Multilevel Community Engagement to Inform a Randomized Clinical Trial.

OBJECTIVE: To explore how patients, community-based perinatal support professionals, and health system clinicians and staff perceived facilitators and barriers to implementation of a randomized clinical trial (RCT) designed to optimize Black maternal heart health. METHODS: This article describes the formative work that we believed needed to occur before the start of the Change of H.E.A.R.T (Here for Equity, Advocacy, Reflection and Transformation) RCT. We used a qualitative, descriptive design and community-based, participatory approach, the latter of which allowed our team to intentionally focus on avoiding harm and equalizing power dynamics throughout the research process. Data were collected between November 2021 and January 2022 through six semistructured focus groups that included attending physicians and midwives (n=7), residents (n=4), nurses (n=6), support staff (n=7), community-based perinatal support professionals (n=6), and patients (n=8). RESULTS: Four primary themes emerged. The first three themes were present across all groups and included: 1) Trauma in the Community and Health System, 2) Lack of Trust, and 3) Desire to Be Heard and Valued. The fourth theme, Hope and Enthusiasm, was expressed predominantly by patients, community-based perinatal support professionals, residents, and support staff, and less so by the attending physician group. CONCLUSION: Participants articulated a number of key sentiments regarding facilitators and barriers to implementing Change of H.E.A.R.T. We noted variability in perceptions from different groups. This has important implications for health equity efforts in similarly underresourced health systems where Black birthing people experience the greatest morbidity and mortality. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT05499507.

A novel method for the quantitative assessment of the fitted containment efficiency of face coverings.

BACKGROUND: Face masks reduce disease transmission by protecting the wearer from inhaled pathogens and reducing the emission of infectious aerosols. Although methods quantifying efficiency for wearer protection are established, current methods for assessing face mask containment efficiency rely on measurement of a low concentration of aerosols emitted from an infected or noninfected individual. METHODS: A small port enabled the introduction of 0.05 µm sodium chloride particles at a constant rate behind the mask worn by a study participant. A condensation particle counter monitored ambient particle numbers 60 cm in front of the participant over 3-minute periods of rest, speaking, and coughing. The containment efficiency (%) for each mask and procedure was calculated as follows: 100 × (1 - average ambient concentration with face covering worn/average ambient concentration with a sham face covering in place). The protection efficiency (%) was also measured using previously published methods. The probability of transmission (%) from infected to uninfected (a function of both the containment efficiency and the protection efficiency) was calculated as follows: {1 - (containment efficiency/100)}×{1 - (protection efficiency/100)}×100. RESULTS: The average containment efficiencies for each mask over all procedures and repeated measures were 94.6%, 60.9%, 38.8%, and 43.2%, respectively, for the N95 mask, the KN95 mask, the procedure face mask, and the gaiter. The corresponding protection efficiencies for each mask were 99.0%, 63.7%, 45.3%, and 24.2%, respectively. For example, the transmission probability for 1 infected and 1 uninfected individual in close proximity was ∼14.2% for KN95 masks, compared to 36%-39% when only 1 individual wore a KN95 mask. CONCLUSION: Overall, we detected a good correlation between the protection and containment that a face covering afforded to a wearer.

Trauma-informed interprofessional education: Preliminary evaluation of building student capacity for system-wide collaboration.

INTRODUCTION: In urban areas, numerous barriers exist for children and families to access needed behavioral health care. Compounding the general deficit of behavioral health workers in the United States is lack of access to culturally responsive care. Additional challenges include inherent racism and oppression in our health and human service systems and siloed approaches to behavioral health care training and practice. Integrated care is an emerging field nationally, yet training and education in integrated care is limited. This article provides an overview of the Child/Adolescent Interprofessional Practice and Education (CAIPE) program, a novel training approach in its first year of implementation for behavioral health students that prioritizes trauma-informed and social-justice oriented practice, integrated care, and interprofessional teamwork. METHOD: This study employs a mixed-methods approach to program evaluation. Data sources include program application materials (demographics and data related to clinical interests, student goals, and preparedness for interprofessional work). Data is also drawn from measures of student outcomes (self-efficacy navigating complex care patients, empathy, and complex care knowledge). RESULTS: Baseline data are reported for demographics, students' goals and interprofessional interests, and student outcomes. Information is also presented relevant to trainings conducted in the grant's first year and planned for subsequent years. Preliminary data and implementation suggest that the program has drawn diverse trainees who are committed to interprofessional, integrated care for underserved youth. DISCUSSION: Recruitment and program development challenges are discussed, along with grant goals' fit with students' interests and plans for future evaluation. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Standardization of techniques for using planar (2D) imaging for aerosol deposition assessment of orally inhaled products.

