AIMS:The Black Triangle Scheme, introduced in 2018 in Australia, does not appear to have increased the quantity of adverse drug event (ADE) reports. This study evaluated healthcare professionals' (HCPs') and consumers' awareness of the scheme, its influence on intentions for future ADE reporting, and suggested improvements. METHODS:A mixed-methods study was conducted (August-December 2024) consisting of an online questionnaire and follow-up interviews with HCPs (doctors, pharmacists, nurses) and consumers in Australia. Descriptive and qualitative data analyses were conducted. RESULTS:A total of 405 participants completed the questionnaire (138 HCPs, 267 consumers). Half of the HCPs (52%) and a tenth of the consumers (10%) were aware of the scheme. After viewing the symbol, 66.2% reported being likely or very likely to report an ADE linked to a medicine carrying it. Twenty-one participated in the interviews (11 HCPs, 10 consumers). Interviewees suggested various strategies to improve awareness, including social media, television, posters and printed labels. Most noted that the Black Triangle symbol, in its current form and placement within medicine leaflets, is easy to miss. Once the scheme's purpose was explained, participants described it as "very important" and a "good initiative" to enhance medicine safety. Interview participants expressed mixed views on the scheme's impact on their future ADE reporting. CONCLUSION:Awareness of the scheme was notably lower among consumers than HCPs. Once informed, most participants viewed the scheme favourably and indicated a greater likelihood of reporting. However, issues related to the visibility and meaning of the Black Triangle symbol were raised.

BackgroundAdverse medicine events (AMEs) are unintended effects that occur following administration of medicines. Up to 70% of AMEs are not reported to, and hence remain undetected by, health care professionals and only 6% of AMEs are reported to regulators. Increased reporting by consumers, health care professionals, and pharmaceutical companies to medicine regulatory authorities is needed to increase the safety of medicines. ObjectiveWe describe a project that aims to co-design a digital reporting platform to improve detection and management of AMEs by consumers and health care professionals and improve reporting to regulators. MethodsThe project will be conducted in 3 phases and uses a co-design methodology that prioritizes equity in designing with stakeholders. Our project is guided by the Consolidated Framework for Implementation Research. In phase 1, we will engage with 3 stakeholder groups—consumers, health care professionals, and regulators—to define digital platform development standards. We will conduct a series of individual interviews, focus group discussions, and co-design workshops with the stakeholder groups. In phase 2, we will work with a software developer and user interaction design experts to prototype, test, and develop the digital reporting platform based on findings from phase 1. In phase 3, we will implement and trial the digital reporting platform in South Australia through general practices and pharmacies. Consumers who have recently started using medicines new to them will be recruited to use the digital reporting platform to report any apparent, suspected, or possible AMEs since starting the new medicine. Process and outcome evaluations will be conducted to assess the implementation process and to determine whether the new platform has increased AME detection and reporting. ResultsThis project, initiated in 2023, will run until 2026. Phase 1 will result in persona profiles and user journey maps that define the standards for the user-friendly platform and interactive data visualization tool or dashboard that will be developed and further improved in phase 2. Finally, phase 3 will provide insights of the implemented platform regarding its impact on AME detection, management, and reporting. Findings will be published progressively as we complete the different phases of the project. ConclusionsThis project adopts a co-design methodology to develop a new digital reporting platform for AME detection and reporting, considering the perspectives and lived experience of stakeholders and addressing their requirements throughout the entire process. The overarching goal of the project is to leverage the potential of both consumers and technology to address the existing challenges of underdetection and underreporting of AMEs to health care professionals and regulators. The project potentially will improve individual patient safety and generate new data for regulatory purposes related to medicine safety and effectiveness. International Registered Report Identifier (IRRID)DERR1-10.2196/60084

