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Background Poor diet quality significantly contributes to hypertension disparities affecting Black adults. While the Dietary Approaches to Stop Hypertension (DASH) eating pattern lowers blood pressure (BP), access to DASH-patterned groceries is a major barrier for residents of urban food deserts. Methods The Groceries for Black Residents of Boston to Stop Hypertension among Adults without Treated Hypertension (GoFresh) study is one of five projects in the RESTORE Network, an AHA-funded initiative focused on hypertension prevention. GoFresh is testing whether online, dietitian-assisted, home-delivered, DASH-patterned groceries lowers BP among Black adults with elevated BP. This individual-level, parallel-arm trial will enroll up to 176 Black adults with SBP (systolic blood pressure) between 120 and Results The primary outcome is the difference in SBP after 3 months. Secondary outcomes include a change in 24-hour ambulatory BP, body mass index, 24-hour urine sodium and potassium, hemoglobin A1C, lipids, fruit and vegetable intake, and saturated fat intake. Qualitative interviews with 45 participants 6 months after baseline assessments will determine barriers and facilitators to long-term maintenance of DASH-patterned grocery shopping. Discussion Findings from this study will inform ongoing work on scalable interventions to prevent hypertension among Black adults with implications for public and healthcare-based food supplementation programs. Trial registration NCT05121337. Registered on 16 November 2021, at ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT05121337

OBJECTIVE The aim of this study was to compare the ability of 1) CT-derived bone lesion quality (classification of vertebral bone metastases [BM]) and 2) computed CT-measured volumetric bone mineral density (vBMD) for evaluating the strength and stiffness of cadaver vertebrae from donors with metastatic spinal disease. METHODS Forty-five thoracic and lumbar vertebrae were obtained from cadaver spines of 11 donors with breast, esophageal, kidney, lung, or prostate cancer. Each vertebra was imaged using microCT (21.4 μm), vBMD, and bone volume to total volume were computed, and compressive strength and stiffness experimentally measured. The microCT images were reconstructed at 1-mm voxel size to simulate axial and sagittal clinical CT images. Five expert clinicians blindly classified the images according to bone lesion quality (osteolytic, osteoblastic, mixed, or healthy). Fleiss’ kappa test was used to test agreement among 5 clinical raters for classifying bone lesion quality. Kruskal-Wallis ANOVA was used to test the difference in vertebral strength and stiffness based on bone lesion quality. Multivariable regression analysis was used to test the independent contribution of bone lesion quality, computed vBMD, age, gender, and race for predicting vertebral strength and stiffness. RESULTS A low interrater agreement was found for bone lesion quality (κ = 0.19). Although the osteoblastic vertebrae showed significantly higher strength than osteolytic vertebrae (p = 0.0148), the multivariable analysis showed that bone lesion quality explained 19% of the variability in vertebral strength and 13% in vertebral stiffness. The computed vBMD explained 75% of vertebral strength (p < 0.0001) and 48% of stiffness (p < 0.0001) variability. The type of BM affected vBMD-based estimates of vertebral strength, explaining 75% of strength variability in osteoblastic vertebrae (R2 = 0.75, p < 0.0001) but only 41% in vertebrae with mixed bone metastasis (R2 = 0.41, p = 0.0168), and 39% in osteolytic vertebrae (R2 = 0.39, p = 0.0381). For vertebral stiffness, vBMD was only associated with that of osteoblastic vertebrae (R2 = 0.44, p = 0.0024). Age and race inconsistently affected the model’s strength and stiffness predictions. CONCLUSIONS Pathologic vertebral fracture occurs when the metastatic lesion degrades vertebral strength, rendering it unable to carry daily loads. This study demonstrated the limitation of qualitative clinical classification of bone lesion quality for predicting pathologic vertebral strength and stiffness. Computed CT-derived vBMD more reliably estimated vertebral strength and stiffness. Replacing the qualitative clinical classification with computed vBMD estimates may improve the prediction of vertebral fracture risk.

Supplementary Data from Organoid Sensitivity Correlates with Therapeutic Response in Patients with Pancreatic Cancer

Purpose:Pancreatic ductal adenocarcinoma (PDAC) remains a significant health issue. For most patients, there are no options for targeted therapy, and existing treatments are limited by toxicity. The HOPE trial (Harnessing Organoids for PErsonalized Therapy) was a pilot feasibility trial aiming to prospectively generate patient-derived organoids (PDO) from patients with PDAC and test their drug sensitivity and correlation with clinical outcomes.Experimental Design:PDOs were established from a heterogeneous population of patients with PDAC including both basal and classical PDAC subtypes.Results:A method for classifying PDOs as sensitive or resistant to chemotherapy regimens was developed to predict the clinical outcome of patients. Drug sensitivity testing on PDOs correlated with clinical responses to treatment in individual patients.Conclusions:These data support the investigation of PDOs to guide treatment in prospective interventional trials in PDAC.

