Association between Mental Disorders and Subsequent Medical Conditions.

BACKGROUND: Persons with mental disorders are at a higher risk than the general population for the subsequent development of certain medical conditions. METHODS: We used a population-based cohort from Danish national registries that included data on more than 5.9 million persons born in Denmark from 1900 through 2015 and followed them from 2000 through 2016, for a total of 83.9 million person-years. We assessed 10 broad types of mental disorders and 9 broad categories of medical conditions (which encompassed 31 specific conditions). We used Cox regression models to calculate overall hazard ratios and time-dependent hazard ratios for pairs of mental disorders and medical conditions, after adjustment for age, sex, calendar time, and previous mental disorders. Absolute risks were estimated with the use of competing-risks survival analyses. RESULTS: A total of 698,874 of 5,940,299 persons (11.8%) were identified as having a mental disorder. The median age of the total population was 32.1 years at entry into the cohort and 48.7 years at the time of the last follow-up. Persons with a mental disorder had a higher risk than those without such disorders with respect to 76 of 90 pairs of mental disorders and medical conditions. The median hazard ratio for an association between a mental disorder and a medical condition was 1.37. The lowest hazard ratio was 0.82 for organic mental disorders and the broad category of cancer (95% confidence interval [CI], 0.80 to 0.84), and the highest was 3.62 for eating disorders and urogenital conditions (95% CI, 3.11 to 4.22). Several specific pairs showed a reduced risk (e.g., schizophrenia and musculoskeletal conditions). Risks varied according to the time since the diagnosis of a mental disorder. The absolute risk of a medical condition within 15 years after a mental disorder was diagnosed varied from 0.6% for a urogenital condition among persons with a developmental disorder to 54.1% for a circulatory disorder among those with an organic mental disorder. CONCLUSIONS: Most mental disorders were associated with an increased risk of a subsequent medical condition; hazard ratios ranged from 0.82 to 3.62 and varied according to the time since the diagnosis of the mental disorder. (Funded by the Danish National Research Foundation and others; COMO-GMC ClinicalTrials.gov number, NCT03847753.).

The impact of removing financial incentives and/or audit and feedback on chlamydia testing in general practice: A cluster randomised controlled trial (ACCEPt-able).

BACKGROUND: Financial incentives and audit/feedback are widely used in primary care to influence clinician behaviour and increase quality of care. While observational data suggest a decline in quality when these interventions are stopped, their removal has not been evaluated in a randomised controlled trial (RCT), to our knowledge. This trial aimed to determine whether chlamydia testing in general practice is sustained when financial incentives and/or audit/feedback are removed. METHODS AND FINDINGS: We undertook a 2 × 2 factorial cluster RCT in 60 general practices in 4 Australian states targeting 49,525 patients aged 16-29 years for annual chlamydia testing. Clinics were recruited between July 2014 and September 2015 and were followed for up to 2 years or until 31 December 2016. Clinics were eligible if they were in the intervention group of a previous cluster RCT where general practitioners (GPs) received financial incentives (AU$5-AU$8) for each chlamydia test and quarterly audit/feedback reports of their chlamydia testing rates. Clinics were randomised into 1 of 4 groups: incentives removed but audit/feedback retained (group A), audit/feedback removed but incentives retained (group B), both removed (group C), or both retained (group D). The primary outcome was the annual chlamydia testing rate among 16- to 29-year-old patients, where the numerator was the number who had at least 1 chlamydia test within 12 months and the denominator was the number who had at least 1 consultation during the same 12 months. We undertook a factorial analysis in which we investigated the effects of removal versus retention of incentives (groups A + C versus groups B + D) and the effects of removal versus retention of audit/feedback (group B + C versus groups A + D) separately. Of 60 clinics, 59 were randomised and 55 (91.7%) provided data (group A: 15 clinics, 11,196 patients; group B: 14, 11,944; group C: 13, 11,566; group D: 13, 14,819). Annual testing decreased from 20.2% to 11.7% (difference -8.8%; 95% CI -10.5% to -7.0%) in clinics with incentives removed and decreased from 20.6% to 14.3% (difference -7.1%; 95% CI -9.6% to -4.7%) where incentives were retained. The adjusted absolute difference in treatment effect was -0.9% (95% CI -3.5% to 1.7%; p = 0.2267). Annual testing decreased from 21.0% to 11.6% (difference -9.5%; 95% CI -11.7% to -7.4%) in clinics where audit/feedback was removed and decreased from 19.9% to 14.5% (difference -6.4%; 95% CI -8.6% to -4.2%) where audit/feedback was retained. The adjusted absolute difference in treatment effect was -2.6% (95% CI -5.4% to -0.1%; p = 0.0336). Study limitations included an unexpected reduction in testing across all groups impacting statistical power, loss of 4 clinics after randomisation, and inclusion of rural clinics only. CONCLUSIONS: Audit/feedback is more effective than financial incentives of AU$5-AU$8 per chlamydia test at sustaining GP chlamydia testing practices over time in Australian general practice. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614000595617.

