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Daniel SJ Costa,1 Neil K Aaronson,2 Peter M Fayers,3,4 Peter S Grimison,5,6 Monika Janda,7 Julie F Pallant,8 Donna Rowen,9 Galina Velikova,10 Rosalie Viney,11 Tracey A Young,9 Madeleine T King1On behalf of the MAUCa Consortium1Psycho-oncology Co-operative Research Group, University of Sydney, Sydney, NSW, Australia; 2Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, the Netherlands; 3Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 4Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway; 5Chris O'Brien Lifehouse, 6Sydney Medical School, University of Sydney, Sydney, NSW, 7School of Public Health, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, 8Rural Health Academic Centre, University of Melbourne, Shepparton, VIC, Australia; 9School of Health and Related Research, University of Sheffield, Sheffield; 10University of Leeds, St James's Institute of Oncology, Leeds, UK; 11Centre for Health Economics Research and Evaluation, University of Technology, Sydney, NSW, AustraliaBackground: Multi attribute utility instruments (MAUIs) are preference-based measures that comprise a health state classification system (HSCS) and a scoring algorithm that assigns a utility value to each health state in the HSCS. When developing a MAUI from a health-related quality of life (HRQOL) questionnaire, first a HSCS must be derived. This typically involves selecting a subset of domains and items because HRQOL questionnaires typically have too many items to be amendable to the valuation task required to develop the scoring algorithm for a MAUI. Currently, exploratory factor analysis (EFA) followed by Rasch analysis is recommended for deriving a MAUI from a HRQOL measure.Aim: To determine whether confirmatory factor analysis (CFA) is more appropriate and efficient than EFA to derive a HSCS from the European Organisation for the Research and Treatment of Cancer's core HRQOL questionnaire, Quality of Life Questionnaire (QLQ-C30), given its well-established domain structure.Methods: QLQ-C30 (Version 3) data were collected from 356 patients receiving palliative radiotherapy for recurrent/metastatic cancer (various primary sites). The dimensional structure of the QLQ-C30 was tested with EFA and CFA, the latter informed by the established QLQ-C30 structure and views of both patients and clinicians on which are the most relevant items. Dimensions determined by EFA or CFA were then subjected to Rasch analysis.Results: CFA results generally supported the proposed QLQ-C30 structure (comparative fit index =0.99, Tucker–Lewis index =0.99, root mean square error of approximation =0.04). EFA revealed fewer factors and some items cross-loaded on multiple factors. Further assessment of dimensionality with Rasch analysis allowed better alignment of the EFA dimensions with those detected by CFA.Conclusion: CFA was more appropriate and efficient than EFA in producing clinically interpretable results for the HSCS for a proposed new cancer-specific MAUI. Our findings suggest that CFA should be recommended generally when deriving a preference-based measure from a HRQOL measure that has an established domain structure.Keywords: multi attribute utility instrument, health state classification system, confirmatory factor analysis, exploratory factor analysis, European Organisation for the Research and Treatment of Cancer QLQ-C30

Data on routine childhood vaccination coverage can only tell us who is under-vaccinated; it cannot explain why vaccine coverage is low. Collecting data on the reasons behind under-vaccination is necessary to implement cost-effective strategies that address key barriers and target interventions appropriately. However, no instruments that measure both vaccine acceptance and access factors among parents of children <5 y have been validated in high-income countries. This study aims to develop and validate the Vaccine Barriers Assessment Tool (VBAT) for Australia. We applied three phases of mixed methods data collection and analysis. In Phase 1, we developed a comprehensive list of 80 items reflecting all potential parental barriers to childhood vaccination, derived from published literature and behavioral theory. Through cognitive interviews ( n  = 28), we refined this list to 45 items. In Phase 2, we conducted a two-wave online survey to test the reliability and validity of these items in an Australian sample of parents ( n  = 532) with structural equation modeling, further refining the list to 35 items. In Phase 3, we conducted a final parent survey ( n  = 156), administering these items along with the Parent Attitudes toward Childhood Vaccination (PACV) scale for comparison. We reviewed participants' immunization register data to assess the predictive validity of the proposed models. The final 6-item short form and 15-item long form Vaccine Barriers Assessment Tool assess access, communal benefit, personal risk, equity, commitment, social norms, and trust in health-care workers. It is being applied for national surveillance in Australia and will be adapted for additional populations and vaccines.

Abstract: Productivity loss because of chronic pain in the working age population is a widespread concern internationally. Interventions for chronic pain in working age adults might be expected to achieve enhanced productivity in terms of reduced costs of workers' compensation insurance, reduced disability support, and improved rates of return to work for injured workers. This would require the use of measures of productivity in the evaluation of chronic pain management interventions. The aim of this review was to identify and interpret the productivity outcomes of randomised controlled trials reported by studies that conducted economic evaluations (eg, cost-effectiveness and cost-utility) of chronic pain management interventions in the working age population published from database inception to March 2023. Econlit, Embase, and Pubmed electronic databases were searched, yielding 12 studies that met the selection criteria. All 12 studies used absenteeism to measure productivity, translating return to work measures into indirect costs. Only one study included return to work as a primary outcome. Ten studies found no statistically significant improvements in productivity-related costs. Despite evidence for reduced pain-related disability after pain management interventions, this review suggests that the use of measures for assessing productivity gains is lacking. Including such measures would greatly assist administrators and payers when considering the broader societal benefits of such interventions., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.)

