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Background and aims: Patient-reported outcomes (PROs) will become increasingly important as primary endpoints in future clinical trials. We aimed to evaluate the relationship between health-related quality of life (HRQoL) and the combination of patient-reported clinical symptoms (ClinPRO2) and Mayo endoscopic subscore (MES) in patients with ulcerative colitis (UC). Methods: We conducted a prospective cross-sectional study of 90 consecutive UC patients who were scheduled for sigmoidoscopy or colonoscopy. All patients completed the following questionnaires: (1) self-rated rectal bleeding and stool frequency (ClinPRO2); (2) Short Inflammatory Bowel Disease Questionnaire (SIBDQ); (3) European Quality of Life 5-Dimensions 3-Level (EQ5D3L); (4) Work Productivity and Activity Impairment questionnaire (WPAI); (5) Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F); and (6) Hospital Anxiety and Depression Scale (HADS). The endoscopic images were graded according to the MES. “No symptoms” was defined as a symptom score of 0, and “mucosal healing” was defined as MES score of 0–1. Correlations between the combined ClinPRO2 and MES with HRQoL were assessed using Spearman’s correlation coefficients. Results: The combination of the ClinPRO2 and MES was well correlated to SIBDQ (r = −0.70), EQ5D3L (r = −0.51), WPAI (r = 0.62), FACIT-F (r = −0.58), and HADS-depression (r = 0.45). SIBDQ scores had strong correlations with FACIT-F (r = 0.86), WPAI (r = −0.80), and HADS-depression (r = −0.75) (p < 0.05 for all correlations). Patients with no symptoms reported the greatest all HRQoL scores. Conclusions: In patients with ulcerative colitis, the combination of a ClinPRO2 and the MES had good correlation with the SIBDQ. In addition, SIBDQ was well correlated to the various HRQoL.

BACKGROUND: Medication Therapy Management (MTM) is a strategy for developing a variety of non-dispensing clinical pharmacy services to patients which aim to optimize therapeutic outcomes by identifying and resolving drug therapy problems. We conducted a pilot study to see if MTM could serve as a measurable value-add as demonstrated by improved outcomes for IBD injectable biologic patients and reduced disease management burden for clinicians and office staff. METHODS: Adult patients with either UC or CD prescribed new self-injectable biologic agents (adalimumab [ADA], certolizumab pegol [CTZ], golimumab [GOL], or ustekinumab [USTE]) were recruited from outpatient clinics at Mayo Clinic Rochester, Arizona, Florida or Health System. Exclusion criteria included prescriptions that were refills, patients with need for urgent hospitalization, pregnant patients, those without a reliable and confirmed shipping address or reliable telephone access, or patients residing outside of the United States. Patients were randomized to receive standard care or be enrolled in a collaborative, high-touch MTM program administered by Curant Health PharmD's. Patients randomized to MTM were further stratified to either having medications filled by Curant Health or specialty pharmacy as dictated by insurance plan. Patients receiving standard care were managed as per discretion of the treating physician. Patients receiving MTM arms were contacted per a defined protocol with calls at specified time points. The primary outcome of interest was number of unsolicited calls/messages from patients to practice sites during the study time period along with total time spent on the managing of those messages either electronically or via telephone. Secondary outcomes of interest included medication adherence as defined by percent of patients with a score of >6 at week 24 (MMAS-8) and disease activity as measured by relevant disease indices. RESULTS: 20 patients were randomized to MTM and 19 to standard care. There was no difference in median age or sex distribution among groups. The majority of patients were started on ADA, 1 CTZ and 1 USTE. One patient was enrolled twice with different medications to the standard group. Nine MTM patients required additional support to optimize therapy with 1 patient requiring 6 additional calls. The majority of calls involved injection administration, how to treat injection site reaction, pain and misfiring. The number of unsolicited calls overall in the MTM arm were significantly higher than standard care: 3 vs 1 ( P < 0.05). The overall adherence to medication at week 24 was significantly higher with MTM; scores ranged from 7.5–8 vs 5.5–6 in the standard care group ( P < 0.05). The median disease score of the MTM group also improved significantly for both diseases by >50% at week 24 for 13/20 patients compared with 10/19 for standard group. CONCLUSION(S): Patients in the high-touch, collaborative MTM arm received additional engagement as evidenced by the significant increase in unsolicited patient calls. MTM patients also showed improved adherence and improved disease outcomes to injectable therapy. This suggests that MTM services are an effective mechanism to relieve burden of office staff while improving patient care.

The NCCN Guidelines for Prostate Cancer include recommendations regarding diagnosis, risk stratification and workup, treatment options for localized disease, and management of recurrent and advanced disease for clinicians who treat patients with prostate cancer. The portions of the guidelines included herein focus on the roles of germline and somatic genetic testing, risk stratification with nomograms and tumor multigene molecular testing, androgen deprivation therapy, secondary hormonal therapy, chemotherapy, and immunotherapy in patients with prostate cancer.