Purpose: Pancreatic ductal adenocarcinoma (PDAC) remains a significant health issue. For most patients, there are no options for targeted therapy, and existing treatments are limited by toxicity. The HOPE trial (Harnessing Organoids for PErsonalized Therapy) was a pilot feasibility trial aiming to prospectively generate patient-derived organoids (PDO) from patients with PDAC and test their drug sensitivity and correlation with clinical outcomes. Experimental Design: PDOs were established from a heterogeneous population of patients with PDAC including both basal and classical PDAC subtypes. Results: A method for classifying PDOs as sensitive or resistant to chemotherapy regimens was developed to predict the clinical outcome of patients. Drug sensitivity testing on PDOs correlated with clinical responses to treatment in individual patients. Conclusions: These data support the investigation of PDOs to guide treatment in prospective interventional trials in PDAC.

STUDY OBJECTIVES: Although subjective-objective sleep discrepancy has long been observed in patients with insomnia, the profiles of this discrepancy are poorly understood. Further, sleep discrepancy in insomnia with sleep comorbidities remains underexplored. We sought to better characterize sleep discrepancy among patient groups with and without insomnia and comorbid conditions such as obstructive sleep apnea (OSA). METHODS: Using data from the Sleep Heart Health Study, we conducted a secondary analysis describing (1) the profile of self-reported and objective sleep measures in patients with insomnia (IS group; n = 73) and comorbid OSA (IS + OSA group; n = 143), compared with individuals with OSA only (OSA group; n = 296) and normal sleep control patients (NSC group; n = 126); (2) the comparative magnitude of sleep misperception between these 4 groups; and (3) the self-reported quality of life (QOL) in the 4 groups. RESULTS: Subjective-objective sleep discrepancy existed in all 4 groups, including the NSC group. Controlling for age, sex, mental health conditions, sleep apnea severity, and objectively measured sleep time, the presence of self-reported insomnia had the strongest association with sleep discrepancy. In patients with insomnia, sleep onset latency was overestimated (7.8 ± 36.8 min in the IS group; P < .001 when compared to the NSC and OSA groups), with the largest differences seen in the comorbid IS + OSA group (15.0 ± 56.8 min). Insomnia conferred the most negative impact on QOL, with the combined IS + OSA group reporting the lowest QOL. CONCLUSIONS: Self-reported insomnia is associated with sleep discrepancy and negative QOL. Those with comorbid OSA reported the greatest sleep discrepancy and the lowest QOL. Future research is warranted to further understand individual profiles of misperception and insomnia phenotypes. CITATION: Ma Y, Goldstein MR, Davis RB, Yeh GY. Profile of subjective-objective sleep discrepancy in patients with insomnia and sleep apnea. J Clin Sleep Med. 2021;17(11):2155–2163.

Background: Diabetic foot osteomyelitis is a common infection where treatment involves multiple services, including infectious diseases, podiatry, and pathology. Despite its ubiquity in the hospital, consensus on much of its management is lacking. Methods: Representatives from infectious diseases, podiatry, and pathology interested in quality improvement developed multidisciplinary institutional recommendations culminating in an educational intervention describing optimal diagnostic and therapeutic approaches to diabetic foot osteomyelitis (DFO). Knowledge acquisition was assessed by preintervention and postintervention surveys. Inpatients with forefoot DFO were retrospectively reviewed before and after intervention to assess frequency of recommended diagnostic and therapeutic maneuvers, including appropriate definition of surgical bone margins, definitive histopathology reports, and unnecessary intravenous antibiotics or prolonged antibiotic courses. Results: A postintervention survey revealed significant improvements in knowledge of antibiotic treatment duration and the role of oral antibiotics in managing DFO. There were 104 consecutive patients in the preintervention cohort (April 1, 2018, to April 1, 2019) and 32 patients in the postintervention cohort (November 5, 2019, to March 1, 2020), the latter truncated by changes in hospital practice during the coronavirus disease 2019 pandemic. Noncategorizable or equivocal disease reports decreased from before intervention to after intervention (27.0% versus 3.3%, respectively; P = .006). We observed nonsignificant improvement in correct bone margin definition (74.0% versus 87.5%; P = .11), unnecessary peripherally inserted central catheter line placement (18.3% versus 9.4%; P = .23), and unnecessary prolonged antibiotics (21.9% versus 5.0%; P = .10). In addition, by working as an interdisciplinary group, many solvable misunderstandings were identified, and processes were adjusted to improve the quality of care provided to these patients. Conclusions: This quality improvement initiative regarding management of DFO led to improved provider knowledge and collaborative competency between these three departments, improvements in definitive pathology reports, and nonsignificant improvement in several other clinical endpoints. Creating collaborative competency may be an effective local strategy to improve knowledge of diabetic foot infection and may generalize to other common multidisciplinary conditions.

Objective The evaluation of the effect of a mammography decision aid (DA) designed for older women at risk for lower health literacy (LHL) on their knowledge of mammography’s benefits and harms and decisional conflict. Methods Using a pretest-posttest design, women > 75 years at risk for LHL reviewing a mammography DA before and after their [B] primary care provider visit. Women were recruited from an academic medical center and community health centers and clinics. Results Of 147 eligible women approached, 43 participated. Receipt of the DA significantly affected knowledge of mammography’s benefits and harms [B] (pre-test (M = 3.75, SD = 1.05) to post-test (M = 4.42, SD = 1.19), p = .03). Receipt of the DA did not significantly affect decisional conflict (pre-test (M = 3.10, SD = .97) to post-test (M = 3.23, SD = 1.02), p = .71, higher scores = lower decisional conflict). The majority of the women (97%) indicated that the DA was helpful. Conclusions Women found a mammography screening DA helpful and its use was associated with these women having increased knowledge of mammography’s benefits and harms. Practice Implications With the shift toward shared decision-making for women > 75 years, there is a need to engage women of all literacy levels to participate in these decisions and have tools such as the one tested in this study.