When should matching be used in the design of cluster randomized trials?

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.

Challenging the status quo: results of an acceptability and feasibility study of hypertensive disorders of pregnancy (HDP) management pathways in Indonesian primary care.

BACKGROUND: Hypertensive disorders of pregnancy (HDP) are the leading cause of maternal mortality in Indonesia. Focused HDP management pathways for Indonesian primary care practice have been developed from a consensus development process. However, the acceptability and feasibility of the pathways in practice have not been explored. This study reports on the implementation process of the pathways to determine their acceptability and feasibility in Indonesian practice. METHODS: The pathways were implemented in three public primary care clinics (Puskesmas) in Yogyakarta province for a month, guided by implementation science frameworks of Medical Research Council (MRC) and the Practical Robust Implementation and Sustainability Model (PRISM). The participating providers (general practitioners (GPs), midwives, and nurses) were asked to use recommendations in the pathways for a month. The pathway implementation evaluations were then conducted using clinical audits and a triangulation of observations, focus groups (FGs), and interviews with all of the participants. Clinical audit data were analysed descriptively, and qualitative data were analysed using a mix of the inductive-deductive approach of thematic analysis. RESULTS: A total of 50 primary care providers, four obstetricians, a maternal division officer in the local health office and 61 patients agreed to participate, and 48 of the recruited participants participated in evaluation FGs or interviews. All of the providers in the Puskesmas attempted to apply recommendations from the pathways to various degrees, mainly adopting preeclampsia risk factor screenings and HDP monitoring. The participants expressed that the recommendations empowered their practice when it came to HDP management. However, their practices were challenged by professional boundaries and hierarchical barriers among health care professionals, limited clinical resources, and regulations from the local health office. Suggestions for future scale-up studies were also mentioned, such as involving champion obstetricians and providing more patient education toolkits. CONCLUSION: The HDP management pathways are acceptable and feasible in Indonesian primary care. A further scale-up study is desired and can be initiated with investigations to minimise the implementation challenges and enhance the pathways' value in primary care practice.

Hypertensive disorders of pregnancy (HDP) management pathways: results of a Delphi survey to contextualise international recommendations for Indonesian primary care settings.

BACKGROUND: Hypertensive disorders of pregnancy (HDP) are a significant contributor to the high maternal mortality rate in Indonesia. At the moment, limited guidelines are available to assist primary care providers in managing HDP cases. A previous review of 16 international HDP guidelines has identified opportunities for improving HDP management in Indonesian primary care, but it has not determined the suitability of the recommendations in practice. This study aims to achieve consensus among the experts regarding the recommendations suitability and to develop HDP pathways in Indonesian primary care. METHODS: Maternal health experts, including GPs, midwives, nurses, medical specialists and health policy researchers from Indonesia and overseas were recruited for the study. They participated in a consensus development process that applied a mix of quantitative and qualitative questions in three Delphi survey rounds. At the first and second-round survey, the participants were asked to rate their agreement on whether each of 125 statements about HDP and HDP management is appropriate for use in Indonesian primary care settings. The third-round survey presented the drafts of HDP pathways and sought participants' agreement and further suggestions. The participants' agreement scores were calculated with a statement needing a minimum of 70% agreement to be included in the HDP pathways. The participants' responses and suggestions to the free text questions were analysed thematically. RESULTS: A total of 52 participants were included, with 48, 45 and 37 of them completing the first, second and third round of the survey respectively. Consensus was reached for 115 of the 125 statements on HDP definition, screening, management and long-term follow-up. Agreement scores for the statements ranged from 70.8-100.0%, and potential implementation barriers of the pathways were identified. Drafts of HDP management pathways were also agreed upon and received suggestions from the participants. CONCLUSIONS: Most evidence-based management recommendations achieved consensus and were included in the developed HDP management pathways, which can potentially be implemented in Indonesian settings. Further investigations are needed to explore the acceptability and feasibility of the developed HDP pathways in primary care practice.

