Healthcare Disparities and Outcomes of Cancer Patients in a Community Setting from a COVID-19 Epicenter

There have been numerous studies demonstrating how cancer patients are at an increased risk of mortality. Within New York City, our community hospital emerged as an epicenter of the first wave of the pandemic in the spring of 2020 and serves a unique population that is predominately uninsured, of a lower income, and racially/ethnically diverse. In this single institution retrospective study, the authors seek to investigate COVID-19 diagnosis, severity and mortality in patients with an active cancer diagnosis. Demographic, clinical characteristics, treatment, SARS-CoV-2 laboratory results, and outcomes were evaluated. In our community hospital during the first wave of the COVID-19 pandemic in the United States, patients with active cancer diagnosis appear to be at increased risk for mortality (30%) and severe events (50%) due to the SARS-CoV-2 infection compared to the general population. A higher proportion of active cancer patients with Medicaid insurance, Hispanic ethnicity, other race, and male sex had complications and death from COVID-19 infection. The pandemic has highlighted the health inequities that exist in vulnerable patient populations and underserved communities such as ours

Randomized clinical trials of machine learning interventions in health care: a systematic review

Importance: Despite the potential of machine learning to improve multiple aspects of patient care, barriers to clinical adoption remain. Randomized clinical trials (RCTs) are often a prerequisite to large-scale clinical adoption of an intervention, and important questions remain regarding how machine learning interventions are being incorporated into clinical trials in health care. Objective: To systematically examine the design, reporting standards, risk of bias, and inclusivity of RCTs for medical machine learning interventions. Evidence Review: In this systematic review, the Cochrane Library, Google Scholar, Ovid Embase, Ovid MEDLINE, PubMed, Scopus, and Web of Science Core Collection online databases were searched and citation chasing was done to find relevant articles published from the inception of each database to October 15, 2021. Search terms for machine learning, clinical decision-making, and RCTs were used. Exclusion criteria included implementation of a non-RCT design, absence of original data, and evaluation of nonclinical interventions. Data were extracted from published articles. Trial characteristics, including primary intervention, demographics, adherence to the CONSORT-AI reporting guideline, and Cochrane risk of bias were analyzed. Findings: Literature search yielded 19737 articles, of which 41 RCTs involved a median of 294 participants (range, 17-2488 participants). A total of 16 RCTS (39%) were published in 2021, 21 (51%) were conducted at single sites, and 15 (37%) involved endoscopy. No trials adhered to all CONSORT-AI standards. Common reasons for nonadherence were not assessing poor-quality or unavailable input data (38 trials [93%]), not analyzing performance errors (38 [93%]), and not including a statement regarding code or algorithm availability (37 [90%]). Overall risk of bias was high in 7 trials (17%). Of 11 trials (27%) that reported race and ethnicity data, the median proportion of participants from underrepresented minority groups was 21% (range, 0%-51%). Conclusions and Relevance: This systematic review found that despite the large number of medical machine learning-based algorithms in development, few RCTs for these technologies have been conducted. Among published RCTs, there was high variability in adherence to reporting standards and risk of bias and a lack of participants from underrepresented minority groups. These findings merit attention and should be considered in future RCT design and reporting.Published versionThis study was supported by grants K23-DK125718 (Dr Shung) and K08-DE030216 (Dr Kann) from the National Institutes of Health, grant T32GM007753 from the National Institute of General Medical Sciences (Ms Plana), and grant F30-CA260780 from the National Cancer Institute (Ms Plana)

Clinical validation of deep learning algorithms for radiotherapy targeting of non-small-cell lung cancer:an observational study

BACKGROUND: Artificial intelligence (AI) and deep learning have shown great potential in streamlining clinical tasks. However, most studies remain confined to in silico validation in small internal cohorts, without external validation or data on real-world clinical utility. We developed a strategy for the clinical validation of deep learning models for segmenting primary non-small-cell lung cancer (NSCLC) tumours and involved lymph nodes in CT images, which is a time-intensive step in radiation treatment planning, with large variability among experts. METHODS: In this observational study, CT images and segmentations were collected from eight internal and external sources from the USA, the Netherlands, Canada, and China, with patients from the Maastro and Harvard-RT1 datasets used for model discovery (segmented by a single expert). Validation consisted of interobserver and intraobserver benchmarking, primary validation, functional validation, and end-user testing on the following datasets: multi-delineation, Harvard-RT1, Harvard-RT2, RTOG-0617, NSCLC-radiogenomics, Lung-PET-CT-Dx, RIDER, and thorax phantom. Primary validation consisted of stepwise testing on increasingly external datasets using measures of overlap including volumetric dice (VD) and surface dice (SD). Functional validation explored dosimetric effect, model failure modes, test-retest stability, and accuracy. End-user testing with eight experts assessed automated segmentations in a simulated clinical setting. FINDINGS: We included 2208 patients imaged between 2001 and 2015, with 787 patients used for model discovery and 1421 for model validation, including 28 patients for end-user testing. Models showed an improvement over the interobserver benchmark (multi-delineation dataset; VD 0·91 [IQR 0·83-0·92], p=0·0062; SD 0·86 [0·71-0·91], p=0·0005), and were within the intraobserver benchmark. For primary validation, AI performance on internal Harvard-RT1 data (segmented by the same expert who segmented the discovery data) was VD 0·83 (IQR 0·76-0·88) and SD 0·79 (0·68-0·88), within the interobserver benchmark. Performance on internal Harvard-RT2 data segmented by other experts was VD 0·70 (0·56-0·80) and SD 0·50 (0·34-0·71). Performance on RTOG-0617 clinical trial data was VD 0·71 (0·60-0·81) and SD 0·47 (0·35-0·59), with similar results on diagnostic radiology datasets NSCLC-radiogenomics and Lung-PET-CT-Dx. Despite these geometric overlap results, models yielded target volumes with equivalent radiation dose coverage to those of experts. We also found non-significant differences between de novo expert and AI-assisted segmentations. AI assistance led to a 65% reduction in segmentation time (5·4 min; p<0·0001) and a 32% reduction in interobserver variability (SD; p=0·013). INTERPRETATION: We present a clinical validation strategy for AI models. We found that in silico geometric segmentation metrics might not correlate with clinical utility of the models. Experts' segmentation style and preference might affect model performance. FUNDING: US National Institutes of Health and EU European Research Council

