From ownership to custodianship of tumor biopsy tissue in genomic testing: a mixed methods study of patient views.

Tumor mutation profiling (MP) is often conducted on tissue from biopsies conducted for clinical purposes (diagnostic tissue). We aimed to explore the views of patients with cancer on who should own tumor biopsy tissue, pay for its storage, and decide on its future use; and determine their attitudes to and predictors of undergoing additional biopsies if required for research purposes. In this mixed methods, cross-sectional study, patients with advanced solid cancers enrolled in the Molecular Screening and Therapeutics Program (n = 397) completed a questionnaire prior to undergoing MP (n = 356/397). A subset (n = 23) also completed a qualitative interview. Fifty percent of participants believed they and/or relatives should own and control access to diagnostic tissue. Most (65.5%) believed the government should pay for tissue preparation. Qualitative themes included (1) custodianship of diagnostic tissue, (2) changing value of tissue across time and between cultures, (3) equity regarding payment, and (4) cost-benefit considerations in deciding on additional biopsies. Policy and regulation should consider patient perspectives. Extension of publicly funded health care to include tissue retrieval for clinical trials should be considered.

Carer preparedness improved by providing a supportive educational intervention for carers of patients with high-grade glioma: RCT results.

BACKGROUND: High-grade glioma (HGG) is a rapidly progressing and debilitating disease. Family carers take on multiple responsibilities and experience high levels of distress. We aimed to deliver a nurse-led intervention (Care-IS) to carers to improve their preparedness to care and reduce distress. METHODS: We conducted a randomised controlled trial (ACTRN:12612001147875). Carers of HGG patients were recruited during patients' combined chemoradiation treatment. The complex intervention comprised four components: (1) initial telephone assessment of carer unmet needs; (2) tailored hard-copy resource folder; (3) home visit; and, (4) monthly telephone support for up to 12 months. Primary outcomes included preparedness for caregiving and distress at 2, 4, 6 and 12 months. Intervention effects were estimated using linear mixed models which included a time by group interaction. Secondary outcomes included anxiety, depression, quality of life, carer competence and strain. RESULTS: We randomised 188 carers (n = 98 intervention, n = 90 control). The intervention group reported significantly higher preparedness for caregiving at 4 months (model ß = 2.85, 95% CI 0.76-4.93) and all follow-up timepoints including 12 months (model ß = 4.35, 95% CI 2.08-6.62), compared to the control group. However, there was no difference between groups in carer distress or any secondary outcomes. CONCLUSIONS: This intervention was effective in improving carer preparedness. However, carer distress was not reduced, potentially due to the debilitating/progressive nature of HGG and ongoing caring responsibilities. Future research must explore whether carer interventions can improve carer adjustment, self-efficacy and coping and how we support carers after bereavement. Additionally, research is needed to determine how to implement carer support into practice.

Health-related quality of life of Australians during the 2020 COVID-19 pandemic: a comparison with pre-pandemic data and factors associated with poor outcomes.

