Evaluating the implementation of a prescription only regulatory model for nicotine vaping products: A qualitative study on the experiences and views of healthcare professionals.

BACKGROUND: Deciding how to regulate nicotine vaping products (NVPs) is a challenge for many countries. Balanced regulation should consider the potential harms to young people from uptake of NVPs alongside the possible benefits of NVPs as a smoking cessation aid. One option is to make NVPs only available via medical prescription to adults who smoke. From October 2021, Australia adopted a unique model that allows prescription access to NVPs that meet a product standard without requiring the NVPs to be approved as therapeutic goods. This research explored the impact of this regulatory model on the smoking cessation practices of health professionals, and their views on the model. METHODS: Semi-structured interviews were conducted with 39 Australian health professionals recruited from professional networks and social media. Health professionals were eligible if they provided smoking cessation advice as part of their role, and included medical practitioners (n = 9), pharmacists (n = 9), and other health professionals that provided smoking cessation counselling (n = 21). Interviews were mostly completed by phone and online teleconferencing software. Questions focused on smoking cessation practices, advice and information provided to patients about NVPs, views about the effectiveness of the model for supporting use of NVPs for smoking cessation and preventing youth uptake, and barriers and facilitators to prescribing and dispensing NVPs. Coding and analysis used a combination of inductive and deductive approaches. RESULTS: Findings indicated a lack of consensus amongst the participants about NVPs as a cessation or harm reduction tool. Participants broadly agreed that the model has not been effective in improving quality control of NVPs, or in reducing youth access. Many participants eligible to prescribe or dispense NVPs felt that the current regulatory model placed an undue time and responsibility burden on clinicians. CONCLUSION: Our research identified several limitations associated with the current Australian prescription-only regulatory model. These were perceived by healthcare professionals to limit the potential for the regulations to reduce youth use and to increase access to safer NVP products for people who smoke to use for smoking cessation.

National Health and Medical Research Council statement on electronic cigarettes: 2022 update.

INTRODUCTION: Electronic cigarette (e-cigarette) use in Australia has rapidly increased since the 2017 National Health and Medical Research Council (NHMRC) Chief Executive Officer (CEO) statement on e-cigarettes. The type of products available and the demographic characteristics of people using these products have changed. New evidence has been published and there is growing concern among public health professionals about the increased use, particularly among young people who do not currently smoke combustible cigarettes. The combination of these issues led NHMRC to review the current evidence and provide an updated statement on e-cigarettes. In this article, we describe the comprehensive process used to review the evidence and develop the 2022 NHMRC CEO statement on electronic cigarettes. MAIN RECOMMENDATIONS: E-cigarettes can be harmful; all e-cigarette users are exposed to chemicals and toxins that have the potential to cause adverse health effects. There are no health benefits of using e-cigarettes if you do not currently smoke tobacco cigarettes. Adolescents are more likely to try e-cigarettes if they are exposed to e-cigarettes on social media. Short term e-cigarette use may help some smokers to quit who have been previously unsuccessful with other smoking cessation aids. There are other proven safe and effective options available to help smokers to quit. CHANGES IN MANAGEMENT AS A RESULT OF THIS STATEMENT: The evidence base for the harms of e-cigarette use has strengthened since the previous NHMRC statement. Significant gaps in the evidence base remain, especially about the longer term health harms of using e-cigarettes and the toxicity of many chemicals in e-cigarettes inhaled as an aerosol.

Feasibility and Acceptability of Facilitated Advance Care Planning in Outpatient Clinics: A Qualitative Study of Patient and Caregivers Experiences.

Guidelines recommend advance care planning (ACP) for people with advanced illness; however, evidence supporting ACP as a component of outpatient care is lacking. We sought to establish the feasibility and acceptability of a facilitated ACP intervention for people attending tertiary outpatient clinics. Data from 20 semi-structured interviews with patient (M = 79.3 ± 7.7, 60% male) and caregiver (M = 68.1 ± 11.0, 60% female) participants recruited as part of a pragmatic, randomized controlled trial (RCT) were analyzed using qualitative descriptive methodology. Patients were randomized to intervention (e.g., facilitated support) or control (e.g., standard care). Intervention patients expressed high satisfaction, reporting the facilitated ACP session was clear, straightforward, and suited to their needs. Intervention caregivers did not report any significant concerns with the facilitated ACP process. Control participants reported greater difficulty completing ACP compared to intervention participants. Embedding facilitated ACP into tertiary outpatient care appears feasible and acceptable for people with advanced illnesses.