Objective: Parents and their infants with complex congenital heart disease (CHD) face relational challenges, including marked distress, early separations, and infant hospitalizations and medical procedures, yet the prevalence of parent-infant interaction difficulties remains unclear. Using a standardized observational paradigm, this study investigated mother-infant dyadic synchrony, interactional patterns, and associated predictors in mother-infant pairs affected by CHD, compared with typically-developing pairs., Methods: In this prospective, longitudinal cohort study, mothers and their infants requiring cardiac surgery before age 6-months (n=110 pairs) and an age- and sex-matched Australian community sample (n=85 pairs) participated in a filmed, free-play interaction at 6.9±1.0 months. Mother-infant dyadic synchrony, maternal and infant interactional patterns, and relational risk were assessed using the Child-Adult Relationship Experimental (CARE) Index. Maternal and infant predictors were assessed at 32 weeks gestation, 3- and 6-months postpartum., Results: Most mother-infant interactions were classified as "high risk" or "inept" (cardiac: 94%, control: 81%; p=.007). Dyadic synchrony (p<.001), maternal sensitivity (p=.001), and infant cooperativeness (p=.001) were lower for cardiac than control pairs. Higher maternal traumatic stress at 6-months postpartum predicted lower dyadic synchrony for mother-infant pairs affected by CHD (B=-.04, p=.03). Dyadic synchrony was higher among older infants in the total (B=.40, p=.003) but not cardiac sample (B=.24, p=.06)., Conclusions: Relational difficulties were almost universal among mother-infant pairs affected by CHD and were also high in the Australian community sample. Widespread education initiatives are recommended to increase awareness of heightened mother-infant relational risk in congenital heart care and well-child settings, alongside relationally-focused prevention and early intervention programs., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Aims: Patients with chronic health conditions not responding to conventional treatment can access medicinal cannabis (MC) prescriptions from clinicians in Australia. We aimed to assess overall health-related quality of life (HRQL), pain, fatigue, sleep, anxiety, and depression in a large real-world sample of patients accessing prescribed medicinal cannabis. We hypothesized that all patient-reported outcomes (PROs) would improve from baseline to 3-months., Methods: The QUEST Initiative is a large prospective multicenter study of patients with any chronic health condition newly prescribed medicinal cannabis between November 2020 and December 2021. Eligible patients were identified by 120 clinicians at medical centers across six Australian states. Consenting participants completed the EuroQol Group EQ-5D-5L health status questionnaire; European Organization for Research & Treatment of Cancer Quality of Life questionnaire (QLQ-C30); Patient-Reported Outcomes Measurement Information System (PROMIS) Short Forms in Fatigue and Sleep Disturbance, and the Depression Anxiety Stress Scale (DASS-21) before starting therapy, at 2-weeks titration, then monthly for 3-months., Results: Of the 2762 consenting participants, 2327 completed baseline and at least one follow-up questionnaire. Ages ranged between 18-97 years (mean 51y; SD = 15.4), 62.8% were female. The most commonly treated conditions were chronic pain (n = 1598/2327; 68.7%), insomnia (n = 534/2327; 22.9%), generalized anxiety (n = 508/2327; 21.5%), and mixed anxiety and depression (n = 259/2327; 11%). Across the whole cohort both EQ-5D-5L utility scores and QLQ-C30 summary scores showed clinically meaningful improvement in HRQL from baseline to mean follow-up with d = 0.54 (95%CI:0.47 to 0.59) and d = 0.64 (95%CI:0.58 to 0.70) respectively; and clinically meaningful improvement in fatigue (d = 0.54; 95%CI:0.48 to 0.59). There was clinically meaningful reduction of pain for those with chronic pain (d = 0.65; 95%CI:0.57 to 0.72); significant improvements for those with moderate to extremely severe anxiety (X2 = 383; df = 4; p<0.001) and depression (X2 = 395; df = 4; p<0.001); and no changes in sleep disturbance., Conclusions: We observed statistically significant, clinically meaningful improvements in overall HRQL and fatigue over the first 3-months in patients with chronic health conditions accessing prescribed medical cannabis. Anxiety, depression, and pain also improved over time, particularly for those with corresponding health conditions. The study continues to follow-up patients until 12-months to determine whether improvements in PROs are maintained long-term., Trail Registration: Study registration - Australian New Zealand Clinical Trials Registry: ACTRN12621000063819. https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12621000063819., Competing Interests: The University of Sydney received funding from Little Green Pharma Pty Ltd. to support MT and CR to conduct the submitted work; LW is a paid employee of Little Green Pharma Pty Ltd.; no other relationships or activities that could appear to have influenced the submitted work. All authors have completed the ICMJE uniform disclosure form. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2023 Tait et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: The City Birth Trauma Scale (BiTS; Ayers, Wright & Thornton, 2018) is self-report measure of Post-Traumatic Stress Disorder (PTSD) symptoms following childbirth, based on DSM-5 criteria. We report on the first study of the psychometric properties of the BiTS in the Australian population., Methods: Participants were mothers of infants aged 0-12 months (N = 705), who completed the BiTS and measures of related constructs. Confirmatory factor analysis was performed to assess the factor structure of the BiTS. Examination of the reliability, convergent, divergent and discriminant validity and acceptability of the BiTS was also examined., Results: Confirmatory factor analysis supported a bi-factor model of Birth-related Symptoms (BRS) and General Symptoms (GS) of post-partum PTSD as well as a global CB-PTSD factor. Internal consistency was found for the BiTS total scale and two proposed subscales (BRS and GS). BiTS total scores were significantly associated with an established measure of PTSD, providing support for convergent validity. Evidence of discriminant validity was examined by comparing the BiTS to an established measure of postpartum depression., Limitations: The present sample may over-represent participants with traumatic birth experiences in comparison to the general public. Furthermore, use of self-report measures limits the capacity to confirm the diagnostic status of participants., Conclusion: These findings suggest that the BiTS is a valid and reliable measure of childbirth-related PTSD, suited for use in postpartum populations. Total scores on the measure may be informative for clinical and research purposes, while evidence suggests strong support for interpretation of subscale scores., Competing Interests: Conflict of interest We declare no conflict of interest for the manuscript attached., (Copyright © 2023 Elsevier B.V. All rights reserved.)

