The Impact of Telemedicine on Human Immunodeficiency Virus (HIV)-Related Clinical Outcomes During the COVID-19 Pandemic.

The coronavirus disease of 2019 (COVID-19) pandemic exacerbated barriers to care for people living with human immunodeficiency virus (HIV) (PLWH). The quick uptake of telemedicine in the outpatient setting provided promise for care continuity. In this study, we compared appointment and laboratory no-show rates in an urban outpatient HIV clinic during three time periods: (1) Pre-COVID-19: 9/15/2019-3/14/2020 (predominately in-person), (2) "Early" COVID-19: 3/15/2020-9/14/2020 (predominately telemedicine), and (3) "Later" COVID-19: 9/15/2020-3/14/2021 (mixed in-person/telemedicine). Multivariable logistic regression models evaluated the two study hypotheses: (i) equivalence of Period 2 with Period 1 and of Period 3 with Period 1 and (ii) improved outcomes with telemedicine over in-person visits. No-show rates were 1% in Period 1, 4% in Period 2, and 18% in Period 3. Compared to the pre-pandemic period, individuals had a higher rate of appointment no-shows during Period 2 [OR (90% CI): 7.67 (2.68, 21.93)] and 3 [OR (90% CI): 30.91 (12.83 to 75.06). During the total study period, those with telemedicine appointments were less likely to no-show than those with in-person appointments [OR (95% CI): 0.36 (0.16-0.80), p = 0.012]. There was no statistical difference between telemedicine and in-person appointments for laboratory completion rates. Our study failed to prove that no-show rates before and during the pandemic were similar; in fact, no-show rates were higher during both the early and later pandemic. Overall, telemedicine was associated with lower no-show rates compared to in-person appointments. In future pandemics, telemedicine may be a valuable component to maintain care in PLWH.

Outreach to primary care patients in lung cancer screening: A randomized controlled trial.

Current guidelines recommend annual lung cancer screening (LCS), but rates are low. The current study evaluated strategies to increase LCS. This study was a randomized controlled trial designed to evaluate the effects of patient outreach and shared decision making (SDM) about LCS among patients in four primary care practices. Patients 50 to 80 years of age and at high risk for lung cancer were randomized to Outreach Contact plus Decision Counseling (OC-DC, n = 314), Outreach Contact alone (OC, n = 314), or usual care (UC, n = 1748). LCS was significantly higher in the combined OC/OC-DC group versus UC controls (5.5% vs. 1.8%; hazard ratio, HR = 3.28; 95% confidence interval, CI: 1.98 to 5.41; p = 0.001). LCS was higher in the OC-DC group than in the OC group, although not significantly so (7% vs. 4%, respectively; HR = 1.75; 95% CI: 0.86 to 3.55; p = 0.123). LCS referral/scheduling was also significantly higher in the OC/OC-DC group compared to controls (11% v. 5%; odds ratio, OR = 2.02; p = 0.001). We observed a similar trend for appointment keeping, but the effect was not statistically significant (86% v. 76%; OR = 1.93; p = 0.351). Outreach contacts significantly increased LCS among primary care patients. Research is needed to assess the additional value of SDM on screening uptake.

Predictors of overall and test-specific colorectal Cancer screening adherence.

This study investigated predictors of overall and test-specific colorectal cancer screening (CRCS). Stool blood test (SBT) and/or colonoscopy screening were offered to primary care patients in two randomized controlled trials which assessed the impact of behavioral interventions on screening. Data were obtained through surveys and electronic medical records. Among 1942 participants, 646 (33%) screened. Exposure to interventions was associated with higher overall CRCS by twofold to threefold; older age, African American race, being married, and having a higher screening decision stage were also associated with higher overall CRCS (odds ratios = 1.30, 1.31, 1.34, and 5.59, respectively). Intervention, older age, female gender, and being married were associated with higher SBT adherence, while preference for colonoscopy was associated with lower SBT adherence. Intervention and higher decision stage were associated with higher colonoscopy adherence, while preference for SBT was associated with lower colonoscopy adherence. Among older individuals, African Americans had higher overall CRCS than whites, but this was not true among younger individuals (interaction p = .041). The higher screening adherence of African Americans over whites was due to stronger screening with a non-preferred test, i.e., higher SBT adherence only among individuals who preferred colonoscopy and higher colonoscopy adherence only among individuals who preferred SBT. Intervention exposure, sociodemographic background, and screening decision stage predicted overall CRCS adherence. Gender and test preference also affected test-specific screening adherence. Interactions involving race and test preference suggest that it is important to provide both colonoscopy and SBT screening options to patients, particularly African Americans.

