Bernd Buerkle

Activity of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin and doxorubicin in women with recurrent, platinum-resistant ovarian cancer: Preliminary clinical experience

OBJECTIVE To assess the activity of laparoscopic Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in women with recurrent, platinum-resistant ovarian cancer. METHODS Prospective case series using repeated courses q 28-42 days of PIPAC containing cisplatin 7.5 mg/m(2) and doxorubicin 1.5 mg/m(2) at 12 mmHg and 37°C for 30 min. Objective tumor response was defined as tumor regression on histology and peritoneal carcinomatosis index (PCI) improvement on repeated video-laparoscopy. RESULTS 34 PIPAC procedures were performed in 18 women, in 8 instances combined with cytoreductive surgery (CRS). Eight women had repeated PIPAC and objective tumor response was observed in 6 (complete remission: 1; partial remission: 2; stable disease: 3). Five adverse events WHO grade ≥ 2 were noted, 3 of them after combined CRS. No perioperative mortality occurred. Median follow-up was 192 days (min. 13-max. 639). Cumulative survival after 400 days was 62% and mean actuarial survival time was 442 days. In a multivariable regression analysis with objective tumor response (yes vs. no) as the dependent variable and PIPAC (1 vs.>1), patient age (<75 vs.≥75 years), serum CA-125 (<1000 vs.>1000 U/mL), and the presence of ascites (yes vs. no) as independent variables, PIPAC independently predicted objective tumor response. CONCLUSION PIPAC has activity in women with recurrent, platinum-resistant ovarian cancer and should be investigated in prospective clinical trials.

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in a woman with pseudomyxoma peritonei: A case report

Highlights • This is the first report of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in a woman with pseudomyxoma peritonei.• PIPAC achieved clinical and histological disease remission.• PIPAC with cisplatin and doxorubicin may be effective in pseudomyxoma peritonei.

Objective structured assessment of technical skills evaluation of theoretical compared with hands-on training of shoulder dystocia management: a randomized controlled trial.

OBJECTIVE: To compare the skills of performing a shoulder dystocia management algorithm after hands-on training compared with demonstration. METHODS: We randomized medical students to a 30-minute hands-on (group 1) and a 30-minute demonstration (group 2) training session teaching a standardized shoulder dystocia management scheme on a pelvic training model. Participants were tested with a 22-item Objective Structured Assessment of Technical Skills scoring system after training and 72 hours thereafter. Objective Structured Assessment of Technical Skills scores were the primary outcome. Performance time, self-assessment, confidence, and global rating scale were the secondary outcomes. Statistics were performed using Mann-Whitney U test, &khgr;2 test, and multiple linear regression analysis. RESULTS: Two hundred three participants were randomized. Objective Structured Assessment of Technical Skills scores were significantly higher in group 1 (n=103) compared with group 2 (n=100) (17.95±3.14 compared with 15.67±3.18, respectively; P<.001). The secondary outcomes global rating scale (GRS; 10.94±2.71 compared with 8.57±2.61, respectively; P<.001), self-assessment (3.15±0.94 compared with 2.72±1.01; P=.002), and confidence (3.72±0.98 compared with 3.34±0.90, respectively; P=.005), but not performance time (3:19±0:48 minutes compared with 3:31±1:05 minutes; P=.1), were also significantly different, favoring group 1. After 72 hours, Objective Structured Assessment of Technical Skills scores were still significantly higher in group 1 (n=67) compared with group 2 (n=60) (18.17±2.76 compared with 14.98±3.03, respectively; P<.001) as were GRS (10.80±2.62 compared with 8.15±2.59; P<.001) and self assessment (SA; 3.44±0.87 compared with 2.95±0.94; P=.003). In a multiple linear regression analysis, group assignment (group 1 compared with 2; P<.001) and sex (P=.002) independently influenced Objective Structured Assessment of Technical Skills scores. CONCLUSION: Hands-on training helps to achieve a significant improvement of shoulder dystocia management on a pelvic training model. CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.gov, NCT01618565. LEVEL OF EVIDENCE: I

Fertility awareness among medical and non-medical students: a case-control study.