Two-dimensional (2D or planar) imaging with (99m)Tc radiolabels enables quantification of whole-lung and regional lung depositions for orally inhaled drug products. This article recommends standardized methodology for 2D imaging studies. Simultaneous anterior and posterior imaging with a dual-headed gamma camera is preferred, but imaging with a single-headed gamma camera is also acceptable. Correction of raw data for the effects of gamma ray attenuation is considered essential for accurate quantification, for instance, using transmission scanning with a flood-field source of (99m)Tc or (57)Co. Evidence should be provided of the accuracy of the quantification method, for instance, by determining "mass balance." Lung deposition may be expressed as a percentage of ex-valve or ex-device dose, but should also be given as mass of drug when possible. Assessment of regional lung deposition requires delineation of the lung borders, using X-ray computed tomography, radioactive gas scans ((133)Xe or (81m)Kr), or transmission scans. When quantifying regional lung deposition, the lung should be divided into outer (O) and inner (I) zones. A penetration index should be calculated, as the O/I ratio for aerosol, normalized to that for a radioactive gas or transmission scan. A variety of methods can be used to assess lung deposition and distribution. Methodology and results should be documented in detail, so that data from different centers may be compared. The use of appropriate methodology will provide greater confidence in the results of 2D imaging studies, and should allay concerns that such studies are qualitative or semiquantitative in nature.

The Coalition Against Major Diseases: developing tools for an integrated drug development process for Alzheimer's and Parkinson's diseases.

Aiming to emulate the successful accelerated development of HIV/AIDS drugs, the Critical Path Institute (C-Path), in collaboration with the Engelberg Center for Health Care Reform at the Brookings Institution, has formed the Coalition Against Major Diseases (CAMD). Members include 6 nonprofit groups representing patients' interests, 15 leading pharmaceutical companies, the US Food and Drug Administration (FDA), the European Medicines Agency (EMEA), 2 institutes of the National Institutes of Health (NIH)-the National Institute on Aging (NIA) and the National Institute of Neurological Disorders and Stroke (NINDS)-and representatives from academia. The coalition's purpose is to transform the drug development paradigm for neurodegenerative diseases and serve as a model for other major diseases.

Dialysis for end-stage renal disease. Determining a cost-effective approach.

OBJECTIVE: Renal replacement therapy (RRT) is essential for maintenance of life for those with end-stage renal disease. However, there remain many areas of uncertainty about which method of RRT should be chosen. This paper reports an economic model based on a systematic review that attempts to determine which method of dialysis, continuous ambulatory peritoneal dialysis (CAPD) or hemodialysis, a patient should have as the initial method of RRT. METHODS: A systematic review and a costing exercise carried out in a Scottish hospital were used to populate a Markov model. Scenario analysis was used to model plausible variations in variables included in the model. RESULTS: In 8 of the 16 scenarios developed hemodialysis dominated CAPD. In a further eight scenarios, the cost per life-year displayed considerable variability, ranging from between 5,000 Pounds to 51,000 Pounds. The higher costs per life-year were associated with minimum estimates of additional survival for a patient starting RRT on hospital hemodialysis. CONCLUSION: It may be more cost-effective to manage patients starting on RRT with hospital hemodialysis than CAPD. This has particular implications for the United Kingdom, given that up to 50% of new patients receive CAPD.

Comparison between the transabdominal and retroperitoneal approaches for aortic reconstruction in patients at high risk.

