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General practitioners are well positioned to contribute to the pharmacovigilance of medical cannabis via the general practice electronic medical record (EMR). The aim of this research is to interrogate de-identified patient data from the Patron primary care data repository for reports of medicinal cannabis to ascertain the feasibility of using EMRs to monitor medicinal cannabis prescribing in Australia. Methods. EMR rule-based digital phenotyping of 1 164 846 active patients from 109 practices was undertaken to investigate reports of medicinal cannabis use from September 2017 to September 2020. Results. Eighty patients with 170 prescriptions of medicinal cannabis were identified in the Patron repository. Reasons for prescription included anxiety, multiple sclerosis, cancer, nausea, and Crohn’s disease. Nine patients showed symptoms of a possible adverse event, including depression, motor vehicle accident, gastrointestinal symptoms, and anxiety. Conclusions. The recording of medicinal cannabis effects in the patient EMR provides potential for medicinal cannabis monitoring in the community. This is especially feasible if monitoring were to be embedded into general practitioner workflow.

OBJECTIVE: We sought to explore physician perspectives on the prescribing of cannabinoids to patients to gain a deeper understanding of the issues faced by prescriber and public health advisors in the rollout of medicinal cannabis. DESIGN: A thematic qualitative analysis of 21 in-depth interviews was undertaken to explore the narrative on the policy and practice of medicinal cannabis prescribing. The analysis used the Diffusion of Innovations (DoI) theoretical framework to model the conceptualisation of the rollout of medicinal cannabis in the Australian context. SETTING: Informants from the states and territories of Victoria, New South Wales, Tasmania, Australian Capital Territory, and Queensland in Australia were invited to participate in interviews to explore the policy and practice of medicinal cannabis prescribing. PARTICIPANTS: Participants included 21 prescribing and non-prescribing key informants working in the area of neurology, rheumatology, oncology, pain medicine, psychiatry, public health, and general practice. RESULTS: There was an agreement among many informants that medicinal cannabis is, indeed, a pharmaceutical innovation. From the analysis of the informant interviews, the factors that facilitate the diffusion of medicinal cannabis into clincal practice include the adoption of appropriate regulation, the use of data to evaluate safety and efficacy, improved prescriber education, and the continuous monitoring of product quality and cost. Most informants asserted the widespread assimilation of medicinal cannabis into practice is impeded by a lack of health system antecedents that are required to facilitate safe, effective, and equitable access to medicinal cannabis as a therapeutic. CONCLUSIONS: This research highlights the tensions that arise and the factors that influence the rollout of cannabis as an unregistered medicine. Addressing these factors is essential for the safe and effective prescribing in contemporary medical practice. The findings fr

For cluster randomized trials (CRTs) with a small number of clusters, the matched-pair (MP) design, where clusters are paired before randomizing one to each trial arm, is often recommended to minimize imbalance on known prognostic factors, add face-validity to the study, and increase efficiency, provided the analysis recognizes the matching. Little evidence exists to guide decisions on when to use matching. We used simulation to compare the efficiency of the MP design with the stratified and simple designs, based on the mean confidence interval width of the estimated intervention effect. Matched and unmatched analyses were used for the MP design; a stratified analysis was used for the stratified design; and analyses without and with post-stratification adjustment for factors that would otherwise have been used for restricted allocation were used for the simple design. Results showed the MP design was generally the most efficient for CRTs with 10 or more pairs when the correlation between cluster-level outcomes within pairs (matching correlation) was moderate to strong (0.3-0.5). There was little gain in efficiency for the MP or stratified designs compared to simple randomization when the matching correlation was weak (0.05-0.1). For trials with four pairs of clusters, the simple and stratified designs were more efficient than the MP design because greater degrees of freedom were available for the analysis, although an unmatched analysis of the MP design recovered precision for weak matching correlations. Practical guidance on choosing between the MP, stratified, and simple designs is provided.

