Preventing metastatic recurrence in low-risk ER/PR + breast cancer patients-a retrospective clinical study exploring the evolving challenge of persistence with adjuvant endocrine therapy.

PURPOSE: In the genomic era, more women with low-risk breast cancer will forego chemotherapy and rely on adjuvant endocrine therapy (AET) to prevent metastatic recurrence. However, some of these patients will unfortunately relapse. We sought to understand this outcome. Preliminary work suggested that early discontinuation of AET, also known as non-persistence, may play an important role. A retrospective analysis exploring factors related to our breast cancer patients' non-persistence with AET was performed. METHODS: Women who underwent Oncotype-DX® testing between 2011 and 2014 with minimum 5 years follow-up were included. 'Low risk' was defined as Oncotype score < 26. Outcomes of recurrence and persistence were determined by chart review. Patient, tumor and treatment factors were collected, and persistent versus non-persistent groups compared using multivariable ANOVA and Fisher Chi square exact test. RESULTS: We identified six cases of distant recurrence among low-risk patients with a median follow-up of 7.7 years. Among them, five of six patients (83%) were non-persistent with AET. The non-persistence rate in our cohort regardless of recurrence was 57/228 (25%). Non-persistent patients reported more severe side effects compared with persistent patients (p = 0.002) and were more likely to be offered a switch in endocrine therapy, rather than symptom-relief (p = 0.006). In contrast, persistent patients were 10.3 times more likely to have been offered symptom-alleviating medications compared with non-persistent patients (p < 0.001). A subset analysis revealed that patients who persisted with therapy had a higher Oncotype-DX® score than patients who discontinued early (p = 0.028). CONCLUSION: Metastatic recurrence in low-risk breast cancer patients may be primarily due to non-persistence with endocrine therapy. Further work is needed to optimize care for patients who struggle with side effects. To our knowledge, these are the first published data suggesting that Oncotype-DX® score may influence persistence with AET.

Applying the Peter Parker Principle to Healthcare.

The role of power in healthcare can raise many ethical challenges. Power is ownership, whether given, ceded, or taken of another person's autonomy. When a person has power over someone else, they can control or strongly influence the decision-making freedom of that person. From the principalist perspective1,2 of healthcare ethics, denying a person their freedom to choose should only occur when justifying conditions related to beneficence and nonmaleficence are sufficiently satisfied. In healthcare, it is rare to be able to identify situations where paternalism is justified. However, experience suggests that abusive power in healthcare is used too frequently without justifying criteria.

SMART-ly Managing Type 1 Diabetes - Modifying Glucose Metabolism With an Online Mind-Body Intervention: A Feasibility and Pilot Study.

Objective: Managing type 1 diabetes is stressful. Stress physiology influences glucose metabolism. Continuous glucose monitors allow us to track glucose variability in the real-world environment. Managing stress and cultivating resiliency should improve diabetes management and reduce glucose variability. Research Design and Methods: The study was designed as a randomized prospective cohort pre-post study with wait time control. Participants were adult type 1 diabetes patients who used a continuous glucose monitor and recruited from an academic endocrinology practice. The intervention was the Stress Management and Resiliency Training (SMART) program conducted over 8 sessions over web-based video conference software. The main outcome measures were Glucose variability, the Diabetes Self-Management questionnaire (DSMQ),Short-Form Six-Dimension (SF-6D), and the Connor-Davidson Resiliency (CD-RSIC) instrument. Results: There was statistically significant improvement in participants DSMQ and CD RISC scores though the SF-6D did not change. Participants under age 50 years-old showed a statistically significant reduction in average glucose (p = .03) and Glucose Management Index (GMI) (p = .02). Participants also had reduced percentage of time high and increased time in range though this did not reach statistical significance. The participants found doing the intervention online acceptable if not always ideal. Conclusions: An 8-session stress management and resiliency training program reduced diabetes related stress and improved resiliency and reduced average blood glucose and GMI in those under 50 years-old. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT04944264.

Informing the Management of Asymptomatic Nephrolithiasis: Markov Decision Analysis for the 1 cm Renal Stone.

