Addressing the challenges of cross-jurisdictional data linkage between a national clinical quality registry and government-held health data.

OBJECTIVE: To describe the challenges of obtaining state and nationally held data for linkage to a non-government national clinical registry. METHODS: We reviewed processes negotiated to achieve linkage between the Australian Stroke Clinical Registry (AuSCR), the National Death Index, and state held hospital data. Minutes from working group meetings, national workshop meetings, and documented communications with health department staff were reviewed and summarised. RESULTS: Time from first application to receipt of data was more than two years for most state data-sets. Several challenges were unique to linkages involving identifiable data from a non-government clinical registry. Concerns about consent, the re-identification of data, duality of data custodian roles and data ownership were raised. Requirements involved the development of data flow methods, separating roles and multiple governance and ethics approvals. Approval to link death data presented the fewest barriers. CONCLUSION: To our knowledge, this is the first time in Australia that person-level data from a clinical quality registry has been linked to hospital and mortality data across multiple Australian jurisdictions. Implications for Public Health: The administrative load of obtaining linked data makes projects such as this burdensome but not impossible. An improved national centralised strategy for data linkage in Australia is urgently needed.

Responding to Young People's Health Risks in Primary Care: A Cluster Randomised Trial of Training Clinicians in Screening and Motivational Interviewing.

OBJECTIVE: To evaluate the effectiveness of a complex intervention implementing best practice guidelines recommending clinicians screen and counsel young people across multiple psychosocial risk factors, on clinicians' detection of health risks and patients' risk taking behaviour, compared to a didactic seminar on young people's health. DESIGN: Pragmatic cluster randomised trial where volunteer general practices were stratified by postcode advantage or disadvantage score and billing type (private, free national health, community health centre), then randomised into either intervention or comparison arms using a computer generated random sequence. Three months post-intervention, patients were recruited from all practices post-consultation for a Computer Assisted Telephone Interview and followed up three and 12 months later. Researchers recruiting, consenting and interviewing patients and patients themselves were masked to allocation status; clinicians were not. SETTING: General practices in metropolitan and rural Victoria, Australia. PARTICIPANTS: General practices with at least one interested clinician (general practitioner or nurse) and their 14-24 year old patients. INTERVENTION: This complex intervention was designed using evidence based practice in learning and change in clinician behaviour and general practice systems, and included best practice approaches to motivating change in adolescent risk taking behaviours. The intervention involved training clinicians (nine hours) in health risk screening, use of a screening tool and motivational interviewing; training all practice staff (receptionists and clinicians) in engaging youth; provision of feedback to clinicians of patients' risk data; and two practice visits to support new screening and referral resources. Comparison clinicians received one didactic educational seminar (three hours) on engaging youth and health risk screening. OUTCOME MEASURES: Primary outcomes were patient report of (1) clinician detection of at least one of six health risk behaviours (tobacco, alcohol and illicit drug use, risks for sexually transmitted infection, STI, unplanned pregnancy, and road risks); and (2) change in one or more of the six health risk behaviours, at three months or at 12 months. Secondary outcomes were likelihood of future visits, trust in the clinician after exit interview, clinician detection of emotional distress and fear and abuse in relationships, and emotional distress at three and 12 months. Patient acceptability of the screening tool was also described for the intervention arm. Analyses were adjusted for practice location and billing type, patients' sex, age, and recruitment method, and past health risks, where appropriate. An intention to treat analysis approach was used, which included multilevel multiple imputation for missing outcome data. RESULTS: 42 practices were randomly allocated to intervention or comparison arms. Two intervention practices withdrew post allocation, prior to training, leaving 19 intervention (53 clinicians, 377 patients) and 21 comparison (79 clinicians, 524 patients) practices. 69% of patients in both intervention (260) and comparison (360) arms completed the 12 month follow-up. Intervention clinicians discussed more health risks per patient (59.7%) than comparison clinicians (52.7%) and thus were more likely to detect a higher proportion of young people with at least one of the six health risk behaviours (38.4% vs 26.7%, risk difference [RD] 11.6%, Confidence Interval [CI] 2.93% to 20.3%; adjusted odds ratio [OR] 1.7, CI 1.1 to 2.5). Patients reported less illicit drug use (RD -6.0, CI -11 to -1.2; OR 0.52, CI 0.28 to 0.96), and less risk for STI (RD -5.4, CI -11 to 0.2; OR 0.66, CI 0.46 to 0.96) at three months in the intervention relative to the comparison arm, and for unplanned pregnancy at 12 months (RD -4.4; CI -8.7 to -0.1; OR 0.40, CI 0.20 to 0.80). No differences were detected between arms on other health risks. There were no differences on secondary outcomes, apart from a greater detection of abuse (OR 13.8, CI 1.71 to 111). There were no reports of harmful events and intervention arm youth had high acceptance of the screening tool. CONCLUSIONS: A complex intervention, compared to a simple educational seminar for practices, improved detection of health risk behaviours in young people. Impact on health outcomes was inconclusive. Technology enabling more efficient, systematic health-risk screening may allow providers to target counselling toward higher risk individuals. Further trials require more power to confirm health benefits. TRIAL REGISTRATION: ISRCTN.com ISRCTN16059206.