PURPOSE: Compare the health-related quality of life (HRQL) of the Australian general population during the COVID-19 pandemic (2020) with pre-pandemic data (2015-2016) and identify pandemic-related and demographic factors associated with poorer HRQL. METHODS: Participants were quota sampled from an online panel by four regions (defined by active COVID-19 case numbers); then by age and sex. Participants completed an online survey about their HRQL [EORTC QLQ-C30 questionnaire and General Health Question (GHQ)], demographic characteristics, and the impact of the pandemic on daily life. HRQL scores were compared to a 2015-2016 reference sample using independent t-tests, adjusted for multiple testing. Associations between 22 pre-specified factors (pandemic-related and demographic) and 15 QLQ-C30 domains and GHQ, were assessed with multiple regressions. RESULTS: Most domains were statistically significantly worse for the 2020 sample (n = 1898) compared to the reference sample (n = 1979), except fatigue and pain. Differences were largest for the youngest group (18-29 years) for cognitive functioning, nausea, diarrhoea, and financial difficulties. Emotional functioning was worse for 2020 participants aged 18-59, but not for those 60 +. All models were statistically significant at p < .001; the most variance was explained for emotional functioning, QLQ-C30 global health/QOL, nausea/vomiting, GHQ, and financial difficulties. Generally, increased workload, negative COVID-19 impacts, COVID-19-related worries, and negative attitudes towards public health order compliance were associated with poorer HRQL outcomes. CONCLUSION: During the COVID-19 pandemic, Australians reported poorer HRQL relative to a pre-pandemic sample. Risk factors for poor HRQL outcomes included greater negative pandemic-related impacts, poorer compliance attitudes, and younger age. TRIAL REGISTRATION: ANZCTR number is: ACTRN12621001240831. Web address of your trial: https://www.anzctr.org.au/ACTRN12621001240831.aspx . Date submitted: 26/08/2021 2:56:53 PM. Date registered: 14/09/2021 9:40:31 AM. Registered by: Margaret-Ann Tait. Principal Investigator: Madeleine King.

Bereavement outcomes of carers of patients with high grade glioma: Experiences of support before and after the death.

Carers of people with High Grade Glioma (HGG) completed a survey assessing their anxiety, depression, and grief in addition to open-ended questions exploring their experiences of support pre- and post-death (N = 25). One-third reported borderline or clinical levels of anxiety, depression, and grief related distress. Given the poor prognosis and rapid deterioration of patients with HGG, the findings highlight the importance of sensitive communication about prognosis early in the disease trajectory, information tailored to disease stage, the initiation of a referral to psychological support services, and timely discussions about the preferred place of care and death.

Further validation of the Perceptions of Uncertainties in Genome Sequencing scale among patients with cancer undergoing tumor sequencing.

It is important to understand how individuals perceive uncertainties and the consequent impact on their psychological well-being and health behavior. The Perceptions of Uncertainties in Genome Sequencing (PUGS) scale measures clinical, affective, and evaluative uncertainties about information from sequencing. The PUGS scale has been shown to be valid and reliable among individuals receiving results about their genomes. This study assessed whether its validity generalized to patients with cancer undergoing tumor sequencing. Exploratory factor analysis (EFA) was conducted on data from the Molecular Screening and Therapeutics Program (n = 310) to identify a measurement model. Confirmatory factor analysis (CFA) was used to determine the adequacy of the resulting fit. EFA identified the same three-factor structure reported previously. CFA confirmed that the measurement model yielded a good fit (χ2 /df = 3.72, CFI = 0.96, SRMR = 0.05, and RMSEA = 0.09) and satisfied convergent and discriminant validity. These findings provide further evidence of the validity and reliability of the PUGS scale in measuring three types of uncertainty. Continued application will facilitate an evidence-based approach to intervention and enhance understanding of what it is like to receive results. In turn, this will improve clinical outcomes as undergoing sequencing becomes an increasingly common experience.

Evaluating patient-reported symptoms and late adverse effects following completion of first-line chemotherapy for ovarian cancer using the MOST (Measure of Ovarian Symptoms and Treatment concerns).