BACKGROUND: Effective person-centred interventions are needed to support people living with mental-physical multimorbidity to achieve better health and wellbeing outcomes. Depression is identified as the most common mental health condition co-occurring with a physical health condition and is the focus of this intervention development study. The aim of this study is to identify the key components needed for an effective intervention based on a clear theoretical foundation, consideration of how motivational interviewing can inform the intervention, clinical guidelines to date, and the insights of primary care nurses. METHODS: A multimethod approach to intervention development involving review and integration of the theoretical principles of Theory of Planned Behavior and the patient-centred clinical skills of motivational interviewing, review of the expert consensus clinical guidelines for multimorbidity, and incorporation of a thematic analysis of group interviews with Australian nurses about their perspectives of what is needed in intervention to support people living with mental-physical multimorbidity. RESULTS: Three mechanisms emerged from the review of theory, guidelines and practitioner perspective; the intervention needs to actively 'engage' patients through the development of a collaborative and empathic relationship, 'focus' on the patient's priorities, and 'empower' people to make behaviour change. CONCLUSION: The outcome of the present study is a fully described primary care intervention for people living with mental-physical multimorbidity, with a particular focus on people living with depression and a physical health condition. It builds on theory, expert consensus guidelines and clinician perspective, and is to be tested in a clinical trial.

BACKGROUND: Mental health policies outline the need for codesign of services and quality improvement in partnership with service users and staff (and sometimes carers), and yet, evidence of systematic implementation and the impacts on healthcare outcomes is limited. OBJECTIVE: The aim of this study was to test whether an adapted mental health experience codesign intervention to improve recovery-orientation of services led to greater psychosocial recovery outcomes for service users. DESIGN: A stepped wedge cluster randomized-controlled trial was conducted. SETTING AND PARTICIPANTS: Four Mental Health Community Support Services providers, 287 people living with severe mental illnesses, 61 carers and 120 staff were recruited across Victoria, Australia. MAIN OUTCOME MEASURES: The 24-item Revised Recovery Assessment Scale (RAS-R) measured individual psychosocial recovery. RESULTS: A total of 841 observations were completed with 287 service users. The intention-to-treat analysis found RAS-R scores to be similar between the intervention (mean = 84.7, SD= 15.6) and control (mean = 86.5, SD= 15.3) phases; the adjusted estimated difference in the mean RAS-R score was -1.70 (95% confidence interval: -3.81 to 0.40; p = .11). DISCUSSION: This first trial of an adapted mental health experience codesign intervention for psychosocial recovery outcomes found no difference between the intervention and control arms. CONCLUSIONS: More attention to the conditions that are required for eight essential mechanisms of change to support codesign processes and implementation is needed. PATIENT AND PUBLIC INVOLVEMENT: The State consumer (Victorian Mental Illness Awareness Council) and carer peak bodies (Tandem representing mental health carers) codeveloped the intervention. The adapted intervention was facilitated by coinvestigators with lived-experiences who were coauthors for the trial and process evaluation protocols, the engagement model and explanatory model of change for the trial.

BACKGROUND: Cardiovascular disease (CVD) accounts for 40% of the excess mortality identified in people with severe mental illness (SMI). Modifiable CVD risk factors are higher and can be exacerbated by the cardiometabolic impact of psychotropic medications. People with SMI frequently attend primary care presenting a valuable opportunity for early identification, prevention and management of cardiovascular health. The ACCT Healthy Hearts Study will test a coproduced, nurse-led intervention delivered with general practitioners to reduce absolute CVD risk (ACVDR) at 12 months compared with an active control group. METHODS/DESIGN: ACCT is a two group (intervention/active control) individually randomised (1:1) controlled trial (RCT). Assessments will be completed baseline (pre-randomisation), 6 months, and 12 months. The primary outcome is 5-year ACVDR measured at 12 months. Secondary outcomes include 6-month ACVDR; and blood pressure, lipids, HbA1c, BMI, quality of life, physical activity, motivation to change health behaviour, medication adherence, alcohol use and hospitalisation at 6 and 12 months. Linear mixed-effects regression will estimate mean difference between groups for primary and secondary continuous outcomes. Economic cost-consequences analysis will be conducted using quality of life and health resource use information and routinely collected government health service use and medication data. A parallel process evaluation will investigate implementation of the intervention, uptake and outcomes. DISCUSSION: ACCT will deliver a coproduced and person-centred, guideline level cardiovascular primary care intervention to a high need population with SMI. If successful, the intervention could lead to the reduction of the mortality gap and increase opportunities for meaningful social and economic participation. Trial registration ANZCTR Trial number: ACTRN12619001112156.

