Developing, Implementing, and Evaluating the Effectiveness of a Sleep Health Educational Module for Pharmacy Students.

OBJECTIVE: Pharmacists need sleep health knowledge and management skills to deliver evidence-based treatments to patients with sleep disorders/disturbances. This study aimed to develop, implement, and evaluate a pedagogically informed, interactive sleep health educational module for pharmacy students. METHODS: An educational module utilizing a flipped classroom approach, with an interactive lecture, student self-reflection of sleep patterns, case discussions, and pharmacist-patient role-play scenarios, was designed and implemented. A questionnaire assessing pre/post-module changes in knowledge about and attitudes toward sleep health as well as post-module learning satisfaction, was administered to all participating second-year pharmacy students at an Australian university. RESULTS: Mean total knowledge scores for participating students (n = 125, 70.4% female) improved significantly, from a baseline of 11.1 ± 3.8 to 17.1 ± 3.5 post-module (range: 0-25). Attitudes toward sleep health were moderately high at baseline (28.8 ± 3.2) and improved marginally post-module (29.4 ± 3.8) (range: 10-50); however, this increase was insignificant. Participants expressed high satisfaction with the module through subjective feedback, and post-module reflective statements indicated plans for changing sleep behaviors. CONCLUSION: The results of this study have shown that a targeted educational module for pharmacy students improved sleep health knowledge. It appeared that positive attitudes toward sleep health were not significantly increased which may reflect a ceiling effect. Future modules should focus on attitudinal aspects of positive sleep health to enhance pharmacists' skills in providing clinically related sleep health care to patients with sleep disturbance.

Exploring First Nations' and Cultural Safety Content of Pharmacy Curricula With Academics in Australia.

OBJECTIVE: This study aimed to explore academics' views on Aboriginal and/or Torres Strait Islander Health and Cultural Safety content in pharmacy school curricula to inform recommendations for future curricula. METHODS: All 18 Australian pharmacy schools were contacted, and interviews were conducted with consenting heads of school and/or their delegate(s). The interviews covered what the school was doing with respect to the First Nations theme in the revised accreditation standards and further ideas for improvement. Audio recordings of interviews were transcribed verbatim via an online transcription service. Transcripts were thematically analyzed and coded according to the framework approach and mapped to the Aboriginal and Torres Strait Islander Health Curriculum Framework. Coding was facilitated using NVivo software. RESULTS: All 18 schools consented to participate and a total of 22 interviews were conducted. The pharmacy accreditation standards were well known to most educators, however, the dissemination of the Aboriginal and Torres Strait Islander Health Curriculum Framework, introduced in 2014, appeared to be poor. Many interviewees (n = 14) expressed that the current content regarding Aboriginal health and cultural safety/competence was lacking and cited barriers that have led to a lack of development such as a lack of First Nations staff and expertize. CONCLUSION: While cultural safety/competency was taught in all Australian pharmacy schools, it is apparent that pharmacy schools are at various stages in their development of Aboriginal and Torres Strait Islander Health curriculum design and implementation. Future resources should be developed and made available.

Over-the-counter use of short-acting beta-2 agonists: a systematic review.

BACKGROUND: The widespread use of short-acting beta-2 agonists (SABA) as an as-needed treatment for asthma is well-established. However, excessive use of SABA has been linked to undesirable outcomes such as increased risk of asthma attacks, exacerbations, and even death. The availability of SABA as an over-the-counter (OTC) medication has contributed to their overuse, leading to undertreated asthma and reduced access to asthma education. OBJECTIVE: This systematic review aimed to summarize the prevalence, characteristic features of, and factors contributing to over-the-counter SABA purchase or overuse. METHODS: The databases searched included PubMed, Scopus, Springer Link, Google Scholar, CINAHL, and APA PsycArticles. Original research articles reporting the prevalence, characteristics features, and factors regarding over-the-counter SABA use, available as full text, published in English language between the year 2000 and April 2023 were included in this review. Commentaries, letters to editor, review articles, qualitative studies, clinical trials, and conference proceedings were excluded. Data extraction was followed by a review of the quality of studies included and data were then synthesized for meaningful findings. This systematic review had been registered in the PROSPERO with registration number CRD42023421007. RESULTS: A total of 18 articles were included. The prevalence range of OTC SABA users in populations were 1.4% to 39.6% and SABA over-users among OTC users were 14% to 66.4%. Factors mostly associated with this behavior were moderate-severe asthma, and less use of preventers. On top of that, not understanding the risk of SABA overuse was clear in many studies that explored this factor. CONCLUSION: Over-the-counter purchase and overuse of SABA medication is a common problem, leading to adverse consequences such as uncontrolled asthma and increased healthcare utilization. Addressing these issues requires improved patient education about their conditions and adequate information regarding the potential long-term effects of SABA use by the healthcare providers. Management and education of asthma patients, including regular monitoring and follow-up, can help reduce overuse of SABA medication and prevent negative consequences.