Background In Australia, motor vehicle crashes (MVC)-related health data are available from insurance claims and hospitals but not from primary care settings. This study aimed to identify the frequency of MVC-related consultations in Australian general practices, explore the pharmacological management of health conditions related to those crashes, and investigate general practitioners' (GPs) perceived barriers and enablers in managing these patients.Methods Mixed-methods study. The quantitative component explored annual MVC-related consultation rates over seven years, the frequency of chronic pain, depression, anxiety or sleep issues after MVC, and management with opioids, antidepressants, anxiolytics or sedatives in a sample of 1,438,864 patients aged 16 + years attending 402 Australian general practices (MedicineInsight). Subsequently, we used content analysis of 81 GPs' qualitative responses to an online survey that included some of our quantitative findings to explore their experiences and attitudes to managing patients after MVC.Results MVC-related consultation rates remained stable between 2012 and 2018 at around 9.0 per 10,000 consultations. In 2017/2018 compared to their peers, those experiencing a MVC had a higher frequency of chronic pain (48% vs. 26%), depression/anxiety (20% vs. 13%) and sleep issues (7% vs. 4%). In general, medications were prescribed more after MVC. Opioid prescribing was much higher among patients after MVC than their peers, whether they consulted for chronic pain (23.8% 95%CI 21.6;26.0 vs. 15.2%, 95%CI 14.5;15.8 in 2017/2018, respectively) or not (15.8%, 95%CI 13.9;17.6 vs. 6.7%, 95% CI 6.4;7.0 in 2017/2018). Qualitative analyses identified a lack of guidelines, local referral pathways and decision frameworks as critical barriers for GPs to manage patients after MVC. GPs also expressed interest in having better access to management tools for specific MVC-related consequences (e.g., whiplash/seatbelt injuries, acute/chronic pain management, mental health issues).Conclusion Chronic pain, mental health issues and the prescription of opioids were more frequent among patients experiencing MVC. This reinforces the relevance of appropriate management to limit the physical and psychological impact of MVC. GPs identified a lack of available resources (e.g. education, checklists and management support tools) for managing MVC-related consequences, and the need for local referral pathways and specific guidelines to escalate treatments.

BACKGROUND:Influenza vaccination is recommended for Australians 18+ years old with medical risk factors, but coverage is suboptimal. We aimed to examine whether automatic, opportunistic patient reminders (SMS and/or printed) before appointments with a general practitioner increased influenza vaccination uptake. METHODS:This clustered non-randomised feasibility study in Australian general practice included patients aged 18-64 years with at least one medical risk factor attending participating practices between May and September 2021. Software installed at intervention practices identified unvaccinated eligible patients when they booked an appointment, sent vaccination reminders (SMS on booking and 1 h before appointments), and printed automatic reminders on arrival. Control practices provided usual care. Clustered analyses adjusted for sociodemographic differences among practices were performed using logistic regression. RESULTS:A total of 12,786 at-risk adults attended 16 intervention practices (received reminders = 4066; 'internal control' receiving usual care = 8720), and 5082 individuals attended eight control practices. Baseline influenza vaccination uptake (2020) was similar in intervention and control practices (∼34%). After the intervention, uptake was similar in all groups (control practices = 29.3%; internal control = 30.0%; intervention = 31.6% (p-value = 0.203). However, SMS 1 h before appointments increased vaccination coverage (39.3%, adjusted OR = 1.65; 95%CI 1.20;2.27; number necessary to treat = 13), especially when combined with other reminder forms. That effect was more evident among adults with chronic respiratory, rheumatologic, or inflammatory bowel disease. CONCLUSION:These findings indicate that automated SMS reminders delivered at proximate times to appointments are a low-cost strategy to increase influenza vaccination among adults at higher risk of severe disease attending Australian general practices.

BACKGROUND:Insomnia and obstructive sleep apnoea are the two most common sleep disorders and frequently co-exist. Patients with comorbid insomnia and sleep apnoea experience worse daytime function, mental health and physical health than patients with either disorder alone. General practitioners may face unique challenges in the assessment and management of this prevalent and debilitating condition.OBJECTIVE:This article aims to provide an overview of the prevalence, consequences, assessment and management of patients with comorbid insomnia and sleep apnoea in Australian general practice.DISCUSSION:Patients with either insomnia or sleep apnoea should be assessed for both conditions. Treatments for both disorders should be offered to patients with both conditions. The recommended treatment for insomnia is cognitive behavioural therapy, whereas the recommended first-line treatment for moderate and severe obstructive sleep apnoea is lifestyle/weight management advice (where relevant) and continuous positive airway pressure therapy.

