Successful implementation of the Department of Veterans Affairs' National Surgical Quality Improvement Program in the private sector: the Patient Safety in Surgery study.

BACKGROUND: The Veterans Affairs' (VA) National Surgical Quality Improvement Program (NSQIP) has been associated with significant reductions in postoperative morbidity and mortality. We sought to determine if NSQIP methods and risk models were applicable to private sector (PS) hospitals and if implementation of the NSQIP in the PS would be associated with reductions in adverse postoperative outcomes. METHODS: Data from patients (n = 184,843) undergoing major general or vascular surgery between October 1, 2001, and September 30, 2004, in 128 VA hospitals and 14 academic PS hospitals were used to develop prediction models based on VA patients only, PS patients only, and VA plus PS patients using logistic regression modeling, with measures of patient-related risk as the independent variables and 30-day postoperative morbidity or mortality as the dependent variable. RESULTS: Nine of the top 10 predictors of postoperative mortality and 7 of the top 10 for postoperative morbidity were the same in the VA and PS models. The ratios of observed to expected mortality and morbidity in the PS hospitals based on a model using PS data only versus VA + PS data were nearly identical (correlation coefficient = 0.98). Outlier status of PS hospitals was concordant in 26 of 28 comparisons. Implementation of the NSQIP in PS hospitals was associated with statistically significant reductions in overall postoperative morbidity (8.7%, P = 0.002), surgical site infections (9.1%, P = 0.02), and renal complications (23.7%, P = 0.004). CONCLUSIONS: The VA NSQIP methods and risk models in general and vascular surgery were fully applicable to PS hospitals. Thirty-day postoperative morbidity in PS hospitals was reduced with the implementation of the NSQIP.

Open mesh versus laparoscopic mesh repair of inguinal hernia.

BACKGROUND: Repair of inguinal hernias in men is a common surgical procedure, but the most effective surgical technique is unknown. METHODS: We randomly assigned men with inguinal hernias at 14 Veterans Affairs (VA) medical centers to either open mesh or laparoscopic mesh repair. The primary outcome was recurrence of hernias at two years. Secondary outcomes included complications and patient-centered outcomes. RESULTS: Of the 2164 patients who were randomly assigned to one of the two procedures, 1983 underwent an operation; two-year follow-up was completed in 1696 (85.5 percent). Recurrences were more common in the laparoscopic group (87 of 862 patients [10.1 percent]) than in the open group (41 of 834 patients [4.9 percent]; odds ratio, 2.2; 95 percent confidence interval, 1.5 to 3.2). The rate of complications was higher in the laparoscopic-surgery group than in the open-surgery group (39.0 percent vs. 33.4 percent; adjusted odds ratio, 1.3; 95 percent confidence interval, 1.1 to 1.6). The laparoscopic-surgery group had less pain initially than the open-surgery group on the day of surgery (difference in mean score on a visual-analogue scale, 10.2 mm; 95 percent confidence interval, 4.8 to 15.6) and at two weeks (6.1 mm; 95 percent confidence interval, 1.7 to 10.5) and returned to normal activities one day earlier (adjusted hazard ratio for a shorter time to return to normal activities, 1.2; 95 percent confidence interval, 1.1 to 1.3). In prespecified analyses, there was a significant interaction between the surgical approach (open or laparoscopic) and the type of hernia (primary or recurrent) (P=0.012). Recurrence was significantly more common after laparoscopic repair than after open repair of primary hernias (10.1 percent vs. 4.0 percent), but rates of recurrence after repair of recurrent hernias were similar in the two groups (10.0 percent and 14.1 percent, respectively). CONCLUSIONS: The open technique is superior to the laparoscopic technique for mesh repair of primary hernias.

The patient safety in surgery study: background, study design, and patient populations.

BACKGROUND: 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. STUDY DESIGN: 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. RESULTS: 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. CONCLUSIONS: 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.

Patient-reported outcomes after inguinal herniorrhaphy.

