Try a new search

Format these results:

Searched for:

in-biosketch:true

person:goldss01

Total Results:

204


A perspective on the revised American College of Obstetricians and Gynecologists' guidance for transvaginal ultrasound in the evaluation of postmenopausal bleeding

Goldstein, Steven R
The American College of Obstetricians and Gynecologists (ACOG) recently revised its guidance regarding the evaluation of postmenopausal bleeding (PMB), recommending combined transvaginal ultrasonography (TV U/S) and endometrial (EM) sampling for most patients undergoing initial assessment. This perspective examines the evidence underlying these recommendations and considers their potential implications for clinical practice. Prior ACOG guidance recognized that, when the endometrium is fully visualized and measures ≤4 mm, TV U/S provides a highly effective means of excluding endometrial cancer (EC) in most women with PMB if the TV U/S is adequate and there is no persistent bleeding. Their revised recommendations place greater emphasis on EM sampling, including in several patient populations previously considered appropriate candidates for ultrasound-based evaluation. This perspective reviews the evidence this new guidance relied upon, as well as limitations of blind EM sampling, including published false-negative rates even in cases of known carcinoma, technical challenges associated with tissue acquisition, and potential procedural complications. Particular attention is given to women receiving menopausal hormone therapy, as well as nulliparous women in whom EM sampling may be technically difficult. My perspective is that former guideline-based approaches remain generally appropriate. The concern about the increasing mortality of EC in the United States is appropriate, as is the concern about racial disparities in the incidence and mortality of EC. However, the new ACOG revision will result in inappropriate, invasive EM sampling in a large number of women. The potential harms, as well as difficulties in obtaining tissue, will be substantial. Any real attempt to reduce the mortality of EC will require a better understanding of patient-specific risk factors, as well as information about less common non-EM type II cancers, especially in Black women, and better patient and practitioner education relative to PMB.
PMID: 42677969
ISSN: 1530-0374
CID: 6071940

The International Menopause Society celebrates another milestone [Editorial]

Cano, Antonio; Goldstein, Steve R; Wender, Maria Celeste O; Palacios, Santiago
PMID: 42383389
ISSN: 1473-0804
CID: 6062832

Rebalancing the narrative on MHT - the menopause momentum continues following FDA 'unboxing'! [Editorial]

Nappi, Rossella E; Ang, Seng Bing; Goldstein, Steven R; Maki, Pauline; Panay, Nick; Wolfman, Wendy
PMID: 41649082
ISSN: 1473-0804
CID: 6000562

Development and Validation of an Endometrial Cancer Algorithm in US Claims Data

Daniels, Kimberly; Wenziger, Cachet; Gandhi, Sampada; Schott, Kevin; Wang, Li; Coley, Bahar; Goldstein, Steven; Parlett, Lauren; Shanmugasandaram, Saravanan; Wolter, Kevin; Dai, Feng; Azarmina, Pejman; Lanes, Stephan
PURPOSE/OBJECTIVE:This study developed and validated algorithms to identify the incidence of endometrial cancer using ICD-9-CM and ICD-10-CM coding systems as part of a post-authorization safety study (EU PAS: EUPAS45602) of vaginal estrogen, estrogen and progestin combination hormone therapy, and non-users of vaginal estrogen. METHODS:Using national claims data in the HealthCare Integrated Research Database, provisional endometrial cancer cases were identified using a screening algorithm comprising at least one endometrial cancer diagnosis code at any location and position between January 1, 2007 and December 31, 2021. One medical record per case was obtained for 700 provisional cases. Two experts in obstetrics and gynecology adjudicated the medical records classifying each patient as a confirmed case, confirmed non-case, or unknown. Positive predictive value (PPV), conditional sensitivity assuming all cases were identified by the screening algorithm, and their respective 95% confidence intervals (CI) were calculated. Algorithms were generated by choosing the codes and number of encounters to balance endometrial cancer detection and false positives. Algorithms were trained in a sample of non-users of vaginal estrogen and tested across treatment groups. RESULTS:Among the non-user training set, two visits with ICD-9-CM code 182.0 or 182.8 had a PPV of 91.2% (85.4%-95.2%) and sensitivity of 99.3% (95.9%-100.0%). Two visits on separate days with ICD-10-CM code C54.1, C54.8, or C54.9 had a PPV of 97.0% (93.6%-98.9%) and sensitivity of 99.5% (97.2%-100.0%). PPVs and sensitivities were over 75% across testing set cohorts for both algorithms. CONCLUSION/CONCLUSIONS:Two visits with an endometrial cancer diagnosis code accurately identified endometrial cancer cases in both coding systems. There were very few false positive endometrial cancer diagnoses. PPVs and sensitivities were high and similar in all cohorts.
PMID: 41565479
ISSN: 1099-1557
CID: 5988492

