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Amy K Rosen,
Hillary J Mull,
Haytham Kaafarani,
Jonathan Nebeker,
Stephanie Shimada,
Amy Helwig,
Brian Nordberg,
Brenna Long,
Lucy A Savitz,
Christopher W Shanahan, Kamal Itani
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ABSTRACT: The objective of this study is to evaluate the performance of 5 triggers to detect adverse events (AEs) associated with outpatient surgery. Triggers use surveillance algorithms derived from clinical logic to flag cases where AEs have most likely occurred. Current efforts to detect AEs have focused primarily on the inpatient setting, despite the increase in outpatient surgery in all health care settings.
Using trigger logic, we retrospectively evaluated data from 3 large health care systems' electronic medical records. Patients were eligible for inclusion if they had an outpatient (same-day) surgery in 2007 and at least 1 clinical note in the 6 months after the surgery. Two nurse abstractors reviewed a sample of trigger-flagged cases from each health care system. After reaching interrater reliability targets (κ > 0.60), we calculated the positive predictive value (PPV) of each trigger and the confidence interval of the estimate.
The surgical triggers flagged between 1% and 22% of the outpatient surgery cases, with a wide range in PPVs (6.0%-62.0%). The pulmonary embolism and deep vein thrombosis and emergency department triggers had the lowest proportion of flagged cases along with the highest PPVs, showing the most promise for screening cases with a high probability of AE occurrence.
Triggers may be useful in identifying a narrow set of surgeries for further review to determine if a surgical AE occurred, complementing existing tools and initiatives used to detect AEs. Improved detection of AEs in outpatient surgery should help target potential areas for quality improvement.
Journal of Patient Safety 03/2011; 7(1):45-59.
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Aaron S Fink,
Allan V Prochazka,
William G Henderson,
Debra Bartenfeld,
Carsie Nyirenda,
Alexandra Webb,
David H Berger, Kamal Itani,
Thomas Whitehill,
James Edwards,
Mark Wilson,
Cynthia Karsonovich,
Patricia Parmelee
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ABSTRACT: In this randomized, controlled, unblinded trial, we sought to test Repeat Back's (RB) effect on comprehension following informed consent discussions.
RB has been suggested as a method to improve patient comprehension when obtaining informed consent. In this technique, patients are asked to recount what they have been told in the informed consent discussion. Despite preliminary data, this practice has not been evaluated in any large scale study.
This study was conducted in 7 Veterans Health Administration Medical Centers where informed consent is obtained using iMedConsent, the VA's computer based platform. Patients scheduled for elective surgeries were randomized to RB (a module added to the iMedConsent package) or standard iMedConsent (no RB). Comprehension was tested after the informed consent using procedure-specific questionnaires. Time stamps in the iMedConsent program estimated the time spent completing the informed consent process. Provider and patient satisfaction were measured using 5-point Likert scales. Statistical comparisons of groups were performed using t-tests and chi tests.
A total of 575 patients were enrolled. In the RB group, providers spent 2.6 minutes longer (P < 0.0001) obtaining informed consent. The mean comprehension score was significantly higher in the RB group (71.4%) versus the no RB group (68.2%, P = 0.03); the effect was greatest in carotid endarterectomy patients (RB = 73.4% vs. no RB = 67.7%, P = 0.02). Quality of decision making was rated similarly. Providers were neutral to slightly favorable regarding RB.
RB implemented within an electronic informed consent system improved patient comprehension. The additional time required was acceptable to providers. RB should be considered as an enhancement to surgical informed consent.This clinical trial was registered at http://www.clinicaltrials.gov (Identifier NCT00288899).
Annals of surgery 07/2010; 252(1):27-36. · 7.90 Impact Factor
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Aaron S Fink,
Allan V Prochazka,
William G Henderson,
Debra Bartenfeld,
Carsie Nyirenda,
Alexandra Webb,
David H Berger, Kamal Itani,
Thomas Whitehill,
James Edwards,
Mark Wilson,
Cynthia Karsonovich,
Patricia Parmelee
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ABSTRACT: Patient comprehension during surgical informed consent remains problematic. Using data from our randomized trial of methods to improve informed consent comprehension, we performed an additional analysis to define independent factors associated with improved patient understanding.
