Autologous CD34+ Stem Cell Therapy Increases Coronary Flow Reserve and Reduces Angina in Patients With Coronary Microvascular Dysfunction.

BACKGROUND: Coronary microvascular dysfunction results in angina and adverse outcomes in patients with evidence of ischemia and nonobstructive coronary artery disease; however, no specific therapy exists. CD34+ cell therapy increases microvasculature in preclinical models and improves symptoms, exercise tolerance, and mortality in refractory angina patients with obstructive coronary artery disease. The objective of this research was to evaluate the safety, tolerability, and efficacy of intracoronary CD34+ cell therapy in patients with coronary microvascular dysfunction. METHODS: We conducted a 2-center, 20-participant trial of autologous CD34+ cell therapy (protocol CLBS16-P01; NCT03508609) in patients with ischemia and nonobstructive coronary artery disease with persistent angina and coronary flow reserve ≤2.5. Efficacy measures included coronary flow reserve, angina frequency, Canadian Cardiovascular Society angina class, Seattle Angina Questionnaire, SF-36, and modified Bruce exercise treadmill test obtained at baseline and 6 months after treatment. Autologous CD34+ cells (CLBS16) were mobilized by administration of granulocyte-colony stimulating factor 5µg/kg/day for 5 days and collected by leukapheresis. Participants received a single intracoronary left anterior descending infusion of isolated CD34+ cells in medium that enhances cell function. RESULTS: Coronary flow reserve improved from 2.08±0.32 at baseline to 2.68±0.79 at 6 months after treatment (P<0.005). Angina frequency decreased (P<0.004), Canadian Cardiovascular Society class improved (P<0.001), and quality of life improved as assessed by the Seattle Angina Questionnaire (P≤0.03, all scales) and SF-36 (P≤0.04, all scales). There were no cell-related serious adverse events. CONCLUSIONS: In this pilot clinical trial of microvascular angina, patients with ischemia and nonobstructive coronary artery disease receiving intracoronary infusion of CD34+ cell therapy had higher coronary flow reserve, less severe angina, and better quality of life at 6 months. The current study supports a potential therapeutic role for CD34+ cells in patients with microvascular angina. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03508609.

Breast screening navigator programs within three settings that assist underserved women.

Medically underserved women in the Greater Denver Metropolitan Area had low rates of routine repeat mammograms in the latter 1990s. "Increasing Mammography Adherence among Medically Underserved Women" was designed to increase annual rescreening among medically underserved populations living in this area. Four community-based organizations collaborated to implement this 5-year study. A culturally modified navigator model including both face-to-face and telephone formats was used to facilitate mammography for African Americans, Latinas, Native Americans, and poor White women who had not been rescreened in more than 18 months. The navigator-implemented intervention was statistically significant at the 0.05 level for increasing rescreening.

A Digital Cognitive Aid for Anesthesia to Support Intraoperative Crisis Management: Results of the User-Centered Design Process.

BACKGROUND: Stressful situations during intraoperative emergencies have negative impact on human cognitive functions. Consequently, task performance may decrease and patient safety may be compromised. Cognitive aids can counteract these effects and support anesthesiologists in their crisis management. The Professional Association of German Anesthesiologists set up a project to develop a comprehensive set of digital cognitive aids for intraoperative emergencies. A parallel development for several software platforms and stationary and mobile devices will accommodate the inhomogeneity of the information technology infrastructure within German anesthesia departments. OBJECTIVE: This paper aimed to provide a detailed overview of how the task of developing a digital cognitive aid for intraoperative crisis management in anesthesia was addressed that meets user requirements and is highly user-friendly. METHODS: A user-centered design (UCD) process was conducted to identify, specify, and supplement the requirements for a digital cognitive aid. The study covered 4 aspects: analysis of the context of use, specification of user requirements, development of design solutions, and evaluation of design solutions. Three prototypes were developed and evaluated by end users of the application. Following each evaluation, the new requirements were prioritized and used for redesign. For the first and third prototype, the System Usability Scale (SUS) score was determined. The second prototype was evaluated with an extensive Web-based questionnaire. The evaluation of the third prototype included a think-aloud protocol. RESULTS: The chosen methods enabled a comprehensive collection of requirements and helped to improve the design of the application. The first prototype achieved an average SUS score of 74 (SD 12), indicating good usability. The second prototype included the following main revisions: 2-column layout, initial selection of patient type (infant, adult, or parturient), 4 offered search options, and the option to check off completed action steps. Its evaluation identified the following major revision points: add quick selection for resuscitation checklists, design the top bar and tabs slightly larger, and add more pictograms to the text. The third prototype achieved an average SUS score of 77 (SD 15). The evaluation of the think-aloud protocol revealed a good intuitiveness of the application and identified a missing home button as the main issue. CONCLUSIONS: Anesthesiology-as an acute medical field-is particularly characterized by its high demands on decision making and action in dynamic, or time-critical situations. The integration of usability aspects is essential for everyday and emergency suitability. The UCD process allowed us to develop a prototypical digital cognitive aid, exhibiting high usability and user satisfaction in the demanding environment of anesthesiological emergencies. Both aspects are essential to increase the acceptance of the application in later stages. The study approach, combining different methods for determining user requirements, may be useful for other implementation projects in a highly demanding environment.