Management of Lung Cancer in the Patient with Interstitial Lung Disease.

Patients with interstitial lung disease (ILD), especially those with pulmonary fibrosis, are at increased risk of developing lung cancer. Management of lung cancer in patients with ILD is particularly challenging. Diagnosis can be complicated by difficulty differentiating lung nodules from areas of focal fibrosis, and percutaneous biopsy approaches confer an increased risk of complications in those with pulmonary fibrosis. Lung cancer treatment in these patients pose several specific considerations. The degree of lung function impairment may preclude lobectomy or surgical resection of any type. Surgical resection can trigger an acute exacerbation of the underlying ILD. The presence of ILD confers an increased risk of pneumonitis with radiotherapy, and many of the systemic therapies also carry an increased risk of pneumonitis in this population. The safety of immunotherapy in the setting of ILD remains to be fully elucidated and concerns remain as to triggering pneumonitis. The purpose of this review is to summarize the evidence regarding consideration for tissue diagnosis, chemotherapy and immunotherapy, radiotherapy, and surgery, in this patient population and discuss emerging areas of research. We also propose a multidisciplinary approach and practical considerations for monitoring for ILD progression during lung cancer treatment.

Concordance Between Genomic Alterations Detected by Tumor and Germline Sequencing: Results from a Tertiary Care Academic Center Molecular Tumor Board.

OBJECTIVE: The majority of tumor sequencing currently performed on cancer patients does not include a matched normal control, and in cases where germline testing is performed, it is usually run independently of tumor testing. The rates of concordance between variants identified via germline and tumor testing in this context are poorly understood. We compared tumor and germline sequencing results in patients with breast, ovarian, pancreatic, and prostate cancer who were found to harbor alterations in genes associated with homologous recombination deficiency (HRD) and increased hereditary cancer risk. We then evaluated the potential for a computational somatic-germline-zygosity (SGZ) modeling algorithm to predict germline status based on tumor-only comprehensive genomic profiling (CGP) results. METHODS: A retrospective chart review was performed using an academic cancer center's databases of somatic and germline sequencing tests, and concordance between tumor and germline results was assessed. SGZ modeling from tumor-only CGP was compared to germline results to assess this method's accuracy in determining germline mutation status. RESULTS: A total of 115 patients with 146 total alterations were identified. Concordance rates between somatic and germline alterations ranged from 0% to 85.7% depending on the gene and variant classification. After correcting for differences in variant classification and filtering practices, SGZ modeling was found to have 97.2% sensitivity and 90.3% specificity for the prediction of somatic versus germline origin. CONCLUSIONS: Mutations in HRD genes identified by tumor-only sequencing are frequently germline. Providers should be aware that technical differences related to assay design, variant filtering, and variant classification can contribute to discordance between tumor-only and germline sequencing test results. In addition, SGZ modeling had high predictive power to distinguish between mutations of somatic and germline origin without the need for a matched normal control, and could potentially be considered to inform clinical decision-making.

Implementation of an educational intervention to improve medical student cost awareness: a prospective cohort study.

BACKGROUND: In the context of rising healthcare costs, formal education on treatment-related financial hardship is lacking in many medical schools, leaving future physicians undereducated and unprepared to engage in high-value care. METHOD: We performed a prospective cohort study to characterize medical student knowledge regarding treatment-related financial hardship from 2019 to 2020 and 2020-2021, with the latter cohort receiving a targeted educational intervention to increase cost awareness. Using Kirkpatrick's four-level training evaluation model, survey data was analyzed to characterize the acceptability of the intervention and the impact of the intervention on student knowledge, attitudes, and self-reported preparedness to engage in cost-conscious care. RESULTS: Overall, N = 142 medical students completed the study survey; 61 (47.3%) in the non-intervention arm and 81 (66.4%) in the intervention arm. Of the 81 who completed the baseline survey in the intervention arm, 65 (80.2%) completed the immediate post-intervention survey and 39 (48.1%) completed the two-month post-intervention survey. Following the educational intervention, students reported a significantly increased understanding of common financial terms, access to cost-related resources, and level of comfort and preparedness in engaging in discussions around cost compared to their pre-intervention responses. The majority of participants (97.4%) reported that they would recommend the intervention to future students. A greater proportion of financially stressed students reported considering patient costs when making treatment decisions compared to their non-financially stressed peers. CONCLUSIONS: Targeted educational interventions to increase cost awareness have the potential to improve both medical student knowledge and preparedness to engage in cost-conscious care. Student financial stress may impact high-value care practices. Robust curricula on high-value care, including treatment-related financial hardship, should be formalized and universal within medical school training.