Impact of a general practice nurse intervention to improve blood pressure control: The ImPress study.

BACKGROUND AND OBJECTIVES: Hypertension is a highly prevalent but often poorly controlled risk factor for cardiovascular disease (CVD). This study examined the effectiveness of a general practice nurse (GPN) intervention to reduce blood pressure in adults with hypertension who are at high risk of CVD. METHOD: A cluster randomised control trial was performed across 10 general practices. Systolic (SBP) and diastolic (DBP) blood pressure were evaluated at six and 12 months. RESULTS: The adjusted mean difference between intervention and control groups at six months was 8.1 mmHg (95% confidence interval [CI]: -2.92, 18.94 mmHg; P=0.146) for SBP and 0.18 mmHg (95% CI: -6.54, 4.91 mmHg; P=0.775) for DBP. The adjusted mean difference between groups at 12 months was 11.3 mmHg (95% CI: 1.18, 21.42 mmHg; P=0.030) for SBP and 7.1 mmHg (95% CI: -8.62, 22.90 mmHg; P=0.362) for DBP. DISCUSSION: Clinically significant between-group differences in mean SBP at six and 12 months provide evidence for GPNs to play a greater role in managing hypertension.

Telehealth's future in Australian primary health care: a qualitative study exploring lessons learnt from the COVID-19 pandemic.

BACKGROUND: During the COVID-19 pandemic, telehealth emerged as a means of safely providing primary healthcare (PHC) consultations. In Australia, changes to telehealth funding led to the reconsideration of the role of telehealth in the ongoing provision of PHC services. AIM: To investigate GPs', registered nurses' (RNs), nurse practitioners' (NPs), and allied health (AH) clinicians perceptions of the sustainability of telehealth in PHC post-pandemic. DESIGN & SETTING: Semi-structured interviews were undertaken with 33 purposively selected clinicians, including GPs (n = 13), RNs (n = 5), NPs (n = 9), and AH clinicians (n = 6) working in PHC settings across Australia. Participants were drawn from responders to a national survey of PHC providers (n = 217). METHOD: The thematic analysis approach reported by Braun and Clarke was used to analyse the interview data. RESULTS: Data analysis revealed that the perception of providers was represented by the following two themes: lessons learnt; and the sustainability of telehealth. Lessons learnt included the need for rapid adaptation to telehealth, use of technology, and the pandemic being a catalyst for long-term change. The sustainability of telehealth in PHC comprised four subthemes around challenges: the funding model, maintaining patient and provider safety, hybrid service models, and access to support. CONCLUSION: Providers required resilience and flexibility to adapt to telehealth. Funding models must reward providers from an outcome focus, rather than placing limits on telehealth's use. Hybrid approaches to service delivery will best meet the needs of the community but must be accompanied by support and education for PHC professionals.

Effectiveness of a New Service Delivery Model for Management of Knee Osteoarthritis in Primary Care: A Cluster Randomized Controlled Trial.

