Incorporating patient-reported outcome measures (PROMs) into a clinical quality registry (CQR) for ovarian cancer: considerations and challenges.

As medical treatment increasingly focuses on improving health-related quality of life, patient-reported outcome measures (PROMs) are an essential component of clinical research. The National Gynae-Oncology Registry (NGOR) is an Australian clinical quality registry. A suitable PROM was required for the NGOR ovarian cancer module to complement clinical outcomes and provide insights into outcomes important to patients. Our narrative review aimed to identify existing ovarian cancer-specific PROMs and ascertain which tool would be most appropriate for implementation into the NGOR ovarian cancer module.A literature review of Cochrane Library, Embase, MEDLINE and PubMed databases was performed to identify existing ovarian cancer-specific PROM tools. A steering committee was convened to (1) determine the purpose of, and criteria for our required PROM; and (2) to review the available tools against the criteria and recommend the most appropriate one for implementation within the NGOR.The literature review yielded five tools: MOST, EORTC QLQ-OV28, FACIT-O, NFOSI-18 and QOL-OVCA. All were developed and validated for use in clinical trials, but none had been validated for use in clinical quality registry. Our expert steering committee pre-determined purpose of a PROM tool for use within the NGOR was to enable cross-service comparison and benchmarking to drive quality improvements. They identified that while there was no ideal, pre-existing, ovarian cancer-specific PROM tool for implementation into the NGOR, on the basis of its psychometric properties, its available translations, its length and its ability to be adapted, the EORTC tool is most fit-for-purpose for integration into the NGOR.This process enabled identification of the tool most appropriate to provide insights into how ovarian cancer treatments impact patients' quality of life and permit benchmarking across health services.

A Comparison of Adolescent versus Young Adult Outpatients with First-Presentation Borderline Personality Disorder: Findings from the MOBY Randomized Controlled Trial.

OBJECTIVE: The increasing focus on adolescent personality disorder has tended to ignore evidence of the developmental continuity of the period from puberty to young adulthood. This study aims to: (1) describe the characteristics of a sample of young people with borderline personality disorder (BPD) who had no previous history of evidence-based treatment for the disorder and (2) compare their characteristics by participant age group. METHODS: One hundred and thirty-nine young people (15 to 25 years) with BPD, newly enrolled in the Monitoring Outcomes of BPD in Youth randomized controlled trial, completed semi-structured interview and self-report measures assessing demographic, clinical, and functional characteristics. Younger (aged 15 to 17 years; n = 64) and older (aged 18 to 25 years; n = 75) participants were compared on these same variables using t-tests, chi-square tests, and logistic regression. RESULTS: Young outpatients with BPD had extensive and severe psychopathology and were functioning poorly. Adolescents and young adults with BPD showed substantial similarities on 20 key aspects of their presentation. Significant between-groups differences were observed in household makeup, treatment history, antisocial personality disorder, emotion dysregulation, substance use, age of commencement and extent of self-harm, and achievement of age-appropriate educational milestones. Adolescent BPD group membership was predicted by family composition and self-harm, whereas young adult BPD group membership was predicted by not achieving age-appropriate milestones, vocational disengagement, and emotion dysregulation. The final model explained 54% of the variance and correctly classified 80.2% of the sample by age. CONCLUSIONS: Both adolescents and young adults with early stage BPD present with severe and often similar problems to one another, supporting developmental continuity across this age range. However, there are also meaningful differences in presentation, suggesting that pathways to care might differ by age and/or developmental stage. Detection and intervention for personality disorder should not be delayed until individuals reach 18 years of age.

Effect of 3 Forms of Early Intervention for Young People With Borderline Personality Disorder: The MOBY Randomized Clinical Trial.