Patient Characteristics Associated With Quality of Colonoscopy Preparation: A Systematic Review and Meta-analysis.

BACKGROUND & AIMS: Some features of patients are associated with inadequate bowel preparation, which reduces the effectiveness of colonoscopy examination. We performed a systematic review and meta-analysis of the association between patients' sociodemographic characteristics, health conditions, and medications with inadequate bowel preparation. METHODS: We searched the PubMed, Scopus, and Cochrane Review databases for randomized controlled trials cohort (prospective and retrospective), case-control, and cross-sectional studies published through March 2016. We collected information on study design, study population, and bowel preparation. For each factor, we obtained the odds ratio (OR) for inadequate bowel preparation. We conducted the meta-analyses using the random-effects approach and investigated any identified heterogeneity and publication bias via graphical methods, stratification, and meta-regression. RESULTS: We performed a meta-analysis of 67 studies, comprising 75,818 patients. The estimated pooled OR for inadequate bowel preparation was small for sociodemographic characteristics: 1.14 for age, and 1.23 for male sex (excluding studies in Asia, which had substantial heterogeneity and publication bias), and 1.49 for low education. The effect of high body mass index differed significantly in studies with mostly female patients (OR, 1.05) vs those with mostly male patients (OR, 1.30) (P = .013 for the difference). ORs for constipation and cirrhosis were heterogeneous; adjusted ORs were larger than unadjusted ORs (1.97 vs 1.29 for constipation and 3.41 vs 1.36 for cirrhosis). Diabetes (OR, 1.79), hypertension (OR, 1.25), stroke or dementia (OR, 2.09), and opioid use (OR, 1.70) were associated with inadequate bowel preparation. History of abdominal surgery (OR, 0.99) did not associate with inadequate bowel preparation. Use of tricyclic antidepressants had a larger effect on risk of inadequate bowel preparation in studies of mostly female patients (OR, 2.62) than studies of mostly male patients (OR, 1.42) (P = .085 for the difference). CONCLUSIONS: In a systematic review and meta-analysis, we found no single patient-related factor to be solely associated with inadequate bowel preparation. Health conditions and use of some medications appear to be stronger predictors than sociodemographic characteristics.

Intratumoral Infection with Murine Cytomegalovirus Synergizes with PD-L1 Blockade to Clear Melanoma Lesions and Induce Long-term Immunity.

Cytomegalovirus is an attractive cancer vaccine platform because it induces strong, functional CD8(+) T-cell responses that accumulate over time and migrate into most tissues. To explore this, we used murine cytomegalovirus expressing a modified gp100 melanoma antigen. Therapeutic vaccination by the intraperitoneal and intradermal routes induced tumor infiltrating gp100-specific CD8(+) T-cells, but provided minimal benefit for subcutaneous lesions. In contrast, intratumoral infection of established tumor nodules greatly inhibited tumor growth and improved overall survival in a CD8(+) T-cell-dependent manner, even in mice previously infected with murine cytomegalovirus. Although murine cytomegalovirus could infect and kill B16F0s in vitro, infection was restricted to tumor-associated macrophages in vivo. Surprisingly, the presence of a tumor antigen in the virus only slightly increased the efficacy of intratumoral infection and tumor-specific CD8(+) T-cells in the tumor remained dysfunctional. Importantly, combining intratumoral murine cytomegalovirus infection with anti-PD-L1 therapy was synergistic, resulting in tumor clearance from over half of the mice and subsequent protection against tumor challenge. Thus, while a murine cytomegalovirus-based vaccine was poorly effective against established subcutaneous tumors, direct infection of tumor nodules unexpectedly delayed tumor growth and synergized with immune checkpoint blockade to promote tumor clearance and long-term protection.

Association of Adipokines with Insulin Resistance, Microvascular Dysfunction, and Endothelial Dysfunction in Healthy Young Adults.

