Variation in ovarian cancer care in Australia: An analysis of patterns of care in diagnosis and initial treatment in New South Wales.

OBJECTIVE: Ovarian cancer has the highest mortality of all gynaecological cancers. This study aimed to identify the extent to which women across New South Wales experienced variation in their care in diagnosis and initial treatment for ovarian cancer against the national optimal care pathway for ovarian cancer. METHOD: Clinical audit methodology was utilised to explore variations for women with primary ovarian cancer; 171 eligible cases were identified through by the NSW Cancer Registry for the period of 1 March 2017 to 28 February 2018. RESULTS: Limited variation was detected with 86% of women being reviewed by a specialist gynaecological oncology multidisciplinary team; 54% of women received their first treatment within 28 days of their first specialist appointment, 66% of women having their first surgery completed by a gynaecological oncologist and 45% of women received their first treatment in a specialist gynaecological oncology hospital. CONCLUSION: Deviation from effective ovarian cancer care is apparent particularly in the location and timeliness of first treatment, with implications for the quality of care received and care outcomes. Understanding factors that contribute to variation is critical to ensure optimal and appropriate ovarian cancer care and to tackle systemic barriers to the provision of effective care.

Patterns of surgical care for women with ovarian cancer in New South Wales.

BACKGROUND: Little is known about the delivery of surgical services and outcomes for women with ovarian cancer across New South Wales (NSW). AIM: The study objective was to provide a descriptive analysis of the proportion of women who had surgery for ovarian cancer in NSW in specialist gynaecological oncology hospitals and compare outcomes for women attending specialist and non-specialist services in NSW. MATERIALS AND METHODS: This study is a retrospective analysis of women with primary ovarian, fallopian tube or peritoneal cancer from 2009 to 2012. Data were analysed from the NSW Cancer Registry, NSW Admitted Patient Data Collection and Register of Births Deaths and Marriages. Treating hospitals were characterised as public specialist, public non-specialist and private. Morbidity and mortality outcomes are reported. RESULTS: The study included 1106 women. Fifty-seven hospitals performed surgery: seven public specialist, 27 private and 23 public non-specialist hospitals. The highest proportion of surgery was performed in public specialist hospitals (61%). There was considerable variation in the utilisation of public specialist hospitals between local health districts. There was no significant difference in outcomes related to the type of hospital where surgery was performed. CONCLUSIONS: Although the majority of women are having surgery in a specialist gynaecological oncology public hospital across NSW, many are not. Women living in regional and remote NSW were less likely to have their surgery in a specialist hospital. This is the first step in understanding where women in NSW are currently receiving their surgical care, as well as the outcomes related to this.

Comparison of outcomes from a phase 3 study of age-related macular degeneration with a matched, observational cohort.

OBJECTIVE: To compare outcomes of intravitreal therapy from an observational study cohort with those of participants receiving treatment in the Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab (MARINA) for the treatment of neovascular age-related macular degeneration (wet AMD). DESIGN: Database observational study. Participants in the observational cohort were chosen to match demographic features and entry criteria of the treatment group from MARINA. Outcomes over 12 months were compared. PARTICIPANTS: Eight hundred twenty-one anti-vascular endothelial growth factor (anti-VEGF)-naïve eyes treated with ranibizumab with 12 months or more of follow-up were included in the total Fight Retinal Blindness! (FRB-All) cohort, whereas a subset of this cohort of 401 eyes who were matched to the MARINA treatment group were included as the FRB-MARINA cohort. INTERVENTION: Intravitreal ranibizumab therapy of 0.5 mg for wet AMD. METHODS: Visual acuity (VA) in logarithm of the minimum angle of resolution (logMAR) letters and treatments given were recorded continuously and anonymously in an electronic database for 12 months. Locally weighted scatterplot smoothing (LOESS) regression was used to plot change in visual acuity data over the course of 12 months for both the FRB-All cohort and the FRB-MARINA cohort, whereas results from the MARINA trial were taken from the published study report. MAIN OUTCOME MEASURES: Change in VA in logMAR letters over 12 months, treatment, and visit intensity. RESULTS: Mean visual acuity improvement after 12 months in FRB-MARINA (+5.5 letters) was similar to that of the 0.5-mg group from MARINA (+7.2 letters). Improvement in FRB-ALL was slightly less (+4.9 letters). Mean treatment effect compared with the MARINA control group was similar for the MARINA treated group (+17.6 letters) and the FRB-MARINA cohort (+15.9 letters). A mean of 7.3 injections in 12 months was received by the observational cohorts. CONCLUSIONS: Similarity of mean VA improvement in the matched observational cohort with that of the phase 3 clinical trial suggests that these results can be achieved in real-world clinical practice with a modified treatment regimen.