The prevention access and risk taking in young people (PARTY) project protocol: a cluster randomised controlled trial of health risk screening and motivational interviewing for young people presenting to general practice.

BACKGROUND: There are growing worldwide concerns about the ability of primary health care systems to manage the major burden of illness in young people. Over two thirds of premature adult deaths result from risks that manifest in adolescence, including injury, neuropsychiatric problems and consequences of risky behaviours. One policy response is to better reorientate primary health services towards prevention and early intervention. Currently, however, there is insufficient evidence to support this recommendation for young people. This paper describes the design and implementation of a trial testing an intervention to promote psychosocial risk screening of all young people attending general practice and to respond to identified risks using motivational interviewing. MAIN OUTCOMES: clinicians' detection of risk-taking and emotional distress, young people's intention to change and reduction of risk taking. SECONDARY OUTCOMES: pathways to care, trust in the clinician and likelihood of returning for future visits. The design of the economic and process evaluation are not detailed in this protocol. METHODS: PARTY is a cluster randomised trial recruiting 42 general practices in Victoria, Australia. Baseline measures include: youth friendly practice characteristics; practice staff's self-perceived competency in young people's care and clinicians' detection and response to risk taking behaviours and emotional distress in 14-24 year olds, attending the practice. Practices are then stratified by a social disadvantage index and billing methods and randomised. Intervention practices receive: nine hours of training and tools; feedback of their baseline data and two practice visits over six weeks. Comparison practices receive a three hour seminar in youth friendly practice only. Six weeks post-intervention, 30 consecutive young people are interviewed post-consultation from each practice and followed-up for self-reported risk taking behaviour and emotional distress three and 12 months post consultation. DISCUSSION: The PARTY trial is the first to examine the effectiveness and efficiency of a psychosocial risk screening and counselling intervention for young people attending primary care. It will provide important data on health risk profiles of young people attending general practice and on the effects of the intervention on engagement with primary care and health outcomes over 12 months. TRIAL REGISTRATION: ISRCTN16059206.

Supportive-expressive group therapy for women with metastatic breast cancer: survival and psychosocial outcome from a randomized controlled trial.

BACKGROUND: Mixed reports exist about the impact of supportive-expressive group therapy (SEGT) on survival. METHODS: From 485 women with advanced breast cancer recruited between 1996-2002, 227 (47%) consented and were randomized within an average 10 months of cancer recurrence in a 2:1 ratio to intervention with 1 year or more of weekly SEGT plus three classes of relaxation therapy (147 women) or to control receiving three classes of relaxation therapy (80 women). The primary outcome was survival; psychosocial well-being was appraised secondarily. Analysis was by intention-to-treat. RESULTS: SEGT did not prolong survival (median survival 24.0 months in SEGT and 18.3 in controls; univariate hazard ratio for death 0.92 [95% CI, 0.69-1.26]; multivariate hazard ratio, 1.06 [95% CI, 0.74-1.51]). Significant predictors of survival were treatment with chemotherapy and hormone therapy (p<0.001), visceral metastases (p<0.001) and advanced disease at first diagnosis (p<0.05). SEGT ameliorated and prevented new DSM-IV depressive disorders (p = 0.002), reduced hopeless-helplessness (p = 0.004), trauma symptoms (p = 0.04) and improved social functioning (p = 0.03). CONCLUSIONS: SEGT did not prolong survival. It improved quality of life, including treatment of and protection against depression.

Psychological morbidity and quality of life in women with advanced breast cancer: a cross-sectional survey.

OBJECTIVE: Our purpose was to determine the frequency of psychiatric morbidity and to assess the quality of life of women with advanced breast cancer. METHODS: The 227 women in the sample were recruited in Melbourne, Australia, and were interviewed (prior to intervention) for a randomized controlled trial of supportive-expressive group therapy. The main outcome measures were DSM-IV psychiatric diagnoses plus quality of life data based on the EORTC QLQ-C30 (core) and QLQ-BR23 (breast module) instruments. RESULTS: Forty-two percent of the women (97/227) had a psychiatric disorder; 35.7% (81) of these had depression or anxiety or both. Specific diagnoses were minor depression in 58 women (25.6%), major depression in 16 (7%), anxiety disorder in 14 (6.2%), and phobic disorder in 9 (4%). Seventeen (7.5%) women had more than one disorder. In terms of quality of life, one-third felt less attractive, one-quarter were dissatisfied with their body image, and, in most, sexual interest had waned. Menopausal symptoms such as hot flashes affected less than one-third, whereas symptoms of lymphedema were experienced by 26 (11.5%). SIGNIFICANCE: Women with advanced breast cancer have high rates of psychiatric and psychological disturbance. Quality of life is substantially affected. Clinicians need to be vigilant in monitoring psychological adjustment as part of a comprehensive biopsychosocial approach.

