Patients Report Infrequent Counseling by Physicians and Inadequate Knowledge about Inflammatory Bowel Disease and Reproductive Health Issues.

OBJECTIVE: Inflammatory bowel disease (IBD) reproductive health counseling is associated with higher knowledge, lower voluntary childlessness, greater medication adherence during pregnancy, and improved outcomes of pregnancy. Our aims were to assess counseling and knowledge about IBD and reproductive health in a tertiary care IBD patient population. STUDY DESIGN: We anonymously surveyed women and men ages 18 to 45 cared for at the Stanford IBD clinic about reproductive health and administered the CCPKnow questionnaire. STATA was used to summarize descriptive statistics and compare categorical variables using Fisher's exact test. RESULTS: Of the 100 patients (54% women) who completed the survey, only 33% reported prior reproductive health counseling. Both men and women considered not having a child due to IBD (31% women, 15% men) and most (83%) had no prior counseling. A minority of patients had an adequate (≥8/17) CCPKnow score (45% women, 17% men). The majority of women with prior pregnancy had pre-existing IBD (67%), yet many did not seek gastrointestinal (GI) care (38% preconception, 25% during pregnancy) and 33% stopped/changed medications, with 40% not discussing this with a physician. Prior counseling was significantly associated with education level (p = 0.013), biologic use (p = 0.003), and an adequate CCPKnow score (p = 0.01). Overall, 67% of people wanted more information on IBD and reproductive health. CONCLUSION: In an educated tertiary care cohort, the majority of patients had low CCPKnow scores and rates of IBD reproductive health counseling. Many patients with IBD prior to pregnancy reported no GI care preconception or during pregnancy and stopped/changed medications without consulting a physician. There is an urgent need for proactive counseling by gastroenterologists and obstetricians on IBD and reproductive health. KEY POINTS: · There is inadequate reproductive health counseling in IBD.. · Many IBD patients do not seek prenatal/perinatal GI care.. · Patients change medications without consultation.. · GIs and OBs should proactively counsel IBD patients..

Association of Reduced Hospitalizations and Mortality Rates Among COVID-19-Vaccinated Patients With Heart Failure.

BACKGROUND: Patients with heart failure (HF) are at high risk for adverse outcomes when they have COVID-19. Reports of COVID-19 vaccine-related cardiac complications may contribute to vaccine hesitancy in patients with HF. METHODS: To analyze the impact of COVID-19 vaccine status on clinical outcomes in patients with HF, we conducted a retrospective cohort study of the association of COVID-19 vaccination status with hospitalizations, intensive care unit admission and mortality after adjustment for covariates. Inverse probability treatment-weighted models were used to adjust for potential confounding. RESULTS: Of 7094 patients with HF, 645 (9.1%) were partially vaccinated, 2200 (31.0%) were fully vaccinated, 1053 were vaccine-boosted (14.8%), and 3196 remained unvaccinated (45.1%) by January 2022. The mean age was 73.3 ± 14.5 years, and 48% were female. Lower mortality rates were observed in patients who were vaccine-boosted, followed by those who were fully vaccinated; they experienced lower mortality rates (HR 0.33; CI 0.23, 0.48) and 0.36 (CI 0.30, 0.43), respectively, compared to unvaccinated individuals (P< 0.001) over the mean follow-up time of 276.5 ± 104.9 days, whereas no difference was observed between those who were unvaccinated or only partially vaccinated. CONCLUSION: COVID-19 vaccination was associated with significant reduction in all-cause hospitalization rates and mortality rates, lending further evidence to support the importance of vaccination implementation in the high-risk population of patients living with HF.

Declining Use of Primary Care Among Commercially Insured Adults in the United States, 2008-2016.