Clinical and functional outcomes in patients with major depressive disorder and painful physical symptoms switched to treatment with duloxetine.

OBJECTIVE: This post hoc analysis of a multicenter, single-arm, open-label trial (the Attributes of Response in Depressed Patients Switched to Treatment with Duloxetine [ARDENT] study) assessed the relationship between functional improvement in the Sheehan Disability Scale (SDS) and clinical outcomes of mood, pain, and anxiety over 8 weeks after switching treatment to duloxetine in patients with major depressive disorder. METHODS: Analyses included all 195 patients who completed the study. Pearson's correlation and multivariate regression analyses were used to evaluate the relationship between change from baseline in SDS total score and 17-item Hamilton Rating Scale for Depression (HAMD(17)) Maier score (mood), Brief Pain Inventory-Short Form average pain score (pain), and Hamilton Anxiety Rating Scale total score (anxiety) at week 8. RESULTS: At week 8, change in SDS total score was positively correlated with change in mood (r = 0.49), anxiety (r = 0.44), and pain (r = 0.40). Multivariate linear regression coefficients for mood and pain were estimated at 1.21 (standard error [SE] = 0.184) and 1.16 (SE = 0.180), respectively (both p < 0.0001) compared with 0.02 (SE = 0.097; p = 0.82) for anxiety. Overall, 43% of patients achieved both HAMD(17) and SDS total remission. CONCLUSIONS: Functional improvement at 8 weeks was positively correlated with mood, pain, and anxiety in patients with major depressive disorder switched to duloxetine. Change in mood and pain exerted a relatively stronger joint effect on functioning than did anxiety in this patient population. Copyright © 2011 John Wiley & Sons, Ltd.

The integral inventory for depression, a new, self-rated clinimetric instrument for the emotional and painful dimensions in major depressive disorder.

OBJECTIVE: To assess the reliability and validity of the Integral Inventory for Depression (IID) scale using post hoc analyses of data from a multi-country study (ClinicalTrials.gov: NCT00561509) of patients with major depressive disorder (MDD). METHODS: Patients (N = 1629) completed the IID (comprising two separate dimensions for emotional and physically painful symptoms; maximum score of 65) and a reference scale (16-item Quick Inventory of Depressive Symptomatology Self-Report) at baseline and at follow-up (8 and 24 weeks). Physicians rated MDD symptoms using the Clinical Global Impressions of Severity scale at each visit. Inter-item correlation, internal consistency, external validity, factor structure, and exploratory analysis of an optimal severity cut-off point were assessed. RESULTS: The IID displayed two distinct dimensions (i.e. painful and emotional) with little item redundancy and good internal consistency (Cronbach's α > 0.83 at each visit). The IID displayed good external validity (Pearson's correlations coefficients >0.60 at each visit) and statistically significant agreement (McNemar's test; P < 0.001 at follow-up) with the reference scale. Results suggest that a cut-off score of ≤24 had adequate precision (>80%) to identify patients with and without moderate MDD. CONCLUSIONS: Results suggest that the IID may be a reliable and valid tool for assessing emotional and painful symptoms of MDD.