Prior to the COVID-19 pandemic there were many barriers to telemedicine primary care for adults ≥65 years including insurance coverage restrictions and having lower digital access and literacy. With the pandemic, insurance coverage broadened and many older adults utilized telemedicine creating an opportunity to learn from their experiences to inform future policy.Between April 2020 and June 2021, we conducted a cross-sectional multimethod study of English-speaking, cognitively-intact, adults ≥65, who had a phone-only and/or video telemedicine visit with their primary care physician within one large Massachusetts health system (10 different practices) since March 2020. The study questionnaire asked participants their overall satisfaction with telemedicine (7-point scale) and to compare telemedicine with in-person care. We used linear regression to examine the association between participants' demographics, Charlson comorbidity score, and survey completion date with their satisfaction score. The questionnaire also included open-ended questions on perceptions of telemedicine; which were analyzed using qualitative methods.Of 278 eligible patients reached, 208 completed the questionnaire; mean age was 74.4 years (±4.4), 61.5% were female, 91.4% were non-Hispanic White, 64.4% had ≥1 comorbidity, and 47.2% had a phone-only visit. Regardless of their age, participants reported being satisfied with telemedicine; median score was 6.0 on the 7-point scale (25th percentile = 5.0 and 75th percentile = 7.0). Non-Whites satisfaction scores were on average 1 point lower than those of non-Hispanic Whites (p = 0.02). Those with comorbidity reported scores that on average were 0.5 points lower than those without comorbidity (p = 0.07). Overall, 39.5% felt their telemedicine visit was worse than in-person care; 4.9% thought it was better. Participants appreciated telemedicine's convenience but described frustrating technical challenges. While participants preferred in-person care, most wanted telemedicine to remain available.Adults ≥65 reported being satisfied with primary care telemedicine during the pandemic's first 14 months and wanted telemedicine to remain available.

Objectives Lupus anticoagulant (LA) detection requires (1) prolongation of a phospholipid (PL)–dependent clot-based screening assay, (2) noncorrection upon adding normal pooled plasma, and (3) a confirmatory PL dependency test. Paired LA assays run screening and confirmatory tests simultaneously, with their test ratio (TR) or differences used to evaluate test results. We evaluated patients whose paired testing demonstrated PL dependence suggestive of LA, yet the low PL screen was not prolonged. Methods Clinical and laboratory parameters are compared across (1) true positive (screen prolonged, TR positive) vs borderline (screen not prolonged, TR positive); (2) low-, moderate-, and high-TR subgroups; and (3) dilute Russell viper venom time (dRVVT) vs silica clotting time (SCT). Results Borderline samples are not statistically different from true positives in their rate of repeat LA positivity or association with other anti-PL antibodies. Compared with true positives, borderline dRVVT is more frequent in pregnancy, women, and younger age. Elevated activated partial thromboplastin time is more frequent in true-positive dRVVT and SCT vs borderline and with an increasing dRVVT TR. LA persistence is more frequent with an increasing SCT TR. In addition, dRVVT true positivity is more frequent with thromboembolic events, while SCT is more frequent with autoimmunity and pregnancy complications. Conclusions Negative low-PL screens may not necessarily lack LA. A reevaluation of the laboratory criteria for LA detection may be needed.

Mind–body modalities are promising strategies to maintain the benefits gained after completion of conventional pulmonary rehabilitation in persons with COPD. In this pilot randomised controlled study we examined Tai Chi in persons with COPD after completing pulmonary rehabilitation. Participants were randomised 2:2:1 to Tai Chi (TC), usual care (UC) or group walking (GW) for 24 weeks. We assessed feasibility; primary outcome was exercise capacity measured by 6-min walk test (6MWT) distance at 24 weeks. Secondary outcomes included health-related quality of life measured by Chronic Respiratory Questionnaire (CRQ), dyspnoea, mood, stress, social support, self-efficacy, physical activity and exercise engagement. Effect size estimates and estimates from generalised estimating equations were calculated. Ninety-one persons (36 TC, 37 UC, 18 GW) were enrolled, with mean age 69±6 years, 59% male, and forced expiratory volume in 1 s % predicted (FEV1 % pred) 48±19%. There was no difference in adherence and adverse events between groups. There was a small between-group effect size (ES=0.25) in change in 6MWT distance favouring TC compared to UC; 24-week comparison was nonsignificant (p=0.10). There were no differences in secondary outcomes. In exploratory analyses, there was a greater percentage of participants in TC who improved 6MWT distance at 24 weeks, compared to UC, 64% versus 39%, p=0.05. There were higher percentages of participants in TC who improved CRQ Fatigue (59% versus 31%, p=0.02) and CRQ Mastery (47% versus 20%, p=0.01) domain scores, compared to UC. For GW, there were no differences compared with TC. Tai Chi may be a feasible option to maintain the benefits gained after completing conventional pulmonary rehabilitation., Tai Chi, a mind–body modality, may be a feasible option to maintain the benefits gained in exercise capacity and health-related quality of life after completion of outpatient conventional pulmonary rehabilitation https://bit.ly/32YI7Zp

