Removal of pregnancy categories and likelihood of prescribing: a randomized trial.

OBJECTIVES: To assess the degree to which removal of FDA' Pregnancy Categories (PC) of medications (A, B, C, and D) from labeling, affects the likelihood that providers will prescribe those medications. METHODS: Over a one-year period a convenience sample of providers was recruited into a randomized, survey-based, study. Two versions of the survey were randomly distributed; version 1 presented clinical vignettes, drug information, and PC, while version 2, presented the identical information without the PC. Respondents were asked to estimate their likelihood of prescribing the drug. A mixed linear model was constructed, with likelihood of prescription as the dependent variable, treated as interval-scaled. RESULTS: Out of 169 surveys given out, 162 (96%) were returned. Simple effects analysis showed that the presence of PC letter significantly affected the decision to prescribe category B (p<0.001) and C drugs (p=0.008) but not the A or D. Participants were significantly less likely to prescribe class B and C drugs when the letters were not available for review. These findings remained significant even when controlling for covariates (p=0.001). CONCLUSIONS: When a PC letter is absent on labeling, physicians were less likely to use category B and C drugs, the most common medications prescribed in pregnancy.

To Morcellate or Not to Morcellate: A Cross-Sectional Survey Of Gynecologic Surgeons.

BACKGROUND AND OBJECTIVES: The inadvertent dissemination of uterine cancer cells with the power morcellator has received much attention in the press and a warning from the U.S. Food and Drug Administration. Many hospitals prohibit the use of the morcellator in gynecologic surgery. We conducted a survey in an attempt to assess gynecologic surgeons' beliefs regarding the intracorporeal power morcellation of fibroids in light of the risk of dissemination of malignancy in patients in whom the presence of cancer is unknown before surgery. METHODS: We conducted an Internet-based survey of 3505 members of the Society of Laparoendoscopic Surgeons (SLS) to assess demographics, current use of the intracorporeal power morcellator, and whether the recent negative press has affected gynecologic surgeons' use of the morcellator. RESULTS: Of the 3505 SLS members surveyed, 518 responded (response rate, 14.77%). Three hundred thirteen (61%) of the respondents were not using the intracorporeal power morcellator. Of those, 48% reported the reason was a hospital-wide ban, and an additional 17% reported lack of availability (not in stock). Senior attendings with >20 years of experience used the morcellator more often than junior attendings and fellows (P = .007). Furthermore, the morcellator was used significantly less among those with the belief that morcellation of occult malignancy affects survival (P = .013). Three hundred sixty-one (76%) of the participants currently perform laparotomy in fewer than a quarter of their cases; most those cases are still performed using laparoscopic and robot-assisted techniques. CONCLUSION: The recent negative press suggesting that intracorporeal power morcellation can disseminate occult malignancy and affect survival has decreased the use of the morcellator. Despite the declining use of power morcellation, most practicing gynecologic surgeons have not converted their procedures to laparotomy.

Postoperative adhesion formation in a rabbit model: monopolar electrosurgery versus ultrasonic scalpel.

BACKGROUND AND OBJECTIVES: To determine if surgery using ultrasonic energy for dissection results in less adhesion formation than monopolar electrosurgical energy in the late (8 weeks) postoperative period. METHODS: Injuries were induced in rabbits by using ultrasonic energy on one uterine horn and the adjacent pelvic sidewall and using monopolar energy on the opposite side. Eight weeks postoperatively, the rabbits underwent autopsy and clinical and pathologic scoring of adhesions was performed by blinded investigators. RESULTS: There was no significant difference in clinical adhesion scores between the two modalities. The mean clinical score for monopolar cautery was 1.00 versus 0.88 for the Harmonic device (Ethicon Endo-Surgery, Cincinnati, Ohio) (P = .71). Furthermore, there was no significant difference found in the pathologic adhesion scores between the ultrasonic scalpel and monopolar energy. The mean pathologic score for monopolar electrosurgery was 4.35 versus 3.65 for the Harmonic scalpel (P = .30). CONCLUSION: Neither monopolar electrosurgery nor ultrasonic dissection is superior in the prevention of adhesion formation in the late postoperative period.

New insights in the pathophysiology of ovarian cancer and implications for screening and prevention.

Despite advances in medicine, ovarian cancer remains the deadliest of the gynecological malignancies. Herein we present the latest information on the pathophysiology of ovarian cancer and its significance for ovarian cancer screening and prevention. A new paradigm for ovarian cancer pathogenesis presupposes 2 distinct types of ovarian epithelial carcinoma with distinct molecular profiles: type I and type II carcinomas. Type I tumors include endometrioid, clear-cell carcinoma, and low-grade serous carcinoma and mostly arise via defined sequence either from endometriosis or from borderline serous tumors, mostly presenting in an early stage. More frequent type II carcinomas are usually high-grade serous tumors, and recent evidence suggests that the majority arise from the fimbriated end of the fallopian tube. Subsequently, high-grade serous carcinomas usually present at advanced stages, likely as a consequence of the rapid peritoneal seeding from the open ends of the fallopian tubes. On the other hand, careful clinical evaluation should be performed along with risk stratification and targeted treatment of women with premalignant conditions leading to type I cancers, most notably endometriosis and endometriomas. Although the chance of malignant transformation is low, an understanding of this link offers a possibility of prevention and early intervention. This new evidence explains difficulties in ovarian cancer screening and helps in forming new recommendations for ovarian cancer risk evaluation and prophylactic treatments.

Cerebral spinal fluid and serum ionized magnesium and calcium levels in preeclamptic women during administration of magnesium sulfate.

OBJECTIVE: To study the distribution of ionized and total magnesium (Mg) in serum and cerebral spinal fluid (CSF) in preeclamptic women receiving MgSO(4) and how this treatment affects the ionized calcium (Ca(2+)) and ionized Ca:Mg ratios compared with healthy nonpregnant women and pregnant control women (HP). DESIGN: Controlled clinical study. SETTING: An academic medical center. PATIENT(S): African-American women older than 20 and less than 35 years. The pregnant preeclamptic study and pregnant control groups each consisted of 16 women; the nonpregnant group consisted of 10 subjects. INTERVENTION(S): The preeclamptic women received a 6-g bolus of MgSO(4) IV started at least 4.5 hours before delivery during 15-20 minutes, then 2 g/h baseline. MAIN OUTCOME MEASURE(S): The CSF and serum levels of Ca(2+) and Mg(2+) and total Mg were measured in all three groups of women. The Ca(2+):Mg(2+) ratios were determined. Physiologic monitoring was done and recorded every 4 hours where appropriate. Bloods were drawn every 6 hours for complete blood count, metabolic panel, lactate dehydrogenase, uric acid, and electrolytes. Serum pH, total Mg, Apgar scores, and general health of the infants born to preeclamptic mothers given MgSO(4) were followed. RESULT(S): The HP showed a reduction in mean serum ionized and total Mg, increase in ionized Ca, and a large increase in Ca(2+):Mg(2+) ratios compared with healthy nonpregnant women. Although the CSF ionized and total Mg and Ca(2+):Mg(2+) ratios were not altered with MgSO(4) treatment in the preeclamptic women receiving MgSO(4), the mean serum Mg values increased 3-fold. All infants were full-term, regardless of MgSO(4) treatment, and normal with respect to birth weight, Apgar scores, blood pH, total Mg, and neurologic scores. CONCLUSION(S): The data indicate that there is a direct relationship between the serum and CSF Ca(2+):Mg(2+) ratios in HP and this ratio may be crucial in preventing vascular and neurologic complications in preeclampsia-eclampsia.