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., (© 2022. The Author(s).)

Cognitive behavior therapy (CBT) for young people with obsessive compulsive disorder (OCD) has recently been enhanced to target family environment factors. However, the process of change for OCD symptoms and family factors during treatment is not well understood. Uniquely, we explored patterns of change for OCD symptoms and a range of family variables throughout Baseline, Early, Mid, and Late treatment phases of family-based CBT (FCBT) for 15 young people with OCD using multiple informants. We predicted a linear reduction in OCD symptom severity and family accommodation (FA) across treatment phases, however the investigation into other family factor change patterns was exploratory. OCD symptom severity, FA, parental distress tolerance (DT), and conflict all showed significant linear change patterns across treatment phases according to multiple informants. In addition, the largest proportion of change for these variables typically occurred during the first third of treatment, highlighting the importance of identifying participants with and without early gains in future research. Blame also showed a significant linear change pattern, although with small reductions between treatment phases. Preliminary bivariate analyses sought to better understand whether family factor change predicted subsequent OCD severity change or vice versa. Similar patterns emerged across informants, including identification of OCD severity as a significant predictor of change for Blame at subsequent treatment phases. Analyses also showed bi-directional effects for DT and OCD symptoms across informants, where DT predicted OCD severity at subsequent treatment phases and vice versa. These outcomes support further research aimed at understanding the role of family factors in pediatric OCD symptom change., Competing Interests: Conflict of InterestThe authors declare no competing interests., (© The Author(s) 2022, corrected publication 2023.)