OBJECTIVES: Knowledge on the course of symptoms patients with ovarian cancer experience is limited. We documented the prevalence and trajectories of symptoms after first-line chemotherapy using the Measure of Ovarian Symptoms and Treatment concerns (MOST). METHODS: A total of 726 patients who received platinum-based chemotherapy for ovarian cancer were asked to complete the MOST every 3 months, beginning 6 months post-diagnosis and continuing for up to 4 years. We used descriptive statistics to examine temporal changes in MOST-S26 index scores for disease or treatment-related (MOST-DorT), neurotoxicity (MOST-NTx), abdominal (MOST-Abdo), and psychological (MOST-Psych) symptoms, and wellbeing (MOST-Wellbeing) and selected individual symptoms. We used group-based trajectory models to identify groups with persistently poor symptoms. RESULTS: The median MOST-Abdo, MOST-DorT and MOST-Wellbeing score were worst at chemotherapy-end but improved and stabilised by 1, 3 and 12 months after treatment, respectively. The median MOST-NTx score peaked at 1 month after treatment before improving, while the median MOST-Psych score did not change substantially over time. Long-term moderate-to-severe fatigue (32%), trouble sleeping (31%), sore hands and feet (21%), pins and needles (20%) and anxiety (18%) were common. Trajectory models revealed groups of patients with persistent symptoms had MOST-DorT scores above 30 and MOST-NTx scores above 40 at treatment-end. CONCLUSIONS: Although many patients report improvements in symptoms by 3 months after first-line chemotherapy for ovarian cancer, patients who score > 30/100 on MOST-S26-DorT or > 40/100 on MOST-S26-NTx at the end of chemotherapy are likely to have persistent symptoms. The MOST could triage this at-risk subset for early intervention.

Measure of Ovarian Symptoms and Treatment concerns (MOST) indexes and their associations with health-related quality of life in recurrent ovarian cancer.

PURPOSE: The Measure of Ovarian Symptoms and Treatment (MOST) concerns is a validated patient-reported symptom assessment tool for assessing symptom benefit and adverse effects of palliative chemotherapy in women with recurrent ovarian cancer (ROC). We aimed to examine (i) how symptoms within MOST symptom indexes track together (i.e. co-occur) and (ii) the association between MOST symptom indexes and key aspects of health-related quality of life (HRQL). METHOD: A prospective cohort of women with ROC completed the MOST-T35, EORTC QLQ-C30 and EORTC QLQ-OV28 at baseline and before each cycle of chemotherapy. Analyses were conducted on baseline and end-of-treatment data. Exploratory factor analysis and hierarchical cluster analysis identified groups of co-occurring symptoms. Path models examined associations between MOST symptom indexes and HRQL. RESULTS: Data from 762 women at baseline and 681 at treatment-end who completed all 22 symptom-specific MOST items and at least one HRQL measure were analysed. Four symptom clusters emerged at baseline and treatment-end: abdominal symptoms, symptoms associated with peripheral neuropathy, nausea and vomiting, and psychological symptoms. Psychological symptoms (MOST-Psych) and symptoms due to disease (ovarian cancer) or treatment (MOST-DorT) were associated with poorer scores on QLQ-C30 and OV28 functioning domains and worse overall health at both time points. CONCLUSION: Four MOST symptom clusters were consistent across statistical methods and time points. These findings suggest that routine standardized assessment of psychological and physical symptoms in clinical practice with MOST plus appropriate symptom management referral pathways is an intervention for improving HRQL that warrants further research.

A review of the content and psychometric properties of cancer-related fatigue (CRF) measures used to assess fatigue in intervention studies.

PURPOSE: Cancer-related fatigue (CRF) is a common and debilitating consequence of cancer and its treatment. Numerous supportive care interventions have been developed to alleviate CRF; however, the diversity of outcome measures used to assess CRF limits comparability of findings. We aimed to evaluate the content and psychometric properties of measures used to assess CRF in interventions targeting fatigue, to inform the selection of suitable measures in future research. METHODS: Included measures were identified from a systematic review of interventions targeting CRF. General characteristics of each measure were extracted, and item content was assessed against domains specified by the National Comprehensive Cancer Network (NCCN) definition of CRF. Psychometric properties were evaluated against COnsensus-based Standards for the selection of heath Measurement INstruments (COSMIN) criteria. RESULTS: Of 54 measures identified, 25 met inclusion criteria. Seventeen were fatigue-specific and eight a fatigue subscale or single item within a broader measure. Only 14 (56%) were specifically developed for cancer populations. Content coverage according to the NCCN CRF definition ranged from 0 to 75%. Evidence for fulfilment of COSMIN criteria in cancer populations ranged from 0 to 93%, with only five measures meeting > 70% of the COSMIN criteria. CONCLUSION: The Piper Fatigue Scale-Revised had good content coverage, but did not comprehensively address COSMIN criteria. The EORTC-FA12 and FACIT/FACT-F had excellent psychometric properties, with each capturing different aspects of fatigue. Ultimately, the choice of CRF measure should be guided by the research question and the CRF domains most relevant to the particular research context.