The Role of Adult Vaccines as Part of Antimicrobial Stewardship: A Scoping Review.

BACKGROUND: Antimicrobial resistance (AMR) is a significant global health concern, causing an estimated 700,000 deaths annually. Although immunisation has been shown to significantly reduce AMR, the role of vaccines as part of antimicrobial stewardship (AMS) practices is often overlooked. OBJECTIVE: To identify and examine the available literature on the role of vaccines as part of AMS practices. METHOD: A scoping review was conducted in the following databases: MEDLINE, Embase, Scopus, CINAHL, CCRCT, IPA, and WoS, along with grey literature sources. The review was conducted using the JBI Methodology for Scoping Reviews and reported in line with the PRISMA-SCr checklist. RESULTS: Among the 1711 records identified, 34 met the inclusion criteria; 8 discussed only the concept, while 26 discussed both the concept and the vaccine implementation method in AMS practices. There were eight recommended and/or utilised types of AMS activities identified involving vaccines, under four key themes of vaccine-related AMS strategies: Education, Screening, Vaccination, and Monitoring. Influenza and pneumococcal vaccines had the most evidence for inclusion. CONCLUSION: Overall, the evidence supports the role of vaccines as part of AMS practices and the value of their inclusion in creating improved and comprehensive AMS strategies to further combat the development of AMR.

Cannabinol (CBN; 30 and 300 mg) effects on sleep and next-day function in insomnia disorder ('CUPID' study): protocol for a randomised, double-blind, placebo-controlled, cross-over, three-arm, proof-of-concept trial.

OBJECTIVE: Insomnia is the most prevalent sleep disorder, with few effective pharmacotherapies. Anecdotal reports and recent preclinical research suggest that cannabinol (CBN), a constituent of Cannabis sativa derived from delta-9-tetrahydrocannabinol, could be an effective treatment. Despite this, the isolated effects of CBN on sleep have yet to be systematically studied in humans. METHODS: The present protocol paper describes a randomised, double-blind, placebo-controlled, single-dose, three-arm, cross-over, proof-of-concept study which investigates the effects of CBN on sleep and next-day function in 20 participants with clinician-diagnosed insomnia disorder and an Insomnia Severity Index Score ≥15. Participants receive a single fixed oral liquid dose of 30 mg CBN, 300 mg CBN and matched placebo, in random order on three treatment nights; each separated by a 2-week wash-out period. Participants undergo overnight sleep assessment using in-laboratory polysomnography and next-day neurobehavioural function tests. The primary outcome is wake after sleep onset minutes. Secondary outcomes include changes to traditional sleep staging, sleep-onset latency and absolute spectral power during non-rapid eye movement (NREM) sleep. Tertiary outcomes include changes to sleep spindles during NREM sleep, arousal indices, absolute spectral power during REM sleep and subjective sleep quality. Safety-related and exploratory outcomes include changes to next-day simulated driving performance, subjective mood and drug effects, postural sway, alertness and reaction time, overnight memory consolidation, pre and post-sleep subjective and objective sleepiness; and plasma, urinary, and salivary cannabinoid concentrations. The study will provide novel preliminary data on CBN efficacy and safety in insomnia disorder, which will inform larger clinical trials. ETHICS AND DISSEMINATION: Human Research Ethics Committee approval has been granted by Bellberry (2021-08-907). Study findings will be disseminated in a peer-reviewed journal and at academic conferences. TRIAL REGISTRATION NUMBER: NCT05344170.