Proinflammatory adipokines (inflammation markers) from visceral adipose tissue may initiate the development of insulin resistance (IR) and endothelial dysfunction (ED). This study's objective was to investigate the association of five inflammation markers (CRP and four adipokines: IL-6, TNFα, PAI-1, and adiponectin) with IR (quantitative insulin resistance check index (QUICKI)), microvascular measures (capillary density and albumin-to-creatinine ratio (ACR)), and endothelial measures (forearm blood flow (FBF) increases from resting baseline to maximal vasodilation). Analyses were conducted via multiple linear regression. The 295 study participants were between 18 and 45 years of age, without diabetes or hypertension. They included 24% African Americans and 21% Asians with average body mass index of 25.4 kg/m(2). All five inflammation markers were significantly associated with QUICKI. All but adiponectin were significantly associated with capillary density, but none were associated with ACR. Finally, IL-6 and PAI-1 were significantly associated with FBF increase. We also identified a potential interaction between obesity and IL-6 among normal-weight and overweight participants: IL-6 appeared to be positively associated with QUICKI and capillary density (beneficial effect), but the inverse was true among obese individuals. These study findings suggest that inflammation measures may be potential early markers of cardiovascular risk in young asymptomatic individuals.

The potential value of phosphohistone-h3 mitotic index determined by digital image analysis in the assessment of pancreatic endocrine tumors in fine-needle aspiration cytology specimens.

OBJECTIVE: According to the World Health Organization, pancreatic endocrine tumors are graded by assessment of the Ki67 proliferation index and/or mitotic count. The objective was to find comparable grading on the basis of the novel mitotic marker phosphohistone-H3 (PHH3). STUDY DESIGN: A computer-assisted system was used to assess 23 cell blocks stained with PHH3 and Ki67 antibodies. We investigated possible cut-points for PHH3 and computed percent agreement between the PHH3- and Ki67-based grading. RESULTS: The Spearman correlation between percent Ki67 positive and percent PHH3 positive was 0.76 (p = 0.001). A value of 0.3% for the lower cut-point ('cut-point 1', differentiating between grades 1 and 2) and values of about 1.8-1.9% for the higher cut-point ('cut-point 2', differentiating between grades 2 and 3) shows optimal agreement between PHH3 and Ki67 grading. The percentage of positive cells was much higher for Ki67 than for PHH3 (mean 10.6 vs. 3.0%). CONCLUSIONS: PHH3 has good correlation with Ki67, but the range of PHH3 positivity is much narrower than that of Ki67 (range 0-4% for PHH3 vs. 0-50% for Ki67). Therefore, to be as accurate, grading on the basis of PHH3 requires evaluation of a larger number of tumor cells for a precise determination of percent PHH3-positive nuclei.

Stage of change and other predictors of participant retention in a behavioral weight management program in primary care.

High attrition often limits the efficacy of weight management programs, particularly those that serve primary care patients. We investigated stage of change and other predictors of retention in a behavioral intervention program that enrolled adult obese patients at three primary care sites. The program included practice improvements and provider training, as well as individual lifestyle counseling and educational group classes for participants. We analyzed predictors of whether participants returned for counseling visits and whether they attended group classes. The 461 participants were mainly women (84%) and minorities (87%), and most of them were in the preparation stage for dietary and physical activity changes. A total of 134 (29%) participants returned for at least one follow-up visit with their counselor and 85 (18%) attended at least one class. Baseline stage of change was not significantly associated with either return visits or class attendance (p = .875 and .182, respectively). Men and participants with children in the household were less likely to return for subsequent counseling sessions (p = .012 and .027, respectively). Age and employment were associated with class attendance (p = .099 and .034, respectively). Focus groups with participants confirmed that reasons for dropout included physical limitations or health issues, family issues, stress, and lack of social support. We conclude that prescreening of patients for readiness to participate and attention to personal barriers related to family and work might improve program retention. More frequent contacts between visits and stronger provider engagement might also strengthen the intervention.

Identifying potential adverse effects by patients' ratings: a proof-of-concept study of a novel approach.