Getting the MOST out of follow-up: a randomized controlled trial comparing 3 monthly nurse led follow-up via telehealth, including monitoring CA125 and patient reported outcomes using the MOST (Measure of Ovarian Symptoms and Treatment concerns) with routine clinic based or telehealth follow-up, after completion of first line chemotherapy in patients with epithelial ovarian cancer.

BACKGROUND: Physical symptoms, anxiety, depression, fear of recurrence, sexual dysfunction, and social withdrawal are common in women after treatment for ovarian cancer. Most patients would like and need help dealing with these symptoms. The traditional model of follow-up care is unstructured and largely focused on diagnosing recurrent disease, and most oncologists lack skills to identify and manage psychosocial issues. No high quality prospective clinical trials have been conducted to determine the optimal follow-up regimen or the cost effectiveness of ovarian cancer surveillance strategies. PRIMARY OBJECTIVES: To assess emotional wellbeing, acceptability, safety, and cost effectiveness of nurse led follow-up via telehealth for women with ovarian cancer following completion of primary treatment. STUDY HYPOTHESIS: We hypothesize that compared with routine clinic based follow-up, nurse led follow-up via telehealth, including serum CA125 monitoring and completion of a patient reported outcome instrument, the Measure of Ovarian Symptoms and Treatment concerns-Surveillance (MOST-S26), will improve emotional wellbeing in women with ovarian cancer; be feasible, safe, acceptable, and not delay the time to diagnosis of recurrent disease; will result in greater patient satisfaction; will identify more patients with psychological distress, lead to better care, and improved psychological outcomes; and be cost-effective. TRIAL DESIGN: Phase II multicenter randomized trial comparing 3 monthly nurse led telehealth consultations that include serum CA125 monitoring and completion of the MOST-S26, with routine clinic based follow-up. The allocation ratio will be 1:1. MAJOR INCLUSION/EXCLUSION CRITERIA: Eligible patients will be women with high grade epithelial ovarian cancer who have normalized serum CA125 (to <35 kU/L) at completion of first line chemotherapy. PRIMARY ENDPOINTS: Emotional wellbeing at 12 months. SAMPLE SIZE: 150 patients. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: July 2023. Results expected in 2025, 24 months after the last participant is enrolled. TRIAL REGISTRATION: ACTRN12620000332921.

Perceived benefits and limitations of using patient-reported outcome measures in clinical practice with individual patients: a systematic review of qualitative studies.

PURPOSE: Patient-reported outcome measures (PROMs) are increasingly used in clinical settings to inform individual patient care. In-depth understanding of end-users' experiences may help identify factors that promote or hinder their use in clinical decision-making. We aimed to examine stakeholder perceptions of the utility of using PROMs in clinical practice based on real-life experience. METHODS: Systematic review searching Medline, Embase and PsychINFO from inception to May 2021. Qualitative studies examining patients' and/or clinicians' experiences of using PROMs in clinical settings were included. Study screening and data extraction were performed by two independent reviewers. Qualitative data from included studies was analysed thematically. RESULTS: Of 2388 abstracts retrieved, 52 articles reporting 50 studies met eligibility. Five key benefits were identified: (1) promotes active patient involvement (enables goal setting and discussion of sensitive topics); (2) enhances the focus of consultations (prioritizes patient needs); (3) improves quality of care (enables tailored, holistic care and prompts action); (4) enables standardized monitoring of patient outcomes; and (5) enhances the patient-clinician relationship (provides reassurance). Perceived limitations included the capacity of PROMs to shift the focus of consultations; inaccurately estimate problems; raise unrealistic expectations for care; inhibit patient-clinician interaction; lack clinically meaningful information; and not be suitable for all patients. CONCLUSION: Both patients and clinicians reported benefits of using PROMs across diverse health conditions and clinical settings, but also highlighted several limitations. These limitations shed some light on why PROM use may not always improve patient outcomes and provide considerations for the design and implementation of future PROM initiatives.