Perceptions, attitudes, and behaviors of asthma patients towards the use of short-acting ß2-agonists: A systematic review.

BACKGROUND: Short-acting ß2-agonists (SABA), the most potent and rapid-acting relievers are commonly used to provide quick relief of asthma symptoms. However, there is an increasing concern regarding the misuse of SABA medicines. OBJECTIVE: This qualitative systematic review aims to determine, evaluate, and summarize the perceptions, attitudes, and behaviors towards the use of SABA from the patients' perspectives. METHODS: The databases searched included PubMed, Scopus, PsycINFO, CINAHL, and Cochrane database. Original research articles reporting the perceptions, attitudes, or behaviors of asthma patients towards the use of SABA, which was available as full text, published in the English language between the year 2000 and February 2023 were included in the review. Commentaries, letters to editor, review articles, and conference proceedings were excluded. RESULTS: A total of five articles were included. Six overarching themes were obtained: (1) perceptions on health status; (2) perceptions and attitudes towards the impact of asthma; (3) perceptions towards asthma control; (4) perceptions towards asthma knowledge; (5) risk perceptions; (6) perceptions, attitudes, and behaviors towards the use of SABA. CONCLUSION: Despite the fact that SABA could rapidly alleviate asthma symptoms, SABA over-users were less likely to describe their health status and asthma control as 'excellent'. Most SABA over-users did not know that frequent SABA usage would worsen their asthma control, and they exhibited psychological linkage towards the use of SABA. Collaborative efforts between policymakers, healthcare professionals and patients are warranted to reconstruct SABA prescribing practice and usage.

Improving sleep health management in primary care: A potential role for community nurses?

AIMS: To explore community nurses sleep health practices and their perspectives on improving sleep health care provision. DESIGN: An exploratory study utilizing the qualitative description methodology. METHODS: Semi-structured interviews were conducted with community nurses from May 2019 - October 2021. Interviews were audio-recorded, transcribed, and subjected to an inductive thematic analysis using a constructivist-interpretive paradigm. RESULTS: Twenty-three Australian community nurses were interviewed. Participants frequently encountered sleep disturbances/disorders in their patients. Data analysis yielded three main themes: (1) Sleep health in the community serviced, (2) sleep health awareness and management, and (3) community nurses' A to Z of improving sleep health. The most common sleep disorder presentations were insomnia and sleep apnea. Although most community sleep apnea cases were appropriately managed, insomnia was often mismanaged. Participants described their sleep health knowledge as deficient, with the majority advocating for increased sleep-related education tailored to their profession. Other important factors needed for improving sleep health provision were standardized patient treatment/referral pathways, increased interprofessional collaboration, and sufficient time for patient consults. CONCLUSION: Community nurses service a patient population that requires increased sleep health care. However, they are currently underequipped to do so, leading to suboptimal treatment provision. Providing community nurses with the appropriate resources, such as increased sleep-related education and standardized treatment frameworks, could enable them to better manage sleep disturbance/disorder presentations, such as insomnia. IMPACT: Little is known about how community nurses care for patients with sleep disturbance/sleep disorders. This study found that contemporary sleep health care was lacking due to knowledge deficits, competing challenges, and a need for standardized care pathways. These findings can inform the development of targeted education/training and standardized guidelines for community nurses providing sleep health care to patients as well as the design of future practice models of care provision. PATIENT OR PUBLIC CONTRIBUTION: Previous research by authors has involved extensive engagement with patients and health professionals, such as community pharmacists, general practitioners, and naturopaths who play a role in sleep health in the primary health care sector. These previous research projects built a significant understanding of the patient and health practitioner experience and have provided the background to the concept and design of this study.

Healthcare expenditure and its socio-demographic and clinical predictors in Australians with poorly controlled asthma.

