Navigating privacy and security in telemedicine for primary care.

OBJECTIVE: To examine patient and provider perspectives on privacy and security considerations in telemedicine during the COVID-19 pandemic. STUDY DESIGN: Qualitative study with patients and providers from primary care practices in 3 National Patient-Centered Clinical Research Network sites in New York, New York; North Carolina; and Florida. METHODS: Semistructured interviews were conducted, audio recorded, transcribed verbatim, and coded using an inductive process. Data related to privacy and information security were analyzed. RESULTS: Sixty-five patients and 21 providers participated. Patients and providers faced technology-related security concerns as well as difficulties ensuring privacy in the transformed shared space of telemedicine. Patients expressed increased comfort doing telemedicine from home but often did not like their providers to offer virtual visits from outside an office setting. Providers initially struggled to find secure and Health Insurance Portability and Accountability Act-compliant platforms and devices to host the software. Whereas some patients preferred familiar platforms such as FaceTime, others recognized potential security concerns. Audio-only encounters sometimes raised patient concerns that they would not be able to confirm the identity of the provider. CONCLUSIONS: Telemedicine led to novel concerns about privacy because patients and providers were often at home or in public spaces, and they shared concerns about software and hardware security. In addition to technological safeguards, our study emphasizes the critical role of physical infrastructure in ensuring privacy and security. As telemedicine continues to evolve, it is important to address and mitigate concerns around privacy and security to ensure high-quality and safe delivery of care to patients in remote settings.

Multi-cancer early detection (MCED) tests: prioritizing equity from bench to bedside.

Multi-cancer early detection (MCED) tests are blood-based tests designed to screen for signals of multiple cancers. There is growing interest and investment in examining the potential benefits and applications of MCED tests. If MCED tests are shown to have clinical utility, it is important to ensure that all people-regardless of their demographic or socioeconomic background-equitably benefit from these tests. Unfortunately, with health care innovation, such considerations are often ignored until after inequities emerge. We urge for-profit companies, scientists, clinicians, payers, and government agencies to prioritize equity now-when MCEDs are still being developed and researched. In an effort to avoid creating and exacerbating cancer inequities, we propose 9 equity considerations for MCEDs.

What Affects Treatment Underuse in Multiple Myeloma in the United States: A Qualitative Study.

BACKGROUND: Multiple myeloma (MM) is the second most common hematologic malignancy. African Americans are more likely than Whites to be diagnosed with and die of MM, but they experience the same survival times in clinical trials, suggesting that differences in survival may be attributed to differences in receipt of treatment or differences in access to new treatments. We undertook this study to identify the reasons and needs underlying disparities in treatment among patients diagnosed with MM. METHODS: We conducted in-depth interviews in 2019-2020 with patients diagnosed with MM between 2010 and 2014 who were identified as eligible for transplant and maintenance therapy and having experienced delays in or underuse of treatment for MM. Underuse was defined as the lack of a particular treatment that the patient was eligible to receive, not being transplanted if eligible, and/or not receiving maintenance therapy. Underuse included patients' decision to delay harvest or autologous stem cell transplant (ASCT) for the time being and return to the decision in the future. All interviews were audio-recorded and transcribed verbatim. Four investigators independently coded transcripts through inductive analysis to assess reasons for treatment decisions. RESULTS: Of the 29 patients interviewed, 68% experienced treatment underuse: 21% self-identified as African American, 5% as Hispanic, 10% as mixed race, 57% as White, and 16% as Asian. There were no racial differences in reasons for underuse or delay. Themes relating to treatment underuse included: perceived pros and cons of treatment, including potential harm or lack thereof in delaying treatment; physician recommendations; and personal agency. CONCLUSION: Patients' decision making, delays, and underuse of MM treatment are influenced by social, personal, medical, and contextual factors. Patients consider their relationship with their physician to be one of the most significant driving forces in their decisions and treatment plans.

Clinical and sociodemographic risk factors associated with the development of second primary cancers among postmenopausal breast cancer survivors.

