Economic evaluation of Australian stroke services: a prospective, multicenter study comparing dedicated stroke units with other care modalities

Background and Purpose: Level I evidence from randomized controlled trials demonstrates that the model of hospital care influences stroke outcomes; however, the economic evaluation of such is limited. An economic appraisal of 3 acute stroke care models was facilitated through the Stroke Care Outcomes: Providing Effective Services (SCOPES) study in Melbourne, Australia. The aim was to describe resource use up to 28 weeks poststroke for each model and examine the cost-effectiveness of stroke care units (SCUs). Methods: A prospective, multicenter, cohort study design was used. Costs and outcomes of stroke patients receiving 100% treatment in 1 of 3 inpatient care models (SCUs, mobile service, conventional care) were compared. Health-sector resource use up to 28 weeks was measured in 1999. Outcomes were thorough adherence to a suite of important clinical processes and the number of severe inpatient complications. Results: The sample comprised 395 participants (mean age 73 [SD 14], 77% first-ever strokes, males 53%). When compared with conventional care (n=84), costs for mobile service (n=209) were significantly higher (P=0.024), but borderline for SCU (n=102, P=0.08; $AUD12 251; $AUD15 903; $AUD15 383 respectively). This was primarily explained by the greater use of specialist medical services. The incremental cost-effectiveness of SCUs over conventional care was $AUD9867 per patient achieving thorough adherence to clinical processes and $AUD16 372 per patient with severe complications avoided, based on costs to 28 weeks. Conclusions: Although acute SCU costs are generally higher, they are more cost-effective than either mobile service or conventional care.

Rationale and design of the national benchmarking and evidence-based national clinical guidelines for chronic heart failure management programs study

OBJECTIVES: The National Benchmarks and Evidence-Based National Clinical Guidelines for Heart Failure Management Programs Study is a national, multicenter study designed to determine the nature, range, and effect of interventions applied by chronic heart failure management programs (CHF-MPs) throughout Australia on patient outcomes. Its primary objective is to use these data to develop national benchmarks and evidence-based clinical guidelines and optimize their cost-effective application by reducing quality and outcome variability. DATA SOURCES/STUDY SETTING: Primary data will be collected from CHF-MP coordinators and CHF patients enrolled in these programs on a national basis. Secondary outcome data will be collected from a national morbidity record and from patients' medical records. STUDY DESIGN: Stage I of the study involves a prospective clinical audit of all CHF-MPs throughout Australia (n = 45) to determine the extent of variability in programs currently. Stage II is a prospective cross-sectional survey design enrolling 1,500 patients (average of 40 patients per program) to firstly determine the typical profile of patients being managed via a CHF-MP in Australia and, secondly, the subsequent morbidity and mortality during the 6-month follow-up. Outcome data will be subject to multivariate analysis to determine the key components of care in this regard. All study data will be then examined in the final stage of the study (III) to develop national benchmarks for the application and auditing of CHF-MPs in Australia. CONCLUSION: Variability in patient outcomes is a product of heterogeneity among CHF-MPs. The development of national benchmarks will minimize such heterogeneity and will provide a greater level of evidence for their cost-effective application.

Should older people in residential care receive vitamin D to prevent falls? Results of a randomized trial

Objectives: To determine whether vitamin D supplementation can reduce the incidence of falls and fractures in older people in residential care who are not classically vitamin D deficient.

Design: Randomized, placebo-controlled double-blind, trial of 2 years' duration.

Setting: Multicenter study in 60 hostels (assisted living facilities) and 89 nursing homes across Australia.

Participants: Six hundred twenty-five residents (mean age 83.4) with serum 25-hydroxyvitamin D levels between 25 and 90 nmol/L.

Intervention: Vitamin D supplementation (ergocalciferol, initially 10,000 IU given once weekly and then 1,000 IU daily) or placebo for 2 years. All subjects received 600 mg of elemental calcium daily as calcium carbonate.

Measurements: Falls and fractures recorded prospectively in study diaries by care staff.

