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Abstract Introduction Although prostate magnetic resonance imaging (MRI) is commonly used in the diagnosis, staging and active surveillance of prostate cancer, little is known about patient perspectives on MRI. Methods We performed a qualitative study consisting of in‐depth, semi‐structured interviews of patients with low‐ and intermediate‐risk prostate cancer managed with active surveillance. Interviews focused on experiences with and knowledge of prostate MRI and MRI‐ultrasound fusion biopsy during active surveillance. We purposively sampled patients who received prostate MRI as part of their clinical care, conducted interviews until reaching thematic saturation and performed conventional content analysis to analyse data. Results Twenty patients aged 51–79 years (mean = 68 years) participated in the study. At diagnosis, 17 (85%) had a Gleason grade group 1, and three (15%) had a grade group 2 tumour. Overall, participants viewed prostate MRI as a valuable tool that accurately localizes and monitors prostate cancer over time, and they considered prostate MRI central to active surveillance monitoring. We identified five thematic categories related to MRI use: (1) the experiential aspects of undergoing an MRI scan; (2) the experience of visualizing one's own prostate and prostate cancer; (3) adequacy of provider explanations of MRI results; (4) confidence in prostate MRI in decision‐making; and (5) the role of prostate MRI in longitudinal follow‐up, including an interest in using MRI to modify the timing of, or replace, prostate biopsy. Conclusion Patients value prostate MRI as a tool that enhances their confidence in the initial diagnosis and monitoring of prostate cancer. This work can inform future studies to optimize patient experience, education and counselling during active surveillance for prostate cancer.

Abstract Background Tissue‐based gene expression (genomic) tests provide estimates of prostate cancer aggressiveness and are increasingly used for patients considering or engaged in active surveillance. However, little is known about patient experiences with genomic testing and its role in their decision‐making. Methods We performed a qualitative study consisting of in‐depth, semi‐structured interviews of patients with low‐ or favourable‐intermediate‐risk prostate cancer managed with active surveillance. We purposively sampled to include patients who received biopsy‐based genomic testing as part of clinical care. The interview guide focused on experiences with genomic testing during patients' decision‐making for prostate cancer management and understanding of genomic test results. We continued interviews until thematic saturation was reached, iteratively created a code key and used conventional content analysis to analyse data. Results Participants' (n = 20) mean age was 68 years (range 51–79). At initial biopsy, 17 (85%) had a Gleason grade group 1, and 3 (15%) had a grade group 2 prostate cancer. The decision to undergo genomic testing was driven by both participants and physicians' recommendations; however, some participants were unaware that testing had occurred. Overall, participants understood the role of genomic testing in estimating their prostate cancer risk, and the test results increased their confidence in the decision for active surveillance. Participants had some misconceptions about the difference between tissue‐based gene expression tests and germline genetic tests and commonly believed that tissue‐based tests measured hereditary cancer risk. While some participants expressed satisfaction with their physicians' explanations, others felt that communication was limited and lacked sufficient detail. Conclusion Patients interact with and are influenced by the results of biopsy‐based genomic testing during active surveillance for prostate cancer, despite gaps in understanding about test results. Our findings indicate areas for improvement in patient counselling in order to increase patient knowledge and comfort with genomic testing.

Purpose: The landmark randomized trial on chest irradiation in extensive disease small cell lung cancer (CREST) demonstrated that consolidative thoracic radiation therapy (cTRT) improved overall (OS) and progression-free survival (PFS) after initial chemotherapy (chemo) in extensive-stage small cell lung cancer, with potentially increased benefit in women compared with men. It is unknown whether similar findings would apply after chemoimmunotherapy became the standard first-line treatment. In this analysis, we report national practice patterns and survival outcomes of cTRT according to patient sex. Methods and Materials: We included patients from de-identified electronic health record-derived database diagnosed with stage IV small cell lung cancer (2014-2021) who completed 4 to 6 cycles of first-line systemic therapy (platinum-doublet chemotherapy or chemoimmunotherapy). We evaluated OS and PFS using multivariable Cox proportional hazards regression with receipt of cTRT as an independent variable and stratified by sex. As a sensitivity analysis, we weighted the models by the inverse probability of receiving cTRT. Results: A total of 1227 patients were included (850 chemotherapy, 377 chemoimmunotherapy). There were no statistically significant differences in baseline characteristics between patients who did and did not receive cTRT. Among women, cTRT was associated with superior OS (adjusted hazard ratio [HR], 0.67; 95% CI, 0.52-0.87) and PFS (HR, 0.63; 95% CI, 0.49-0.82) compared with those not receiving cTRT. Conversely, no OS or PFS benefit with cTRT was observed in men (OS HR, 1.03; 95% CI, 0.80-1.31; PFS HR, 1.12; 95% CI, 0.85-1.47). Findings were similar in weighted analyses. Conclusions: The survival efficacy of cTRT may be moderated by sex, with female patients appearing more likely to benefit than male patients. These findings reflect sex-based survival trends with similar effect sizes to those observed in the CREST trial. Although the underpinnings of this association need to be elucidated, stratification by sex should be considered for randomized-controlled trials studying cTRT in extensive-stage small cell lung cancer.

