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ABSTRACT: Urinary tract infections (UTIs) are the most common hospital-acquired infections in the United States. We hypothesized that the risk of UTI after colorectal surgery exceeds the risk after other gastrointestinal operations.
We used National Surgical Quality Improvement Program (NSQIP) data from 2005 to 2008 to compute rates of UTI after colorectal resections and other gastrointestinal and general surgery. We used a validated multivariate UTI prediction model to compare risk-adjusted rates of UTI by type of procedure. Then we identified predictors of UTI after colorectal resection using stepwise logistic regression models.
Crude UTI rates were significantly greater after colorectal resection (4.1%) than after other gastrointestinal (1.8%) or nongastrointestinal procedures (1.2%; all p < 0.001). Even using standard risk-adjustment from the NSQIP, rates of UTI were significantly higher after segmental colectomy (2.8%; 95% CI 2.5% to 3.2%), total colectomy (3.5%; 95% CI 2.9% to 4.3%), proctectomy (3.5%, 95% CI 3.1% to 4.2%), proctocolectomy (4.6%, 95% CI 3.8% to 5.7%), and abdominoperineal resection (5.6%, 95% CI 4.6% to 6.8%) than after noncolorectal gastrointestinal surgery (2.6%, 95% CI 2.2% to 2.9%). Factors associated with UTI after colorectal resections include age, sex, functional status, American Society of Anesthesiologists class, and resection type.
Colorectal resections incur substantial risk of postoperative UTI, exceeding rates predicted by the NSQIP model. Because of their patients' unanticipated high incidence of UTI, surgeons with a specialty interest in colorectal surgery risk being flagged as "high outliers," particularly if they perform many rectal resections. A simple set of risk factors discriminates 10-fold differences in the rate of UTI after colorectal resection.
Journal of the American College of Surgeons 09/2011; 213(6):784-92. · 4.55 Impact Factor
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Anesthesiology 06/2011; 114(6):1269-70. · 5.36 Impact Factor
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ABSTRACT: Surgical care is a vital component of health care worldwide, yet there is no clinically meaningful measure of operative outcomes that could be applied globally. The Surgical Apgar Score, a simple metric derived from 3 intraoperative parameters, has been shown in U.S. academic medical centers to predict 30-day patient outcomes after operation, but has not been validated more broadly.
We collected the components of the Surgical Apgar Score at the time of operation for 5,909 adult patients undergoing noncardiac operative procedures under general anesthesia at 8 hospitals in diverse international settings and evaluated the relationship between patients' scores and the incidence of inpatient postoperative morbidity and mortality, using generalized estimating equations to adjust for clustering within sites.
During the first 30 days of postoperative hospitalization, 544 patients (9.2%) experienced ≥ 1 complications. Compared with patients with the median score of 7--whose complication rate was 9.1%-those with a Surgical Apgar Score <5 (n = 302) had an adjusted complication rate of 32.9% (relative risk [RR],3.6; 95% CI, 2.9-4.5), whereas those with a score of 10 (n = 238) had a 3.0% adjusted complication rate (RR, 0.3; 95% CI, 0.1-1.1). The score's c-statistic for prediction of any complication is 0.70; for death it is 0.77.
The Surgical Apgar Score is easily calculated, predictive, and moderately discriminative for major complications among adults undergoing inpatient noncardiac operative procedures. Such a score could provide objective indication of relative postoperative risk for inpatients and provide a potential target for quality improvement efforts, particularly in resource-limited settings.
Surgery 01/2011; 149(4):519-24. · 3.10 Impact Factor
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ABSTRACT: A 10-point Surgical Apgar Score, based on patients' estimated blood loss, lowest heart rate, and lowest mean arterial pressure during surgery, was developed to rate patients' outcomes in general and vascular surgery but has not been tested for patients having orthopaedic surgery.
For patients undergoing hip and knee arthroplasties, we asked (1) whether the score provides accurate risk stratification for major postoperative complications, and (2) whether it captures intraoperative variables contributing to postoperative risk based on the three parameters independent of preoperative risk.
We retrospectively reviewed the electronic records for all 3511 patients who underwent a hip or knee arthroplasty from March 2003 to August 2006 and extracted data to calculate a Surgical Apgar Score. We evaluated the relationship between scores and likelihood of major postoperative in-hospital complications and assessed its discrimination and calibration.
