Effectiveness of a new model of primary care management on knee pain and function in patients with knee osteoarthritis: Protocol for THE PARTNER STUDY

© 2018 The Author(s). Background: To increase the uptake of key clinical recommendations for non-surgical management of knee osteoarthritis (OA) and improve patient outcomes, we developed a new model of service delivery (PARTNER model) and an intervention to implement the model in the Australian primary care setting. We will evaluate the effectiveness and cost-effectiveness of this model compared to usual general practice care. Methods: We will conduct a mixed-methods study, including a two-arm, cluster randomised controlled trial, with quantitative, qualitative and economic evaluations. We will recruit 44 general practices and 572 patients with knee OA in urban and regional practices in Victoria and New South Wales. The interventions will target both general practitioners (GPs) and their patients at the practice level. Practices will be randomised at a 1:1 ratio. Patients will be recruited if they are aged =45 years and have experienced knee pain =4/10 on a numerical rating scale for more than three months. Outcomes are self-reported, patient-level validated measures with the primary outcomes being change in pain and function at 12 months. Secondary outcomes will be assessed at 6 and 12 months. The implementation intervention will support and provide education to intervention group GPs to deliver effective management for patients with knee OA using tailored online training and electronic medical record support. Participants with knee OA will have an initial GP visit to confirm their diagnosis and receive management according to GP intervention or control group allocation. As part of the intervention group GP management, participants with knee OA will be referred to a centralised multidisciplinary service: the PARTNER Care Support Team (CST). The CST will be trained in behaviour change support and evidence-based knee OA management. They will work with patients to develop a collaborative action plan focussed on key self-management behaviours, and communicate with the patients' GPs. Patients receiving care by intervention group GPs will receive tailored OA educational materials, a leg muscle strengthening program, and access to a weight-loss program as appropriate and agreed. GPs in the control group will receive no additional training and their patients will receive usual care. Discussion: This project aims to address a major evidence-to-practice gap in primary care management of OA by evaluating a new service delivery model implemented with an intervention targeting GP practice behaviours to improve the health of people with knee OA. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12617001595303, date of registration 1/12/2017

New Pharmacological Agents to Aid Smoking Cessation and Tobacco Harm Reduction: What has been Investigated and What is in the Pipeline?

A wide range of support is available to help smokers to quit and aid attempts at harm reduction, including three first-line smoking cessation medications: nicotine replacement therapy, varenicline and bupropion. Despite the efficacy of these, there is a continual need to diversify the range of medications so that the needs of tobacco users are met. This paper compares the first-line smoking cessation medications to: 1) two variants of these existing products: new galenic formulations of varenicline and novel nicotine delivery devices; and 2) twenty-four alternative products: cytisine (novel outside of central and eastern Europe), nortriptyline, other tricyclic antidepressants, electronic cigarettes, clonidine (an anxiolytic), other anxiolytics (e.g. buspirone), selective 5-hydroxytryptamine (5-HT) reuptake inhibitors, supplements (e.g. St John’s wort), silver acetate, nicobrevin, modafinil, venlafaxine, monoamine oxidase inhibitors (MAOI), opioid antagonist, nicotinic acetylcholine receptors (nAChR) antagonists, glucose tablets, selective cannabinoid type 1 receptor antagonists, nicotine vaccines, drugs that affect gamma-aminobutyric acid (GABA) transmission, drugs that affect N-methyl-D-aspartate receptors (NMDA), dopamine agonists (e.g. levodopa), pioglitazone (Actos; OMS405), noradrenaline reuptake inhibitors, and the weight management drug lorcaserin. Six criteria are used: relative efficacy, relative safety, relative cost, relative use (overall impact of effective medication use), relative scope (ability to serve new groups of patients), and relative ease of use (ESCUSE). Many of these products are in the early stages of clinical trials, however, cytisine looks most promising in having established efficacy and safety and being of low cost. Electronic cigarettes have become very popular, appear to be efficacious and are safer than smoking, but issues of continued dependence and possible harms need to be considered

Changes in Smoking and Vaping over 18 Months among Smokers and Recent Ex-Smokers: Longitudinal Findings from the 2016 and 2018 ITC Four Country Smoking and Vaping Surveys

This descriptive study of smokers (smoked at least monthly) and recent ex-smokers (quit for ≤2 years) examined transitions over an 18 month period in their smoking and vaping behaviors. Data are from Waves 1 (W1: 2016) and 2 (W2: 2018) of the ITC Four Country Smoking and Vaping Survey, a cohort study of adult (≥18+) smokers, concurrent users (smoke and vape), and recent ex-smokers from Australia, Canada, England, and the United States (US). Respondents (N = 5016) were classified according to their smoking and vaping status, which resulted in eight subgroups: (1) exclusive daily smokers (2) exclusive non-daily smokers; (3-6) concurrent users (subdivided into four groups by each combination of daily/non-daily smoking and daily/non-daily vaping); (7) ex-smokers who vape; (8) ex-smokers not vaping. The analyses focused first on describing changes between groups from W1 to W2. Second, transition outcomes were assessed based on changes in smoking and vaping between W1 and W2. Transitions focused on smoking were: no change in smoking (continued smoking at the same frequency); decreased smoking; increased smoking; discontinued smoking; relapsed (ex-smokers at W1 who were smoking at W2). Transitions focused on vaping were: initiated vaping; switched from smoking to vaping. Overall, this study found that the vast majority of smokers were smoking 18 months later. Non-daily smokers were more likely than daily smokers to have discontinued smoking (p < 0.0001) and to have switched to exclusive vaping (p = 0.034). Exclusive non-daily smokers were more likely than exclusive daily smokers to have initiated vaping (p = 0.04). Among all W1 daily smokers, there were no differences in discontinued smoking between daily smokers who vaped (concurrent users) and exclusive daily smokers; however, concurrent users were more likely than exclusive daily smokers to have decreased to non-daily smoking (p < 0.001) or to have switched to vaping by W2 (p < 0.001). Among all W1 non-daily smokers, there were no significant differences in increased smoking or discontinued smoking between concurrent users or exclusive smokers. Most ex-smokers remained abstinent from smoking, and there was no difference in relapse back to smoking between those who vaped and those who did not