PURPOSE: The purpose of this study was to compare the transabdominal approach with the retroperitoneal approach for elective aortic reconstruction in the patient who is at high risk. METHODS: From January 1992 through January 1997, 148 patients underwent aortic operations: 92 of the patients were classified as American Society of Anesthesia (ASA) class IV. Forty-four operations on the patients of ASA class IV were performed with the transabdominal approach (25 for abdominal aortic aneurysms and 19 for aortoiliac occlusive disease), and 48 operations were performed with the retroperitoneal approach (27 for abdominal aortic aneurysms and 21 for aortoiliac occlusive disease). There were no significant differences between the groups for comorbid risk factors or perioperative care. RESULTS: Among the patients of ASA class IV, eight (8.7%) died after operation (retroperitoneal, 3 [6.26%]; transabdominal, 5 [11.3%]; P =.5). There was no difference between groups in the number of pulmonary complications (retroperitoneal, 23 [47.9%]; transabdominal, 19 [43.2%]; P =.7) or in the development of incisional hernias (retroperitoneal, 6 [12.5%]; transabdominal, 5 [11.3%]; P =.5). The retroperitoneal approach was associated with a significant reduction in cardiac complications (retroperitoneal, 6 [12.5%]; transabdominal, 10 [22.7%]; P =.004) and in gastrointestinal complications (retroperitoneal, 5 [8.3%]; transabdominal, 15 [34.1%]). Operative time was significantly longer in the retroperitoneal group (retroperitoneal, 3.35 hours; transabdominal, 2.98 hours; P =.006), as was blood loss (retroperitoneal, 803 mL; transabdominal, 647 mL; P =.012). The patients in the retroperitoneal group required less intravenous narcotics (retroperitoneal, 36.6 +/- 21 mg; transabdominal, 49.5 +/- 28.5 mg; P =.004) and less epidural analgesics (retroperitoneal, 39.5 +/- 6.4 mg; transabdominal, 56.6 +/- 9.5 mg; P =.004). Hospital length of stay (retroperitoneal, 7.2 +/- 1.6 days; transabdominal, 12.8 +/- 2.3 days; P =.024) and hospital charges (retroperitoneal, $35,587 +/- $980; transabdominal, $54,832 +/- $1105; P =.04) were significantly lower in the retroperitoneal group. The survival rates at the 40-month follow-up period were similar between the groups (retroperitoneal, 81.3%; transabdominal, 78.7%; P =.53). CONCLUSION: In this subset of patients who were at high risk for aortic reconstruction, the postoperative complications were common. However, the number of complications was significantly lower in the retroperitoneal group. Aortic reconstruction in patients of ASA class IV appears to be more safely and economically performed with the retroperitoneal approach.

Preliminary assessment of whole-blood, red-cell and platelet- leucodepleting filters for possible induction of prion release by leucocyte fragmentation during room temperature processing.

Universal leucodepletion is being introduced in the U.K. to reduce a theoretical risk of Creutzfeldt-Jakob disease (CJD) transmission. If CJD infectivity is associated with leucocytes, any cell fragmentation associated with filtration could reduce the potential benefit. Four types each of whole blood, red cell and platelet leucodepletion filters were assessed after holding of blood units for at least 4 h at 22 degrees C. In all cases the mean residual leucocyte content was <1 000 000 per unit, with only two individual filtered whole blood units having a leucocyte content exceeding this. Evidence of leucocyte fragmentation during filtration was sought but not found by assay of soluble elastase, beta-thromboglobulin and normal prion protein, as well as by isotopic labelling of leucocyte external membrane. These preliminary studies indicate that it was possible to prepare leucodepleted blood components by filtration at room temperature, and that this appeared not to be associated with overt cell fragmentation. Definitive demonstration that fragmentation does not occur requires the development of improved general (non-specific) assays for cell membrane fragments.

Non-acute casemix in the Illawarra.

There are problems associated with the use of acute care diagnosis-related groups for prospective payment for rehabilitation medicine services. As a preliminary effort to assist in the development of the National Non-Acute Inpatient Casemix Project, a modified costing study was done in the rehabilitation and geriatrics ward of the Illawarra Regional Hospital; its aim was to assess the validity of the functional independence measure (FIM) and the resource utilization group (RUG) system as predictors of staff time involvement in inpatient rehabilitation services. Data collected on 51 patients over 3 months showed that in a standard Australian rehabilitation unit the costs of staff involvement varied depending on the type of functional impairment and severity of carer burden. The FIM alone was not predictive of rehabilitation costs and the RUG 2 instrument was not comprehensively predictive of cost. The RUG 3 instrument developed in the USA did not allocated weightings appropriate to Australian costs. If, however, functional impairment groups were combined with one of these measures of carer burden, then costs did fall into categories reflective of staff time involvement. An Australian system which incorporates an instrument measuring functional capacity may be useful for resource allocation in rehabilitation care.