Development and implementation of a nurse-based remote patient monitoring program for ambulatory disease management

IntroductionNumerous factors are intersecting in healthcare resulting in an increased focus on new tools and methods for managing care in patients' homes. Remote patient monitoring (RPM) is an option to provide care at home and maintain a connection between patients and providers to address ongoing medical issues.MethodsMayo Clinic developed a nurse-led RPM program for disease and post-procedural management to improve patient experience, clinical outcomes, and reduce health care utilization by more directly engaging patients in their health care. Enrolled patients are sent a technology package that includes a digital tablet and peripheral devices for the collection of symptoms and vital signs. The data are transmitted from to a hub integrated within the electronic health record. Care team members coordinate patient needs, respond to vital sign alerts, and utilize the data to inform and provide individualized patient assessment, patient education, medication management, goal setting, and clinical care planning.ResultsSince its inception, the RPM program has supported nearly 22,000 patients across 17 programs. Patients who engaged in the COVID-19 RPM program experienced a significantly lower rate of 30-day, all-cause hospitalization (13.7% vs. 18.0%, P = 0.01), prolonged hospitalization >7 days (3.5% vs. 6.7%, P = 0.001), intensive care unit (ICU) admission (2.3% vs. 4.2%, P = 0.01), and mortality (0.5% vs. 1.7%, P = 0.01) when compared with those enrolled and unengaged with the technology. Patients with chronic conditions who were monitored with RPM upon hospital discharge were significantly less likely to experience 30-day readmissions (18.2% vs. 23.7%, P = 0.03) compared with those unmonitored. Ninety-five percent of patients strongly agreed or agreed they were likely to recommend RPM to a friend or family member.ConclusionsThe Mayo Clinic RPM program has generated positive clinical outcomes and is satisfying for patients. As technology advances, there are greater opportunities to enhance this clinical care model and it should be extended and expanded to support patients across a broader spectrum of needs. This report can serve as a framework for health care organizations to implement and enhance their RPM programs in addition to identifying areas for further evolution and exploration in developing RPM programs of the future

Effect of Pembrolizumab Plus Neoadjuvant Chemotherapy on Pathologic Complete Response in Women With Early-Stage Breast Cancer: An Analysis of the Ongoing Phase 2 Adaptively Randomized I-SPY2 Trial.

Importance: Approximately 25% of patients with early-stage breast cancer who receive (neo)adjuvant chemotherapy experience a recurrence within 5 years. Improvements in therapy are greatly needed. Objective: To determine if pembrolizumab plus neoadjuvant chemotherapy (NACT) in early-stage breast cancer is likely to be successful in a 300-patient, confirmatory randomized phase 3 neoadjuvant clinical trial. Design, Setting, and Participants: The I-SPY2 study is an ongoing open-label, multicenter, adaptively randomized phase 2 platform trial for high-risk, stage II/III breast cancer, evaluating multiple investigational arms in parallel. Standard NACT serves as the common control arm; investigational agent(s) are added to this backbone. Patients with ERBB2 (formerly HER2)-negative breast cancer were eligible for randomization to pembrolizumab between November 2015 and November 2016. Interventions: Participants were randomized to receive taxane- and anthracycline-based NACT with or without pembrolizumab, followed by definitive surgery. Main Outcomes and Measures: The primary end point was pathologic complete response (pCR). Secondary end points were residual cancer burden (RCB) and 3-year event-free and distant recurrence-free survival. Investigational arms graduated when demonstrating an 85% predictive probability of success in a hypothetical confirmatory phase 3 trial. Results: Of the 250 women included in the final analysis, 181 were randomized to the standard NACT control group (median [range] age, 47 [24.77] years). Sixty-nine women (median [range] age, 50 [27-71] years) were randomized to 4 cycles of pembrolizumab in combination with weekly paclitaxel followed by AC; 40 hormone receptor (HR)-positive and 29 triple-negative. Pembrolizumab graduated in all 3 biomarker signatures studied. Final estimated pCR rates, evaluated in March 2017, were 44% vs 17%, 30% vs 13%, and 60% vs 22% for pembrolizumab vs control in the ERBB2-negative, HR-positive/ERBB2-negative, and triple-negative cohorts, respectively. Pembrolizumab shifted the RCB distribution to a lower disease burden for each cohort evaluated. Adverse events included immune-related endocrinopathies, notably thyroid abnormalities (13.0%) and adrenal insufficiency (8.7%). Achieving a pCR appeared predictive of long-term outcome, where patients with pCR following pembrolizumab plus chemotherapy had high event-free survival rates (93% at 3 years with 2.8 years\u27 median follow-up). Conclusions and Relevance: When added to standard neoadjuvant chemotherapy, pembrolizumab more than doubled the estimated pCR rates for both HR-positive/ERBB2-negative and triple-negative breast cancer, indicating that checkpoint blockade in women with early-stage, high-risk, ERBB2-negative breast cancer is highly likely to succeed in a phase 3 trial. Pembrolizumab was the first of 10 agents to graduate in the HR-positive/ERBB2-negative signature. Trial Registration: ClinicalTrials.gov Identifier: NCT01042379