Achieving Menopausal Health Equity Network (AMEN): an educational intervention to improve OB/GYN knowledge of menopause-related racial and ethnic health disparities

Kalluru, Shilpa; Akande, Celine M; Bellon, Margot B; Mahendru, Nikhita; Jalili, Dona; Sampson, Amani; Goldstein, Steven R; Nachtigall, Margaret J; Nachtigall, Lila E; Dunham, Samantha M; Phillips, Kameelah A; Quinn, Gwendolyn P
OBJECTIVES/OBJECTIVE:To study the impact of an educational intervention on obstetrician-gynecologist clinicians' knowledge of racial and ethnic disparities in the menopause experience. METHODS:Twenty-five obstetrician-gynecologist physicians (residents, fellows, and attendings) at an academic medical center in New York, NY, completed the Achieving Menopausal Health Equity Network course, a brief web-based intervention consisting of four modules delivered through narrated didactic videos and interactive tools, a 10-item pretest and posttest, and a course evaluation survey. The primary outcome was a change in knowledge scores after the completion of the educational intervention. Item analysis was also performed to assess item discrimination, item difficulty, and response frequency. Feedback on modules was obtained, and thematic analysis was performed. RESULTS:In this study, 25 participants completed the educational intervention. There was a statistically significant increase in mean test scores after participation (pretest mean score=7.1/10 vs. posttest mean score=8.1/10, P =0.0021). The following themes emerged in thematic analysis: knowledge building with potential for practical application for clinicians and non-clinicians, clarity and relevance, and opportunities for growth for future iterations of the modules. CONCLUSIONS:This brief, online educational curriculum focused on racial and ethnic disparities in menopause significantly improved the knowledge of obstetrician-gynecologist clinicians at various levels of training and provides a useful model for introducing more formal training on menopause medicine for obstetrician-gynecologist clinicians.
PMID: 40327447
ISSN: 1530-0374
CID: 5839082

Evaluation of postmenopausal bleeding

Goldstein, Steven
PMID: 39998972
ISSN: 1530-0374
CID: 5800772

Early first-trimester transvaginal ultrasound screening for cesarean scar pregnancy in patients with previous cesarean delivery: analysis of the evidence

Timor-Tritsch, Ilan E; Monteagudo, Ana; Goldstein, Steven R
Obstetric hemorrhage is a leading cause of maternal morbidity and mortality. An important etiology of obstetric hemorrhage is placenta accreta spectrum. In the last 2 decades, there has been increased clinical experience of the devastating effect of undiagnosed, as well as late diagnosed, cases of cesarean scar pregnancy. There is a growing body of evidence suggesting that cesarean scar pregnancy is an early precursor of second- and third-trimester placenta accreta spectrum. As such, cesarean scar pregnancy should be diagnosed in the early first trimester. This early diagnosis could be achieved by introducing regimented sonographic screening in pregnancies of patients with previous cesarean delivery. This opinion article evaluates the scientific and clinical basis of whether cesarean scar pregnancy, with special focus on its early first-trimester discovery, complies with the accepted requirements of a screening test. Each of the 10 classical screening criteria of Wilson and Jungner were systematically applied to evaluate if the criteria were met by cesarean scar pregnancy, to analyze if it is possible and realistic to carry out screening in a population-wide fashion.
PMID: 38955324
ISSN: 1097-6868
CID: 5695742