BackgroundTo compare the understanding and perceptions of fertility issues among medical and non-medical University students.MethodsIn a prospective case-control study, using a 43 item questionnaire with 5 sections and 43 questions regarding personal data (8 questions), lifestyle factors (9 questions), plans on having children (5 questions), age and fertility (5 questions), and lifestyle and fertility (16 questions), knowledge of fertility and influencing factors, desired age at commencement and completion of childbearing, among male and female medical and non-medical students in their first academic year at Vienna University, Vienna, Austria were evaluated.Results340 students were included. 262/340 (77%) participants planned to have children in the future. Medical students (n = 170) planned to have fewer and later children and had a higher awareness of the impact of age on fertility than non-medical students (n = 170; estimated knowledge probability 0.55 [medical students] vs. 0.47 [non-medical students]; F (1, 336) = 5.18 and p = .024 (η p = .015). Gender did not independently affect estimated knowledge probability (F (1, 336) = 1.50 and p = .221). More female and male medical students had a positive attitude towards Assisted Reproductive Technology in case of infertility than non-medical students (47 and 55% vs. 23 and 29%, respectively; p = <.001). Medical students had a healthier lifestyle than non-medical students. A healthy lifestyle and female gender were associated with higher fertility awareness.ConclusionsMedical students have a higher awareness of fertility issues than non-medical students. Choice of academic study, gender, and personal life style are important factors affecting fertility awareness. These data may be helpful to address knowledge gaps among young non-medical Academics.

Objective Structured Assessment of Technical Skills (OSATS) evaluation of hysteroscopy training: a prospective study.

OBJECTIVES To describe the performance curve of hysteroscopy-naïve probands repeatedly working through a surgery algorithm on a hysteroscopy trainer. STUDY DESIGN We prospectively recruited medical students to a 30min demonstration session teaching a standardized surgery algorithm. Subjects subsequently performed three training courses immediately after training (T1) and after 24h (T2) and 48h (T3). Skills were recorded with a 20-item Objective Structured Assessment of Technical Skills (OSATS) at T1, T2, and T3. The presence of a sustained OSATS score improvement from T1 to T3 was the primary outcome. Performance time (PT) and self assessment (SA) were secondary outcomes. Statistics were performed using paired T-test and multiple linear regression analysis. RESULTS 92 subjects were included. OSATS scores significantly improved over time from T1 to T2 (15.21±1.95 vs. 16.02±2.06, respectively; p<0.0001) and from T2 to T3 (16.02±2.06 vs. 16.95±1.61, respectively; p<0.0001). The secondary outcomes PT (414±119s vs. 357±88s vs. 304±91s; p<0.0001) and SA (3.02±0.85 vs. 3.80±0.76 vs. 4.41±0.67; p<0.0001) also showed an improvement over time with quicker performance and higher confidence. SA, but not PT demonstrated construct validity. In a multiple linear regression analysis, gender (odds ratio (OR) 0.96; 95% confidence interval (CI) 0.35-2.71; p=0.9) did not independently influence the likelihood of OSATS score improvement. CONCLUSIONS In a hysteroscopy-naïve population, there is a continuous and sustained improvement of surgical proficiency and confidence after multiple training courses on a hysteroscopy trainer. Serial hysteroscopy trainings may be helpful for teaching hysteroscopy skills.

Objective Structured Assessment of Technical Skills (OSATS) evaluation of theoretical versus hands-on training of vaginal breech delivery management: a randomized trial.

OBJECTIVE To compare the skills of performing a vaginal breech (VB) delivery after hands-on training versus demonstration. STUDY DESIGN We randomized medical students to a 30-min demonstration (group 1) or a 30-min hands-on (group 2) training session using a standardized VB management algorithm on a pelvic training model. Subjects were tested with a 25 item Objective Structured Assessment of Technical Skills (OSATS) scoring system immediately after training and 72 h thereafter. OSATS scores were the primary outcome. Performance time (PT), self assessment (SA), confidence (CON), and global rating scale (GRS) were the secondary outcomes. Statistics were performed using the Mann-Whitney U-test, chi-square test, and multiple linear regression analysis. RESULTS 172 subjects were randomized. OSATS scores (primary outcome) were significantly higher in group 2 (n=88) compared to group 1 (n=84) (21.18±2.29 vs. 20.19±2.37, respectively; p=0.006). The secondary outcomes GRS (10.31±2.28 vs. 9.17±2.21; p=0.001), PT (214.60±57.97 s vs. 246.98±59.34 s; p<0.0001), and CON (3.14±0.89 vs. 2.85±0.90; p=0.04) were also significantly different between groups, favoring group 2. After 72 h, primary and secondary outcomes were not significantly different between groups. In a multiple linear regression analysis, group assignment (odds ratio [OR] 1.60; 95% confidence interval [CI] 1.14-2.05; p<0.0001) and gender (OR 2.91; 95% CI 2.45-3.38; p<0.0001) independently influenced OSATS scores. CONCLUSION Hands-on training leads to a significant improvement of VB management in a pelvic training model, but this effect was only seen in the short term.