Background In patients with spinal metastases, kinematic instability is postulated to be a predictor of pathologic vertebral fractures. However, the relationship between this kinematic instability and the loss of spinal strength remains unknown. Methods Twenty-four 3-level thoracic and lumbar segments from 8 cadaver spines from female donors aged 47 to 69 years were kinematically assessed in axial compression (180 N) and axial compression with a flexion or extension moment (7.5 Nm). Two patterns of lytic defects were mechanically simulated: (1) a vertebral body defect, corresponding to Taneichi model C (n = 13); and (2) the model-C defect plus destruction of the ipsilateral pedicle and facet joint, corresponding to Taneichi model E (n = 11). The kinematic response was retested, and compression strength was measured. Two-way repeated-measures analysis of variance was used to test the effect of each model on the kinematic response of the segment. Multivariable linear regression was used to test the association between the kinematic parameters and compressive strength of the segment. Results Under a flexion moment, and for both models C and E, the lesioned spines exhibited greater flexion range of motion (ROM) and axial translation than the control spines. Both models C and E caused lower extension ROM and greater axial, sagittal, and transverse translation under an extension moment compared with the control spines. Two-way repeated-measures analysis revealed that model E, compared with model C, caused significantly greater changes in extension and torsional ROM under an extension moment, and greater sagittal translation under a flexion moment. For both models C and E, greater differences in flexion ROM and sagittal translation under a flexion moment, and greater differences in extension ROM and in axial and transverse translation under an extension moment, were associated with lower compressive strength of the lesioned spines. Conclusions Critical spinal lytic defects result in kinematic abnormalities and lower the compressive strength of the spine. Clinical relevance This experimental study demonstrates that lytic foci degrade the kinematic stability and compressive strength of the spine. Understanding the mechanisms for this degradation will help to guide treatment decisions that address inferred instability and fracture risk in patients with metastatic spinal disease.

Aims Tai chi exercise has been shown in a prior randomized controlled trial to improve depression symptoms and quality of life (QoL) in patients with heart failure (HF), but correlates of these improvements are not well known. The purpose of this secondary analysis was to explore whether tai chi is associated with improvements in biopsychosocial and behavioural measures and whether such improvements are correlated with improved depression and QoL. Methods and results Participants were n = 100 adults with chronic systolic HF (mean age = 67.4, SD = 12.0; 64% male; 96% White; New York Heart Association class = 1–3) randomized to a 12 week tai chi exercise intervention or health education control. Constructs of interest included social support, exercise self‐efficacy, activity engagement, sense of coherence, and inflammatory biomarkers. Tai chi was associated with increased everyday activity engagement compared with the health education group (P

The National Accreditation Program for Breast Centers (NAPBCs) is dedicated to improving the quality of care in patients with breast disease. Geographic distribution of health care resources is an important measure of quality, yet little is known regarding breast center allocation patterns concerning population demand and impact on health outcomes. The purpose of this study was to analyze the distribution of NAPBC programs in the United States (USA) and evaluate the impact on breast cancer survival. Using the Centers for Disease Control and Prevention 2014 data base, we identified the incidence and mortality rates for breast cancer by state. We also determined the concentration of NAPBC programs in each state (ie, the number of centers per 1000 cases of breast cancer). Data were analyzed using Spearman's (nonparametric) rank correlation coefficients. Five hundred and seventy NAPBC programs were identified. Across the United States, there was a mean of 2.8 programs/1000 breast cancer diagnoses. A positive correlation (r = .45) between breast cancer incidence and the number of programs was identified (P = .0009). There was no statistically significant correlation between mortality and NAPBC program concentration (r = -0.20, P = .16). NAPBC-accredited program distribution within the United States correlates with breast cancer incidence per state. However, the number of NAPBC programs per state did not alter overall mortality rates. Added measures beyond survival, as well as further insight into referral patterns to NAPBC programs, may be required to demonstrate the value and impact of NAPBC accreditation.