Abstract The impact and effectiveness of clinical trial data sharing initiatives may differ depending on the data sharing model used. We characterized outcomes associated with models previously used by the U.S. National Institutes of Health (NIH): National Heart, Lung, and Blood Institute’s (NHLBI) centralized model and National Cancer Institute’s (NCI) decentralized model. We identified trials completed in 2010–2013 that met NIH data sharing criteria and matched studies based on cost and/or size, determining whether trial data were shared, and for those that were, the frequency of secondary internal publications (authored by at least one author from the original research team) and shared data publications (authored by a team external to the original research team). We matched 77 NHLBI-funded trials to 77 NCI-funded trials; among these, 20 NHLBI-sponsored trials (26%) and 4 NCI-sponsored trials (5%) shared data (OR 6.4, 95% CI: 2.1, 19.8). From the 4 NCI-sponsored trials sharing data, we identified 65 secondary internal and 2 shared data publications. From the 20 NHLBI-sponsored trials sharing data, we identified 188 secondary internal and 53 shared data publications. The NHLBI’s centralized data sharing model was associated with more trials sharing data and more shared data publications when compared with the NCI’s decentralized model.

Abstract Background Cancer incidence among individuals with incarceration exposure has been rarely studied due to the absence of linked datasets. This study examined cancer incidence during incarceration and postincarceration compared to the general population using a statewide linked cohort. Methods We constructed a retrospective cohort from a linkage of state tumor registry and correctional system data for Connecticut residents from 2005 to 2016, and identified cancers diagnosed during and within 12 months postincarceration. We estimated incidence rates (including for screen‐detectable cancers) and calculated the standardized incidence ratios (SIR) for the incarcerated and recently released populations, relative to the general population. We also examined cancer incidence by race and ethnicity within each group. Results Cancer incidence was lower in incarcerated individuals (SIR = 0.64, 95% CI 0.56–0.72), but higher in recently released individuals (SIR = 1.34, 95% CI 1.23–1.47) compared with the general population, and across all race and ethnic strata. Similarly, nonscreen‐detectable cancer incidence was lower in incarcerated and higher in recently released populations compared to the general population. However, non‐Hispanic Black individuals had elevated incidence of screen‐detectable cancers compared with non‐Hispanic White individuals across all three populations (incarcerated, SIR = 1.66, 95% CI 1.03–2.53; recently released, SIR = 1.83, 95% CI 1.32–2.47; and general population, SIR = 1.18, 95% CI 1.16–1.21). Conclusion Compared with the general population, incarcerated persons have a lower cancer incidence, whereas recently released persons have a higher cancer incidence. Irrespective of incarceration status, non‐Hispanic Black individuals have a higher incidence of screen‐detectable cancers compared with non‐Hispanic White individuals. Supplemental studies examining cancer screening and diagnoses during incarceration are needed to discern the reasons for observed disparities in incidence.

Background: This study aims to quantitatively assess use of the NSQIP surgical risk calculator (NSRC) in contemporary surgical practice and to identify barriers to use and potential interventions that might increase use. Materials and methods: We performed a cross-sectional study of surgeons at seven institutions. The primary outcomes were self-reported application of the calculator in general clinical practice and specific clinical scenarios as well as reported barriers to use. Results: In our sample of 99 surgeons (49.7% response rate), 73.7% reported use of the NSRC in the past month. Approximately half (51.9%) of respondents reported infrequent NSRC use (

Background: Following a 2014 safety warning (that laparoscopic power morcellation may increase tumor dissemination if patients have occult uterine cancer), hysterectomy practice shifted from laparoscopic to abdominal approach. This avoided morcellating occult cancer, but increased perioperative complications. To inform the national impact of this practice change, we examined the cost-effectiveness of hysterectomy practice in the postwarning period, in comparison to counterfactual hysterectomy practice had there been no morcellation warning. Materials and Methods: We constructed a decision tree model to simulate relevant outcomes over the lifetime of patients in the national population undergoing hysterectomy for presumed benign indications. The model accounted for both hysterectomy- and occult cancer-related outcomes. Probability-, cost-, and utility weight-related input parameters were derived from analysis of the State Inpatient Databases, State Ambulatory Surgery and Services Databases, data from the New York Statewide Planning and Research Cooperative System and New York State Cancer Registry, and published literature. Results: With an estimated national sample of 353,567 adult women, base case analysis showed that changes in hysterectomy practice after the morcellation warning led to a net gain of 867.15 quality-adjusted life years (QALYs), but an increase of $19.54 million in costs (incremental cost-effectiveness ratio?=?$22,537/QALY). In probabilistic sensitivity analysis, the practice changes were cost-effective in 54.0% of the simulations when evaluated at a threshold of $50,000/QALY, which increased to 70.9% when evaluated at a threshold of $200,000/QALY. Conclusion: Hysterectomy practice changes induced by the morcellation warning are expected to be cost-effective, but uncertainty in parameter values may affect the cost-effectiveness results.