INTRODUCTION: The management of an incidentally discovered, asymptomatic renal stone includes watchful waiting, shock wave lithotripsy, ureteroscopy with basket extraction of fragmented stones (URS-B) or ureteroscopy with laser "dusting" (URS-D). Each intervention has varying stone-free rates, requirements for ureteral stenting, and variable impact on a patient's quality of life. Decision analysis was used to assess the optimal quality adjusted life-years associated with each treatment option. METHODS: A Markov model was constructed to represent potential outcomes for a single 1 cm renal stone after treatment. The cohort was followed for 1-month cycles over 3 years and toll penalties for receiving a stent and undergoing surgery were standardized and incorporated into each subtree. Probabilities, utilities and toll penalties were derived from existing literature or clinical extrapolation when no published data were available. One-way sensitivity analyses were performed to determine threshold probabilities/utilities that may alter preferred options. RESULTS: Watchful waiting was the preferred intervention, preserving 2.82 quality adjusted life-years over 3 years. The remaining options had similar but decreasing quality adjusted life-years: URS-B provided 2.78 quality adjusted life-years; shock wave lithotripsy provided 2.72 quality adjusted life-years, and URS-D provided 2.67 quality adjusted life-years. One-way sensitivity analysis showed that URS-D was preferred when stone-free rates from URS-B dropped below 37%. Shock wave lithotripsy was preferred over URS-B when stone-free rates from URS-B dropped below 62%. As stents became progressively less bothersome, watchful waiting is preferred, followed by URS-B, shock wave lithotripsy and URS-D. CONCLUSIONS: Watchful waiting is the preferred management decision for asymptomatic renal stones. However, these results are sensitive to both actual stone-free rate and individual stent tolerance.

Medical Qigong for Mobility and Balance Self-Confidence in Older Adults.

Background/Objectives: Physical inactivity, sedentary lifestyle, and impaired neuromuscular function increases fall risk and fractures in our aging population. Mind-body modalities, improve strength, balance and coordination, mitigating these risks. This study examined whether a manualized Medical Qigong protocol measurably improves balance, gait, and health self-confidence among older adults. Design: Randomized prospective cohort pre-post study with wait time control. Setting: Two martial arts centers in Massachusetts and Arizona. Participants: Ninety-five adults age ≥ 50 (mean age 68.6 y.o., range 51-96) were randomly assigned to an immediate start group (N = 53) or 4-week delayed start group (N = 43). Intervention: A 10 form qigong protocol taught over 12 weekly classes. Measurments: Primary outcome measures were the Community Balance and Mobility Scale (CBMS) and Activities-Specific Balance Confidence (ABC) Scale. Data was collected at baseline, 1-month and 4-months. Results: Both groups at both sites demonstrated improved balance and gait (CBMS + 11.9 points, p < 0.001). This effect was strongest in patients in their 60 s (CBMS +12.9 p < 0.01) and 70 s (CBMS + 14.3, p < 0.001), was equal across genders and socioeconomic status. Balance self-confidence did not significantly change (ABC + 0.9, p = 0.48), though several elements within ABC trended toward improvement [e.g., walk up/down ramp (p = 0.07), bend over/pick up (p = 0.09)]. Falls in the past year was inversely correlated with balance self-confidence (p = 0.01). Conclusion: A 12-week manualized Medical Qigong protocol significantly improved balance and gait and modestly improved balance self-confidence among older adults. Medical Qigong may be a useful clinical intervention for older adults at heightened risk for falls and related injuries. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04430751.

Application of a mind-body tool in a rural population to improve post-operative outcomes in women with breast cancer: A pilot study.