Improving the patient-reported outcome sections of clinical trial protocols: a mixed methods evaluation of educational workshops.

INTRODUCTION: Failure to incorporate key patient-reported outcome (PRO) content in trial protocols affects the quality and interpretability of the collected data, contributing to research waste. Our group developed evidence-based training specifically addressing PRO components of protocols. We aimed to assess whether 2-day educational workshops improved the PRO completeness of protocols against consensus-based minimum standards provided in the SPIRIT-PRO Extension in 2018. METHOD: Annual workshops were conducted 2011-2017. Participants were investigators/trialists from cancer clinical trials groups. Although developed before 2018, workshops covered 15/16 SPIRIT-PRO items. Participant feedback immediately post-workshop and, retrospectively, in November 2017 was summarised descriptively. Protocols were evaluated against SPIRIT-PRO by two independent raters for workshop protocols (developed post-workshop by participants) and control protocols (contemporaneous non-workshop protocols). SPIRIT-PRO items were assessed for completeness (0 = not addressed, 10 = fully addressed). Mann-Whitney U tests assessed whether workshop protocols scored higher than controls by item and overall. RESULTS: Participants (n = 107) evaluated the workshop positively. In 2017, 16/41 survey responders (39%) reported never applying in practice; barriers included role restrictions (14/41, 34%) and lack of time (5/41, 12%). SPIRIT-PRO overall scores did not differ between workshop (n = 13, median = 3.81/10, interquartile range = 3.24) and control protocols (n = 9, 3.51/10 (2.14)), (p = 0.35). Workshop protocols scored higher than controls on two items: 'specify PRO concepts/domains' (p = 0.05); 'methods for handling missing data' (p = 0.044). CONCLUSION: Although participants were highly satisfied with these workshops, the completeness of PRO protocol content generally did not improve. Additional knowledge translation efforts are needed to assist protocol writers address SPIRIT-PRO guidance and avoid research waste that may eventuate from sub-optimal PRO protocol content.

Development and validation of the measure of ovarian symptoms and treatment concerns for surveillance (MOST-S26): An instrument to complement the clinical follow-up of women with ovarian cancer after completion of first-line treatment.

OBJECTIVE: The Measure of Ovarian Symptoms and Treatment (MOST-T35) is a patient-reported symptom index, developed and validated in the context of palliative chemotherapy for recurrent ovarian cancer (OC). We aimed to develop and validate a version suitable for surveillance of symptoms following first-line treatment for OC to support clinical follow-up. METHODS: In a prospective study of women following completion of first-line chemotherapy for OC, patients completed MOST-T35 every 3 months for up to 3.5 years and other patient-reported outcome measures. Construct validity (Spearman's correlations), discriminative validity (t-tests/ANOVAs assessing differences between clinically distinct groups), ability to detect clinically important symptoms (receiver operating characteristic analysis), and responsiveness (t-tests examining change) were assessed. RESULTS: Data from 726 women who received ≥3 cycles of chemotherapy, did not progress within 3 months, and completed ≥one MOST-T35 were analysed. The revised version, MOST-S26, has 26 items and 5 multi-item indexes: peripheral neuropathy (MOST-NTx), disease or treatment-related (MOST-DorT), abdominal (MOST-Abdo), and psychological symptoms (MOST-Psych), and MOST-Wellbeing, plus 9 individual items. Construct validity was confirmed (r range = 0.43-0.88). Discriminative validity confirmed expected differences between groups. MOST-NTx and MOST-Psych detected improvements in peripheral neuropathy and psychological symptoms respectively, whereas MOST-Abdo detected worsening of abdominal symptoms pre-recurrence. CONCLUSIONS: This study developed and validated the MOST-S26, for surveillance of women in follow-up after first-line chemotherapy for OC. MOST-S26 reliably detected improvement in symptoms of peripheral neuropathy, psychological distress and may detect symptoms of relapse. Administration of MOST-S26 in follow-up consultations could identify concerning symptoms and facilitate timely and appropriate intervention.

