Background: Replicate, 12-week, phase 3 trials (0126 and 0127) of once-daily nebulized revefenacin 175 μg vs placebo demonstrated significant bronchodilation and improvements in health status in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). This post hoc analysis evaluated improvement in patient-reported outcomes (PROs), including the St. George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Clinical COPD Questionnaire (CCQ) in both women and men.
View Article and Find Full Text PDFPatient Focused Medicines Development (PFMD) is a not-for-profit independent multinational coalition of patients, patient stakeholders, and the pharmaceutical industry with interests across diverse disease areas and conditions. PFMD aims to facilitate an integrated approach to medicines development with all stakeholders involved early in the development process. A key strength of the coalition that differentiates it from other groups that involve patients or patient groups is that PFMD has patient organizations as founding members, ensuring that the patient perspective is the starting point when identifying priorities and developing solutions to meet patients' needs.
View Article and Find Full Text PDFTher Innov Regul Sci
September 2016
In order to better understand and advance the field of patient-focused drug development, a multifunctional patient affairs team developed and piloted a Patient Centricity Team Tool (PCTT) within a large pharmaceutical organization. The tool is a computer-based survey designed to interrogate the frequency of team efforts in 20 areas of patient centricity across 4 dimensions: people, purpose, process, and actions. Results from a pilot with a Phase III product team indicate a spectrum of team activity of different frequencies related to patient-focused drug development.
View Article and Find Full Text PDFThe purpose of medicines is to improve patients' lives. Stakeholders involved in the development and lifecycle management of medicines agree that more effective patient involvement is needed to ensure that patient needs and priorities are identified and met. Despite the increasing number and scope of patient involvement initiatives, there is no accepted master framework for systematic patient involvement in industry-led medicines research and development, regulatory review, or market access decisions.
View Article and Find Full Text PDFStudy Objectives: To evaluate a teaching protocol comparing a critical care attending to a housestaff team in training medical interns in initial airway management skills using a computer-controlled patient simulator (CPS) and scenario-based simulation training (SST).
Design: Prospective, randomized, controlled, unblinded trial.
Setting: Internal medicine residency training program in an urban teaching hospital.
Background: Accurate interpretation of chest radiographs (CXR) is essential as clinical decisions depend on readings.
Objective: We sought to evaluate CXR interpretation ability at different levels of training and to determine factors associated with successful interpretation.
Design: Ten CXR were selected from the teaching file of the internal medicine (IM) department.
We analyzed 385 consecutive central venous catheter (CVC) attempts over a 6-month period. All critically ill patients 18 years of age or older requiring a CVC were included. The rate of mechanical complications not including failure to place was 14%.
View Article and Find Full Text PDFAcute and chronic pulmonary and cardiac diseases often have a high mortality rate, and can be a source of significant suffering. Palliative care, as described by the Institute of Medicine, "seeks to prevent, relieve, reduce or soothe the symptoms of disease or disorder without effecting a cure..
View Article and Find Full Text PDFObjectives: Patient simulation is emerging as a training technique in the field of medicine. It has particular application in training responses to high-risk, low-frequency clinical events, of which a typical example is in-hospital cardiac arrest. A critical element of response by the cardiac arrest team is initial airway management.
View Article and Find Full Text PDFStudy Objectives: To describe the clinical features of radiographically massive pulmonary embolism (MPE).
Design: Retrospective analysis.
Setting: A 1,368-bed teaching hospital.