Ingham Institute

The dual-assay enables routine quantification of biologic-ADA interactions in a cost effective, high throughput LC-MS/MS workflow. It addresses key limitations of immunoassays and may improve detection of immunogenicity in patients receiving biologic therapy. The method is generalizable to other therapeutic antibodies affected by ADA interference.

With increasing cancer survival rates, optimising health-related quality of life (HRQL) has become a major priority. However, longitudinal assessments of HRQL outcomes in people with cancer are limited. This study aimed to examine changes in HRQL outcomes following a cancer diagnosis and to identify the long-term trajectories of HRQL outcomes and associated factors. This study included 1414 women diagnosed with primary invasive cancer from 1996 to 2019 and 2828 women without cancer from a large cohort (born in 1946-51) of the Australian Longitudinal Study on Women’s Health, linked to the Australian Cancer Database. Generalised linear models were used to estimate changes in HRQL outcomes, adjusting for sociodemographic factors and other health conditions. Group-based multitrajectory modelling was applied to identify HRQL trajectories over time. In the short-term (≤ 3 years), we found a significant decline in the adjusted mean difference (AMD) across all HRQL domains from pre-cancer to post-cancer surveys, with the largest decrease in general health (AMD − 10.3, 95% CI: -11.43, -9.18). The corresponding changes within the same period among women without cancer were not significant at p < 0.05, except for physical functioning. In the long-term (≤ 15 years), four HRQL trajectory groups were identified: very low HRQL trajectory (n = 184, 13%), moderate HRQL trajectory (n = 355, 25%), moderate-high HRQL trajectory (n = 532, 38%), and high HRQL trajectory (n = 343, 24%). In the control sample, a greater proportion of women belonged to the high HRQL trajectory group (29% versus 24%). Cancer survivors in the very low or moderate HRQL trajectory groups had significantly lower HRQL domain scores than the corresponding trajectory groups in the control group (p < 0.05). Compared with the high HRQL trajectory group, the very low HRQL trajectory group experienced greater difficulties in managing their available income (60% versus 22%, p < 0.01) and had ≥ 2 comorbidities (42% versus 9%, p < 0.01). Our findings suggest the importance of measuring HRQL soon after diagnosis as a baseline measure and considering both baseline and ongoing HRQL when guiding supportive care for women cancer survivors. Additionally, targeted initiatives that prevent and manage comorbidities and financial hardship in those with low HRQL at baseline are critical for equitable care.

Chronic pain reduces health-related quality of life, but previous research on pain after traumatic brain injury (TBI) has been largely concussion-focused. This systematic review evaluated the prevalence, predictors, and treatment of chronic pain (bodily, headache, any chronic pain), as well as average pain intensity/interference (secondary objective) in adults ≥3 months after complicated mild to severe TBI. Studies were identified through electronic databases and screened against predefined selection criteria. Chronic pain prevalence and mean pain intensity/interference (observational studies), predictor associations (cohort studies), and treatment effects (clinical trials) were synthesized; data were pooled where able using generalized linear mixed-, random-, or fixed-effects models. We assessed heterogeneity using between-cluster variance and sensitivity analyses, risk of bias, publication bias, and evidence certainty (Grading of Recommendations Assessment, Development and Evaluation). Overall, 14,331 studies were screened, with 28 included across the 4 review topics (17,899 participants; 94.61% mod-sev TBI; 9.72% military). Pooled prevalences (95% CI) of chronic pain were as follows: "bodily" 51% (39-63; k = 5 studies; moderate certainty), "headache" 31% (20-45; k = 4; moderate certainty), "any" 40% (31-49; k = 9; low certainty). Pooled 36-Item Short Form Health Survey Bodily Pain score was 70.7 (66.1-75.4; k = 7). Chronic pain predictors were sex, ethnicity, military service, preinjury headache/migraine, penetrating injury, and poor psychosocial outcomes (sleep, depression, posttraumatic stress, anxiety). One trial (Botulinum toxin-A vs placebo) showed moderate short-term reductions in posttraumatic headache frequency (very low certainty). Chronic pain was double the general population rate post-TBI, with bodily pain more prevalent than headache. Rates were similar over time and between civilian and military populations; however, there was greater variance and lower certainty in military estimates. Future research involving high-quality treatment studies is needed.

