However, limitations in the programme were identified, as the programme was short and intensive with no subsequent follow-up, and social welfare was not sufficiently addressed. Participants also found it difficult to maintain knowledge and were lacking individual sessions with the psychologist and had waited long to receive rehabilitation.

CONCLUSION: Multidisciplinary rehabilitation may advantageously be offered to patients with fibromyalgia. However, earlier action with longer programmes, in which patients' social situation is addressed, comprising individual sessions with the psychologist, with multiple repetitions of the content and follow-up sessions, may further enhance the patients' self-efficacy and coping with their illness.

Originalsprog Engelsk
Tidsskrift BBA Clinical
Vol/bind 26
Tidsskriftsnummer 7-8
Sider (fra-til) 931-945
Antal sider 15
ISSN 0962-1067
DOI
Status Udgivet - apr. 2017

Impact of age and sex on the incidence and prevalence of psoriatic arthritis

Egeberg, A. & Kristensen, L. E. 1 aug. 2017 I : Annals of the Rheumatic Diseases.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
ISSN 0003-4967
DOI
Status Udgivet - 1 aug. 2017

OBJECTIVE: To explore and compare the outcomes of adaptation and physical activity programmes regarding activities of daily living (ADL) ability following interdisciplinary rehabilitation in women with fibromyalgia.

METHODS: Participants (n = 85) were quasi-randomized to 16-week adaptation (ADAPT) or physical activity (ACTIVE) programmes following 2-week interdisciplinary rehabilitation. Primary outcomes were ADL motor and ADL process ability, measured with the Assessment of Motor and Process Skills (AMPS) at 4-week follow-up. Data were analysed per protocol.

RESULTS: Participants (ADAPT, n = 21; ACTIVE, n = 27) did not differ from withdrawers (n = 37). Improvements in ADL ability in the ADAPT (ADL motor mean change = 0.43 logits (95% confidence interval (95% CI) = 0.31-0.56); ADL process mean change = 0.34 logits (95% CI = 0.17-0.52)) and ACTIVE (ADL motor mean change = 0.33 logits (95% CI = 0.22-0.43); ADL process mean change = 0.25 logits (95% CI = 0.12-0.38)) groups were statistically significant, with no differences between groups. Responder analyses revealed that 63% of all participants obtained clinically relevant improvements in ADL motor ability and 48% in ADL process ability.

CONCLUSION: Although limited by a large drop-out, this exploratory study showed that both adaptation and physical activity programmes following interdisciplinary rehabilitation improved ADL ability in the majority of participants. ADL ability outcomes were independent of group allocation (ADAPT vs ACTIVE), suggesting efficacy of both programmes.

Originalsprog Engelsk
Tidsskrift Journal of Rehabilitation Medicine
Vol/bind 49
Tidsskriftsnummer 3
Sider (fra-til) 241-250
Antal sider 10
ISSN 1650-1977
DOI
Status Udgivet - 6 mar. 2017

Incidence and prevalence of psoriatic arthritis in Denmark: a nationwide register linkage study

Egeberg, A., Kristensen, L. E., Thyssen, J. P., Gislason, G. H., Gottlieb, A. B., Coates, L. C., Jullien, D., Gisondi, P., Gladman, D., Skov, L. & Mallbris, L. 2017 I : Annals of the Rheumatic Diseases. 76, 9, s. 1591-1597

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: To examine the incidence and temporal trends of psoriatic arthritis (PsA) in the general population in Denmark.

METHODS: Using nationwide registry data, we estimated the number of patients with incident PsA within each 1-year period between 1997 and 2011 and calculated the rate of PsA cases within gender and age subgroups. Incidence rates were presented per 100 000 person-years.

RESULTS: There was a female predominance ranging from 50.3% (1998) to 59.2% (2010), and the mean age at time of diagnosis was 47-50 years. We identified a total of 12 719 patients with PsA (prevalence=0.22%), including 9034 patients where the PsA diagnosis was made by a rheumatologist (prevalence=0.16%). Incidence rates of PsA (per 100 000 person-years) increased from 7.3 in 1997 to a peak incidence of 27.3 in 2010. Incidence rates were highest for women and patients aged 50-59 years, respectively. The use of systemic non-biologic agents, that is, methotrexate, leflunomide, ciclosporin or sulfasalazine increased over the 15-year study course and were used in 66.3% of all patients. Biologic agents (etanercept, infliximab, adalimumab, certolizumab pegol, golimumab or ustekinumab) were used in 17.7% of patients with PsA.

CONCLUSIONS: We found a clear trend of rising PsA incidence on a national level. While the cause remains unclear, our findings might be explained by increased attention by patients and physicians.

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 76
Tidsskriftsnummer 9
Sider (fra-til) 1591-1597
ISSN 0003-4967
DOI
Status Udgivet - 2017

Incidence of knee and hip replacements in rheumatoid arthritis patients following introduction of biological dmards: an interrupted time series analysis using nationwide health care registers

Cordtz, R. L., Hawley, S., Prieto-Alhambra, D., Kristensen, L. E., Overgaard, S., Odgaard, A. & Dreyer, L. 2017 I : Annals of the Rheumatic Diseases. 76, 2, s. 159 1 s., OP0251

Publikation: Bidrag til tidsskriftKonferenceabstrakt i tidsskriftForskningpeer review

Originalsprog Dansk
Artikelnummer OP0251
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 76
Tidsskriftsnummer 2
Sider (fra-til) 159
Antal sider 1
ISSN 0003-4967
Status Udgivet - 2017

Bibliografisk note

COPECARE

Many patients with bipolar disorder (BD) experience debilitating cognitive deficits, with risk of impaired occupational and psychosocial functioning. However, knowledge of how these deficits impact the patients' ability to perform Activities of Daily Living (ADL), tasks related to self-care and domestic life is limited. We explored the relation between impaired cognitive function and the ability to perform ADL in patients with BD. A total of 42 outpatients (mean age 36 years (range 19.0-58.0 years), 69% women) with BD in remission and with subjective cognitive complaints (≥ 13 on the Cognitive Complaints in Bipolar Disorder Rating Assessment questionnaire (COBRA)) were included. Objective neurocognitive function was evaluated with a short comprehensive cognitive test battery and ADL ability was evaluated with the performance-based Assessment of Motor and Process Skills (AMPS) in the homes of the patients. Our findings indicate that low processing speed correlated with decreased ADL ability, and processing speed as measured by the cognitive test battery thus seems to be significantly related to patients' ability to live independently in the community. Overall, adding a performance based test to assess ADL ability in patients with BD home-surroundings seems to provide new insights regarding the effect of cognitive impairment in patients with BD.

Originalsprog Engelsk
Tidsskrift Psychiatry Research
Vol/bind 249
Sider (fra-til) 268-274
Antal sider 7
ISSN 0165-1781
DOI
Status Udgivet - mar. 2017

Infographic: Effects of specific injury prevention programmes in football

Thorborg, K., Krommes, K. K., Esteve, E., Clausen, M. B., Bartels, E. M. & Rathleff, M. S. aug. 2017 I : British Journal of Sports Medicine. 51, 20

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Originalsprog Engelsk
Tidsskrift British Journal of Sports Medicine
Vol/bind 51
Tidsskriftsnummer 20
ISSN 0306-3674
DOI
Status Udgivet - aug. 2017

Pages