Patients scheduled for 1 of 4 elective operations (total hip arthroplasty [n = 137], carotid endarterectomy [n = 178], laparoscopic cholecystectomy [n = 179], or radical prostatectomy [n = 81]) at 7 Department of Veterans Affairs (VA) medical centers were enrolled. All informed consent discussions were performed using iMedConsent (Dialog Medical), the VA's computerized informed consent platform. Using a unique module within iMedConsent, we randomized patients to repeat back (RB), requiring correct reiteration of procedure-specific facts, or standard (STD) iMedConsent. Patient comprehension was tested after the informed consent discussion using procedure-specific questionnaires. Time spent completing the informed consent process was measured using time stamps within iMedConsent. Multiple linear regression identified factors independently associated with improved comprehension.
We enrolled 575 patients (276 RB, 299 standard); 93% were male, 74% were Caucasian, and 89% had at least a high school education. Independent factors associated with improved comprehension included race (p < 0.01), ethnicity (p < 0.05), age (p < 0.02), operation type (p < 0.01), group assignment (+/- RB; p < 0.05), and total consent time (p < 0.0001). Patient comprehension was maximized when informed consent took between 15 and 30 minutes. RB's positive impact on patient comprehension was weaker in the analysis including consent time.
Comprehension during informed consent discussions may be limited in individuals with potential language difficulty due to ethnicity or education. Total consent time was the strongest predictor of patient comprehension. Affording adequate time for informed consent discussions and using informed consent adjuncts such as RB may enhance comprehension in such individuals.
Journal of the American College of Surgeons 06/2010; 210(6):919-26. · 4.55 Impact Factor
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Darrell A Campbell,
William G Henderson,
Michael J Englesbe,
Bruce L Hall,
Michael O'Reilly,
Dale Bratzler,
E Patchen Dellinger,
Leigh Neumayer,
Barbara L Bass,
Matthew M Hutter,
James Schwartz,
Clifford Ko, Kamal Itani,
Steven M Steinberg,
Allan Siperstein,
Robert G Sawyer,
Douglas J Turner,
Shukri F Khuri
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ABSTRACT: Surgical site infections (SSI) continue to be a significant problem in surgery. The American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) Best Practices Initiative compared process and structural characteristics among 117 private sector hospitals in an effort to define best practices aimed at preventing SSI.
Using standard NSQIP methodologies, we identified 20 low outlier and 13 high outlier hospitals for SSI using data from the ACS-NSQIP in 2006. Each hospital was administered a process of care survey, and site visits were conducted to five hospitals. Comparisons between the low and high outlier hospitals were made with regard to patient characteristics, operative variables, structural variables, and processes of care.
Hospitals that were high outliers for SSI had higher trainee-to-bed ratios (0.61 versus 0.25, p < 0.0001), and the operations took significantly longer (128.3+/-104.3 minutes versus 102.7+/-83.9 minutes, p < 0.001). Patients operated on at low outlier hospitals were less likely to present to the operating room anemic (4.9% versus 9.7%, p=0.007) or to receive a transfusion (5.1% versus 8.0%, p=0.03). In general, perioperative policies and practices were very similar between the low and high outlier hospitals, although low outlier hospitals were readily identified by site visitors. Overall, low outlier hospitals were smaller, efficient in the delivery of care, and experienced little operative staff turnover.
Our findings suggest that evidence-based SSI prevention practices do not easily distinguish well from poorly performing hospitals. But structural and process of care characteristics of hospitals were found to have a significant association with good results.
