[Show abstract][Hide abstract] ABSTRACT: To determine casemix adjusted hospital level utilization of minimally invasive surgery for four common surgical procedures (appendectomy, colectomy, total abdominal hysterectomy, and lung lobectomy) in the United States.
BMJ Clinical Research 01/2014; 349:g4198. · 14.09 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Since its Food and Drug Administration (FDA) approval, robot-assisted laparoscopic surgery has grown with expanding indications. One factor used to expand indications is device-related complications. We designed a study to evaluate device-related robotic surgery complications reported to FDA.
We searched the FDA device-related complication database, LexisNexis, and PACER (Public Access to Court Electronic Records) to identify robotic surgery-related complications over a 12-year period (January 1, 2000 to August 1, 2012). Cases from LexisNexis and PACER were cross-referenced with the FDA database to determine cases where an FDA report was inaccurate, filed late or not filed.
A total of 245 events were reported to the FDA during the study period, including 71 deaths and 174 nonfatal injuries. Median time to report an event to the FDA was 30 days (range = 0-930 days). Eight cases were identified from the LexisNexis and PACER searches where FDA reports were improperly filed. In five of these, no report was filed with a mean follow-up of 4.1 years (range = 2.3-5.8 years). In the three cases where a report was filed, the mean time between the event and the FDA report was 20.4 months (611 days, range = 292-930 days).
It is important that the true incidence of complications with robotic-assisted laparoscopic surgery be known to ensure continued safe innovation.
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: A computed tomography (CT) scan is often the only study needed prior to surgery for resectable solid pancreas masses. However, many patients are evaluated with multiple studies and interventions that may be unnecessary. METHODS: We conducted a retrospective review of patients who presented to the Johns Hopkins Multidisciplinary Pancreas Cancer Clinic with a clearly resectable solid pancreas mass, >1 cm in size over a 2-year period (6/2007-6/2009) and underwent resection. Pancreas specialists reviewed patient records and identified an index CT with a solid pancreas mass deemed to be resectable for curative intent. Data were collected on all studies and interventions between the index CT and the surgery. RESULTS: A total of 101 patients had an index CT. Following the index CT and before surgery, 78 patients had at least one CT, 19 had magnetic resonance imaging, 9 had a positron emission tomography scan, and 66 underwent pancreatic biopsy. Patients underwent a mean of three studies with a mean added cost of $3,371 per patient. Preoperative tests and interventions were associated with a longer time to definitive surgical intervention. CONCLUSION: Wide variation exists for evaluation of newly discovered resectable solid pancreas masses, which is associated with delays to surgical intervention and added costs.
Journal of Gastrointestinal Surgery 05/2013; · 2.36 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Catastrophic medical malpractice payouts, $1 million or greater, greatly influence physicians' practice, hospital policy, and discussions of healthcare reform. However, little is known about the specific characteristics and overall cost burden of these payouts. We reviewed all paid malpractice claims nationwide using the National Practitioner Data Bank over a 7-year period (2004-2010) and used multivariate regression to identify risk factors for catastrophic and increased overall payouts. Claims with catastrophic payouts represented 7.9% (6,130/77,621) of all paid claims. Factors most associated with catastrophic payouts were patient age less than 1 year; quadriplegia, brain damage, or lifelong care; and anesthesia allegation group. Compared with court judgments, settlement was associated with decreased odds of a catastrophic payout (odds ratio, 0.31; 95% confidence interval [CI], 0.22-0.42) and lower estimated average payouts ($124,863; 95% CI, $101,509-144,992). A physician's years in practice and previous paid claims history had no effect on the odds of a catastrophic payout. Catastrophic payouts averaged $1.4 billion per year or 0.05% of the National Health Expenditures. Preventing catastrophic malpractice payouts should be only one aspect of comprehensive patient safety and quality improvement strategies. Future studies should evaluate the benefits of targeted interventions based on specific patient safety event characteristics.
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Surgical never events are being used increasingly as quality metrics in health care in the United States. However, little is known about their costs to the health care system, the outcomes of patients, or the characteristics of the providers involved. We designed a study to describe the number and magnitude of paid malpractice claims for surgical never events, as well as associated patient and provider characteristics. METHODS: We used the National Practitioner Data Bank, a federal repository of medical malpractice claims, to identify malpractice settlements and judgments of surgical never events, including retained foreign bodies, wrong-site, wrong-patient, and wrong-procedure surgery. Payment amounts, patient outcomes, and provider characteristics were evaluated. RESULTS: We identified a total of 9,744 paid malpractice settlement and judgments for surgical never events occurring between 1990 and 2010. Malpractice payments for surgical never events totaled $1.3 billion. Mortality occurred in 6.6% of patients, permanent injury in 32.9%, and temporary injury in 59.2%. Based on literature rates of surgical adverse events resulting in paid malpractice claims, we estimated that 4,082 surgical never event claims occur each year in the United States. Increased payments were associated with severe patient outcomes and claims involving a physician with multiple malpractice reports. Of physicians named in a surgical never event claim, 12.4% were later named in at least 1 future surgical never event claim. CONCLUSION: Surgical never events are costly to the health care system and are associated with serious harm to patients. Patient and provider characteristics may help to guide prevention strategies.