Abstract Background Improving oral anticancer agent (OAA) initiation and adherence is the important quality‐of‐care issues, particularly since one fourth of anticancer agents being developed will be administered orally. Our objective was to identify provider‐ and patient‐level characteristics associated with OAA initiation and adherence among individuals with metastatic renal cell carcinoma (mRCC). Methods We used state cancer registry data linked to multi‐payer claims data to identify patients with mRCC diagnosed in 2004–2015. Provider data were obtained from North Carolina Health Professions Data System and the National Plan & Provider Enumeration System. We estimated risk ratios (RRs) and corresponding 95% confidence limits (CLs) using modified Poisson regression to evaluate factors associated with OAA initiation and adherence. Results Among the 207 (out of 687) patients who initiated an OAA following mRCC diagnosis and survived 90 days, median proportion of days covered was 0.91. Patients with a modal provider specializing in hematology/medical oncology were much more likely to initiate OAAs than those seen by other specialties. Additionally, patients with a female provider were more likely to initiate OAAs than those with a male provider. Compared to patients treated by providers practicing in both urban and rural areas, patients with providers practicing solely in urban areas were more likely to initiate OAAs, after controlling for patient‐level factors (RR = 1.37; 95% CL: 1.09–1.73). Medicare patients were less likely to be adherent than those with private insurance (RR = 0.61; 95% CL: 0.42–0.87). Conclusions Our results suggest that provider‐ and patient‐level factors influence OAA initiation in patients with mRCC but only insurance type was associated with adherence.

Although lung cancer screening (LCS) with low dose computed tomography has been shown to reduce lung cancer mortality, benefits and harms of screening vary among eligible adults. The goal of this study was to evaluate whether LCS is more commonly used among populations most likely to benefit, namely adults with high lung cancer risk and low comorbidity. In this cohort study of patients eligible for LCS, we used data from the electronic health record to evaluate the relationship between lung cancer risk, comorbidity, and receipt of LCS. We also evaluated use of diagnostic chest CT. Analyses used a nonparametric test for trend across quartiles of lung cancer risk and comorbidity. The study sample included 551 LCS-eligible adults who were followed for a mean 2.9 years (SD 1.6 years). A cumulative 190 (34 %) received at least 1 LCS, and 141 (26 %) had a diagnostic chest CT. Receipt of LCS increased across quartiles of lung cancer risk (5 per 100 person years in the lowest quartile vs 13 per 100 person-years in the highest, p

Although national guidelines recommend lung cancer screening for adults at high risk, only a small proportion of eligible adults in the US have been screened. The goal of this study was to understand barriers to screening among a specific but important population: patients who have been referred for screening, but who have not completed the test. We used semi-structured interviews to explore barriers to screening among patients at two academic, safety-net primary care practices. We included patients who had been referred for screening at least 6 months prior but who had not completed the test. Among interviewees (N = 16) a consistent theme was a lack of knowledge about the purpose and process of screening. Despite being referred for lung cancer screening, participants expressed that they knew little about how screening was performed or what it was intended to achieve. Preferences and values also played a role in why some participants did not return for screening. Our findings suggest that lack of knowledge about screening is an important barrier to use, as patients are unlikely to prioritize a test if they know little about it.

Objectives: To examine whether the case fatality rate (CFR) of COVID-19 decreased over time and whether the COVID-19 testing rate is a driving factor for the changes if the CFR decreased. Methods: Analyzing COVID-19 cases, deaths and tests in Ontario, Canada, we compared the CFR between the first wave and the second wave across 26 public health units in Ontario. We also explored whether a high testing rate was associated with a large CFR decrease. Results: The first wave CFR ranged from 0.004 to 0.146, whereas the second wave CFR ranged from 0.003 to 0.034. The pooled RR estimate of second wave COVID-19 case fatality, compared with first wave, was 0.24 (95% CI: 0.19-0.32). Additionally, COVID-19 testing percentages were not associated with the estimated relative risk (P=0.246). Conclusions: The COVID-19 CFR decreased significantly in Ontario during the second wave, and COVID-19 testing was not a driving factor for this decrease.

Abstract Background Given the growth in dense breast notification (DBN) legislation in the United States, we examined the association between different types of DBN laws and supplemental screening behaviors among women. Methods We surveyed in March–April 2018 a nationally representative sample of women aged 40‐59 years who received a routine screening mammogram in the past 18 months. Survey items included the following topics regarding supplemental screening: discussing risks or benefits with a provider, knowledge about the risk of false positives, and utilization. We grouped women by state DBN into non‐DBN, generic DBN (mentions breast density but not supplemental screening), DBN that mentions supplemental screening (DBN‐SS), and DBN with mandated insurance coverage for supplemental screening (DBN‐coverage), and estimated adjusted predicted probabilities for supplemental screening behaviors. Results Of 1641 women surveyed, 21.3% resided in non‐DBN, 41.2% in generic DBN, 25.8% in DBN‐SS, and 12.5% in DBN‐coverage states. Overall, 23.0% of respondents had discussed supplemental screening with a provider, 11.3% of whom discussed the risks, and 49.5% discussed the benefits. In adjusted analysis, women living in DBN‐coverage states were more likely to discuss supplemental screening (27.5%) than women in non‐DBN states (13.6%); pairwise contrast 13.8% (95% CI, 2.1% to 25.6%; P = .01). They were also more likely to have received supplemental screening for increased breast density (19.3%) compared to women living in non‐DBN (9.9%); contrast 9.4% (95% CI, 1.6% to 17.3%; P = .01), Generic DBN (7.3%); difference 12.0% (95% CI, 4.6% to 19.4%; P =