OBJECTIVE: Methods to evaluate adverse effects of medications are significantly underdeveloped compared to those for efficacy. In this pilot proof-of-concept study, we preliminarily compared a novel approach-the Symptom Assessment Tool (SAT)-to a systematic and detailed assessment by a physician for identifying symptoms that were potentially adverse effects (sensitivity) and excluding symptoms that were unlikely to be adverse effects (specificity). METHODS: A symptom inventory and rating of symptom severity were completed before starting a psychotropic medication (or increasing its dose), and again 2 weeks later. Each symptom was systematically assessed by the patient-rated SAT and by a physician and was classified as either a potential or unlikely adverse effect. The primary analysis compared the classification of symptoms by the SAT to that by the physician. Potential adverse effects were also subcategorized as possible or probable adverse effects. RESULTS: A sample of 193 symptoms from 15 adults was evaluated, only 37.3% of which were considered potential adverse effects by the physician. Sensitivity of the SAT compared to physician's assessment was 90.3% for potential adverse effects and 97.5% for the subgroup of probable adverse effects. The SAT correctly identified 63.6% of the symptoms as unlikely adverse effects (specificity), and its negative predictive value was 91.7%. CONCLUSIONS: The SAT, appropriate for its intended use as a screening tool, had high sensitivity and moderate specificity and could present physicians with a limited number of potential adverse effects for further assessment and intervention. Further evaluation and refinement of this approach is warranted.

Ablation of tumor progression locus 2 promotes a type 2 Th cell response in Ovalbumin-immunized mice.

The protein kinase encoded by the Tpl2 proto-oncogene regulates ERK activation and cytokine gene expression in macrophages in response to LPS and TNF-alpha. In this study we show that OVA-immunized Tpl2(-/-) mice express high levels of IgE and develop more severe bronchoalveolar eosinophilic inflammation than Tpl2(+/+) controls, when challenged with OVA intranasally. Bronchoalveolar exudates and supernatants of OVA-stimulated splenocytes from immunized Tpl2(-/-) mice express elevated levels of IL-4 and IL-5, suggesting that Tpl2 ablation promotes the Th2 polarization of the T cell response. Anti-CD3 stimulation of CD4(+) T cells of wild-type and Tpl2 knockout mice revealed that Tpl2 ablation gives rise to a cell autonomous T cell defect that is primarily responsible for the Th2 polarization of the T cell response to Ag. This observation was further supported by experiments addressing the expression of Th1 and Th2 cytokines in OVA-stimulated mixed cultures of CD4(+) T cells from Tpl2(+/+)/OT2 or Tpl2(-/-)/OT2 mice and dendritic cells from Tpl2(+/+) or Tpl2(-/-) mice. Further studies revealed that Th1 cells express significantly higher levels of Tpl2 than Th2 cells. As a result, Tpl2(-/-) Th1 cells exhibit a stronger defect in ERK activation by anti-CD3 than Th2 cells and express low levels of T-bet. Given that the development of Th1 and Th2 cells depends on positive feedback signals from the T cells, themselves, the functional defect of the Tpl2(-/-) Th1 cells provides a mechanistic explanation for the T cell autonomous Th2 polarization in Tpl2(-/-) mice.

Pharmacologic Ascorbic Acid as Early Therapy for Hospitalized Patients with COVID-19: A Randomized Clinical Trial.

Despite the widespread availability of effective vaccines, new cases of infection with severe acute respiratory syndrome coronavirus-2, the cause of coronavirus disease 2019 (COVID-19), remain a concern in the settings of vaccine hesitancy and vaccine breakthrough. In this randomized, controlled, phase 2 trial, we hypothesized that high-dose ascorbic acid delivered intravenously to achieve pharmacologic concentrations may target the high viral phase of COVID-19 and thus improve early clinical outcomes. Sixty-six patients admitted with COVID-19 and requiring supplemental oxygen were randomized to receive either escalating doses of intravenous ascorbic acid plus standard of care or standard of care alone. The demographic and clinical characteristics were well-balanced between the two study arms. The primary outcome evaluated in this study was clinical improvement at 72 h after randomization. While the primary outcome was not achieved, point estimates for the composite outcome and its individual components of decreased use of supplemental oxygen, decreased use of bronchodilators, and the time to discharge were all favorable for the treatment arm. Possible favorable effects of ascorbic acid were most apparent during the first 72 h of hospitalization, although these effects disappeared over the course of the entire hospitalization. Future larger trials of intravenous ascorbic acid should be based on our current understanding of COVID-19 with a focus on the potential early benefits of ascorbic in hospitalized patients.

A retrospective analysis of the use of caspofungin in recipients of liver transplant with a modified high index of suspicion for fungal infection. A critical review of mortality, acute cellular rejection, infections, and changes in the liver function tests while on caspofungin.