BACKGROUND: Patient-reported outcomes (PRO) reflect the functional outcomes of inguinal herniorrhaphy. We studied the effect of hernia recurrence and complications on PRO for participants in the Veterans Affairs trial of Open or Laparoscopic Repair of Inguinal Hernia. METHODS: Analyzed PRO included (1) the Medical Outcomes Study Short Form 36, version 2, (2) the Surgical Pain Scale, (3) the Activities Assessment Scale, and (4) patient satisfaction. Recurrences and complications were recorded at follow-up visits. Complications were categorized by (1) hematoma/seroma, (2) orchitis, (3) neuralgia, and (4) other. Univariate and multivariable regression analyses identified variables significantly associated with postoperative PRO. RESULTS: Of the 1603 patients with PRO data, 105 had a recurrence and 342 had a complication at 2 years. Multivariable analyses showed neuralgia (P < .0005) adversely affected all PRO, and recurrence (P < .05) affected patient-reported pain, activity, and satisfaction, but not the score for the Medical Outcomes Study Short Form 3. Patients with a recurrence after open repair had more pain than those with a recurrence after laparoscopic repair (P = .0001). Patients with other complications after laparoscopic repair reported more pain and less activity than those with other complications after open repair (P = .003 and P = .009, respectively). CONCLUSIONS: The effectiveness of inguinal herniorrhaphy should be measured by the rate of recurrence and neuralgia. Postoperative neuralgias have a deleterious effect on all patient-reported outcomes.

Cost effectiveness of laparoscopic versus open mesh hernia operation: results of a Department of Veterans Affairs randomized clinical trial.

BACKGROUND: 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. STUDY DESIGN: 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). RESULTS: 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. CONCLUSIONS: 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.

Tension-free repair versus watchful waiting for men with asymptomatic or minimally symptomatic inguinal hernias: a cost-effectiveness analysis.

BACKGROUND: Watchful waiting (WW) has been shown to be an acceptable option in men with asymptomatic or minimally symptomatic inguinal hernias when clinical and patient-reported outcomes are considered. Although WW is likely to be less costly initially when compared with tension-free repair (TFR) because of the cost of the operation, it is not clear whether WW remains the least costly option when longer-term costs are considered. STUDY DESIGN: We conducted a cost-effectiveness analysis of a randomized controlled trial at six community and academic centers. We examined costs, quality-adjusted life-years (QALY), and cost-effectiveness at 2 years of followup. Costs were assessed by applying Medicare reimbursement rates to patients' health-care use, which was obtained by contacting patients' health-care providers. Quality of life was assessed using the Short Form-36 version 2 health-related quality-of-life survey. Of the 724 men randomized, 641 were available for the economic analysis: 317 were randomized to TFR and 324 were randomized to watchful waiting. RESULTS: At 2 years, TFR patients had $1,831 higher mean costs than WW patients (95% CI, $409-$3,044), with 0.031 higher QALY (95% CI, 0.001-0.058). The cost per additional QALY for TFR patients was $59,065 (95% CI, $1,358-$322,765). The probability that TFR was cost-effective at the $50,000 per QALY level was 40%. CONCLUSION: At 2 years, WW was a cost-effective treatment option for men with minimal or no hernia symptoms.

Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial.

CONTEXT: Many men with inguinal hernia have minimal symptoms. Whether deferring surgical repair is a safe and acceptable option has not been assessed. OBJECTIVE: To compare pain and the physical component score (PCS) of the Short Form-36 Version 2 survey at 2 years in men with minimally symptomatic inguinal hernias treated with watchful waiting or surgical repair. DESIGN, SETTING, AND PARTICIPANTS: Randomized trial conducted January 1, 1999, through December 31, 2004, at 5 North American centers and enrolling 720 men (364 watchful waiting, 356 surgical repair) followed up for 2 to 4.5 years. INTERVENTIONS: Watchful-waiting patients were followed up at 6 months and annually and watched for hernia symptoms; repair patients received standard open tension-free repair and were followed up at 3 and 6 months and annually. MAIN OUTCOME MEASURES: Pain and discomfort interfering with usual activities at 2 years and change in PCS from baseline to 2 years. Secondary outcomes were complications, patient-reported pain, functional status, activity levels, and satisfaction with care. RESULTS: Primary intention-to-treat outcomes were similar at 2 years for watchful waiting vs surgical repair: pain limiting activities (5.1% vs 2.2%, respectively; P = .06 [corrected]); PCS (improvement over baseline, 0.29 points vs 0.13 points; P = .79). Twenty-three percent of patients assigned to watchful waiting crossed over to receive surgical repair (increase in hernia-related pain was the most common reason offered); 17% assigned to receive repair crossed over to watchful waiting. Self-reported pain in watchful-waiting patients crossing over improved after repair. Occurrence of postoperative hernia-related complications was similar in patients who received repair as assigned and in watchful-waiting patients who crossed over. One watchful-waiting patient (0.3%) experienced acute hernia incarceration without strangulation within 2 years; a second had acute incarceration with bowel obstruction at 4 years, with a frequency of 1.8/1000 patient-years inclusive of patients followed up for as long as 4.5 years. CONCLUSIONS: Watchful waiting is an acceptable option for men with minimally symptomatic inguinal hernias. Delaying surgical repair until symptoms increase is safe because acute hernia incarcerations occur rarely.Clinical Trials Registration ClinicalTrials.gov Identifier: NCT00263250.