Background Despite no proven benefit in clinical outcomes, perioperative magnetic resonance imaging (MRI) was rapidly adopted into breast cancer care in the 2000’s, offering a prime opportunity for assessing factors influencing overutilization of unproven technology. Objectives To examine variation among physician patient-sharing networks in their trajectory of adopting perioperative MRI for breast cancer surgery and compare the characteristics of patients, providers, and mastectomy use in physician networks that had different adoption trajectories. Methods and findings Using the Surveillance, Epidemiology, and End Results-Medicare database in 2004–2009, we identified 147 physician patient-sharing networks (caring for 26,886 patients with stage I-III breast cancer). After adjusting for patient clinical risk factors, we calculated risk-adjusted rate of perioperative MRI use for each physician network in 2004–2005, 2006–2007, and 2008–2009, respectively. Based on the risk-adjusted rate, we identified three distinct trajectories of adopting perioperative MRI among physician networks: 1) low adoption (risk-adjusted rate of perioperative MRI increased from 2.8% in 2004–2005 to 14.8% in 2008–2009), 2) medium adoption (8.8% to 45.1%), and 3) high adoption (33.0% to 71.7%). Physician networks in the higher adoption trajectory tended to have a larger proportion of cancer specialists, more patients with high income, and fewer patients who were Black. After adjusting for patients’ clinical risk factors, the proportion of patients undergoing mastectomy decreased from 41.1% in 2004–2005 to 38.5% in 2008–2009 among those in physician networks with low MRI adoption, but increased from 27.0% to 31.4% among those in physician networks with high MRI adoption (p = 0.03 for the interaction term between trajectory group and time). Conclusions Physician patient-sharing networks varied in their trajectory of adopting perioperative MRI. These distinct trajectories were associated with the composition of patients and providers in the networks, and had important implications for patterns of mastectomy use.

BackgroundFirst-line treatment with nivolumab plus ipilimumab (N+I) or nivolumab plus ipilimumab with two cycles of chemotherapy (N+I+chemotherapy) improve overall survival and progression-free survival for patients with metastatic non-small cell lung cancer (NSCLC), yet researchers have not concomitantly compared the cost-effectiveness of N+I and N+I+chemotherapy with chemotherapy alone.Materials and methodsUsing outcomes data from the CheckMate 227 and CheckMate 9LA phase 3 randomized trials, we developed a Markov model with lifetime horizon to compare the costs and effectiveness of N+I and N+I+chemotherapy versus chemotherapy from the U.S. health care sector perspective. Subgroup analysis by programmed death-ligand 1 (PD-L1) expression levels (≥1% and

Introduction: Patients with early-stage NSCLC typically must choose between a surgery with superior local control (lobectomy) or one that preserves lung parenchyma (wedge). Recognizing that many patients with cancer have competing mortality risks unrelated to cancer, we investigated whether an established model of predicting life expectancy could be used to identify patients with stage I NSCLC for whom survival after wedge is not different from lobectomy. Methods: A retrospective cohort study using the National Cancer Institute’s Surveillance Epidemiology and End Results—Medicare was performed to evaluate survival among treatment-naive patients, diagnosed 2005–2015, who underwent lobectomy or wedge for stage I (≤2 cm tumors) NSCLC. Comorbidity-related life expectancy (CR-LE) was estimated using a standard life-table approach based on comorbid conditions, sex, and age. Cox models and perioperative complications were stratified by 5-year CR-LE. Results: A total of 4560 patients (median age 74, interquartile range 70–78) were identified. CR-LE was greater than or equal to 5 years for 4016 patients (wedge = 23%). CR-LE was less than 5 years for 544 patients (wedge = 41%). Among patients with CR-LE greater than or equal to 5, wedge resection was associated with higher risk of mortality than lobectomy (hazard ratio: 1.68, 95% confidence interval: 1.52–1.86, p < 0.001). For those with CR-LE less than 5, there was no significant difference in mortality risk between lobectomy and wedge (hazard ratio: 1.19, 95% confidence interval: 0.96–1.47; p = 0.11). CR-LE less than five patients who underwent a lobectomy had higher 90-day mortality compared with wedge (9% versus 4%, p = 0.04). Conclusion: The survival advantage of lobectomy over wedge for stage I NSCLC seems to dissipate among patients with shorter life expectancy owing to age and comorbidities. Wedge resection may be a reasonable option for patients at high risk of dying from non–cancer-related causes.

Decreased prostate-specific antigen screening since 2008 has generated much concern, including report of recent increase in metastatic prostate cancer incidence among older men. Although increased metastatic disease was temporally proceeded by decreased screening and decreased localized prostate cancer at diagnosis, it is unclear whether the 2 trends are geographically connected. We therefore used the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) database to assess geographic-specific associations between changes in localized (2008-2011) and later changes in metastatic prostate cancer incidence (2012-2015). We examined trends from 200 health-care service areas (HSAs) within SEER 18 registries. While on average for each HSA, localized incidence decreased by 27.4 and metastatic incidence increased by 2.3 per 100 000 men per year, individual HSA-level changes in localized incidence did not correlate with later changes in metastatic disease. Decreased detection of localized disease may not fully explain the recent increase in metastatic disease at diagnosis.