This study is a retrospective analysis of death, adverse events (AE), fungal infections, and hepatic function among recipients of liver transplantation at high risk of fungal infection who received prophylactic treatment with caspofungin. After reviewing data of 105 patients who had received isolated liver transplant between January 2003 and April 2007, we identified and analyzed 82 high-risk patients. Post-transplant patients at high risk for fungal infection are commonly defined by the presence of at least one of the following: (i) re-transplantation; (ii) re-operation; (iii) renal dysfunction. However, in our practice, patients are also considered at high risk for developing fungal infections if they present with the following: (iv) fever of unknown origin; (v) hypothermia; (vi) positive random culture for fungus at the time of transplant (bile and/or ascites); (vii) sepsis; (viii) use of vasopressors; (ix) re-intubation, during the first hospitalization after liver transplant; (x) prolonged intubation (>24 h), and (xi) acute respiratory distress syndrome, until negative fungal cultures are obtained. Exact conditional logistic regression was used to compare the risk of death, AEs, and fungal infections between patients who received caspofungin, other antifungal drugs, and no antifungal drugs. Analyses were then performed with SAS 9.1 (SAS Institute Inc., Cary, NC, USA). Patients were between 27 and 72 yr old (mean = 55), with two-thirds male and three-quarters Caucasian. Sixteen patients received caspofungin (11 preventively), and 32 received other antifungal (26 preventively). There were no proven fungal infections among the patients who received caspofungin, three infections among patients who received other antifungal (3/26 = 12%), and 14 infections among patients who were not preventively treated (14/45 = 31%). These infection rates were significantly different across the three groups (p = 0.029), with caspofungin and other antifungal preventive treatment comparable (p = 0.540), and both better than no preventive treatment at all (OR = 0.15, p = 0.049, for caspofungin versus no preventive treatment; OR = 0.29, p = 0.085, for other antifungal versus no preventive treatment). Caspofungin appears to be an effective preventive agent against fungal infections when used in recipients of liver transplant designated as high risk for fungal infection. Usage of caspofungin in these patients does not carry an apparent increase in risk of death or acute cellular rejection, although we observed a significantly higher risk of AEs, especially acute renal failure (p = 0.001), in patients who received this agent.

Regulation of transforming growth factor-beta1 by insulin in prediabetic African Americans.

Insulin resistance has been associated with kidney disease even in the absence of diabetes; however, pathways linking insulin resistance to kidney disease are unclear. The purpose of this study was to determine if transforming growth factor (TGF)-beta1, a key cytokine associated with kidney disease, responds to circulating levels of glucose and/or insulin. Urinary TGF-beta1 levels were measured in 249 young adult African Americans (mean age 40) at baseline, after an oral glucose tolerance test and after a euglycemic hyperinsulinemic clamp procedure. Baseline urinary geometric mean TGF-beta1 levels were somewhat lower in those with normal compared with the impaired glucose tolerance. The urinary TGF-beta1 level increased by 56% followed by a 23% decrease in the normal glucose tolerance group, changes that were significant and corresponded to the changes in the plasma glucose and insulin concentrations. The impaired tolerance group showed little change in the urinary TGF-beta1 level following glucose ingestion. All participants had a significant increase in urinary TGF-beta1 level after steady-state hyperinsulinemia, with sustained euglycemia during the clamp procedure in both of the groups. At baseline, there was a significant correlation between the urinary TGF-beta1 level and urinary albumin excretion. Thus our results suggest that insulin contributes to increased TGF-beta1 production and possible early renal injury in prediabetic young African Americans.

Efficacy of morning-only compared with split-dose polyethylene glycol electrolyte solution for afternoon colonoscopy: a randomized controlled single-blind study.