Introduction: Advances in the care of patients with single-ventricle congenital heart disease have led to a new generation of individuals living with a Fontan circulation. For people with Fontan physiology, physical, psychological and neurodevelopmental challenges are common. The objective of this study is to describe and develop a deeper understanding of the factors that contribute to quality of life (QOL) among children, adolescents and adults living with a Fontan circulation across Australia and New Zealand, their parents and siblings., Methods and Analysis: This article presents the protocol for the Australian and New Zealand Fontan Registry (ANZFR) QOL Study, a cross-sectional, population-based study designed to examine QOL among people of all ages with a Fontan circulation, their parents and siblings. Study eligibility criteria includes (1) individuals with a Fontan circulation aged ≥6 years, at least 12 months post-Fontan procedure and enrolled in the ANZFR; (2) parents of individuals enrolled in the ANZFR; and (3) siblings aged ≥6 years of an individual enrolled in the ANZFR. A novel, online research platform is used to distribute personalised assessments tailored to participant age and developmental stage. A suite of validated psychometric self-report and parent-proxy report instruments capture potential correlates and predictors of QOL, including symptoms of psychological distress, personality attributes, coping and cognitive appraisals, family functioning, healthcare experiences and costs, access to emotional support and socioeconomic factors. Clinical characteristics are captured via self-report and parent-proxy report, as well as the ANZFR. Descriptive analyses and multilevel models will be used to examine QOL across groups and to investigate potential explanatory variables., Ethics and Dissemination: Approval has been obtained from all relevant Human Research Ethics Committees (HRECs), including the Sydney Children's Hospitals Network and the Royal Children's Hospital Melbourne HRECs. Study findings will be published in peer-reviewed journals and presented at national and international meetings and seminars., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Competing Interests: Declaration of Competing Interest YCL has received honoraria from GSK for participation on Advisory Board. FJ has received honoraria for educational events and consulting fees from AstraZeneca, Clovis, GSK, MSD, and Seagen. JS has received honoraria and fees from PharmaMar, Roche, Astra, GSK, Clovis, NovoCure, MSD, Tesaro. AO acknowledges institutional research grants from MSD K.K., Fuji Pharma Co., Kissei Pharmaceutical Co., Meiji Holdings Co., Taiho Pharmaceutical Co., Kaken Pharmaceutical Co., Chugai Pharmaceutical Co., Tsumura & Co, Daiichi Sankyo Co., Mochida Pharmaceutical Co., ASKA Pharmaceutical CO., Takeda, Pfizer, AstraZeneca, and Terumo Co.; and has received honoraria for educational events from Takeda, Eisai Co., AstraZeneca, Chugai Pharmaceutical Co, Kaken Pharmaceutical Co., MSD K.K. and Zeria Pharmaceutical. JAL acknowledges institutional research grants from AstraZeneca and MSD/Merck; has received honoraria for educational events from AstraZeneca, Neopharm, GSK and Pfizer; and participate on data safety monitoring board of Regeneron. EAL has received honoraria from Roche. MRS acknowledges institutional research grants from Amgen, Astellas, Astra Zeneca, Bayer, Beigene, BMS, Celgene, Medivation, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sanofi and Tilray. MF acknowledges institutional research grants from AstraZeneca, Novartis, and Beigene; has received honoraria (consultancy/educational events) from AstraZeneca, Novartis, GSK, MSD, Takeda, Lily, and ACT-Genomics; and participate on data safety monitoring board for AGITG. RC, MTK, RO, AL, FH, FR, JB, AMO, JSB, DB, AF, MK and KD have declared no conflict of interest., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Introduction: Utility instruments are used to assess patients' health-related quality of life for cost-utility analysis (CUA). However, for cancer patients, the dimensions of generic utility instruments may not capture all the information relevant to the impact of cancer. Cancer-specific utilities provide a useful alternative. Under the auspices of the Multi-Attribute Utility in Cancer Consortium, a cancer-specific utility algorithm was derived from the FACT-G. The new FACT-8D contains eight dimensions: pain, fatigue, nausea, sleep, work, support from family/friends, sadness, and worry health will get worse. The aim of the study was to obtain a Canadian value set for the FACT-8D., Methods: A discrete choice experiment was administered to a Canadian general population online panel, quota sampled by age, sex, and province/territory of residence. Respondents provided responses to 16 choice sets. Each choice set consisted of two health states described by the FACT-8D dimensions plus an attribute representing survival duration. Sample weights were applied and the responses were analyzed using conditional logistic regression, parameterized to fit the quality-adjusted life year framework. The results were converted into utility weights by evaluating the marginal rate of substitution between each level of each FACT-8D dimension with respect to duration., Results: 2228 individuals were recruited. The analysis dataset included n = 1582 individuals, who completed at least one choice set; of which, n = 1501 completed all choice sets. After constraining to ensure monotonicity in the utility function, the largest decrements were for the highest levels of pain (- 0.38), nausea (- 0.30), and problems doing work (- 0.23). The decrements of the remaining dimensions ranged from - 0.08 to - 0.18 for their highest levels. The utility of the worst possible health state was defined as - 0.65, considerably worse than dead., Conclusions: The largest impacts on utility included three generic dimensions (i.e., pain, support, and work) and nausea, a symptom caused by cancer (e.g., brain tumours, gastrointestinal tumours, malignant bowel obstruction) and by common treatments (e.g., chemotherapy, radiotherapy, opioid analgesics). This may make the FACT-8D more informative for CUA evaluating in many cancer contexts, an assertion that must now be tested empirically in head-to-head comparisons with generic utility measures., (© 2022. The Author(s).)

Background: Evidence supports several countries introducing legislation to allow cannabis-based medicine as an adjunctive treatment for the symptomatic relief of chronic pain, chemotherapy-induced nausea, spasticity in multiple sclerosis (MS), epileptic seizures, depression, and anxiety. However, clinical trial participants do not represent the entire spectrum of disease and health status seen in patients currently accessing medicinal cannabis in practice., Objective: This study aims to collect real-world data to evaluate health-related quality of life in patients prescribed medicinal cannabis oil and describe any differences over time, from before starting therapy to after 3 and 12 months of therapy., Methods: Adult patients newly prescribed medicinal cannabis oil by authorized prescribers and under the Special Access Schemes across Australia will be screened for eligibility and invited to participate. A sample size of 2142 is required, with a 3-month follow-up. All participants will complete the EuroQol 5-Dimension; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30; Depression, Anxiety, and Stress Scale-21; Patients' Global Impression of Change; Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) version 1.0: Sleep Disturbance 8b; and PROMIS SF Fatigue 13a questionnaires. Patients with chronic pain conditions will also complete the PROMIS SF version 1.0: Pain Intensity 3a and PROMIS SF version 1.0: Pain Interference 8a. Patients with movement disorders will also complete Quality of Life in Neurological Disorders (Neuro-QoL) SF version 1.0: Upper Extremity Function (Fine Motor and Activities of Daily Living) and if chorea is indicated, the Neuro-QoL SF version 2.0: Huntington's Disease health-related Quality of LIFE-Chorea 6a. All questionnaires will be administered at baseline, 2 weeks (titration), monthly up to 3 months, and then every 2 months up to 1 year., Results: Recruitment commenced in November 2020. By June 2021, 1095 patients were screened for the study by 69 physicians in centers across 6 Australian states: Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria, and Western Australia. Of the patients screened, 833 (39% of the target sample size) provided consent and completed baseline questionnaires. Results are expected to be published in 2022. Results of this study will show whether patient-reported outcomes improve in patients accessing prescribed medicinal cannabis from baseline to 3 months and whether any changes are maintained over a 12-month period. This study will also identify differences in improvements in patient-reported outcomes among patients with different chronic conditions (eg, chronic pain, MS, epilepsy, Parkinson disease, or cancer)., Conclusions: This protocol contains detailed methods that will be used across multiple sites in Australia. The findings from this study have the potential to be integral to treatment assessment and recommendations for patients with chronic pain and other health indicators for accessing medicinal cannabis., Trial Registration: Australian New Zealand Clinical Trials Registry: ANZCTRN12621000063819; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380807&isReview=true., International Registered Report Identifier (irrid): DERR1-10.2196/32327., (©Margaret-Ann Tait, Daniel S J Costa, Rachel Campbell, Richard Norman, Stephan Schug, Claudia Rutherford. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 24.11.2021.)