Use of Erector Spinae Fascial Plane Blocks in Enhanced Recovery for Open Abdominal Surgery.

BACKGROUND: Bilateral erector spinae fascial plane blocks (ESPB) offers a novel, alternative method of regional post-operative pain control to thoracic epidural analgesia (TEA). The aim of this study was to compare rates of postoperative hypotension, and other standard enhanced recovery after surgery (ERAS) endpoints, in patients receiving ESPB versus TEA for open hepatopancreaticobiliary (HPB) surgery. MATERIALS AND METHODS: This retrospective analysis compared historical controls of ERAS patients undergoing open HPB surgery with TEA versus ESPB. The incidence of postoperative hypotension and clinical outcomes, including opioid requirements, were compared. RESULTS: Forty patients receiving TEA were compared to 27 ESPB patients. Return of bowel function and length of stay (mean 7.2 versus7.4 days; P = 0.83) were similar. ESPB patients received less intraoperative colloid (142cc versus 340cc; P = 0.01) and had less postoperative hypotension versus TEA (22% versus 55%; P = 0.03). No ESPB patient required patient-controlled analgesia (versus 32.5% TEA; P< 0.001). ESPB MME requirements decreased over time, while TEA MME requirements increased over 72 hours (P = 0.019). CONCLUSIONS: ESPB is a novel method that shows promising outcomes in improving enhanced recovery parameters and minimizing opioid administration in open HPB surgery.

Using concept mapping to prioritize barriers to diabetes care and self-management for those who experience homelessness.

BACKGROUND: Diabetes is a chronic medical condition which demands that patients engage in self-management to achieve optimal glycemic control and avoid severe complications. Individuals who have diabetes and are experiencing homelessness are more likely to have chronic hyperglycemia and adverse outcomes. Our objective was to collaborate with individuals experiencing homelessness and care providers to understand the barriers they face in managing diabetes, as a first step in identifying solutions for enhancing diabetes management in this population. METHODS: We recruited individuals with lived experience of homelessness and diabetes (i.e. clients; n = 32) from Toronto and health and social care providers working in the areas of diabetes and/or homelessness (i.e. providers; n = 96) from across Canada. We used concept mapping, a participatory research method, to engage participants in brainstorming barriers to diabetes management, which were subsequently categorized into clusters, using the Concept Systems Global MAX software, and rated based on their perceived impact on diabetes management. The ratings were standardized for each participant group, and the average cluster ratings for the clients and providers were compared using t-tests. RESULTS: The brainstorming identified 43 unique barriers to diabetes management. The clients' map featured 9 clusters of barriers: Challenges to getting healthy food, Inadequate income, Navigating services, Not having a place of your own, Relationships with professionals, Diabetes education, Emotional wellbeing, Competing priorities, and Weather-related issues. The providers' map had 7 clusters: Access to healthy food, Dietary choices in the context of homelessness, Limited finances, Lack of stable, private housing, Navigating the health and social sectors, Emotional distress and competing priorities, and Mental health and addictions. The highest-rated clusters were Challenges to getting healthy food (clients) and Mental health and addictions (providers). Challenges to getting healthy food was rated significantly higher by clients (p = 0.01) and Competing priorities was rated significantly higher by providers (p = 0.03). CONCLUSIONS: Experiencing homelessness poses numerous barriers to managing diabetes, the greatest of which according to clients, is challenges to getting healthy food. This study showed that the way clients and providers perceive these barriers differs considerably, which highlights the importance of including clients' insights when assessing needs and designing effective solutions.