BACKGROUND: Breast cancer is the most commonly diagnosed cancer in women in the United States. While improvements in treatment have improved mortality, they can negatively impact quality of life (QOL). Mindfulness-based programs are low-cost interventions shown to improve QOL. The study aim was to evaluate a well-validated mind-body program - determining its feasibility, acceptability, and improvement in symptomatology in post-operative breast cancer patients in a rural setting. METHODS: We recruited patients during post-operative appointments following mastectomy or lumpectomy for breast cancer. Each participant completed 3 surveys before and after the intervention: (8 PROMIS-29, PROMIS -Global QOL, and MAAS (Mindfulness Attention Awareness Scale). The intervention was an 8-week course: "The Stress Management and Resiliency Training (SMART) - Relaxation Response and Resiliency Program (3RP)", which has been well-validated for the treatment of various clinical problems. Feasibility, acceptability, quantitative survey data, and demographics were analyzed. RESULTS: SMART-3RP was highly acceptable with greater than >80% completion rate. 23% of the invited participants enrolled, although over 70% of patients approached (34/48) expressed interest. The principal recruitment deterrent was scheduling. Sleep and anxiety/depression were improved in participants although not significantly due to small sample size. We also demonstrated improving trends in other QOL measures. CONCLUSIONS: This small pilot study proved feasibility, showed excellent acceptability, and demonstrated a benefit in post-operative breast cancer patients. Even with our small sample size, we found trends in improvement in certain QOL measures which emphasizes SMART-3RP's potential effectiveness. A large-scale randomized controlled trial is warranted.

Simulation Analysis and Comparison of Point of Care Testing and Central Laboratory Testing.

Background. In response to demand for fast and efficient clinical testing, the use of point-of-care testing (POCT) has become increasingly common in the United States. However, studies of POCT implementation have found that adopting POCT may not always be advantageous relative to centralized laboratory testing. Methods. We construct a simulation model of patient flow in an outpatient care setting to evaluate tradeoffs involved in POCT implementation across multiple dimensions, comparing measures of patient outcomes in varying clinical scenarios, testing regimes, and patient conditions. Results. We find that POCT can significantly reduce clinical time for patients, as compared to traditional testing regimes, in settings where clinic and central testing areas are far apart. However, as distance from clinic to central testing area decreased, POCT advantage over central laboratory testing also decreased, in terms of time in the clinical system and estimated subsequent productivity loss. For example, testing for pneumonia resulted in an estimated average of 27.80 (central lab) versus 15.50 (POCT) total lost productive hours in a rural scenario, and an average of 14.92 (central lab) versus 15.50 (POCT) hours in a hospital-based scenario. Conclusions. Our results show that POCT can effectively reduce the average time a patient spends in the system for varying condition profiles and clinical scenarios. However, the number of total lost productive hours, a more holistic measure, is greatly affected by testing quality, where POCT often is at a disadvantage. Thus, it is important to consider factors such as clinical setting, target condition, testing costs, and test quality when selecting appropriate testing regime.

Reducing Avoidable Facility Transfers (RAFT): Outcomes of a Team Model to Minimize Unwarranted Emergency Care at Skilled Nursing Facilities.

BACKGROUND: Acute health care interventions for residents of skilled nursing facilities (SNFs) are often unwarranted, unwanted, and/or harmful. We describe a provider-focused care model to reduce unwarranted or unwanted acute health care utilization. OBJECTIVE: Assess the capability of the Reducing Avoidable Facility Transfers (RAFT) model to reduce unwanted and unwarranted acute health care utilization among residents in 3 rural SNFs between January 1, 2016 and June 30, 2017. DESIGN: Prospective cohort, pre/post study. SETTING: Three rural SNFs in collaboration with a geriatric practice in a tertiary academic medical center. PARTICIPANTS: Post-acute care (PAC) and long-term care (LTC) residents of 3 rural SNFs. INTERVENTION: RAFT includes the following components: (1) a small team of providers who manage longitudinal care and after hours call; (2) elicitation of advance care plans and preferences regarding acute care; (3) standardized communication process engaging the provider at the identification of an acute care event; (4) a biweekly case review of all emergency department (ED) transfers. MEASURES: ED and hospital utilization. RESULTS: RAFT demonstrated a 35% reduction in monthly ED transfers and a 30.5% reduction in monthly hospitalizations. These reductions were greatest for LTC residents. CONCLUSIONS/IMPLICATIONS: The RAFT approach substantially reduced unwarranted ED and hospital utilization in this study. Results support replication and evaluation in a larger, more diverse setting and population.

Analysis of the effects of EHR implementation on timeliness of care in a dermatology clinic: a simulation study.

