No abstract

The number of available donor organs limits lung transplantation, the only lifesaving therapy for the increasing population of patients with end-stage lung disease. A prevalent etiology of injury that renders lungs unacceptable for transplantation is gastric aspiration, a deleterious insult to the pulmonary epithelium. Currently, severely damaged donor lungs cannot be salvaged with existing devices or methods. Here we report the regeneration of severely damaged lungs repaired to meet transplantation criteria by utilizing an interventional cross-circulation platform in a clinically relevant swine model of gastric aspiration injury. Enabled by cross-circulation with a living swine, prolonged extracorporeal support of damaged lungs results in significant improvements in lung function, cellular regeneration, and the development of diagnostic tools for non-invasive organ evaluation and repair. We therefore propose that the use of an interventional cross-circulation platform could enable recovery of otherwise unsalvageable lungs and thus expand the donor organ pool.

IMPORTANCE Quality improvement platforms commonly use risk-adjusted morbidity and mortality to profile hospital performance. However, given small hospital caseloads and low event rates for some procedures it is unclear whether these outcomes reliably reflect hospital performance. OBJECTIVE To determine the reliability of risk-adjusted morbidity and mortality for hospital performance profiling using clinical registry data. DESIGN Retrospective cohort study SETTING/DATA SOURCE American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP), 2009 PARTICIPANTS All patients who underwent colon resection, pancreatic resection, laparoscopic gastric by pass, ventral hernia repair, abdominal aortic aneurysm (AAA) repair, and lower extremity by pass (n=55,946 patients). MAIN OUTCOMES AND MEASURES Outcomes included risk-adjusted overall morbidity, severe morbidity, and mortality. We assessed reliability (0 to 1 scale, where 0=completely unreliable and 1=perfectly reliable) for all three outcomes. We also quantified the number of hospitals meeting minimum acceptable reliability thresholds (>0.70=good reliability, >0.50=fair reliability) for each outcome. RESULTS For overall morbidity, the most common outcome studied, the average reliability depended on both the sample size (i.e., how high the hospital caseload was) and the event rate (i.e., how frequently the outcome occurred). For example, average reliability for overall morbidity was low for AAA repair (reliability 0.29; sample size of 25 cases/year and event rate of 18%). In contrast, average reliability for overall morbidity was higher for colon resection (reliability 0.61; sample size 114 cases/year and event rate of 27%). Colon resection (38% of hospitals), pancreatic resection (7% of hospitals), and laparoscopic gastric by pass (12%) were the only procedures for which any hospitals met a reliability threshold of 0.70 for overall morbidity. Because severe morbidity and mortality are less frequent outcomes, their average reliability was lower and even fewer hospitals met thresholds for minimum reliability. CONCLUSIONS AND RELEVANCE Most commonly reported outcome measures have low reliability for differentiating hospital performance. This is especially important for clinical registries that sample rather than collect 100% of cases, which can limit hospital case accrual. Eliminating sampling to achieve the highest possible caseloads, adjusting for reliability, and using advanced modeling strategies (e.g., hierarchical modeling) is necessary for clinical registries to increase their benchmarking reliability.

The Joint Commission on Accreditation requires hospitals to conduct peer review to retain accreditation. Despite the intended purpose of improving quality medical care, the peer review process has suffered several setbacks throughout its tenure. In the 1980s, abuse of peer review for personal economic interest led to a highly publicized multimillion-dollar verdict by the United States Supreme Court against the perpetrating physicians and hospital. The verdict led to decreased physician participation for fear of possible litigation. Believing that peer review was critical to quality medical care, Congress subsequently enacted the Health Care Quality Improvement Act (HCQIA) granting comprehensive legal immunity for peer reviewers to increase participation. While serving its intended goal, HCQIA has also granted peer reviewers significant immunity likely emboldening abuses resulting in Sham Peer Reviews. While legal reform of HCQIA is necessary to reduce sham peer reviews, further measures including the need for standardization of the peer review process alongside external organizational monitoring are critical to improving peer review and reducing the prevalence of sham peer reviews.