BACKGROUND: Advancement in breast cancer (BC) diagnosis and treatment have increased the number of long-term survivors. Consequently, primary BC survivors are at a greater risk of developing second primary cancers (SPCs). The risk factors for SPCs among BC survivors including sociodemographic characteristics, cancer treatment, comorbidities, and concurrent medications have not been comprehensively examined. The purpose of this study is to assess the incidence and clinicopathologic factors associated with risk of SPCs in BC survivors. METHODS: We analyzed 171, 311 women with early-stage primary BC diagnosed between January 2000 and December 2015 from the Medicare-linked Surveillance Epidemiology and End Results (SEER-Medicare) database. SPC was defined as any diagnosis of malignancy occurring within the study period and at least 6 months after primary BC diagnosis. Univariate analyses compared baseline characteristics between those who developed a SPC and those who did not. We evaluated the cause-specific hazard of developing a SPC in the presence of death as a competing risk. RESULTS: Of the study cohort, 21,510 (13%) of BC survivors developed a SPC and BC was the most common SPC type (28%). The median time to SPC was 44 months. Women who were white, older, and with fewer comorbidities were more likely to develop a SPC. While statins [hazard ratio (HR) 1.066 (1.023-1.110)] and anti-hypertensives [HR 1.569 (1.512-1.627)] increased the hazard of developing a SPC, aromatase inhibitor therapy [HR 0.620 (0.573-0.671)] and bisphosphonates [HR 0.905 (0.857-0.956)] were associated with a decreased hazard of developing any SPC, including non-breast SPCs. CONCLUSION: Our study shows that specific clinical factors including type of cancer treatment, medications, and comorbidities are associated with increased risk of developing SPCs among older BC survivors. These results can increase patient and clinician awareness, target cancer screening among BC survivors, as well as developing risk-adapted management strategies.

Achieving universal genetic assessment for women with ovarian cancer: Are we there yet? A systematic review and meta-analysis.

PURPOSE: Several professional organizations recommend universal genetic assessment for people with ovarian cancer as identifying pathogenic variants can affect treatment, prognosis, and all-cause mortality for patients and relatives. We sought to evaluate the literature on genetic assessment for women with ovarian cancer and determine if any interventions or patient characteristics drive utilization of services. METHODS: We searched key electronic databases to identify trials that evaluated genetic assessment for people with ovarian cancer. Trials with the primary aim to evaluate utilization of genetic assessment with or without interventions were included. Eligible trials were subjected to meta-analysis and the moderating influence of health interventions on rates of genetic assessment were examined. RESULTS: A total of 35 studies were included (19 report on utilization of genetic services without an intervention, 7 with an intervention, and 9 with both scenarios). Without an intervention, pooled estimates for referral to genetic counseling and completion of genetic testing were 39% [CI 27-53%] and 30% [CI 19-44%]. Clinician-facilitated interventions included: mainstreaming of genetic services (99% [CI 86-100%]), telemedicine (75% [CI 43-93%]), clinic-embedded genetic counselor (76% [CI 32-95%]), reflex tumor somatic genetic assessment (64% [CI 17-94%]), universal testing (57% [28-82%]), and referral forms (26% [CI 10-53%]). Random-effects pooled proportions demonstrated that Black vs. White race was associated with a lower rate of genetic testing (26%[CI 17-38%] vs. 40% [CI 25-57%]) as was being un-insured vs. insured (23% [CI 18-28%] vs. 38% [CI 26-53%]). CONCLUSIONS: Reported rates of genetic testing for people with ovarian cancer remain well below the goal of universal testing. Interventions such as mainstreaming can improve testing uptake. Strategies aimed at improving utilization of genetic services should consider existing disparities in race and insurance status.

Cancer Beliefs Associated with Posttraumatic Stress Disorder in Neuroendocrine Tumor Survivors.

INTRODUCTION: Earlier detection and improved treatment of neuroendocrine tumors (NETs) have prolonged survivorship in NET patients. We undertook this study to understand the prevalence of NET-related posttraumatic stress disorder (PTSD) and the factors and cancer-related illness beliefs associated with PTSD. METHODS: We recruited patients with a diagnosis of NET from a large NET center in New York City. Cancer-related PTSD was assessed using the Revised Impact of Events scale (IES), with probable PTSD as ≥ 33. We used the Brief Illness Perception Questionnaire (BIPQ) to assess NET-related beliefs. Data on baseline patient characteristics were collected. Comparisons used chi-squares and Fisher exact tests, as appropriate. RESULTS: Of the 73 participants, 48 (66%) were female and the mean age was 60 years (standard deviation (SD) 11.7, see Table 1). Twelve patients (16%) met criteria for probable NET-related PTSD. Women were more likely to meet criteria for probable PTSD (15% vs. 1%, p = 0.04). Those who met criteria for probable PTSD were more likely to have higher overall scores on the BIPQ (64 vs. 57, p = 0.03), report constantly feeling unwell due to their cancer (4 vs. 1, p = 0.04), as well as report more physical and emotional symptoms from their cancer (5 vs. 1, p = 0.03, and 7 vs. 4, p = 0.02, respectively). CONCLUSION: NET patients with probable PTSD were more likely to be women with greater physical and emotional burden due to their cancer. Our findings suggest that specific threatening cancer-related beliefs, not disease characteristics, predict a higher risk of PTSD among NET survivors.