Daily ups and downs in adolescents' depressive symptoms: The role of daily self-criticism, dependency and basic psychological needs.

INTRODUCTION: Although associations between Blatt's personality dimensions of self-criticism and dependency and adolescents' depressive symptoms are well-established, only few studies have examined associations between these variables at the level of daily, within-person fluctuations. Moreover, our understanding of the mechanisms underlying this personality vulnerability to depressive symptoms is limited. Therefore, we studied (a) daily fluctuations in both personality and depressive symptoms over a 7-day period and (b) the possible interplay between daily variations in personality vulnerability, need-based experiences (as conceptualized in Self-Determination Theory), and depressive symptoms. This interplay was examined in terms of both a mediational and a moderating role of the need-based experiences. METHODS: Participants were 121 Belgian adolescents (Mage = 15.81; SDage = 1.50; 52 % male) who completed questionnaires tapping into daily self-criticism, dependency, need-based experiences, and depressive symptoms every evening during seven consecutive days. RESULTS & CONCLUSIONS: Multilevel analysis revealed that self-criticism and dependency fluctuated substantially on a daily basis. These daily fluctuations in personality were related to daily fluctuations in depressive symptoms, with daily variation in need-based experiences mediating these associations. We found no evidence for interactions between personality and the need-based experiences. The findings underscore the importance of considering daily fluctuations in individuals' personality vulnerability and point to the explanatory role of need-based experiences in the relation between personality and depressive symptoms on a daily basis.

Predictive validity of the HCR-20V3 in a sample of Australian forensic psychiatric patients.

The Historical Clinical Risk Management-20 Version 3 is the latest iteration in the HCR-20 series, adopting novel changes such as the addition of Relevance ratings and non-requirement to include the Psychopathy Checklist-Revised. This study aimed to examine these changes and compare the predictive validity of the HCR-20V3 to the HCR-20V2. The sample comprised of 100 forensic psychiatric patients, retrospectively followed up for a maximum period of approximately 13 years post-discharge from the Thomas Embling Hospital. Recidivism data were sourced from official police records. Results indicated good to excellent inter-rater reliability. The HCR-20V3 significantly predicted violent recidivism (area under the curve = .70 to .77), levels of accuracy that were not significantly different from the HCR-20V2. HCR-20V3 Relevance ratings failed to add incremental validity above Presence ratings; however, the PCL-R improved upon the HCR-20V3's validity. The study represented one of the first evaluations of the HCR-20V3 in Australia.

Comparison of generic and disease-specific measures in their ability to detect differences in pressure ulcer clinical groups.

Patient-reported outcomes can be included as end points in pressure ulcer (PU) intervention trials to provide information to inform decision-making and improve the lives of patients. However, the challenge for researchers and clinicians is identifying and choosing an appropriate instrument for each particular application that suits their research questions and clinical context. To provide researchers and clinicians with the information needed to inform choice of patient-reported outcome measures, we compared a generic and disease-specific measures' ability to discriminate between clinical groups known to differ, and determined their responsiveness to change. We performed analyses on a subset of patients recruited to the PRESSURE 2 trial that completed the pressure ulcer quality of life instrument-prevention version (PU-QOL-P) and Short Form 12 Questionnaire (SF12) measures at baseline and 30-day posttreatment. Known-group validity and responsiveness-to-change analyses were conducted. The analysis sample consisted of 617 patients that completed both measures at baseline. Known-group validity revealed that some PU-QOL-P symptoms and function scales differentiated between people with category 2 PUs and those without PUs. A less meaningful pattern of results was observed for the SF12 scales, suggesting that the PU-QOL-P is more sensitive to differences between PU and non-PU populations. Responsiveness analysis revealed that the PU-QOL-P was more responsive in detecting disease severity than the SF12. The PU-QOL-P provides a standardized method for assessing PU-specific symptoms and functioning outcomes and is suitable for quantifying the benefits of PU interventions from the patient's perspective. Generic measures are useful for group comparisons of global quality of life domains. Choice of measure for each particular application should be determined by the purpose of the measurement and the information required.