BACKGROUND: Osteoarthritis (OA) is one of the most common chronic joint diseases and a leading cause of pain and disability in Australia. A National Osteoarthritis Strategy (the Strategy) was developed to outline a national plan to achieve optimal health outcomes for people at risk of, or with, OA. OBJECTIVE: This article focuses on the theme of advanced care of patients with OA within the Strategy. DISCUSSION: The Strategy was developed in consultation with a leadership group, thematic working groups, an implementation advisory committee, multisectoral stakeholders and the public. This Strategy identified three priorities in advanced care for osteoarthritis. In brief, these include surgical decision making, referral for evidence-informed non-surgical alternatives and surgical services. A set of goals within these priority areas and strategies was also proposed by the working group in consultation with stakeholders nationwide. Peak arthritis bodies and major healthcare professional associations currently endorse the Strategy.

In Australia, there is limited use of primary health care data for research and for data linkage between health care settings. This puts Australia behind many developed countries. In addition, without use of primary health care data for research, knowledge about patients' journeys through the health care system is limited. There is growing momentum to establish "big data" repositories of primary care clinical data to enable data linkage, primary care and population health research, and quality assurance activities. However, little research has been conducted on the general public's and practitioners' concerns about secondary use of electronic health records in Australia. International studies have identified barriers to use of general practice patient records for research. These include legal, technical, ethical, social and resource-related issues. Examples include concerns about privacy protection, data security, data custodians and the motives for collecting data, as well as a lack of incentives for general practitioners to share data. Addressing barriers may help define good practices for appropriate use of health data for research. Any model for general practice data sharing for research should be underpinned by transparency and a strong legal, ethical, governance and data security framework. Mechanisms to collect electronic medical records in ethical, secure and privacy-controlled ways are available. Before the potential benefits of health-related data research can be realised, Australians should be well informed of the risks and benefits so that the necessary social licence can be generated to support such endeavours.

BACKGROUND: Meta-analysis and meta-synthesis have been developed to synthesize results across published studies; however, they are still largely grounded in what is already published, missing the tacit 'between the lines' knowledge generated during many research projects that are not intrinsic to the main objectives of studies. OBJECTIVE: To develop a novel approach to expand and deepen meta-syntheses using researchers' experience, tacit knowledge and relevant unpublished materials. METHODS: We established new collaborations among primary health care researchers from different contexts based on common interests in reforming primary care service delivery and a diversity of perspectives. Over 2 years, the team met face-to-face and via tele- and video-conferences to employ the Collaborative Reflexive Deliberative Approach (CRDA) to discuss and reflect on published and unpublished results from participants' studies to identify new patterns and insights. RESULTS: CRDA focuses on uncovering critical insights, interpretations hidden within multiple research contexts. For the process to work, careful attention must be paid to ensure sufficient diversity among participants while also having people who are able to collaborate effectively. Ensuring there are enough studies for contextual variation also matters. It is necessary to balance rigorous facilitation techniques with the creation of safe space for diverse contributions. CONCLUSIONS: The CRDA requires large commitments of investigator time, the expense of convening facilitated retreats, considerable coordination, and strong leadership. The process creates an environment where interactions among diverse participants can illuminate hidden information within the contexts of studies, effectively enhancing theory development and generating new research questions and strategies.

BACKGROUND: Most Western nations have sought primary care (PC) reform due to the rising costs of health care and the need to manage long-term health conditions. A common reform-the introduction of inter-professional teams into traditional PC settings-has been difficult to implement despite financial investment and enthusiasm. OBJECTIVE: To synthesize findings across five jurisdictions in three countries to identify common contextual factors influencing the successful implementation of teamwork within PC practices. METHODS: An international consortium of researchers met via teleconference and regular face-to-face meetings using a Collaborative Reflexive Deliberative Approach to re-analyse and synthesize their published and unpublished data and their own work experience. Studies were evaluated through reflection and facilitated discussion to identify factors associated with successful teamwork implementation. Matrices were used to summarize interpretations from the studies. RESULTS: Seven common levers influence a jurisdiction's ability to implement PC teams. Team-based PC was promoted when funding extended beyond fee-for-service, where care delivery did not require direct physician involvement and where governance was inclusive of non-physician disciplines. Other external drivers included: the health professional organizations' attitude towards team-oriented PC, the degree of external accountability required of practices, and the extent of their links with the community and medical neighbourhood. Programs involving outreach facilitation, leadership training and financial support for team activities had some effect. CONCLUSION: The combination of physician dominance and physician aligned fee-for-service payment structures provide a profound barrier to implement team-oriented PC. Policy makers should carefully consider the influence of these and our other identified drivers when implementing team-oriented PC.

