There is convincing evidence for the known and unambiguously accepted beneficial effects of glucocorticoids at low dosages. However, the implementation of existing recommendations and guidelines on the management of glucocorticoid therapy in rheumatic diseases is lagging behind. As a first step to improve implementation, we aimed at defining conditions under which long-term glucocorticoid therapy may have an acceptably low level of harm. A multidisciplinary European League Against Rheumatism task force group of experts including patients with rheumatic diseases was assembled. After a systematic literature search, breakout groups critically reviewed the evidence on the four most worrisome adverse effects of glucocorticoid therapy (osteoporosis, hyperglycaemia/diabetes mellitus, cardiovascular diseases and infections) and presented their results to the other group members following a structured questionnaire for final discussion and consensus finding. Robust evidence on the risk of harm of long-term glucocorticoid therapy was often lacking since relevant study results were often either missing, contradictory or carried a high risk of bias. The group agreed that the risk of harm is low for the majority of patients at long-term dosages of ≤5 mg prednisone equivalent per day, whereas at dosages of >10 mg/day the risk of harm is elevated. At dosages between >5 and ≤10 mg/day, patient-specific characteristics (protective and risk factors) determine the risk of harm. The level of harm of glucocorticoids depends on both dose and patient-specific parameters. General and glucocorticoid-associated risk factors and protective factors such as a healthy lifestyle should be taken into account when evaluating the actual and future risk.

BACKGROUND: The Osteoarthritis Research Society International (OARSI) has suggested to asses pain after specific activities consistently in clinical trials on knee OA. The Dynamic weight-bearing Assessment of Pain (DAP) assesses pain during activity (30 s of performing repeated deep knee-bends from a standing position). The purpose of this study is to evaluate the construct validity, responsiveness, and interpretability of the DAP for knee osteoarthritis (OA).

METHODS: One-hundred participants with knee OA were tested twice each with the DAP, the Knee injury and Osteoarthritis Outcome Score (KOOS), six-minute-walk-test (6MWT), and 6-min-walk-test with subsequent pain rating (6MWTpain), and once with a transition questionnaire (TRANS-Q) for the patient-reported change in pain after 12 weeks of exercise. Construct validity (baseline-scores) and responsiveness (change-scores) were estimated by Spearman Correlation Coefficients. We hypothesized that no correlations would be excellent (<0.7) (divergent validity), except for the 6MWTpain (convergent validity). The TRANS-Q was used for interpreting the DAP change-scores in terms of responsiveness and Minimal Important Change (MIC).

RESULTS: Divergent validity with the KOOS subscales (r = -0.31 to-0.45) and the 6MWT (r = -0.25) was supported. Convergent validity with the 6MWTpain was not supported (r = 0.54). The DAP change-scores corresponded to patient-reported change in pain (TRANS-Q), while correlations with change-scores on the other instruments were <0.35. The MIC was 2.4 DAP points.

CONCLUSIONS: The DAP possesses divergent validity compared to other instruments for knee OA, supporting the potential for this new way of assessing pain directly during activity. Importantly, the DAP change-scores correspond to patient-reported changes in pain, showing responsiveness. A change of 2.4 or more can be interpreted as clinically relevant. The DAP is a promising alternative to using 'pain on walking' as a clinical trial inclusion criterion/outcome.

Background: Mid-to-late adolescence is a critical period for initiation of alcohol and drug problems, which can be reduced by targeted brief motivational interventions. Web-based brief interventions have advantages in terms of acceptability and accessibility and have shown significant reductions of substance use among college students. However, the evidence is sparse among adolescents with at-risk use of alcohol and other drugs. Objective: This study evaluated the effectiveness of a targeted and fully automated Web-based brief motivational intervention with no face-to-face components on substance use among adolescents screened for at-risk substance use in four European countries. Methods: In an open-access, purely Web-based randomized controlled trial, a convenience sample of adolescents aged 16-18 years from Sweden, Germany, Belgium, and the Czech Republic was recruited using online and offline methods and screened online for at-risk substance use using the CRAFFT (Car, Relax, Alone, Forget, Friends, Trouble) screening instrument. Participants were randomized to a single session brief motivational intervention group or an assessment-only control group but not blinded. Primary outcome was differences in past month drinking measured by a self-reported AUDIT-C-based index score for drinking frequency, quantity, and frequency of binge drinking with measures collected online at baseline and after 3 months. Secondary outcomes were the AUDIT-C-based separate drinking indicators, illegal drug use, and polydrug use. All outcome analyses were conducted with and without Expectation Maximization (EM) imputation of missing follow-up data. Results: In total, 2673 adolescents were screened and 1449 (54.2%) participants were randomized to the intervention or control group. After 3 months, 211 adolescents (14.5%) provided follow-up data. Compared to the control group, results from linear mixed models revealed significant reductions in self-reported past-month drinking in favor of the intervention group in both the non-imputed (P=.010) and the EM-imputed sample (P=.022). Secondary analyses revealed a significant effect on drinking frequency (P=.037) and frequency of binge drinking (P=.044) in the non-imputation-based analyses and drinking quantity (P=.021) when missing data were imputed. Analyses for illegal drug use and polydrug use revealed no significant differences between the study groups (Ps>.05).Conclusions: Although the study is limited by a large drop-out, significant between-group effects for alcohol use indicate that targeted brief motivational intervention in a fully automated Web-based format can be effective to reduce drinking and lessen existing substance use service barriers for at-risk drinking European adolescents. ©Nicolas Arnaud, Christiane Baldus, Tobias H Elgán, Nina De Paepe, Hanne Tønnesen, Ladislav Csémy, Rainer Thomasius.

BACKGROUND: Prostate cancer is the most common non-cutaneous malignancy in men. Today most patients may expect to live years following the diagnosis and may thus experience significant morbidity due to disease progression and treatment toxicity. In order to address some of these problems exercise has been suggested and previously studies have shown improvements of disease specific quality of life and a reduction in treatment-related toxicity. Cohort studies with long term follow up have suggested that physical activity is associated with improved survival in prostate cancer patients. Previously one randomised controlled trial has examined the efficacy of football in prostate cancer patients undergoing androgen deprivation therapy to usual care and reported positive effects on lean body mass and bone markers. Against this background, we wish to examine the effectiveness of community-based football for men diagnosed with prostate cancer.

METHODS: Using a randomised controlled parallel group, multicenter, superiority trial design, two hundred prostate cancer patients will be recruited and randomised (1:1) to either community-based football one hour twice weekly or to a control group. The intervention period will be six months. The primary outcome is quality of life assessed after 12 weeks based on the change from baseline in the Functional Assessment of Cancer Therapy-Prostate questionnaire. Secondary outcomes are change from baseline to six months in quality of life, lean body mass, fat mass, whole body and regional bone markers, as well as physical activity and functional capacity at 12 weeks and six months. Safety outcome variables will be falls resulting in seeking medical assessment and fractures during the six-month period.

DISCUSSION: Football is viewed as a case for non-professional, supervised community-based team sport for promoting long-term physical activity in men diagnosed with prostate cancer. This randomised trial will provide data on effectiveness and safety for men with prostate cancer when football training is delivered in local football clubs.

TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02430792.