OBJECTIVES: Administering a purgative close to the time of colonoscopy is optimal for cleansing. The aim of this study was to compare the efficacy and tolerability of morning-only (AM-only) polyethylene glycol electrolyte solution (PEG-ELS) to split-dose (PM/AM) PEG-ELS for afternoon colonoscopy. METHODS: This was a single-center, prospective, randomized, investigator-blinded, non-inferiority study comparing AM-only to PM/AM PEG-ELS for afternoon outpatient colonoscopy. The primary end point was whole colon prep adequacy. Tolerance and polyp detection were secondary outcomes. RESULTS: Overall, 125 patients were randomized and 9 withdrew without taking any prep. Of 116 analyzed, 62 received AM-only prep and 54 received PM/AM prep. The whole colon prep was adequate in 92% in the AM-only group vs. 94% in the PM/AM group (95% lower confidence limit, LCL, for the difference=-11.3%, non-inferiority P=0.013), whereas the right colon prep was adequate in 93 and 92%, respectively (95% LCL=-7.8%, non-inferiority P=0.003). Polyp detection was greater, and not inferior, in the AM-only group (mean=1.57 vs. 0.94 polyps/patient, non-inferiority P=0.007). The overall incidence of adverse events was not significantly different between the two groups (P=0.273), but the AM-only group had lower incidence of abdominal pain (P=0.024). The AM-only group also had better sleep quality (P=0.007) and less interference with the previous workday (P=0.019). CONCLUSIONS: AM-only and PM/AM PEG-ELS are clinically equivalent with respect to cleansing efficacy and polyp detection. AM-only prep was associated with a lower incidence of abdominal pain, superior sleep quality, and less interference with workday before colonoscopy.

Over-the-counter analgesics in cirrhotic patients: a case-control study examining the risk of hospitalization for liver-associated events.

OBJECTIVE: To assess the association between over-the-counter analgesic (OTCA) use and hospitalization for liver-associated events in cirrhotic patients. MATERIAL AND METHODS: Ninety adult cirrhotics admitted with liver-associated events and 126 non-hospitalized cirrhotic controls were enrolled prospectively into a case-control study. Standardized questionnaires were used to obtain predictor variables, including detailed 30-day OTCA use. Data were analyzed via logistic regression. RESULTS: Hepatitis C (43%), alcohol (34%), and cryptogenic (13%) were the most common etiologies of cirrhosis. OTCA use was similar between cases and controls in the 30 days prior to enrollment (34% vs. 44%; odds ratio, OR = 0.66, 95% confidence interval, CI = 0.37-1.16, p = 0.148). Adjusted analyses also found no significant association between OTCA use and hospitalization for liver-associated events (OR = 0.73, 95% CI = 0.38-1.38, p = 0.330). Furosemide (p = 0.001), lactulose (p = 0.026), and number of prior liver-associated events (p = 0.002) were positively associated with hospitalization, while propranolol showed an inverse association (p = 0.008). CONCLUSION: Our data suggest that non-excessive OTCA use is not significantly associated with hospitalization for liver-associated events.

A validation study of 3 grading systems to evaluate small-bowel cleansing for wireless capsule endoscopy: a quantitative index, a qualitative evaluation, and an overall adequacy assessment.

BACKGROUND: Capsule endoscopy (CE) is a powerful tool for evaluating the small bowel. Assessment of small-bowel cleansing for CE is an essential quality measure. OBJECTIVE: Our purpose was to validate 3 new scales that grade small-bowel cleansing for CE. DESIGN: Prospective, randomized, single-center study. SETTING: Tertiary university hospital. INTERVENTION: Five experienced capsule endoscopists read 40 CEs twice, separated by 1 month, to grade small-bowel cleansing on 3 scales-quantitative index (QI; 0-10), qualitative evaluation (QE; poor, fair, good, excellent), and overall adequacy assessment (OAA; inadequate, adequate). The QI and QE evaluated both the entire and distal small bowel. Investigators received no prior training in these scales. MAIN OUTCOME MEASUREMENTS: Intraclass correlation coefficients to assess intraobserver (test-retest) and interobserver reliability. PATIENTS: Forty patients who underwent 1 CE between June 2005 and May 2006 and who satisfied entry criteria. RESULTS: Intraobserver reliability was moderate to substantial for the QI (0.60-0.66), moderate for the OAA (0.56), and fair to moderate for the QE (0.37-0.47). Interobserver scores were lower: QI and OAA moderate (0.47-0.52, 0.41, respectively) and slight to fair for the QE (0.20-0.24). QI scores for the entire and distal small bowel were highly correlated for each reader (0.57-0.87), and distal small-bowel scores were lower by 1.3 points, indicating poorer cleansing (P = .001). A dichotomized QE of excellent/good versus fair/poor had moderate to substantial intraobserver and interobserver reliability (0.58-0.66, 0.41-0.49, respectively). There was a strong and highly significant association among all 3 scales (P < .001 between QI and both QE and OAA). CONCLUSION: We have described and validated 3 scales for grading small-bowel cleansing for CE. An evaluation of small-bowel cleansing should be routinely incorporated into the CE report.

The role of head computer tomographic scans on the management of MICU patients with neurological dysfunction.