ISSUE ADDRESSED:While the links between sun exposure and skin cancer are well known, the benefits of sun exposure, particularly as a source of vitamin D, are less well known. This paper reports on a deliberative study exploring public perspectives about sun exposure harms and benefits. METHODS:Two citizens' juries were conducted in Brisbane and Adelaide to consider questions about sun exposure, vitamin D and health promotion. Members of the general population (jurors) listened to evidence from expert witnesses about the harms and benefits of sun exposure. Most witness sessions extended for 60 min, with 6 sessions over 2 days. At each citizens' jury, jurors were asked to listen to expert testimony, consider the evidence and make policy recommendations. The planning and design of the citizens' juries were informed by well-established citizens' jury methods. RESULTS:Jurors proposed that Australia needs improved public information about the harms and benefits of sun exposure. They argued for information that supports personal decision-making that accounts for differences in skin tone and geographical region. Jurors agreed that Australia needs an updated sun safety campaign that reflects new research and addresses diversity. A one-size-fits-all approach to sun protection may no longer be appropriate. CONCLUSIONS:While a new campaign should address both harms and benefits, jurors felt the need for skin cancer prevention outweighs the desirability of generating vitamin D through sun exposure. More nuanced public health messages are needed, which balance the need for skin protection and vitamin D, and acknowledge the diversity of Australia's population. SO WHAT?: Previous research studies are typically siloed into the separate areas of vitamin D or skin cancer research. This study incorporated both topics and pooled the views of participants in two citizens' juries who agreed on the need for improved information about the harms and benefits of sun exposure to reflect a modern Australian population.

Tinnitus is among the top three most frequently accepted service-related conditions for Australian veterans. Veterans have described the effects of tinnitus as causing physical, emotional and social problems. In addition, many veterans with tinnitus, especially those with troublesome tinnitus, have other health conditions, such as hearing loss, insomnia, anxiety and depression. Research suggests tinnitus develops due to maladaptive neural changes in auditory and non-auditory pathways. This is thought to be due to actual or potential physical or psychological trauma. Hence, treatments focusing on physical and psychological factors, including emotional, attentional, behavioural and social aspects, obtain the best outcomes in reducing tinnitus-related distress. The most promising therapy to address these factors is cognitive behavioural therapy, particularly in a multidisciplinary setting, for which robust evidence exists.

Despite the importance of prevention in general practice, electronic clinical record systems used in Australian general practice do not present a comprehensive overview of each patient's preventive care status to general practitioners or patients. Data relevant to prevention is scattered between different parts of the patient's record. On-screen reminders to general practitioners are simplistic and easily overlooked, and no reminders are sent automatically to patients. There is no structured means to note a patient's refusal or ineligibility for a particular preventive activity. Electronic clinical record systems should be enhanced to allow patients to be invited automatically, at appropriate times, to review and respond to comprehensive information and advice about preventive care that is recommended for them. Users of electronic clinical record systems will need to lobby their software vendors to have the proposed enhancements made.

Objectives To evaluate a multifaceted intervention on diet, physical activity and health literacy of overweight and obese patients attending primary care. Design A pragmatic two-arm cluster randomised controlled trial. Setting Urban general practices in lower socioeconomic areas in Sydney and Adelaide. Participants We aimed to recruit 800 patients in each arm. Baseline assessment was completed by 215 patients (120 intervention and 95 control). Intervention A practice nurse-led preventive health check, a mobile application and telephone coaching. Primary and secondary outcome measures Primary outcomes were measured at baseline, 6 and 12 months, and included patient health and eHealth literacy, weight, waist circumference and blood pressure. Secondary outcomes included changes in diet and physical activity, preventive advice and referral, blood lipids, quality of life and costs. Univariate and multivariate analyses of difference-in-differences (DiD) estimates for each outcome were conducted. Results At 6 months, the intervention group, compared with the control group, demonstrated a greater increase in Health Literacy Questionnaire domain 8 score (ability to find good health information; mean DiD 0.22; 95% CI 0.01 to 0.44). There were similar differences for domain 9 score (understanding health information well enough to know what to do) among patients below the median at baseline. Differences were reduced and non-statistically significant at 12 months. There was a small improvement in diet scores at 6 months (DiD 0.78 (0.10 to 1.47); p=0.026) but not at 12 months. There were no differences in eHealth literacy, physical activity scores, body mass index, weight, waist circumference or blood pressure. Conclusions Targeted recruitment and engagement were challenging in this population. While the intervention was associated with some improvements in health literacy and diet, substantial differences in other outcomes were not observed. More intensive interventions and using codesign strategies to engage the practices earlier may produce a different result. Codesign may also be valuable when targeting lower socioeconomic populations. Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN 12617001508369) (http://www.ANZCTR.org.au/ACTRN12617001508369.aspx). Trial protocol The protocol for this trial has been published (open access; https://bmjopen.bmj.com/content/8/6/e023239).