Complication rates increased monotonically as the score decreased. Even after controlling for preoperative risk, each 1-point decrease in the score was associated with a 34.0% increase (95% confidence interval, 0.66-0.84) in the odds of a complication. The overall discriminatory performance of the score was a c-statistic of 0.61. Seventy-six percent of all major complications occurred in patients classified as low risk with scores of 7 or greater.
For patients undergoing hip and knee arthroplasties, the score captures important intraoperative information regarding risk of complications and contributes additional information to preoperative risk, but on its own is insufficient to provide comprehensive postoperative risk stratification for arthroplasties.
Level II, prognostic study. See Guidelines for Authors for a complete description of levels of evidence.
Clinical Orthopaedics and Related Research 12/2010; 469(4):1119-26. · 2.53 Impact Factor
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Alexander F Arriaga,
Andrew W Elbardissi, Scott E Regenbogen,
Caprice C Greenberg,
William R Berry,
Stuart Lipsitz,
Donald Moorman,
James Kasser,
Andrew L Warshaw,
Michael J Zinner,
Atul A Gawande
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ABSTRACT: To develop and evaluate an intervention to reduce breakdowns in communication during inpatient surgical care.
Communication breakdowns are the second most common cause of avoidable surgical adverse events after technical errors.
In a pre- and postintervention study, a random selection of patients on the surgical services of 4 teaching hospitals were observed according to 3 measures: (1) resident-attending communication of critical patient events (eg, transfer into the intensive care unit, unplanned intubation, cardiac arrest); (2) resident-attending notification regarding routine weekend patient status; and (3) frequency of weekend patient visits by an attending. All departments then developed and adopted a set of policy and education initiatives designed to increase prompt and consistent resident-attending communication (especially in critical events) and to improve regular attending visits with surgical patients. Specific reinforcement of the policies included a pocket information card for residents, as well as periodic reminders. Repeat audits of the surgical services were then conducted.
We reviewed information for 211 critical events and 1360 patients for the nature of resident and attending communication practices. After the intervention, the proportion of critical events not conveyed to an attending decreased from 33% (26/80) to 2% (1/47), and gaps in the frequency of attending notification of patient status on weekends were virtually eliminated (P < 0.0001); the proportion of weekend patients not visited by an attending for greater than 24 hours decreased by half (from 61% to 33%; P = 0.0002). Contact resulted in attending-led changes in patient management in one-third of cases.
An intervention to improve surgical communication practices at 4 teaching hospitals led to significant reductions in potentially harmful communication breakdowns during inpatient care; significant alterations in patient management were noted in one-third of cases in which there was an adherence to recommended communication practices.
Annals of surgery 12/2010; 253(5):849-54. · 7.90 Impact Factor
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Scott E Regenbogen
Surgery 09/2010; 148(3):602-4. · 3.10 Impact Factor
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ABSTRACT: We previously developed an intraoperative 10-point Surgical Apgar Score-based on blood loss, lowest heart rate, and lowest mean arterial pressure-to predict major complications after colorectal resection. However, because complications often arise after uncomplicated hospitalizations, we sought to evaluate whether this intraoperative metric would predict postdischarge complications after colectomy.
We linked our institution's National Surgical Quality Improvement Program database with an Anesthesia Intraoperative Management System for all colorectal resections over 4 years. Using Chi-square trend tests and logistic regression, we evaluated the Surgical Apgar Score's prediction for major postoperative complications before and after discharge.
Among 795 colectomies, there were 230 (29%) major complications within 30 days; 45 (20%) after uncomplicated discharges. Surgical Apgar Scores predicted both inpatient complications and late postdischarge complications (both P < .0001). Late complications occurred from 0 to 27 (median, 11) days after discharge; the most common were surgical site infections (42%), sepsis (24%), and venous thromboembolism (16%). In pairwise comparisons against average-scoring patients (Surgical Apgar Scores, 7-8), the relative risk of postdischarge complications trended lower, to 0.6 (95% confidence interval [CI], 0.2-1.7) for those with the best scores (9-10); and were significantly higher, at 2.6 (95% CI, 1.4-4.9) for scores 5-6, and 4.5 (95% CI, 1.8-11.0) for scores 0-4.