Guidelines recommend individualized breast cancer screening and prevention interventions for women in their 40s. Yet, few primary care clinicians assess breast cancer risk.Pretest-Posttest trial.Women aged 40-49 years were recruited from one large Boston-based academic primary care practice between July 2017 and April 2019.Participants completed a pretest, received a personalized breast cancer risk report, saw their primary care clinician, and completed a posttest.Using mixed effects models, changes in screening intentions (0-100 scale [0=will not screen to 100=will screen]), mammography knowledge, decisional conflict, and receipt of screening were examined. Analyses were conducted from June 2019 to February 2020.Patient (n=337) mean age was 44.1 (SD=2.9) years, 61.4% were non-Hispanic white, and 76.6% were college graduates; 306 (90.5%) completed follow-up (203 with 5-year breast cancer risk1.1%). Screening intentions declined from pre- to post-visit (79.3 to 68.0, p0.0001), especially for women with 5-year risk1.1% (77.2 to 63.3, p0.0001), but still favored screening. In the 2 years prior, 37.6% had screening mammography compared with 41.8% over a mean 16 months follow-up (p=0.17). Mammography knowledge increased and decisional conflict declined. Eleven (3.3%) women met criteria for breast cancer prevention medications (ten discussed medications with their clinicians), 22 (6.5%) for MRI (19 discussed MRI with their clinician), and 67 (19.8%) for genetic counseling (47 discussed with the clinician).Receipt of a personalized breast cancer report was associated with women in their 40s making more-informed and less-conflicted mammography screening decisions and with high-risk women discussing breast cancer prevention interventions with clinicians.This study is registered at www.clinicaltrials.govNCT03180086.

Purpose: Because financial conflicts of interest (FCOIs) may potentially influence patient care, hospital drug formularies, and treatment guidelines, it is important that these are disclosed. The purpose of this observational study was to quantify the changes in FCOI among U.S.-based academic authors in industry-sponsored oncology trials after a high-impact publication. Methods: A list of all U.S.-based academic authors (authors) of industry-sponsored solid tumor clinical trials published between August 1, 2014, and December 31, 2015, in 6 high-impact journals (New England Journal of Medicine, Nature, Science, Lancet Oncology, Journal of Clinical Oncology, and Cancer Discovery) was assembled. Studies were limited to solid tumor oncology trials. After all authors were identified, direct and research funding was tabulated from CMS Open Payments for the year prior (Ypre) and the first 3 years following publication (Y1, Y2, Y3) in the high-impact journal. Summary statistics were tabulated and repeated-measures linear mixed-effects regression models were fit to examine changes after publication. Results: A total of 102 publications with a total of 620 authors were identified. No FCOI was declared by 11, 12, 21, and 24 authors in Ypre, Y1, Y2, and Y3, respectively. In Ypre, Y1, Y2, and Y3: median FCOI for direct payments was $16,702 (range: $0–$3,180,356), $20,830 (range: $0–$3,180,356), $22,031 (range: $0–$920,746), and $21,356 (range: $0–$920,707), respectively; while median research funding was $559,202 (range: $0–$19,973,818), $505,031 (range $0–$19,920,452), $502,726 (range: $0–$15,729,776), and $497,342 (range: $0–$43,036,716), respectively. There were nonsignificant increases in total direct payments and total direct payments received from the sponsor (P > 0.0125 for both) and statistically significant decreases in total associated research funding and total research funding from the research sponsor in Y1, Y2, and Y3 as compared to Ypre (P < 0.0001 for both). Conclusions: After publication of an industry-sponsored solid tumor clinical trial in a high-impact journal, authors had statistically significant decreases in research funding FCOI in the first 3 years postpublication compared to the year prior.

“Moral distress” describes the psychological strain a provider faces when unable to uphold professional values because of external constraints. Recurrent or intense moral distress risks moral injury, burnout, and physician attrition but has not been systematically studied among neurosurgeons. OBJECTIVE: To develop a unique instrument to test moral distress among neurosurgeons, evaluate the frequency and intensity of scenarios that may elicit moral distress and injury, and determine their impact on neurosurgical burnout and turnover. METHODS: An online survey investigating moral distress, burnout, and practice patterns was emailed to attending neurosurgeon members of the Congress of Neurological Surgeons. Moral distress was evaluated through a novel survey designed for neurosurgical practice. RESULTS: A total of 173 neurosurgeons completed the survey. Half of neurosurgeons (47.7%) reported significant moral distress within the past year. The most common cause was managing critical patients lacking a clear treatment plan; the most intense distress was pressure from patient families to perform futile surgery. Multivariable analysis identified burnout and performing ≥2 futile surgeries per year as predictors of distress (P < .001). Moral distress led 9.8% of neurosurgeons to leave a position and 26.6% to contemplate leaving. The novel moral distress survey demonstrated excellent internal consistency (Cronbach alpha = 0.89). CONCLUSION: We developed a reliable survey assessing neurosurgical moral distress. Nearly, half of neurosurgeons suffered moral distress within the past year, most intensely from external pressure to perform futile surgery. Moral distress correlated with burnout risk caused 10% of neurosurgeons to leave a position and a quarter to consider leaving.