Results: The vitamin D and placebo groups had similar baseline characteristics. In intention-to-treat analysis, the incident rate ratio for falling was 0.73 (95% confidence interval (CI)=0.57–0.95). The odds ratio for ever falling was 0.82 (95% CI=0.59–1.12) and for ever fracturing was 0.69 (95% CI=0.40–1.18). An a priori subgroup analysis of subjects who took at least half the prescribed capsules (n=540), demonstrated an incident rate ratio for falls of 0.63 (95% CI=0.48–0.82), an odds ratio (OR) for ever falling of 0.70 (95% CI=0.50–0.99), and an OR for ever fracturing of 0.68 (95% CI=0.38–1.22).

Conclusion: Older people in residential care can reduce their incidence of falls if they take a vitamin D supplement for 2 years even if they are not initially classically vitamin D deficient.

The role of the medical emergency team in end-of-life care : a multicenter, prospective, observational study

Objective: To investigate the role of medical emergency teams in end-of-life care planning.

Design: One month prospective audit of medical emergency team calls.

Setting: Seven university-affiliated hospitals in Australia, Canada, and Sweden.

Patients: Five hundred eighteen patients who received a medical emergency team call over 1 month.

Interventions: None.

Measurements and Main Results: There were 652 medical emergency team calls in 518 patients, with multiple calls in 99 (19.1%) patients. There were 161 (31.1%) patients with limitations of medical therapy during the study period. The limitation of medical therapy was instituted in 105 (20.3%) and 56 (10.8%) patients before and after the medical emergency team call, respectively. In 78 patients who died with a limitation of medical therapy in place, the last medical emergency team review was on the day of death in 29.5% of patients, and within 2 days in another 28.2%. Compared with patients who did not have a limitation of medical therapy, those with a limitation of medical therapy were older (80 vs. 66 yrs; p < .001), less likely to be male (44.1% vs. 55.7%; p .014), more likely to be medical admissions (70.8% vs. 51.3%; p < .001), and less likely to be admitted from home (74.5% vs. 92.2%, p < .001). In addition, those with a limitation of medical therapy were less likely to be discharged home (22.4% vs. 63.6%; p < .001) and more likely to die in hospital (48.4% vs. 12.3%; p < .001). There was a trend for increased likelihood of calls associated with limitations of medical therapy to occur out of hours (51.0% vs. 43.8%, p .089).

Conclusions: Issues around end-of-life care and limitations of medical therapy arose in approximately one-third of calls, suggesting a mismatch between patient needs for end-of-life care and resources at participating hospitals. These calls frequently occur in elderly medical patients and out of hours. Many such patients do not return home, and half die in hospital. There is a need for improved advanced care planning in our hospitals, and to confirm our findings in other organizations.

Adolescent depressive disorders and family based interventions in the family options multicenter evaluation: study protocol for a randomized controlled trial

Background
There is increasing community and government recognition of the magnitude and impact of adolescent depression. Family based interventions have significant potential to address known risk factors for adolescent depression and could be an effective way of engaging adolescents in treatment. The evidence for family based treatments of adolescent depression is not well developed. The objective of this clinical trial is to determine whether a family based intervention can reduce rates of unipolar depressive disorders in adolescents, improve family functioning and engage adolescents who are reluctant to access mental health services.

Methods/Design
The Family Options study will determine whether a manualized family based intervention designed to target both individual and family based factors in adolescent depression (BEST MOOD) will be more effective in reducing unipolar depressive disorders than an active (standard practice) control condition consisting of a parenting group using supportive techniques (PAST). The study is a multicenter effectiveness randomized controlled trial. Both interventions are delivered in group format over eight weekly sessions, of two hours per session. We will recruit 160 adolescents (12 to 18 years old) and their families, randomized equally to each treatment condition. Participants will be assessed at baseline, eight weeks and 20 weeks. Assessment of eligibility and primary outcome will be conducted using the KID-SCID structured clinical interview via adolescent and parent self-report. Assessments of family mental health, functioning and therapeutic processes will also be conducted. Data will be analyzed using Multilevel Mixed Modeling accounting for time x treatment effects and random effects for group and family characteristics. This trial is currently recruiting. Challenges in design and implementation to-date are discussed. These include diagnosis and differential diagnosis of mental disorders in the context of adolescent development, non-compliance of adolescents with requirements of assessment, questionnaire completion and treatment attendance, breaking randomization, and measuring the complexity of change in the context of a family-based intervention.

