Article

The Patient Safety in Surgery Study: Background, study design, and patient populations

Harvard University, Cambridge, Massachusetts, United States
Journal of the American College of Surgeons (Impact Factor: 4.45). 07/2007; 204(6):1089-102. DOI: 10.1016/j.jamcollsurg.2007.03.028
Source: PubMed

ABSTRACT The purpose of this article is to describe the background, design, and patient populations of the Patient Safety in Surgery Study, as a preliminary to the articles in this journal that will report the results of the Study.
The Patient Safety in Surgery Study was a prospective cohort study. Trained nurses collected preoperative risk factors, operative variables, and 30-day postoperative mortality and morbidity outcomes in patients undergoing major general and vascular operations at 128 Veterans Affairs (VA) medical centers and 14 selected university medical centers between October 1, 2001 and September 30, 2004. An Internet-based data collection system was used to input data from the different private medical centers. Semiannual feedback of observed to expected mortality and morbidity ratios was provided to the participating medical centers.
During the 3-year study, total accrual in general surgery was 145,618 patients, including 68.5% from the VA and 31.5% from the private sector. Accrual in vascular surgery totaled 39,225 patients, including 77.8% from the VA and 22.2% from the private sector. VA patients were older and included a larger proportion of male patients and African Americans and Hispanics. The VA population included more inguinal, umbilical, and ventral hernia repairs, although the private-sector population included more thyroid and parathyroid, appendectomy, and operations for breast cancer. Preoperative comorbidities were similar in the two populations, but the rates of comorbidities were higher in the VA. American Society of Anesthesiologists classification tended to be higher in the VA.
The National Surgical Quality Improvement Program methodology was successfully implemented in the 14 university medical centers. The data from the study provided the basis for the articles in this issue of the Journal of the American College of Surgeons.