INTRODUCTION: Asthma has substantial and increasing health and economic burden worldwide. This study aimed to estimate healthcare expenditure and determine the factors that increase expenditure in Australians with poorly controlled asthma. METHODS: Individuals ≥18 years of age with poorly controlled asthma, as determined by a score ≥1.5 on the Asthma Control Questionnaire, were included in the study. Healthcare utilization costs from medical services and medications were estimated over an average follow-up of 12 months from administratively linked data: the Medicare Benefits Schedule and Pharmaceutical Benefits Scheme. A generalized linear model with gamma distribution and log link was used to predict participants' key baseline characteristics associated with variations in healthcare costs. RESULTS: A total of 341 participants recruited through community pharmacies were included. The mean (standard deviation, SD) age of participants was 56.6 (SD 17.6) years, and approximately 71% were females. The adjusted average monthly healthcare expenditure per participant was $AU386 (95% CI: 336, 436). On top of the average monthly costs, an incremental expenditure was found for each year increase in age ($AU4; 95% CI: 0.78, 7), being unemployed ($AU201; 95% CI: 91, 311), one unit change in worsening quality of life ($AU35; 95% CI: 9, 61) and being diagnosed with depression and anxiety ($AU171; 95% CI: 36, 306). CONCLUSIONS: In a cohort of Australian patients, characterized by poor asthma control and co-morbidities individuals impose substantial economic burden in terms of Medicare funded medical services and medications. Programs addressing strategies to improve the quality of life and manage co-morbid anxiety and depression and encourage asthma patients' engagement in clinically tolerable jobs, may result in significant cost savings to the health system.

Palliative care education in an Australian undergraduate pharmacy curriculum: an exploratory descriptive study.

OBJECTIVES: To examine the self-perceived knowledge, confidence and preparedness of undergraduate pharmacy students to provide palliative care. METHODS: A descriptive exploratory analysis was conducted in 2021 at an Australian university involving final-year pharmacy students (n = 200) who were provided with the opportunity to complete a survey on self-perceived knowledge, confidence and preparedness overall and with respect to a range of graduate capabilities which are essential to provide care in palliative care settings. Key capability areas include: communication, showing empathy, making clinical judgements and self-reflection. This was measured using the Palliative Care Curriculum for Undergraduates Questionnaire which was distributed electronically. Descriptive statistics were undertaken and Mann-Whitney U tests were used to explore any differences in outcomes with respect to factors related to demographics, personal experience and education. Thematic analysis was utilised for qualitative data. KEY FINDINGS: Forty-five percent of the student cohort (n = 89) responded, 70% of whom were female, and the median age for students was 22 years. Median scores (interquartile range) were modest for overall self-perceived knowledge: 5.0 (3.0-5.0), confidence: 4.0 (3.0-5.0) and preparedness: 4.0 (2.5-5.0). Students who had participated in learning about palliative care through clinical placements (n = 25, 28%), self-directed learning activities (n = 18, 20%) or case-/problem-based learning (n = 14, 16%) demonstrated a statistically significant increase in overall preparedness (P = 0.017), confidence with specific capabilities including evidence-based practice (P = 0.013), responding to medication queries (P < 0.05) and managing symptoms other than pain (P = 0.018). CONCLUSIONS: Findings suggest students were confident to manage symptoms and medication-related issues but less confident to address distress or discuss sensitive matters with patients and their families. There may be a need for greater exposure and practical experience in palliative care settings.

A cross-sectional survey exploring the knowledge, experiences and attitudes of Australian pharmacists toward medicinal cannabis.

BACKGROUND: Australian pharmacists currently dispense a wide range of prescription-only cannabis-based medicines. Recent regulatory changes will expand the role of pharmacists, allowing certain low-dose cannabidiol products to be supplied without a prescription in pharmacies. This harmonises Australia with many other countries where cannabidiol products are readily available to consumers. AIM: To examine Australian pharmacists' experience, knowledge and attitudes towards medicinal cannabis and their preparedness to supply over-the-counter low-dose cannabidiol products. METHOD: We conducted a cross-sectional study using a 51-item on-line questionnaire that was informed by previous surveys of health professionals and assessed for face validity. Australian pharmacists were recruited to complete the survey between May and December 2021, primarily through professional pharmacy organisations. Pharmacists were included in the final dataset if they completed the demographic characteristics section and at least one additional section of the questionnaire. Data were analysed using descriptive and relational statistical tests. RESULTS: There were 272 attempts to complete this survey and 217 responses included in the final dataset. Over half of the respondents (60.0%, 130/217) had dispensed at least one medicinal cannabis prescription during their career and 58.5% (127/217) had received at least one medicinal cannabis enquiry in the last fortnight. Only around half (53.9%, 117/217) felt comfortable supplying medicinal cannabis products and fewer (39.3%, 79/201) were confident discussing cannabis-related enquiries. More than half of the respondents (58.7%, 118/201) supported the provision of low-dose cannabidiol products through pharmacies. Two-thirds (67.8%, 80/118) of respondents achieved relatively low scores (< 60%) in the knowledge component of the survey. Most respondents (94.2%, 178/189) endorsed a need for further training in this area. CONCLUSION: Australian pharmacists tended to support medicinal cannabis availability and improved access to low-dose cannabidiol products via pharmacies. However, results highlight a need for improved training and education of pharmacists around cannabis-based medicines.