Validation of patient health questionnaire (PHQ) for major depression in Chinese outpatients with multiple somatic symptoms: A multicenter cross-sectional study

Background: Despite the high co-morbidity of depressive symptoms in patients with multiple somatic symptoms, the validity of the 9-item Patient Health Questionnaire (PHQ-9) has not yet been investigated in Chinese patients with multiple somatic symptoms. Methods: The multicenter cross-sectional study was conducted in ten outpatient departments located in four cities in China. The psychometric properties of the PHQ-9 were examined by confirmative factor analysis (CFA). Criterion validation was undertaken by comparing results with depression diagnoses obtained from the Mini International Neuropsychiatric Interview (MINI) as the gold standard. Results: Overall, 491 patients were recruited of whom 237 had multiple somatic symptoms (SOM+ group, PHQ-15 ≥ 10). Cronbach's α of the PHQ-9 was 0.87, 0.87, and 0.90 for SOM+ patients, SOM- patients, and total sample respectively. All items and the total score were moderately correlated. The factor models of PHQ-9 tested by CFA yielded similar diagnostic performance when compared to sum score estimation. Multi-group confirmatory factor analysis based on unidimensional model showed similar psychometric properties over the groups with low and high somatic symptom burden. The optimal cut-off point to detect depression in Chinese outpatients was 10 for PHQ-9 (sensitivity=0.77, specificity=0.76) and 3 for PHQ-2 (sensitivity=0.77, specificity=0.74). Limitations: Potential selection bias and nonresponse bias with applied sampling method. Conclusions: PHQ-9 (cut-off point=10) and PHQ-2 (cut-off point=3) were reliable and valid to detect major depression in Chinese patients with multiple somatic symptoms.

Association between surgical indications, operative risk, and clinical outcome in infective endocarditis: a prospective study from the International Collaboration on Endocarditis.

Use of surgery for the treatment of infective endocarditis (IE) as related to surgical indications and operative risk for mortality has not been well defined.

Prospective observational study of emergent endotracheal intubation practice in the intensive care unit and emergency department of an Australian regional tertiary hospital

Objective: The present study aimed to describe the characteristics and outcomes of intubation occurring in the ICU and ED of an Australian tertiary teaching hospital. Methods: This was a prospective observational study of intubation practice across the Geelong Hospital over a 6 month period from 1 August 2012 to 31 January 2013. Data were entered by the intubating team through an online data collection form. Results: There were 119 patients intubated and 134 attempts at intubation in the ED and ICU over a 6 month period. The first-pass success rate was 104/119 (87.4%), and all but a single patient was intubated by the second attempt. Propofol, fentanyl, midazolam and suxamethonium were the most common drugs used in rapid sequence induction. AEs were reported in 44/134 (32.8%) of intubation attempts, with transient hypoxia and hypotension being the most common. A significant adverse outcome, namely aspiration pneumonitis, occurred in one patient. There were no peri-intubation deaths. Conclusion: The majority of airways are managed by ICU and ED consultants and trainees, with success rates and AE rates comparable with other published studies. © 2014 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

The ProCaSP study: quality of life outcomes of prostate cancer patients after radiotherapy or radical prostatectomy in a cohort study urological oncology