Background: Cancer continues to rise as a contributor to premature death in the developing world. Despite this, little is known about whether cancer outcomes are related to a country’s income level, and what aspects of national healthcare systems are associated with improved cancer outcomes. Methods: The most recent estimates of cancer incidence and mortality were used to calculate mortality-to-incidence ratio (MIR) for the 85 countries with reliable data. Countries were categorized according to high-income (Gross Domestic Product (GDP) > $15,000) or middle/low-income (GDP < $15,000), and a multivariate linear regression model was used to determine the association between healthcare system indicators and cancer MIR. Indicators study included per capita GDP, overall total healthcare expenditure (THE), THE as a proportion of GDP, total external beam radiotherapy devices (TEBD) per capita, physician density, and the year 2000 WHO healthcare system rankings. Results: Cancer MIR in high-income countries (0.47) was significantly lower than that of middle/low-income countries (0.64), with a p < 0.001. In high-income countries, GDP, health expenditure and TEBD showed significant inverse correlations with overall cancer MIR. A $3040 increase in GDP (p = 0.004), a $379 increase in THE (p < 0.001), or an increase of 0.59 TEBD per 100,000 population (p = 0.027) were all associated with a 0.01 decrease in cancer MIR. In middle/low-income countries, only WHO scores correlated with decreased cancer MIR (p = 0.022); 12 specific cancer types also showed similar significant correlations (p < 0.05) as overall cancer MIR. Conclusions: The analysis of this study suggested that cancer MIR is greater in middle/low-income countries. Furthermore, the WHO healthcare score was associated with improved cancer outcomes in middle/low-income countries while absolute levels of financial resources and infrastructure played a more important role in high-income countries.

There is uncertainty about risk heterogeneity for venous thromboembolism (VTE) in older patients with advanced cancer and whether patients can be stratified according to VTE risk. We performed a retrospective cohort study of the linked Medicare-Surveillance, Epidemiology, and End Results cancer registry in older patients with advanced cancer of lung, breast, colon, prostate, or pancreas diagnosed between 1995–1999. We used survival analysis with demographics, comorbidities, and tumor characteristics/treatment as independent variables. Outcome was VTE diagnosed at least one month after cancer diagnosis. VTE rate was highest in the first year (3.4%). Compared to prostate cancer (1.4 VTEs/100 person-years), there was marked variability in VTE risk (hazard ratio (HR) for male-colon cancer 3.73 (95% CI 2.1–6.62), female-colon cancer HR 6.6 (3.83–11.38), up to female-pancreas cancer HR 21.57 (12.21–38.09). Stage IV cancer and chemotherapy resulted in higher risk (HRs 1.75 (1.44–2.12) and 1.31 (1.0–1.57), resp.). Stratifying the cohort by cancer type and stage using recursive partitioning analysis yielded five groups of VTE rates (nonlocalized prostate cancer 1.4 VTEs/100 person-years, to nonlocalized pancreatic cancer 17.4 VTEs/100 patient-years). In a high-risk population with advanced cancer, substantial variability in VTE risk exists, with notable differences according to cancer type and stage.

Background: Older adults with shorter life expectancies may receive less benefit from colorectal cancer screening than younger, healthier patients. Objective: To determine the degree to which life expectancy after diagnosis of an early-stage cancer varies according to age or coexisting chronic illness. Design: Retrospective cohort study. Setting: Population-based cancer registry with linked administrative claims data. Patients: Patients 67 years of age or older who received a diagnosis of colorectal cancer from 1993 through 1999. Measurements: Chronic conditions were identified by searching Medicare claims. Using a life-table approach, the authors quantified the degree to which life expectancy associated with each cancer stage at diagnosis varied with patient age, sex, and burden of chronic conditions. Results: The final study sample consisted of 35 755 patients. After accounting for cancer stage at diagnosis, the authors found that life expectancy was strongly related to both age and the burden of chronic illness. Among men who received a diagnosis of stage I cancer at 67 years of age, life expectancy decreased from 19.1 years (95% CI, 17.8 to 20.5 years) for patients with no chronic conditions to 12.4 years (CI, 11.4 to 13.5 years) for those with 1 or 2 conditions and 7.6 years (CI, 6.1 to 9.4 years) for those with 3 or more conditions. A similar trend was noted among female counterparts, with life expectancy decreasing from approximately 23 years to 16 years and 7 years for the 3 chronic condition groups, respectively. For men and women 81 years of age with no chronic illnesses, life expectancy after stage I cancer diagnosis was 10.3 years (CI, 9.2 to 11.9 years) and 13.8 years (CI, 12.3 to 15.3 years), respectively. Limitations: Administrative claims may not identify all chronic conditions. Life expectancy estimates at the population level are averages and, therefore, may not accurately predict the life expectancy of individual patients. Conclusions: Coexisting chronic illness is associated with a substantial reduction in life expectancy after diagnosis of early-stage colorectal cancer. Physicians should consider this when deciding whether to screen older persons. [ABSTRACT FROM AUTHOR]