Armodafinil to reduce the sleepiness related side-effects of sleep restriction therapy being used to treat insomnia disorder: An open label clinical trial pilot study compared with historical controls.

Sleep restriction therapy (SRT) is an effective stand-alone behavioural intervention for insomnia disorder. However, its daytime side effects, particularly sleepiness, may be troubling for patients and/or may be a necessary part of the patient's treatment journey. This pilot trial aims to explore the potential benefit of armodafinil, a wakefulness promoter. Patients were treated with SRT with open label adjunctive armodafinil (150 mg/day). Thirty-three patients from previous studies that have undergone exactly the same SRT intervention acted as controls. The primary outcome measure was the insomnia severity index (ISI), and secondary outcomes were the Epworth sleepiness scale, sleep restriction adherence scale (SRAS), and safety from baseline through to 12 weeks. We recruited 25 patients into the trial. Data for the primary end point (ISI at 12 weeks) was available for 20 of the participants. The baseline insomnia severity index was 20.2 (SD 3.3) and decreased to 9.1 (SE 1.1), with no change, to 10.2 and 11.2 at weeks 6 and 12 respectively (all p > 0.05 compared with baseline). The insomnia severity index values for armodafinil patients were statistically inferior to historical controls at the primary time point of 12 weeks (11.2 vs. 6.7, p < 0.01). Sleep restriction therapy plus armodafinil treatment was associated with frequent minor side effects but was generally safe and acceptable to patients. Sleep restriction therapy was associated with a robust clinical response in the insomnia severity index values for insomnia patients. Based upon historical control data, armodafinil does not appear to have beneficial adjunctive effects in addition to sleep restriction therapy alone.

Patient uptake and outcomes following pharmacist-initiated referrals to general practitioners for asthma review.

Uptake and outcomes of pharmacist-initiated general practitioner (GP) referrals for patients with poorly controlled asthma were investigated. Pharmacists referred at-risk patients for GP assessment. Patients were categorized as action takers (consulted their GP on pharmacist's advice) or action avoiders (did not action the referral). Patient clinical data were compared to explore predictors of uptake and association with health outcomes. In total, 58% of patients (n = 148) received a GP referral, of whom 78% (n = 115) were action takers, and 44% (n = 50) reported changes to their asthma therapy. Patient rurality and more frequent pre-trial GP visits were associated with action takers. Action takers were more likely to have an asthma action plan (P = 0.001) at month 12, and had significantly more GP visits during the trial period (P = 0.034). Patient uptake of pharmacist-initiated GP referrals was high and led to GP review and therapy changes in patients with poorly controlled asthma.

Assessing adherence to medications: Is there a difference between a subjective method and an objective method, or between using them concurrently?