Relative association of treatment-emergent adverse events with quality of life of patients with schizophrenia: post hoc analysis from a 3-year observational study.

OBJECTIVE: To explore the relative association of adverse events with health-related quality of life (HRQL) in patients (N = 16 091) with schizophrenia, treated with antipsychotic medication. METHODS: In this post hoc analysis of data from two 3-year observational studies, a mixed effects model with repeated measures was used to evaluate the association between HRQL (EuroQoL visual analogue scale (EQ-VAS)) and pre-specified covariates including: severity of illness, extrapyramidal symptoms, tardive dyskinesia, sexual dysfunction, and clinically significant weight gain (> 7% increase from baseline after > or = 3 months of treatment). RESULTS: Mean EQ-VAS increased from 47.8 +/- 21.7 at baseline to 72.4 +/- 18.4 after 36 months. The rank order of the negative association of adverse events with HRQL was: sexual dysfunction (effect estimate -4.04; 95% CI -4.30 to -3.79), extrapyramidal symptoms (effect estimate -2.09; 95% CI -2.43 to -1.75), and tardive dyskinesia (effect estimate -0.89; 95% CI -1.46 to -0.32). CONCLUSIONS: Differences were observed in the direction and magnitude of the association between each adverse event and HRQL. Recognition of the relative association of adverse events with HRQL may contribute to improved adherence of patients with schizophrenia to antipsychotic therapy.

How oppositionality, inattention, and hyperactivity affect response to atomoxetine versus methylphenidate: a pooled meta-analysis.

OBJECTIVE: To assess how threshold oppositional defiant disorder (ODD), inattention, and hyperactivity-impulsivity affect the response to atomoxetine versus methylphenidate. METHOD: Systematic review of randomized controlled trials (RCTs; ≥6 weeks follow-up). The primary measure was core symptom response-≥40% reduction in ADHD Rating Scale-IV-Parent Version: investigator administered and scored total or domain subscores, as appropriate. RESULTS: Data from 1,391 children and adolescents (823 atomoxetine, 568 methylphenidate; 7 RCTs) were meta-analyzed. The mean difference in response rates for patients with ODD was 0.6% (95% confidence interval [CI] = -11.9%-13.1%). The "without ODD" patient group showed significant between-trial heterogeneity (p < .001). Response rate differences for patients meeting the threshold for inattention or hyperactivity-impulsivity were -3.1% (95% CI = -11.5%-5.3%) and -4.9% (95% CI = -14.3%-4.4%), respectively. CONCLUSIONS: Meeting the threshold criteria for oppositionality, inattention, or hyperactivity-impulsivity did not alter core ADHD symptom response to atomoxetine versus methylphenidate, which was equivalent.

Core ADHD symptom improvement with atomoxetine versus methylphenidate: a direct comparison meta-analysis.

OBJECTIVE: Previous studies comparing atomoxetine and methylphenidate to treat ADHD symptoms have been equivocal. This noninferiority meta-analysis compared core ADHD symptom response between atomoxetine and methylphenidate in children and adolescents. METHOD: Selection criteria included randomized, controlled design; duration 6 weeks; and assessment of ADHD Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS) scores. Six-week response rates, defined as ≥40% reduction in ADHDRS total score, were compared using a noninferiority margin of -15%. RESULTS: Seven studies met inclusion criteria (N = 1,368). After 6 weeks, 53.6% (95% confidence interval [CI] 48.6%-58.4%) of atomoxetine-treated patients (n = 811) had responded compared with 54.4% (47.6%-61.1%) for methylphenidate (n = 557), with atomoxetine demonstrating noninferiority to methylphenidate (absolute difference -0.9%, 95% CI -9.2%-7.5%). CONCLUSION: After 6 weeks of treatment atomoxetine and methylphenidate had comparable efficacy in reducing core ADHD symptoms in children and adolescents.