OBJECTIVE: To evaluate the effectiveness and health costs of a new primary care service delivery model (the Optimising Primary Care Management of Knee Osteoarthritis [PARTNER] model) to improve health outcomes for patients with knee osteoarthritis (OA) compared to usual care. METHODS: This study was a 2-arm, cluster, superiority, randomized controlled trial with randomization at the general practice level, undertaken in Victoria and New South Wales, Australia. We aimed to recruit 44 practices and 572 patients age ≥45 years with knee pain for >3 months. Professional development opportunities on best practice OA care were provided to intervention group general practitioners (GPs). All recruited patients had an initial GP visit to confirm knee OA diagnosis. Control patients continued usual GP care, and intervention patients were referred to a centralized care support team (CST) for 12-months. Via telehealth, the CST provided OA education and an agreed OA action plan focused on muscle strengthening, physical activity, and weight management. Primary outcomes were patient self-reported change in knee pain (Numerical Rating Scale [range 0-10; higher score = worse]) and physical function (Knee Injury and Osteoarthritis Outcome Score activities of daily living subscale [range 0-100; higher score = better] at 12 months. Health care cost outcomes included costs of medical visits and prescription medications over the 12-month period. RESULTS: Recruitment targets were not reached. A total of 38 practices and 217 patients were recruited. The intervention improved pain by 0.8 of 10 points (95% confidence interval [95% CI] 0.2, 1.4) and function by 6.5 of 100 points (95% CI 2.3, 10.7), more than usual care at 12 months. Total costs of medical visits and prescriptions were $3,940 (Australian) for the intervention group versus $4,161 for usual care. This difference was not statistically significant. CONCLUSION: The PARTNER model improved knee pain and function more than usual GP care. The magnitude of improvement is unlikely to be clinically meaningful for pain but is uncertain for function.

International travel in the pandemic era: Implications for health advice.

BACKGROUND: International travel is resuming, but the COVID-19 pandemic has radically changed the context in terms of regulation, risks and models of travel. OBJECTIVE: Providing travel health advice is an important role for general practice. The aim of this article is to cover the changed context and wide-ranging implications of the COVID­19 pandemic for travel health advice. DISCUSSION: Travel in the COVID-19 era requires travellers to be well informed and prepared to comply with complex and evolving public health measures. There are changing patterns of infectious disease risk related to the impacts of the pandemic, increasing antimicrobial resistance and climate change. New models of travel include a shift towards greater environmental sustainability.

COPD-X Australian guidelines for the diagnosis and management of chronic obstructive pulmonary disease: 2022 update.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is a treatable and preventable disease characterised by persistent respiratory symptoms and chronic airflow limitation on spirometry. COPD is highly prevalent and is associated with exacerbations and comorbid conditions. "COPD-X" provides quarterly updates in COPD care and is published by the Lung Foundation Australia and the Thoracic Society of Australia and New Zealand. MAIN RECOMMENDATIONS: The COPD-X guidelines (version 2.65) encompass 26 recommendations addressing: case finding and confirming diagnosis; optimising function; preventing deterioration; developing a plan of care; and managing an exacerbation. CHANGES IN MANAGEMENT AS A RESULT OF THESE GUIDELINES: Both non-pharmacological and pharmacological strategies are included within these recommendations, reflecting the importance of a holistic approach to clinical care for people living with COPD to delay disease progression, optimise quality of life and ensure best practice care in the community and hospital settings when managing exacerbations. Several of the new recommendations, if put into practice in the appropriate circumstances, and notwithstanding known variations in the social determinants of health, could improve quality of life and reduce exacerbations, hospitalisations and mortality for people living with COPD.

Giving Asthma Support to Patients (GASP) program evaluation.

BACKGROUND AND OBJECTIVES: The Giving Asthma Support to Patients (GASP) program, developed in New Zealand, guides practice nurses to provide structured asthma care. This study assessed GASP in the context of Australian general practice. METHOD: The study used a pre-post design and was conducted in 19 practices in Western Sydney and Illawarra/Shoalhaven. Patients aged 5-70 years with moderate-to-severe asthma were invited to participate. Of the 289 patients who attended an initial GASP consultation, 153 attended for one or more follow-up visits. Outcomes were exacerbations requiring medical intervention in the previous 12 months, asthma control in the previous four weeks and quality of asthma care at the time of GASP consultation. RESULTS: There was a decrease in patients having one or more exacerbations (113 [74%] versus 80 [52%], P <0.001), and an increase in patients with good asthma control (21 [14%] versus 40 [26%], P <0.005). There was no significant change in the quality of asthma care variable. DISCUSSION: Implementation of the GASP program was associated with improvement in asthma outcomes.

Effect of Cytisine vs Varenicline on Smoking Cessation: A Randomized Clinical Trial.

