A novel, multidomain, primary care nurse-led and mHealth-assisted intervention for dementia risk reduction in middle-aged adults (HAPPI MIND): study protocol for a cluster randomised controlled trial.

INTRODUCTION: Middle-aged multidomain risk reduction interventions targeting modifiable risk factors for dementia may delay or prevent a third of dementia cases in later life. We describe the protocol of a cluster randomised controlled trial (cRCT), HAPPI MIND (Holistic Approach in Primary care for PreventIng Memory Impairment aNd Dementia). HAPPI MIND will evaluate the efficacy of a multidomain, nurse-led, mHealth supported intervention for assessing dementia risk and reducing associated risk factors in middle-aged adults in the Australian primary care setting. METHODS AND ANALYSIS: General practice clinics (n≥26) across Victoria and New South Wales, Australia, will be recruited and randomised. Practice nurses will be trained to implement the HAPPI MIND intervention or a brief intervention. Patients of participating practices aged 45-65 years with ≥2 potential dementia risk factors will be identified and recruited (approximately 15 patients/clinic). Brief intervention participants receive a personalised report outlining their risk factors for dementia based on Australian National University Alzheimer's Disease Risk Index (ANU-ADRI) scores, education booklet and referral to their general practitioner as appropriate. HAPPI MIND participants receive the brief intervention as well as six individualised dementia risk reduction sessions with a nurse trained in motivational interviewing and principles of behaviour change, a personalised risk reduction action plan and access to the purpose-built HAPPI MIND smartphone app for risk factor self-management. Follow-up data collection will occur at 12, 24 and 36 months. Primary outcome is ANU-ADRI score change at 12 months from baseline. Secondary outcomes include change in cognition, quality of life and individual risk factors of dementia. ETHICS AND DISSEMINATION: Project approved by Monash University Human Research Ethics Committee (ID: 28273). Results will be disseminated in peer-reviewed journals and at healthcare conferences. If effective in reducing dementia risk, the HAPPI MIND intervention could be integrated into primary care, scaled up nationally and sustained over time. TRIAL REGISTRATION NUMBER: ACTRN12621001168842.

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.

Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable health condition. COPD is associated with substantial burden on morbidity, mortality and healthcare resources. OBJECTIVES: To review existing evidence for educational interventions delivered to health professionals managing COPD in the primary care setting. SEARCH METHODS: We searched the Cochrane Airways Trials Register from inception to May 2021. The Register includes records from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Allied and Complementary Medicine Database (AMED) and PsycINFO. We also searched online trial registries and reference lists of included studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and cluster-RCTs. Eligible studies tested educational interventions aimed at any health professionals involved in the management of COPD in primary care. Educational interventions were defined as interventions aimed at upskilling, improving or refreshing existing knowledge of health professionals in the diagnosis and management of COPD. DATA COLLECTION AND ANALYSIS: Two review authors independently reviewed abstracts and full texts of eligible studies, extracted data and assessed the risk of bias of included studies. We conducted meta-analyses where possible and used random-effects models to yield summary estimates of effect (mean differences (MDs) with 95% confidence intervals (CIs)). We performed narrative synthesis when meta-analysis was not possible. We assessed the overall certainty of evidence for each outcome using Grades of Recommendation, Assessment, Development and Evaluation (GRADE). Primary outcomes were: 1) proportion of COPD diagnoses confirmed with spirometry; 2) proportion of patients with COPD referred to, participating in or completing pulmonary rehabilitation; and 3) proportion of patients with COPD prescribed respiratory medication consistent with guideline recommendations. MAIN RESULTS: We identified 38 studies(22 cluster-RCTs and 16 RCTs) involving 4936 health professionals (reported in 19/38 studies) and 71,085 patient participants (reported in 25/38 studies). Thirty-six included studies evaluated interventions versus usual care; seven studies also reported a comparison between two or more interventions as part of a three- to five-arm RCT design. A range of simple to complex interventions were used across the studies, with common intervention features including education provided to health professionals via training sessions, workshops or online modules (31 studies), provision of practice support tools, tool kits and/or algorithms (10 studies), provision of guidelines (nine studies) and training on spirometry (five studies). Health professionals targeted by the interventions were most commonly general practitioners alone (20 studies) or in combination with nurses or allied health professionals (eight studies), and the majority of studies were conducted in general practice clinics. We identified performance bias as high risk for 33 studies. We also noted risk of selection, detection, attrition and reporting biases, although to a varying extent across studies. The evidence of efficacy was equivocal for all the three primary endpoints evaluated: 1) proportion of COPD diagnoses confirmed with spirometry (of the four studies that reported this outcome, two supported the intervention); 2) proportion of patients with COPD who are referred to, participate in or complete pulmonary rehabilitation (of the four studies that reported this outcome, two supported the intervention); and 3) proportion of patients with COPD prescribed respiratory medications consistent with guideline recommendations (12 studies reported this outcome, the majority evaluated multiple drug classes and reported a mixed effect). Additionally, the low quality of evidence and potential risk of bias make the interpretation more difficult. Moderate-quality evidence (downgraded due to risk of bias concerns) suggests that educational interventions for health professionals probably improve the proportion of patients with COPD vaccinated against influenza (three studies) and probably have little impact on the proportion of patients vaccinated against pneumococcal infection (two studies). Low-quality evidence suggests that educational interventions for health professionals may have little or no impact on the frequency of COPD exacerbations (10 studies). There was a high degree of heterogeneity in the reporting of health-related quality of life (HRQoL). Low-quality evidence suggests that educational interventions for health professionals may have little or no impact on HRQoL overall, and when using the COPD-specific HRQoL instrument, the St George's Respiratory Questionnaire (at six months MD 0.87, 95% CI -2.51 to 4.26; 2 studies, 406 participants, and at 12 months MD -0.43, 95% CI -1.52 to 0.67, 4 studies, 1646 participants; reduction in score indicates better health). Moderate-quality evidence suggests that educational interventions for health professionals may improve patient satisfaction with care (one study). We identified no studies that reported adverse outcomes. AUTHORS' CONCLUSIONS: The evidence of efficacy was equivocal for educational interventions for health professionals in primary care on the proportion of COPD diagnoses confirmed with spirometry, the proportion of patients with COPD who participate in pulmonary rehabilitation, and the proportion of patients prescribed guideline-recommended COPD respiratory medications. Educational interventions for health professionals may improve influenza vaccination rates among patients with COPD and patient satisfaction with care. The quality of evidence for most outcomes was low or very low due to heterogeneity and methodological limitations of the studies included in the review, which means that there is uncertainty about the benefits of any currently published educational interventions for healthcare professionals to improve COPD management in primary care. Further well-designed RCTs are needed to investigate the effects of educational interventions delivered to health professionals managing COPD in the primary care setting.

Diagnosing COPD and supporting smoking cessation in general practice: evidence-practice gaps.

OBJECTIVES: To review the accuracy of diagnoses of chronic obstructive pulmonary disease (COPD) in primary care in Australia, and to describe smokers' experiences with and preferences for smoking cessation. DESIGN, SETTING AND PARTICIPANTS: Patients were invited to participate if they were at least 40 years old and had visited participating general practice clinics in Melbourne at least twice during the previous 12 months, reported being current or ex-smokers with a smoking history of at least 10 pack-years, or were being managed for COPD. Interviews based on a structured questionnaire and case finding (FEV1/FEV6 measurement) were followed, when appropriate, by spirometry testing and assessment of health-related quality of life, dyspnoea and symptoms. RESULTS: 1050 patients attended baseline interviews (February 2015 - April 2017) at 41 practices. Of 245 participants managed for COPD, 130 (53.1%) met the spirometry-based definition (post-bronchodilator FEV1/FVC < 0.7) or had a clinical correlation; in 37% of cases COPD was not confirmed, and no definitive result was obtained for 9.8% of patients. Case finding and subsequent spirometry testing identified 142 new COPD cases (17.6% of participants without prior diagnosis; 95% CI, 15.1-20.5%). 690 participants (65.7%) were current smokers, of whom 360 had attempted quitting during the previous 12 months; 286 (81.0% of those attempting to quit) reported difficulties during previous quit attempts. Nicotine replacement therapy (205, 57.4%) and varenicline (110, 30.8%) were the most frequently employed pharmacological treatments; side effects were common. Hypnotherapy was the most popular non-pharmacological option (62 smokers, 17%); e-cigarettes were tried by 38 (11%). 187 current smokers (27.6%) would consider using e-cigarettes in future attempts to quit. CONCLUSIONS: COPD was both misdiagnosed and missed. Case finding and effective use of spirometry testing could improve diagnosis. Side effects of smoking cessation medications and difficulties during attempts to quit smoking are common. Health professionals should emphasise evidence-based treatments, and closely monitor quitting difficulties and side effects of cessation aids. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614001155684.