The intraoperative Surgical Apgar Score remained a useful metric for predicting postcolectomy complications arising after uncomplicated discharges. Even late complications may thus be related to intraoperative condition and events. Surgeons could use this intraoperative metric to target low-scoring patients for intensive postdischarge surveillance and mitigation of postdischarge complications after colectomy.
Surgery 03/2010; 148(3):559-66. · 3.10 Impact Factor
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ABSTRACT: Altham proposed Bayesian p-values for the analysis of a 2 × 2 contingency table that is formed from matched pairs. Using the same Bayesian perspective, we develop an extension of Altham's Bayesian p-values to a 2 × 2 table from matched pairs with missing data that are missing at random. The approach is applied to a rater agreement study, in which two surgeon- reviewers rated whether or not there was a communication breakdown in malpractice cases. We also use a simulation study to explore the power and type I error rate of the Bayesian p-values.
Applied Statistics 06/2009; 58(2):237-246. · 0.83 Impact Factor
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ABSTRACT: New technologies are available to reduce or prevent retained surgical sponges (RSS), but their relative cost effectiveness are unknown. We developed an empirically calibrated decision-analytic model comparing standard counting against alternative strategies: universal or selective x-ray, bar-coded sponges (BCS), and radiofrequency-tagged (RF) sponges.
Key model parameters were obtained from field observations during a randomized-controlled BCS trial (n = 298), an observational study of RSS (n = 191,168), and clinical experience with BCS (n approximately 60,000). Because no comparable data exist for RF, we modeled its performance under 2 alternative assumptions. Only incremental sponge-tracking costs, excluding those common to all strategies, were considered. Main outcomes were RSS incidence and cost-effectiveness ratios for each strategy, from the institutional decision maker's perspective.
Standard counting detects 82% of RSS. Bar coding prevents > or =97.5% for an additional $95,000 per RSS averted. If RF were as effective as bar coding, it would cost $720,000 per additional RSS averted (versus standard counting). Universal and selective x-rays for high-risk operations are more costly, but less effective than BCS-$1.1 to 1.4 million per RSS event prevented. In sensitivity analyses, results were robust over the plausible range of effectiveness assumptions, but sensitive to cost.
Using currently available data, this analysis provides a useful model for comparing the relative cost effectiveness of existing sponge-tracking strategies. Selecting the best method for an institution depends on its priorities: ease of use, cost reduction, or ensuring RSS are truly "never events." Given medical and liability costs of >$200,000 per incident, novel technologies can substantially reduce the incidence of RSS at an acceptable cost.
Surgery 05/2009; 145(5):527-35. · 3.10 Impact Factor
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ABSTRACT: To confirm the utility of a 10-point Surgical Apgar Score to rate surgical outcomes in a large cohort of patients.
Using electronic intraoperative records, we calculated Surgical Apgar Scores during a period of 2 years (July 1, 2003, through June 30, 2005).
Major academic medical center.
Systematic sample of 4119 general and vascular surgery patients enrolled in the National Surgical Quality Improvement Program surgical outcomes database at a major academic medical center.
Incidence of major postoperative complications and/or death within 30 days of surgery.
Of 1441 patients with scores of 9 to 10, 72 (5.0%) developed major complications within 30 days, including 2 deaths (0.1%). By comparison, among 128 patients with scores of 4 or less, 72 developed major complications (56.3%; relative risk, 11.3; 95% confidence interval, 8.6-14.8; P < .001), of whom 25 died (19.5%; relative risk, 140.7; 95% confidence interval, 33.7-587.4; P < .001). The 3-variable score achieves C statistics of 0.73 for major complications and 0.81 for deaths.
The Surgical Apgar Score provides a simple, immediate, objective means of measuring and communicating patient outcomes in surgery, using data routinely available in any setting. The score can be effective in identifying patients at higher- and lower-than-average likelihood of major complications and/or death after surgery and may be useful for evaluating interventions to prevent poor outcomes.
Archives of surgery (Chicago, Ill.: 1960) 01/2009; 144(1):30-6; discussion 37. · 4.32 Impact Factor
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ABSTRACT: Altham proposed Bayesian "p"-values for the analysis of a 2×2 contingency table that is formed from matched pairs. Using the same Bayesian perspective, we develop an extension of Altham's Bayesian "p"-values to a 2×2 table from matched pairs with missing data that are missing at random. The approach is applied to a rater agreement study, in which two surgeon-reviewers rated whether or not there was a communication breakdown in malpractice cases. We also use a simulation study to explore the power and type I error rate of the Bayesian "p"-values. Copyright (c) 2009 Royal Statistical Society.
