Community paramedic hospital reduction and mitigation program: study protocol for a randomized pragmatic clinical trial.

BACKGROUND: New patient-centered models of care are needed to individualize care and reduce high-cost care, including emergency department (ED) visits and hospitalizations for low- and intermediate-acuity conditions that could be managed outside the hospital setting. Community paramedics (CPs) have advanced training in low- and high-acuity care and are equipped to manage a wide range of health conditions, deliver patient education, and address social determinants of health in the home setting. The objective of this trial is to evaluate the effectiveness and implementation of the Care Anywhere with Community Paramedics (CACP) program with respect to shortening and preventing acute care utilization. METHODS: This is a pragmatic, hybrid type 1, two-group, parallel-arm, 1:1 randomized clinical trial of CACP versus usual care that includes formative evaluation methods and assessment of implementation outcomes. It is being conducted in two sites in the US Midwest, which include small metropolitan areas and rural areas. Eligible patients are ≥ 18 years old; referred from an outpatient, ED, or hospital setting; clinically appropriate for ambulatory care with CP support; and residing within CP service areas of the referral sites. Aim 1 uses formative data collection with key clinical stakeholders and rapid qualitative analysis to identify potential facilitators/barriers to implementation and refine workflows in the 3-month period before trial enrollment commences (i.e., pre-implementation). Aim 2 uses mixed methods to evaluate CACP effectiveness, compared to usual care, by the number of days spent alive outside of the ED or hospital during the first 30 days following randomization (primary outcome), as well as self-reported quality of life and treatment burden, emergency medical services use, ED visits, hospitalizations, skilled nursing facility utilization, and adverse events (secondary outcomes). Implementation outcomes will be measured using the RE-AIM framework and include an assessment of perceived sustainability and metrics on equity in implementation. Aim 3 uses qualitative methods to understand patient, CP, and health care team perceptions of the intervention and recommendations for further refinement. In an effort to conduct a rigorous evaluation but also speed translation to practice, the planned duration of the trial is 15 months from the study launch to the end of enrollment. DISCUSSION: This study will provide robust and timely evidence for the effectiveness of the CACP program, which may pave the way for large-scale implementation. Implementation outcomes will inform any needed refinements and best practices for scale-up and sustainability. TRIAL REGISTRATION: ClinicalTrials.gov NCT05232799. Registered on 10 February 2022.

Sorafenib in Hepatopulmonary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.

The tyrosine kinase inhibitor sorafenib improves hepatopulmonary syndrome (HPS) in an experimental model. However, the efficacy and adverse effect profile in patients with HPS are unknown. We aimed to determine the effect of sorafenib on the alveolar-arterial oxygen gradient (AaPO2 ) at 3 months in patients with HPS. We performed a randomized, double-blind, placebo-controlled parallel trial of sorafenib in patients with HPS at 7 centers. A total of 28 patients with HPS were randomized to sorafenib 400 mg by mouth daily or a matching placebo in a 1:1 ratio. We found no statistically significant difference in the median change in AaPO2 from baseline to 12 weeks between the patients allocated to sorafenib (4.5 mm Hg; IQR, -3.8 to 7.0 mm Hg) and those allocated to placebo (-2.4 mm Hg; IQR, -4.8 to 8.2 mm Hg; P = 0.70). There was also no difference between the groups in terms of degree of intrapulmonary shunting by contrast echocardiography. Sorafenib significantly reduced circulating levels of angiogenic markers, including vascular endothelial growth factor receptors (P < 0.01) and TIE2-expressing M2 monocytes (P = 0.03), but it reduced the mental component scores of the Short Form 36 (P = 0.04), indicating a worse quality of life. In conclusion, sorafenib did not change the AaPO2 or other disease markers at 3 months in patients with HPS. Alternative antiangiogenic therapies or treatments targeting other pathways should be investigated.

Why physicians favor use of percutaneous coronary intervention to medical therapy: a focus group study.

BACKGROUND: Percutaneous coronary intervention (PCI) is performed in many patients with stable coronary artery disease, despite evidence of little clinical benefit over optimal medical therapy. OBJECTIVE: To examine physicians' beliefs, practices, and decision-making regarding elective PCI. DESIGN: Six focus groups, three with primary care physicians and three with cardiologists. Participants discussed PCI using hypothetical case scenarios. Transcripts were analyzed using grounded theory, and commonly expressed themes regarding the decision-making pathway to PCI were identified. PARTICIPANTS: Twenty-eight primary care physicians and 20 interventional and non-interventional cardiologists in Butte County, Orange County, and San Francisco Bay Area, California, in 2006. RESULTS: A number of factors led primary care physicians to evaluate non-symptomatic or minimally symptomatic patients for coronary artery disease and refer them to a cardiologist. The use of screening tests often led to additional testing and referral, as well as fear of missing a coronary stenosis, perceived patient expectations, and medicolegal concerns. The end result was a cascade such that any positive test would generally lead to the catheterization lab, where an "oculostenotic reflex" made PCI a virtual certainty. CONCLUSIONS: The widespread use of PCI in patients with stable coronary artery disease--despite evidence of little benefit in outcomes over medical therapy--may in part be due to psychological and emotional factors leading to a cascade effect wherein testing leads inevitably to PCI. Determining how to help physicians better incorporate evidence-based medicine into decision-making has important implications for patient outcomes and the optimal use of new technologies.

Pistachio skin phenolics are destroyed by bleaching resulting in reduced antioxidative capacities.

Pistachio shells split naturally prior to maturity leading to their unique crack-shell form. Within 24 h of harvest, hull-trapped moisture may cause shell staining. The illegal process of bleaching has been used to restore a desirable white color to pistachio shells. It is not known whether bleaching adversely affects phytochemical levels in pistachios. Therefore, we identified for the first time multiple pistachio skin phenolics as quercetin (14.9 microg/g), luteolin (10.0 microg/g), eriodictyol (10.2 microg/g), rutin (1.6 microg/g), naringenin (1.2 microg/g), apigenin (0.2 microg/g), and the anthocyanins, cyanidin-3-galactoside (696 microg/g) and cyanidin-3-glucoside (209 microg/g). We investigated the effects of bleaching (0.1-50% hydrogen peroxide) on phenolic levels and antioxidative capacities in raw and roasted nuts. Because of their flavylium cation structures, anthocyanins were the most sensitive to bleaching. Bleaching decreased total anthocyanin levels [mug/g of skins (% hydrogen peroxide)]: 905 and 549 (0%); 653 and 145 (0.1%); 111 and 18.4 (5%); 6.1 and 3.2 (25%); 0 and 0 (50%) for raw and roasted nuts, respectively. Bleaching also reduced antioxidative capacity [microM/g of Trolox (% hydrogen peroxide)]: 945 and 725 (0%); 940 and 472 (0.1%); 930 and 455 (5%); 433 and 370 (25%); 189 and 173 (50%), for raw and roasted nuts, respectively. Raw nuts preserved phenolic levels and antioxidant capacity better than roasted nuts, suggesting contributing effects of other substances and/or matrix effects that are destroyed by the roasting process. The destruction of bioactive phenolics in pistachio skins may negatively impact the potential health benefits arising from pistachio consumption.