Establishing Validity for a Vaginal Hysterectomy Simulation Model for Surgical Skills Assessment.

OBJECTIVE: To use the Messick validity framework for a simulation-based assessment of vaginal hysterectomy skills. METHODS: Video recordings of physicians at different levels of training and experience performing vaginal hysterectomy on a high-fidelity vaginal surgery model were objectively assessed using a modified 10-item Vaginal Surgical Skills Index, a one-item global scale of overall performance, and a pass-fail criterion. Participants included obstetrics and gynecology trainees and faculty from five institutions. Video recordings were independently assessed by expert surgeons blinded to the identities of the study participants. RESULTS: Fifty surgeons (11 faculty, 39 trainees) were assessed. Experience level correlated strongly with both the modified Vaginal Surgical Skills Index and global scale score, with more experienced participants receiving higher scores (Pearson r=0.81, P<.001; Pearson r=0.74, P<.001). Likewise, surgical experience was also moderately correlated with the modified Vaginal Surgical Skills Index and global scale score (Pearson r=0.55, P<.001; Pearson r=0.58, P<.001). The internal consistency of the modified Vaginal Surgical Skills Index was excellent (Cronbach's alpha=0.97). Interrater reliability of the modified Vaginal Surgical Skills Index and global scale score, as measured by the intraclass correlation coefficient, was moderate to good (0.49-0.95; 0.50-0.87). Using the receiver operating characteristic curve and the pass-fail criterion, a modified Vaginal Surgical Skills Index cutoff score of 27 was found to most accurately (area under the curve 0.951, 95% CI 0.917-0.983) differentiate competent from noncompetent surgeons. CONCLUSION: We demonstrated validity evidence for using a high-fidelity vaginal surgery model with the modified Vaginal Surgical Skills Index or global scale score to assess vaginal hysterectomy skills.

Comparing Ketorolac With Ibuprofen for Postoperative Pain: A Randomized Clinical Trial.

OBJECTIVES: The objective of this study was to identify differences in pain perception and satisfaction with pain control in women receiving nonsteroidal anti-inflammatory drugs postoperatively. METHODS: This was a prospective, randomized controlled trial including urogynecology surgical patients. After surgery, all patients were randomized to receive either intravenous (IV) ketorolac or ibuprofen. The patients completed 3 visual analog scales (VAS) assessing pain at rest, pain with ambulation, and satisfaction with pain control. Postoperative opioid use was also measured. RESULTS: A total of 224 patients (112 in each arm) were included. Pain scores (SD) at rest in all patients who received ketorolac versus those who received ibuprofen was 2.30 (2.1) versus 2.68 (2.34) (P = 0.20). Pain scores (SD) with ambulation was 3.94 (2.57) versus 4.16 (2.73) (P = 0.57) in patients who received ketorolac and ibuprofen, respectively. Patients who received ketorolac rated their satisfaction with their pain regimen similarly to those who received ibuprofen (P = 0.50). The average amount (SD) of hydromorphone used in the ketorolac and ibuprofen arm was 3.68 (4.58) mg and 4.04 (4.97) mg, respectively (P = 0.58). A subgroup analysis based on type of surgery showed decreased pain at rest (VAS, 2.77 vs 4.88; P = 0.04) and increased satisfaction (VAS, 1.69 vs 4.67; P = 0.003) in patients who had laparotomy and received ketorolac. CONCLUSIONS: There was no difference in pain and satisfaction with IV ketorolac compared with IV ibuprofen in patients who underwent all modalities of urogynecologic surgery. A subgroup of patients who underwent laparotomy had less pain with ketorolac.

The Location and Distribution of Transurethral Bulking Agent: 3-Dimensional Ultrasound Study.