Context: A key aim of reforms to primary health care (PHC) in many countries has been to enhance interprofessional teamwork. However, the impact of these changes on practitioners has not been well understood. Objective: To assess the impact of reform policies and interventions that have aimed to create or enhance teamwork on professional communication relationships, roles, and work satisfaction in PHC practices. Design: Collaborative synthesis of 12 mixed methods studies. Setting: Primary care practices undergoing transformational change in three countries: Australia, Canada, and the USA, including three Canadian provinces (Alberta, Ontario, and Quebec). Methods: We conducted a synthesis and secondary analysis of 12 qualitative and quantitative studies conducted by the authors in order to understand the impacts and how they were influenced by local context. Results: There was a diverse range of complex reforms seeking to foster interprofessional teamwork in the care of patients with chronic disease. The impact on communication and relationships between different professional groups, the roles of nursing and allied health services, and the expressed satisfaction of PHC providers with their work varied more within than between jurisdictions. These variations were associated with local contextual factors such as the size, power dynamics, leadership, and physical environment of the practice. Unintended consequences included deterioration of the work satisfaction of some team members and conflict between medical and nonmedical professional groups. Conclusion: The variation in impacts can be understood to have arisen from the complexity of interprofessional dynamics at the practice level. The same characteristic could have both positive and negative influence on different aspects (eg, larger practice may have less capacity for adoption but more capacity to support interprofessional practice). Thus, the impacts are not entirely predictable and need to be monitored, and so

Cross-sectional studies have demonstrated that the brain-derived neurotrophic factor (BDNF) Val66Met single-nucleotide polymorphism moderates the association between exposure to negative life events and depression outcomes. Yet, it is currently unclear whether this moderating effect is applicable to positive life events and if the moderating effect is stable over time. To address these gaps in the literature, we examined clinical and BDNF genotypic data from a 5-year prospective cohort of 310 primary care attendees. Primary care attendees were selected based on existence of depressive symptoms at screening. Depressive symptoms were assessed at baseline and annually for 5 years post-baseline using the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire-9 (PHQ-9). Linear mixed models assessed differences in depressive symptom severity over the 5-year follow-up period by BDNF Val66Met and history of life events, both negative and positive. Analysis identified a novel three-way interaction between the BDNF Val66Met polymorphism, history of severe childhood abuse, and time. Post hoc analysis stratified by time showed a two-way interaction between Val66Met and severe childhood abuse at baseline that was not detectable at any other time point. An interaction between Val66Met and positive life events was not detected. Our longitudinal results suggest that the BDNF Val66Met polymorphism moderates the depressive symptom severity experienced by those with a history of severe childhood abuse but does so in a time-dependent manner. Our results further support the notion that gene-environment-depression interactions are dynamic and highlight the importance of longitudinal assessment of these interactions. Given these novel longitudinal findings; replication is required.