Importance: Cytisine is more effective than placebo and nicotine replacement therapy for smoking cessation. However, cytisine has not been tested against the most effective smoking cessation medication, varenicline, which is associated with adverse events known to lead to discontinuation of therapy. Objective: To examine whether standard cytisine treatment (25 days) was at least as effective as standard varenicline treatment (84 days) for smoking cessation. Design, Setting, and Participants: This noninferiority, open-label randomized clinical trial with allocation concealment and blinded outcome assessment was undertaken in Australia from November 2017 through May 2019; follow-up was completed in January 2020. A total of 1452 Australian adult daily smokers willing to make a quit attempt were included. Data collection was conducted primarily by computer-assisted telephone interview, but there was an in-person visit to validate the primary outcome. Interventions: Treatments were provided in accordance with the manufacturers' recommended dosage: cytisine (n = 725), 1.5-mg capsules taken 6 times daily initially then gradually reduced over the 25-day course; varenicline (n = 727), 0.5-mg tablets titrated to 1 mg twice daily for 84 days (12 weeks). All participants were offered referral to standard telephone behavioral support. Main Outcomes and Measures: The primary outcome was 6-month continuous abstinence verified using a carbon monoxide breath test at 7-month follow-up. The noninferiority margin was set at 5% and the 1-sided significance threshold was set at .025. Results: Among 1452 participants who were randomized (mean [SD] age, 42.9 [12.7] years; 742 [51.1%] women), 1108 (76.3%) completed the trial. Verified 6-month continuous abstinence rates were 11.7% for the cytisine group and 13.3% for the varenicline group (risk difference, -1.62% [1-sided 97.5% CI, -5.02% to ∞]; P = .03 for noninferiority). Self-reported adverse events occurred less frequently in the cytisine group (997 events among 482 participants) compared with the varenicline group (1206 events among 510 participants) and the incident rate ratio was 0.88 (95% CI, 0.81 to 0.95; P = .002). Conclusions and Relevance: Among daily smokers willing to quit, cytisine treatment for 25 days, compared with varenicline treatment for 84 days, failed to demonstrate noninferiority regarding smoking cessation. Trial Registration: anzctr.org.au Identifier: ACTRN12616001654448.

Smoking cessation intervention in Australian general practice: a secondary analysis of a cluster randomised controlled trial.

BACKGROUND: GPs have limited capacity to routinely provide smoking cessation support. New strategies are needed to reach all smokers within this setting. AIM: To evaluate the effect of a pharmacist-coordinated interdisciplinary smoking cessation intervention delivered in Australian general practice. DESIGN AND SETTING: Secondary analysis of a cluster randomised controlled trial (RCT) conducted in 41 Australian general practices. METHOD: In all, 690 current smokers were included in this study: 373 from intervention clinics (n = 21) and 317 from control clinics (n = 18). A total of 166 current smokers had spirometry-confirmed chronic obstructive pulmonary disease (COPD). In the intervention clinics, trained pharmacists provided smoking cessation support plus Quitline referral. Control clinics provided usual care plus Quitline referral. Those with COPD in the intervention group (n = 84) were referred for home medicines review (HMR) and home-based pulmonary rehabilitation (HomeBase), which included further smoking cessation support. Outcomes included carbon monoxide (CO)-validated smoking abstinence, self-reported use of smoking cessation aids, and differences between groups in readiness-to-quit score at 6 months. RESULTS: Intention-to-treat analysis showed similar CO-validated abstinence rates at 6 months in the intervention (4.0%) and control clinics (3.5%). No differences were observed in readiness-to-quit scores between groups at 6 months. CO-validated abstinence rates were similar in those who completed HMR and at least six sessions of HomeBase to those with COPD in usual care. CONCLUSION: A pharmacist-coordinated interdisciplinary smoking cessation intervention when integrated in a general practice setting had no advantages over usual care. Further research is needed to evaluate the effect of HMR and home-based pulmonary rehabilitation on smoking abstinence in smokers with COPD.

A step-by-step model for a brief behavioural treatment for insomnia in Australian general practice.

