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Leigh Neumayer

Publications and source records attributed to Leigh Neumayer.

At least 19 recordsLinked to original sources
PubMed2006

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.

Aged↗
PubMed2006

Impact of inguinal hernia repair on family and other informal caregivers.

HYPOTHESIS: Inguinal hernia significantly affects family and other informal caregivers, and hernia repair will significantly reduce caregiver burden. METHODS: We analyzed data from a Veterans Affairs Cooperative Study with mixed models to compare the level of burden among caregivers of inguinal hernia patients from preoperative measurement to measurement at 2 weeks and at 3 months postoperatively. RESULTS: Most caregivers were wives (73%) and lived with the patients (88%). There were no differences in caregiver burden by type of treatment. The time caregivers spent assisting patients increased significantly over the 2 weeks following treatment (odds ratio, 4.34). In contrast, 3 months after treatment, caregivers reported spending less time on additional chores than before treatment (odds ratio, 0.12). Furthermore, caregivers' concerns about patients' abilities to perform normal household activities decreased by 2 weeks posttreatment (odds ratio, 0.52). Wives/girlfriends and caregivers of patients with complications were more likely to report these concerns. CONCLUSIONS: Inguinal hernia and its repair significantly affect informal caregivers. Caregivers assumed the heaviest time and effort-related burden 2 weeks following hernia repair and expended additional effort if the patient experienced complications. Interventions should reflect when burden is greatest and target the subgroups of caregivers who most need support.

Adult↗
PubMed2006

Overnight activities of medical students on call: is it really educational?

BACKGROUND: To validate self-report of activities and to assess time allocation of medical students taking in-house call during their third-year surgery clerkship. METHODS: Informed consent was obtained from students who agreed to participate while rotating on the third-year surgery clerkship. Students were randomized to 1 of 2 groups, either the self-report group or the shadow group. All students kept a log of their activities during weekdays. Students randomized to the self-report group kept a log of their activities on nights (6 pm to 7 am weeknights) and weekends (7 am to 7 am Saturday and Sunday) when they were assigned to in-house call. Students randomized to the shadow group kept a log of their activities and also were shadowed while on call by a research assistant (observer) who recorded their activities. All students categorized each activity as patient-care activities related to educational objectives (educational), patient-care activities unrelated to educational objectives (noneducational), and personal care (personal). To validate self-report, student and observer logs were compared. Percentages of time engaged in educational versus other activities were compared between the shadowed and nonshadowed groups and among weekdays (WD), weeknights (WN), weekend days (WED), and weekend nights (WEN). RESULTS: A total of 34 students (16 shadow, 18 self-report) agreed to participate. Five (15%) students, all in the self-report group, did not turn in their logs. Data were available for the remaining 29 students for 138 shifts (WD, 44; WN, 46; WED, 24; WEN, 24). Observer and self-report were correlated highly for educational and personal activities, but not for noneducational activities. On WD, students averaged 76.1% of their time in educational activities, compared with 46.7%, 63.3%, and 50.2% of their time while on WN, WED, and WEN, respectively (P <.05 for WD vs. all others). Students spent between 9% and 14% of their time in noneducational activities, and between 9% and 49% of their time in personal activities during call shifts. CONCLUSIONS: This study validates student self-report of activities while on surgery call. Students spend significantly more time engaged in educational activities during weekdays than any call shifts (weeknights, weekend days, weekend nights). This information can be used for curricular planning.

Clinical Clerkship↗
PubMed2006

Clinical research.

Explore the source record for details and available documents.

Biomedical Research↗
PubMed2006

Surgical management of inguinal hernia.

