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.).

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.

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.

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.

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.

Uncovering the wisdom hidden between the lines: the Collaborative Reflexive Deliberative Approach.

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.

Contextual levers for team-based primary care: lessons from reform interventions in five jurisdictions in three countries.

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.

Self-rated health and long-term prognosis of depression.

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.

Written plans: an overlooked mechanism to develop recovery-oriented primary care for depression?

There is a global shift to foster patient-centred and recovery-oriented mental health services. This has resulted from the expansion of how the concept of recovery is understood in mental health literature and practice. Recovery is now more than a return to function or reduction in symptoms; it is a subjective, individualised and multi-faceted experience. To date there has not been investigation of how recovery-oriented services can be translated and implemented into the primary mental health care system. This paper presents the results of a survey from a prospective cohort of primary care patients with probable depression about the importance of written plans to recover. The benefits of having a written plan to recover from depression, as outlined by the participants, were analysed using Leximancer software. The findings provide insights into how written plans may be an important mechanism for implementing a recovery-oriented primary mental health care system. We conclude that the benefits of a written plan provide insight into how patients conceptualise recovery.

Methylenetetrahydrofolate reductase (MTHFR) genetic variation and major depressive disorder prognosis: A five-year prospective cohort study of primary care attendees.

Methylenetetrahydrofolate reductase (MTHFR) genetic variation has been associated with the diagnosis of major depressive disorder (MDD) but no study to date has examined the effect MTHFR variation has on MDD prognosis. We sought to examine the prospective effects of two common MTHFR variants (C677T and A1298C) as well as seven haplotype-tagging single nucleotide polymorphisms (htSNPs) on MDD prognosis over a 5-year (60-month) period. Participants were 147 depressed primary care attendees enrolled in the Diagnosis, Management and Outcomes of Depression in Primary Care (diamond) prospective cohort study. Prognosis of MDD was measured using three methods: (1) DSM-IV criteria, (2) Primary Care Evaluation of Mental Disorders Patient Health Questionnaire-9 (PHQ-9), and (3) Center for Epidemiologic Studies Depression Scale (CESD). DSM-IV criteria for MDD was assessed using the Composite International Diagnostic Interview at baseline and 24, 36, 48, and 60 months post-baseline; whereas, PHQ-9 and CESD measures were employed at baseline and 12, 24, 36, 48, and 60 months post-baseline. Repeated measures analysis of variance showed that PHQ-9 symptom severity trajectories differed by C677T genotype (F = 3.34, df = 2,144, P = 0.038), with 677CC genotype showing the most severe symptom severity course over the 60 months of observation. Neither the A1298C polymorphism nor any of the htSNPs were associated with MDD prognosis regardless of measure used. Our results suggest that the MTHFR C677T polymorphism may serve as a marker for MDD prognosis pending independent replication.

Chiropractic Observation and Analysis Study (COAST): providing an understanding of current chiropractic practice.

OBJECTIVES: COAST (Chiropractic Observation and Analysis Study) aimed to describe the clinical practices of chiropractors in Victoria, Australia. DESIGN: Cross-sectional study using the BEACH (Bettering the Evaluation and Care of Health) methods for general practice. SETTING AND PARTICIPANTS: 180 chiropractors in active clinical practice in Victoria were randomly selected from the list of 1298 chiropractors registered on Chiropractors Registration Board of Victoria. Twenty-four chiropractors were ineligible, 72 agreed to participate, and 52 completed the study. MAIN OUTCOME MEASURES: Each participating chiropractor documented encounters with up to 100 consecutive patients. For each chiropractor-patient encounter, information collected included patient health profile, patient reasons for encounter, problems and diagnoses, and chiropractic care. RESULTS: Data were collected on 4464 chiropractor-patient encounters from 52 chiropractors between 11 December 2010 and 28 September 2012. In most (71%) encounters, patients were aged 25-64 years; 1% of encounters were with infants (age < 1 year; 95% CI, 0.3%-3.2%). Musculoskeletal reasons for encounter were described by patients at a rate of 60 per 100 encounters (95% CI, 54-67 encounters) and maintenance and wellness or check-up reasons were described at a rate of 39 per 100 encounters (95% CI, 33-47 encounters). Back problems were managed at a rate of 62 per 100 encounters (95% CI, 55-71 encounters). The most frequent care provided by the chiropractors was spinal manipulative therapy and massage. CONCLUSIONS: A range of conditions are managed by chiropractors in Victoria, Australia, but most commonly these conditions are musculoskeletal-related. These results can be used by stakeholders of the chiropractic profession in workforce development, education and health care policy.

Evaluation of the Social Participation Questionnaire in adult patients with depressive symptoms using Rasch analysis.

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.

Corrigendum to: Use of electronic medical records to monitor the safe and effective prescribing of medicinal cannabis: is it feasible?

BACKGROUND: 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.

The association between chronic illness, multimorbidity and depressive symptoms in an Australian primary care cohort.