Characterizing participants in the North Carolina Breast and Cervical Cancer Control Program: A retrospective review of 90,000 women.

BACKGROUND: The North Carolina Breast and Cervical Cancer Control Program (NC BCCCP) provides breast cancer screening services to underserved women to mitigate disparities in access to care. The authors sought to characterize this understudied population. METHODS: Women 21 years old or older who underwent their first breast cancer screen through NC BCCCP from 2008 to 2018 were included. Demographic factors associated with the timeline of care and odds of a breast cancer diagnosis were identified with negative binomial and logistic regression, respectively. RESULTS: Of the 88,893 women identified, 45.5% were non-Hispanic (NH) White, 30.9% were NH Black, 19.6% were Hispanic, 1.7% were American Indian, and 1.1% were Asian. Breast cancer was diagnosed in 2.5% of the women (n = 2255). Hispanic women were the least likely to be diagnosed with breast cancer (odds ratio vs NH White women, 0.40; 95% confidence interval [CI], 0.34-0.47). Among patients with breast pathology, the median time to diagnosis was 19 days (interquartile range [IQR], 10-33 days), and the time to treatment was 33 days (IQR, 19-54 days). After adjustments, a longer time to diagnosis was significantly associated with age (incidence rate ratio [IRR], 1.01; 95% CI, 1.01-1.02) and being NH Black (vs NH White; IRR, 1.17; 95% CI, 1.06-1.29). A longer time to treatment was significantly associated with age (IRR, 1.01; 95% CI, 1.01-1.01), being NH Black (vs NH White; IRR, 1.20; 95% CI, 1.10-1.31), and being Hispanic (vs NH White; IRR, 1.22; 95% CI, 1.05-1.41). CONCLUSIONS: NC BCCCP participants with breast cancer received treatment within approximately 1 month of presentation, and this finding aligns with quality care benchmarks. Nevertheless, racial/ethnic disparities in timeliness of care persist, and this suggests opportunities for improvement. LAY SUMMARY: This review of approximately 90,000 participants in a breast cancer screening program for uninsured and underinsured women highlights the importance of safety net programs in providing timely care to underserved patients. The authors found that the North Carolina Breast and Cervical Cancer Control Program met timeliness benchmarks from the Centers for Disease Control and Prevention across all racial/ethnic groups. However, non-Hispanic Black women experienced relative delays in the time to diagnosis, and both non-Hispanic Black women and Hispanic women experienced relative delays in the time to treatment. These findings demonstrate how racial/ethnic disparities in the timeliness of care can persist even within a program intended to reduce barriers to access.

Association of Smartphone Ownership and Internet Use With Markers of Health Literacy and Access: Cross-sectional Survey Study of Perspectives From Project PLACE (Population Level Approaches to Cancer Elimination).