BACKGROUND: COAST (Chiropractic Observational and Analysis STudy) reported the clinical practices of chiropractors. The aims of this study were to: 1) describe the chiropractic patient demographic and health characteristics; 2) describe patient-stated reasons for visiting a chiropractor; 3) describe chiropractic patient lifestyle characteristics; 4) compare, where possible, chiropractic patient characteristics to the general Australian population. METHODS: Fifty-two chiropractors in Victoria, Australia, provided information for up to 100 consecutive encounters. If patients attended more than once during the 100 encounters, only data from their first encounter were included in this study. Where possible patient characteristics were compared with the general Australian population. RESULTS: Data were collected from December 2010 to September 2012. Data were provided for 4464 encounters, representing 3287 unique individuals. The majority of chiropractic encounters were for musculoskeletal conditions or for wellness/maintenance. The majority of patient comorbidities were musculoskeletal, circulatory or endocrine/metabolic in nature. Eight hundred chiropractic patients (57 %, 95 % CI: 53-61) described their self-reported health as excellent or very good and 138 patients (10 %, 95 % CI: 8-12) as fair or poor. Seventy-one percent of adult male patients (18 years and older), and 53 % of adult female patients, were overweight or obese. Fourteen percent (n = 188, 95 % CI: 12-16) were current smokers and 27 % (n = 359, 95 % CI: 24-31) did not meet Australian alcohol consumption guidelines. Less than half of the chiropractic patients participated in vigorous exercise at least twice per week. Approximately 20 % ate one serving of vegetables or less each day, and approximately 50 % ate one serve of fruit or less each day. Compared to the general Australian population, chiropractic patients were less likely to smoke, less likely to be obese and more likely to describe their health

BACKGROUND: Subthreshold depression is prevalent in primary care and is associated with poorer quality of life, higher health care use and increased risk of major depressive disorder (MDD). Currently, it is unclear how subthreshold depression should be managed in primary care and no studies have investigated the relationship between current models of care and the development of MDD. This study aimed to describe usual care over a six month follow-up for primary care patients with subthreshold depression and to investigate the relationship between usual care and the development of MDD. METHODS: Data were derived from 250 participants with subthreshold depression from the diamond study, a longitudinal cohort study of primary care patients. Participants completed questionnaires at three and six months on their health care use, the interventions they received and their depression status. Interventions were categorised according to the NICE guidelines for the management of depression in adults. Generalised estimating equation (GEE) models and logistic regression were used to estimate the association between receiving an intervention and MDD over six months. RESULTS: Four fifths (80.8%) of participants received a mental health intervention. Therapeutic listening, reassurance, pharmacotherapy and advice to exercise were most common. Subsequent MDD was predicted by history of depression, baseline depressive symptom severity and receiving a mental health intervention. LIMITATIONS: Usual care was assessed via patient self-report. CONCLUSIONS: Primary care physicians deliver mental health interventions to most subthreshold patients. However, it appears that current interventions are not averting MDD. Further research to identify effective interventions which are feasible in primary care is needed.

Internationally, health systems face an increasing demand for services from people living with multimorbidity. Multimorbidity is often associated with high levels of treatment burden. Targeting lifestyle factors that impact across multiple conditions may promote quality of life and better health outcomes for people with multimorbidity. Motivational interviewing (MI) has been studied as one approach to supporting lifestyle behaviour change. A systematic review was conducted to assess the effectiveness of MI in healthcare settings and to consider its relevance for multimorbidity. Twelve meta-analyses pertinent to multimorbidity lifestyle factors were identified. As an intervention, MI has been found to have a small-to-medium statistically significant effect across a wide variety of single diseases and for a range of behavioural outcomes. This review highlights the need for specific research into the application of MI to determine if the benefits of MI seen with single diseases are also present in the context of multimorbidity.

PURPOSE: Indicators of prognosis should be considered to fully inform clinical decision making in the treatment of depression. This study examines whether self-rated health predicts long-term depression outcomes in primary care. METHODS: Our analysis was based on the first 5 years of a prospective 10-year cohort study underway since January 2005 conducted in 30 randomly selected Australian primary care practices. Participants were 789 adult patients with a history of depressive symptoms. Main outcome measures include risks, risk differences, and risk ratios of major depressive syndrome (MDS) on the Patient Health Questionnaire. RESULTS: Retention rates during the 5 years were 660 (84%), 586 (74%), 560 (71%), 533 (68%), and 517 (66%). At baseline, MDS was present in 27% (95% CI, 23%-30%). Cross-sectional analysis of baseline data showed participants reporting poor or fair self-rated health had greater odds of chronic illness, MDS, and lower socioeconomic status than those reporting good to excellent self-rated health. For participants rating their health as poor to fair compared with those rating it good to excellent, risk ratios of MDS were 2.10 (95% CI, 1.60-2.76), 2.38 (95% CI, 1.77-3.20), 2.22 (95% CI, 1.70-2.89), 1.73 (95% CI, 1.30-2.28), and 2.15 (95% CI, 1.59-2.90) at 1, 2, 3, 4, and 5 years, after accounting for missing data using multiple imputation. After adjusting for age, sex, multimorbidity, and depression status and severity, self-rated health remained a predictor of MDS up to 5 years. CONCLUSIONS: Self-rated health offers family physicians an efficient and simple way to identify patients at risk of poor long-term depression outcomes and to inform therapeutic decision making.