[Show abstract][Hide abstract] ABSTRACT: OBJECTIVE: Surgical site infections (SSIs) are common, costly, and often preventable. There are no national requirements for measuring or reporting hospital SSI rates and state-level monitoring occurs with little coordination between states. We designed a study to describe the current status of SSI reporting in the United States. METHODS: We reviewed SSI monitoring and reporting legislation in all 50 states in September 2010. Data collected included whether SSI monitoring and reporting legislation exists, if public reporting is required, how the data are accessible, and for which procedures SSI data are reported. RESULTS: Twenty-one (42%) states have legislation for SSI monitoring and reporting. All 21 of these states require public release of findings. Of the states with legislation, eight (38%) currently have SSI data available publicly. A range of two to seven procedures were reported for SSI measurement by individual states. Eighteen (86%) states use state agency websites to make their data publicly available. CONCLUSION: There is wide variation in state monitoring and reporting of SSI rates. Standardized reporting may be needed so that consumers can make informed health choices based on quality metrics.
[Show abstract][Hide abstract] ABSTRACT: Hospital readmission is emerging as a quality indicator by the state, federal, and private payors with the goal of denying payment for select readmissions.
We designed a study to measure the rate, cost, and risk factors for hospital readmission after colorectal surgery.
We reviewed commercial health insurance records of 10,882 patients who underwent colorectal surgery over a 7-year period (2002-2008).
All patients undergoing colon and/or rectal resection ages 18 to 64 were included.
The 30-day and 90-day readmission rates, the number of readmissions per patient, the median cost, length of stay, and risk factors for readmission were analyzed.
Thirty-day readmission occurred in 11.4% (1239/10,882) of patients. Readmission between 31 and 90 days occurred in an additional 11.9% (1027/10,882) of patients for a total 90-day readmission rate of 23.3%. Two or more readmissions occurred in 1.4% (155) and 5.2% (570) of patients in the first 30 and 90 days. Mean readmission length of stay was 8 days, and the median cost per stay was $8885. Initial hospitalization risk factors for readmission were the diagnosis of a surgical site infection (OR 1.2), creation of a stoma (OR 1.2), discharge to nursing home (OR 1.2), index admission length of stay >7 days (OR 1.2), proctectomy (OR 1.1), and severity of illness score (severity of illness 3 = OR 1.1; severity of illness 4 = OR 1.3).
Readmission after colorectal surgery occurs frequently and is associated with a cost of approximately $9000 per readmission. Nationwide these findings account for $300 million in readmission costs annually for colorectal surgery alone. Clinical and systems-based prevention strategies are needed to reduce readmission.
Diseases of the Colon & Rectum 12/2011; 54(12):1475-9. · 3.34 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Surgical wound classification has been the foundation for infectious risk assessment, perioperative protocol development, and surgical decision-making. The wound classification system categorizes all surgeries into: clean, clean/contaminated, contaminated, and dirty, with estimated postoperative rates of surgical site infection (SSI) being 1%-5%, 3%-11%, 10%-17%, and over 27%, respectively. The present study evaluates the associated rates of the SSI by wound classification using a large risk adjusted surgical patient database.
A cross-sectional study was performed using the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) dataset between 2005 and 2008. All surgical cases that specified a wound class were included in our analysis. Patient demographics, hospital length of stay, preoperative risk factors, co-morbidities, and complication rates were compared across the different wound class categories. Surgical site infection rates for superficial, deep incisional, and organ/space infections were analyzed among the four wound classifications using multivariate logistic regression.
A total of 634,426 cases were analyzed. From this sample, 49.7% were classified as clean, 35.0% clean/contaminated, 8.56% contaminated, and 6.7% dirty. When stratifying by wound classification, the clean, clean/contaminated, contaminated, and dirty wound classifications had superficial SSI rates of 1.76%, 3.94%, 4.75%, and 5.16%, respectively. The rates of deep incisional infections were 0.54%, 0.86%, 1.31%, and 2.1%. The rates for organ/space infection were 0.28%, 1.87%, 2.55%, and 4.54%.
Using ACS-NSQIP data, the present study demonstrates substantially lower rates of surgical site infections in the contaminated and dirty wound classifications than previously reported in the literature.
Journal of Surgical Research 06/2011; 174(1):33-8. · 2.02 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To examine the prevalence and content of robotic surgery information presented on websites of U.S. hospitals. We completed a systematic analysis of 400 randomly selected U.S. hospital websites in June of 2010. Data were collected on the presence and location of robotic surgery information on a hospital's website; use of images or text provided by the manufacturer; use of direct link to manufacturer website; statements of clinical superiority; statements of improved cancer outcome; mention of a comparison group for a statement; citation of supporting data and mention of specific risks. Forty-one percent of hospital websites described robotic surgery. Among these, 37% percent presented robotic surgery on their homepage, 73% used manufacturer-provided stock images or text, and 33% linked to a manufacturer website. Statements of clinical superiority were made on 86% of websites, with 32% describing improved cancer control, and 2% described a reference group. No hospital website mentioned risks. Materials provided by hospitals regarding the surgical robot overestimate benefits, largely ignore risks and are strongly influenced by the manufacturer.
Journal for Healthcare Quality 05/2011; 33(6):48-52.