We present an EEG-based tool for prehospital LVO stroke detection using a hybrid EMD-PSD feature representation and a lightweight classifier. In 67 patients, the method achieved 88% accuracy, demonstrating that compact EEG triage can support rapid routing decisions.

To compare the ALGO Smart Pump (ALGO), operating in Adaptive Pulsatile Aspiration (APA™) and Static modes, with the Penumbra ENGINE during in-vitro mechanical thrombectomy, and to determine whether adaptive pulsatile aspiration improves complete clot ingestion (CCI) and reduces aspiration time across catheters sizes and catheter-to-artery (C/A) ratios. Apre-specified integrative analysis of two previously completed in-vitro thrombectomy studies was conducted using astandardized middle cerebral artery occlusion model. Atotal of 720 thrombectomy procedures were performed by two experienced operators using twelve commercial catheters (six small-bore, six large-bore). Three aspiration modalities were tested: ALGO APA™, ALGO Static, and Penumbra ENGINE continuous aspiration (n = 30 per catheter-pump pairing). The primary endpoint was CCI; secondary endpoint was aspiration time. Outcome analysis included two-way ANOVA and Chi-squared tests, with catheter, operator, and C/A ratio terms. The ALGO demonstrated ahigher median CCI rate than Penumbra (81.4% vs. 56.1%, χ2(1) = 52.364, p < 0.001). Aspiration times were significantly shorter with ALGO, particularly in APA™ mode (43.8 s vs. 60.6 s, p < 0.001). Two-way ANOVA demonstrated significant interaction between catheter size and pump type (p < 0.001), with ALGO notably improving small-bore catheter performance. CCI correlated positively with catheter-to-artery (C/A) ratio across both systems, with ALGO maintaining higher success across all ratios. Adaptive pulsatile aspiration enhances clot ingestion efficiency and reduces aspiration time in an in-vitro thrombectomy model, particularly for smaller catheters. These findings support further translational studies on optimizing aspiration dynamics to enhance first-pass success in endovascular stroke therapy.

Autism is highly heterogeneous and reliance on behavioural assessments alone may not provide sufficient insight into the unique characteristics of autistic individuals. Biomarkers, like hair cortisol concentration (HCC), may help unravel mechanisms underlying clinical variation in autism and support diagnostic measures, especially in young children who may not be able to effectively communicate their distress. We examined the relationship between HCC and autistic traits along with commonly co-occurring conditions including sleep disturbances in autistic children compared to non-autistic children. We conducted a cross-sectional analysis utilising data from the Australian Autism Biobank comprising clinical and biological samples from Australian children aged 2-17 years. Primary analysis included multivariable linear regression analyses to identify significant associations with HCC after controlling for key sociodemographic covariates, including child's intelligence quotient (IQ). The study included 307 autistic children, 158 non-autistic siblings, and 124 unrelated non-autistic children. The commonly reported co-occurring conditions were global developmental delay (8.5 %), intellectual disability (6.1 %), and otitis media (6.1 %). Higher severity of autistic traits and in particular social affect issues, co-occurring attention-deficit/hyperactivity disorder (ADHD), internalising, and maladaptive behaviours were significantly associated with lower normalised HCC. Higher sleep anxiety and IQ were associated with higher HCC. Regarding sociodemographic factors, older age and higher family income were associated with lower HCC. The findings indicate the clinical value of HCC as a viable biomarker to identify subgroups based on co-occurring medical and mental health conditions. Further research to elucidate the link to individual and family/environmental factors as potential sources of stress is needed to offer targeted supports.

Automated contour quality assurance (QA) has the potential to reduce resource and cost requirements for clinical trial QA. While several studies have developed such models, few have been translated for use in prospective real-world trials. This study aimed to implement a contour QA tool using a previously developed model and evaluate its performance during deployment within the TROG 18.01 NINJA prostate cancer trial. A software tool was developed using an existing prostate clinical target volume (CTV) QA model and integrated into the trial QA workflow. A pilot study was conducted over an 18-month period, during which 56 CTVs were assessed. Reports generated by the tool flagged cases for review and were provided to radiation oncologists to support QA processes. All five protocol-violating CTVs were correctly identified during deployment, yielding a sensitivity of 1.0. However, a higher-than-expected false positive rate resulted in an accuracy of 0.46 and specificity of 0.41. Retrospective analysis showed that many cases submitted deviated from the model's training distribution, primarily due to inconsistencies in MRI acquisition and variation in submitted CTV definitions. Incorporating out-of-distribution detection based on histogram correlation and model uncertainty improved accuracy to 0.69 for in-distribution cases. Radiation oncologists reported time savings of up to 60min per case. However, preparation of data remained time intensive for QA coordinators, highlighting the need for further workflow automation. These findings support the feasibility of automated contour QA in multicentre trials and offer guidance for future implementation at scale.