OBJECTIVE: to investigate women's views and experiences of public antenatal care. DESIGN: population-based survey in two states. SETTING: South Australia and Victoria, Australia. PARTICIPANTS: 4366 women surveyed at 5-6 months post partum. FINDINGS: of 8468 eligible women mailed the survey, 52% returned completed questionnaires. Fifty-seven per cent of women (2496/4339) received public antenatal care. Of these, half attended a GP for some/all antenatal visits, 38% attended a public hospital clinic or midwives clinic, and 12% had primary midwife care, mostly in a midwifery group practice. Women with complex needs - young women, those experiencing multiple social health problems, women of non-English speaking background, and women at higher risk of complications in pregnancy - were the least likely to say that care met their needs. Women attending a GP or midwife as a primary caregiver were the most positive about their antenatal care: 69% and 74% respectively describing their antenatal care as 'very good'. Women attending a standard public hospital clinic were the least positive about their antenatal care with only 48% rating their care as 'very good'. Women enroling in GP shared care or attending a midwives clinic at a public hospital gave intermediate ratings. CONCLUSION AND IMPLICATIONS FOR PRACTICE: Models of public antenatal care involving a designated lead primary caregiver (GP or midwife) came closest to meeting women's need for information, individualised care and support.

PURPOSE: The aim of this study was to explore the psychometric properties of the 22-item Social Participation Questionnaire (SPQ). METHODS: The SPQ was administered to 789 adult primary care patients with depressive symptoms. As the items were intended to be summed together to provide total score, Rasch analysis (partial credit model) was applied to assess the overall fit of the model, individual item fit, differential item functioning (DIF), targeting of persons, response dependency, unidimensionality and person separation. RESULTS: To improve the scale's fit, it was necessary to re-score the response format. Two items demonstrated some DIF for gender and eight items showed DIF for age. To support the assumption of unidimensionality post hoc principal component analysis was performed. The analysis showed two subtests of the residuals with positive and negative loadings, but the person estimates derived from these two subtests were not statistically different to that derived from all items taken together. The response dependence between two items was identified; however, the magnitude of difficulty was very small. Although the questionnaire appeared to have insufficient items to assess the full spectrum of informal social contact, the SPQ was reasonably well targeted. CONCLUSION: The SPQ is a promising questionnaire for the measurement of social participation although it could benefit from the inclusion of further items to measure informal social contact. This study found support for the internal validity, internal consistency reliability, and unidimensionality. A future study will investigate whether targeting can be improved when additional items are included.

Background: Research literature consistently documents that scientifically based therapeutic recommendations are not always followed in the hospital or in the primary care setting. Currently, there is evidence that some general practitioners in Australia are not prescribing appropriately for patients diagnosed with 1) hypertension (HT) and 2) chronic heart failure (CHF). The objectives of this study were to improve general practitioners drug treatment management of these patients through feedback on their own prescribing and small group discussions with peers and a trained group facilitator. The impact evaluation includes quantitative assessment of prescribing changes at 6, 9, 12 and 18months after the intervention. Methods. A pragmatic multi site cluster RCT began recruiting practices in October 2009 to evaluate the effects of a multi-faceted quality improvement (QI) intervention on prescribing practice among Australian general practitioners (GP) in relation to patients with CHF and HT. General practices were recruited nationally through General Practice Networks across Australia. Participating practices were randomly allocated to one of three groups: two groups received the QI intervention (the prescribing indicator feedback reports and small group discussion) with each group undertaking the clinical topics (CHF and HT) in reverse order to the other. The third group was waitlisted to receive the intervention 6months later and acted as a control for the other two groups.De-identified data on practice, doctor and patient characteristics and their treatment for CHF and HT are extracted at six-monthly intervals before and after the intervention. Post-test comparisons will be conducted between the intervention and control arms using intention to treat analysis and models that account for clustering of practices in a Network and clustering of patients within practices and GPs. Discussion. This paper describes the study protocol for a project that will contribute to the