BACKGROUND: Chronic insomnia is a prevalent and debilitating disorder managed in Australian general practice. The most effective and recommended first-line treatment for insomnia is cognitive behavioural therapy. This treatment has been translated to a condensed brief behavioural therapy for insomnia (BBTi), which is suitable for delivery in the general practice setting. There is evidence that BBTi improves insomnia, daytime functioning and quality of life, with effects persisting far beyond treatment cessation. BBTi appears to be a cost-effective treatment that is superior to sedative-hypnotic management. OBJECTIVE: The aim of this article is to present a step-by-step approach for Australian general practitioners to administer BBTi. DISCUSSION: BBTi is an effective treatment for insomnia that may be administered in the Australian general practice setting. General practitioners may choose to use existing funding support to administer BBTi to treat chronic insomnia according to guideline recommendations.

Smoking cessation.

BACKGROUND: Although Australia is a world leader in tobacco control, smoking remains the behavioural risk factor making the largest contribution to death and disease. Smoking rates remain high in Aboriginal and Torres Strait Islander people and in people with mental health problems. Priority groups for cessation include women who are pregnant and people with cardiovascular disease. OBJECTIVE: This article, based on the recently published second edition of Supporting smoking cessation: A guide for health professionals, provides an update on current evidence-based practice to support quitting. A brief, time-efficient intervention approach (Ask, Advise, Help) is proposed. New approaches to the use of pharmacotherapy are covered, as is the controversial role of nicotine-containing e-cigarettes and advice for groups with high smoking prevalence and those with special needs. DISCUSSION: A combination of behavioural support along with pharmacotherapy to treat nicotine dependence maximises the chances of successful long-term cessation. Combination nicotine replacement therapy (patch and short-acting oral form) or varenicline are the most effective forms of pharmacotherapy.

Supporting anticoagulant treatment decision making to optimise stroke prevention in complex patients with atrial fibrillation: a cluster randomised trial.

BACKGROUND: Anticoagulation for preventing stroke in atrial fibrillation is under-utilised despite evidence supporting its use, resulting in avoidable death and disability. We aimed to evaluate an intervention to improve the uptake of anticoagulation. METHODS: We carried out a national, cluster randomised controlled trial in the Australian primary health care setting. General practitioners received an educational session, delivered via telephone by a medical peer and provided information about their patients selected either because they were not receiving anticoagulation or for whom anticoagulation was considered challenging. General practitioners were randomised to receive feedback from a medical specialist about the cases (expert decisional support) either before or after completing a post-test audit. The primary outcome was the proportion of patients reported as receiving oral anticoagulation. A secondary outcome assessed antithrombotic treatment as appropriate against guideline recommendations. RESULTS: One hundred and seventy-nine general practitioners participated in the trial, contributing information about 590 cases. At post-test, 152 general practitioners (84.9%) completed data collection on 497 cases (84.2%). A 4.6% (Adjusted Relative Risk = 1.11, 95% CI = 0.86-1.43) difference in the post-test utilization of anticoagulation between groups was not statistically significant (p = 0.42). Sixty-one percent of patients in both groups received appropriate antithrombotic management according to evidence-based guidelines at post-test (Adjusted Relative Risk = 1.0; 95% CI = 0.85 to 1.19) (p = 0.97). CONCLUSIONS: Specialist feed-back in addition to an educational session did not increase the uptake of anticoagulation in patients with AF. TRIAL REGISTRATION: ANZCTRN12611000076976 Retrospectively registered.

Travel and immunosuppressant medication.

BACKGROUND: The use of potent immunosuppressant medications is becoming more common, particularly the use of biologicals for a range of conditions such as rheumatoid arthritis and inflammatory bowel disease. OBJECTIVE: This article focuses on the implications of immunosuppressant medications for travel, including pre-travel vaccinations, minimising risks during travel and travelling with medicines. DISCUSSION: Pre-travel risk assessment is essential to prepare for safe travel. Live vaccines are contraindicated in people with significant immunosuppression because of the higher risk of adverse events and vaccine-associated disease. Inactivated vaccines can be used but may be less effective. Assessing the degree of immunocompromise in patients taking immunosuppressants includes considering both the medications and the underlying conditions. An individualised approach, often involving expert input, is needed to provide pre-travel health advice and immunisation. Planning ahead for travel is needed to minimise risks.

