Safety assessment of compounded non-FDA-approved hormonal therapy versus FDA-approved hormonal therapy in treating postmenopausal women.

OBJECTIVE: To assess the safety and serum estradiol (E2) and total testosterone (T) concentrations in postmenopausal women treated with Pellet Hormonal Therapy (PHT) and Food and Drug Administration approved Hormonal Therapy (FHT). METHODS: A total of 539 postmenopausal women were identified, including 384 on PHT and 155 on FHT. Data extracted from medical records include demographics, indication for hormone therapy, treatment duration, side effects, serum E2 and T levels, and frequency of laboratory follow-up. RESULTS: The incidence of overall side effects was significantly higher in PHT compared with FHT (221 [57.6%] vs 23 [14.8%], P < 0.00001, odds ratio [95% CI] =8.0[4.5-14.2]). When examining women with an intact uterus prior to hormone therapy initiation, 55.3% (136/246) on PHT vs 15.2% (12/79) on FHT had at least one episode of abnormal uterine bleeding (P < 0.0001, odds ratio [95% CI] = 7.9[3.6-17.0]). Furthermore, a significantly higher proportion of women on PHT (20.3% [50/246]), compared with 6.3% (5/79) on FHT, had a hysterectomy (P = 0.036, odds ratio [95% CI] = 3.2[1.1-9.3]). Both mean (SD, Min-Max) peak E2 (pg/mL) and peak T (ng/dL) are significantly higher in the PHT group than those in the FHT group (E2: 237.70 [168.55, 10-1,111] vs 93.45 [130.77, 5.5-465.8], T: 194.04 [84.94, 4.3-599] vs 15.59 [19.52, 0.2-70], P < 0.00001). Of those on PHT, four women had E2 level > 1,000 pg/mL and nine women with T level > 400 ng/dL. CONCLUSION: Women on PHT had a significantly higher incidence of side effects than FHT as well as a significantly higher supraphysiological level of peak E2 and T during the treatment.

CREOG In-Training Examination Results: Contemporary Use to Predict ABOG Written Examination Outcomes.

BACKGROUND: The in-training examination (ITE) offers formative assessments of residents' developing medical knowledge. Identification of an ITE performance level associated with success on the specialty board examination allows identification of "at risk" residents. OBJECTIVE: This study sought to identify a threshold score for obstetrics and gynecology residents' performance on the Council on Resident Education in Obstetrics and Gynecology (CREOG) ITE that predicts successful performance on the American Board of Obstetrics and Gynecology (ABOG) written examination. METHODS: We analyzed ITE and ABOG results of 80 residents who completed 4 years of CREOG ITEs at 2 institutions between 2002 and 2012. We assessed the level of performance associated with successful performance on the ABOG written examination. RESULTS: Data analyzed included scores for 71 of 80 residents (89%), with an overall pass rate of 82%. A postgraduate year (PGY) 4 score of 200 on the CREOG ITE or twice in any of the PGY training years was associated with a 100% ABOG pass rate. Scoring ≥ 205 in any PGY also was associated with a 100% pass rate. Residents who did not attain a score of 200 had a 35% to 45% chance of failing the ABOG written examination, depending on the PGY of the ITE performance. CONCLUSIONS: Our findings suggest that a CREOG ITE score of at least 200 twice, or as a PGY-4, offers assurance of successful performance on the ABOG examination. Scores lower than this threshold may be used to identify "at risk" residents for added learning and provide program elements in need of improvement.