12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.

The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent regulatory findings and case studies involving stability and nonclinical immunogenicity. Conclusions and consensus from discussions of these topics are included in this article.

Bisphosphonate use and incident cardiovascular events among older breast cancer survivors.

BACKGROUND: Cardiovascular disease (CVD) is a leading cause of mortality in early-stage breast cancer survivors. Recent studies suggest that bisphosphonates may decrease CVD risk in older patients. OBJECTIVE: This study sought to assess whether bisphosphonate use is associated with lower rates of incident CVD events among early-stage breast cancer survivors. METHODS: Longitudinal, population-based cohort study was conducted by using data from the Surveillance, Epidemiology and End Results registry linked to Medicare claims. We identified women >65 years with no history of CVD who were diagnosed with stage 0-III primary breast cancer between 2007 and 2010. Our primary outcome was a composite of incident angina pectoris, myocardial infarction, atrial fibrillation/flutter, heart failure, or stroke within 36 months of cancer diagnosis. Bisphosphonate use was defined as the presence of ≥1 pharmacy claim from 6 months prior to cancer diagnosis to the incident CVD event. We used propensity scores to create a matched group of breast cancer survivors without bisphosphonate exposure to compare rates of incident CVD events. RESULTS: A total of 2178 breast cancer survivors had ≥1 bisphosphonate prescription; the average length of bisphosphonate use was 15 months. Analyses of the matched data showed that 13.0% of bisphosphonate users and 23.4% of non-bisphosphonate users experienced an incident CVD event (p < 0.0001) after breast cancer diagnosis. Bisphosphonate use was significantly associated with fewer incident CVD events (hazard ratio: 0.51, 95% confidence interval: 0.44 to 0.59). CONCLUSIONS: Bisphosphonate use is associated with lower incidence of CVD events among older early-stage breast cancer survivors. Future studies should prospectively evaluate whether bisphosphonate use can decrease CVD incidence.

Breast Cancer: Does Type of Hospital Where You Get Surgery Affect Survival?

Under the Affordable Care Act (ACA), more women are insured with Medicaid, which should improve healthcare access. We sought to determine whether there are survival differences among patients with breast cancer undergoing surgery at facilities with varying proportions of Medicaid patients. We used New York State (NYS) Vital Statistics death records data linked with NYS discharge inpatient and ambulatory surgery databases to examine 90-day survival after surgery from 2008 to 2013. We used all Medicaid discharges to calculate and create quintiles of facilities based on Medicaid volume. We calculated survival hazard ratios using a marginal Cox model controlling for clustering of patients within hospitals, age, race, insurance, year of surgery, and comorbidities. Women who received surgery in facilities with the highest quintile of Medicaid volume had higher 90-day mortality (2.1% vs. 0.07%, p < .001) compared with those treated in facilities with lowest Medicaid volume, even after adjusting for multiple confounders. Consequently, although the ACA may improve access, healthcare quality remains questionable because patients treated at facilities with high proportions of Medicaid volume appear to have worse 90-day survival, likely due to quality of surgical and postsurgical care. Policymakers must ensure that quality of care is not negatively impacted by programs to reduce costs.

The effect of statins on survival in patients with stage IV lung cancer.

OBJECTIVES: Prior studies have shown an anticancer effect of statins in patients with certain malignancies. However, it is unclear whether statins have a mortality benefit in lung cancer. We compared survival of patients with stage IV non-small cell lung cancer (NSCLC) receiving vs. not receiving statins prior to diagnosis. METHODS: Using data from the Surveillance, Epidemiology and End Results registry linked to Medicare claims, we identified 5118 patients >65 years of age diagnosed with stage IV NSCLC between 2007 and 2009. We used propensity score methods to assess the association of statin use with overall and lung cancer-specific survival while controlling for measured confounders. RESULTS: Overall, 27% of patients were on statins at time of lung cancer diagnosis. Median survival in the statin group was 7 months, compared to 4 months in patients not treated with statins (p<0.001). Propensity score analyses found that statin use was associated with improvement in overall (hazard ratio [HR]: 0.76, 95% confidence interval [CI]: 0.73-0.79) and lung cancer-specific survival (HR: 0.77, 95% CI: 0.73-0.81), after controlling for baseline patient characteristics, cancer characteristics, staging work-up and chemotherapy use. CONCLUSIONS: Statin use is associated with improved survival among patients with stage IV NSCLC suggesting a potential anticancer effect. Further research should evaluate plausible biological mechanisms as well as test the effect of statins in prospective clinical trials.