Background: Primary care is known to improve outcomes and lower health care costs, prompting recent U.S. policy efforts to expand its role. Nonetheless, there is early evidence of a decline in per capita primary care visit rates, and little is understood about what is contributing to the decline. Objective: To describe primary care provider (PCP) visit trends among adults enrolled with a large, national, commercial insurer and assess factors underlying a potential decline in PCP visits. Design: Descriptive repeated cross-sectional study using 100% deidentified claims data from the insurer, 2008-2016. A 5% claims sample was used for Poisson regression models to quantify visit trends. Setting: National, population-based. Participants: Adult health plan members aged 18 to 64 years. Measurements: PCP visit rates per 100 member-years. Results: In total, 142 million primary care visits among 94 million member-years were examined. Visits to PCPs declined by 24.2%, from 169.5 to 134.3 visits per 100 member-years, while the proportion of adults with no PCP visits in a given year rose from 38.1% to 46.4%. Rates of visits addressing low-acuity conditions decreased by 47.7% (95% CI, -48.1% to -47.3%). The decline was largest among the youngest adults (-27.6% [CI, -28.2% to -27.1%]), those without chronic conditions (-26.4% [CI, -26.7% to -26.1%]), and those living in the lowest-income areas (-31.4% [CI, -31.8% to -30.9%]). Out-of-pocket cost per problem-based visit rose by $9.4 (31.5%). Visit rates to specialists remained stable (-0.08% [CI, -0.56% to 0.40%]), and visits to alternative venues, such as urgent care clinics, increased by 46.9% (CI, 45.8% to 48.1%). Limitation: Data were limited to a single commercial insurer and did not capture nonbilled clinician-patient interactions. Conclusion: Commercially insured adults have been visiting PCPs less often, and nearly one half had no PCP visits in a given year by 2016. Our results suggest that this decline may be explained by decreased real or perceived visit needs, financial deterrents, and use of alternative sources of care. Primary Funding Source: None.

National Trends in Primary Care Visit Use and Practice Capabilities, 2008-2015.

PURPOSE: Recent evidence shows a national decline in primary care visit rates over the last decade. It is unclear how changes in practice-including the use and content of primary care visits-may have contributed. METHODS: We analyzed nationally representative data of adult visits to primary care physicians (PCPs) and physician practice characteristics from 2007-2016 (National Ambulatory Medical Care Survey). United States census estimates were used to calculate visits per capita. Measures included visit rates per person year; visit duration; number of medications, diagnoses, and preventive services per visit; percentage of visits with scheduled follow-up; and percentage of physicians with practice capabilities including an electronic medical record (EMR). RESULTS: Our weighted sample represented 3.2 billion visits (83,368 visits, unweighted). Visits per capita declined by 20% (-0.25 visits per person, 95% CI, -0.32 to -0.19) during this time, while visit duration increased by 2.4 minutes per visit (95% CI, 1.1-3.8). Per visit, PCPs addressed 0.30 more diagnoses (95% CI, 0.16-0.43) and 0.82 more medications (95% CI, 0.59-1.1), and provided 0.24 more preventive services (95% CI, 0.12-0.36). Visits with scheduled PCP followup declined by 6.0% (95% CI, -12.4 to 0.46), while PCPs reporting use of EMR increased by 44.3% (95% CI, 39.1-49.5) and those reporting use of secure messaging increased by 60.9% (95% CI, 27.5-94.3). CONCLUSION: From 2008 to 2015, primary care visits were longer, addressed more issues per visit, and were less likely to have scheduled follow-up for certain patients and conditions. Meanwhile, more PCPs offered non-face-to-face care. The decline in primary care visit rates may be explained in part by PCPs offering more comprehensive in-person visits and using more non-face-to-face care.

Large Sessile Serrated Polyps Can Be Safely and Effectively Removed by Endoscopic Mucosal Resection.