BACKGROUND To help inform screening decisions, a mammography screening decision aid (DA) for women aged 75 years and older was tested in a cluster randomized clinical trial of 546 women. DA use increased women's knowledge of the benefits and harms of mammography and lowered screening rates. In the current study, the objective was to examine whether participants' views of the DA and/or its effects differed by educational attainment. METHODS A secondary analysis was conducted of 283 women who received the DA before a personal care provider (PCP) visit during the trial to examine the acceptability of the DA and its effects on knowledge of the benefits and harms of mammography, screening intentions, and receipt of screening by educational attainment. Adjusted analyses accounted for clustering by PCP. RESULTS Of the 283 participants, 43% had a college education or less. Regardless of educational attainment, 87.2% found the DA helpful. Women with lower educational attainment were less likely to understand all of the DA's content (46.3% vs 67.5%; P

Objective The effects of shared clinical notes on patients, care partners, and clinicians (“open notes”) were first studied as a demonstration project in 2010. Since then, multiple studies have shown clinicians agree shared progress notes are beneficial to patients, and patients and care partners report benefits from reading notes. To determine if implementing open notes at a hematology/oncology practice changed providers’ documentation style, we assessed the length and readability of clinicians’ notes before and after open notes implementation at an academic medical center in Boston, MA, USA. Materials and Methods We analyzed 143 888 notes from 60 hematology/oncology clinicians before and after the open notes debut at Beth Israel Deaconess Medical Center, from January 1, 2012 to September 1, 2016. We measured the providers’ (medical doctor/nurse practitioner) documentation styles by analyzing character length, the number of addenda, note entry mode (dictated vs typed), and note readability. Measurements used 5 different readability formulas and were assessed on notes written before and after the introduction of open notes on November 25, 2013. Results After the introduction of open notes, the mean length of progress notes increased from 6174 characters to 6648 characters (P Conclusions After the implementation of open notes, progress notes and A&P sections became both longer and easier to read. This suggests clinician documenters may be responding to the perceived pressures of a transparent medical records environment.

BACKGROUND: Axillary lymph node dissection (ALND) with or without postmastectomy radiation therapy (PMRT) was traditionally the standard of care for patients with a positive sentinel node following mastectomy. However, recent clinical trial data has led to an interest in de-escalating therapy and a debate over optimal axillary management. We sought to assess current practice patterns and the impact of different approaches to managing positive sentinel nodes following mastectomy. METHODS: Using the National Cancer Database (NCDB), patients with clinical T1-2 N0 M0 breast cancer from 2012-2015 treated with a mastectomy who were found to have a single positive sentinel node were analyzed. A logistic regression model stratified by patients’ characteristics in association to the type of axillary treatment received was performed.RESULTS: We identified 12,137 women with a positive sentinel lymph node biopsy (SLNB) at the time of mastectomy. Of these, 4,221 had an ALND; 1,609 received PMRT; 1,565 underwent combination therapy, and 4,742 had no further treatment following SLNB (NFT). Factors associated with an increased likelihood of further axillary treatment included younger age (CONCLUSION: Our study indicates significant practice variation in the axillary management of patients with metastasis limited to a single sentinel node undergoing mastectomy. The clinical variation observed raises the possibility of unnecessary or overtreatment of the axilla. These findings suggest a need to expand the adoption of evidenced-based clinical protocols to improve quality of care.

PURPOSE OpenNotes is a national movement established in 2010 that gives patients access to their visit notes through online patient portals, and its goal is to improve transparency and communication. To determine whether granting patients access to their medical notes will have a measurable effect on provider behavior, we developed novel methods to quantify changes in the length and frequency of use of n-grams (sets of words used in exact sequence) in the notes. METHODS We analyzed 102,135 notes of 36 hematology/oncology clinicians before and after the OpenNotes debut at Beth Israel Deaconess Medical Center. We applied methods to quantify changes in the length and frequency of use of sequential co-occurrence of words ( n-grams) in the unstructured content of the notes by unsupervised hierarchical clustering and proportional analysis of n-grams. RESULTS The number of significant n-grams averaged over all providers did not change, but for individual providers, there were significant changes. That is, all significant observed changes were provider specific. We identified eight providers who were late note signers. This group significantly reduced its late signing behavior after OpenNotes implementation. CONCLUSION Although the number of significant n-grams averaged over all providers did not change, our text-mining method detected major content changes in specific providers’ documentation at the n-gram level. The method successfully identified a group of providers who decreased their late note signing behavior.

Background: The diagnostic framework and clinical reasoning process of Chinese medicine are central to the practice of acupuncture and other related disciplines. There is growing interest in integrating it into clinical trials of acupuncture and Chinese herbal medicine to guide individualized treatment protocols and evaluate outcomes. Strategies that enhance diagnostic reliability may contribute to this integration. Objectives: (1) To evaluate inter-rater reliability among practitioners of Traditional Chinese Medicine (TCM) when assessing women with dysmenorrhea using a structured assessment questionnaire (Traditional East Asian Medicine Structure Interview [TEAMSI]-TCM) compared to using a TCM questionnaire from routine clinical practice, not developed for research purposes (CONTROL); and (2) To evaluate the impact of training in the use of each approach on reliability. Design: Thirty-eight acupuncturists were asked to complete assessments of 10 subjects based on the viewing of a videotape of the initial assessment interview, a picture of the tongue, and a description of the pulse. Acupuncturists were randomized into one of four groups comparing the use of two questionnaires, TEAMSI-TCM versus CONTROL, and comparing training in the use of each versus no training. Analysis: The authors used Cohen's kappa to estimate agreement on TCM diagnostic categories relevant to dysmenorrhea between 2 practitioners with respect to questionnaires and training over all 10 patients and all 10 TCM diagnostic categories. For all analyses, the authors estimated kappa values for questionnaire, training, and experience level. Analysis of variance was used to test agreement among various groupings. Results: Regardless of the questionnaire used or training, analysis of inter-rater reliability indicated overall agreement to be low among practitioners (median 0.26). Kappa varied slightly by questionnaire and training, among 38 practitioners, but the difference was not statistically significant (p = 0.227 and p = 0.126, respectively). Conclusions: A structured assessment interview instrument designed for research purposes with or without training did not significantly improve reliability of TCM diagnosis of dysmenorrhea compared to a commonly used instrument. Challenges in assessing reliability in TCM remain.