0 Followers
 · 
222 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Financial penalties for readmission have been expanded beyond medical conditions to include surgical procedures. Hospitals are working to reduce readmissions; however, little is known about the reasons for surgical readmission. To characterize the reasons, timing, and factors associated with unplanned postoperative readmissions. Patients undergoing surgery at one of 346 continuously enrolled US hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) between January 1, 2012, and December 31, 2012, had clinically abstracted information examined. Readmission rates and reasons (ascertained by clinical data abstractors at each hospital) were assessed for all surgical procedures and for 6 representative operations: bariatric procedures, colectomy or proctectomy, hysterectomy, total hip or knee arthroplasty, ventral hernia repair, and lower extremity vascular bypass. Unplanned 30-day readmission and reason for readmission. The unplanned readmission rate for the 498,875 operations was 5.7%. For the individual procedures, the readmission rate ranged from 3.8% for hysterectomy to 14.9% for lower extremity vascular bypass. The most common reason for unplanned readmission was surgical site infection (SSI) overall (19.5%) and also after colectomy or proctectomy (25.8%), ventral hernia repair (26.5%), hysterectomy (28.8%), arthroplasty (18.8%), and lower extremity vascular bypass (36.4%). Obstruction or ileus was the most common reason for readmission after bariatric surgery (24.5%) and the second most common reason overall (10.3%), after colectomy or proctectomy (18.1%), ventral hernia repair (16.7%), and hysterectomy (13.4%). Only 2.3% of patients were readmitted for the same complication they had experienced during their index hospitalization. Only 3.3% of patients readmitted for SSIs had experienced an SSI during their index hospitalization. There was no time pattern for readmission, and early (≤7 days postdischarge) and late (>7 days postdischarge) readmissions were associated with the same 3 most common reasons: SSI, ileus or obstruction, and bleeding. Patient comorbidities, index surgical admission complications, non-home discharge (hazard ratio [HR], 1.40 [95% CI, 1.35-1.46]), teaching hospital status (HR, 1.14 [95% CI 1.07-1.21]), and higher surgical volume (HR, 1.15 [95% CI, 1.07-1.25]) were associated with a higher risk of hospital readmission. Readmissions after surgery were associated with new postdischarge complications related to the procedure and not exacerbation of prior index hospitalization complications, suggesting that readmissions after surgery are a measure of postdischarge complications. These data should be considered when developing quality indicators and any policies penalizing hospitals for surgical readmission.
    JAMA The Journal of the American Medical Association 02/2015; 313(5):483-95. DOI:10.1001/jama.2014.18614 · 30.39 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background: Preoperative anemia is independently associated with adverse outcomes after general and cardiac surgery. Outcomes after breast reconstruction are not established. We assessed the effect of preoperative anemia on 30-day postoperative morbidity and length of hospital stay (LOS) in patients undergoing immediate breast reconstruction. Methods: We identified patients undergoing immediate breast reconstruction from 2008 to 2010 from the American College of Surgeons’ National Surgical Quality Improvement Program database (a prospective outcomes-based registry from hospitals worldwide). De-identified data were obtained for demographics, preoperative risk factors, 30-day morbidity, and LOS. Morbidity variables included flap/graft/prosthesis, cardiac, respiratory, neurological, urinary, wound, and venous thromboembolism outcomes. Logistic regression assessed the crude and adjusted effect of anemia (hematocrit <36%) on postoperative 30-day morbidity. Measures of central tendency of LOS were compared across increasing severities of anemia in patients developing adverse events versus controls. Results: The study population included 10,958 patients; 1556 (16.74%) had preoperative anemia. Crude odds ratio for 30-day morbidity was significantly higher in anemic patients, unadjusted odds ratio = 1.33 (P < 0.008). This prevailed after extensive adjustment for confounding, yielding an adjusted odds ratio = 1.38 (P < 0.03). Patients who experienced adverse effects had protracted LOS, and the presence of anemia significantly amplified this effect. Conclusions: These data provide new insight into the effect of anemia in immediate breast reconstruction, demonstrating an independent association between preoperative anemia and 30-day morbidity. These findings suggest treating anemia when possible; however, prospective studies should explore the efficacy, safety, and cost-effectiveness of such treatments.
    08/2013; 1(5):e30. DOI:10.1097/GOX.0b013e3182a18c6f
  • [Show abstract] [Hide abstract]
    ABSTRACT: The Revised Cardiac Risk Index (RCRI) was incorporated into the American College of Cardiology/American Heart Association (ACC/AHA) recommendations for the preoperative evaluation of the cardiac patient for noncardiac surgery. The purpose of this review was to analyze studies on cardiovascular clinical risk prediction that had used the previous "standard best" model, the RCRI, as a comparator. This review aims to determine whether modification of the current risk factors or adoption of other risk factors or other risk indices would improve upon the discrimination of cardiac risk prediction when compared with the RCRI. This is necessary because recent risk prediction models have shown better discrimination for major adverse cardiac events, and the pre-eminence of the RCRI is now in question. There is now a need for a new "best standard" cardiovascular risk prediction model to supersede the RCRI. This is desirable because it would: (1) allow for a global standard of cardiovascular risk assessment; (2) provide a standard comparator in all risk prediction research; (3) result in comparable data collection; and (4) allow for individual patient data meta-analyses. This should lead to continued progress in cardiovascular clinical risk prediction. A review of the current evidence suggests that to improve the preoperative clinical risk stratification for adverse cardiac events, a new risk stratification model be built that maintains the clinical risk factors identified in the RCRI, with the following modifications: (1) additional glomerular filtration rate cut points (as opposed to a single creatinine cut point); (2) age; (3) a history of peripheral vascular disease; (4) functional capacity; and (5) a specific surgical procedural category. One would expect a substantial improvement in the discrimination of the RCRI with this approach. Although most noncardiac surgeries will benefit from a standard "generic" cardiovascular risk prediction model, there are data to suggest that patients with human immunodeficiency virus disease who are undergoing vascular surgery may benefit from specific cardiovascular risk prediction models.

Full-text (2 Sources)

Download
480 Downloads
Available from
Jun 1, 2014