OBJECTIVES: To use 3-dimensional endovaginal ultrasound to describe the location and distribution of bulking agent after an uncomplicated transurethral injection. METHODS: Endovaginal ultrasound was performed in 24 treatment-naive patients immediately after bulking agent was injected. The distance between the center of the hyperechoic density of bulking agent and the urethrovesical junction (UVJ) was measured in the sagittal and axial views. This was calculated in percentile length of urethra. Also, the pattern of tracking of bulking agent was assessed if it is presented. RESULTS: After the 2 subjects were excluded because of the poor quality of images, 22 patients were included in this study. Eighteen (82%) subjects showed 2 sites of bulking agents, and mostly, they were located around 3- and 9-o'clock positions. The average distance of bulking agent from left UVJ was at 16.9% of the length of the urethra (6.2 mm; range, 0.5-17 mm) and at 25.5% of the length of the urethra (8.9 mm; range, 0-24.8 mm) in the right side. The average length of urethra was 36.7 mm. Eleven of the 22 subjects (50%) had both sides within upper one third of urethra. The difference in distance between the 2 sides was less than 10 mm in 12 of 22 patients (54%). Nine of the 22 patients (41%) had a significant spread of bulking agent mostly either into the bladder neck or toward the distal urethra. CONCLUSIONS: Although the bulking agent is most often found at 3- and 9-o'clock positions as intended, the distance from the UVJ is highly variable after an uncomplicated office-based transurethral injection. The bulking material does not form the characteristic spheres in 41% of cases and tracks toward the bladder neck or the distal urethra.

Surgical Site Infiltration for Abdominal Surgery: A Novel Neuroanatomical-based Approach.

BACKGROUND: Provision of optimal postoperative analgesia should facilitate postoperative ambulation and rehabilitation. An optimal multimodal analgesia technique would include the use of nonopioid analgesics, including local/regional analgesic techniques such as surgical site local anesthetic infiltration. This article presents a novel approach to surgical site infiltration techniques for abdominal surgery based upon neuroanatomy. METHODS: Literature searches were conducted for studies reporting the neuroanatomical sources of pain after abdominal surgery. Also, studies identified by preceding search were reviewed for relevant publications and manually retrieved. RESULTS: Based on neuroanatomy, an optimal surgical site infiltration technique would consist of systematic, extensive, meticulous administration of local anesthetic into the peritoneum (or preperitoneum), subfascial, and subdermal tissue planes. The volume of local anesthetic would depend on the size of the incision such that 1 to 1.5 mL is injected every 1 to 2 cm of surgical incision per layer. It is best to infiltrate with a 22-gauge, 1.5-inch needle. The needle is inserted approximately 0.5 to 1 cm into the tissue plane, and local anesthetic solution is injected while slowly withdrawing the needle, which should reduce the risk of intravascular injection. CONCLUSIONS: Meticulous, systematic, and extensive surgical site local anesthetic infiltration in the various tissue planes including the peritoneal, musculofascial, and subdermal tissues, where pain foci originate, provides excellent postoperative pain relief. This approach should be combined with use of other nonopioid analgesics with opioids reserved for rescue. Further well-designed studies are necessary to assess the analgesic efficacy of the proposed infiltration technique.

Informed consent training improves surgery resident performance in simulated encounters with standardized patients.

BACKGROUND: Although informed consent is vital to patient-physician communication, little training is provided to surgical trainees. We hypothesized that highlighting critical aspects of informed consent would improve resident performance. METHODS: Eighty (out of 88) surgical postgraduate year 1 surgical residents were randomly assigned to one of the 2 cases (laparoscopic cholecystectomy or ventral herniorrhaphy) and instructed to obtain and document informed consent with a standardized patient (SP) followed by a didactic training session. The residents then obtained and documented informed consent with the other case with the other SP. SPs graded encounters ("Checklist"); trained raters graded notes. Repeated measures multivariate analysis of variance (MANOVA) was used to determine differences between pre- and post-training and Checklist versus "Note" scores. RESULTS: Statistically significant pre- to post differences for Note (P < .01) and Checklist (P < .01) along with significant differences between Note and Checklist (P < .01) were noted. CONCLUSIONS: Training improved surgery residents' ability to discuss and document informed consent. Despite this improvement, significant differences between discussion and documentation persisted. Documentation training is a future area for improvement.

Validity: applying current concepts and standards to gynecologic surgery performance assessments.