Cluster randomised trials (CRTs) are studies in which groups (clusters) of individuals, such as a group of patients that see the same general practitioner (GP), are randomised to one of two (or more) treatment conditions that are being compared, rather than the individuals themselves. CRTs have certain design and analytical challenges not found in trials that randomise individuals. One design issue is related to the greater risk of imbalance of important prognostic factors between trial arms, especially when the number of clusters randomised is small. In order to avoid chance imbalance on important factors, a matched-pair design is often employed, where clusters are paired according to a number of different characteristics, such as size of the practice,geographical location or baseline score on the outcome of interest, and then one cluster within each pair is randomised to the intervention arm and the other to the control arm. To date, the literature is unclear regarding when it is sensible to match clusters in pairs in the design of a CRT in order to provide greater assurance that known prognostic factors are balanced between the trial arms, especially when the number of clusters is small. Furthermore, there are a number of unique design and analytical challenges associated with the matched-pair design related to having only one cluster in each combination of trial arm and pair of clusters. This research aimed to provide guidance to assist researchers and applied statisticians in deciding when to use a matched-pair CRT and how best to analyse data from such studies. The research aim was addressed with four major components of original research. Firstly, a systematic review was performed to investigate recent practice in primary care research use of the matched-pair design and it sets the context for the research. Three extensive simulation studies were performed to address some of the gaps identified in the literature. The first two simulation studies evaluated the

BACKGROUND: Depression and related disorders represent a significant part of general practitioners (GPs) daily work. Implementing the evidence about what works for depression care into routine practice presents a challenge for researchers and service designers. The emerging consensus is that the transfer of efficacious interventions into routine practice is strongly linked to how well the interventions are based upon theory and take into account the contextual factors of the setting into which they are to be transferred. We set out to develop a conceptual framework to guide change and the implementation of best practice depression care in the primary care setting. METHODS: We used a mixed method, observational approach to gather data about routine depression care in a range of primary care settings via: audit of electronic health records; observation of routine clinical care; and structured, facilitated whole of organisation meetings. Audit data were summarised using simple descriptive statistics. Observational data were collected using field notes. Organisational meetings were audio taped and transcribed. All the data sets were grouped, by organisation, and considered as a whole case. Normalisation Process Theory (NPT) was identified as an analytical theory to guide the conceptual framework development. RESULTS: Five privately owned primary care organisations (general practices) and one community health centre took part over the course of 18 months. We successfully developed a conceptual framework for implementing an effective model of depression care based on the four constructs of NPT: coherence, which proposes that depression work requires the conceptualisation of boundaries of who is depressed and who is not depressed and techniques for dealing with diffuseness; cognitive participation, which proposes that depression work requires engagement with a shared set of techniques that deal with depression as a health problem; collective action, which proposes that agr

BACKGROUND: Intimate partner abuse (IPA) is a major public health problem with serious implications for the physical and psychosocial wellbeing of women, particularly women of child-bearing age. It is a common, hidden problem in general practice and has been under-researched in this setting. Opportunities for early intervention and support in primary care need to be investigated given the frequency of contact women have with general practice. Despite the high prevalence and health consequences of abuse, there is insufficient evidence for screening in primary care settings. Furthermore, there is little rigorous evidence to guide general practitioners (GPs) in responding to women identified as experiencing partner abuse. This paper describes the design of a trial of a general practice-based intervention consisting of screening for fear of partner with feedback to GPs, training for GPs, brief counselling for women and minimal practice organisational change. It examines the effect on women's quality of life, mental health and safety behaviours. METHODS/DESIGN: weave is a cluster randomised controlled trial involving 40 general practices in Victoria, Australia. Approximately 500 women (16-50 years) seen by the GP in the previous year are mailed a short lifestyle survey containing an item to screen for IPA. Women who indicate that they were afraid of a partner/ex-partner in the last year and provide contact details are invited to participate. Once baseline data are collected, GPs are randomly assigned to either a group involving healthy relationship and responding to IPA training plus inviting women for up to 6 sessions of counselling or to a group involving basic education and usual care for women. Outcomes will be evaluated by postal survey at 6 and 12 months following delivery of the intervention. There will be an economic evaluation, and process evaluation involving interviews with women and GPs, to inform understanding about implementation and outcomes. DISCUSSION: T