What do primary care prediabetes patients need? A baseline assessment of patients engaging in a technology-enhanced lifestyle intervention.

OBJECTIVE: This study assessed the baseline knowledge, perceptions, attitudes and behaviors of prediabetes patients in order to tailor a new technology-enhanced primary care-based lifestyle modification intervention. METHODS: Patients with a diagnosis of prediabetes were enrolled in a randomized, controlled pilot study, Avoiding Diabetes Thru Action Plan Targeting (ADAPT), a technology-based intervention to promote action plan discussions around patient-selected behavior change goals. RESULTS: A total of 54 adults (82% female) were enrolled in the pilot study. Most (89%) had comorbid conditions and mean BMI was 36. Participants exhibited high risk of diabetes knowledge (knowledge score 20 on a 32 point scale) and high levels of willingness to make changes to decrease diabetes risk. Number of daily steps was inversely correlated with perceived physical activity (r=-0.35082, p<0.001). Poorer scores on diet quality were inversely correlated with BMI. CONCLUSION: Participants in this sample demonstrated requisite levels of knowledge, self-efficacy, motivation and risk perception for effective behavior change. These data suggest that primary care-based prediabetes interventions can move beyond educational goals and focus on enhancing patients' ability to select, plan and enact action plans.

Beliefs and attitudes about lung cancer screening among smokers.

The National Lung Screening Trial (NLST) recently reported that annual computed tomography (CT) screening is associated with decreased lung cancer mortality in high-risk smokers. Beliefs about lung cancer and screening, particularly across race and ethnicity, and their influence on CT screening utilization are largely unexamined. Our study recruited asymptomatic, high-risk smokers, 55-74 years of age from primary care clinics in an academic urban hospital. Guided by the self-regulation theory, we evaluated cognitive and affective beliefs about lung cancer. Intention to screen for lung cancer with a CT scan was assessed by self-report. We used univariate and logistic regression analyses to compare beliefs about screening and intention to screen among minority (Blacks and Hispanics) and non-minority participants. Overall, we enrolled 108 participants, of which 40% were Black and 34% were Hispanic; the mean age was 62.3 years, and median pack-years of smoking was 26. We found that intention to screen was similar among minorities and non-minorities (p=0.19); however, Hispanics were less likely to report intention to screen if they had to pay for the test (p=0.02). Fatalistic beliefs, fear of radiation exposure, and anxiety related to CT scans were significantly associated with decreased intention to screen (p<0.05). Several differences were observed in minority versus non-minority participants' beliefs toward lung cancer and screening. In conclusion, we found that concerns about cost, which were particularly prominent among Hispanics, as well as fatalism and radiation exposure fears may constitute barriers to lung cancer screening. Lung cancer screening programs should address these factors to ensure broad participation, particularly among minorities.

Physician attitudes toward opioid prescribing for patients with persistent noncancer pain.

OBJECTIVES: Physicians frequently express dissatisfaction about caring for patients with chronic pain and frequently report that inadequate training and concern about addiction are impediments to prescribing opioids. Elderly patients with chronic pain may be at increased risk of experiencing uncontrolled pain and this patient population is increasingly being cared for by geriatricians rather than internists. We sought to determine if there is a differential impact on internists and geriatricians of the factors that adversely affect attitudes toward opioid prescribing. METHODS: Anonymous survey of geriatric and internal medicine physicians at a large urban academic medical center about their beliefs and behaviors regarding opioid prescribing. RESULTS: One hundred thirty-two of 187 physicians completed the survey for an overall response rate of 71%. Controlling for level of training, internists were more likely to be concerned about illegal diversion (adjusted odds ratio=10.0, P=0.004), were more concerned about causing addiction (38% vs. 0%, P<0.001), and were more likely to be concerned about their inability to prescribe the correct opioid dose (adjusted odds ratio=11.1, P=0.020). DISCUSSION: Factors shown to have an adverse affect on opioid prescribing disproportionately impact on the attitudes of internists compared with geriatricians. Further research is needed to determine if there is also a differential impact on how internists care for their elderly patients with chronic pain.