Journal of the American College of Surgeons 12/2008; 207(6):810-20. · 4.55 Impact Factor
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ABSTRACT: The aims of this study are to track those AVAS podium resident prize winners and to determine patterns of fellowship training type of practice, and primary area of specialization and whether their prize winning paper reflects their current area of specialization today. We also determined whether these residents, once completing their training, ever practiced at a VA hospital, and, whether they have been or currently are members of the AVAS. There have been 43 residents who have won 46 podium awards during this 18 year period. Three/46 (6%) awards were won by a resident twice during different years. Among the 42 locatable residents, 3/42 (7%) are still in surgery training. Among those 39 who are in practice, 30/39 (76%) undertook a clinical fellowship and 22/39 (56%) are in an academic setting. Only 3/39 (8%) has ever worked at a VA hospital; all 3 are currently members of the AVAS. Among those with a specific area of clinical or research specialization (n = 32), in 25/32 (78%), their paper reflects their current area of specialization. Among our cohort of annual AVAS resident prize winners most have taken fellowship training. Greater than 50% pursue academic practice. Among those with an area of specialization, their prize winning paper reflects on their current area of specialization today. Few have ever worked in a VA hospital and thus few have ever been members of the AVAS.
American journal of surgery 12/2008; 196(5):621-2. · 2.36 Impact Factor
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Annals of surgery 10/2008; 248(3):501. · 7.90 Impact Factor
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ABSTRACT: Surgical site infection (SSI) is a potentially preventable complication. We developed and tested a model to predict patients at high risk for surgical site infection.
Data from the Patient Safety in Surgery Study/National Surgical Quality Improvement Program from a 3-year period were used to develop and test a predictive model of SSI using logistic regression analyses.
From October 2001 through September 2004, 7,035 of 163,624 (4.30%) patients undergoing vascular and general surgical procedures at 14 academic and 128 Department of Veterans Affairs (VA) medical centers experienced SSI. Fourteen variables independently associated with increased risk of SSI included patient factors (age greater than 40 years, diabetes, dyspnea, use of steroids, alcoholism, smoking, recent radiotherapy, and American Society of Anesthesiologists class 2 or higher), preoperative laboratory values (albumin<3.5 mg/dL, total bilirubin>1.0 mg/dL), and operative characteristics (emergency, complexity [work relative value units>/=10], type of procedure, and wound classification). The SSI risk score is more accurate than the National Nosocomial Infection Surveillance score in predicting SSI (c-indices 0.70, 0.62, respectively).
We developed and tested an accurate prediction score for SSI. Clinicians can use this score to predict their patient's risk of an SSI and implement appropriate prevention strategies.
Journal of the American College of Surgeons 07/2007; 204(6):1178-87. · 4.55 Impact Factor
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ABSTRACT: Evidence comparing laparoscopic versus open hernia repair has varied with time and with changes in techniques used. Cost effectiveness is an important consideration when evidence for predominance of one surgical technique is lacking. Current cost estimates of hernia repair are not available.
This study is a cost effectiveness analysis within a randomized controlled trial comparing open (OPEN) versus laparoscopic (LAP) hernia repair using mesh at 14 Department of Veterans Affairs medical centers, with 2-year followup for each patient. Between January 1999 and November 2001, 2,164 men with inguinal hernia were randomized and 1,983 had an operation; 1,395 patients (708 OPEN and 687 LAP) with outpatient hernia operations were included in the cost effectiveness analysis. Outcomes included surgical and postoperative costs, quality adjusted life years (QALY), and incremental cost per QALY gained or the incremental cost effectiveness ratio (ICER).
Over 2 years, LAP cost an average of $638 more than OPEN. QALYs at 2 years were similar, resulting in $45,899 per QALY gained (95% CI: -$669,045, $722,457). The probability that LAP is cost effective at the $50,000 per QALY level (slightly more costly but more effective), was 51%. For unilateral primary and unilateral recurrent hernia repair, the probabilities that LAP is cost effective at the $50,000 per QALY level were 64% and 81%, respectively. For bilateral hernia repair, OPEN was less costly and more effective.
Overall, laparoscopic hernia repair is not cost effective compared with open repair. For patients with unilateral (primary or recurrent) hernia, laparoscopic repair is a cost effective treatment option.