Journal of the Royal Statistical Society Series C. 01/2009; 58(2):237-246.
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ABSTRACT: To prospectively evaluate and accurately describe the rate and type of discrepancies encountered in the surgical count.
Despite near-universal implementation of manual counting protocols for surgical instruments and sponges, incidents of retained sponges and instruments (RSI) persist. Retrospective analyses have shown that RSI are rare and most often involve final counts erroneously thought to be correct, leading some surgeons to question the value of counting. Crucial data regarding how often the surgical count successfully detects meaningful problems before the patient leaves the operating room is lacking.
Trained physician-observers documented prospective field observations during 148 elective general surgery operations using standardized intake forms. Data collection focused on the performance of the counting protocols, and the frequency and outcomes of discrepancies (instances in which a subsequent count does not agree with the previous count).
A mean of 16.6 counting episodes occurred per case, occupying 8.6 minutes per case. A total of 29 discrepancies involving sponges (45%), instruments (34%) or needles (21%) were observed among 19 (12.8%) operations. Most discrepancies indicated a misplaced item (59%) as opposed to a miscount (3%) or error in documentation (38%). Each discrepancy took on average 13 minutes to resolve. Counting activities after personnel changes were significantly more likely to involve a discrepancy than those for which the original team was present.
One in 8 surgical cases involves an intraoperative discrepancy in the count. The majority of these discrepancies detect unaccounted-for sponges and instruments, which represent potential RSI. Thus, despite the recognized limitations of manual surgical counts, discrepancies should always prompt a thorough search and reconciliation process and never be ignored.
Annals of surgery 08/2008; 248(2):337-41. · 7.90 Impact Factor
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ABSTRACT: To evaluate whether Surgical Apgar Scores measure the relationship between intraoperative care and surgical outcomes.
With preoperative risk-adjustment now well-developed, the role of intraoperative performance in surgical outcomes may be considered. We previously derived and validated a 10-point Surgical Apgar Score--based on intraoperative blood loss, heart rate, and blood pressure--that effectively predicts major postoperative complications within 30 days of general and vascular surgery. This study evaluates whether the predictive value of this score comes solely from patients' preoperative risk or also measures care in the operating room.
Among a systematic sample of 4119 general and vascular surgery patients at a major academic hospital, we constructed a detailed risk-prediction model including 27 patient-comorbidity and procedure-complexity variables, and computed patients' propensity to suffer a major postoperative complication. We evaluated the prognostic value of patients' Surgical Apgar Scores before and after adjustment for this preoperative risk.
After risk-adjustment, the Surgical Apgar Score remained strongly correlated with postoperative outcomes (P < 0.0001). Odds of major complications among average-scoring patients (scores 7-8) were equivalent to preoperative predictions (likelihood ratio (LR) 1.05, 95% CI 0.78-1.41), significantly decreased for those who achieved the best scores of 9-10 (LR 0.52, 95% CI 0.35-0.78), and were significantly poorer for those with low scores--LRs 1.60 (1.12-2.28) for scores 5-6, and 2.80 (1.50-5.21) for scores 0-4.
Even after accounting for fixed preoperative risk--due to patients' acute condition, comorbidities and/or operative complexity--the Surgical Apgar Score appears to detect differences in intraoperative management that reduce odds of major complications by half or increase them by nearly 3-fold.
Annals of surgery 08/2008; 248(2):320-8. · 7.90 Impact Factor
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ABSTRACT: Little is known about the amount and availability of surgical care globally. We estimated the number of major operations undertaken worldwide, described their distribution, and assessed the importance of surgical care in global public-health policy.
We gathered demographic, health, and economic data for 192 member states of WHO. Data for the rate of surgery were sought from several sources including governmental agencies, statistical and epidemiological organisations, published studies, and individuals involved in surgical policy initiatives. We also obtained per-head total expenditure on health from analyses done in 2004. Major surgery was defined as any intervention occurring in a hospital operating theatre involving the incision, excision, manipulation, or suturing of tissue, usually requiring regional or general anaesthesia or sedation. We created a model to estimate rates of major surgery for countries for which such data were unavailable, then used demographic information to calculate the total worldwide volume of surgery.