Objective: Adolescents and young adults (AYAs) diagnosed with cancer commonly experience elevated psychological distress and need appropriate detection and management of the psychosocial impact of their illness and treatment. This paper describes the multinational validation of the Distress Thermometer (DT) for AYAs recently diagnosed with cancer and the relationship between distress and patient concerns on the AYA-Needs Assessment (AYA-NA)., Methods: AYA patients (N = 288; 15-29 years, M age  = 21.5 years, SD age  = 3.8) from Australia (n = 111), Canada (n = 67), the UK (n = 85) and the USA (n = 25) completed the DT, AYA-NA, Hospital Anxiety Depression Scale (HADS) and demographic measures within 3 months of diagnosis. Using the HADS as a criterion, receiver operating characteristics analysis was used to determine the optimal cut-off score and meet the acceptable level of 0.70 for sensitivity and specificity. Correlations between the DT and HADS scores, prevalence of distress and AYA-NA scores were reported., Results: The DT correlated strongly with the HADS-Total, providing construct validity evidence (r = 0.65, p < 0.001). A score of 5 resulted in the best clinical screening cut-off on the DT (sensitivity = 82%, specificity = 75%, Youden Index = 0.57). Forty-two percent of AYAs scored at or above 5. 'Loss of meaning or purpose' was the AYA-NA item most likely to differentiate distressed AYAs., Conclusions: The DT is a valid distress screening instrument for AYAs with cancer. The AYA-POST (DT and AYA-NA) provides clinicians with a critical tool to assess the psychosocial well-being of this group, allowing for the provision of personalised support and care responsive to individuals' specific needs and concerns., (© 2021 The Authors. Psycho-Oncology published by John Wiley & Sons Ltd.)

Research in health literacy is fundamentally impacted by our ability to adequately assess the construct. Although various measures of health literacy have been developed, there are few reflective discussions of the challenges and learnings from the instrument development process. This is somewhat surprising given that health literacy is a multi-dimensional and contested concept (with inherent measurement challenges), and that there are important practical considerations owing to the fact that people completing health literacy assessments may have lower general literacy (i.e. ability to read and write) and English-language skills. This paper discusses our learnings from developing a performance-based measure of parenting health literacy skills (the Parenting Plus Skills Index). The performance-based instrument is characterised by its grounding in health literacy as asset, with items spanning Nutbeam's functional, communicative and critical health literacy skills, and was designed chiefly to capture improvements resulting from health literacy skills training. This paper elucidates critical junctures in the development process, particularly regarding the conceptualisation and operationalisation of the construct. We also outline our approach to addressing practical measurement issues (e.g. administration time; item difficulty). In summarising these, we offer a 13-item checklist to inform the development of health literacy instruments for other health contexts or health conditions., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Purpose: To ensure clarity in communication in the field of quality of life research, and meaningful use of 'quality of life' as a research outcome, requires two things: awareness that there is a range of conceptualisations and definitions of 'quality of life', and for any particular study, consistency between the way the term is defined and operationalised in that setting. We aimed to identify how frequently research articles described (HR)QOL as a construct of interest, how frequently they referred to "patient-reported outcome (measures)", which patient-reported outcome measures were used, and how (HR)QOL was defined., Methods: We reviewed all Quality of Life Research articles published in 2017 and recorded whether they described health-related quality of life or quality of life as constructs of interest, and/or mentioned the term(s) patient-reported outcome (measures). We recorded definitions of (HR)QOL stated and questionnaires used. We classified articles according to constructs assessed and instruments used, and examined whether articles citing the same definition used the same questionnaires., Results: We reviewed 300 articles; 65% stated that (HR)QOL was a construct of interest, 27% mentioned patient-reported outcome (measures), and 20% mentioned neither. Fifty-one articles provided definitions of (HR)QOL, citing 66 sources, with 11 definitions cited more than once. PROMIS, SF, EQ-5D, and EORTC instruments were the most commonly used. The only definition and questionnaire consistently used together were the WHO definitions/instruments., Conclusion: These results demonstrate considerable heterogeneity in the definition and operationalisation of (HR)QOL, between and within studies. This limits meaningful interpretation of (HR)QOL scores and complicates literature searches. Investigators should define constructs and select instruments aligned with their definitions., (© 2021. Crown.)