BACKGROUND: Telehealth is an increasingly important component of health care delivery in response to the COVID-19 pandemic. However, well-documented disparities persist in the use of digital technologies. OBJECTIVE: This study aims to describe smartphone and internet use within a diverse sample, to assess the association of smartphone and internet use with markers of health literacy and health access, and to identify the mediating factors in these relationships. METHODS: Surveys were distributed to a targeted sample designed to oversample historically underserved communities from April 2017 to December 2017. Multivariate logistic regression was used to estimate the association of internet and smartphone use with outcomes describing health care access and markers of health literacy for the total cohort and after stratifying by personal history of cancer. Health care access was captured using multiple variables, including the ability to obtain medical care when needed. Markers of health literacy included self-reported confidence in obtaining health information. RESULTS: Of the 2149 participants, 1319 (61.38%) were women, 655 (30.48%) were non-Hispanic White, and 666 (30.99%) were non-Hispanic Black. The median age was 51 years (IQR 38-65). Most respondents reported using the internet (1921/2149, 89.39%) and owning a smartphone (1800/2149, 83.76%). Compared with the respondents with smartphone or internet access, those without smartphone or internet access were more likely to report that a doctor was their most recent source of health information (344/1800, 19.11% vs 116/349, 33.2% for smartphone and 380/1921, 19.78% vs 80/228, 35.1% for internet, respectively; both P<.001). Internet use was associated with having looked for information on health topics from any source (odds ratio [OR] 3.81, 95% CI 2.53-5.75) and confidence in obtaining health information when needed (OR 1.83, 95% CI 1.00-3.34) compared with noninternet users. Smartphone owners had lower odds of being unable to obtain needed medical care (OR 0.62, 95% CI 0.40-0.95) than nonsmartphone owners. Among participants with a prior history of cancer, smartphone ownership was significantly associated with higher odds of confidence in ability to obtain needed health information (OR 5.63, 95% CI 1.05-30.23) and lower odds of inability to obtain needed medical care (OR 0.17, 95% CI 0.06-0.47), although these associations were not significant among participants without a prior history of cancer. CONCLUSIONS: We describe widespread use of digital technologies in a community-based cohort, although disparities persist. In this cohort, smartphone ownership was significantly associated with ability to obtain needed medical care, suggesting that the use of smartphone technology may play a role in increasing health care access. Similarly, major illnesses such as cancer have the potential to amplify health engagement. Finally, special emphasis must be placed on reaching patient populations with limited digital access, so these patients are not further disadvantaged in the new age of telehealth.

Body mass index, diabetes, and triple-negative breast cancer prognosis.

Higher body mass index (BMI) and diabetes are associated with worse breast cancer prognosis. However, few studies have focused on triple-negative breast cancer (TNBC). The goal of this study is to examine this association in a cohort of patients with TNBC. We retrospectively reviewed 501 consecutive patients with TNBC seen at the Washington University Breast Oncology Clinic. Cox proportional hazard models were used to determine the relationship between BMI and diabetes at diagnosis with overall survival (OS) and disease free survival (DFS). Four hundred and forty-eight patients had BMI recorded and 71 patients had diabetes. The median age at diagnosis was 53 (23-98) years and follow-up was 40.1 months (IQR 25.2-62.9). Baseline BMI and diabetes were not associated with OS or DFS. OS hazard ratios (HRs) for patients who were overweight (BMI 25.0-29.99), with class I obesity (BMI 30-34.99), or BMI ≥35 were 1.22 (CI 0.78-1.91), 0.92 (CI 0.59-1.43), and 1.16 (CI 0.70-1.90), respectively. The HRs for DFS in patients who were overweight, with class I obesity, or BMI ≥35 were 1.01 (CI 0.65-1.56), 0.94 (CI 0.60-1.47), and 0.99 (CI 0.63-1.57), respectively. Similarly, the HRs for diabetics were 1.27 (CI 0.82-1.96) for OS and 0.98 (CI 0.64-1.51) for DFS. Obesity and diabetes did not significantly affect survival for patients with TNBC in this study.

Ovarian, Uterine, and Vulvovaginal Cancers: Screening, Treatment Overview, and Prognosis.

Ovarian, uterine, and vulvovaginal cancers affect approximately 96,000 women per year in the United States, resulting in approximately 29,000 deaths annually. Routine screening protocols do not detect these malignancies; thus, the recognition of risk factors and evaluation of worrisome symptoms are essential for early detection and improved prognoses. Treatment is managed by gynecologic oncologists, and often involves a combination of surgery, chemotherapy, and possible radiation treatments. Survivor care is managed by the primary-care clinician: expert attention to the mental, physical, and sexual health of each patient will ensure the best outcomes and quality of life.

The association between non-English primary language and COVID-19 clinical trial eligibility and enrollment: A retrospective cohort study.

BACKGROUND: Establishing equitable access to COVID-19 clinical trials is an important step in mitigating outcomes disparities. Historically, language has served as a barrier to equitable clinical trial participation. METHODS: A centralized research infrastructure was established at our institution to screen potential trial participants and to promote efficient and equitable access to COVID-19 clinical trials. Rates of eligibility and enrollment in COVID-19 clinical trials by primary language between April 9 and July 31, 2020 (during the first regional COVID-19 surge) were evaluated using logistic regression. Estimates were adjusted for potential confounders including age, sex, and time. RESULTS: A total of 1245 patients were admitted to the hospital with COVID-19 during the study period and screened for clinical trial eligibility. Among all screened patients, 487 (39%) had a non-English primary language. After adjustment, patients with a non-English primary language had 1.98 times higher odds (CI 1.51 to 2.59) of being eligible for 1 or more COVID-19 clinical trials. Among eligible patients, those with a non-English primary language had 1.83 times higher odds (CI 1.36 to 2.47) of enrolling in COVID-19 clinical trials than patients with English as the primary language. CONCULSION: These findings suggest that there are modifiable barriers that can be addressed to lessen the impact of language discordance on access to clinical trials and provide an opportunity to further investigate factors associated with clinical trial participation for patients whose primary language is not English.