Background: Patients’ adherence to medication can be assessed by several subjective or objective methods. The Global Initiative for Asthma (GINA) has recommended the use of both measures simultaneously. Objective: To assess patients’ adherence to medication using a subjective or an objective method separately, and via using a combination of both methods. As well as identifying the degree of agreement between the two methods. Methods: Participants who met the study inclusion criteria completed the Adherence to Asthma Medication Questionnaire (AAMQ). A retrospective audit was conducted in order to extract pharmacy refill records for the previous twelve months. The patients’ pharmacy refill records were expressed using the Medication Possession Ratio (MPR). Data were analyzed using the Statistical Package for Social Science. The degree of agreement was determined by Cohen’s kappa coefficient (κ). Results: In terms of the difference in the ability of each method to identify non-adherent patients, a higher percentage of non-adherent patients were identified using the self-reported AAMQ (61.4%) compared to the pharmacy refill records (34.3%). When both methods, in combination, were used to assess adherence, the percentage of non-adherent patients was 80.0%, which is higher than each method when used separately. Twenty percent of the patients were considered adherent on both assessment methods, while 15.7% were considered non-adherent via both methods. Consequently, the AAMQ and pharmacy refill records agreed on 35.7% of the patients. The degree of agreement analysis showed a low correlation between the two methods. Conclusion: The combination strategy resulted in a higher percentage of non-adherent patients, compared to using a subjective (the AAMQ) or an objective (the pharmacy refill records) method. The GINA guideline proposition may be supported by the present study’s findings. (AU)

Narcolepsy: Comorbidities, complexities and future directions.

Patients with narcolepsy live with a lifelong sleep-wake disorder, impairing their quality of life, productivity, educational and employment outcomes. Clinicians are becoming aware that a significant aspect of the burden of this disease relates to frequent comorbid conditions, including aspects of the patient's emotional, metabolic, sleep and immune health. This review explores the literature describing the comorbidities seen in patients with narcolepsy, to enhance understanding of these often complex presentations. It hopes to encourage a multidisciplinary approach, to collaborate with patients and a broad clinical team, and to maximise clinical and quality of life outcomes, for those living with narcolepsy.

Development and validation of the Adherence to Asthma Medication Questionnaire (AAMQ).

Background: Adherence to medication is the cornerstone to achieve the best treatment outcome. Pharmacists are healthcare professionals found in a pivotal position to assess asthmatic patients' adherence to medication. A brief, reliable, and valid measure of patients adherence to mediations is useful to enable the pharmacists to deliver that vital service. Objective: To develop a reliable and valid adherence assessment tool for asthmatic patients. Methods: The Adherence to Asthma Medication Questionnaire (AAMQ-13) was developed based on an extensive literature review, followed by applying the Delphi technique, and then it was pilot-tested by 55 patients. The final AAMQ-13 was completed by 213 patients. Psychometric evaluation was assessed including reliability, criterion validity, and construct validity. Results: The AAMQ-13 is a feasible 13-item questionnaire, as it can be completed within an average of two minutes. It has high reliability (Cronbach's alpha= 0.87). Criterion-concurrent validity was established by comparing the AAMQ-13 to the Test of the Adherence to Inhaler (TAI) and the pharmacy refill records. Criterion-convergent validity was established by comparing the AAMQ-13 to the Asthma Control Test (ACT) questionnaire and the Positive Health Behaviors Scale (PHBS). Construct validity was established through AAMQ-13 factor analysis which revealed two factors explaining 51.76% of the total variance. Conclusion: The AAMQ-13 is a reliable and valid questionnaire with several desirable characteristics as it has high reliability, good criterion validity, and strong construct validity. The AAMQ-13 is a suitable questionnaire that can identify non-adherent patients and reveal the reasons behind their non-adherence : Asthma; Adherence to medication; Compliance; Questionnaire; Self-report; Scale; Survey.

Comparing comprehensibility of standard and enhanced prescription medicine labels: a randomized simulation.

OBJECTIVES: The objective of this study is to develop and user-test the comparative effectiveness of two enhanced label designs to improve comprehension of patients with low English proficiency versus a standard label representative of the pharmacist-affixed medicine labels currently used in practice. METHODS: Using a randomized two-group study design, 66 participants from Sydney, Australia were allocated to view a set of standard labels followed by a set of enhanced labels named 'linguistically enhanced labels' or 'linguistically and graphically enhanced labels'. Each set of labels depicted medicine directions of three levels of complexity, which participants viewed consecutively. The 'enhanced labels' incorporated several features documented in the literature as improving understanding of low-health-literate/linguistically compromised individuals such as translated directions in a language the person is more proficient in, numeric presentations of numbers/counts, carriage returns and graphic depiction of directions. A user-testing questionnaire relating to comprehensibility was conducted after each label was viewed. Differences in comprehensibility were assessed using a generalized linear model, Cochran-Mantel-Haenszel test for trend and a chi-square test. KEY FINDINGS: Results indicated significant improvements in comprehensibility with both types of enhanced labels compared with standard labels (P < 0.0001). The 'linguistically and graphically enhanced label' improved comprehensibility of the most complex directions to a greater extent than the 'linguistically enhanced label' (P < 0.0001). CONCLUSIONS: This study has highlighted the scope for improvement of existing pharmacist-affixed prescription medicine labels to ensure better understanding by individuals with low English proficiency. The enhanced labels trialled presented a means with which this may be achieved through the incorporation of key design elements, such as simpler, translated and graphically supported directions.