Objective: Quantify the downstream impact on patient wait times and overall length of stay due to small increases in encounter times caused by the implementation of a new electronic health record (EHR) system. Methods: A discrete-event simulation model was created to examine the effects of increasing the provider-patient encounter time by 1, 2, 5, or 10 min, due to an increase in in-room documentation as part of an EHR implementation. Simulation parameters were constructed from an analysis of 52 000 visits from a scheduling database and direct observation of 93 randomly selected patients to collect all the steps involved in an outpatient dermatology patient care visit. Results: Analysis of the simulation results demonstrates that for a clinic session with an average booking appointment length of 15 min, the addition of 1, 2, 5, and 10 min for in-room physician documentation with an EHR system would result in a 5.2 (22%), 9.8 (41%), 31.8 (136%), and 87.2 (373%) minute increase in average patient wait time, and a 6.2 (12%), 11.7 (23%), 36.7 (73%), and 96.9 (193%) minute increase in length of stay, respectively. To offset the additional 1, 2, 5, or 10 min, patient volume would need to decrease by 10%, 20%, 40%, and >50%, respectively. Conclusions: Small changes to processes, such as the addition of a few minutes of extra documentation time in the exam room, can cause significant delays in the timeliness of patient care. Simulation models can assist in quantifying the downstream effects and help analyze the impact of these operational changes.

Decreasing patient length of stay via new flexible exam room allocation policies in ambulatory care clinics.

To address prolonged lengths of stay (LOS) in ambulatory care clinics, we analyze the impact of implementing flexible and dynamic policies for assigning exam rooms to providers. In contrast to the traditional approaches of assigning specific rooms to each provider or pooling rooms among all practitioners, we characterize the impact of alternate compromise policies that have not been explored in previous studies. Since ambulatory care patients may encounter multiple different providers in a single visit, room allocation can be determined separately for each encounter accordingly. For the first phase of the visit, conducted by the medical assistant, we define a dynamic room allocation policy that adjusts room assignments based on the current state of the clinic. For the second phase of the visit, conducted by physicians, we define a series of room sharing policies which vary based on two dimensions, the number of shared rooms and the number of physicians sharing each room. Using a discrete event simulation model of an outpatient cardiovascular clinic, we analyze the benefits and costs associated with the proposed room allocation policies. Our findings show that it is not necessary to fully share rooms among providers in order to reduce patient LOS and physician idle time. Instead, most of the benefit of pooling can be achieved by implementation of a compromise room allocation approach, limiting the need for significant organizational changes within the clinic. Also, in order to achieve most of the benefits of room allocation policies, it is necessary to increase flexibility in the two dimensions simultaneously. These findings are shown to be consistent in settings with alternate patient scheduling and distinctions between physicians.

Implementation of a Workflow Initiative for Integrating Transitional Care Management Codes in a Geriatric Primary Care Practice.

We implemented a transitional care management service led by a nurse care manager. An interdisciplinary team developed a workflow using a Plan-Do-Study-Act cycle for contacting patients. Of the 146 (97.9%) eligible patients, 143 (97.9%) had a phone call within 48 hours. There were 84 of 120 (70.0%) and 117 of 120 (97.5%) attendance rates of those attending visits within 7 and 14 days. A care manager-led workflow was successfully and easily implemented within a primary care practice.

Correction: Relaxation Response and Resiliency Training and Its Effect on Healthcare Resource Utilization.

[This corrects the article DOI: 10.1371/journal.pone.0140212.].

Telemedicine and primary care obesity management in rural areas - innovative approach for older adults?

BACKGROUND: The growing prevalence of obesity is paralleling a rise in the older adult population creating an increased risk of functional impairment, nursing home placement and early mortality. The Centers for Medicare and Medicaid recognized the importance of treating obesity and instituted a benefit in primary care settings to encourage intensive behavioral therapy in beneficiaries by primary care clinicians. This benefit covers frequent, brief, clinic visits designed to address older adult obesity. DISCUSSION: We describe the challenges in the implementation and delivery into real-world settings. The challenges in rural settings that have the fastest growing elderly population, high obesity rates, but also workforce shortages and lack of specialized services are emphasized. The use of Telemedicine has successfully been implemented in other specialties and could be a useful modality in delivering much needed intensive behavioral therapy, particularly in distant, under-resourced environments. This review outlines some of the challenges with the current benefit and proposed solutions in overcoming rural primary care barriers to implementation, including changes in staffing models. CONCLUSIONS: Recommendations to extend the benefit's coverage to be more inclusive of non-physician team members is needed but also for improvement in reimbursement for telemedicine services for older adults with obesity.