Introduction Accurate, patient-centred evaluation of physical function in patients with cancer can provide important information on the functional impacts experienced by patients both from the disease and its treatment. Increasingly, digital health technology is facilitating and providing new ways to measure symptoms and function. There is a need to characterise the longitudinal measurement characteristics of physical function assessments, including clinician-reported outcome, patient-reported ported outcome (PRO), performance outcome tests and wearable data, to inform regulatory and clinical decision-making in cancer clinical trials and oncology practice.Methods and analysis In this prospective study, we are enrolling 200 English-speaking and/or Spanish-speaking patients with breast cancer or lymphoma seen at Mayo Clinic or Yale University who will receive intravenous cytotoxic chemotherapy. Physical function assessments will be obtained longitudinally using multiple assessment modalities. Participants will be followed for 9 months using a patient-centred health data aggregating platform that consolidates study questionnaires, electronic health record data, and activity and sleep data from a wearable sensor. Data analysis will focus on understanding variability, sensitivity and meaningful changes across the included physical function assessments and evaluating their relationship to key clinical outcomes. Additionally, the feasibility of multimodal physical function data collection in real-world patients with breast cancer or lymphoma will be assessed, as will patient impressions of the usability and acceptability of the wearable sensor, data aggregation platform and PROs.Ethics and dissemination This study has received approval from IRBs at Mayo Clinic, Yale University and the US Food and Drug Administration. Results will be made available to participants, funders, the research community and the public.Trial registration number NCT05214144; Pre-results.

BackgroundThe complex relationship between incarceration and cancer survival has not been thoroughly evaluated. We assessed whether cancer diagnosis during incarceration or the immediate post-release period is associated with higher rates of mortality compared with those never incarcerated.MethodsWe conducted a population-based study using a statewide linkage of tumor registry and correctional system movement data for Connecticut adult residents diagnosed with invasive cancer from 2005 through 2016. The independent variable was place of cancer diagnosis: during incarceration, within 12 months post-release, and never incarcerated. The dependent variables were five-year cancer-related and overall survival rates.ResultsOf the 216,540 adults diagnosed with invasive cancer during the study period, 239 (0.11%) people were diagnosed during incarceration, 479 (0.22%) within 12 months following release, and the remaining were never incarcerated. After accounting for demographics and cancer characteristics, including stage of diagnosis, the risk for cancer-related death at five years was significantly higher among those diagnosed while incarcerated (AHR = 1.39, 95% CI = 1.12-1.73) and those recently released (AHR = 1.82, 95% CI = 1.57-2.10) compared to the never-incarcerated group. The risk for all-cause mortality was also higher for those diagnosed with cancer while incarcerated (AHR = 1.92, 95% CI = 1.63-2.26) and those recently released (AHR = 2.18, 95% CI = 1.94-2.45).Conclusions and relevanceThere is a higher risk of cancer mortality among individuals diagnosed with cancer during incarceration and in the first-year post-release, which is not fully explained by stage of diagnosis. Cancer prevention and treatment efforts should target people who experience incarceration and identify why incarceration is associated with worse outcomes.

Objectives To examine company characteristics associated with better transparency and to apply a tool used to measure and improve clinical trial transparency among large companies and drugs, to smaller companies and biologics.Design Cross-sectional descriptive analysis.Setting and participants Novel drugs and biologics Food and Drug Administration (FDA) approved in 2016 and 2017 and their company sponsors.Main outcome measures Using established Good Pharma Scorecard (GPS) measures, companies and products were evaluated on their clinical trial registration, results dissemination and FDA Amendments Act (FDAAA) implementation; companies were ranked using these measures and a multicomponent data sharing measure. Associations between company transparency scores with company size (large vs non-large), location (US vs non-US) and sponsored product type (drug vs biologic) were also examined.Results 26% of products (16/62) had publicly available results for all clinical trials supporting their FDA approval and 67% (39/58) had public results for trials in patients by 6 months after their FDA approval; 58% (32/55) were FDAAA compliant. Large companies were significantly more transparent than non-large companies (overall median transparency score of 95% (IQR 91–100) vs 59% (IQR 41–70), p

Introduction Incarceration is associated with decreased cancer screening rates and a higher risk for hospitalisation and death from cancer after release from prison. However, there is a paucity of data on the relationship between incarceration and cancer outcomes and quality of care. In the Incarceration and Cancer-Related Outcomes Study, we aim to develop a nuanced understanding of how incarceration affects cancer incidence, mortality and treatment, and moderates the relationship between socioeconomic status, structural racism and cancer disparities.Methods and analysis We will use a sequential explanatory mixed-methods study design. We will create the first comprehensive linkage of data from the Connecticut Department of Correction and the statewide Connecticut Tumour Registry. Using the linked dataset, we will examine differences in cancer incidence and stage at diagnosis between individuals currently incarcerated, formerly incarcerated and never incarcerated in Connecticut from 2005 to 2016. Among individuals with invasive cancer, we will assess relationships among incarceration, quality of cancer care and mortality, and will assess the degree to which incarceration status moderates relationships among race, socioeconomic status, quality of cancer care and cancer mortality. We will use multivariable logistic regression and Cox survival models with interaction terms as appropriate. These results will inform our conduct of in-depth interviews with individuals diagnosed with cancer during or shortly after incarceration regarding their experiences with cancer care in the correctional system and the immediate postrelease period. The results of this qualitative work will help contextualise the results of the data linkage.Ethics and dissemination The Yale University Institutional Review Board (#2000022899) and the Connecticut Department of Public Health Human Investigations Committee approved this study. We will disseminate study findings through peer-reviewed publications and academic and community presentations. Access to the deidentified quantitative and qualitative datasets will be made available on review of the request.