Asthma, bones and corticosteroids: Are inhaled corticosteroids associated with fractures in children with asthma?

AIM: The prevalence of asthma worldwide among older children varies between 10 and 20%. One of the most effective therapies to treat asthma and prevent exacerbations is inhaled corticosteroids (ICSs). Systemic corticosteroids are known to decrease bone mineral density and increase the risk of fractures among children, but little is known about the effect of ICSs on fracture risk in children with asthma. The aim of this study was to investigate the fracture rates in children with asthma using ICSs. METHODS: A survey on fracture history and risk, bone health and asthma was administered by a researcher to children aged 6-18 years attending a tertiary care children's hospital in Melbourne, Australia over a 6-month period. Fracture risks were compared in children on low or high dose ICS with those not on any ICS and non-asthmatics. RESULTS: A total of 216 healthy control participants were compared with 211 children with asthma - 22% (n = 46) on low dose ICS therapy, 44% (n = 94) on high dose ICS and 34% (n = 71) not on any ICS. There was no difference in the incidence of fractures between children with asthma (24.6% n = 53) and healthy controls (24% n = 51) (χ2 = 0.132; P = 0.717). There were no differences in fracture incidence in the sub-groups of children with asthma (P = 0.695). CONCLUSION: ICS use was not associated with fracture risk in children with asthma.

Improving osteoporosis management in general practice: a pharmacist-led drug use evaluation program.

OBJECTIVE: The aim of the study was to evaluate the impact of a drug use evaluation (DUE) program on osteoporosis management in general practice. METHODS: A DUE program, led by pharmacists integrated into two general practice clinics in Melbourne, Australia, was undertaken as part of the Pharmacists in Practice Study. Data on use of anti-osteoporosis medicines and calcium and vitamin D supplements were collected at baseline and 12 months. Following the baseline audit, an intervention comprising prescriber feedback, group education and individual case-conferences with prescribers, and patient education mail-outs was implemented. The primary outcome was the proportion of patients with a diagnosis of osteoporosis and without contraindications to anti-osteoporosis medicines who were prescribed an anti-osteoporosis medicine. Feedback from practice staff and pharmacists was explored qualitatively to evaluate the acceptability of the program. RESULTS: The proportion of patients without documented contraindications to osteoporosis therapies who were prescribed an anti-osteoporosis medicine increased significantly (134/227 [59.0 %] vs. 168/240 [70.0 %], p = 0.002). The proportion of patients for whom vitamin D and/or calcium supplement use was documented also increased significantly (145/227 [63.9 %] vs. 205/240 [85.4 %], p = 0.002). Practice staff and pharmacists were generally positive about the DUE program. CONCLUSIONS: A practice pharmacist-led DUE program improved the management of osteoporosis in general practice.