Fully-automated sarcopenia assessment in head and neck cancer:development and external validation of a deep learning pipeline

PURPOSE: Sarcopenia is an established prognostic factor in patients diagnosed with head and neck squamous cell carcinoma (HNSCC). The quantification of sarcopenia assessed by imaging is typically achieved through the skeletal muscle index (SMI), which can be derived from cervical neck skeletal muscle (SM) segmentation and cross-sectional area. However, manual SM segmentation is labor-intensive, prone to inter-observer variability, and impractical for large-scale clinical use. To overcome this challenge, we have developed and externally validated a fully-automated image-based deep learning (DL) platform for cervical vertebral SM segmentation and SMI calculation, and evaluated the relevance of this with survival and toxicity outcomes. MATERIALS AND METHODS: 899 patients diagnosed as having HNSCC with CT scans from multiple institutes were included, with 335 cases utilized for training, 96 for validation, 48 for internal testing and 393 for external testing. Ground truth single-slice segmentations of SM at the C3 vertebra level were manually generated by experienced radiation oncologists. To develop an efficient method of segmenting the SM, a multi-stage DL pipeline was implemented, consisting of a 2D convolutional neural network (CNN) to select the middle slice of C3 section and a 2D U-Net to segment SM areas. The model performance was evaluated using the Dice Similarity Coefficient (DSC) as the primary metric for the internal test set, and for the external test set the quality of automated segmentation was assessed manually by two experienced radiation oncologists. The L3 skeletal muscle area (SMA) and SMI were then calculated from the C3 cross sectional area (CSA) of the auto-segmented SM. Finally, established SMI cut-offs were used to perform further analyses to assess the correlation with survival and toxicity endpoints in the external institution with univariable and multivariable Cox regression. RESULTS: DSCs for validation set (n = 96) and internal test set (n = 48) were 0.90 (95% CI: 0.90 - 0.91) and 0.90 (95% CI: 0.89 - 0.91), respectively. The predicted CSA is highly correlated with the ground-truth CSA in both validation (r = 0.99, &lt; 0.0001) and test sets (r = 0.96, &lt; 0.0001). In the external test set (n = 377), 96.2% of the SM segmentations were deemed acceptable by consensus expert review. Predicted SMA and SMI values were highly correlated with the ground-truth values, with Pearson r ß 0.99 (p &lt; 0.0001) for both the female and male patients in all datasets. Sarcopenia was associated with worse OS (HR 2.05 [95% CI 1.04 - 4.04], p = 0.04) and longer PEG tube duration (median 162 days vs. 134 days, HR 1.51 [95% CI 1.12 - 2.08], p = 0.006 in multivariate analysis. CONCLUSION: We developed and externally validated a fully-automated platform that strongly correlates with imaging-assessed sarcopenia in patients with H&amp;N cancer that correlates with survival and toxicity outcomes. This study constitutes a significant stride towards the integration of sarcopenia assessment into decision-making for individuals diagnosed with HNSCC. SUMMARY STATEMENT: In this study, we developed and externally validated a deep learning model to investigate the impact of sarcopenia, defined as the loss of skeletal muscle mass, on patients with head and neck squamous cell carcinoma (HNSCC) undergoing radiotherapy. We demonstrated an efficient, fullyautomated deep learning pipeline that can accurately segment C3 skeletal muscle area, calculate cross-sectional area, and derive a skeletal muscle index to diagnose sarcopenia from a standard of care CT scan. In multi-institutional data, we found that pre-treatment sarcopenia was associated with significantly reduced overall survival and an increased risk of adverse events. Given the increased vulnerability of patients with HNSCC, the assessment of sarcopenia prior to radiotherapy may aid in informed treatment decision-making and serve as a predictive marker for the necessity of early supportive measures

A Modern Radiotherapy Series of Survival in Hispanic Patients with Glioblastoma.