The CORE study-An adapted mental health experience codesign intervention to improve psychosocial recovery for people with severe mental illness: A stepped wedge cluster randomized-controlled 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.

Moving from "let's fix them" to "actually listen": the development of a primary care intervention for mental-physical multimorbidity.

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.

Assessing the suitability of general practice electronic health records for clinical prediction model development: a data quality assessment.

BACKGROUND: The use of general practice electronic health records (EHRs) for research purposes is in its infancy in Australia. Given these data were collected for clinical purposes, questions remain around data quality and whether these data are suitable for use in prediction model development. In this study we assess the quality of data recorded in 201,462 patient EHRs from 483 Australian general practices to determine its usefulness in the development of a clinical prediction model for total knee replacement (TKR) surgery in patients with osteoarthritis (OA). METHODS: Variables to be used in model development were assessed for completeness and plausibility. Accuracy for the outcome and competing risk were assessed through record level linkage with two gold standard national registries, Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and National Death Index (NDI). The validity of the EHR data was tested using participant characteristics from the 2014-15 Australian National Health Survey (NHS). RESULTS: There were substantial missing data for body mass index and weight gain between early adulthood and middle age. TKR and death were recorded with good accuracy, however, year of TKR, year of death and side of TKR were poorly recorded. Patient characteristics recorded in the EHR were comparable to participant characteristics from the NHS, except for OA medication and metastatic solid tumour. CONCLUSIONS: In this study, data relating to the outcome, competing risk and two predictors were unfit for prediction model development. This study highlights the need for more accurate and complete recording of patient data within EHRs if these data are to be used to develop clinical prediction models. Data linkage with other gold standard data sets/registries may in the meantime help overcome some of the current data quality challenges in general practice EHRs when developing prediction models.

Use of antidepressants with pharmacogenetic prescribing guidelines in a 10-year depression cohort of adult primary care patients.

OBJECTIVE: To describe the usage patterns of antidepressants with published CYP2D6- and CYP2C19-based prescribing guidelines among depressed primary care patients and estimate the proportion of patients taking antidepressants not recommended for them based on their CYP2C19 and CYP2D6 genotype-predicted metabolizer status. METHODS: Medication use and pharmacogenetic testing results were collected on 128 primary care patients enrolled in a 10-year depression cohort study. At each 12-month interval, we calculated the proportion of patients that: (1) reported use of one or more of the 13 antidepressant medications (i.e. amitriptyline, citalopram, escitalopram, clomipramine, desipramine, doxepin, fluvoxamine, imipramine, nortriptyline, paroxetine, sertraline, trimipramine, venlafaxine) with published CYP2D6- and CYP2C19-based prescribing guidelines, (2) were taking an antidepressant that was not recommended for them based on their CYP2C19 and CYP2D6 genotype-predicted metabolizer phenotype, and (3) switched medications from the previous 12-month interval. RESULTS: The annual proportion of individuals taking an antidepressant with a CYP2D6- and CYP2C19-based prescribing guidelines ranged from 45 to 84%. The proportion of participants that used an antidepressant that was not recommended for them, based on available CYP2D6 and CYP2C19 metabolizer phenotype, ranged from 18 to 29% and these individuals tended to switch medications more frequently (10%) compared to their counterparts taking medication aligned with their metabolizer phenotype (6%). CONCLUSION: One-quarter of primary care patients used an antidepressant that was not recommended for them based on CYP2D6- and CYP2C19-based prescribing guidelines and switching medications tended to be more common in this group. Studies to determine the impact of CYP2D6 and CYP2C19 genotyping on reducing gene-antidepressant mismatches are warranted.

Antidepressant treatment for primary care patients with depressive symptoms: Data from the diamond longitudinal cohort study.