National Institute of Biomedical Imaging and Bioengineering Point-of-Care Technology Research Network: Advancing Precision Medicine.

To advance the development of point-of-care technology (POCT), the National Institute of Biomedical Imaging and Bioengineering established the POCT Research Network (POCTRN), comprised of Centers that emphasize multidisciplinary partnerships and close facilitation to move technologies from an early stage of development into clinical testing and patient use. This paper describes the POCTRN and the three currently funded Centers as examples of academic-based organizations that support collaborations across disciplines, institutions, and geographic regions to successfully drive innovative solutions from concept to patient care.

Relaxation Response and Resiliency Training and Its Effect on Healthcare Resource Utilization.

BACKGROUND: Poor psychological and physical resilience in response to stress drives a great deal of health care utilization. Mind-body interventions can reduce stress and build resiliency. The rationale for this study is therefore to estimate the effect of mind-body interventions on healthcare utilization. OBJECTIVE: Estimate the effect of mind body training, specifically, the Relaxation Response Resiliency Program (3RP) on healthcare utilization. DESIGN: Retrospective controlled cohort observational study. SETTING: Major US Academic Health Network. SAMPLE: All patients receiving 3RP at the MGH Benson-Henry Institute from 1/12/2006 to 7/1/2014 (n = 4452), controls (n = 13149) followed for a median of 4.2 years (.85-8.4 yrs). MEASUREMENTS: Utilization as measured by billable encounters/year (be/yr) stratified by encounter type: clinical, imaging, laboratory and procedural, by class of chief complaint: e.g., Cardiovascular, and by site of care delivery, e.g., Emergency Department. Subgroup analysis by propensity score matched pre-intervention utilization rate. RESULTS: At one year, total utilization for the intervention group decreased by 43% [53.5 to 30.5 be/yr] (p <0.0001). Clinical encounters decreased by 41.9% [40 to 23.2 be/yr], imaging by 50.3% [11.5 to 5.7 be/yr], lab encounters by 43.5% [9.8 to 5.6], and procedures by 21.4% [2.2 to 1.7 be/yr], all p < 0.01. The intervention group's Emergency department (ED) visits decreased from 3.6 to 1.7/year (p<0.0001) and Hospital and Urgent care visits converged with the controls. Subgroup analysis (identically matched initial utilization rates-Intervention group: high utilizing controls) showed the intervention group significantly reduced utilization relative to the control group by: 18.3% across all functional categories, 24.7% across all site categories and 25.3% across all clinical categories. CONCLUSION: Mind body interventions such as 3RP have the potential to substantially reduce healthcare utilization at relatively low cost and thus can serve as key components in any population health and health care delivery system.

Systems Engineering and Point of Care Testing: Report from the NIBIB POCT/Systems Engineering Workshop.

The first part of this manuscript is an introduction to systems engineering and how it may be applied to health care and point of care testing (POCT). Systems engineering is an interdisciplinary field that seeks to better understand and manage changes in complex systems and projects as whole. Systems are sets of interconnected elements which interact with each other, are dynamic, change over time and are subject to complex behaviors. The second part of this paper reports on the results of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) workshop exploring the future of point of care testing and technologies and the recognition that these new technologies do not exist in isolation. That they exist within ecosystems of other technologies and systems; and these systems influence their likelihood of success or failure and their effectiveness. In this workshop, a diverse group of individuals from around the country, from disciplines ranging from clinical care, engineering, regulatory affairs and many others to members of the three major National Institutes of Health (NIH) funded efforts in the areas the Centers for POCT for sexually transmitted disease, POCT for the future of Cancer Care, POCT primary care research network, gathered together for a modified deep dive workshop exploring the current state of the art, mapping probable future directions and developing longer term goals. The invitees were broken up into 4 thematic groups: Home, Outpatient, Public/shared space and Rural/global. Each group proceeded to explore the problem and solution space for point of care tests and technology within their theme. While each thematic area had specific challenges, many commonalities also emerged. This effort thus helped create a conceptual framework for POCT as well as identifying many of the challenges for POCT going forward. Four main dimensions were identified as defining the functional space for both point of care testing and treatment, these are: Time, Location, Interpretation and Tempo. A framework is presented in this paper. There were several current and future challenges identified through the workshop. These broadly fall into the categories of technology development and implementation. More specifically these are in the areas of: 1) Design, 2) Patient driven demand and technology, 3) Information Characteristics and Presentation, 4) Health Information Systems, 5) Connectivity, 6) Workflow and implementation, 7) Maintenance/Cost, and 8) Quality Control. Definitions of these challenge areas and recommendations to address them are provided.