BACKGROUND & AIMS: As many as 50% of large sessile serrated adenomas/polyps (SSPs) are removed incompletely, which is significant because SSPs have been implicated in the development of interval cancers. It is unclear if endoscopic mucosal resection (EMR) is an optimal method for removal of SSPs. We assessed the efficacy and safety of removal of SSPs 10 mm and larger using a standardized inject-and-cut EMR technique. METHODS: We performed a retrospective analysis of colonoscopy data, collected over 7 years (2007-2013) at 2 centers, from 199 patients with proximal colon SSPs 10 mm and larger (251 polyps) removed by EMR by 4 endoscopists. The primary outcome measure was local recurrence. The secondary outcome measure was safety. RESULTS: At the index colonoscopy, patients had a median of 1 serrated lesion (range, 1-12) and 1 nonserrated neoplastic lesion (range, 0-15). The mean SSP size was 15.9 ± 5.3 mm; most were superficially elevated (84.5%) and located in the ascending colon (51%), and 3 SSPs (1.2%) had dysplasia. Surveillance colonoscopies were performed on 138 patients (69.3%) over a mean follow-up period of 25.5 ± 17.4 months. Of these patients, 5 had local recurrences (3.6%; 95% confidence interval, 0.5%-6.7%), detected after 17.8 ± 15.4 months, with a median size of 4 mm. No patients developed postprocedural bleeding, perforation, or advanced colon cancer, or had a death related to the index colorectal lesion during the study period. CONCLUSIONS: Inject-and-cut EMR is a safe and effective technique for the resection of SSPs. Less than 5% of patients have a local recurrence, which is usually small and can be treated endoscopically.

Clinical Trial Diversity, Equity, and Inclusion: Roadmap of the Cardiothoracic Surgical Trials Network.

BACKGROUND: There is a recognized lack of diversity among patients enrolled in cardiovascular interventional and surgical trials. Diverse patient representation in clinical trials is necessary to enhance generalizability of findings, which may lead to better outcomes across broader populations. The Cardiothoracic Surgical Trials Network (CTSN) recently developed a plan of action to increase diversity among participating investigators and trial participants and is the focus of this review. METHODS: A review of literature and enrollment data from CTSN trials was conducted. RESULTS: CTSN completed more than a dozen major clinical trials (2008-2022), enrolling >4000 patients, of whom 30% were women, 11% were non-White, and 5.6% were Hispanic. CTSN also completed trials of hospitalized patients with coronavirus disease 2019, wherein enrollment was more diverse, with 42% women, and 58% were Asian, Black, Hispanic, or from another underrepresented racial group. The discrepancy in diversity of enrollment between cardiac surgery trials and coronavirus disease trials highlights the need for a more comprehensive understanding of (1) the prevalence of underlying disease requiring cardiac interventions across broad populations, (2) differences in access to care and referral for cardiac surgery, and (3) barriers to enrollment in cardiac surgery trials. CONCLUSIONS: Committed to diversity, CTSN's multifaceted action plan includes developing site-specific enrollment targets, collecting social determinants of health data, understanding reasons for nonparticipation, recruiting sites that serve diverse populations, emphasizing greater diversity among clinical trial teams, and implicit bias training. The CTSN will prospectively assess how these interventions influence enrollment as we work to ensure trial participants are more representative of the communities we serve.

Migration of implanted markers for image-guided lung tumor stereotactic ablative radiotherapy.

The purpose of this study was to quantify postimplantation migration of percutaneously implanted cylindrical gold seeds ("seeds") and platinum endovascular embolization coils ("coils") for tumor tracking in pulmonary stereotactic ablative radiotherapy (SABR). We retrospectively analyzed the migration of markers in 32 consecutive patients with computed tomography scans postimplantation and at simulation. We implanted 147 markers (59 seeds, 88 coils) in or around 34 pulmonary tumors over 32 procedures, with one lesion implanted twice. Marker coordinates were rigidly aligned by minimizing fiducial registration error (FRE), the root mean square of the differences in marker locations for each tumor between scans. To also evaluate whether single markers were responsible for most migration, we aligned with and without the outlier causing the largest FRE increase per tumor. We applied the resultant transformation to all markers. We evaluated migration of individual markers and FRE of each group. Median scan interval was 8 days. Median individual marker migration was 1.28 mm (interquartile range [IQR] 0.78-2.63 mm). Median lesion FRE was 1.56 mm (IQR 0.92-2.95 mm). Outlier identification yielded 1.03 mm median migration (IQR 0.52-2.21 mm) and 1.97 mm median FRE (IQR 1.44-4.32 mm). Outliers caused a mean and median shift in the centroid of 1.22 and 0.80 mm (95th percentile 2.52 mm). Seeds and coils had no statistically significant difference. Univariate analysis suggested no correlation of migration with the number of markers, contact with the chest wall, or time elapsed. Marker migration between implantation and simulation is limited and unlikely to cause geometric miss during tracking.