Assessment of patient functional status after surgery.

BACKGROUND: Improvement in day-to-day functioning is a valued outcome of surgical intervention. A new functional status assessment instrument, the Activities Assessment Scale (AAS), was designed for a randomized clinical trial evaluating laparoscopic versus open hernia repair procedures. STUDY DESIGN: The study data set included 2,164 patients at baseline and 1,562 patients at 3-month followup. Only male patients were enrolled in the trial. The psychometric characteristics of the AAS were examined in statistical analyses of cross-sectional and longitudinal data from the trial. Correlational analyses, factor analyses, and t-tests were used to evaluate scale performance. RESULTS: We found that the AAS was a reliable measure (Cronbach's Coefficient Alpha =0.85) in the patient population studied. Factor analyses identified three subscales (sedentary activities; ambulatory activities; work and exercise activities). Construct validity was demonstrated by a correlation of 0.65 between the AAS and the physical functioning (PF) dimension of the SF-36 (p < 0.001); comparisons between clinical subgroups further confirmed its validity (p < 0.001). Patients reporting improvement on the physical functioning dimension after surgery showed an effect size of 1.20 for preoperative-postoperative change in their AAS scores. CONCLUSIONS: The AAS has been demonstrated to be a reliable, valid, and clinically responsive instrument that can be used to evaluate patient functioning after hernia surgery. It is easy to administer and requires less than 5 minutes of patient time to complete. This measurement system may prove useful in assessing surgical outcomes in both research and office practice settings.

Visual analog scales for assessing surgical pain.

BACKGROUND: Four visual analog scales were constructed to assess sensory and affective components of operative pain. The Surgical Pain Scales (SPS) measure pain while at rest, pain during normal activities, pain during work or exercise, and pain unpleasantness. STUDY DESIGN: Longitudinal data from 2,164 patients in a randomized trial of laparoscopic versus open hernia repair established the reliability, validity, and sensitivity to change of the SPS. Correlations and t-tests were used to determine their psychometric properties compared with the SF-36 health status instrument. RESULTS: Intraclass correlation coefficients of 0.95 for the sensory scales and 0.94 for the unpleasantness rating confirmed that the SPS produced reliable measurements. Correlations ranging from 0.44 to 0.60 between the visual analog scales and the bodily pain dimension on the SF-36 and significant differences between SPS levels for patients requiring more and less time to resume normal activities (p< or =0.015 to p< or =0.002) supported the validity of the scales. Clinical responsiveness was demonstrated by a 33.5-mm reduction (standard error = 1.4 mm) in the mean rating on a 150-mm scale measuring pain during normal activities for patients reporting postoperative improvement on the bodily pain dimension (p< or =0.0001). CONCLUSIONS: The Surgical Pain Scales demonstrated excellent psychometric properties in this study population. The SPS can be used to compare pain levels between groups at a single point in time or to track change for individual patients over time or after operations. Individualized pain management interventions can be tailored based on the sensory and effective ratings.

Career pathways of graduates of general surgery residency programs: an analysis of graduates from 1983 to 1990.

BACKGROUND: Approximately 1,000 individuals complete graduate surgical education in general surgery each year. Their subsequent career pathways have not been described but may have relevance to the supply of general surgeons available to provide a broad range of surgical care to the population of the USA. STUDY DESIGN: Data for this study were obtained from the American College of Surgeons's Surgery Resident Masterfile, developed for the annual Longitudinal Study of Surgery Residents, and the American Board of Medical Specialties's Official Directory of Board Certified Medical Specialists. For verification purposes, the American Medical Association's Physician Masterfile and the American Board of Surgery's certified database were searched. Yearly analyses of certified general surgery graduates from 1983 to 1990 were conducted, and rates of certification between US or Canadian medical school graduates and international medical school graduates (IMG) were compared. RESULTS: Ten to 18 years after completion of a residency program in general surgery, 93.6% of graduates had been certified in general surgery or by another American Board of Medical Specialties board. A total of 43.7% of the 8,068 graduates were certified, in addition, in a general surgery-based specialty. Overall, evidence of certification was not available for 6.4% of graduates. The certification rate for US or Canadian graduates was 95.8% of general surgeons and increased for IMG surgeons from 69.4% for 1983 graduates to 94.7% for 1990 graduates. The number of IMGs in general surgery residency programs declined from 19.7% of 1983 graduates to 7.8% of 1990 graduates. The rates of American Board of Surgery certification are 96.1% for male and 93.6% for female US or Canadian graduates; 79.2% of male IMG graduates and 83.7% of female IMG graduates became certified. CONCLUSIONS: Most surgeons who completed a general surgery residency program from 1983 to 1990 are certified and presumably have met high standards for knowledge and experience. More than half of the graduates specialize further.