Study Design: Within-subject, randomised cross-over trial., Objectives: To determine whether a commercially available 3D head-mounted (HMD) virtual reality (VR) device results in significant reductions in neuropathic pain compared to using a 2D screen device in people with spinal cord injury (SCI)., Setting: Greenwich Hospital, Sydney, Australia., Methods: Sixteen men with established SCI and chronic neuropathic pain participated in a single-session randomised cross-over trial. We compared the effects of 3D HMD VR and a 2D screen application on SCI neuropathic pain intensity and levels of perceived presence., Results: Participants reported significantly lower pain intensity after 3D HMD VR compared to 2D screen application (1.9 ± SD 1.8 versus 3.4 ± SD 1.6, mean 95% CI: 1.5, P < 0.0001). Participants reported significantly higher perceived levels of presence with the 3D HMD VR compared to 2D screen of (49.6 ± SD 8.9 versus 32.8 ± SD 11.1, mean 95% CI: 16.6, P < 0.0001). Increased perceived presence was associated with significantly lower pain intensity regardless of randomised sequencing of the two conditions (mean 95% CI: 0.06, P = 0.005). Effect size for pain reduction using 3D HMD VR was 0.80., Conclusions: We suggest that 3D HMD VR may provide neuropathic pain relief for people with SCI. Given the lack of cybersickness and ease of access, we propose that immersive VR could be a helpful adjunct to current pharmacotherapy. Further research is required to show that VR can be effective for more long-term reductions in SCI pain.

Purpose: Psychological interventions targeting fear of cancer recurrence (FCR) are effective in reducing fear and distress. Process evaluations are an important, yet scarce adjunct to published intervention trials, despite their utility in guiding the interpretation of study outcomes and optimizing intervention design for broader implementation. Accordingly, this paper reports the findings of a process evaluation conducted alongside a randomized controlled trial of a psychological intervention for melanoma patients. Methods: Men and women with a history of Stage 0-II melanoma at high-risk of developing new primary disease were recruited via High Risk Melanoma Clinics across Sydney, Australia and randomly allocated to receive the psychological intervention ( n = 80) or usual care ( n = 84). Intervention participants received a tailored psycho-educational resource and three individual psychotherapeutic sessions delivered via telehealth. Qualitative and quantitative data on intervention context, processes, and delivery (reach, dose, and fidelity), and mechanisms of impact (participant responses, moderators of outcome) were collected from a range of sources, including participant surveys, psychotherapeutic session audio-recordings, and clinical records. Results: Almost all participants reported using the psycho-educational resource (97%), received all intended psychotherapy sessions (96%), and reported high satisfaction with both intervention components. Over 80% of participants would recommend the intervention to others, and a small proportion (4%) found discussion of melanoma-related experiences confronting. Perceived benefits included enhanced doctor-patient communication, talking more openly with family members about melanoma, and improved coping. Of potential moderators, only higher FCR severity at baseline (pre-intervention) was associated with greater reductions in FCR severity (primary outcome) at 6-month follow-up (primary endpoint). Conclusions: Findings support the acceptability and feasibility of a psychological intervention to reduce FCR amongst individuals at high risk of developing another melanoma. Implementation into routine melanoma care is an imperative next step, with FCR screening recommended to identify those most likely to derive the greatest psychological benefit., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Kan, Dieng, Butow, Mireskandari, Tesson, Menzies, Costa, Morton, Mann, Cust and Kasparian.)

Purpose: Fear of cancer recurrence (FCR) affects 50%-70% of cancer survivors. This multicenter, single-arm study sought to determine the participant-rated usefulness of an oncologist-delivered FCR intervention., Methods: Women who completed treatment for early breast cancer (could be receiving endocrine therapy) with baseline FCR > 0 were invited to participate. FCR was measured using a validated 42-item FCR Inventory. The brief oncologist-delivered intervention entailed (1) FCR normalization; (2) provision of personalized prognostic information; (3) recurrence symptoms education, (4) advice on managing worry, and (5) referral to psycho-oncologist if FCR was high. FCR, depression, and anxiety were assessed preintervention (T0), at 1 week (T1), and 3 months (T2) postintervention. The primary outcome was participant-rated usefulness. Secondary outcomes included feasibility and efficacy., Results: Five oncologists delivered the intervention to 61/255 women invited. Mean age was 58 ± 12 years. Mean time since breast cancer diagnosis was 2.5 ± 1.3 years. Forty-three women (71%) were on adjuvant endocrine therapy. Of 58 women who completed T1 assessment, 56 (97%) found the intervention to be useful. FCR severity decreased significantly at T1 (F = 18.5, effect size = 0.39, P < .0001) and T2 (F = 24, effect size = 0.68, P < .0001) compared with baseline. There were no changes in unmet need or depression or anxiety. Mean consultation length was 22 minutes (range, 7-47 minutes), and mean intervention length was 8 minutes (range, 2-20 minutes). The intervention was perceived as useful and feasible by oncologists., Conclusion: A brief oncologist-delivered intervention to address FCR is useful and feasible, and has preliminary efficacy in reducing FCR. Plans for a cluster randomized trial are underway., Competing Interests: Jia LiuResearch Funding: AstraZeneca Belinda E. KielyHonoraria: NovartisConsulting or Advisory Role: RocheTravel, Accommodations, Expenses: Roche Mun N. HuiTravel, Accommodations, Expenses: Roche Annabel GoodwinConsulting or Advisory Role: PfizerExpert Testimony: Pfizer Catriona M. McNeilResearch Funding: MSD Oncology Jane M. BeithTravel, Accommodations, Expenses: Novartis, RocheNo other potential conflicts of interest were reported.