BACKGROUND: Australia is developing a chlamydia screening program. This study aimed to determine the attitudes of young women to the introduction of chlamydia screening in Australian General Practice. METHODS: In-depth face-to-face interviews with 24 young women from across Victoria, Australia, attending a randomly selected sample of general practices. RESULTS: Young women reported that they would accept age-based screening for chlamydia in general practice, during both sexual-health and non-sexual-health related consultations. Trust in their general practitioner (GP) was reported to be a major factor in the acceptability of chlamydia screening. The women felt chlamydia screening should be offered to all young women rather than targeted at "high risk" women based on sexual history and they particularly emphasised the importance of normalising chlamydia screening. The women reported that they did not want to be asked to provide a sexual history as part of being asked to have a chlamydia test. Some reported that they would lie if asked how many partners they had had CONCLUSION: Women do not want a sexual history taken when being asked to have a chlamydia test while attending a general practitioner. They prefer the offer of chlamydia screening to be based on age rather than assessment of sexual risk. Chlamydia screening needs to be normalised and destigmatised.

BACKGROUND: Australia is considering implementing a chlamydia screening program in general practice. The views of general practitioners (GPs) are necessary to inform the design of the program. This paper aimed to investigate Australian GPs' views on how chlamydia screening could work in the Australian context. METHODS: This project used both qualitative interviews and a quantitative questionnaire. GPs were randomly selected from a national database of medical practitioners for both the qualitative and quantitative components. Semi-structured interviews were conducted with GPs and a thematic analysis conducted. The results of the interviews were used to design a quantitative postal questionnaire for completion by a larger sample of GPs. Up to three reminders were sent to non-responders. RESULTS: Twenty one GPs completed an interview and 255 completed the postal questionnaire. The results of the postal survey were in strong concordance with those of the interview. GPs identified a number of barriers to increased screening including lack of time, knowledge of GPs and the public about chlamydia, patient embarrassment and support for partner notification. GPs felt strongly that screening would be easier if there was a national program and if the public and GPs had a greater knowledge about chlamydia. Incentive payments and mechanisms for recall and reminders would facilitate screening. Greater support for contact tracing would be important if screening is to increase. CONCLUSION: Chlamydia screening in general practice is acceptable to Australian GPs. If screening is to succeed, policy makers must consider the facilitators identified by GPs.

BACKGROUND: Chlamydia trachomatis is a common sexually transmitted infection that can have serious consequences. It is universally agreed that screening for chlamydia infection should be offered to sexually active young women. We undertook a literature review to document the views, attitudes and opinions of women about being screened, tested and diagnosed with Chlamydia trachomatis. METHODS: Online databases (MEDLINE, Meditext, PsycINFO, Web of Science) and reference lists searched up to August 2005. Search terms: chlamydia, attitude, attitude to health, interview, qualitative, women. ELIGIBILITY CRITERIA: about chlamydia, included women, involved interviews/surveys/focus groups, looked at women's views/opinions/attitudes, published in English. Thematic analysis identified the main and recurrent themes emerging from the literature. We compared our thematic analysis with the Theory of Planned Behaviour to provide a model that could assist in planning chlamydia screening programs. RESULTS: From 561 identified articles, 25 fulfilled inclusion criteria and were reviewed. 22: USA, UK; 3: Holland, Sweden, Australia. Major themes identified: need for knowledge and information, choice and support; concerns about confidentiality, cost, fear, anxiety and stigma. Women are more likely to find chlamydia screening/testing acceptable if they think chlamydia is a serious, common condition which can cause infertility and if they understand that chlamydia infection can be asymptomatic. Women want a range of options for chlamydia testing including urine tests, self-administered swabs, pelvic exams and clinician-collected swabs, home-testing and community-based testing. Tests should be free, easy and quick. Women want support for dealing with the implications of a chlamydia diagnosis, they feel chlamydia diagnoses need to be normalised and destigmatised and they want assistance with partner notification. Women need to know that their confidentiality will be maintained. CONCLUSION: Our