Background: This study describes and compares health-related quality of life (HRQOL) of prostate cancer patients who received either radical prostatectomy (nerve-sparing, nsRP, or non-nerve-sparing, nnsRP) or radiotherapy (external RT, brachytherapy, or both combined) for treatment of localised prostate cancer. Methods: The prospective, multicenter cohort study included 529 patients. Questionnaires included the IIEF, QLQ-C30, and PORPUS-P. Data were collected before (baseline), three, six, twelve, and twenty-four months after treatment. Differences between groups' baseline characteristics were assessed; changes over time were analysed with generalised estimating equations (GEE). Missing values were treated with multiple imputation. Further, scores at baseline and end of follow-up were compared to German reference data. Results: The typical time trend was a decrease of average HRQOL three months after treatment followed by (partial) recovery. RP patients experienced considerable impairment in sexual functioning. The covariate-adjusted GEE identified a significant - but not clinically relevant - treatment effect for diarrhoea (b∈=∈7.0 for RT, p∈=∈0.006) and PORPUS-P (b∈=∈2.3 for nsRP, b∈=∈2.2 for RT, p∈=∈0.045) compared to the reference nnsRP. Most of the HRQOL scores were comparable to German norm values. Conclusions: Findings from previous research were reproduced in a specific setting of a patient cohort in the German health care system. According to the principle of evidence-based medicine, this strengthens the messages regarding treatment in prostate cancer and its impacts on patients' health-related quality of life. After adjustment for baseline HRQOL and other covariates, RT patients reported increased symptoms of diarrhoea, and nnsRP patients decreased prostate-specific HRQOL. RP patients experienced considerable impairment in sexual functioning. These differences should be taken into account by physicians when choosing the best therapy for a patient.

Multicenter randomized controlled trial of a home walking intervention after outpatient cardiac rehabilitation on health-related quality of life in women

BACKGROUND: Poor health-related quality of life (HRQL) has been shown to be predictive of adverse outcomes in cardiac patients. As women with coronary heart disease have been shown to have lower HRQL than men with coronary heart disease, women are at greater risk of a poor clinical outcome. This study tested the effect of a 12-week home walking intervention after completion of outpatient cardiac rehabilitation (OCR) on HRQL and maintenance of physical activity among women. DESIGN: Multicenter two-group randomized trial. METHODS: After completion of OCR, participants were randomly allocated to the intervention or usual care groups. The outcomes were HRQL (assessed using the MacNew Heart Disease HRQL instrument) and self-reported physical activity (assessed using the Stages of Change model of exercise behavior) at 3, 6, and 12 months after OCR. RESULTS: Seventy-two women were randomized to the intervention and 81 to usual care. Attrition was greater in the treatment group (13 vs. 1%). HRQL scores increased relative to the base level in both arms and were significantly higher in the intervention group at 6 months, but not at 3 or 12 months. Maintenance of physical activity declined over time in both groups, however, this decline was significantly reduced among women in the intervention group. CONCLUSION: HRQL improved in both groups, but seemed to increase earlier among women in the intervention group. As maintenance of physical activity was higher among women in the intervention group, this minimal intervention could be used to facilitate women's progression from supervised to independent exercise.

Quality of life in children with advanced cancer: a report from the PediQUEST study

CONTEXT: Modifiable factors of health-related quality of life (HRQOL) are poorly described among children with advanced cancer. Symptom distress may be an important factor for intervention. OBJECTIVES: We aimed to describe patient-reported HRQOL and its relationship to symptom distress. METHODS: Prospective, longitudinal data from the multicenter Pediatric Quality of Life and Symptoms Technology study included primarily patient-reported symptom distress and HRQOL, measured at most weekly with the Memorial Symptoms Assessment Scale and Pediatric Quality of Life inventory, respectively. Associations were evaluated using linear mixed-effects models adjusting for sex, age, cancer type, intervention arm, treatment intensity, and time since disease progression. RESULTS: Of 104 enrolled patients, 49% were female, 89% were white, and median age was 12.6 years. Nine hundred and twenty surveys were completed over nine months of follow-up (84% by patients). The median total Pediatric Quality of Life score was 74 (interquartile range 63-87) and was "poor/fair" (e.g., <70) 38% of the time. "Poor/fair" categories were highest in physical (53%) and school (48%) compared to emotional (24%) and social (16%) subscores. Thirteen of 24 symptoms were independently associated with reductions in overall or domain-specific HRQOL. Patients commonly reported distress from two or more symptoms, corresponding to larger HRQOL score reductions. Neither cancer type, time since progression, treatment intensity, sex, nor age was associated with HRQOL scores in multivariable models. Among 25 children completing surveys during the last 12 weeks of life, 11 distressing symptoms were associated with reductions in HRQOL. CONCLUSION: Symptom distress is strongly associated with HRQOL. Future research should determine whether alleviating distressing symptoms improves HRQOL in children with advanced cancer.