Menopause and MHT in 2024: addressing the key controversies - an International Menopause Society White Paper

Panay, Nick; Ang, Seng Bin; Cheshire, Rebecca; Goldstein, Steven R; Maki, Pauline; Nappi, Rossella E; ,
The vision of the International Menopause Society (IMS) is that all women across the world will have easy and equitable access to evidence-based knowledge and health care, empowering them to make fully informed midlife health choices. The aim of this White Paper is to provide a well-balanced educational narrative of the menopause and menopause hormone therapy (MHT) from IMS experts, leading into World Menopause Day 2024. This is achieved by exploring the anthropology and history of menopause, the principles and controversies of prescribing MHT, and by placing this into regulatory and menopause society contexts. The White Paper also lays the groundwork for the forthcoming updated IMS recommendations on menopause and will act as a blueprint for the future ethical management of menopause from practical and aspirational perspectives. An important section of the paper is 'The 5Ws of prescribing MHT': WHO is MHT for; WHAT types and doses of MHT; WHEN should MHT be started and stopped; WHY is MHT important; WHERE can MHT be accessed? A key points summary of this information is provided for healthcare professionals and the public. The summary provides 'easy to access' advice regarding several recent controversial MHT prescribing issues in the healthcare and media spotlights.
PMID: 39268862
ISSN: 1473-0804
CID: 5690752

Oral lasofoxifene's effects on moderate to severe vaginal atrophy in postmenopausal women: two phase 3, randomized, controlled trials

Kagan, Risa; Simon, James A; Goldstein, Steven R; Komm, Barry S; Jenkins, Simon N; Portman, David J
OBJECTIVE:The aim of this study was to demonstrate whether lasofoxifene improves vaginal signs/symptoms of genitourinary syndrome of menopause. METHODS:Two identical, phase 3 trials randomized postmenopausal women with moderate to severe vaginal symptoms to oral lasofoxifene 0.25 or 0.5 mg/d, or placebo, for 12 week. Changes from baseline to week 12 in most bothersome symptom, vaginal pH, and percentages of vaginal parabasal and superficial cells were evaluated. These coprimary endpoints were analyzed using analysis of covariance, except superficial cells, which were analyzed by the nonparametric, rank-based Kruskal-Wallis test. RESULTS:The two studies enrolled 444 and 445 women (mean age, ~60 y), respectively. Coprimary endpoints at week 12 improved with lasofoxifene 0.25 and 0.5 mg/d greater than with placebo ( P < 0.0125 for all). Study 1: most bothersome symptom (least square mean difference from placebo: -0.4 and -0.5 for 0.25 and 0.5 mg/d, respectively), vaginal pH (-0.65, -0.58), and vaginal superficial (5.2%, 5.4%), and parabasal (-39.9%, -34.9%) cells; study 2: most bothersome symptom (-0.4, -0.5), vaginal pH (-0.57, -0.67), and vaginal superficial (3.5%, 2.2%) and parabasal (-34.1%, -33.5%) cells. Some improvements occurred as early as week 2. Most treatment-emergent adverse events were mild or moderate and hot flushes were most frequently reported (lasofoxifene vs placebo: 13%-23% vs 9%-11%). Serious adverse events were infrequent and no deaths occurred. CONCLUSIONS:In two phase 3 trials, oral lasofoxifene 0.25 and 0.5 mg/d provided significant and clinically meaningful improvements in vaginal signs/symptoms with a favorable safety profile, suggesting beneficial effects of lasofoxifene on genitourinary syndrome of menopause.
PMID: 38652875
ISSN: 1530-0374
CID: 5653992

Endometrial safety and efficacy of ospemifene

Goldstein, Steven R
PMID: 37467145
ISSN: 1530-0374
CID: 5535822