Total integrated performance excellence system (TIPES): A true north direction for a clinical trial support center.

This paper presents the quality journey taken by a Federal organization over more than 20 years. These efforts have resulted in the implementation of a Total Integrated Performance Excellence System (TIPES) that combines key principles and practices of established quality systems. The Center has progressively integrated quality system frameworks including the Malcom Baldrige National Quality Award (MBNQA) Framework and Criteria for Performance Excellence, ISO 9001, and the Organizational Project Management Maturity Model (OPM3), as well as supplemental quality systems of ISO 15378 (packaging for medicinal products) and ISO 21500 (guide to project management) to systematically improve all areas of operations. These frameworks were selected for applicability to Center processes and systems, consistency and reinforcement of complimentary approaches, and international acceptance. External validations include the MBNQA, the highest quality award in the US, continued registration and conformance to ISO standards and guidelines, and multiple VA and state awards. With a focus on a holistic approach to quality involving processes, systems and personnel, this paper presents activities and lessons that were critical to building TIPES and establishing the quality environment for conducting clinical research in support of Veterans and national health care.

In situ medical simulation investigation of emergency department procedural sedation with randomized trial of experimental bedside clinical process guidance intervention.

INTRODUCTION: Patient safety during emergency department procedural sedation (EDPS) can be difficult to study. Investigators sought to delineate and experimentally assess EDPS performance and safety practices of senior-level emergency medicine residents through in situ simulation. METHODS: Study sessions used 2 pilot-tested EDPS scenarios with critical action checklists, institutional forms, embedded probes, and situational awareness questionnaires. An experimental informatics system was separately developed for bedside EDPS process guidance. Postgraduate year 3 and 4 subjects completed both scenarios in randomized order; only experimental subjects were provided with the experimental system during second scenarios. RESULTS: Twenty-four residents were recruited into a control group (n = 12; 6.2 ± 7.4 live EDPS experience) and experimental group (n = 12; 11.3 ± 8.2 live EDPS experience [P = 0.10]). Critical actions for EDPS medication selection, induction, and adverse event recognition with resuscitation were correctly performed by most subjects. Presedation evaluations, sedation rescue preparation, equipment checks, time-outs, and documentation were frequently missed. Time-outs and postsedation assessments increased during second scenarios in the experimental group. Emergency department procedural sedation safety probe detection did not change across scenarios in either group. Situational awareness scores were 51% ± 7% for control group and 58% ± 12% for experimental group. Subjects using the experimental system completed more time-outs and scored higher Simulation EDPS Safety Composite Scores, although without comprehensive improvements in EDPS practice or safety. CONCLUSIONS: Study simulations delineated EDPS and assessed safety behaviors in senior emergency medicine residents, who exhibited the requisite medical knowledge base and procedural skill set but lacked some nontechnical skills that pertain to emergency department microsystem functions and patient safety. The experimental system exhibited limited impact only on in-simulation time-out compliance.

Simulation intervention with manikin-based objective metrics improves CPR instructor chest compression performance skills without improvement in chest compression assessment skills.

INTRODUCTION: Cardiopulmonary resuscitation (CPR) instructor/coordinator (CPR-I/C) adherence to published guidelines during resuscitation and learner assessment for basic life support (BLS)/CPR skills has not been experimentally studied. Investigators sought to (1) determine the quality of CPR-I/C chest compression and the accuracy of CPR-I/C chest compression assessment, and (2) improve CPR-I/C compression and assessment skills through cardiac arrest simulations with objective in-scenario performance feedback. METHODS: Thirty CPR-I/Cs (median, 20 years [range, 4-40 years] of BLS provider experience; 6 years [range 1-40 years] of BLS instructor experience) were randomized to control or experimental group. Each subject performed compressions during a 2-minute simulation, then reviewed 6 videos of simulated CPR performances (featuring prespecified chest compression parameters) for scoring as "pass" or "needs remediation." Subjects participated in a second simulation with or without real-time manikin compression feedback, then reviewed 6 additional videos. Primary outcome variables were the proportion of subjects with more than 80% (American Heart Association regional criteria) or more than 23 of 30 (ie, 77%; American Heart Association instructor manual criteria) correct compressions and subjects' accuracy of "pass"/"needs remediation" assessment for videos. The secondary outcome variable was correlation between subjects' correctness of chest compressions and their assessment accuracy for simulated CPR compression performance. RESULTS: All CPR-I/C subjects compressed suboptimally at baseline; real-time manikin feedback improved the proportion of subjects with more than 77% correct compressions to 0.53 (P < 0.01). Video review data revealed persistently low CPR-I/C assessment accuracy. Correlation between subjects' correctness of compressions and their assessment accuracy remained poor regardless of interventions. CONCLUSIONS: Real-time compression feedback during simulation improved CPR-I/C's chest compression performance skills without comparable improvement in chest compression assessment skills.