Nonlinear complexity measures computed from beat-to-beat arterial BP dynamics have shown associations with standard cardiac surgical risk indices. They reflect the physiological adaptability of a system and has been proposed as dynamical biomarkers of overall health status. We sought to determine the impact of anesthetic induction and cardiopulmonary bypass (CPB) upon the complexity measures computed from perioperative BP time series. In this prospective, observational study, 300 adult patients undergoing cardiac surgery were included. Perioperative period was divided as: (1) Preoperative (PreOp); (2) ORIS—induction to sternotomy; (3) ORSB- sternotomy to CPB; (4) ORposB—post CPB and within 30 min before leaving OR and (5) postoperative phase (PostOp)—initial 30 min in the cardiac surgical intensive care unit. BP waveforms for systolic (SAP), diastolic (DAP), mean arterial pressure (MAP) and pulse pressure (PP) were recorded, and their corresponding complexity index (MSE∑) was calculated. Significant decrease in MSE∑ from Preop to PostOp phases was observed for all BP time series. Maximum fall was seen during post anesthetic induction (ORIS) phase. Mild recovery during the subsequent phases was observed but they never reached the baseline values. In an exploratory analysis, preoperative MSE∑ showed a significant correlation with postoperative length of ICU stay. Blood pressure complexity varies at different time points and is not fixed for a given individual. Preoperative BP Complexity decreased significantly following anesthetic induction and did not recover to baseline until 30 min after surgery. Prevention of this significant fall may offer restoration of MSE∑ throughout surgery. Furthermore, preoperative BP complexity needs to be explored as a predictor of major postoperative adverse events by itself or in addition with the current risk indices.

In the current opioid epidemic, identifying high-risk patients among those with substance and opioid use may prevent deaths. The objective of this study was to determine whether frequent emergency department (ED) use and degree of frequent use are associated with mortality among ED patients with substance and opioid use.This cohort study used linked population-based ED (National Ambulatory Care Reporting System) and mortality data from Alberta. All adults ≥ 18 years with substance or opioid use-related visits based on diagnostic codes from April 1, 2012, to March 31, 2013, were included (n = 16,389). Frequent use was defined by ≥ 5 visits in the previous year. Outcomes were unadjusted and adjusted (for age, sex, income) mortality within 90 days (primary), and 30 days, 365 days, and 2 years (secondary). To examine degree, frequent use was subcategorized into 5-10, 11-15, 16-20, andgt; 20 visits.Frequent users were older, lower income, and made lower acuity visits than non-frequent users. Frequent users with substance use had higher mortality at 365 days (hazard ratio [HR] 1.36 [1.04, 1.77]) and 2 years (HR 1.32 [1.04, 1.67]), but not at 90 or 30 days. Mortality did not differ for frequent users with opioid use overall. By degree, patients with substance use andgt; 20 visits/year and with opioid use and 16-20 visits/year demonstrated a higher 365-day and 2-year mortality.Among patients with substance use, frequent ED use and extremely frequent use (gt; 20 visits/year) were associated with long-term but not short-term mortality. These findings suggest a role for targeted screening and preventive intervention.Dans le contexte actuel de l’épidémie de surdoses d'opioïdes, la détection des patients à risque élevé parmi ceux qui font usage d'opioïdes ou d'autres substances psychoactives peut avoir, pour effet, la prévention de la mort. L’étude visait donc à déterminer si les consultations fréquentes au service des urgences (SU) et le degré de fréquence étaient associés à la mortalité chez les patients faisant usage d'opioïdes ou d'autres substances psychoactives, traités au SU.Il s'agit d'une étude de cohortes fondée sur la population et reposant sur des bases de données liées en ce qui concerne les consultations au SU (Système national d'information sur les soins ambulatoires) et la mortalité, en Alberta. Ont été inclus dans l’étude tous les adultes ≥ 18 ans ayant consulté pour des troubles liés à l'usage d'opioïdes ou d'autres substances psychoactives, d'après les codes de diagnostic inscrits du 1er avril 2012 au 31 mars 2013 (n = 16 389). On entendait par « visites fréquentes » ≥ 5 consultations (cons.) au cours de l'année précédente. Les résultats recherchés consistaient en la mortalité brute et la mortalité rajustée selon l’âge, le sexe et les revenus au cours des 90 jours suivants (critère d’évaluation principal) ainsi qu'au bout de 30 jours, de 365 jours et de 2 ans (critères d’évaluation secondaires). Quant au degré de fréquence, le nombre de visites a été subdivisé en tranches de 5-10, 11-15, 16-20 et20 consultations.Les usagers fréquents étaient des personnes plus âgées, ayant des revenus plus faibles et consultant pour des troubles moins graves que les usagers non fréquents. Parmi les usagers fréquents, ceux qui utilisaient des substances psychoactives connaissaient une mortalité plus élevée au bout de 365 jours (rapport des risques instantanés [RRI] : 1,36 [1,04–1,77]) et de 2 ans (RRI : 1,32 [1,04–1,67]), mais pas au bout de 90 jours ou de 30 jours. Par contre, il n'y avait pas de différence de mortalité chez les usagers fréquents utilisant des opioïdes, dans l'ensemble. Enfin, la mortalité calculée en fonction du degré de fréquence chez les patients faisant usage de substances psychoactives et comptant20 cons./année ainsi que chez ceux faisant usage d'opioïdes et comptant 16-20 cons./année était plus élevée au bout de 365 jours et de 2 ans.Une fréquence élevée et extrêmement élevée de consultations (20/année) au SU chez les patients faisant usage de substances psychoactives a été associée à la mortalité à long terme mais pas à court terme. Les résultats laissent donc croire à la pertinence d'un dépistage ciblé et d'interventions préventives.