Importance: Clinical trials have neither focused on early intervention for psychosocial impairment nor on the contribution of components of borderline personality disorder (BPD) treatment beyond individual psychotherapy. Objective: To evaluate the effectiveness of 3 early interventions for BPD of differing complexity. Design, Settings, and Participants: This single-blinded randomized clinical trial recruited young people between March 17, 2011, and September 30, 2015, into parallel groups. The study took place at 2 government-funded mental health services for young people in Melbourne, Australia. Inclusion criteria were age 15 to 25 years (inclusive), recent DSM-IV-TR BPD diagnosis, and never receiving evidence-based BPD treatment. A total of 139 participants were randomized (pool of 876; 70 declined, 667 excluded), balanced for sex, age, and depressive symptomatology. Data analysis completed May 2020. Interventions: (1) The Helping Young People Early (HYPE) dedicated BPD service model for young people, combined with weekly cognitive analytic therapy (CAT); (2) HYPE combined with a weekly befriending psychotherapy control condition; and (3) a general youth mental health service (YMHS) model, combined with befriending. Therefore, the 3 treatment arms were HYPE + CAT, HYPE + befriending, and YMHS + befriending. Participants were randomly assigned both to 1 treatment arm (in a 1:1:1 ratio) and to a clinician. Main Outcomes and Measures: Psychosocial functioning, measured with the Inventory of Interpersonal Problems Circumplex Version and the Social Adjustment Scale Self-report. Results: One hundred twenty-eight participants (104 [81.3%] were female; mean [SD] age, 19.1 [2.8] years; HYPE + CAT: 40 [31.3%]; HYPE + befriending: 45 [35.2%]; YMHS + befriending: 43 [33.6%]) who provided postbaseline data were included in the intent-to-treat analysis. Regardless of group, from baseline to 12 months, there was a mean of 19.3% to 23.8% improvement in the primary outcomes and 40.7% to 52.7% for all secondary outcomes, except severity of substance use and client satisfaction. The latter remained high across all time points. Planned comparisons (YMHS + befriending vs HYPE; HYPE + CAT vs befriending) showed that neither the service model nor the psychotherapy intervention was associated with a superior rate of change in psychosocial functioning by the 12-month primary end point. The HYPE service model was superior to YMHS + befriending for treatment attendance (median [IQR], 22 [19] vs 3 [16] contacts; median duration, 200 [139.5] vs 94 [125] days) and treatment completion (44 of 92 [47.8%] vs 9 of 47 [19.2%]). HYPE + CAT was superior to befriending for treatment attendance (median [IQR], 12 [16.5] vs 3 [9.8] sessions) and treatment completion (24 of 46 [52.2%] vs 29 of 93 [31.2%]). Conclusions and Relevance: In this randomized clinical trial of 3 interventions for young people with BPD, effective early intervention was not reliant on availability of specialist psychotherapy but did require youth-oriented clinical case management and psychiatric care. A dedicated early intervention BPD service model (HYPE), with or without individual psychotherapy, achieved greater treatment attendance and completion, making it more likely to meet service user, family, and community expectations of care. Trial Registration: anzctr.org.au Identifier: ACTRN12610000100099.

Codesigning a supportive online resource for Australian cancer carers: a thematic analysis of informal carers' and healthcare professionals' perspectives about carers' responsibilities and content needs.

OBJECTIVE: To gather preliminary qualitative data that will assist in the codesign and development of a new informational and supportive website to assist informal cancer carers in Australia. DESIGN AND SETTING: Utilising a previously tested codesign process, informal carers' experiences and perspectives, including those of healthcare professionals', were examined via focus groups and/or interviews. Data were analysed via thematic analysis. PARTICIPANTS: Rural (n=9) and urban (n=11) carers', and healthcare professionals' (n=8) perspectives were collected. Carers participated in a focus group (n=9) or telephone interview (n=11). Healthcare professionals completed an interview (n=6) or online survey (n=2). RESULTS: Rural and urban carers typically felt ill prepared for their multitudinal caregiving responsibilities. Supporting patient-to-healthcare professional liaisons could especially challenge. Carers' biopsychosocial and fiscal strains were affected by patients' hardships and available informal supports. Rural carers described greater social support than urban carers. Both rural and urban carers also described discontentment related to a carer neglecting healthcare system. Both carers and healthcare professionals endorsed the need for a user-friendly, carer-specific website encompassing practical information and resources, peer-driven advice and evidence-based illness information, tailored to the Australian context. CONCLUSIONS: Carers and healthcare professionals recognise the pressing need for an Australian, cancer carer-specific online resource. Findings will inform the next phase, where a resource will be designed, developed and tested.

Comorbid externalising behaviour in AD/HD: evidence for a distinct pathological entity in adolescence.

While the profiling of subtypes of Attention Deficit Hyperactivity Disorder (AD/HD) have been the subject of considerable scrutiny, both psychometrically and psychophysiologically, little attention has been paid to the effect of diagnoses comorbid with AD/HD on such profiles. This is despite the greater than 80% prevalence of comorbidity under the DSM-IV-TR diagnostic definitions. Here we investigate the event related potential (ERP) and psychometric profiles of Controls, AD/HD, and comorbid AD/HD (particularly AD/HD+ODD/CD) groups on six neurocognitive tasks thought to probe the constructs of selective and sustained attention, response inhibition and executive function. Data from 29 parameters extracted from a child group (age range 6 to 12; 52 Controls and 64 AD/HD) and from an adolescent group (age range 13 to 17; 79 Controls and 88 AD/HD) were reduced via a Principal Components Analysis, the 6 significant eigenvectors then used as determinants of cluster membership via a Two-Step Cluster Analysis. Two clusters were found in the analysis of the adolescent age group--a cluster dominated by Control and AD/HD participants without comorbidity, while the second cluster was dominated by AD/HD participants with externalising comorbidity (largely oppositional defiant/conduct disorder ODD/CD). A similar segregation within the child age group was not found. Further analysis of these objectively determined clusters in terms of their clinical diagnoses indicates a significant effect of ODD/CD comorbidity on a concurrent AD/HD diagnosis. We conclude that comorbid externalising behaviour in AD/HD constitutes a distinct pathological entity in adolescence.