Improvements in health status with revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist for chronic obstructive pulmonary disease.

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. METHODS: Participants were pooled from the two 12-week studies (411 [51%] women and 401 [49%] men). Changes in PROs were assessed overall and separately in men and women. RESULTS: Revefenacin improved SGRQ and CAT total scores from baseline in both studies; improvement in CCQ total score reached significance only in 0126. In pooled data, a greater proportion of patients achieved clinically meaningful response in SGRQ score (≥4-unit decrease from baseline) with revefenacin vs placebo (odds ratio, 1.5; 95% confidence interval, 1.1-2.1; P = 0.012). Clinically meaningful responses were also seen in CAT (≥2-unit decrease from baseline) and CCQ (≥0.4-unit decrease from baseline) scores with revefenacin vs placebo. When stratified by sex, improvements from baseline in SGRQ, CAT, and CCQ scores following revefenacin vs placebo reached statistical significance only in women. CONCLUSIONS: Maintenance treatment with revefenacin improved health status in patients with moderate to very severe COPD; however, the effect was more pronounced for women than men. CLINICALTRIALS: GOV: NCT02459080; NCT02512510.

Culture and Process Change as a Priority for Patient Engagement in Medicines Development.

Patient 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. In addition, PFMD has from inception been formed as an equal collaboration among patient groups, patients, and pharmaceutical industry and has adopted a unique trans-Atlantic setup and scope that reflects its global intent. This parity extends to its governance model, which ensures at least equal or greater share of voice for patient group members. PFMD is actively inviting additional members and aims to expand the collaboration to include stakeholders from other sectors. The establishment of PFMD is particularly timely as patient engagement (PE) has become a priority for many health stakeholders and has led to a surge of mostly disconnected activities to deliver this. Given the current plethora of PE initiatives, an essential first step has been to determine, based on a comprehensive mapping, those strategic areas of most need requiring a focused initial effort from the perspective of all stakeholders. PFMD has identified four priority areas that will need to be addressed to facilitate implementation of PE. These are (1) culture and process change, (2) development of a global meta-framework for PE, (3) information exchange, and (4) training. This article discusses these priority themes and ongoing or planned PFMD activities within each.

Achieving housestaff competence in emergency airway management using scenario based simulation training: comparison of attending vs housestaff trainers.

STUDY 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. PARTICIPANTS: Forty-nine starting internal medicine interns in July 2003, all of whom had been certified in advanced cardiac life support in June 2003. INTERVENTIONS: All interns were tested and scored with a CPS while responding to a standardized respiratory arrest scenario. Random allocation to either training by a single experienced teaching attending or by a housestaff team occurred immediately following testing. All interns were retested using the same scenario 6 weeks following the initial training, and their clinical performance of airway management was scored during actual patient events throughout the year. MEASUREMENTS: Initial airway management was divided into specific scorable steps. For each intern, individual step scores and total scores were recorded before and after training. For 10 consecutive months following training, intern airway management scores were recorded for actual patient airway events. RESULTS: All starting medical interns demonstrated poor initial airway management skills. SST was effective in improving these skills, both on retesting with the patient simulator and in actual patient situations. Interns trained by a housestaff team performed as well as interns trained by the attending. CONCLUSIONS: SST is effective in training medical interns, and the results are equivalent whether the training is provided by an experienced teaching attending or by a housestaff training team.

Competency in chest radiography. A comparison of medical students, residents, and fellows.

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. Participants were asked to record the most important diagnosis, their certainty in that diagnosis, interest in a pulmonary career and adequacy of CXR training. Two investigators independently scored each CXR on a scale of 0 to 2. PARTICIPANTS: Participants (n=145) from a single teaching hospital were third year medical students (MS) (n=25), IM interns (n=44), IM residents (n=45), fellows from the divisions of cardiology and pulmonary/critical care (n=16), and radiology residents (n=15). RESULTS: The median overall score was 11 of 20. An increased level of training was associated with overall score (MS 8, intern 10, IM resident 13, fellow 15, radiology resident 18, P<.001). Overall certainty was significantly correlated with overall score (r=.613, P<.001). Internal medicine interns and residents interested in a pulmonary career scored 14 of 20 while those not interested scored 11 (P=.027). Pneumothorax, misplaced central line, and pneumoperitoneum were diagnosed correctly 9%, 26%, and 46% of the time, respectively. Only 20 of 131 (15%) participants felt their CXR training sufficient. CONCLUSION: We identified factors associated with successful CXR interpretation, including level of training, field of training, interest in a pulmonary career and overall certainty. Although interpretation improved with training, important diagnoses were missed.

A Patient Centricity Team Tool to Enable Patient-Focused Drug Development.

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. Given the lack of tool validation, interpretation of results remains a reflection of the team, asset, and lifecycle stage as opposed to a diagnostic of activities. Over time and with increased use across teams, tool implementation and associated learnings may yield organizational, product, and ultimately patient benefits.

Palliative and end-of-life care for patients with cardiopulmonary diseases: American College of Chest Physicians position statement.

Acute 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... Palliative care in this broad sense is not restricted to those who are dying or those enrolled in hospice programs." The American College of Chest Physicians strongly supports the position that such palliative and end-of-life care of the patient with an acute devastating or chronically progressive pulmonary or cardiac disease and his/her family should be an integral part of cardiopulmonary medicine. This care is best provided through an interdisciplinary effort by competent and experienced professionals under the leadership of a knowledgeable and compassionate physician. To that end, it is hoped that this statement will serve as a framework within which physicians may develop their own approach to the management of patients requiring palliative care.

Partnering With Patients in the Development and Lifecycle of Medicines: A Call for Action.