Development of simulated chest compression videos for objective evaluation of CPR instructors.

The goal of the development phase of the CPR Instructor Real-time Review through Use of Simulation (CIRRUS) research program was to create a video library portraying a spectrum of objectively verified simulation chest compression performances. Investigators scripted and recorded 12 two-person cardiopulmonary resuscitation (CPR) videos with specific chest compression parameters encompassing a range of hand positions, rates, depths, and chest releases in combinations that proportionately reflected typical learner cohort performances. Six videos were designated to portray adequate chest compressions, whereas the other six videos were to feature inadequate compressions. All 12 final 2-minute videos showed chest compression parameters as originally specified within tolerances to comply with American Heart Association recommendations. Deviations from specification were 1 to 10 cpm (mode = 4 cpm) for compression rate and -1.4 to 1.3 cm (mode = 0.9 cm) for depth. The program's collection of simulated CPR videos with objectively verified chest compression performances may help researchers and educators study and improve CPR instruction and provider preparation for the effective delivery of optimal patient care.

Pilot-phase findings from high-fidelity In Situ medical simulation investigation of emergency department procedural sedation.

INTRODUCTION: Emergency department procedural sedation (EDPS) is becoming widespread. Simulation may enhance patient safety through evidence-based training, effective assessment, and research of EDPS operators in pertinent knowledge, skills, processes, and teamwork. METHODS: Investigators developed a 2-scenario in situ simulation-based methodology and research tool kit for objective examination of EDPS practice. The emphasis was on protocol-driven presedation preparation, intrasedation vigilance and readiness for adverse events, and postsedation reassessment. Pilot sessions were conducted to test the methodology at an academic 719-bed hospital, with Institutional Review Board approval. RESULTS: Five interns and 5 attending emergency physicians completed pilot sessions resulting in protocol revisions to optimize simulation consistency, research tool sets, data acquisition, and operational conditions. Pilot data sets demonstrated interscenario consistency and intersubject reproducibility for timing, progression, and duration of critical EDPS events; high levels of perceived realism and relevance; and utility and suggested validity of the study methodology as an EDPS research mechanism. Small sample sizes limited the study methodology's ability to distinguish between the subject groups' clinical performances (critical action completion, probe detection, and situational awareness) except with composite scoring of presedation and postsedation assessments. Key EDPS preparation, adverse event management, and reassessment actions were selected to derive a Simulation EDPS Safety Composite Score that differentiated inexperienced [4.60 ± 0.8 on a 10-point score (n = 3)] and experienced EDPS operators [8.95 ± 1.03 (n = 5); P = 0.0007]. CONCLUSIONS: In situ simulation is a useful and relevant means to investigate EDPS patient safety. Pilot sessions have cleared the way for further experimental safety intervention research and development with the simulation-based methodology.

Comparison of sudden cardiac arrest resuscitation performance data obtained from in-hospital incident chart review and in situ high-fidelity medical simulation.