The Lichtenstein repair is now the gold standard for open hernia repairs. This repair is easier to learn and easy to implement for the average general surgeon. Open mesh repairs are not the end-all in hernia operations, however, and surgeons must retain the knowledge for open tissue-based procedures. Laparoscopic inguinal hernia repair is a safe alternative to open repair for inguinal hernias but is much more operator dependent. Open mesh repair has a lower recurrence rate when compared with TEP or TAPP repairs for less experienced laparoscopists. Laparoscopic repair has a quicker return to work, is associated with less postoperative pain, and has a better cosmetic result. It is more difficult to learn, however, and hospital costs are higher. Surgeons need to look at their own numbers and experience to decide which approach is better given the clinical situation based on their proficiency with the various techniques.

Anesthesia, Local↗
PubMed2005

Predictors of wound infection in ventral hernia repair.

BACKGROUND: Postoperative wound infection is a significant risk factor for recurrence after ventral hernia repair (VHR). The current study examines patient- and procedure-specific variables associated with wound infection. METHODS: A cohort of subjects undergoing VHR from 13 regional Veterans Health Administration (VHA) sites was identified. Patient-specific risk variables were obtained from National Surgical Quality Improvement Program (NSQIP) data. Operative variables were obtained from physician-abstracted operative notes. Univariate and multivariable logistic regression analysis was used to model predictors of postoperative wound infection. RESULTS: A total of 1505 VHR cases were used for analysis; wound infection occurred in 5% (n = 74). Best-fit logistic regression models demonstrated that steroid use, smoking, prolonged operative time, and use of absorbable mesh, acting as a surrogate marker for a more complex procedure, were significant independent predictors of wound infection. CONCLUSION: Permanent mesh placement was not associated with postoperative wound infection. Smoking was the only modifiable risk factor and preoperative smoking cessation may improve surgical outcomes in VHR.

Adult↗
PubMed2005

The role of the Veterans Affairs Medical Centers in patient care, surgical education, research and faculty development.

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.

Biomedical Research↗
PubMed2005

Variation in Institutional Review processes for a multisite observational study.

BACKGROUND: The Veterans Administration is an ideal setting for multisite studies; however, individual VA Institutional Review Board (IRB) approval is necessary. This study examines the burden of multisite IRB approval on a Health Services Research and Development (HSRD) ventral hernia outcomes observational study. METHODS: Data gathered on the IRB process per site included time required for application completion, staff training and compliance, IRB affiliation (VA or university), approval status, and time to IRB approval. Wilcoxon rank sum tests were used to determine differences in median times for application completion and approval. Financial and temporal expenses were calculated. RESULTS: Significant differences were found in median time to complete applications by IRB affiliation (P < .01) and median time to approval by changes required to the consent letter (P < .05). CONCLUSIONS: The IRB process for a multisite observational study is expensive in both time and money. A VA national IRB for multisite studies would significantly decrease the financial and temporal burden for observational studies.

Ethics Committees, Research↗
PubMed2005

Does surgeon frustration and satisfaction with the operation predict outcomes of open or laparoscopic inguinal hernia repair?

BACKGROUND: A surgeon's level of frustration when performing an operation and level of satisfaction at completion may be correlated with patients' outcomes. We evaluated the relationship between the attending surgeons' frustration and satisfaction and recurrence and complications of open and laparoscopic inguinal hernia repair. STUDY DESIGN: Men with detectable inguinal hernias were randomized to undergo open or laparoscopic herniorrhaphy at 14 Veterans Affairs hospitals. After completion of the procedure, surgeons were asked to assess their level of frustration during the operation and their overall satisfaction with the operative result. Two subjective scales ranging from 1 (not frustrated/not satisfied) to 5 (very frustrated/very satisfied) were used to independently assess both parameters. Reasons for surgeon frustration were evaluated. Patients were followed for 2 years for recurrence and complications. RESULTS: Of 1,983 patients who underwent hernia repair, 1,622 were available for analysis; 808 had open repair and 813 had laparoscopic repair. Surgeons reported less frustration and more satisfaction with open than with laparoscopic repair (p = 0.0001 and 0.0001, respectively). Frustration was associated with a higher rate of hernia recurrence at 2 years (adjusted odds ratio, 2.01, 95% CI, 1.15-3.51) in open repair, and a higher overall rate of postoperative complications (adjusted odds ratio, 1.27, 95% CI, 1.03-1.56) in both open and laparoscopic hernia repair. Satisfaction was not correlated with recurrence or complications. CONCLUSIONS: The level of a surgeon's frustration during performance of an inguinal herniorrhaphy was a better predictor of outcomes of the operation than was satisfaction with the procedure. Sources of intraoperative frustration should be controlled to improve outcomes.