AKI is a global concern with a high incidence among patients across acute care settings. AKI is associated with significant clinical consequences and increased health care costs. Preventive measures, as well as rapid identification of AKI, have been shown to improve outcomes in small studies. Providing high-quality care for patients with AKI or those at risk of AKI occurs across a continuum that starts at the community level and continues in the emergency department, hospital setting, and after discharge from inpatient care. Improving the quality of care provided to these patients, plausibly mitigating the cost of care and improving short- and long-term outcomes, are goals that have not been universally achieved. Therefore, understanding how the management of AKI may be amenable to quality improvement programs is needed. Recognizing this gap in knowledge, the 22nd Acute Disease Quality Initiative meeting was convened to discuss the evidence, provide recommendations, and highlight future directions for AKI-related quality measures and care processes. Using a modified Delphi process, an international group of experts including physicians, a nurse practitioner, and pharmacists provided a framework for current and future quality improvement projects in the area of AKI. Where possible, best practices in the prevention, identification, and care of the patient with AKI were identified and highlighted. This article provides a summary of the key messages and recommendations of the group, with an aim to equip and encourage health care providers to establish quality care delivery for patients with AKI and to measure key quality indicators.

Abstract Background Vedolizumab effectiveness estimates immediately after Food and Drug Administration (FDA) approval for ulcerative colitis (UC) and Crohn’s disease (CD) are limited by use in refractory populations. We aimed to compare treatment patterns and outcomes of vedolizumab in 2 time frames after FDA approval. Methods We used 2 data sets for time trend analysis, an academic multicenter vedolizumab consortium (VICTORY) and the Truven MarketScan database, and 2 time periods, May 2014–June 2015 (Era 1) and July 2015–June 2017 (Era 2). VICTORY cumulative 12-month clinical remission, corticosteroid-free remission, and mucosal healing rates, and Truven 12-month hospitalization and surgery rates, were compared between Eras 1 and 2 using time-to-event analyses. Results A total of 3661 vedolizumab-treated patients were included (n = 1087 VICTORY, n = 2574 Truven). In both cohorts, CD and UC patients treated during Era 2 were more likely to be biologic naïve. Compared with Era 1, Era 2 CD patients in the VICTORY consortium had higher rates of clinical remission (31% vs 40%, P = 0.03) and mucosal healing (42% vs 58%, P < 0.01). These trends were not observed for UC. In the Truven database, UC patients treated during Era 2 had lower rates of inflammatory bowel disease–related hospitalization (22.4% vs 9.6%, P < 0.001) and surgery (17.2% vs 9.4%, P = 0.008), which was not observed for CD. Conclusion Since FDA approval, remission and mucosal healing rates have increased for vedolizumab-treated CD patients, and vedolizumab-treated UC patients have had fewer hospitalizations and surgeries. This is likely due to differences between patient populations treated immediately after drug approval and those treated later.

Abstract Abstract Background: Pulmonary hypertension (PH) is a significant preoperative risk factor. We aimed to determine predictors of perioperative morbidity and mortality after noncardiac surgery for patients with precapillary PH. Methods: We conducted a retrospective cohort study of adults with pulmonary hypertension having surgery at a single large medical referral center. The PH and surgical databases were reviewed from 2010 to 2017. Patients were excluded if PH was attributable to left-sided heart disease or they had undergone cardiac or transplant operations. To assess whether PH-specific diagnostic or cardiopulmonary testing parameters were predictive of perioperative complications, analyses were performed using generalized estimating equations. Results: Of 196 patients with PH undergoing noncardiac operations, 53 (27%) experienced 1 or more complications, including 5 deaths (3%) within 30 days. After adjustment for age and PH type, there were more complications in those undergoing moderate-to-high vs low-risk procedures (odds ratio [OR], 4.17 [95% CI, 2.07 to 8.40]; P<0.001). After adjustment for age, surgical risk, and PH type, the risk for complications was higher for patients with worse functional status (OR, 2.39 [95% CI, 1.19 to 4.78]; P=0.01 for class 3/4 vs class 1/2) and elevated serum N-terminal fragment of the prohormone brain natriuretic peptide (NT-proBNP) (OR, 2.28 [95% CI, 1.05 to 4.96]; P=0.04 for ≥300 vs. <300 pg/mL). From an analysis that included covariates for age, surgical risk, and functional status, elevated serum NT-proBNP levels remained associated with increased risk (OR, 2.23 [95% CI, 1.05 to 4.76]; P=0.04). Conclusions: Patients with PH undergoing noncardiac surgery with general anesthesia have a high frequency of perioperative complications. Specific clinical (functional status), diagnostic (serum NT-proBNP), and intraoperative factors (higher-risk surgery) are predictive of worse outcomes.