BackgroundStudies have shown racial differences in cancer outcomes. We investigate whether survival differences existed in Hispanic patients with glioblastoma (GBM) compared with other ethnicities from our modern radiotherapy series, because no study to date has focused on outcomes in this group after radiation therapy.MethodsWe retrospectively evaluated 428 patients diagnosed with GBM from 1996 to 2014 at our institution, divided into 4 groups based on self-report: white, black, Hispanic, and Asian/Indian. The primary outcome was overall survival. We analyzed differences in prognostic factors among the whole cohort compared with the Hispanic cohort alone.ResultsBaseline characteristics of the 4 racial groups were comparable. With a median follow-up of 387 days, no survival differences were seen by Kaplan-Meier analysis. Median overall survival for Hispanic patients was 355 days versus 450 days for the entire cohort. Factors significant for patient outcomes in the entire cohort differed slightly from those specific to Hispanic patients. Low Karnofsky Performance Status was significant on multivariate analysis in the whole population, but not in Hispanic patients. Extent of resection, recursive partitioning analysis class, and radiation therapy total dose were significant on multivariate analysis in both the whole population and Hispanic patients.ConclusionsWe found that Hispanic patients with GBM had no difference in survival compared with other ethnicities in our cohort. Differences exist in factors associated with outcomes on single and multivariate analysis for Hispanic patients with GBM compared with the entire cohort. Additional studies focusing on Hispanic patients will aid in more personalized treatment approaches in this group

Development and Validation of an Automated Image-Based Deep Learning Platform for Sarcopenia Assessment in Head and Neck Cancer

Peer reviewe

iTMT v1.0: Automated temporalis muscle segmentation and thickness assessment with deep learning

iTMT v1.0: Automated temporalis muscle segmentation and thickness assessment with deep learning Github Repo: https://github.com/AIM-KannLab/itm

The impact of air pollution on deaths, disease burden, and life expectancy across the states of India: the Global Burden of Disease Study 2017

Summary: Background: Air pollution is a major planetary health risk, with India estimated to have some of the worst levels globally. To inform action at subnational levels in India, we estimated the exposure to air pollution and its impact on deaths, disease burden, and life expectancy in every state of India in 2017. Methods: We estimated exposure to air pollution, including ambient particulate matter pollution, defined as the annual average gridded concentration of PM2.5, and household air pollution, defined as percentage of households using solid cooking fuels and the corresponding exposure to PM2.5, across the states of India using accessible data from multiple sources as part of the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2017. The states were categorised into three Socio-demographic Index (SDI) levels as calculated by GBD 2017 on the basis of lag-distributed per-capita income, mean education in people aged 15 years or older, and total fertility rate in people younger than 25 years. We estimated deaths and disability-adjusted life-years (DALYs) attributable to air pollution exposure, on the basis of exposure–response relationships from the published literature, as assessed in GBD 2017; the proportion of total global air pollution DALYs in India; and what the life expectancy would have been in each state of India if air pollution levels had been less than the minimum level causing health loss. Findings: The annual population-weighted mean exposure to ambient particulate matter PM2·5 in India was 89·9 μg/m3 (95% uncertainty interval [UI] 67·0–112·0) in 2017. Most states, and 76·8% of the population of India, were exposed to annual population-weighted mean PM2·5 greater than 40 μg/m3, which is the limit recommended by the National Ambient Air Quality Standards in India. Delhi had the highest annual population-weighted mean PM2·5 in 2017, followed by Uttar Pradesh, Bihar, and Haryana in north India, all with mean values greater than 125 μg/m3. The proportion of population using solid fuels in India was 55·5% (54·8–56·2) in 2017, which exceeded 75% in the low SDI states of Bihar, Jharkhand, and Odisha. 1·24 million (1·09–1·39) deaths in India in 2017, which were 12·5% of the total deaths, were attributable to air pollution, including 0·67 million (0·55–0·79) from ambient particulate matter pollution and 0·48 million (0·39–0·58) from household air pollution. Of these deaths attributable to air pollution, 51·4% were in people younger than 70 years. India contributed 18·1% of the global population but had 26·2% of the global air pollution DALYs in 2017. The ambient particulate matter pollution DALY rate was highest in the north Indian states of Uttar Pradesh, Haryana, Delhi, Punjab, and Rajasthan, spread across the three SDI state groups, and the household air pollution DALY rate was highest in the low SDI states of Chhattisgarh, Rajasthan, Madhya Pradesh, and Assam in north and northeast India. We estimated that if the air pollution level in India were less than the minimum causing health loss, the average life expectancy in 2017 would have been higher by 1·7 years (1·6–1·9), with this increase exceeding 2 years in the north Indian states of Rajasthan, Uttar Pradesh, and Haryana. Interpretation: India has disproportionately high mortality and disease burden due to air pollution. This burden is generally highest in the low SDI states of north India. Reducing the substantial avoidable deaths and disease burden from this major environmental risk is dependent on rapid deployment of effective multisectoral policies throughout India that are commensurate with the magnitude of air pollution in each state. Funding: Bill & Melinda Gates Foundation; and Indian Council of Medical Research, Department of Health Research, Ministry of Health and Family Welfare, Government of India