Supportive-expressive group therapy: the transformation of existential ambivalence into creative living while enhancing adherence to anti-cancer therapies.

Supportive-Expressive Group Therapy (SEGT) has been developed and manualised in the research setting, but there have been few clinical accounts of its utility. In this qualitative review of its application in the Melbourne-based randomised control trial (RCT) for women with advanced breast cancer, SEGT is considered from the perspective of the structure and framework of therapy, its therapists, the issues that develop in exploring its common themes and what constitutes a well functioning group. Groups move through identifiable developmental phases. The mature group process transforms existential ambivalence into creative living, evidenced by humour, celebration, assertiveness, altruism, new creative pursuits and eventually courageous acceptance of dying. Challenges and pitfalls include avoidance, non-containment of ambivalence, intolerance of difference, anti-group phenomena and splitting. A key element is the medicalization of the group culture whereby members and co-therapists explore health beliefs and attitudes about care. This promotes compliance with anti-cancer treatments, including both the initiation of and perseverance with chemotherapy. This mechanism could prove to be a potentially important pathway in promoting longer survival.

Screening for depression in women with metastatic breast cancer: a comparison of the Beck Depression Inventory Short Form and the Hospital Anxiety and Depression Scale.

OBJECTIVE: To compare two self-report questionnaires for identifying possible depression in women with metastatic breast cancer. METHOD: We conducted structured psychiatric interviews and administered the Beck Depression Inventory Short Form (BDI-SF) and Hospital Anxiety and Depression Scale (HADS) to 227 women with stage IV breast cancer. The accuracy for identifying DSM-IV-defined major and minor depression was examined. Sensitivity, specificity, positive (PPV) and negative (NPV) predictive values were calculated and receiver operating characteristic curves plotted. RESULTS: Seventy-four (32.6%) patients satisfied DSM-IV criteria for a depressive disorder. With a cut-off of 4, the BDI-SF had a sensitivity of 0.84, specificity of 0.63, and PPV of 0.52. A cut-off of 11 on the HADS-Depression scale (HADS-D) resulted in sensitivity, specificity, and PPV of 0.16, 0.97, and 0.75, respectively. For major depression alone, the BDI-SF with a cut-off of 5 had excellent sensitivity but poor PPV; the HADS, with a cut-off of 7, had weak sensitivity and PPV. CONCLUSIONS: Overall, the two scales perform similarly in identifying major depression, while the BDI-SF is the more useful in screening for DSM-IV major or minor depression categories in this clinical group.

Psychiatric disorder in women with early stage and advanced breast cancer: a comparative analysis.

OBJECTIVE: To assess psychosocial morbidity in women with breast cancer and to compare the differential rates between women with early stage and advanced disease. METHOD: In this report, 303 women with early stage breast cancer, psychiatrically assessed at baseline (as part of a study of cognitive-existential group therapy during adjuvant chemotherapy), are compared with 200 women with advanced breast cancer (similarly assessed in a trial of supportive-expressive group therapy). A structured psychiatric interview plus self-report measures were used to assess psychiatric morbidity, quality of life and cognitive attitude to cancer. RESULTS: The early stage patients, whose mean age was 46 years, were on average 3 months post-surgery and had an overall prevalence of DSM-IV psychiatric diagnosis of 45%. The metastatic patients, whose mean age was 51 years, were on average 63 months post-primary diagnosis and had an overall prevalence of DSM-IV diagnosis of 42%; the difference between the two rates was not statistically significant. Of women with early stage breast cancer, 36.7% had mood disorders, 9.6% suffering from major depression and 27.1% from minor depression. In the metastatic sample 31% had mood disorders, 6.5% having major depression and 24.5% with minor depression. Anxiety disorders were present in 8.6% of the early stage group and 6% of women with advanced disease. Fatigue, a past history of depression, and cognitive attitudes of helplessness, hopelessness or resignation were significantly associated with depression in both groups. The women from the metastatic sample were significantly less distressed by hair loss but more dissatisfied with body image, and had higher rates of lymphoedema and hot flushes than the early stage women. CONCLUSIONS: The rates of psychosocial distress are high, and similar, across patients with both early and advanced stage breast cancer, although the illness related causes of distress are different. These data present a challenge to clinical services to provide a comprehensive range of support services to ameliorate this distress.