Protocol for the process and feasibility evaluations of a new model of primary care service delivery for managing pain and function in patients with knee osteoarthritis (PARTNER) using a mixed methods approach.

INTRODUCTION: This protocol outlines the rationale, design and methods for the process and feasibility evaluations of the primary care management on knee pain and function in patients with knee osteoarthritis (PARTNER) study. PARTNER is a randomised controlled trial to evaluate a new model of service delivery (the PARTNER model) against 'usual care'. PARTNER is designed to encourage greater uptake of key evidence-based non-surgical treatments for knee osteoarthritis (OA) in primary care. The intervention supports general practitioners (GPs) to gain an understanding of the best management options available through online professional development. Their patients receive telephone advice and support for OA management by a centralised, multidisciplinary 'Care Support Team'. We will conduct concurrent process and feasibility evaluations to understand the implementation of this new complex health intervention, identify issues for consideration when interpreting the effectiveness outcomes and develop recommendations for future implementation, cost effectiveness and scalability. METHODS AND ANALYSIS: The UK Medical Research Council Framework for undertaking a process evaluation of complex interventions and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks inform the design of these evaluations. We use a mixed-methods approach including analysis of survey data, administrative records, consultation records and semistructured interviews with GPs and their enrolled patients. The analysis will examine fidelity and dose of the intervention, observations of trial setup and implementation and the quality of the care provided. We will also examine details of 'usual care'. The semistructured interviews will be analysed using thematic and content analysis to draw out themes around implementation and acceptability of the model. ETHICS AND DISSEMINATION: The primary and substudy protocols have been approved by the Human Research Ethics Committee of The University of Sydney (2016/959 and 2019/503). Our findings will be disseminated to national and international partners and stakeholders, who will also assist with wider dissemination of our results across all levels of healthcare. Specific findings will be disseminated via peer-reviewed journals and conferences, and via training for healthcare professionals delivering OA management programmes. This evaluation is crucial to explaining the PARTNER study results, and will be used to determine the feasibility of rolling-out the intervention in an Australian healthcare context. TRIAL REGISTRATION NUMBER: ACTRN12617001595303; Pre-results.

Clinical Characteristics Of Patients With Asthma COPD Overlap (ACO) In Australian Primary Care.

Purpose: Many older adults with a history of smoking and asthma develop clinical features of both asthma and COPD, an entity sometimes called asthma-COPD overlap (ACO). Patients with ACO may be at higher risk of poor health outcomes than those with asthma or COPD alone. However, understanding of ACO is limited in the primary care setting and more information is needed to better inform patient management. We aimed to compare the characteristics of patients with ACO or COPD in Australian general practices. Patients and methods: Data were from the RADICALS (Review of Airway Dysfunction and Interdisciplinary Community-based care of Adult Long-term Smokers) trial, an intervention study of an interdisciplinary community-based model of care. Baseline demographic and clinical characteristics, pre- and post-bronchodilator spirometry, dyspnoea and St. George's Respiratory Questionnaire scores were compared between 60 ACO patients and 212 with COPD alone. Results: Pre-bronchodilator Forced Expiratory Volume in 1 second (mean±SD 58.4±14.3 vs 67.5±20.1% predicted) and Forced Vital Capacity (mean 82.1±16.9 v 91.9±17.2% predicted) were significantly lower in the ACO group (p<0.001), but no difference was found in post-bronchodilator spirometry. Demographic and clinical characteristics, dyspnoea, quality of life, comorbidities and treatment prescribed did not differ significantly between groups. Conclusion: This is the first study describing the clinical characteristics of ACO patients in Australian general practices. Our finding of lower pre-bronchodilator lung function in the ACO group compared to those with COPD reinforces the importance of spirometry in primary care to inform management. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12614001155684.