Hernia, Inguinal↗
PubMed2005

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.

Activities of Daily Living↗
PubMed2005

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.

Activities of Daily Living↗
PubMed2004

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.

Hernia, Inguinal↗
PubMed2004

Does the National Board of Medical Examiners' Surgery Subtest level the playing field?

BACKGROUND: We sought to determine if scores on the National Board of Medical Examiners' Surgery Subject Examination (NBME-SS) correlated with ward assessment of Fund of Knowledge and how the NBME-SS scores impacted surgery clerkship grade. METHODS: Student evaluations from 4 academic years (1999-2003) were analyzed. Scores from the Fund of Knowledge subsection were compared with scores on the NBME-SS. Student final grades were calculated with (at a weight of 10%) and without NBME-SS score. RESULTS: Data were available for all 399 students who rotated on surgery during the study period. Fund of Knowledge score and NBME-SS scores correlated minimally (Pearson's r = 0.108, P = 0.031). Performance on the NBME-SS helped 11% of students' grades, but 64% of students' grades were hurt. Fifteen percent of the students missed receiving honors because of their performance on the NBME-SS. CONCLUSIONS: The NBME-SS negatively influenced the grades of a large proportion of students and correlated only minimally with Fund of Knowledge scores as assessed on ward evaluations.

Adult↗
PubMed2004

Design and conduct issues in surgical clinical trials.

The design and conduct of surgical clinical trials present unique challenges to the investigator that are not encountered in drug studies. Using the Veterans Affairs Cooperative Studies Program Hernia Trial as a case study, this article explores the potential problems and solutions.

Clinical Trials as Topic↗
PubMed2004

Repair of ventral incisional hernia: the design of a randomized trial to compare open and laparoscopic surgical techniques.

The appearance of incisional hernia after laparotomy closure continues to be an important postoperative complication. Advances in anesthesia techniques, adequate prevention and treatment of infection during surgery, and the use of new suture materials have reduced the incidence of incisional hernia. Nevertheless, incisional hernia still occurs in 0.5% to 11% of all laparotomies performed. There are many different techniques currently in use for ventral incisional hernia (VIH) repair. Among these techniques, laparoscopic repair has been reported to be superior to open repair because of less pain, a lower recurrence rate, fewer complications, and earlier return to work. The lower rate of complications may be a major contributing factor to a reduced incidence of recurrence. However, laparoscopic repair requires expensive equipment and supplies, and it is not yet generally accepted. No conclusive randomized trial of sufficient size and power has been done to establish the "gold standard" for VIH repair, and surgeons are calling for proper evaluation. This randomized clinical trial conducted at 3 Veterans Affairs medical centers was designed to compare open VIH repair with the laparoscopic technique with respect to postoperative complications at 8 weeks, health-related quality of life, postoperative pain, time to return to normal activities, patient satisfaction, and recurrence rate of the hernia at 1 and 2 years. The study design calls for randomization of 314 men over a period of 32 months. This will allow > or =80% power to detect a 15% difference in complication rates between the 2 surgical procedures at 8 weeks. Randomization is stratified by hospital, whether the hernia is recurrent and whether the patient's body mass index is > or =35 or <35. We report the design and beginning of a multicenter trial comparing open and laparoscopic VIH repair. When completed, this study will provide surgeons and their patients with information that will help guide their choice of surgical technique.

Adolescent↗