Lynnmccall6807

Conservative treatments such as exercise are recommended for the management of people with neurogenic claudication from spinal stenosis. However, the effectiveness and mechanisms of effect are unknown. This protocol outlines an a priori plan for a secondary analysis of a multicentre randomised controlled trial of a physiotherapist-delivered, combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme).

We will use causal mediation analysis to estimate the mechanistic effects of the BOOST programme on the primary outcome of disability (measured by the Oswestry Disability Index). The primary mechanism of interest is walking capacity, and secondary mediators include fear-avoidance behaviour, walking self-efficacy, physical function, physical activity and/or symptom severity. All mediators will be measured at 6 months and the outcome will be measured at 12 months from randomisation. Patient characteristics and possible confounders of the mediator-outcome effect will be measured at baseline. Sensitivity analyses will be conducted to evaluate the robustness of the estimated effects to varying levels of residual confounding.

Ethical approval was given on 3 March 2016 (National Research Ethics Committee number 16/LO/0349). The results of this analysis will be disseminated in peer-reviewed journals and at relevant scientific conferences.

ISRCTN12698674.

ISRCTN12698674.

Postoperative pancreatic fistula (POPF) is still the most frequently occurring and clinically relevant complication after distal pancreatectomy (DP). Preoperative endoscopic injection of botulinum toxin (BTX) into the sphincter of Oddi represents an innovative approach to prevent POPF. The aim of this project (PREBOT

) is to generate the first randomised controlled trial data on the safety, feasibility and efficacy of preoperative endoscopic BTX injection into the sphincter of Oddi to prevent clinically relevant POPF following DP.

PREBOT

is an investigator-initiated, single-centre, randomised, controlled, open-label, phase II clinical trial with two parallel study groups and an exploratory study design. 60 patients scheduled for DP will be randomised to intervention and control group. In the intervention group, patients will undergo preoperative endoscopic injection of BTX into the sphincter of Oddi, whereas in the control group no preoperative endoscopy will be performed. The combined primary endpoint is the occurrence of clinically relevant POPF and/or death within 30 days after DP. The secondary endpoints comprise further postoperative outcome parameters and quality of life up to 3 months after DP as well as safety and feasibility of the procedure. Statistical analysis is based on the modified intention-to-treat population, excluding patients without status post DP. For safety analysis, rates of adverse events (AEs) and serious AEs will be calculated with 95% CIs for group comparisons.

PREBOT

has been approved by the German Federal Institute for Drugs and Medical Devices (reference number 4043654) and the Ethics Committee of Heidelberg University (reference number AFmo-523/2019). This trial is supported by the German Federal Ministry of Education and Research (BMBF). this website The results of the trial will be presented at national and international conferences and published in a peer-reviewed journal.

DRKS00020401.

DRKS00020401.

Drug misuse is associated with significant global morbidity, mortality, economic costs and social costs. Many primary care facilities have integrated drug misuse screening and brief intervention (BI) into their usual care delivery. However, the efficacy of BI for drug misuse in primary care has not been substantiated through meta-analysis. The aim of this systematic review and meta-analysis is to determine the efficacy of BI for drug misuse in primary care settings.

We will include all randomised controlled trials comparing primary care-delivered BI for drug misuse with no intervention or minimal screening/assessment and usual care. Primary outcomes are (1) drug use frequency scores and (2) severity scores at intermediate follow-up (4-8 months). We will retrieve all studies through searches in CENTRAL, Embase, MEDLINE and PsycINFO until 31 May 2020. The reference list will be supplemented with searches in trial registries (eg, www.clinicaltrials.gov) and through relevant existing study reference lists identified in the literature. We will conduct a random-effect pairwise meta-analysis for primary and secondary outcomes. We will assess statistical heterogeneity though visual inspection of a forest plot and calculate



statistics. We will assess risk of bias using the Cochrane Risk of Bias Tool V.2 and evaluate the certainty of evidence through the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Sensitivity analyses will account for studies with control group variations and studies with a high risk of bias. If heterogeneity is present, subgroup analyses will consider patient variables of age, sex/gender, race/ethnicity, per cent insured, baseline severity and primary drug misused.

This study will use published aggregate data and will not require ethical approval. Findings will be disseminated in a peer-reviewed journal.

This study will use published aggregate data and will not require ethical approval. Findings will be disseminated in a peer-reviewed journal.

Only a few studies on health inequalities in terms of lung cancer are available. We examined whether social inequalities are present for the occurrence of lung cancer. Confining the analyses to patients, it was also examined whether survival over the observation period and over a standardised period of 18 months differed by occupational position and income.

Our findings are based on claims data from a German statutory health insurance covering 2005-2016. The database comprised N=3 163 211 women (50.7%) and men (49.3%) aged 18 years and older. Diagnoses (International Statistical Classification of Diseases and Related Health Problems 10th Revision C34.0 to C34.9) were hospital-based, and income and occupational position were used as indicators of socioeconomic position. Analyses on social gradients were performed for employed and retired insured, but only for employed insured information on occupation and on income were available, for retired women and men only income was available. Analyses were performed by means of proportional hazard regression.