Validity is critical for meaningful assessment of surgical competency. According to the Standards for Educational and Psychological Testing, validation involves the integration of data from well-defined classifications of evidence. In the authoritative framework, data from all classifications support construct validity claims. The two aims of this study were to develop a categorization method for validity evidence published in support of surgery performance assessments and to summarize the results of applying this methodology to the gynecologic surgery literature. This was a critical analysis of published observations reported as validity evidence in studies with a construct validity claim. Medline and Embase databases were searched using keywords: "surgery" and "construct validity". Parameters included English-language articles published from 2000 to 2012. Gynecologic studies were analyzed for definitions of construct validity and nonstandard terminology. Categorization criteria were developed and applied by the researchers to all observations. Two independent evaluators examined reported observations for compliance with guidelines provided by the Standards. Inter-rater agreement was calculated using weighted kappa. The initial search returned 167 articles. Twenty-five articles were left for inclusion in our analysis. Eighteen (72 %) articles defined construct validity as the ability to discriminate between expert and novice levels of proficiency. Within the sample, 80 discrete observations of reported validity evidence were identified and categorized according to standard classifications. Nearly 30 % of all published observations intended to demonstrate differences in performance by level of proficiency, 25 % described a scoring model, and 14 % demonstrated support of assessment content. Not one article contained a statistical correlation between assessment scores and objective outcomes from the authentic surgical environment. Medians for level of rigor ranged from 0 to 1 across all forms of evidence. Weighted kappa values ranged 0.60-0.91. Validity claims in gynecologic surgical assessment over-rely on generalizability evidence. No test-criterion evidence was observed. Increased awareness of current standards and systematic argument development is needed for gynecologic performance assessments.

Pain management strategies for urogynecologic surgery: a review.

OBJECTIVES: The objectives of this study were to review the recent literature on surgical pain management strategies and to identify those pertinent to urogynecologic surgery. METHODS: A literature search using Pubmed and MEDLINE was performed for trials on pain management in gynecologic surgery. Evidenced-based recommendations for preoperative, intraoperative, and postoperative pain control strategies for gynecologic procedures by various surgical routes were identified. Articles specifically describing urogynecologic procedures were sought, but quality, randomized trials on pain management modalities in other gynecologic procedures were also included. RESULTS: Although few randomized trials on pain management strategies in urogynecologic surgery exist, quality evidence suggests that several preemptive and multimodal analgesia strategies reduce pain and opioid-related adverse events in abdominal, laparoscopic, and vaginal surgery. Evidence supporting these strategies is outlined. Many are likely applicable to urogynecologic procedures. CONCLUSIONS: Evidence guiding pain management in specific urogynecologic procedures is sparse and should be sought in future studies. When possible, procedure-specific strategies, including preemptive and multimodal techniques, should be implemented.

Compounded estradiol cream: a cost conscious alternative.

BACKGROUND: Vaginal estrogen is a common therapy for many gynecologic conditions. Medication cost poses a barrier to medication compliance. The purpose of our study is to report patient cost savings by utilizing compounding pharmacies in the preparation of topical vaginal estrogen. METHODS: A survey of 10 topical vaginal estrogen compounding pharmacies was performed and prescription cost data was obtained. The University of Oklahoma Outpatient Pharmacy and the 2008 Wolters Kluwer Health Pharmaceutical Audit Suite were cost comparisons for compounded estrogen. All data was processed using statistical software yielding descriptive statistics. RESULTS: The average cost of compounded estrogen was $42.22. At the University of Oklahoma Outpatient Pharmacy, average cost for branded vaginal estrogen preparation was $137.70. The national cost average for branded vaginal estrogen preparations was $82.42. Cost savings of $94.98 (69%) locally and $40.20 (51%) nationally was identified. CONCLUSIONS: Compounded estrogen is a cost conscious alternative than branded preparations.

Obstetric laceration repair in the United States: is there a common practice?

OBJECTIVE: To assess practice preferences in the repair of severe obstetric lacerations among obstetrician/gynecologists in the United States. STUDY DESIGN: A survey detailing third and fourth degree laceration repair techniques was distributed to 634 obstetrician/gynecologists from demographically diverse areas of the United States. Categorical outcomes were compared among respondents using chi2 or Fisher's exact test where appropriate. RESULTS: Of the 266 respondents, there were 124 self-reported "experts" (47%) and 106 physicians-in-training (40%). Repair techniques were compared between experts versus nonexperts and trainees versus practicing physicians. There were no significant differences found between either comparison group on the type and size of suture utilized or preferred method of closure for repair. CONCLUSION: There is little variation in the practice pattern of complex laceration repairs among obstetrician-gynecologists in the United States. This commonality should encourage the design of standard teaching models and techniques for physicians in training.