PURPOSE: To assess the link between multimorbidity, type of chronic physical health problems and depressive symptoms METHOD: The study was a cross-sectional postal survey conducted in 30 General Practices in Victoria, Australia as part of the diamond longitudinal study. Participants included 7,620 primary care attendees; 66% were females; age range from 18 to 76 years (mean = 51 years SD = 14); 81% were born in Australia; 64% were married and 67% lived in an urban area. The main outcome measures include the Centre for Epidemiologic Studies Depression Scale (CES-D) and a study-specific self-report check list of 12 common chronic physical health problems. RESULTS: The prevalence of probable depression increased with increasing number of chronic physical conditions (1 condition: 23%; 2 conditions: 27%; 3 conditions: 30%; 4 conditions: 31%; 5 or more conditions: 41%). Only 16% of those with no listed physical conditions recorded CES-D scores of 16 or above. Across the listed physical conditions the prevalence of 'probable depression' ranged from 24% for hypertension; 35% for emphysema; 35% for dermatitis to 36% for stroke. The dose-response relationship is reduced when functional limitations and self-rated health are taken into account, suggesting that these factors mediate the relationship. CONCLUSIONS: A clear dose-response relationship exists between the number of chronic physical problems and depressive symptoms. The relationship between multimorbidity and depression appears to be mediated via self-perceived health related quality of life. Primary care practitioners will identify more cases of depression if they focus on those with more than one chronic health problem, no matter what the problems may be, being especially aware in the group who rate their health as poor/fair.

Prescribing Data in General Practice Demonstration (PDGPD) project--a cluster randomised controlled trial of a quality improvement intervention to achieve better prescribing for chronic heart failure and hypertension.

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 practitioner's 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 18 months 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 6 months 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 development of acceptable and sustainable methods to promote QI activities within routine general practice, enhance prescribing practices and improve patient outcomes in the context of CHF and HT. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR), Trial # 320870.

Use of electronic medical records to monitor the safe and effective prescribing of medicinal cannabis: is it feasible?

BACKGROUND: 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.

Economic evaluation of the Target-D platform to match depression management to severity prognosis in primary care: A within-trial cost-utility analysis.

BACKGROUND: Target-D, a new person-centred e-health platform matching depression care to symptom severity prognosis (minimal/mild, moderate or severe) has demonstrated greater improvement in depressive symptoms than usual care plus attention control. The aim of this study was to evaluate the cost-effectiveness of Target-D compared to usual care from a health sector and partial societal perspective across 3-month and 12-month follow-up. METHODS AND FINDINGS: A cost-utility analysis was conducted alongside the Target-D randomised controlled trial; which involved 1,868 participants attending 14 general practices in metropolitan Melbourne, Australia. Data on costs were collected using a resource use questionnaire administered concurrently with all other outcome measures at baseline, 3-month and 12-month follow-up. Intervention costs were assessed using financial records compiled during the trial. All costs were expressed in Australian dollars (A$) for the 2018-19 financial year. QALY outcomes were derived using the Assessment of Quality of Life-8D (AQoL-8D) questionnaire. On a per person basis, the Target-D intervention cost between $14 (minimal/mild prognostic group) and $676 (severe group). Health sector and societal costs were not significantly different between trial arms at both 3 and 12 months. Relative to a A$50,000 per QALY willingness-to-pay threshold, the probability of Target-D being cost-effective under a health sector perspective was 81% at 3 months and 96% at 12 months. From a societal perspective, the probability of cost-effectiveness was 30% at 3 months and 80% at 12 months. CONCLUSIONS: Target-D is likely to represent good value for money for health care decision makers. Further evaluation of QALY outcomes should accompany any routine roll-out to assess comparability of results to those observed in the trial. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616000537459).

Maximising retention in a longitudinal study of genital Chlamydia trachomatis among young women in Australia.

BACKGROUND: Cohort studies are an important study design however they are difficult to implement, often suffer from poor retention, low participation and bias. The aims of this paper are to describe the methods used to recruit and retain young women in a longitudinal study and to explore factors associated with loss to follow up. METHODS: The Chlamydia Incidence and Re-infection Rates Study (CIRIS) was a longitudinal study of Australian women aged 16 to 25 years recruited from primary health care clinics. They were followed up via the post at three-monthly intervals and required to return questionnaires and self collected vaginal swabs for chlamydia testing. The protocol was designed to maximise retention in the study and included using recruiting staff independent of the clinic staff, recruiting in private, regular communication with study staff, making the follow up as straightforward as possible and providing incentives and small gifts to engender good will. RESULTS: The study recruited 66% of eligible women. Despite the nature of the study (sexual health) and the mobility of the women (35% moved address at least once), 79% of the women completed the final stage of the study after 12 months. Loss to follow up bias was associated with lower education level [adjusted hazard ratio (AHR): 0.7 (95% Confidence Interval (CI): 0.5, 1.0)], recruitment from a sexual health centre as opposed to a general practice clinic [AHR: 1.6 (95% CI: 1.0, 2.7)] and previously testing positive for chlamydia [AHR: 0.8 (95% CI: 0.5, 1.0)]. No other factors such as age, numbers of sexual partners were associated with loss to follow up. CONCLUSIONS: The methods used were considered effective for recruiting and retaining women in the study. Further research is needed to improve participation from less well-educated women.