The important first step in the critical appraisal of a randomised trial is not an evaluation of the statistical analyses. The most important aspect to consider when reviewing a study of a new drug is the appropriateness and quality of the trial design and methods The next most important aspect is the effect size of different treatments and its clinical significance. Rather than reporting statistical significance, studies should report the difference between treatments and its precision Over-reliance on statistical significance and p values may lead to incorrect conclusions. Trial reports about drugs should therefore avoid the term statistical significance and quote p values with caution.

Background Insomnia is a prevalent and debilitating disorder commonly managed by family physicians. Insomnia guidelines recommend cognitive behavioral therapy for insomnia (CBTi) as the 'first-line' treatment. However, family physicians report limited time, knowledge, access, support, and referral options to manage patients with CBTi. Consequently, many patients with insomnia are prescribed potentially harmful and addictive sedative-hypnotic medicines (e.g. benzodiazepines). Family physicians require an insomnia management pathway that is specifically tailored to the guideline-recommendations, time demands, and capacity of family practice. Methods This mixed-methods implementation trial will test the feasibility, acceptability and effectiveness of a comprehensive digital insomnia management pathway in family practice. This novel pathway includes digital recruitment of family physicians, automatic identification of patients whose electronic medical records contain recent sedative-hypnotic prescriptions using a software management pathway and real-time notifications prompting physicians to refer patients to a well-established digital CBTi program. At least 10 family physicians and 375 patients with insomnia will be recruited. Physicians will be provided with an eBook to guide gradual sedative-hypnotic withdrawal. Feasibility and acceptability will be assessed from the perspective of patients and physicians. Effectiveness will be determined by co-primary outcomes: cessation of sedative-hypnotic use, and improvement in self-reported insomnia symptoms from baseline to 12-month follow-up. Analysis of trends in costs, cost-effectiveness and cost-utility analyses will be conducted from a societal perspective. Results and discussion This implementation trial will pave the way for future scaling-up of this insomnia management pathway to improve access to CBTi and reduce reliance on sedative-hypnotic medicines in family practice. Trial Registration: This trial was prospectively registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12619001539123).

INTRODUCTION An understanding of contextual factors that influence whether general practitioners advise their patients to be screened for colorectal cancer (CRC) might guide interventions to increase screening participation from its persistently low rate. We report on the use of a theory-based tool to explore contextual factors that might influence implementation of a novel quality improvement (QI) intervention to increase CRC screening in general practice (CRC-QI). The objective was to identify and incorporate strategies into the intervention that will enable flexible implementation across different practice settings. STUDY TYPE A qualitative study to explore contextual facilitators of, and barriers to, the implementation of a novel CRC-QI intervention. METHODS Eighteen staff, from three self-nominated general practices, participated in focus group discussions. The Consolidated Framework for Implementation Research (CFIR), which included constructs relevant to CRC screening in primary care, guided the formative evaluation. Findings were aligned to the CFIR model using a deductive thematic analysis. RESULTS Contextual facilitators of, and barriers to, the implementation of the CRC-QI intervention were identified in each CFIR domain and CRC-relevant construct. Five consistent themes were identified that potentially influence elements of the CRC-QI intervention: priority setting and incentives, information technology, patient-level barriers, clinical practice, and the National Bowel Cancer Screening Program (NBCSP). Participants proposed that incentive payments and NBCSP policy changes (outer-setting strategies) would facilitate organisational change (inner-setting strategies) and the effective implementation of the CRC-QI intervention. CONCLUSION There may be an opportunity to better engage general practice in CRC screening via outer-setting constructs that support existing clinical practice. For example, improvements to the National Cancer Screening Register and Quality Improvement Incentive - Practice Incentives Program (PIP) could be made without altering the NBCSP design.

Objectives To evaluate the impact of a patient-specific national programme targeting older Australians and health professionals that aimed to increase use of emollient moisturisers to reduce to the risk of skin tears. Design A prospective cohort intervention. Participants The intervention targeted 52 778 Australian Government's Department of Veterans' Affairs patients aged over 64 years who had risk factors for wound development, and their general practitioners (GPs) (n=14 178). Outcome measures An interrupted time series model compared the rate of dispensing of emollients in the targeted cohort before and up to 23 months after the intervention. Commitment questions were included in self-report forms. Results In the first month after the intervention, the rate of claims increased 6.3-fold (95% CI: 5.2 to 7.6, p<0.001) to 10 emollient dispensings per 1000 patients in the first month after the intervention. Overall, the intervention resulted in 10 905 additional patient-months of treatment. The increased rate of dispensing among patients who committed to talking to their GP about using an emollient was six times higher (rate ratio: 6.2, 95% CI: 4.4 to 8.7) than comparison groups. Conclusions The intervention had a sustained effect over 23 months. Veterans who responded positively to commitment questions had higher uptake of emollients than those who did not.