In this pilot feasibility randomized controlled trial, participants with moderate to severe COPD were randomized to a 12-week tai chi or MBB intervention. Participants were assessed at baseline, 12 weeks, and 24 weeks. Feasibility, as assessed by intervention adherence, was the primary outcome. We also estimated preliminary between-group differences in COPD symptoms and health-related quality of life, cognitive-emotional function, and functional status across three timepoints: baseline, 12, and 24 weeks. A total of 92 participants were randomized 2:1 to tai chi (n = 61) or MBB (n = 31). The overall group adherence in the first 12 weeks was 62% in tai chi and 75% in MBB. From baseline to 12 weeks, tai chi demonstrated greater improvements in depressive symptoms (Cohen’s d effect size (ES) = −.53; adj mean diff = −2.31 [−5.7, 1.07]), 6-minute walk test distance (ES = .47; adj mean diff = 62.04 [2.85, 121.22]), social support (ES = .36; adj mean diff = .19 [−0.11, 0.49]) and chair stand (ES = .44; adj mean diff = .91 [−0.05, 1.86]). Only improvements in social support were maintained at 24-week follow-up. Tai chi and MBB are feasible for individuals with COPD. Preliminary effects suggest that while our mindful breathing intervention may not be sufficient to impact outcomes, tai chi may result in short-term benefits in mood, social support and functional capacity. More work is needed to better understand mindful breathing for COPD and to examine methods for maintaining improvements from tai chi over time.

Residents planning careers in primary care have unique training needs that are not addressed in traditional internal medicine training programs, where there is a focus on inpatient training. There are no evidence-based approaches for primary care training. Design and test the effect of a novel immersive primary care training program on educational and clinical outcomes. Nested intervention study. Twelve primary care residents, 86 of their categorical peers, and an 11-year historical cohort of 69 primary care trainees in a large urban internal medicine residency training program. Two 6-month blocks of primary care immersion alternating with two 6-month blocks of standard residency training during the second and third post-graduate years. Total amount of ambulatory and inpatient training time, subjective and objective educational outcomes, clinical performance on cancer screening, and chronic disease management outcomes. Participants in the intervention increased ambulatory training in both general medicine and specialty medicine and still met all ACGME training requirements. Residents reported improved subjective educational outcomes on a variety of chronic disease management topics and ambulatory care skills. They reported higher satisfaction with the amount of ambulatory training (4.3/5 vs. 3.6/5, p=0.008), attended more ambulatory clinics (242 vs. 154, p

Reduced sodium meal plans are recommended by the Centers of Disease Control to lower blood pressure in older adults, however, this strategy has not been tested in a clinical trial. The Satter House Trial of Reduced Sodium Meals (SOTRUE) was an individual-level, double-blind, randomized controlled pilot study of adults living in a congregate living facility subsidized by the Federal Department of Housing and Urban Development (HUD). Adults over age 60 years ate 3 isocaloric meals with two snacks daily for 14 days. The meal plans differed in sodium density (&lt, 0.95 vs. &gt, 2 mg/kcal), but were equivalent in potassium and macronutrients. Seated systolic BP (SBP) was the primary outcome, while urine sodium-creatinine ratio was used to measure compliance. Twenty participants were randomized (95% women, 95% white, mean age 78 ± 8 years), beginning in 7 October 2019. Retention was 100% with the last participant ending November 4, 2019. Mean baseline SBP changed from 121 to 116 mmHg with the typical sodium diet (−5 mmHg, 95%CI: −18, 8) and from 123 to 112 mmHg with the low sodium diet (−11 mmHg, 95%CI: −15.2, −7.7). Compared to the typical sodium meal plan, the low sodium meal plan lowered SBP by 4.8 mmHg (95%CI: −14.4, 4.9, p = 0.31) and urine sodium-creatinine ratio by 36% (−36.0, 95%CI: −60.3, 3.4, p = 0.07), both non-significant. SOTRUE demonstrates the feasibility of sodium reduction in federally mandated meal plans. A longer and larger study is needed to establish the efficacy and safety of low sodium meals in older adults.