Engaging community pharmacists in the primary prevention of cardiovascular disease: protocol for the Pharmacist Assessment of Adherence, Risk and Treatment in Cardiovascular Disease (PAART CVD) pilot study.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death globally. Community pharmacist intervention studies have demonstrated clinical effectiveness for improving several leading individual CVD risk factors. Primary prevention strategies increasingly emphasise the need for consideration of overall cardiovascular risk and concurrent management of multiple risk factors. It is therefore important to demonstrate the feasibility of multiple risk factor management by community pharmacists to ensure continued currency of their role. METHODS/DESIGN: This study will be a longitudinal pre- and post-test pilot study with a single cohort of up to 100 patients in ten pharmacies. Patients aged 50-74 years with no history of heart disease or diabetes, and taking antihypertensive or lipid-lowering medicines, will be approached for participation. Assessment of cardiovascular risk, medicines use and health behaviours will be undertaken by a research assistant at baseline and following the intervention (6 months). Validated interview scales will be used where available. Baseline data will be used by accredited medicines management pharmacists to generate a report for the treating community pharmacist. This report will highlight individual patients' overall CVD risk and individual risk factors, as well as identifying modifiable health behaviours for risk improvement and suggesting treatment and behavioural goals. The treating community pharmacist will use this information to finalise and implement a treatment plan in conjunction with the patient and their doctor. Community pharmacists will facilitate patient improvements in lifestyle, medicines adherence, and medicines management over the course of five counselling sessions with monthly intervals. The primary outcome will be the change to average overall cardiovascular risk, assessed using the Framingham risk equation. DISCUSSION: This study will assess the feasibility of implementing holistic primary CVD prevention programs into community pharmacy, one of the most accessible health services in most developed countries. TRIAL REGISTRATION: Australia and New Zealand Clinical Trial Registry Number: ACTRN12609000677202.

Factors associated with medication nonadherence in patients with COPD.

STUDY OBJECTIVES: To identify the predictors of medication adherence in patients with COPD and contrast the health beliefs, experiences, and behaviors of COPD patients self-reporting good adherence with those of patients reporting suboptimal adherence to their medications. DESIGN: Cross-sectional self-administered questionnaire. SETTING: Ambulatory care. PARTICIPANTS: Patients with chronic respiratory ailments identified through respiratory support groups and from a pulmonary rehabilitation database. MEASUREMENTS AND RESULTS: A 30-item questionnaire comprising items pertaining to health beliefs, experiences, and behaviors along with a valid self-reported measure of adherence-the medication adherence report scale (MARS)-was administered to 525 ambulatory patients with chronic lung conditions. A total of 276 usable responses were received (52.6%). The mean age of the respondents was 71 years, and there were slightly more male patients (54.4%). COPD was the underlying disease condition in 90.6% of the respondents; two thirds of the respondents had comorbid conditions. The respiratory condition was managed by both general practitioners and respiratory specialists in 61.2% of cases. One third of the respondents self-reported complementary and alternative medicine use. The mean score (+/- SD) on the MARS among the respondents was 23.37 +/- 2.09. One hundred two patients self-reported perfect adherence on the MARS. Differences in knowledge about the illness and treatment, faith in and satisfaction with the treatment and doctors, concerns about the treatment, and intentional and unintentional deviations from the recommended treatment were detected between the adherent and less adherent groups. In multivariate analysis, "I vary my recommended management based on how I am feeling" and "I get confused about my medications" were found to be significant independent predictors of nonadherence. CONCLUSIONS: Patients' acceptance of the disease process and recommended treatment, knowledge about and faith in the treatment, effective patient-clinician interaction, and routinization of drug therapy are critical for optimal medication adherence in patients with COPD.

Use of complementary and alternative medicines by patients with chronic obstructive pulmonary disease.

OBJECTIVES: To investigate complementary and alternative medicine (CAM) use by patients with chronic obstructive pulmonary disease (COPD) and to explore their beliefs about CAM. DESIGN AND PARTICIPANTS: Cross-sectional study of 173 patients with moderate to severe COPD, and in depth interviews with a purposive sample of 28 patients. SETTING: Ambulatory care. MAIN OUTCOME MEASURES: Use of CAM; beliefs about the value of CAM. RESULTS: 71 patients (41%) claimed to be using some form of CAM. Most commonly used were multivitamins and minerals, and garlic was the most commonly used herbal preparation. Patients reported that advertisements and people with prior experience of using CAM were their major sources of information. Extent of knowledge about CAM, degree of faith in CAM and personal attitudes influenced decisions to try CAM. Patients used CAM to promote general wellbeing, to counteract drug side effects, to compensate for dietary deficiencies and to ameliorate their disease. Efficacy appeared less important to users than safety. CAM practitioners were regarded as more convincing, informative, considerate and available compared with mainstream health professionals. CONCLUSIONS: Communication between patients and mainstream health professionals about CAM use could be improved by health professionals being more accepting of CAM use and having some basic knowledge about commonly used CAM preparations.