BACKGROUND:Understanding factors causing variation in family physicians/general practitioners (GPs) screening knowledge, understanding and support of organised population-based colorectal cancer (CRC) programs can direct interventions that maximise the influence of a CRC screening recommendation from a GP. This study aims to assess contextual factors that influence knowledge and quality improvement (QI) practice directed to CRC screening in Australian general practice.METHODS:A convenience sample of anonymous general practice staff from all Australian states and territories completed a web-based survey. Multivariate analyses assessed the association between CRC screening knowledge and QI-CRC practice scores and patient, organisational and environmental-level contextual factors.  Results: Of 1,013 survey starts, 918 respondents (90.6%) completed the survey. Respondents less likely to recommend FOBT screening had lower knowledge and QI practice scores directed to CRC screening. Controlling for individual and practice characteristics, respondents' rating of the Australian National Bowel Cancer Screening Program (NBCSP) support for preventive care, attending external education, and sufficient practice resources to implement QI practice (generally) were the strongest factors associated with QI practice directed towards CRC screening. Knowledge scores were less amenable to the influence of contextual factors explored.CONCLUSION:More active engagement of family medicine/general practice to improve screening promotion could be achieved through better QI resourcing without changing the fundamental design of population-based CRC screening programs.

BACKGROUND:Colorectal cancer (CRC) is rising in incidence in young adults, and this observation is currently unexplained. We investigated whether having a personal history of type 2 diabetes mellitus (T2D) was a potential risk factor for young-onset colorectal cancer (YOCRC).METHODS:The South Australian Young Onset (SAYO) CRC study is a series of young adults with CRC below age 55. Ninety unrelated YOCRC cases were recruited to the study. Personal history and detailed family history of T2D were obtained at face-to-face interview and confirmed from medical records. Whole exome sequencing was conducted on germline DNA from each CRC case. Controls for personal history studies of T2D were 240 patients with proven clear colonoscopies and no known CRC predispositions.RESULTS:The median age of YOCRC cases was 44 years (18-54) and of controls was 45 years (18-54), and 53% of both cases and controls were females (P = 0.99). Left-sided (distal) CRC was seen in 67/89 (75%) of cases. A personal history of T2D was confirmed in 17/90 (19%) YOCRC patients compared with controls (12/240, 5%; P < 0.001; odds ratio = 4.4; 95% confidence interval, 2.0-9.7). YOCRC patients frequently reported at least one first-degree relative with T2D (32/85, 38%). Ten of 87 (12%) of YOCRC cases had CRC-related pathogenic germline variants, however, no pathogenic variants in familial diabetes-associated genes were seen.CONCLUSIONS:Though the mechanism remains unclear, our observations suggest that there is enrichment for personal history of T2D in YOCRC patients.IMPACT:A diagnosis of T2D could therefore potentially identify a subset of young adults at increased risk for CRC and in whom early screening might be appropriate.

Primary health care (PHC) plays a vital support role in organised colorectal cancer (CRC) screening programs by encouraging patient participation and ensuring timely referral for diagnostic assessment follow up. A systematic scoping review of the current evidence was conducted to inform strategies that better engage the PHC sector in organised CRC screening programs. Articles published from 2005 to November 2019 were searched across five databases. Evidence was synthesised and interventions that specifically require PHC involvement were mapped to stages of the CRC screening pathway. Fifty-seven unique studies were identified in which patient, provider and system-level interventions align with defined stages of the CRC screening pathway: namely, identifying/reminding patients who have not responded to CRC screening (non-adherence) (n=46) and follow up of a positive screen referral (n=11). Self-management support initiatives (patient level) and improvement initiatives (system level) demonstrate consistent benefits along the CRC screening pathway. Interventions evaluated as part of a quality-improvement process tended to report effectiveness; however, the variation in reporting makes it difficult to determine which elements contributed to the overall study outcomes. To maximise the benefits of population-based screening programs, better integration into existing primary care services can be achieved through targeting preventive and quality care interventions along the entire screening pathway.