The 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. Patient engagement is very productive in some indications, but inconsistent and fragmentary on a broader level. This often results in inefficient drug development, increasing evidence requirements, lack of patient-centered outcomes that address unmet medical needs and facilitate adherence, and consequently, lack of required therapeutic options and high costs to society and involved parties. Improved patient involvement can drive the development of innovative medicines that deliver more relevant and impactful patient outcomes and make medicine development faster, more efficient, and more productive. It can lead to better prioritization of early research; improved resource allocation; improved trial protocol designs that better reflect patient needs; and, by addressing potential barriers to patient participation, enhanced recruitment and retention. It may also improve trial conduct and lead to more focused, economically viable clinical trials. At launch and beyond, systematic patient involvement can also improve the ongoing benefit-risk assessment, ensure that public funds prioritize medicines of value to patients, and further the development of the medicine. Progress toward a universal framework for patient involvement requires a joint, precompetitive, and international approach by all stakeholders, working in true partnership to consolidate outputs from existing initiatives, identify gaps, and develop a comprehensive framework. It is essential that all stakeholders participate to drive adoption and implementation of the framework and to ensure that patients and their needs are embedded at the heart of medicines development and lifecycle management.

Mechanical complications of central venous catheters.

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%. Complications included failure to place the CVC (n = 86), arterial puncture (n = 18), improper position (n = 14), pneumothorax (n = 5 in 258 subclavian and internal jugular attempts), hematoma (n = 3), hemothorax (n = 1), and asystolic cardiac arrest of unknown etiology (n = 1). Male patients had a significantly higher complication rate than female patients (37% vs 27%, P = .04). The subclavian approach had a higher complication rate than the internal jugular or the femoral approach (39% vs 33% vs. 24%, P = .02). The complication rate increased with the number of percutaneous punctures, with a rate of 54% when more than 2 punctures were required.

Achieving house staff competence in emergency airway management: results of a teaching program using a computerized patient simulator.

OBJECTIVES: 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. In teaching hospitals, medical interns are first responders to in-hospital cardiac arrests. Our objective was to design and test a program using a computer-controlled patient simulator to train medical interns and demonstrate their competence in initial airway management. DESIGN: Prospective, randomized, controlled, unblinded trial. SETTING: Internal medicine residency training program in an urban teaching hospital. PARTICIPANTS: All 50 starting internal medicine interns in July 2002, all Advanced Cardiac Life Support certified in June 2002. INTERVENTIONS: All interns were tested in initial airway management skills and then were randomly assigned to receive either immediate or delayed individualized training using a computer-controlled patient simulator. The computer-simulated training process consisted of a scenario of respiratory arrest. The interns were challenged with the scenario twice following testing. The interns were debriefed extensively and given hands-on training by the attending using the simulator until they achieved perfect performance. MEASUREMENTS AND MAIN RESULTS: Initial airway management was divided into specific scorable steps. Individual step scores and total scores were recorded for each intern on initial and repeat testing. For 10 months following simulator training, intern airway management skills were scored in actual patient airway events. Despite recent Advanced Cardiac Life Support training and certification, all starting medical interns demonstrated poor airway management skills. The immediate training group showed significant improvement in initial airway management when tested before and 4 wks after training. In contrast, the delayed training group showed no significant improvement. Direct observation of interns in actual initial airway events revealed excellent clinical performance. CONCLUSIONS: Individualized training of medical interns using a computer-controlled patient simulator is an effective means of achieving and measuring competence in initial airway management skills. The improvement appears to be transferable to the bedside of real patients.

Massive pulmonary embolism: a comparison of radiological and clinical characteristics and outcomes.

STUDY OBJECTIVES: To describe the clinical features of radiographically massive pulmonary embolism (MPE). DESIGN: Retrospective analysis. SETTING: A 1,368-bed teaching hospital. PATIENTS OR PARTICIPANTS: Patients with pulmonary embolism between June 1997 and December 1999. INTERVENTIONS: Radiographic reports of patients with a radiographic diagnosis of pulmonary embolism were reviewed to determine whether MPE (>50% vascular occlusion) was present. For patients with MPE, vital signs, respiratory and cardiac symptoms, medical history, arterial blood gases, electrocardiographic (ECG) and echocardiographic results, treatment, and hospital mortality were recorded. MEASUREMENTS AND RESULTS: Fifty-four patients with MPE were identified. Patient age range was 28-91 years (mean 71 years). Symptoms were: dyspnea in 38 (70%), chest pain in 21 (38%), syncope in 12 (22%), palpitations in 6 (11%), systolic blood pressure <90 mmHg in 12 (22%), tachycardia (>120 beats/min) in 15 (28%) and tachypnea (respiratory rate >30) in 15 (28%). Pa O(2) (arterial partial pressure of oxygen) was less than 60 mmHg in 28 (71%) and the alveolar-arterial oxygen gradient was always greater than 20. ECG had an S1Q3T3 pattern in 6 (12%). Echocardiography revealed right ventricular dilatation in 12/31 (38%). Forty-nine patients received anticoagulation treatment, 4 (7%) received thrombolytic therapy with anticoagulation, 5 had inferior vena cava filters (IVC) alone, 6 received IVC filters with anticoagulation, and 2 received thrombolytic therapy, anticoagulation, and IVC filters. Eighteen (33%) patients were treated in the intensive care unit, 3 (5.5%) with mechanical ventilation. Fifty (93%) patients were eventually discharged and 4 (7%) died. Two of the deaths were not attributable to MPE. CONCLUSIONS: Patients with MPE usually present with dyspnea and hypoxemia, and most survive without thrombolytic therapy.