Journal of the American College of Surgeons 11/2006; 203(4):447-57. · 4.55 Impact Factor
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Walter E Longo,
William Cheadle,
Aaron Fink,
Robert Kozol,
Ralph DePalma,
Robert Rege,
Leigh Neumayer,
John Tarpley,
Margaret Tarpley,
Ray Joehl,
Thomas A Miller,
Douglas Rosendale, Kamal Itani
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ABSTRACT: Veterans Administration (VA) medical centers have had a long history of providing medical care to those who have served their country. Over time, the VA has evolved into a facility that has had a major role in graduate medical education. In surgery, this had provided experience in the medical and surgical management of complex surgical disease involving the head and neck, chest, and gastrointestinal tract, and in the fields of surgical oncology, peripheral vascular disease, and the subspecialties of urology, orthopedics, and neurosurgery. The VA provides a venue for the attending physician and resident to work in concert to allow the resident to shoulder increasing accountability in decision-making and delivery of care in the outpatient arena, the operating room, and the intensive care unit. Medical students assigned to a VA hospital are afforded a great opportunity to be exposed to preoperative planning, discussions leading to informed consent for surgery, the actual operation, and postoperative care. Numerous opportunities at the VA are available for novice and experienced medical faculty members to develop and/or enhance skills and abilities in patient care, medical education, and research. In addition, the VA offers unique opportunities for academic physicians and other healthcare professionals to administer its many programs, thereby developing leadership skills and experience in the process. The VA is uniquely situated to design and conduct multicenter clinical trials. The most important aspect of this is the infrastructure provided by the VA Cooperative Studies Program. Of the four missions of the Department of Veterans Affairs, research and education is essential to provide quality, state of the art clinical care to the veteran. The National Surgical Quality Improvement Program (NSQIP) is an example of how outcomes based research can favorably impact on patient outcome. Looking across the horizon of information solutions available to surgeons, the options are limited. This is not the case for the Department of Veterans Affairs. With the congressionally mandated charge for the VA to compare its quality to private clinicians, the advent of the "Surgery Package" became possible. The VA will continue its leadership position in the healthcare arena if it can successfully address the challenges facing it.
The American Journal of Surgery 12/2005; 190(5):662-75. · 2.78 Impact Factor
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Journal of the American College of Surgeons 10/2005; 201(3):486-7; author reply 487-8. · 4.55 Impact Factor
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Leigh Neumayer,
Olga Jonasson,
Robert Fitzgibbons,
William Henderson,
James Gibbs,
C James Carrico, Kamal Itani,
Lawrence Kim,
Theodore Pappas,
Domenic Reda,
Dorothy Dunlop,
Martin McCarthy,
Denise Hynes,
Anita Giobbie-Hurder,
Martin J London,
Stephanie Hatton-Ward
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ABSTRACT: Inguinal hernia is a common condition in men and represents a large component of health-care expenditures. Approximately 700,000 herniorrhaphies are performed each year in the United States. The most effective method of repair of an inguinal hernia is not known.
A multicenter, randomized, clinical trial was designed to compare open tension-free inguinal hernia repair with laparoscopic tension-free repair on recurrence rates, complications, patient-centered outcomes, and cost. The study design called for randomization of 2,200 men over a period of 3 years. These men will be followed for a minimum of 2 years. This will allow determination of as little as a 3% absolute difference in recurrence rates with 80% power. Randomization is stratified by hospital, whether the hernia is unilateral or bilateral and whether the hernia is primary or recurrent.
This is a report of the study design and current status. The study involves 14 Veterans Affairs medical centers with previous experience in laparoscopic hernia repair. After 35 months of enrollment, 2,165 men were randomized and recruitment was then closed. The majority of the patients (82.3%) had unilateral hernias and 90.6% of the hernias were primary. Sixty-seven percent of the patients had an outpatient operation.
We report successful recruitment into a large multicenter trial comparing open and laparoscopic hernia repair. When followup is complete, this study will provide data regarding both clinical (recurrence rates) and patient-centered outcomes.
Journal of the American College of Surgeons 06/2003; 196(5):743-52. · 4.55 Impact Factor
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Kamal Itani
The American Journal of Surgery 10/2002; 184(3):196-203. · 2.78 Impact Factor
