Dataset Information

Hysterectomy Practice Patterns in the Postmorcellation Era.

ABSTRACT:

Objective

To characterize long-term national trends in surgical approach for hysterectomy after the U.S. Food and Drug Administration (FDA) warning against power morcellation for laparoscopic specimen removal.

Methods

This was a descriptive study using data from the American College of Surgeons National Surgical Quality Improvement Program from 2012 to 2016. We identified hysterectomies using Current Procedural Terminology codes. We used an interrupted time-series analysis to evaluate abdominal and supracervical hysterectomy trends surrounding The Wall Street Journal article first reporting morcellation safety concerns and the FDA safety communication. We compared categorical and continuous variables using ?, t, and Wilcoxon rank sum tests.

Results

We identified 179,950 hysterectomies; laparoscopy was the most common mode of hysterectomy in every quarter. Before The Wall Street Journal article, there was no significant change in proportion of abdominal hysterectomies (0.3% decrease/quarter, P=.14). After The Wall Street Journal article, use of abdominal hysterectomy increased 1.1% per quarter for two quarters through the FDA warning (P<.001), plateaued for three quarters until March 2015 (P=.65), then decreased by 0.8% per quarter through 2016 (P<.001). Supracervical hysterectomy volume continuously decreased after the FDA warning (1.0% decrease per quarter, P<.001) and after three quarters (0.7% decrease per quarter, P=.01), then plateaued from April 2015 through 2016 (0.05% decrease per quarter, P=.40). Mode of supracervical hysterectomy was unchanged from 2012 to 2013 (P=.43), followed by two quarters of significant increase in proportion of supracervical abdominal hysterectomies (11.7%/quarter, P<.001). This change in mode of supracervical hysterectomy then plateaued through 2016 (P=.06).

Conclusion

Despite early studies suggesting that minimally invasive hysterectomy decreased in response to safety concerns regarding power morcellation, we found that this effect reversed 1 year after the FDA safety communication. However, there was a sustained decline in supracervical hysterectomy, and the remaining supracervical hysterectomies were more likely to be performed using laparotomy.

SUBMITTER: Jorgensen EM

PROVIDER: S-EPMC7848851 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Publications

Hysterectomy Practice Patterns in the Postmorcellation Era.

Jorgensen Elisa M EM Modest Anna M AM Hur Hye-Chun HC Hacker Michele R MR Awtrey Christopher S CS

Obstetrics and gynecology 20190401 4

<h4>Objective</h4>To characterize long-term national trends in surgical approach for hysterectomy after the U.S. Food and Drug Administration (FDA) warning against power morcellation for laparoscopic specimen removal.<h4>Methods</h4>This was a descriptive study using data from the American College of Surgeons National Surgical Quality Improvement Program from 2012 to 2016. We identified hysterectomies using Current Procedural Terminology codes. We used an interrupted time-series analysis to eval ...[more]

PMID: 30870280

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Project description:OBJECTIVE:To model the effect of implementing minimum-volume standards for women who underwent hysterectomy on patient outcomes and surgeon practice patterns. METHODS:We conducted a retrospective cohort study using the New York Statewide Planning and Research Cooperative System to capture data for all women who underwent hysterectomy from 2010 to 2014. We estimated the number of hysterectomies performed by each patient's physician during the prior year. Multivariable models were used to estimate the ratio of observed to expected complications based on each surgeon's volume during the prior year. The mean observed/expected ratio of surgeons was then plotted by volume. The number of patients and surgeons who would be eliminated and the reduction in complications if minimum-volume standards (lowest fifth and 10th percentiles) were implemented were analyzed. Separate analyses were performed for each route of hysterectomy. RESULTS:We identified a total of 127,202 patients. For abdominal hysterectomy, increasing surgeon volume was associated with a decreasing rate of complications (P<.001). Overall, 17.5% of surgeons (n=1,260) had a prior year volume of one abdominal hysterectomy. The mean observed/expected ratio of surgeons with a prior year abdominal hysterectomy volume of one was 1.47 (SD 2.71). Within this group of surgeons, 31.4% had an observed/expected ratio of 1 or greater, indicating a higher than expected complication rate, and 68.7% of the surgeons had a observed/expected ratio of less than 1, suggesting a lower complication rate than expected based on case mix. Selection of a prior year volume standard of one would restrict 12.5% of surgeons performing robotic-assisted, 16.8% of those performing laparoscopic, and 27.6% of surgeons performing vaginal hysterectomy. CONCLUSION:Implementing minimum-volume standards for hysterectomy, for even the lowest volume physicians, would restrict a significant number of gynecologic surgeons, including many with outcomes that are better than predicted.