Rethinking the gold standard - The feasibility of randomized controlled trials within health services effectiveness research.

BACKGROUND: An evidence-based randomized controlled trial for a novel Pharmacy Asthma Service was tested in 3 Australian states. Positive asthma outcomes were achieved after the 12-month intervention, albeit in both the intervention and comparator arms. The current investigation uses a mixed methods approach to 1) qualitatively explore how comparator arm pharmacists implemented the trial protocol and 2) quantitatively examine how this may have impacted patient outcomes in this trial. METHODS: Post-intervention semi-structured qualitative interviews were conducted with 20 pharmacists, representing 21 of 37 (57%) comparator arm pharmacies that completed the trial. Based on these interviews, pharmacies were classified as 'adherent' to the trial protocol (reporting no interventions other than general practitioner referral) or 'non-adherent' (reporting at least one extra intervention to the trial protocol), or 'inconclusive'. These subgroups were compared descriptively in relation to patient outcomes. RESULTS: Overall, 33% (n = 8/24) of the comparator pharmacies who were interviewed (n = 21) or determined to have monitoring by a project officer to ensure adherence to the protocol (n = 3) were classified as adherent), 58% (n = 14/24) as non-adherent, 8% inconclusive (n = 2/24). While all patients commenced with uncontrolled asthma (Asthma Control Questionnaire score (ACQ) > 1.5), after 12 months the mean ACQ score for patients from adherent comparator pharmacies ('true control') was 1.8 (still uncontrolled asthma) compared to a score of 1.4 (controlled asthma) in the non-adherent comparator group. Quality of life significantly improved in the non-adherent comparator group over the 12 months of the trial. CONCLUSION: The majority of pharmacists in the comparator arm who were interviewed, introduced their own interventions, which may have influenced the outcomes of the trial. The naturalistic setting of the study was not protective against these confounders. These findings question the feasibility of comparator arms within primary care settings and that alternative study designs should be considered when designing future intervention studies in pharmacy practice.

To "tell or not to tell"-Exploring disclosure about medicine use by people living with sleep disorders.

OBJECTIVE: To explore the difference in rates and reasons for disclosure of either conventional or complementary medicine (CM) to healthcare practitioners between people living with sleep disorders (SDs) and those without SDs. METHODS: A cross-sectional survey (N = 2019 adults) that measured sociodemographic characteristics, health status, health service utilisation, health literacy and health communication (medicine disclosure) of a representative sample of Australians was conducted. Data from participants reporting an SD (n = 265) were compared to those not reporting an SD to assess measures of health communication and disclosure about medicine use. RESULTS: Overall, rates of medicine disclosure to both conventional and CM practitioners were high, in respondents with (70%) and without an SD (57%). Those reporting an SD had higher expectations of their conventional health practitioner's knowledge of CM, associated clinical decision-making skills, and approval of CM use, and held a higher degree of concern about drug interactions (P < 0.05). The main reasons cited for disclosing CM use to conventional health practitioners and conventional medicine use to CM practitioners were "I want them to fully understand my health status" and "I was concerned about drug interactions with the CMs used." CONCLUSION: The high rate of medicine use disclosure by people with SDs is driven by an intention to inform their healthcare practitioner about their health status and concerns about potential medicine interactions. Therefore, research about the expectations that people with an SD have of their conventional healthcare practitioners' knowledge of CM and CM-drug interactions requires further examination. Likewise, further examination of CM practitioner's conventional medicine knowledge is encouraged.