Objectives Although demand for price transparency in healthcare is growing, variation in private payors’ payments to surgeons for oncologic resection has not been well characterised. Our aim was to assess variation of private payors’ payments to surgeons for cancer resection using data based on fee-for-service allowed amounts, billed by a large mix of commercial payors and third-party administrators.Setting Fair Health (FH), an independent, not-for-profit organisation that collects and compiles claims data from payors nationwide. FH maintains the nation’s largest repository of privately billed medical and dental claims representing over 125 million covered lives in the USA.Participants We performed a cross-sectional study assessing private payer data for five common types of cancer surgery: simple mastectomy (SM), modified radical mastectomy (MRM), open lobectomy, video-assisted thoracoscopic surgery (VATS) lobectomy and radical prostatectomy during 2012 and 2013.Primary and secondary outcome measures To assess variation across regions, we compared regional median allowed payments. To assess intraregion variability, we evaluated the distribution of regional IQRs of allowed payments.Results Median allowed payments varied substantially across regions. For SM, median allowed payments ranged from $550 in the least expensive to $1380 in the costliest region. For MRM, the range was $842–$1760, for lobectomy $326–$3066, for VATS $317–$3307 and for prostatectomy $1716–$4867. There was also substantial variation within geographic areas. For example, the mean IQRs in surgeon payment within regions were: SM $577 (25th percentile) to $1132 (75th percentile); MRM $850–$1620; lobectomy $861–$2767; VATS $1024–$3122; and prostatectomy $2286–$3563.Conclusions There is a wide range of variation both across and within geographic regions in allowed amounts of surgeon payments for common oncologic resections. Transparency about these allowed amounts may have a profound impact on patient and employer choice and facilitate future assessments of value in cancer care.

BackgroundSurvival in hepatocellular carcinoma (HCC) is lower in the USA than in Taiwan. Little is known about the extent to which differences in stage at diagnosis and treatment contribute to this difference. We examined treatment patterns and survival in HCC and analyzed factors driving the difference.MethodsUsing a uniform methodology, we identified patients aged 66 years and older with newly diagnosed HCC between 2004 and 2011 in the USA and Taiwan. We compared treatment within 6 months after HCC diagnosis and 2-year stage-specific survival between the two countries.ResultsCompared with patients in Taiwan (n = 32,987), patients in the USA (n = 7,003) were less likely to be diagnosed as stage IA (4% vs 8%) and II (13% vs 22%), or receive cancer-directed treatments (41% vs 58%; all p < .001). Stage-specific 2-year survival rates were lower in the USA than in Taiwan (stage IA: 57% vs 77%; stage IB: 38% vs 63%; stage II: 40% vs 57%, stage III: 14% vs 18%; stage IV: 4% vs 5%, respectively; all p < .001 except p = .018 for stage IV). Differences in age and sex (combined), stage, and receipt of treatment accounted for 3.8%, 17.0%, and 16.8% of the survival difference, respectively, leaving 62.5% unexplained.ConclusionsDifferential stage at diagnosis and treatment were substantially associated with the survival difference, but approximately two-thirds of the difference remained unexplained. Identifying the main drivers of the difference could help improve HCC survival in the USA.

There are inconsistent and limited data regarding the risk of myeloid neoplasms (MN) among breast cancer survivors who received radiotherapy (RT) in the absence of chemotherapy. Concern about subsequent MN might influence the decision to use adjuvant RT for women with localized disease. As patients with therapy-related MN have generally poor outcomes, the presumption of subsequent MN being therapy-related could affect treatment recommendations.We used the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database to study older women with in-situ or stage 1-3 breast cancer diagnosed 2001-2009 who received surgery. Chemotherapy and RT were ascertained using Medicare claims, and new MN diagnoses were captured using both SEER registry and Medicare claims. We excluded women who received chemotherapy for initial treatment, and censored at receipt of subsequent chemotherapy. Competing-risk survival analysis was used to assess the association between RT and risk of subsequent MN adjusting for relevant characteristics.Median follow-up for 60,426 eligible patients was 68 months (interquartile range, 46 to 92 months), with 47.6% receiving RT. In total, 316 patients (0.52%) were diagnosed with MN; the cumulative incidence per 10,000 person-years was 10.6 vs 9.0 among RT-treated vs non-RT-treated women, respectively (p = .004); the increased risk of subsequent MN persisted in the adjusted analysis (hazard ratio = 1.36, 95% confidence interval: 1.03-1.80). The results were consistent in multiple sensitivity analyses.Our data suggest that RT is associated with a significant risk of subsequent MN among older breast cancer survivors, though the absolute risk increase is very small. These findings suggest the benefits of RT outweigh the risks of development of subsequent MN.