Patient-reported outcomes as predictors of survival in patients with bowel cancer: a systematic review.

INTRODUCTION: The prognostic value of patient-reported outcomes (PROs) has been determined in some cancers, but a focussed review in colorectal cancer (CRC) has not yet been conducted. We systematically reviewed PRO predictors of CRC patient survival. METHODS: We searched four electronic databases (from inception to May 2018), reference lists and professional organisations to identify studies reporting pre-treatment PRO predictors of overall survival (OS) or progression-free survival (PFS) in CRC identified through univariate or multivariate models. Two reviewers independently applied inclusion criteria and extracted data on study characteristics, median and 1-year survival rates, PROs assessed and model results. RESULTS: In 25 of 27 studies (n = 12,544), at least one PRO was significantly associated with survival. Physical functioning, fatigue, pain and appetite loss predicted OS more often than other PROs in metastatic disease (19/27 studies). One study explored PRO predictors in early-stage CRC, finding emotional well-being and mood predicted OS. In mixed-stage samples (7/27 studies), physical functioning predicted OS more often than other PROs. Few studies modelled PFS, for which few PROs had predictive value. CONCLUSIONS: Physical and psychological functioning, pain, fatigue and appetite loss had prognostic significance above and beyond clinical predictors in CRC. Routine monitoring of these PROs may allow earlier detection and amelioration of problems, which may improve quality of life and perhaps extend survival. More research is needed to determine prognostic value of PROs in early-stage CRC, and prognostic significance of changes in PRO scores.

Sexual Partner Characteristics, Relationship Type, and HIV Risk Among a Community Venue-based Sample of Urban Adolescent and Young Adult Men Who Have Sex with Men.

Few studies have examined sexual partnerships and HIV risk in diverse samples of African American/black and Hispanic/Latino adolescent and young adult men who have sex with men (YMSM), a group that have a high burden of HIV in the U.S. A community-venue recruitment approach was used, which identified significant differences in HIV risk by sexual partner type among 1215 YMSM. Those with casual partners had a higher number of sexual partners, had more STIs, and were more likely to engage in transactional sex, to use alcohol, marijuana, or other substances compared with those with main partners only. Among those with female sexual partners, many used condoms "every time" when engaging in vaginal sex with casual partners, but a sizeable proportion "never/rarely" used condoms with their main partners. Our findings demonstrate a need for tailored HIV prevention education and counseling with necessary skills regarding consistent and correct condom use with all sexual partnerships.

Difficult case: rituximab in anti-SRP antibody myositis in pregnancy.

A 30-year-old nulliparous woman presented at 15-week gestation with severe skeletal and respiratory muscle weakness, having been diagnosed with anti-signal recognition particle antibody myositis 3 years before. Remission had previously been induced with rituximab (after failure of standard therapies). She had continued oral prednisolone and rituximab every 6 months but had stopped this when planning pregnancy. At 16-weeks gestation, she restarted corticosteroids and rituximab, with clinical and biochemical recovery and no complications. Rituximab should ideally be given in the first trimester; treatment later in pregnancy increases the risk of neonatal B-cell depletion and cytopenias. The fetal risk from drug therapy must be weighed against the risk to mother and fetus from untreated disease. This report highlights the importance of preconception counselling for disease control and patient education regarding medication safety and early referral to obstetric medicine clinics, to facilitate complex clinical decision-making.