Defining new directions for more effective management of surgical pain in the United States: highlights of the inaugural Surgical Pain Congress™.

Despite advances in pharmacologic options for the management of surgical pain, there appears to have been little or no overall improvement over the last two decades in the level of pain experienced by patients. The importance of adequate and effective surgical pain management, however, is clear, because inadequate pain control 1) has a wide range of undesirable physiologic and immunologic effects; 2) is associated with poor surgical outcomes; 3) has increased probability of readmission; and 4) adversely affects the overall cost of care as well as patient satisfaction. There is a clear unmet need for a national surgical pain management consensus task force to raise awareness and develop best practice guidelines for improving surgical pain management, patient safety, patient satisfaction, rapid postsurgical recovery, and health economic outcomes. To comprehensively address this need, the multidisciplinary Surgical Pain Congress™ has been established. The inaugural meeting of this Congress (March 8 to 10, 2013, Celebration, Florida) evaluated the current surgical pain management paradigm and identified key components of best practices.

Training community gynecologists to perform intraoperative cystoscopy: a competency-based training experience.

OBJECTIVE: This study aimed to pilot a cystoscopy training program for community gynecologists that is validated by posttraining examination. METHODS: Twenty-eight gynecologists were trained to perform cystoscopy using a competency-based training approach. Baseline information included years in practice and number of incontinence procedures and/or cystoscopies performed per month. Three 5-hour workshops were administered that included applied practice. After learners individually trained until they felt comfortable with their skills on a model, they were individually tested on a cadaver. Performance was evaluated with 2 instruments, namely, a task-specific checklist and a global rating scale based on the objective structured assessment of technical skill model. Failure was defined as inability to independently complete elements of the task-specific checklist for cystoscopic examination. Likert-type self-report scales were used during pretesting and posttesting, assessing confidence to perform component tasks for diagnostic cystoscopy. RESULTS: Twenty-four of 28 trainees successfully performed a systematic cadaveric bladder examination during the primary posttest. After debriefing, the 4 trainees who initially failed successfully performed cystoscopy during a second trial. Median age was 51 years and median time in practice was 19.5 years. All participants reported high confidence in identifying ureteral injury at the course's conclusion. CONCLUSIONS: A task-specific training program can successfully improve the confidence and skill of community gynecologists to perform intraoperative diagnostic cystoscopy. Professionals may not be able to define when they have received enough instruction in terms of hands-on training with models, before acquisition of technical skills. Formal evaluation of technical skills is recommended after training to ensure competence.

Evaluation of vaginal cysts and masses by 3-dimensional endovaginal and endoanal sonography.

The purpose of this pictorial essay is to describe the utility of 3-dimensional endovaginal and endoanal sonography in the assessment of vulvovaginal cysts and masses. It is accepted that compared with transabdominal pelvic sonography, transvaginal end-fire sonography provides improved resolution for visualization of female reproductive organs with fewer artifacts. To visualize the structures that are located in or lateral to the vaginal canal, side-fire 3-dimensional endovaginal or endoanal sonography can be used. This special technique has the advantage of maintaining the spatial anatomic relationship of any abnormality in the vagina.

Referral pattern for vaginal mesh and graft complications to the University of Oklahoma Pelvic and Bladder Health Clinic.

OBJECTIVE: To evaluate the referral pattern to a tertiary care center for vaginal mesh complications following surgeries for pelvic organ support defect. METHODS: This was a retrospective review of women presenting to our clinic for complications of vaginal mesh. RESULTS: One hundred thirty three patients were included in the study. The median age was 58.4 years, median parity was two, and 95.4% were Caucasian. The pattern of referral was as follows: 10% continued care at the tertiary center where mesh or graft was initially inserted, 18% were referred by the surgeon who initially implanted the mesh or graft, 71% were referred from an outside secondary health care provider, and 1% was self referred. CONCLUSION: The majority of patients presenting to our clinic with mesh vaginal mesh complications were referred by someone other than the implanting surgeon.

Medical student knowledge of global health problems: obstetric fistulas in developing countries.