Randomized trials of anti-hypertensive treatment demonstrating reduced risk of cardiovascular events in older adults included participants with less comorbidity than clinical populations. Whether these results generalize to all older adults, most of whom have multiple chronic conditions, is uncertain.To determine the association between anti-hypertensive medications and CV events and mortality in a nationally representative population of older adults.Competing risk analysis with propensity score adjustment and matching in the Medicare Current Beneficiary Survey cohort over three-year follow-up through 2010.4,961 community-living participants with hypertension.Anti-hypertensive medication intensity, based on standardized daily dose for each anti-hypertensive medication class participants used.Cardiovascular events (myocardial infarction, unstable angina, cardiac revascularization, stroke, and hospitalizations for heart failure) and mortality.Of 4,961 participants, 14.1% received no anti-hypertensives; 54.6% received moderate, and 31.3% received high, anti-hypertensive intensity. During follow-up, 1,247 participants (25.1%) experienced cardiovascular events; 837 participants (16.9%) died. Of deaths, 430 (51.4%) occurred in participants who experienced cardiovascular events during follow-up. In the propensity score adjusted cohort, after adjusting for propensity score and other covariates, neither moderate (adjusted hazard ratio, 1.08 [95% CI, 0.89-1.32]) nor high (1.16 [0.94-1.43]) anti-hypertensive intensity was associated with experiencing cardiovascular events. The hazard ratio for death among all participants was 0.79 [0.65-0.97] in the moderate, and 0.72 [0.58-0.91] in the high intensity groups compared with those receiving no anti-hypertensives. Among participants who experienced cardiovascular events, the hazard ratio for death was 0.65 [0.48-0.87] and 0.58 [0.42-0.80] in the moderate and high intensity groups, respectively. Results were similar in the propensity score-matched subcohort.In this nationally representative cohort of older adults, anti-hypertensive treatment was associated with reduced mortality but not cardiovascular events. Whether RCT results generalize to older adults with multiple chronic conditions remains uncertain.

Some argue that by precluding individualized treatment, randomized clinical trials (RCTs) provide substandard medical care, while others claim that participation in clinical research is associated with improved patient outcomes. However, there are few data to assess the impact of random treatment assignment on RCT participants. We therefore performed a systematic review to quantify the differences in health outcomes between randomized trial participants and eligible non-participants.Studies were identified by searching Medline, the Web of Science citation database, and manuscript references. Studies were eligible if they documented baseline characteristics and clinical outcomes of RCT participants and eligible non-participants, and allowed non-participants access to the same interventions available to trial participants. Primary study outcomes according to patient group (randomized trial participants versus eligible non-participants) were extracted from all eligible manuscripts. For 22 of the 25 studies (88%) meeting eligibility criteria, there were no significant differences in clinical outcomes between patients who received random assignment of treatment (RCT participants) and those who received individualized treatment assignment (eligible non-participants). In addition, there was no relation between random treatment assignment and clinical outcome in 15 of the 17 studies (88%) in which randomized and nonrandomized patients had similar health status at baseline.These findings suggest that randomized treatment assignment as part of a clinical trial does not harm research participants.

BACKGROUND: It is widely claimed that racial and ethnic minorities, especially in the US, are less willing than non-minority individuals to participate in health research. Yet, there is a paucity of empirical data to substantiate this claim. METHODS AND FINDINGS: We performed a comprehensive literature search to identify all published health research studies that report consent rates by race or ethnicity. We found 20 health research studies that reported consent rates by race or ethnicity. These 20 studies reported the enrollment decisions of over 70,000 individuals for a broad range of research, from interviews to drug treatment to surgical trials. Eighteen of the twenty studies were single-site studies conducted exclusively in the US or multi-site studies where the majority of sites (i.e., at least 2/3) were in the US. Of the remaining two studies, the Concorde study was conducted at 74 sites in the United Kingdom, Ireland, and France, while the Delta study was conducted at 152 sites in Europe and 23 sites in Australia and New Zealand. For the three interview or non-intervention studies, African-Americans had a nonsignificantly lower overall consent rate than non-Hispanic whites (82.2% versus 83.5%; odds ratio [OR] = 0.92; 95% confidence interval [CI] 0.84-1.02). For these same three studies, Hispanics had a nonsignificantly higher overall consent rate than non-Hispanic whites (86.1% versus 83.5%; OR = 1.37; 95% CI 0.94-1.98). For the ten clinical intervention studies, African-Americans' overall consent rate was nonsignificantly higher than that of non-Hispanic whites (45.3% versus 41.8%; OR = 1.06; 95% CI 0.78-1.45). For these same ten studies, Hispanics had a statistically significant higher overall consent rate than non-Hispanic whites (55.9% versus 41.8%; OR = 1.33; 95% CI 1.08-1.65). For the seven surgery trials, which report all minority groups together, minorities as a group had a nonsignificantly higher overall consent rate than non-Hispanic whites (65.8% versus 47.8%; OR = 1.26; 95% CI 0.89-1.77). Given the preponderance of US sites, the vast majority of these individuals from minority groups were African-Americans or Hispanics from the US. CONCLUSIONS: We found very small differences in the willingness of minorities, most of whom were African-Americans and Hispanics in the US, to participate in health research compared to non-Hispanic whites. These findings, based on the research enrollment decisions of over 70,000 individuals, the vast majority from the US, suggest that racial and ethnic minorities in the US are as willing as non-Hispanic whites to participate in health research. Hence, efforts to increase minority participation in health research should focus on ensuring access to health research for all groups, rather than changing minority attitudes.