INTRODUCTION: High-fidelity medical simulation of sudden cardiac arrest (SCA) presents an opportunity for systematic probing of in-hospital resuscitation systems. Investigators developed and implemented the SimCode program to evaluate simulation's ability to generate meaningful data for system safety analysis and determine concordance of observed results with institutional quality data. METHODS: Resuscitation response performance data were collected during in situ SCA simulations on hospital medical floors. SimCode dataset was compared with chart review-based dataset of actual (live) in-hospital resuscitation system performance for SCA events of similar acuity and complexity. RESULTS: 135 hospital personnel participated in nine SimCode resuscitations between 2006 and 2008. Resuscitation teams arrived at 2.5+/-1.3 min (mean+/-SD) after resuscitation initiation, started bag-valve-mask ventilation by 2.8+/-0.5 min, and completed endotracheal intubations at 11.3+/-4.0 min. CPR was performed within 3.1+/-2.3 min; arrhythmia recognition occurred by 4.9+/-2.1 min, defibrillation at 6.8+/-2.4 min. Chart review data for 168 live in-hospital SCA events during a contemporaneous period were extracted from institutional database. CPR and defibrillation occurred later during SimCodes than reported by chart review, i.e., live: 0.9+/-2.3 min (p<0.01) and 2.1+/-4.1 min (p<0.01), respectively. Chart review noted fewer problems with CPR performance (simulated: 43% proper CPR vs. live: 98%, p<0.01). Potential causes of discrepancies between resuscitation response datasets included sample size and data limitations, simulation fidelity, unmatched SCA scenario pools, and dissimilar determination of SCA response performance by complementary reviewing methodologies. CONCLUSION: On-site simulations successfully generated SCA response measurements for comparison with live resuscitation chart review data. Continued research may refine simulation's role in quality initiatives, clarify methodologic discrepancies and improve SCA response.

Lenticular island pedicle flap.

BACKGROUND: Various modifications of island pedicle flaps have been devised to address difficult reconstructive situations. Nevertheless, currently described designs can have limited applicability in many cases, especially for large defects and defects near free margins. OBJECTIVE: Our purpose is to describe and illustrate a curvilinear lens-shaped island pedicle flap modification flap called the "lenticular" island pedicle flap (LIPF). METHODS: Illustrative examples with the descriptive technique and a flap comparison chart are provided for the LIPF. RESULTS: Conceptually, the LIPF is a hybrid design between a rotation flap and a traditional triangular island pedicle flap (TIPF). The flap fills a void between the designs and applications of the TIPF and the dog-ear rotation flap. As such, the flap reproducibly exhibits simultaneous rotational and translational movement to achieve wound coverage in situations in which neither a rotation flap nor a TIPF would be ideal. The lenticular shape is not incidental but, in fact, maximizes wound coverage by the flap. The lenticular design is often accommodated by a teardrop-shaped wound modification, which facilitates inset of the flap. The benefits of the LIPF include (a) closure of wounds in skin too tight to accommodate a TIPF or a rotation flap, (b) redirection of the closure's tension vector, and (c) an esthetically superior scar line. CONCLUSION: The LIPF modification provides several benefits relative to commonly used flaps that rely primarily on either translational or rotational movement to achieve wound closure.

Treatment of palmoplantar keratoderma with continuous infusion 5-fluorouracil.

A 49-year-old man electively chose to undergo a trial of intravenous chemotherapy with 5-fluorouracil (5-FU) for his inherited punctate palmoplantar keratoderma (PPK). His father also had this skin disorder, which coincidentally cleared after 2 courses of chemotherapy consisting of 5-FU and cisplatin to treat his lung cancer, prompting the patient to undergo this trial of therapy. After the patient's first course of a 5-day continuous infusion (CI) of 5-FU (1000 mg/m2 per day), the lesions on his hands and feet regressed by approximately 80%. However, after completion of each course, the lesions seemed to reappear to some degree. The patient desired to pursue further therapy; therefore, CI 5-FU at a dose of 250 mg/m2 per day (500 mg/d) was instituted, while pyridoxine was avoided in the hope of causing a hand-foot syndrome that may provide some long-term benefit. After receiving a 12-week course of therapy of CI 5-FU at 250 mg/m2 per day, his lesions were approximately 95% improved, with only a few minute punctate keratoses remaining. At follow-up nearly 4 years later, the lesions remain 90% cleared.

The role of the pharmacy coordinating center in the DIG trial.

Large simple trials (LSTs) emerged in response to the need for large sample sizes to answer important clinical questions in which treatments have a moderate effect on clinical endpoints. Between 1991 and 1996 the National Heart, Lung, and Blood Institute and the Department of Veterans Affairs (VA) Cooperative Studies Program conducted an LST entitled "Digitalis Investigation Group (DIG): Trial to Evaluate the Effect of Digitalis on Mortality in Heart Failure." The VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center served as the DIG pharmacy coordinating center (PCC). As a direct result of involvement in the DIG trial, the PCC identified the need for an increased emphasis on computerization and automated support of clinical trials, especially LSTs.