We obtained surgical data for 56 (29%) of 192 WHO member states. We estimated that 234.2 (95% CI 187.2-281.2) million major surgical procedures are undertaken every year worldwide. Countries spending US$100 or less per head on health care have an estimated mean rate of major surgery of 295 (SE 53) procedures per 100 000 population per year, whereas those spending more than $1000 have a mean rate of 11 110 (SE 1300; p<0.0001). Middle-expenditure ($401-1000) and high-expenditure (>$1000) countries, accounting for 30.2% of the world's population, provided 73.6% (172.3 million) of operations worldwide in 2004, whereas poor-expenditure (</=$100) countries account for 34.8% of the global population yet undertook only 3.5% (8.1 million) of all surgical procedures in 2004.
Worldwide volume of surgery is large. In view of the high death and complication rates of major surgical procedures, surgical safety should now be a substantial global public-health concern. The disproportionate scarcity of surgical access in low-income settings suggests a large unaddressed disease burden worldwide. Public-health efforts and surveillance in surgery should be established.
The Lancet 07/2008; 372(9633):139-44. · 38.28 Impact Factor
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ABSTRACT: A randomized, controlled trial was performed to evaluate a computer-assisted method for counting sponges using a bar-code system.
Retained sponges are a rare and preventable problem but persist in surgery despite standardized protocols for counting. Technology that improves detection of counting errors could reduce risk to surgical patients.
We performed a randomized controlled trial comparing a bar-coded sponge system with a traditional counting protocol in 300 general surgery operations. Observers monitored sponge and instrument counts and recorded all incidents of miscounted or misplaced sponges. Surgeons and operating room staff completed postoperative and end-of-study surveys evaluating the bar-code system.
The bar-code system detected significantly more counting discrepancies than the traditional protocol (32 vs.13 discrepancies, P = 0.007). These discrepancies involved both misplaced sponges (21 vs. 12 sponges, P = 0.17) and miscounted sponges (11 vs. 1 sponge, P = 0.007). The system introduced new technical difficulties (2.04 per 1000 sponges) and increased the time spent counting sponges (5.3 vs. 2.4 minutes, P < 0.0001). In postoperative surveys, there was no difference in surgical teams' confidence that all sponges were accounted for, but they rated the counting process and team performance lower in operations randomized to the bar-code arm. By the end of the study, however, most providers found the system easy to use, felt confident in its ability to track sponges, and reported a positive effect on the counting process.
Use of automated counting using bar-coded surgical sponges improved detection of miscounted and misplaced sponges and was well tolerated by surgical staff members.
Annals of Surgery 04/2008; 247(4):612-6. · 7.49 Impact Factor
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ABSTRACT: To identify the most prevalent patterns of technical errors in surgery, and evaluate commonly recommended interventions in light of these patterns.
The majority of surgical adverse events involve technical errors, but little is known about the nature and causes of these events. We examined characteristics of technical errors and common contributing factors among closed surgical malpractice claims.
Surgeon reviewers analyzed 444 randomly sampled surgical malpractice claims from four liability insurers. Among 258 claims in which injuries due to error were detected, 52% (n = 133) involved technical errors. These technical errors were further analyzed with a structured review instrument designed by qualitative content analysis.
Forty-nine percent of the technical errors caused permanent disability; an additional 16% resulted in death. Two-thirds (65%) of the technical errors were linked to manual error, 9% to errors in judgment, and 26% to both manual and judgment error. A minority of technical errors involved advanced procedures requiring special training ("index operations"; 16%), surgeons inexperienced with the task (14%), or poorly supervised residents (9%). The majority involved experienced surgeons (73%), and occurred in routine, rather than index, operations (84%). Patient-related complexities-including emergencies, difficult or unexpected anatomy, and previous surgery-contributed to 61% of technical errors, and technology or systems failures contributed to 21%.
Most technical errors occur in routine operations with experienced surgeons, under conditions of increased patient complexity or systems failure. Commonly recommended interventions, including restricting high-complexity operations to experienced surgeons, additional training for inexperienced surgeons, and stricter supervision of trainees, are likely to address only a minority of technical errors. Surgical safety research should instead focus on improving decision-making and performance in routine operations for complex patients and circumstances.