Saliva cortisol levels and subjective stress are not associated with number of oocytes after controlled ovarian hyperstimulation in patients undergoing in vitro fertilization

OBJECTIVE To establish an association between the number of oocytes retrieved after controlled ovarian hyperstimulation (COH) and saliva cortisol (F) levels, as well as subjective stress, in women undergoing their first IVF cycle. DESIGN Prospective clinical study. SETTING Academic research institution. PATIENT(S) Women with primary or secondary infertility undergoing IVF. INTERVENTION(S) Fertility problem inventory (FPI) questionnaire and measurement of morning and evening saliva F by RIA. MAIN OUTCOME MEASURE(S) Number of oocytes and stress, defined as low morning F and/or a positive FPI result. RESULT(S) Eighty-three women provided saliva specimens, 66 of whom also filled in the FPI. The median number of oocytes was 8.4 (range 0-26). A state of stress was observed in 38/83 (46%) women. The mean number of oocytes was not significantly different between women with and without stress (7.3 ± 4.3 vs. 8.9 ± 6.9, respectively). In a multivariate analysis, stress (odds ratio 2.6; 95% confidence interval 0.03-225.7) and morning F (odds ratio 0.9; 95% confidence interval 0.6-1.3) were not significantly associated with the number of oocytes. There were no statistically significant correlations between F concentrations, FPI results, and age, number of poor responders, live birth rate, and clinical pregnancy rate (PR). CONCLUSION(S) Stress, as measured by saliva F and the FPI questionnaire, does not negatively impact the effectiveness of COH and is not associated with a reduced number of oocytes.

Quality of websites of obstetrics and gynecology departments: a cross-sectional study

BackgroundThe internet has become an easily accessible and widely used source of healthcare information. There are, however, no standardized or commonly accepted criteria for the quality of Obstetrics and Gynecology websites. In this study, we aimed to evaluate the quality of websites of Obstetrics and Gynecology departments in German-speaking countries and to compare websites nationally and internationally.MethodsWe scored 672 websites from Germany (n = 566), Austria (n = 57), and Switzerland (n = 49) using the objective criteria: Google search rank (2 items), technical aspects (11 items), navigation (8 items), and content (6 items) for a 26 point score. Scores were compared nationally and internationally. Multivariable regression models assessed good quality scores (≥50% of maximum) as the dependent variables and country, academic affiliation, being member of a healthcare consortium, confessional affiliation, and content management system (CMS) use as independent variables.ResultsThe mean score of websites was 13.8 ± 3.3. 4.2% were rated as good (≥75% of maximum), 61.8% as fair (≥50% of maximum). German (14.0 ± 3.2) and Swiss (13.8 ± 4.0) websites scored significantly higher compared to Austrian websites (11.6 ± 2.5) (P < 0.001 and P = 0.005, respectively). Within Germany, academic had higher scores than non-academic departments (14.9 ± 3.2 vs. 13.7 ± 3.1, P < 0.001). Single institutions had higher scores compared to healthcare consortium institutions (14.1 ± 3.2 vs. 13.2 ± 2.6, P = 0.003). Departments in Northern and Southern states had higher scores compared to Eastern states (14.4 ± 3.2 and 14.2 ± 3.2 vs. 13.0 ± 3.0, P < 0.001). In multivariate regression models, all subscores (all: P < 0.001) independently predicted a website’s reaching a good quality score, with navigation subscore as strongest predictor. Affiliations were predictors for some good individual subscores, but not for others. High content subscore was associated with good Google search rank, technical aspects, and navigation subscores.ConclusionsThe quality of websites of Obstetrics and Gynecology departments varies widely. We found marked differences depending on country, affiliation, and region.