Objectives: To develop a cancer-specific multi-attribute utility instrument derived from the Functional Assessment of Cancer Therapy - General (FACT-G) health-related quality of life (HRQL) questionnaire., Methods: We derived a descriptive system based on a subset of the 27-item FACT-G. Item selection was informed by psychometric analyses of existing FACT-G data (n = 6912) and by patient input (n = 82). We then conducted an online valuation survey, with participants recruited via an Australian general population online panel. A discrete choice experiment (DCE) was used, with attributes being the HRQL dimensions of the descriptive system and survival duration, and 16 choice-pairs per participant. Utility decrements were estimated with conditional logit and mixed logit modeling., Results: Eight HRQL dimensions were included in the descriptive system: pain, fatigue, nausea, sleep, work, social support, sadness, and future health worry; each with 5 levels. Of 1737 panel members who accessed the valuation survey, 1644 (95%) completed 1 or more DCE choice-pairs and were included in analyses. Utility decrements were generally monotonic; within each dimension, poorer HRQL levels generally had larger utility decrements. The largest utility decrements were for the highest levels of pain (-0.40) and nausea (-0.28). The worst health state had a utility of -0.54, considerably worse than dead., Conclusions: A descriptive system and preference-based scoring approach were developed for the FACT-8D, a new cancer-specific multi-attribute utility instrument derived from the FACT-G. The Australian value set is the first of a series of country-specific value sets planned that can facilitate cost-utility analyses based on items from the FACT-G and related FACIT questionnaires containing FACT-G items., (Copyright © 2021 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Introduction: Insomnia is a prevalent sleep disorder that causes substantial personal and societal harm. There is evidence that placebo interventions can reduce insomnia symptoms, but this research has involved deceptively administering the placebo under the guise of a real medication (conventional placebo, CP), which has obvious ethical constraints. Open-label placebo (OLP) treatment, in which a placebo is administered with full disclosure that there are no active ingredients, has been proposed as a method of using the placebo effect ethically, but the efficacy and acceptability of OLP for insomnia is currently unknown., Methods and Analysis: This study uses a cohort multiple randomised controlled trial design to compare OLP, CP and no treatment for insomnia. Two-hundred and sixty-seven participants with self-reported insomnia symptoms (Insomnia Severity Index, ISI ≥10) will be recruited into an observational study and have their sleep monitored over a 2-week period. Participants will then be randomised to one of three groups: invite to OLP, invite to CP described deceptively as a new pharmacological agent, or no invite/observational control. Those in OLP and CP accepting the invite receive identical placebos for a 2-week treatment period while sleep is monitored in all participants. The primary outcome is ISI at the end of the treatment period. Secondary outcomes include treatment uptake and clinically significant response rates, objective and subjective sleep parameters, fatigue, mood, expectancy, treatment satisfaction and side effects. Predictors of uptake and responses to OLP and CP will be explored., Ethics and Dissemination: The trial has been approved by The University of Sydney Human Research Ethics Committee. Written informed consent is obtained from every participant. OLP and CP participants accepting the invite undergo an additional consent process. Results will be disseminated via peer-reviewed conference proceedings and publications., Trial Registration Number: ACTRN12620001080910., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring repeated treatment and endoscopic examinations that can occur life-long. In this context, patient-reported outcomes (PROs) are important considerations to patients and managing clinicians. We undertook a systematic review to synthesise PRO results relevant to NMIBC treatment to explore trajectories overtime and differences between treatment options., Methods: We searched databases AMED, MEDLINE, EMbase, PsycINFO, Web of Knowledge and Scopus (inception to 5th December 2019), reference lists and contacted key authors to identify studies that reported PROs after NMIBC treatment. Two reviewers independently applied inclusion and quality criteria and extracted findings. Results for PROs were synthesised for treatment groups across three time periods: acute/during induction therapy; during maintenance therapy; and long-term follow-up (> 1 year)., Results: Of 3193 papers screened, 29 were eligible. These provided evidence about induction treatment effects, but few reported maintenance or long-term evidence, and evidence about differences between NMIBC treatment options was lacking. A range of symptoms (pain in bladder area, urinary frequency and urgency, pain or burning during urination) were commonly experienced during and soon after treatment for NMIBC. Less common symptoms included fatigue, disrupted sleep and gastrointestinal problems., Conclusions: Treatments for NMIBC can cause symptoms and functional impairment during the acute treatment phase and reduce quality of life. Clinicians should be aware of these impairments to prepare patients for short-term sequelae and enable those with treatment options to exercise preferences in choosing among them. However, gaps in current evidence limit our understanding of PRO trajectories from diagnosis through to long-term survivorship and treatment effects.