Primary care provider perspectives on screening mammography in older women: A qualitative study.

OBJECTIVE: Guidelines informing screening mammography for older women are lacking. This study sought to characterize PCP perspectives on screening mammography for patients aged 75 and older. METHODS: This was an exploratory, qualitative study based on semi-structured, one-on-one interviews with PCPs from six clinics affiliated with a tertiary medical center. Two independent coders analyzed interview transcripts and identified themes, subthemes, and representative quotes using inductive analysis methodology. RESULTS: Ten providers completed interviews. The majority (90%) of providers reported insufficient evidence to suggest a best practice for screening in this population. Providers relied on shared decision-making with patients, a process facilitated by strong provider-patient relationships. Providers took into consideration factors such as functional status, personal risk of breast cancer, and patient preference. Time constraints disincentivized providers to engage in discussions. CONCLUSIONS: PCPs make decisions about screening mammography for older patients on an individualized basis, taking into account patient overall health status and desire for aggressive intervention. They often rely on shared decision-making given unclear clinical guidelines. PRACTICE IMPLICATIONS: These findings suggest that fostering strong provider-patient relationships, addressing patient knowledge gaps, and compensating providers for time spent on counseling may facilitate cost-efficient and patient-centered utilization of screening mammography.

Patient Perspectives on the Financial Costs and Burdens of Breast Cancer Surgery.

PURPOSE: Although financial toxicity is a well-documented aspect of cancer care, little is known about how patients narratively characterize financial experiences related to breast cancer treatment. We sought to examine these patient experiences through mixed methods analysis. METHODS: Women (≥ 18 years old) with a history of breast cancer were recruited from the Love Research Army and Sisters Network to complete an 88-item electronic survey including an open-ended response. Quantitative data were used to sort and stratify responses to the open-ended question, which comprised the qualitative data evaluated here. Descriptive statistics and qualitative content analysis were used to evaluate the financial costs and other burdens resulting from breast cancer surgery. RESULTS: In total, 511 respondents completed the survey in its entirety and wrote an open-ended response. Participants reported significant financial burden in different categories including direct payments for medical care and indirect costs such as lost wages and travel expenses. Treatment-related costs burdened participants for years after diagnosis, forming a financial arc for many participants. Discrepancies existed between the degree of financial burden reported on multiple-choice questions and participants' corresponding open-ended descriptions of financial burden. Participants described a lack of communication surrounding costs with their providers and difficulty negotiating payments with insurance. CONCLUSION: Breast cancer care can result in ongoing financial burden years after diagnosis among all patients, even those with adequate insurance patient populations.

Improving the digital literacy competence of nursing and midwifery students: A qualitative study of the experiences of NICE student champions.

Developing competence in digital literacy is an important component of health professional education in order to increase confidence in accessing best evidence for clinical practice. Regulators of pre-registration nursing programmes in the UK have stipulated an increasing number of digital competencies that will be required by future nurses. The teaching of digital literacy skills may be achieved through a range of methods, including didactic, experiential and peer-taught approaches. The UK National Institute for Health and Care Excellence (NICE) have developed the NICE student champion scheme (NICE SCS) to train health care students to deliver digital literacy sessions on using the NICE Evidence Search engine to peers. This scheme has previously been evaluated from the perspective of medical and pharmacy students, but there has been no published evaluation of the experiences of nursing and midwifery students. In this study focus groups were used to explore the experiences of those who acted as NICE student champions. Findings were that student champions experienced benefits, which ranged from greater facility in using the search engine and a better understanding of accessing resources and information about evidence-based care. Student champions described improvements in their presentation skills and knowledge, despite some challenges in facilitating sessions.

Effect of Budesonide Added to Large-Volume, Low-pressure Saline Sinus Irrigation for Chronic Rhinosinusitis: A Randomized Clinical Trial.