Trends in Pediatric Primary Care Visits Among Commercially Insured US Children, 2008-2016.

Importance: Primary care is the foundation of pediatric care. While policy interventions have focused on improving access and quality of primary care, trends in overall use of primary care among children have not been described. Objective: To assess trends in primary care visit rates and out-of-pocket costs, to examine variation in these trends by patient and visit characteristics, and to assess shifts to alternative care options (eg, retail clinics, urgent care, and telemedicine). Design, Setting, and Participants: Observational cohort study of claims data from 2008 to 2016 for children 17 years and younger covered by a large national commercial health plan. Visit rate per 100 child-years was determined for each year overall, by child and geographic characteristics, and by visit type (eg, primary diagnosis), and trends were assessed with a series of child-year Poisson models. Data were analyzed from November 2017 to September 2019. Main Outcomes and Measures: Visits to primary care and other settings. Results: This cohort study included more than 71 million pediatric primary care visits over 29 million pediatric child-years (51% male in 2008 and 2016; 37% between 12-17 years in 2008 and 38% between 12-17 years in 2016). Unadjusted results for primary care visit rates per 100 child-years decreased from 259.6 in 2008 to 227.2 in 2016, yielding a regression-estimated change in primary care visits across the 9 years of -14.4% (95% CI, -15.0% to -13.9%; absolute change: -32.4 visits per 100 child-years). After controlling for shifts in demographics, the relative decrease was -12.8% (95% CI, -13.3% to -12.2%). Preventive care visits per 100 child-years increased from 74.9 in 2008 to 83.2 visits in 2016 (9.9% change in visit rate; 95% CI, 9.0%-10.9%; absolute change: 8.3 visits per 100 child-years), while problem-based visits per 100 child-years decreased from 184.7 in 2008 to 144.1 in 2016 (-24.1%; 95% CI, -24.6% to -23.5%; absolute change: -40.6 visits per 100 child-years). Visit rates decreased for all diagnostic groups except for the behavioral and psychiatric category. Out-of-pocket costs for problem-based primary care visits increased by 42% during the same period. Per 100 child-years, visits to other acute care venues increased from 21.3 to 27.6 (30.3%; 95% CI, 28.5% to 32.1%; absolute change: 6.3 visits per 100 child-years) and visits to specialists from 45.2 to 53.5 (16.4%; 95% CI, 14.8% to 18.0%, absolute change: 8.3 visits per 100 child-years). Conclusions and Relevance: Primary care visit rates among commercially insured children decreased over the last decade. Increases in out-of-pocket costs and shifts to other venues appear to explain some of this decrease.

Physical Performance and Risk of Postoperative Delirium in Older Adults Undergoing Aortic Valve Replacement.

BACKGROUND: Delirium is a major risk factor for poor recovery after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). It is unclear whether preoperative physical performance tests improve delirium prediction. OBJECTIVE: To examine whether physical performance tests can predict delirium after SAVR and TAVR, and adapt an existing delirium prediction rule for cardiac surgery, which includes Mini-Mental State Examination (MMSE), depression, prior stroke, and albumin level. DESIGN: Prospective cohort, 2014-2017. SETTING: Single academic center. SUBJECTS: A total of 187 patients undergoing SAVR (n=77) or TAVR (n=110). METHODS: The Short Physical Performance Battery (SPPB) score was calculated based on gait speed, balance, and chair stands (range: 0-12 points, lower scores indicate poor performance). Delirium was assessed using the Confusion Assessment Method. We fitted logistic regression to predict delirium using SPPB components and risk factors of delirium. RESULTS: Delirium occurred in 35.8% (50.7% in SAVR and 25.5% in TAVR). The risk of delirium increased for lower SPPB scores: 10-12 (28.2%), 7-9 (34.5%), 4-6 (37.5%) and 0-3 (44.1%) (p-for-trend=0.001). A model that included gait speed <0.46 meter/second (OR, 2.7; 95% CI, 1.2-6.4), chair stands time ≥11.2 seconds (OR, 3.5; 95% CI, 1.0-12.4), MMSE <24 points (OR, 2.9; 95% CI, 1.3-6.4), isolated SAVR (OR, 5.4; 95% CI, 2.1-13.8), and SAVR and coronary artery bypass grafting (OR, 15.8; 95% CI, 5.5-45.7) predicted delirium better than the existing prediction rule (C statistics: 0.71 vs 0.61; p=0.035). CONCLUSION: Assessing physical performance, in addition to cognitive function, can help identify high-risk patients for delirium after SAVR and TAVR.