BACKGROUND: In light of emerging evidence questioning the safety of antidepressants, it is timely to investigate the appropriateness of antidepressant prescribing. This study estimated the prevalence of possible over- and under-treatment with antidepressants among primary care attendees and investigated the factors associated with potentially inappropriate antidepressant use. METHODS: In all, 789 adult primary care patients with depressive symptoms were recruited from 30 general practices in Victoria, Australia, in 2005 and followed up every 3 months in 2006 and annually from 2007 to 2011. For this study, we first assessed appropriateness of antidepressant use in 2007 at the 2-year follow-up to enable history of depression to be taken into account, providing 574 (73%) patients with five yearly assessments, resulting in a total of 2870 assessments. We estimated the prevalence of use of antidepressants according to the adapted National Institute for Health and Care Excellence guidelines and used regression analysis to identify factors associated with possible over- and under-treatment. RESULTS: In 41% (243/586) of assessments where antidepressants were indicated according to adapted National Institute for Health and Care Excellence guidelines, patients reported not taking them. Conversely in a third (557/1711) of assessments where guideline criteria were unlikely to be met, participants reported antidepressant use. Being female and chronic physical illness were associated with antidepressant use where guideline criteria were not met, but no factors were associated with not taking antidepressants where guideline criteria were met. CONCLUSIONS: Much antidepressant treatment in general practice is for people with minimal or mild symptoms, while people with moderate or severe depressive symptoms may miss out. There is considerable scope for improving depression care through better allocation of antidepressant treatment.

The elephant in the room: an exploratory study of hypertensive disorders of pregnancy (HDP) management in Indonesian primary care settings.

BACKGROUND: Indonesia has the highest maternal mortality rate in South East Asia, that a third of the mortality is caused by hypertensive disorders of pregnancy (HDP), including preeclampsia and eclampsia. Research suggests that maternal deaths from HDP are avoidable with appropriate initial management in primary care. However, little is known regarding the exact way HDP management is conducted in Indonesian primary care. This research aims to explore the way HDP management is provided, including its barriers and facilitators in Indonesian primary care settings. METHODS: This research applied a practical qualitative methodology using interviews with a topic guide. It is guided by the implementation science framework of the Medical Research Council (MRC) framework and Practical Robust Implementation and Sustainability Model (PRISM) to design and evaluate complex healthcare interventions. Primary care key stakeholders from Yogyakarta province were recruited from May-December 2018. The interviews were conducted in face-to-face, telephone, and teleconference interviews. Data from the interviews were analysed thematically using a mix of inductive and deductive approaches. RESULTS: A total of 24 participants were interviewed, consisting of four general practitioners, five midwives, three nurses, three obstetricians, a cardiologist, five policymakers and three women with a previous history of HDP. Referrals are the usual management performed for HDP women in primary care and the primary care providers' practice is challenged by three identified themes: (i) providers' limited confidence to perform HDP management, (ii) fragmented continuity of care, and (iii) community beliefs. Many participants also desired to have more focused guidance to improve HDP management in primary care practice. CONCLUSION: Even though Indonesian antenatal care and referrals are generally accessible, there are many challenges and fragmentation of HDP management. The most prominent challenge is the primary care providers' lack of confidence in performing the management and the 'elephant' of an urgent need of practice guidelines in primary care that has never been appropriately described in the literature. Further development of an evidence-based primary care-focused guidance will potentially improve primary care providers' skills to perform optimal HDP management and provide appropriate education to their patients.

The Joint Effect of Physical Multimorbidity and Mental Health Conditions Among Adults in Australia.

INTRODUCTION: The prevalence of chronic physical and mental health conditions is rising globally. Little evidence exists on the joint effect of physical and mental health conditions on health care use, work productivity, and health-related quality of life in Australia. METHODS: We analyzed data from the Household, Income and Labour Dynamics in Australia (HILDA) Survey, waves 9 (2009), 13 (2013), and 17 (2017). Economic effects associated with multimorbidity were measured through health service use, work productivity loss, and health-related quality of life. We used generalized estimating equations to assess the effect of the association between physical multimorbidity and mental health conditions and economic outcomes. RESULTS: From 2009 through 2017 the prevalence of physical multimorbidity increased from 15.1% to 16.2%, and the prevalence of mental health conditions increased from 11.2% to 17.3%. The number of physical health conditions was associated with the number of health services used (general practitioner visits, incidence rate ratio = 1.41), work productivity loss (labor force participation, adjusted odds ratio = 0.71), and reduced health-related quality of life (SF-6D score: Coefficient = -0.03). These effects were exacerbated by the presence of mental health conditions and low socioeconomic status. CONCLUSION: Having multiple physical health conditions (physical multimorbidity) creates substantial health and financial burdens on individuals, the health system, and society, including increased use of health services, loss of work productivity, and decreased health-related quality of life. The adverse effects of multimorbidity on health, quality of life, and economic well-being are exacerbated by the co-occurrence of mental health conditions and low socioeconomic status.