Abstract Background Inflammatory bowel disease (IBD) prevalence is rising worldwide, creating major challenges for sustainable, high-quality care. In Australia alone, approximately 180,000 people are affected, with the national economic burden projected to reach $77.9 billion by 2035.1 The absence of an IBD National Clinical Quality Registry (CQR) limits benchmarking and cost-effective care. This cost:benefits analysis examines the likely outcomes from scaling a nascent CQR (CCCare) into a National CQR. Methods Cost estimates were derived from published national datasets and conservative assumptions for reductions in healthcare utilisation were informed by local studies.2,3 Savings were modelled at three CQR sizes: current (16,000 consumers), interim target (60,000), and national coverage (180,000) over a two-year period. Return on investment (ROI) was calculated using a $1 million investment for current and interim sizes and $3 million for national coverage. Social return on investment (SROI) was estimated using a conservative Quality-Adjusted Life Years (QALY) gain of 0.03% per patient per year,1 valued at $50,000 per QALY. Results At current scale, CCCare CQR yields $10.7M in direct savings (ROI: 969%). Scaling to 60,000 consumers increases savings to $40.1 million (ROI: 3,909%), while national coverage projects $121.3M in savings (ROI 3,945%). Cost reductions were driven primarily by avoided hospitalisations and surgical episodes, with incremental contributions from outpatient care. QALY-based SROI modelling estimates up to $180 in social returns for every $1 invested at national coverage. Conclusion Scaling an IBD-specific CQR like CCCare nationally can deliver substantial ROI and SROI, by reducing costly, avoidable interventions while improving care quality. Although modelled with Australian data, the conservative parameters used are transferable across health systems. For international stakeholders, savings translate into value capture for payers through reduced diagnostic and outpatient costs, and for providers through fewer admissions and surgeries. CCCare’s participation in the Global IBD Registry (GLIDE) underscores the international relevance of ROI-positive registries, offering a scalable framework for providers, payers, and policymakers worldwide.

ABSTRACTBackgroundPatterns of steroid use in inflammatory bowel disease remain poorly characterized in real‐world settings. Steroid exposure is associated with adverse effects and often indicates suboptimally controlled disease. Therefore, patterns and predictors of steroid use in a large inflammatory bowel disease cohort were examined.MethodsSteroid exposure over a 3‐year window was explored. Use was classified by duration—short (1–28 days), moderate (29–56 days), prolonged (> 56 days), and recency (within last year, prior years or no exposure). Associations with demographic and disease‐related factors were assessed using multivariable logistic regression.ResultsAmong 5436 people (median age 42 years, IQR 32–56), 18.3% (n = 994) were steroid exposed. 57.6% had Crohn's disease and 50.2% were female. Crohn's disease was associated with lower odds of both prolonged and recent exposure compared to ulcerative colitis (AOR 0.72, p = 0.001 and AOR 0.78, p = 0.037, respectively). Females had a greater likelihood of both prolonged and recent exposure (AOR 1.22, p = 0.048 and AOR 1.23, p = 0.041, respectively). Young adults (20–29 years) had higher odds of prolonged and recent use than those > 70 years (AOR 6.59 and 9.12, respectively, p < 0.001). Combination immunomodulator and advanced therapy use was associated with a higher likelihood of both prolonged and recent use compared to 5‐aminosalicylic acid therapy alone (AOR 4.01, p = 0.002 and AOR 4.54, p < 0.001). Age at diagnosis had a modest effect size (AOR 1.03, p < 0.001).ConclusionSteroid use was modest, with over 80% unexposed over 3 years. Proactive optimization of therapy, particularly in younger individuals and those with ulcerative colitis, may further reduce steroid exposure.