Annals of Surgery 12/2007; 246(5):705-11. · 7.49 Impact Factor
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ABSTRACT: Communication breakdowns are a common threat to surgical safety, but there are little data to guide initiatives to improve communication.
In surgeon-review of 444 surgical malpractice claims from 4 liability insurers, we identified 60 cases involving communication breakdowns resulting in harm to patients. Two surgeon-reviewers analyzed these cases to identify common characteristics and associated factors. Based on identified patterns, potential interventions to prevent communication breakdowns were developed and their potential impact was assessed.
The 60 cases involved 81 communication breakdowns, occurring in the preoperative (38%), intraoperative (30%), and postoperative periods (32%). Seventy-two percent of cases involved one communication breakdown. The majority of breakdowns were verbal communications (92%) involving 1 transmitter and 1 receiver (64%). Attending surgeons were the most common team member involved. Status asymmetry (74%) and ambiguity about responsibilities (73%) were commonly associated factors. Forty-three percent of communication breakdowns occurred with handoffs and 39% with transfers in the patient's location. The most common communication breakdowns involved residents failing to notify the attending surgeon of critical events and a failure of attending-to-attending handoffs. Proposed interventions could prevent 45% to 73% of communication breakdowns in this cases series.
Serious communication breakdowns occur across the continuum of care, typically result from a failure in verbal communication between a surgical attending and another caregiver, and often involve ambiguity about responsibilities. Interventions to prevent these breakdowns should involve: defined triggers that mandate communication with an attending surgeon; structured handoffs and transfer protocols; and standard use of read-backs.
Journal of the American College of Surgeons 05/2007; 204(4):533-40. · 4.55 Impact Factor
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ABSTRACT: Delays and underreporting limit the success of hospital incident reporting systems, but little is known about the causes or implications of delayed reporting. Setting and
The authors examined 6880 incident reports filed by physicians and nurses for three years at a national university hospital in Japan and evaluated the lag time between each incident and the submission of a report.
Although physicians and nurses reported nearly equal numbers of events resulting in major injury (32 v 31), physicians reported far fewer minor incidents (430 v 6387) and far fewer incidents overall (462 v 6418). In univariate analyses, lag time was significantly longer for physicians than nurses (3.79 v 2.20 days; p<0.001). In multivariate analysis, physicians had adjusted reporting lag time 75% longer than nurses (p<0.001) and lag time for major injuries was 18% shorter than for minor injuries (p = 0.011). Adjusted lag time in 2002 and 2004 were 34% longer than in 2003 (p<0.001).
Physicians report fewer incidents than nurses and take longer to report them. Quantitative evaluation of lag time may facilitate improvements in incident reporting systems by distinguishing institutional obstacles to physician reporting from physicians' lesser willingness to report.
Quality and Safety in Health Care 04/2007; 16(2):101-4. · 1.68 Impact Factor
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ABSTRACT: Surgical teams have not had a routine, reliable measure of patient condition at the end of an operation. We aimed to develop an Apgar score for the field of surgery, an outcomes score that teams could calculate at the end of any general or vascular surgical procedure to accurately grade a patient's condition and chances of major complications or death.
We derived our surgical score in a retrospective analysis of data from medical records and the National Surgical Quality Improvement Program for 303 randomly selected patients undergoing colectomy at Brigham and Women's Hospital, Boston. The primary outcomes measure was incidence of major complication or death within 30 days of operation. We validated the score in two prospective, randomly selected cohorts: 102 colectomy patients and 767 patients undergoing general or vascular operations at the same institution.
A 10-point score based on a patient's estimated amount of blood loss, lowest heart rate, and lowest mean arterial pressure during general or vascular operations was significantly associated with major complications or death within 30 days (p < 0.0001; c-index = 0.72). Of 767 general and vascular surgery patients, 29 (3.8%) had a surgical score <or= 4. Major complications or death occurred in 17 of these 29 patients (58.6%) within 30 days. By comparison, among 220 patients with scores of 9 or 10, only 8 (3.6%) experienced major complications or died (relative risk 16.1; 95% CI, 7.6-34.0; p < 0.0001).
A simple score based on blood loss, heart rate, and blood pressure can be useful in rating the condition of patients after general or vascular operations.
Journal of the American College of Surgeons 03/2007; 204(2):201-8. · 4.55 Impact Factor