Neurological dysfunction is common in patients admitted to the medical intensive care unit (MICU). However, the indications for head imaging in those patients are unclear. The objective of this study was to assess whether clinical variables would be useful in selecting patients who are likely to have an abnormality on head computerized tomographic (CT) scanning and to determine the impact of such scans on management decisions. We reviewed the charts of 740 patients admitted to our MICU between October 2002 and July 2004. A total of 123 patients (16.6%) had a head CT scan performed, with a new finding being present in 26 (21.1%) patients. In the patients with a new CT finding, there was a change in diagnosis in 11 (42%) patients and a change in treatment in 6 (23%) patients. Logistic regression analysis failed to determine any clinical characteristic that could predict a new finding on the CT scan. This study suggests that clinicians should have a low threshold for ordering a CT scan in MICU patients with acute neurological dysfunction.

Phase I trial of alisertib with concurrent fractionated stereotactic re-irradiation for recurrent high grade gliomas.

BACKGROUND AND PURPOSE: We conducted a phase I trial of alisertib, an oral aurora kinase inhibitor, with fractionated stereotactic re-irradiation therapy (FSRT) for patients with recurrent high grade glioma (HGG). MATERIALS AND METHODS: Adult patients with recurrent HGG were enrolled from Feb 2015 to Feb 2017. Patients were treated with concurrent FSRT and alisertib followed by maintenance alisertib. Concurrent alisertib dose was escalated from 20 mg to 50 mg twice daily (BID). RESULTS: 17 patients were enrolled. Median follow-up was 11 months. Median FSRT dose was 35 Gy. There were 6, 6, 3, and 2 patients enrolled in 20 mg, 30 mg, 40 mg, and 50 mg cohort, respectively. Only one DLT was observed. One patient in the 20 mg cohort had severe headache (Grade 3) resolved with steroids. There was no non-hematological grade 3 or higher toxicity. There were two Grade 4 late toxicities (one with grade 4 neutropenia and leukopenia, one with pulmonary embolism). One patient developed radiation necrosis (Grade 3). Sixteen patients finished concurrent treatment and received maintenance therapy (median cycles was 3, range 1-9). OS for all cohorts at 6 months was 88.2% with median survival time of 11.1 months. PFS at 6 months was 35.3% with median time to progression of 4.9 months. The trial stopped early due to closure of alisertib program with only 2 of 3 planned patients enrolled in the 50 mg cohort. CONCLUSION: Re-irradiation with FSRT combined with alisertib is safe and well tolerated for HGG with doses up to 40 mg BID. Although no DLT observed in the 50 mg cohort, this cohort was not fully enrolled and MTD was not reached. Clinical outcomes appear comparable to historical results. (NCT02186509).

Decision Support and Navigation to Increase Colorectal Cancer Screening Among Hispanic Patients.

BACKGROUND: Effective strategies are needed to raise colorectal cancer screening rates among Hispanics. METHODS: We surveyed and randomized 400 Hispanic primary care patients either to a Decision Support and Navigation Intervention (DSNI) Group (n = 197) or a Standard Intervention (SI) Group (n = 203). Both groups received a colorectal cancer screening kit [bilingual informational booklet, fecal immunochemical stool blood test (SBT), and colonoscopy screening instructions]. The DSNI Group received a telephone contact from a patient navigator. The navigator clarified screening test preference and likelihood of test performance, helped to develop a screening plan, and provided guidance through test performance. An endpoint telephone survey and medical chart review were completed. Multivariable analyses were conducted to assess 12-month screening adherence, change in decision stage, and knowledge and perceptions. RESULTS: Screening adherence was significantly higher in the DSNI Group than the SI Group [OR, 4.8; 95% confidence interval (CI), 3.1-7.6]. The DSNI Group, compared with the SI Group, also displayed higher SBT screening [OR, 4.2; 95% CI, 2.6-6.7), higher colonoscopy screening (OR, 8.8; 95% CI, 4.1-18.7), and greater forward change in screening decision stage (OR, 4.9; 95% CI, 2.6-9.5). At endpoint, study groups did not differ in screening knowledge or perceptions. CONCLUSIONS: The DSNI had a greater positive impact on colorectal cancer screening outcomes than the SI. IMPACT: Health system implementation of DSNI strategies may help to reduce Hispanic colorectal cancer screening disparities in primary care.