OBJECTIVE: To evaluate medical students in the United States at several medical schools regarding their knowledge of the global health burden of obstetric fistulas. STUDY DESIGN: A cross-sectional survey was conducted in 8 schools across the United States over a period of 6 months. The survey was composed of 18 questions on epidemiology, pathology, and treatment of fistulas. It was a web-based module accessed through an emailed link. It was sent to 5,103 medical students' email addresses at the 8 institutions once a week for 4 weeks. SPSS paired student t tests was used for statistical analysis. RESULTS: Of the 1,089 students from 8 medical schools that initially began the survey, 965 completed this voluntary and anonymous survey, with a 21% response rate and 19% completion rate. Overall the students averaged 11/18 (60.7%) correct on this survey. The knowledge of obstetric fistula improved, but not significantly, with increasing level of medical school education, with first-year medical students achieving 10/18 (55%) correct and senior medical students achieving 12/18 (67%) correct (p = 0.1). CONCLUSION: U.S. medical students' knowledge of obstetric fistulas in developing countries does not increase significantly over 4 years of medical school education. While this condition presents largely in the developing world, given rapid globalization as well as increased international health experiences for U.S.-trained health professionals,further effort should be placed in improving medical student knowledge of this devastating condition.

Randomized trial comparing office flexible to rigid cystoscopy in women.

INTRODUCTION AND HYPOTHESIS: The objective of the study was to compare office rigid cystoscopy (RC) versus flexible cystoscopy (FC) in women. METHODS: This was a prospective randomized trial comparing FC to RC. Aims were to assess 1-week post-procedural complications, compare procedure pain scores, and to assess physician perception of patient discomfort. Pain scores were assessed by visual analogue scale (VAS) and 5-point verbal descriptor scale (VDS). Chi-square was used for categorical comparison and t tests or Wilcoxon test for continuous variables. RESULTS: One hundred women were enrolled. The mean age of participants was 59.7 years (± SD 14.6), and 91 % were Caucasian. This was the first cystoscopy for 86 % of participants. On the 1-week post-procedure questionnaire (85 % response rate), participants in the FC group reported urinary frequency more often than in the RC group (p = 0.041). The FC group reported urgency with urination lasting 1-2 days (p = 0.030) and burning with urination lasting >3 days (p = 0.026), more than the RC group. These symptoms did not persist at 7 days. The duration of the procedure was slightly faster for the FC group (4.6 ± 1.8 min vs 5.7 ± 3.4 min, p = 0.046). Median VAS scores were 0.9 (0.1-2.72) for the FC group and 0.5 (0-2.4) for the RC group (p = 0.505). There were no significant differences between patient or physician perception of pain in either group. CONCLUSIONS: Urinary frequency and duration of urinary burning post procedure occurred more frequently in the FC group, although these symptoms were transient. Both office FC and RC are generally well tolerated in women with overall low morbidity.

Anterior and posterior compartment 3D endovaginal ultrasound anatomy based on direct histologic comparison.

INTRODUCTION AND HYPOTHESIS: We used direct histologic comparison to validate the use of 3D endovaginal ultrasound (EVUS) as a novel and emerging technology for evaluating the structures found in the anterior and posterior pelvic floor compartments. METHODS: A young nulliparous female pelvis specimen was dissected and histologic slides were prepared by making 8-Micron-thick sagittal cuts. The slides were stained with Mallory trichrome and arranged to form large sections encompassing each anterior and posterior sagittal plane. Healthy nulliparous women underwent 3D EVUS to obtain 3D cubes of the anterior and posterior compartments. Two investigators independently evaluated the anterior and posterior midsagittal structures. The investigators mutually viewed the images and calculated urethral and anal sphincter measurements. RESULTS: Thirty-one nulliparous women underwent 3D EVUS; 77% of the participants were Caucasian, with mean age 31.8 [standard deviation (SD) 5.8] and mean body mass index (BMI) of 28.5 (SD 7.9). The following mean (SD) measurements were obtained: urethral length 36 mm (± 5); striated urogenital sphincter area 0.6 cm(2) (± 0.16); longitudinal and circular smooth muscle area 1.1 cm(2) (± 0.4); urethral complex width 14 mm (± 2); urethral complex area 1.3 cm(2) (± 0.4); internal anal sphincter length 26 mm (± 4); internal anal sphincter thickness 3.2 mm (± 0.8); and rectovaginal septum length 31 mm (± 5). The agreement for visualization of structures was as follows: vesical trigone 96% (κ = 0.65), trigonal ring 94% (κ = 0.8), trigonal plate 84% (κ = 0.6); longitudinal and circular smooth muscle 100%; compressor urethra 97% (κ = 0.85); striated urogenital sphincter 97% (κ = 0.85); rectovaginal septum 100%; internal anal sphincter 100%; external anal sphincter subdivisions 100%. CONCLUSIONS: Three-dimensional EVUS can be used to visualize structures of the anterior and posterior compartments in nullipara.