A Web-Based Mental Health Intervention to Improve Social and Occupational Functioning in Adults With Type 2 Diabetes (The Springboard Trial): 12-Month Outcomes of a Randomized Controlled Trial.

BACKGROUND: People with type 2 diabetes mellitus (T2DM) often experience mental health symptoms that exacerbate illness and increase mortality risk. Access to psychological support is low in people with T2DM. Detection of depression is variable in primary care and can be further hampered by mental health stigma. Electronic mental health (eMH) programs may provide an accessible, private, nonstigmatizing mental health solution for this group. OBJECTIVE: This study aims to evaluate the efficacy over 12 months of follow-up of an eMH program (myCompass) for improving social and occupational functioning in a community sample of people with T2DM and self-reported mild-to-moderate depressive symptoms. myCompass is a fully automated and self-guided web-based public health program for people with depression or anxiety. The effects of myCompass on depressive symptoms, diabetes-related distress, anxiety symptoms, and self-care behavior were also examined. METHODS: Adults with T2DM and mild-to-moderate depressive symptoms (N=780) were recruited via online advertisements, community organizations, and general practices. Screening, consent, and self-report questionnaires were administered online. Eligible participants were randomized to receive either myCompass (n=391) or an attention control generic health literacy program (Healthy Lifestyles; n=379) for 8 weeks. At baseline and at 3, 6, and 12 months postintervention, participants completed the Work and Social Adjustment Scale, the Patient Health Questionnaire-9 item, the Diabetes Distress Scale, the Generalized Anxiety Disorder Questionnaire-7 item, and items from the Self-Management Profile for Type 2 Diabetes. Glycosylated hemoglobin measurements were obtained at baseline and 6 and 12 months postintervention. RESULTS: A total of 38.9% (304/780) of the trial participants completed all postintervention assessments. myCompass users logged in on an average of 6 times and completed an average of 0.29 modules. Healthy Lifestyles users logged in on an average of 4 times and completed an average of 1.37 modules. At baseline, the mean scores on several outcome measures, including the primary outcome of work and social functioning, were close to the normal range, despite a varied and extensive recruitment process. Intention-to-treat analyses revealed slightly greater improvement at 12 months in work and social functioning for the Healthy Lifestyles group relative to the myCompass group. All participants reported equivalent improvements in depression anxiety, diabetes distress, diabetes self-management, and glycemic control across the trial. CONCLUSIONS: The Healthy Lifestyles group reported higher ratings of social and occupational functioning than the myCompass group, but no differences were observed for any secondary outcome. Although these findings should be interpreted in light of the near-floor symptom scores at baseline, the trial yields important insights into how people with T2DM might be engaged in eMH programs and the challenges of focusing specifically on mental health. Several avenues emerge for continued investigation into how best to deal with the growing mental health burden in adults with T2DM. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry Number (ACTRN) 12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109&isReview=true.

The influence of personality on trajectories of distress, health and functioning in mild-to-moderately depressed adults with type 2 diabetes.

Identification of mental health risk is important for optimising diabetes care in type 2 diabetes mellitus (T2DM). Personality is linked to diabetes health and may assist detection of individuals with T2DM most at risk of chronic mental health difficulties. This study examined the moderator effect of personality factors on changes in psychological distress and functioning in adults with T2DM and mild-to-moderate depressive symptoms across a 12-month period. Data were obtained from participants in a randomised controlled trial of adults with T2DM.  Participants completed measures of depression (Patient Health Questionnaire-9), anxiety (General Anxiety Disorder-7), general functioning (Work and Social Adjustment Scale), diabetes distress (Diabetes Distress Scale), and diabetes self-management (Self-Management Profile for Type 2 Diabetes) at baseline, 3-, 6- and 12-months. Glycaemic control (HbA1c) was measured at baseline, 6- and 12-months. Two hundred trial completers agreed to complete a personality inventory (Big Five Inventory). Low neuroticism was linked with reduced depression, anxiety, functional impairment and diabetes distress over the year. High extraversion was associated with decreased anxiety and functional impairment. High conscientiousness was linked to increased healthy eating. No personality trait moderated HbA1c levels. Personality screening may help identify mental health risk and guide medical carer approach in T2DM patients.