The development of a clinical trial to determine if watchful waiting is an acceptable alternative to routine herniorrhaphy for patients with minimal or no hernia symptoms.

BACKGROUND: This article describes the development and implementation of a randomized clinical trial designed to answer the question: Is watchful waiting an acceptable alternative to operation for men with asymptomatic or minimally symptomatic inguinal hernias? STUDY DESIGN: A clinical trial has been designed to compare watchful waiting and operation for men with an asymptomatic or a relatively asymptomatic inguinal hernia. Men are randomized to watchful waiting or a standard open operation, the Lichtenstein tension-free hernia repair, and are followed for a minimum of 2 years. The target sample size of 753 patients was chosen so that the trial would have power sufficiently high to detect a clinically meaningful difference between treatment groups in either of the two primary outcomes as measured at 2 years: pain or discomfort interfering with normal activities and the physical component summary score of the SF-36 health-related quality-of-life survey. The study was begun in five centers located in both community and academic environments. At 18 months, a sixth site was added and at 28 months, after enrollment of 145 patients, one of the centers was terminated for reasons related to inadequate followup; all data from this center were deleted. As a routine measure, an independent experienced trial manager audited all clinical sites. RESULTS: Enrollment of patients began in January 2000 and will end on December 31, 2002. As of November 1, 2002, 637 patients had been randomized, 85% of the target enrollment. An additional 2,115 patients were screened but not randomized, yielding a recruitment rate of 23.1%. Analysis and publication of the results of the study will take place on completion of the minimum 2-year followup period for all patients. CONCLUSIONS: A trial to compare the outcomes of watchful waiting and operation for management of inguinal hernias in men is needed to provide data to surgeons and to patients that can aid in choice of treatment. A description of the design of such a trial is presented.

Tension-free inguinal hernia repair: the design of a trial to compare open and laparoscopic surgical techniques.

BACKGROUND: 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. STUDY DESIGN: 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. RESULTS: 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. CONCLUSIONS: 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.

Does resident post graduate year influence the outcomes of inguinal hernia repair?

INTRODUCTION: We evaluated the effect of the postgraduate medical education level (PGY) of surgery residents on recurrence of inguinal hernia, complications, and operative time. METHODS: Post hoc analysis was performed on prospectively collected data from a multicenter Veterans Affairs (VA) cooperative study. Men were randomly assigned to open or laparoscopic inguinal hernia repairs with mesh. Surgery residents performed repairs with designated attending surgeons present throughout all procedures. PGY level of the resident was recorded for each procedure. All patients were followed for 2 years for hernia recurrence and complications. PGY levels were grouped as follows: group I = PGY 1 and 2; group II = PGY 3; group III = PGY >/= 4; rates of recurrence, complications and mean operative time were compared. RESULTS: A total of 1983 patients underwent hernia repair. group III residents had significantly lower recurrence rates for open repairs when compared with group I (adjusted odds ratio = 0.24, 95% confidence interval [CI], 0.06, 0.997). The recurrence rate was similar among the groups for laparoscopic repair (P > 0.05) Complication rates were not different for either repair (P > 0.05). Mean operative time was significantly shorter for group III compared with group I for both open (-6.6 minutes; 95% CI, -11.7, -1.5) and laparoscopic repairs (-12.9 minutes; 95% CI, -19.8, -6.0) and between group II and group I for laparoscopic repair (-15.0; 95% CI, -24.3, -5.7). CONCLUSIONS: Despite the presence of an attending surgeon, open hernia repairs performed by junior residents were associated with higher recurrence rates than those repaired by senior residents. Lower resident level was associated with increased operative time for both open and laparoscopic repair.