Reported cystoscopic experience correlates poorly with objective assessment of cystoscopic skills.

OBJECTIVE: Although gynecologists perform a large number of surgeries in close proximity to the ureters and the urinary bladder, traditionally, Obstetrics and Gynecology resident physicians are not formally taught to perform cystoscopy. The primary objective was to document resident physicians' performance in diagnostic cystoscopic instrumentation and technique. The secondary objective was to examine if reported prior cystoscopic experience was associated with superior performance. METHODS: Fifty-one postgraduate year 4 residents with reported experience with cystoscopy were evaluated using an operation-specific checklist and a global ratings scale based on the Objective Structured Assessment of Technical Skill model. Before evaluation, they attended a formal training session in cystoscopy, which included practice on a bench model of a simulated bladder. RESULTS: Forty-three of the 51 residents were able to successfully perform a thorough diagnostic examination immediately after the course. Six of the 8 failures were re-evaluated 2 weeks later and successfully performed a complete examination at that time. Before the course, the residents had performed a mean of 12.2 cystoscopic examinations as the primary surgeon (median, 12; range, 2-33). The number of reported cystoscopic examinations performed before the course did not correlate with the ability to perform a thorough cystoscopic examination (r = -0.109; P = 0.496). CONCLUSIONS: For this group of residents, there was poor correlation between the number of reported cystoscopic examinations and the ability to perform diagnostic cystoscopy. Trainees may not be able to determine when they have received enough instruction in hands-on training with models before acquisition of technical skills.

Randomized trial comparing 2 fiber regimens for the reduction of symptoms of constipation.

OBJECTIVE: : This study aimed to compare the effects of a special bowel recipe with psyllium on symptoms of constipation. METHODS: : Women with symptoms of constipation were randomized to 6 weeks of either psyllium or a special bowel recipe. Patients completed a constipation scoring questionnaire and recorded characteristics of each bowel movement. RESULTS: : A total of 53 participants completed prestudy and poststudy constipation scoring questionnaires. Both groups demonstrated improvement in constipation scores (psyllium: 13.9 ± 4.7 to 9.0 ± 4.6, P < 0.001; recipe: 13.6 ± 4.1 to 8.5 ± 5.0, P < 0.001). Mean differences in pretreatment and posttreatment constipation scores were not statistically different between the 2 groups.Subjects taking the bowel recipe strained only 20% of the time compared with those using psyllium who strained 57% of the time (P = 0.007). Other symptoms improved from baseline, but the majority was not different between treatment groups. CONCLUSIONS: : The bowel recipe demonstrated no significant difference in efficacy to pure fiber.

Three-dimensional ultrasound imaging for diagnosis of urethrovaginal fistula.

We present a novel technique for visualization of a urethrovaginal fistula. A 52-year-old patient presented with persistent urinary incontinence, after having three mid-urethral sling procedures performed within the past year. The diagnosis of a urethrovaginal fistula was made by endovaginal 3-D endovaginal ultrasound and confirmed intraoperatively. We have described a novel technique that may benefit patients with urethrovaginal fistulas that are difficult to visualize.

Surgical reconstitution of a unilaterally avulsed symptomatic puborectalis muscle using autologous fascia lata.

BACKGROUND: The puborectalis muscle is an important muscle for the maintenance of fecal continence. We present a novel surgical technique for repair of symptomatic avulsed puborectalis muscle. CASE: This woman presented with dyspareunia and fecal incontinence since the vaginal birth of her child 2 years before. The diagnosis of an avulsed right puborectalis was made by physical examination and confirmed by magnetic resonance imaging and three-dimensional ultrasonography. Fascia lata was harvested from the patient's thigh and used to reconstitute the missing portion of the puborectalis muscle. At 12 months postoperatively, the patient was continent of stool and relieved of dyspareunia. CONCLUSION: The patient's dyspareunia and fecal incontinence were alleviated by restoring normal anatomy.