Population effectiveness of opportunistic chlamydia testing in primary care in Australia: a cluster-randomised controlled trial.

BACKGROUND: Screening young adults who are sexually active for genital Chlamydia trachomatis infection is promoted in several high-income countries, but its effectiveness at the population level is highly debated. We aimed to investigate the effects of opportunistic chlamydia testing in primary care on the estimated chlamydia prevalence in the population aged 16-29 years in Australia. METHODS: We did a cluster-randomised controlled trial. Clusters were rural towns with a minimum of 500 women and men aged 16-29 years and no more than six primary care clinics. We randomly allocated each cluster using a computer-generated minimisation algorithm to receive a multifaceted, clinic-based chlamydia testing intervention or to continue usual care. The intervention included computerised reminders to test patients, an education package, payments for chlamydia testing, and feedback on testing rates. The primary outcome was chlamydia prevalence, estimated before randomisation (survey 1) and at the end of the trial (survey 2) in patients aged 16-29 years who attended the clinics. Analyses were done by intention to treat. General practitioners and clinic staff were aware of group allocation, whereas patients and laboratory staff who performed the chlamydia tests were not. This trial was completed on Dec 31, 2015, and is registered (ACTRN12610000297022). FINDINGS: Between Dec 14, 2010, and Sept 14, 2015, 26 clusters (63 clinics) received the chlamydia testing intervention and 26 (67 clinics) continued usual care. Over a mean duration of 3·1 years (SD 0·3), 93 828 young adults attended intervention clinics and 86 527 attended control clinics. The estimated chlamydia prevalence decreased from 5·0% (95% CI 3·8 to 6·2) at survey 1 to 3·4% (2·7 to 4·1) at survey 2 in the intervention clusters (difference -1·6%, 95% CI -2·9 to -0·3) and from 4·6% (95% CI 3·5 to 5·7) at survey 1 to 3·4% (2·4 to 4·5) at survey 2 in the control clusters (difference -1·1%, -2·7 to 0·5). The unadjusted odds ratio for the difference between intervention and control clusters was 0·9 (95% CI 0·5 to 1·5). INTERPRETATION: These findings, in conjunction with evidence about the feasibility of sustained uptake of opportunistic testing in primary care, indicate that sizeable reductions in chlamydia prevalence might not be achievable. FUNDING: Australian Government Department of Health, National Health and Medical Research Council, Victorian Department of Health and Human Services, and New South Wales Ministry of Health.

Gathering data for decisions: best practice use of primary care electronic records for research.

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.

Misconceptions and the Acceptance of Evidence-based Nonsurgical Interventions for Knee Osteoarthritis. A Qualitative Study.