Unilateral Arm Urticaria Presenting as a Paraneoplastic Manifestation of Metachronous Bilateral Breast Cancer

Various paraneoplastic syndromes (PNS) are reported to be associated with breast cancer and can range from mild dermatological symptoms to severe neurological complications. Neurological and dermatological manifestations tend to be the more commonly seen paraneoplastic manifestations, albeit both are relatively rare. Diagnosis of the underlying malignancy is often delayed since the presence and severity of paraneoplastic manifestations are not dependent on the tumor size or stage. Herein, we describe a unique case of unilateral arm urticaria presenting as a paraneoplastic manifestation of metachronous bilateral breast cancer. Similar reports and other PNS associated with breast cancer are described. Recognition of PNS associated with underlying malignancies and age-appropriate screening can facilitate diagnosis of the underlying occult malignancy. Resection of the underlying malignancy can lead to resolution and/or improvement of the PNS for some patients

Follow-up care for breast cancer survivors

Breast cancer survivorship guidelines recommend at least annual follow-up visits, yet the degree to which this occurs in clinical practice is uncertain. Claims data from a US commercial insurance database (OptumLabs) were used to identify women treated with curative intent surgery for newly diagnosed breast cancer between 2006 and 2014. In 25 035 women, median follow-up was 3 years. In the second year after surgery, 9.6% of the patients did not visit a primary care provider, an oncologist, or a surgeon (guideline-nonadherent). The guideline-nonadherent proportion increased from 7.8% in women diagnosed in 2006 to 12.2% in those diagnosed in 2014 (two-sided Wald P < .001). During years 2-6, guideline-nonadherence was also associated with older age, nonwhite race, no radiation, no chemotherapy, no endocrine therapy, and increasing time after surgery. There is a substantial and increasing rate of inadequate follow-up among breast cancer survivors. This has the potential to impair outcomes

Breast Cancer Survivorship Care Variations Between Adjuvant Chemotherapy Regimens

BackgroundTreatment-related toxicity can vary substantially between chemotherapy regimens. In this study we evaluated the frequency of outpatient office visits among a cohort of early stage breast cancer survivors after completion of 4 different adjuvant chemotherapy regimens to better understand how differences in toxicities between regimens might affect health care use.Materials and methodsWe analyzed administrative claims data from a US commercial insurance database (OptumLabs) to identify women who received adjuvant doxorubicin/cyclophosphamide (AC), AC followed or preceded by docetaxel or paclitaxel (AC-T), AC concurrent with docetaxel or paclitaxel (TAC), or docetaxel/cyclophosphamide (TC) between 2008 and 2014. We compared mean numbers of visits per patient (adjusted for age, race/ethnicity, region, year, surgery type, radiation, chronic conditions, and previous hospitalizations) across the different regimens (TC = reference) for 12 months, starting 4 months after the end of chemotherapy.ResultsIn 6247 eligible patients, the mean adjusted number of outpatient visits per patient was significantly higher in patients who received AC-T (8.1) or TAC (7.3) than TC (6.5) or AC (6.0; P < .001 for comparisons of AC-T and TAC with TC), primarily because of differences in Medical Oncology visits. Approximately 40% did not see a primary care provider at all during this time frame.ConclusionsAC-T and TAC are associated with more subsequent outpatient visits than TC. Visits to primary care providers are infrequent during the year after completion of chemotherapy