Importance: Recent studies suggest that budesonide added to saline nasal lavage can be an effective treatment for patients with chronic rhinosinusitis (CRS). Objective: To evaluate the incremental effect of adding budesonide to large-volume, low-pressure saline sinus irrigation. Design, Setting, and Participants: This double-blind, placebo-controlled, randomized clinical trial was conducted at a quaternary care academic medical center between January 1, 2016, and February 16, 2017. A total of 80 adult patients with CRS were enrolled; 74 completed baseline assessments; and 61 remained in the trial to complete all analyses. Data analysis was conducted from March 2017 to August 2017. Interventions: All study participants were provided with a sinus rinse kit including saline and identical-appearing capsules that contained either budesonide (treatment group) or lactose (control group). Patients were instructed to dissolve the capsules in the saline and use the resulting solution to irrigate both nasal cavities, using half the solution for each cavity, once daily for 30 days. Main Outcomes and Measures: The primary outcome measure was the change in Sino-Nasal Outcome Test (SNOT-22) scores, pretreatment to posttreatment, in the budesonide group compared with the control group. Secondary outcome measures included patient-reported response to treatment, as measured with a modification of the Clinical Global Impressions scale, and endoscopic examination scored by the Lund-Kennedy grading system. Results: Of the 74 participants who completed baseline assessments (37 in each study arm), mean (SD) age, 51 (14.7) years, 50 (68%) were women. Of the 61 who remained in the trial to complete all analyses, 29 were randomized to budesonide treatment, and 32 to saline alone. The average change in SNOT-22 scores was 20.7 points for those in the budesonide group and 13.6 points for those in the control group, for a mean difference of 7 points in favor of the budesonide group (95% CI, -2 to 16). A total of 23 participants (79%) in the budesonide group experienced a clinically meaningful reduction in their SNOT-22 scores compared with 19 (59%) in the control group, for a difference of 20% (95% CI, -2.5% to 42.5%). The average change in endoscopic scores was 3.4 points for the budesonide group and 2.7 points for the control group. There were no related adverse events. Conclusions and Relevance: This study shows that budesonide in saline nasal lavage results in clinically meaningful benefits beyond the benefits of saline alone for patients with CRS. Given the imprecision in the treatment effect, further research is warranted to define the true effect of budesonide in saline nasal lavage. Trial Registration: ClinicalTrials.gov Identifier: NCT02696850.

Reporting of Effect Size and Confidence Intervals in JAMA Otolaryngology-Head & Neck Surgery.

Importance: Effect sizes and confidence intervals (CIs) are critical for the interpretation of the results for any outcome of interest. Objective: To evaluate the frequency of reporting effect sizes and CIs in the results of analytical studies. Design, Setting, and Participants: Descriptive review of analytical studies published from January 2012 to December 2015 in JAMA Otolaryngology-Head & Neck Surgery. Methods: A random sample of 121 articles was reviewed in this study. Descriptive studies were excluded from the analysis. Seven independent reviewers participated in the evaluation of the articles, with 2 reviewers assigned per article. The review process was standardized for each article; the Methods and Results sections were reviewed for the outcomes of interest. Descriptive statistics for each outcome were calculated and reported accordingly. Main Outcomes and Measures: Primary outcomes of interest included the presence of effect size and associated CIs. Secondary outcomes of interest included a priori descriptions of statistical methodology, power analysis, and expectation of effect size. Results: There were 107 articles included for analysis. The majority of the articles were retrospective cohort studies (n = 36 [36%]) followed by cross-sectional studies (n = 18 [17%]). A total of 58 articles (55%) reported an effect size for an outcome of interest. The most common effect size used was difference of mean, followed by odds ratio and correlation coefficient, which were reported 17 (16%), 15 (13%), and 12 times (11%), respectively. Confidence intervals were associated with 29 of these effect sizes (27%), and 9 of these articles (8%) included interpretation of the CI. A description of the statistical methodology was provided in 97 articles (91%), while 5 (5%) provided an a priori power analysis and 8 (7%) provided a description of expected effect size finding. Conclusions and Relevance: Improving results reporting is necessary to enhance the reader's ability to interpret the results of any given study. This can only be achieved through increasing the reporting of effect sizes and CIs rather than relying on P values for both statistical significance and clinically meaningful results.