Tumor volume-adapted dosing in stereotactic ablative radiotherapy of lung tumors.

PURPOSE: Current stereotactic ablative radiotherapy (SABR) protocols for lung tumors prescribe a uniform dose regimen irrespective of tumor size. We report the outcomes of a lung tumor volume-adapted SABR dosing strategy. METHODS AND MATERIALS: We retrospectively reviewed the outcomes in 111 patients with a total of 138 primary or metastatic lung tumors treated by SABR, including local control, regional control, distant metastasis, overall survival, and treatment toxicity. We also performed subset analysis on 83 patients with 97 tumors treated with a volume-adapted dosing strategy in which small tumors (gross tumor volume <12 mL) received single-fraction regimens with biologically effective doses (BED) <100 Gy (total dose, 18-25 Gy) (Group 1), and larger tumors (gross tumor volume ≥12 mL) received multifraction regimens with BED ≥100 Gy (total dose, 50-60 Gy in three to four fractions) (Group 2). RESULTS: The median follow-up time was 13.5 months. Local control for Groups 1 and 2 was 91.4% and 92.5%, respectively (p = 0.24) at 12 months. For primary lung tumors only (excluding metastases), local control was 92.6% and 91.7%, respectively (p = 0.58). Regional control, freedom from distant metastasis, and overall survival did not differ significantly between Groups 1 and 2. Rates of radiation pneumonitis, chest wall toxicity, and esophagitis were low in both groups, but all Grade 3 toxicities developed in Group 2 (p = 0.02). CONCLUSION: A volume-adapted dosing approach for SABR of lung tumors seems to provide excellent local control for both small- and large-volume tumors and may reduce toxicity.

High retention and safety of percutaneously implanted endovascular embolization coils as fiducial markers for image-guided stereotactic ablative radiotherapy of pulmonary tumors.

PURPOSE: To compare the retention rates of two types of implanted fiducial markers for stereotactic ablative radiotherapy (SABR) of pulmonary tumors, smooth cylindrical gold "seed" markers ("seeds") and platinum endovascular embolization coils ("coils"), and to compare the complication rates associated with the respective implantation procedures. METHODS AND MATERIALS: We retrospectively analyzed the retention of percutaneously implanted markers in 54 consecutive patients between January 2004 and June 2009. A total of 270 markers (129 seeds, 141 coils) were implanted in or around 60 pulmonary tumors over 59 procedures. Markers were implanted using a percutaneous approach under computed tomography (CT) guidance. Postimplantation and follow-up imaging studies were analyzed to score marker retention relative to the number of markers implanted. Markers remaining near the tumor were scored as retained. Markers in a distant location (e.g., pleural space) were scored as lost. CT imaging artifacts near markers were quantified on radiation therapy planning scans. RESULTS: Immediately after implantation, 140 of 141 coils (99.3%) were retained, compared to 110 of 129 seeds (85.3%); the difference was highly significant (p<0.0001). Of the total number of lost markers, 45% were reported lost during implantation, but 55% were lost immediately afterwards. No additional markers were lost on longer-term follow-up. Implanted lesions were peripherally located for both seeds (mean distance, 0.33 cm from pleural surface) and coils (0.34 cm) (p=0.96). Incidences of all pneumothorax (including asymptomatic) and pneumothorax requiring chest tube placement were lower in implantation of coils (23% and 3%, respectively) vs. seeds (54% and 29%, respectively; p=0.02 and 0.01). The degree of CT artifact was similar between marker types. CONCLUSIONS: Retention of CT-guided percutaneously implanted coils is significantly better than that of seed markers. Furthermore, implanting coils is at least as safe as implanting seeds. Using coils should permit implantation of fewer markers and require fewer repeat implantation procedures owing to lost markers.