This study explored whether the psychological composition of a group, with respect to mood, catastrophising, fear of movement and pain self-efficacy characteristics at baseline, is associated with individuals' treatment outcomes following group cognitive behavioural therapy (CBT)-based programmes for chronic pain. Retrospective analyses of outcomes from two independently run CBT-based pain management programmes (Programme A: N = 317 and Programme B: N = 693) were conducted. Mixed modelling analyses did not consistently support the presence of associations between group median scores of depression, catastrophising or fear avoidance with outcomes for individuals in either programme. These results suggest that the psychological profiles of groups are not robust predictors of individual outcomes in CBT groups for chronic pain. By implication, efforts made to consider group composition with respect to psychological attributes may be unnecessary., Competing Interests: Conflict of interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: G.L.M. received support from Pfizer; AIA Australia; SwissRe; Gallagher Bassett; Kaiser Permanente; Workers’ Compensation Boards in Australia, Europe and North America; the International Olympic Committee; the Port Adelaide Football Club; and the Arsenal Football Club. He also received royalties for several books on pain and speakers’ fees for talks on pain, physiotherapy and rehabilitation. M.K.N. received royalties from the self-management book, Manage Your Pain, HarperCollins. He is the Director of Pain Education and Pain Management Programs at the Pain Management Research Institute from where some of this research was conducted. D.W. was a co-owner and principal physiotherapist at Roberts Physiotherapy, where the Paragon Pain Management Programme was run and where another part of this research was conducted. The authors report no other conflicts of interest., (© The British Pain Society 2019.)

Background and Objectives: Fatigue is a very common and debilitating symptom and identified by patients as a critically important core outcome to be included in all trials involving patients receiving hemodialysis. A valid, standardized measure for fatigue is needed to yield meaningful and relevant evidence about this outcome. This study validated a core patient-reported outcome measure for fatigue in hemodialysis., Design, Setting, Participants, & Measurements: A longitudinal cohort study was conducted to assess the validity and reliability of a new fatigue measure (Standardized Outcomes in Nephrology-Hemodialysis Fatigue [SONG-HD Fatigue]). Eligible and consenting patients completed the measure at three time points: baseline, a week later, and 12 days following the second time point. Cronbach α and intraclass correlation coefficient were calculated to assess internal consistency, and Spearman rho was used to assess convergent validity. Confirmatory factor analysis was also conducted. Hemodialysis units in the United Kingdom, Australia, and Romania participated in this study. Adult patients aged 18 years and over who were English speaking and receiving maintenance hemodialysis were eligible to participate. Standardized Outcomes in Nephrology-Hemodialysis, the Visual Analog Scale for fatigue, the 12-Item Short Form Survey, and Functional Assessment of Chronic Illness Therapy-Fatigue were used., Results: In total, 485 participants completed the study across the United Kingdom, Australia, and Romania. Psychometric assessment demonstrated that Standardized Outcomes in Nephrology-Hemodialysis is internally consistent (Cronbach α =0.81-0.86) and stable over a 1-week period (intraclass correlation coefficient =0.68-0.74). The measure demonstrated convergence with Functional Assessment of Chronic Illness Therapy-Fatigue and had moderate correlations with other measures that assessed related but not the same concept (the 12-Item Short Form Survey and the Visual Analog Scale). Confirmatory factor analysis supported the one-factor model., Conclusions: SONG-HD Fatigue seems to be a reliable and valid measure to be used in trials involving patients receiving hemodialysis., (Copyright © 2020 by the American Society of Nephrology.)

Objective: This study aimed to validate the Bereaved Cancer Needs Instrument (BCNI), an instrument designed to assess the unmet psychosocial needs of adolescents and young adults (AYAs, 12-25 years) who have experienced the death of a parent or sibling to cancer., Methods: In total, 335 participants aged 12 to 25 (M = 15.80, SD = 3.32) who had experienced the death of a parent (N = 297) or sibling (N = 38) from cancer took part in this study. Participants completed the BCNI, the Kessler-10 psychological distress scale (K10), and several items assessing the acceptability of the BCNI., Results: Exploratory factor analysis indicated that a seven-factor structure best fit the BCNI, accounting for 56.65% of the variance in unmet psychosocial needs of cancer-bereaved AYAs. The measure had good psychometric properties, high levels of internal consistency for all domains, and correlated strongly with the K10 (r = .59, p < .001). Item response theory analysis demonstrated that the response scale was appropriate, with strong discrimination indices. Analyses also indicated the potential to reduce the BCNI from 58 items to a 37-item short-form, although this will require further validation., Conclusions: The BCNI is the first psychometrically validated instrument to identify the unmet psychosocial needs of bereaved AYAs who have experienced the death of a parent or sibling to cancer. The instrument can be used in research and health care settings to identify the unmet needs of young people bereaved by cancer and provide targeted support to reduce psychological distress.