BACKGROUND: In contrast to best practice guidelines for knee osteoarthritis (OA), findings from several different healthcare settings have identified that nonsurgical treatments are underused and TKA is overused. Empirical evidence and qualitative observations suggest that patients' willingness to accept nonsurgical interventions for knee OA is low. A qualitative investigation of why patients may feel that such interventions are of little value may be an important step toward increasing their use in the treatment of knee OA QUESTIONS/PURPOSES: This qualitative study was embedded in a larger study investigating patient-related factors (beliefs/attitudes toward knee OA and its treatment) and health-system related factors (access, referral pathways) known to influence patients' decisions to seek medical care. In this paper we focus on the patient-related factors with the aim of exploring why patients may feel that nonsurgical interventions are of little value in the treatment of knee OA. METHODS: A cross-sectional qualitative study was conducted in a single tertiary hospital in Australia. Patients with endstage knee OA on the waiting list for TKA were approached during their preadmission appointment and invited to participate in one-to-one interviews. As prescribed by the qualitative approach, data collection and data analysis were performed in parallel and recruitment continued until the authors agreed that the themes identified would not change through interviews with subsequent participants, at which point, recruitment stopped. Thirty-seven patients were approached and 27 participated. Participants were 48% female; mean age was 67 years. Participants' beliefs about knee OA and its treatment were identified in the interview transcripts. Beliefs were grouped into five belief dimensions: identity beliefs (what knee OA is), causal beliefs (what causes knee OA), consequence beliefs (what the consequences of knee OA are), timeline beliefs (how long knee OA lasts) and treatment beliefs (how knee OA can be controlled). RESULTS: All participants believed that their knee OA was "bone on bone" (identity beliefs) and most (> 14 participants) believed it was caused by "wear and tear" (causal beliefs). Most (> 14 participants) believed that loading the knee could further damage their "vulnerable" joint (consequence beliefs) and all believed that their pain would deteriorate over time (timeline beliefs). Many (>20 participants) believed that physiotherapy and exercise interventions would increase pain and could not replace lost knee cartilage. They preferred experimental and surgical treatments which they believed would replace lost cartilage and cure their knee pain (treatment beliefs). CONCLUSIONS: Common misconceptions about knee OA appear to influence patients' acceptance of nonsurgical, evidence-based treatments such as exercise and weight loss. Once the participants in this study had been "diagnosed" with "bone-on-bone" changes, many disregarded exercise-based interventions which they believed would damage their joint, in favor of alternative and experimental treatments, which they believed would regenerate lost knee cartilage. Future research involving larger, more representative samples are needed to understand how widespread these beliefs are and if/how they influence treatment decisions. In the meantime, clinicians seeking to encourage acceptance of nonsurgical interventions may consider exploring and targeting misconceptions that patients hold about the identity, causes, consequences, timeline, and treatment of knee OA. LEVEL OF EVIDENCE: Level II, prognostic study.

Developing management pathways for hypertensive disorders of pregnancy (HDP) in Indonesian primary care: a study protocol.

BACKGROUND: National and international guidelines for the management of hypertensive disorders of pregnancy (HDP) are available in developing countries. However, more detailed clinical pathways for primary care settings are limited. This study focuses on Indonesia, where 72% of women who died from HDP and its complications had received less appropriate treatment according to international guidelines. There is an urgent need to develop primary care focused pathways that enable general practitioners (GPs), midwives and other relevant providers to manage HDP better. OBJECTIVES: This paper describes a study protocol for the development of HDP management pathways for Indonesian primary care settings. METHODS: This study design is informed by Implementation Science theories and consists of three phases. The exploratory phase will involve conducting semi-structured interviews with key Indonesian primary care stakeholders to explore their experiences and views on HDP management. The development phase will apply evidence from the literature review and results of the exploratory phase to develop HDP management pathways contextualised to Indonesian primary care settings. Consensus will be sought from approximately 50 experts, consist of general practitioners (GPs), midwives, obstetricians, nurses and policy makers using Delphi technique survey. The evaluation phase will involve a pilot study to evaluate the pathways' acceptability and feasibility in a sample of Indonesian primary care practices using mixed methods. DISCUSSION: The implementation science frameworks inform and guide the phases in this study. Qualitative interviews in the exploratory phase are conducive to eliciting opinions from key stakeholders. Using Delphi technique at the development phase is suitable to seek participants' consensus on HDP management in primary care. Observations, focus group discussions, interviews as well as analysis of patients' medical records at the evaluation phase are expected to provide a comprehensive investigation of the implementation of the pathways in practice settings.

A Web-Based Cognitive Behavior Therapy Intervention to Improve Social and Occupational Functioning in Adults With Type 2 Diabetes (The SpringboarD Trial): Randomized Controlled Trial.