Patient-clinician concordance, face-time and access.

PURPOSE: People in socially disadvantageous positions may receive less time with their clinicians and consequently reduced access to healthcare resources, potentially magnifying health disparities. Socio-cultural characteristics of clinicians and patients may influence the time spent together. The purpose of this paper is to explore the relationship between clinician/patient time and clinician and patient characteristics using real-time location systems (RTLS). DESIGN/METHODOLOGY/APPROACH: In the MGH/MGPO Outpatient RFID (radio-frequency identification) project clinicians and patients wore RTLS tags during the workday to measure face-time (FT), the duration patients and clinicians are co-located, wait time (WT); i.e. from registration to clinical encounter and flow time (FLT) from registration to discharge. Demographic data were derived from the health system's electronic medical record (EMR). The RTLS and EMR data were synthesized and analyzed using standard structured-query language and statistical analytic methods. FINDINGS: From January 1, 2009 to January 1, 2011, 1,593 clinical encounters were associated with RTLS measured FTs, which differed with socioeconomic status and gender: women and lower income people received greater FT. WT was significantly longer for lower socioeconomic patients and for patients seeing trainee clinicians, women or majority ethnic group clinicians (Caucasian). FLT was shortest for men, higher socioeconomic status and for attending physician patients. Demographic concordance between patient and clinician did not significantly affect process times. RESEARCH LIMITATIONS/IMPLICATIONS: The study demonstrates the feasibility of using RTLS to capture clinically relevant process measures and suggests that the clinical delivery system surrounding a clinical encounter may more significantly influence access to clinician time than individual patient and clinician characteristics. ORIGINALITY/VALUE: Applying RTLS to healthcare is coming. We can now successfully install and run these systems in healthcare settings and extract useful information from them. Interactions with the clinical delivery system are at least as important as interactions with clinicians for providing access to care: measure FT, WT and FLT with RTLS; link clinical behavior, e.g. FT, with patient characteristics; explore how individual characteristics interact with system behavior.

Balancing clinical experience in outpatient residency training.

BACKGROUND: To receive adequate training experience, resident panels in teaching clinics must have a sufficiently diverse patient case-mix. However, case-mix can differ from one resident panel to another, resulting in inconsistent training. METHOD: Encounter data from primary care residency clinics at Massachusetts General Hospital from July 2008 to May 2010 (64 residents and ~3800 patients) were used to characterize patients by gender, age, major disease category (both acute and chronic, e.g., Cardio Acute, Cardio Chronic, etc., for a total of 44 disease categories), and number of disease categories. Imbalance across resident panels was characterized by the standard deviation for disease category, patient panel size, and annual visit frequency. To balance case-mix in resident panels, patient reassignment algorithms were proposed. First, patients were sorted by complexity; then patients were allocated sequentially to the panel with the least overall complexity. Patient reassignment across resident panels was considered under 3 scenarios: 1) within preceptor, 2) within a group of preceptors, and 3) across the entire practice annually. RESULTS: were compared with case-mix (pre-July 2012) and post-July 2012. Results. All 3 reassignment algorithms produced significant reductions in standard deviation of either number of disease categories or diagnoses across residents when compared with baseline (pre-July 2012) and actual July 2012 reassignment. Reassignment across the clinic and group provided the best and second best scenarios, respectively, although both came at the cost of initially reduced patient-preceptor continuity. CONCLUSION: Systematically reallocating patient panels in teaching clinics potentially can improve the consistency and breadth of the educational experience. The method in principle can be extended to any target of health care system reform where there is patient or clinician turnover.