How Should Risk Managers Respond to Cases for Which No Risk Profile Exists?

Rapid innovation makes some devices available for patient implantation prior to extensive preclinical trials. This article reviews information that risk managers can utilize to help patient-subjects and clinician-researchers make informed decisions about new device implantation in the absence of preclinical trial data. Novel devices should be regarded by risk managers as sources of unknowns with potential for procedural complications and other harms. Risk-benefit analyses during informed consent should include patient-subjects' preferences, experience of the implanting surgical team, disclosure of conflicts of interest, and postprocedure follow-up planning. Checklists can help risk managers facilitate critical conversations and decision making about whether to implant devices with no extant risk profile.

Interprofessional Practice and Education in Clinical Learning Environments: Frontlines Perspective.

This Invited Commentary is written by coauthors working to implement and study new models of interprofessional practice and education in clinical learning environments. There are many definitions and models of collaborative care, but the essential element is a spirit of collaboration and shared learning among health professionals, patients, and family members. This work is challenging, yet the benefits are striking. Patients and family members feel seen, heard, and understood. Health care professionals are able to contribute and feel appreciated in satisfying ways. Learners feel included. Care interactions are richer and less hierarchical, and human dimensions are more central. A crucial insight is that collaborative care requires psychological safety, so that people feel safe to speak up, ask questions, and make suggestions. The most important transformation is actively engaging patients and families as true partners in care creation. A leveling occurs between patients, family members, and health professionals, resulting from closer connections, deeper understandings, and greater mutual appreciation. Leadership happens at all levels in collaborative care, requiring team-level capabilities that can be learned and modeled, including patience, curiosity, and sharing power. These abilities grow as teams work and learn together, and can be intentionally advanced by reconfiguring organizational structures and care routines to support collective team reflection. Collaborative care requires awareness and deliberate practice both individually and as a team together. Respectful work is required, and setbacks should be considered normal at first. Once people have experienced the benefits of collaborative care, most "never want to go back."

Multivariable prediction of in-hospital mortality associated with aortic and mitral valve surgery in Northern New England.

BACKGROUND: Predicting risk for aortic and mitral valve surgery is important both for informed consent of patients and objective review of surgical outcomes. Development of reliable prediction rules requires large data sets with appropriate risk factors that are available before surgery. METHODS: Data from eight Northern New England Medical Centers in the period January 1991 through December 2001 were analyzed on 8943 heart valve surgery patients aged 30 years and older. There were 5793 cases of aortic valve replacement and 3150 cases of mitral valve surgery (repair or replacement). Logistic regression was used to examine the relationship between risk factors and in-hospital mortality. RESULTS: In the multivariable analysis, 11 variables in the aortic model (older age, lower body surface area, prior cardiac operation, elevated creatinine, prior stroke, New York Heart Association [NYHA] class IV, congestive heart failure [CHF], atrial fibrillation, acuity, year of surgery, and concomitant coronary artery bypass grafting) and 10 variables in the mitral model (female sex, older age, diabetes, coronary artery disease, prior cerebrovascular accident, elevated creatinine, NYHA class IV, CHF, acuity, and valve replacement) remained independent predictors of the outcome. The mathematical models were highly significant predictors of the outcome, in-hospital mortality, and the results are in general agreement with those of others. The area under the receiver operating characteristic curve for the aortic model was 0.75 (95% confidence interval [CI], 0.72 to 0.77), and for the mitral model, 0.79 (95% CI, 0.76 to 0.81). The goodness-of-fit statistic for the aortic model was chi(2) [8 df] = 11.88, p = 0.157, and for the mitral model it was chi(2) [8 df] = 5.45, p = 0.708. CONCLUSIONS: We present results and methods for use in day-to-day practice to calculate patient-specific in-hospital mortality after aortic and mitral valve surgery, by the logistic equation for each model or a simple scoring system with a look-up table for mortality rate.

Surgical management of scimitar syndrome: an alternative approach.

OBJECTIVE: The scimitar syndrome is a congenital anomaly that consists in part of total or partial anomalous venous drainage of the right lung to the inferior vena cava. Surgical approaches to the scimitar syndrome have varied according to the anatomic and pathologic features presented in each case. The aim of this study was to present an alternative approach to the surgical correction of scimitar syndrome. METHODS: Nine patients with the scimitar syndrome were operated on between 1990 and 2000. They comprised 1 male and 8 female patients (mean age 11.5 +/- 17.6 years). All patients had symptoms, with recurrent pneumonia or respiratory tract infections and pulmonary/systemic flow ratios greater than 1.5:1.0. None of the patients had pulmonary hypertension or an atrial septal defect. All patients underwent repair of the anomalous scimitar vein by direct reimplantation into the left atrium without cardiopulmonary bypass. Two patients underwent concomitant resection of a right lower lobe sequestration. Follow-up was complete in all cases. RESULTS: There were no operative or late deaths, and no patients have required reoperation. At the time of follow-up (mean 55 +/- 46 months), echocardiography demonstrated a patent anastomosis in all patients without any evidence of restenosis. CONCLUSION: This clinical experience indicates that an alternative surgical approach to scimitar syndrome is direct anastomosis of the scimitar vein to the posterior aspect of the left atrium using a right thoracotomy without cardiopulmonary bypass. This procedure is safe and effective and obviates the need for long intra-atrial baffles and the use of the extracorporeal circuit.

John M. Eisenberg Patient Safety Awards. System innovation: Concord Hospital.

BACKGROUND: The Cardiac Surgery Program at Concord Hospital (Concord, NH) restructured clinical teamwork for improved safety and effectiveness on the basis of theory and practice from human factors science, aviation safety, and high-reliability organization theory. A team-based, collaborative rounds process--the Concord Collaborative Care Model--that involved use of a structured communications protocol was conducted daily at each patient's bedside. METHODS: The entire care team agreed to meet at the same time each day (8:45 AM to 9:30 AM) to share information and develop a plan of care for each patient, with patient and family members as active participants. The cardiac surgery team developed a structured communications protocol adapted from human factors science. To provide a forum for discussion of team goals and progress and to address system-level concerns, a biweekly system rounds process was established. RESULTS: Following implementation of collaborative rounds, mortality of Concord Hospital's cardiac surgery patients declined significantly from expected rates. Satisfaction rates of open heart patients scores were consistently in the 97th-99th percentile nationally. A quality of work life survey indicated that in every category, providers expressed greater satisfaction with the collaborative care process than with the traditional rounds process. Practice patterns in the Cardiac Surgery Program at Concord Hospital have changed to a much more collaborative and participatory process, with improved outcomes, happier patients, and more satisfied practitioners. A culture of continuous program improvement has been implemented that continues to evolve and produce benefits.