BACKGROUND: Depressive symptoms are common in people with type 2 diabetes mellitus (T2DM). Effective depression treatments exist; however, access to psychological support is characteristically low. Web-based cognitive behavioral therapy (CBT) is accessible, nonstigmatizing, and may help address substantial personal and public health impact of comorbid T2DM and depression. OBJECTIVE: The aim of this study was to evaluate the Web-based CBT program, myCompass, for improving social and occupational functioning in adults with T2DM and mild-to-moderate depressive symptoms. myCompass is a fully automated, self-guided public health treatment program for common mental health problems. The impact of treatment on depressive symptoms, diabetes-related distress, anxiety symptoms, and self-care behavior was also examined. METHODS: Participants with T2DM and mild-to-moderate depressive symptoms (N=780) were recruited online via Google and Facebook advertisements targeting adults with T2DM and via community and general practice settings. Screening, consent, and self-report scales were all self-administered online. Participants were randomized using double-blind computerized block randomization to either myCompass (n=391) for 8 weeks plus a 4-week tailing-off period or an active placebo intervention (n=379). At baseline and postintervention (3 months), participants completed the Work and Social Adjustment Scale, the primary outcome measure. Secondary outcome measures included the Patient Health Questionnaire-9 item, Diabetes Distress Scale, Generalized Anxiety Disorder Questionnaire-7 item, and items from the Self-Management Profile for Type 2 Diabetes. RESULTS: myCompass users logged in an average of 6 times and completed an average of .29 modules. Healthy Lifestyles users logged in an average of 4 times and completed an average of 1.37 modules. At baseline, mean scores on several outcome measures, including the primary outcome of work and social functioning, were near to the normal range, despite an extensive recruitment process. Approximately 61.6% (473/780) of participants completed the postintervention assessment. Intention-to-treat analyses revealed improvement in functioning, depression, anxiety, diabetes distress, and healthy eating over time in both groups. Except for blood glucose monitoring and medication adherence, there were no specific between-group effects. Follow-up analyses suggested the outcomes did not depend on age, morbidity, or treatment engagement. CONCLUSIONS: Improvement in social and occupational functioning and the secondary outcomes was generally no greater for myCompass users than for users of the control program at 3 months postintervention. These findings should be interpreted in light of near-normal mean baseline scores on several variables, the self-selected study sample, and sample attrition. Further attention to factors influencing uptake and engagement with mental health treatments by people with T2DM, and the impact of illness comorbidity on patient conceptualization and experience of mental health symptoms, is essential to reduce the burden of T2DM. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109&isReview=true (Archived by WebCite at http://www.webcitation.org/7850eg8pi).

Recruiting to a Randomized Controlled Trial of a Web-Based Program for People With Type 2 Diabetes and Depression: Lessons Learned at the Intersection of e-Mental Health and Primary Care.

BACKGROUND: E-mental health (eMH) interventions are now widely available and they have the potential to revolutionize the way that health care is delivered. As most health care is currently delivered by primary care, there is enormous potential for eMH interventions to support, or in some cases substitute, services currently delivered face to face in the community setting. However, randomized trials of eMH interventions have tended to recruit participants using online recruitment methods. Consequently, it is difficult to know whether participants who are recruited online differ from those who attend primary care. OBJECTIVE: This paper aimed to document the experience of recruiting to an eMH trial through primary care and compare the characteristics of participants recruited through this and other recruitment methods. METHODS: Recruitment to the SpringboarD randomized controlled trial was initially focused on general practices in 2 states of Australia. Over 15 months, we employed a comprehensive approach to engaging practice staff and supporting them to recruit patients, including face-to-face site visits, regular contact via telephone and trial newsletters, and development of a Web-based patient registration portal. Nevertheless, it became apparent that these efforts would not yield the required sample size, and we therefore supplemented recruitment through national online advertising and promoted the study through existing networks. Baseline characteristics of participants recruited to the trial through general practice, online, or other sources were compared using the analysis of variance and chi square tests. RESULTS: Between November 2015 and October 2017, 780 people enrolled in SpringboarD, of whom 740 provided information on the recruitment source. Of these, only 24 were recruited through general practice, whereas 520 were recruited online and 196 through existing networks. Key barriers to general practice recruitment included perceived mismatch between trial design and diabetes population, prioritization of acute health issues, and disruptions posed by events at the practice and community level. Participants recruited through the 3 different approaches differed in age, gender, employment status, depressive symptoms, and diabetes distress, with online participants being distinguished from those recruited through general practice or other sources. However, most differences reached only a small effect size and are unlikely to be of clinical importance. CONCLUSIONS: Time, labor, and cost-intensive efforts did not translate into successful recruitment through general practice in this instance, with barriers identified at several different levels. Online recruitment yielded more participants, who were broadly similar to those recruited via general practice.