Project description:ImportanceIn November 2014, the US Food and Drug Administration (FDA) issued a black box warning against the use of power morcellation for excision of uterine fibroids to decrease the risk of disseminating malignant cells and worsening survival outcomes of patients with unexpected malignant neoplasms. After the FDA statement was issued, studies showed decreased rates of minimally invasive surgery and increased rates of open abdominal hysterectomy. However, there are limited and controversial data on the association of these changed rates with 30-day hysterectomy complications.ObjectiveTo assess changes in the rates of 30-day major and minor complications of hysterectomy for benign gynecologic indications following the FDA-issued statement.Design, setting, and participantsThis retrospective cohort study used the American College of Surgeons National Surgical Quality Improvement Program database and included 603 hospitals participating between January 1, 2013, and December 31, 2015. Thirty-day posthysterectomy complications were compared before and after the FDA-issued warning. Women who underwent hysterectomy for benign gynecologic indications (n = 75 487), including hysterectomies with indication of uterine fibroids (n = 25 571), were included. Complication rates and procedure distributions between the periods were compared with χ2 tests and multivariable logistic regression controlling for patient and operative factors.Main outcomes and measuresMajor and minor 30-day complication rates before (from 2013 through the first quarter of 2014) and after (from the fourth quarter of 2014 through 2015) the FDA-issued warning.ResultsOf 75 487 women (mean [SD] age, 47.8 [10.7] years) who underwent hysterectomy for benign gynecologic indications, 32 186 (42.6%) were treated before and 43 301 (57.4%) after the FDA-issued warning. Non-Hispanic white women comprised most (59.4%) of the total population, followed by African American women (15.1%). Overall, major and minor complications remained stable before and after the FDA-issued warning. By contrast, among a subset of 25 571 women (33.9%) who underwent hysterectomy for uterine fibroids, major complications significantly increased after the FDA-issued warning from 1.9% to 2.4% (adjusted odds ratio [OR], 1.23; 95% CI, 1.04-1.47; P = .02), and minor complications significantly increased from 2.7% to 3.3% (adjusted OR, 1.21; 95% CI, 1.04-1.40; P = .01). In this subgroup, the rate of open abdominal surgery increased from 37.2% to 43.0%, and the rate of minimally invasive surgery (total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, and laparoscopic-assisted vaginal hysterectomy) decreased from 56.1% to 49.7% (P < .001).Conclusions and relevanceMajor and minor 30-day complication rates among women undergoing hysterectomy for uterine fibroids increased following the FDA-issued statement. This increased risk corresponding with a decreased use of minimally invasive surgery should be balanced against the potential harms of morcellation during a shared decision-making process between clinician and patient. Regulatory bodies and medical societies should consider these findings when issuing relevant communications.

Project description:PurposeUtilization of stereotactic radiosurgery (SRS) for brain metastases (BM) has increased, prompting reassessment of whole brain radiation therapy (WBRT). A pattern of care analysis of SRS and WBRT dose-fractionations was performed in patients presenting with BM at the time of cancer diagnosis.Methods and materialsAdults with BM at cancer diagnosis between 2010 to 2015 and no prior malignancy were identified in the National Cancer Database. SRS was defined using published thresholds. Short (ShWBRT), standard (StWBRT), and extended (ExWBRT) dose-fractionations were defined as 4 to 9, 10 to 15, and >15 fractions. Radioresistant histology was defined as melanoma, renal cell carcinoma, sarcoma or spindle cell, or gastrointestinal primary.ResultsOf 4,087,967 adults with their first lifetime cancer, 90,388 (2.2%) had BM at initial diagnosis. Of these, 11,486 (12.7%) received SRS and 24,262 (26.8%) WBRT as first-course radiation therapy. The proportion of annual WBRT use decreased from 27.8% to 23.5% of newly diagnosed patients, and SRS increased from 8.7% to 17.9%. Common dose-fractionations were 30 Gy in 10 fractions (56.8%) for WBRT and 20 Gy in 1 fraction (13.0%) for SRS. On multivariate analysis, factors significantly associated with SRS versus WBRT included later year of diagnosis (2015 vs 2010, adjusted odds ratio [aOR] = 2.4), radioresistance (aOR = 2.0), academic facility (aOR = 1.9), highest income quartile (aOR = 1.6), chemotherapy administration (aOR = 1.4), and longer travel distance (>15 vs < 5 miles, aOR = 1.4). Linear regression revealed significant ExWBRT reductions (-22.4%/y, R2 = 0.97, P < .001) and no significant change for ShWBRT or StWBRT. Patients were significantly more likely to receive ShWBRT than StWBRT if not treated with chemotherapy (aOR = 3.5).ConclusionsUtilization of WBRT, particularly ExWBRT, decreased while SRS utilization doubled as the first radiation therapy course in patients with BM at diagnosis. Patients with radioresistant histologies were more likely to receive SRS. Those not receiving chemotherapy, potentially owing to poor performance status, were less likely to receive SRS and more likely to receive ShWBRT.

Project description:PurposeThis study sought to identify patterns of self-reported regret after hysterectomy.MethodsWomen undergoing hysterectomy for a benign indication were recruited in the 2 weeks prior to surgery. Women reported demographics and completed validated questionnaires (Decisional Regret Scale, Patient Health Questionnaire-9, Decisional Conflict Scale, and the Comprehensive Score for Financial Toxicity) up to 7 times over the first year postsurgery. Medical records were reviewed for clinical and operative details. Latent class growth mixture models were applied to the repeated regret scores to identify patterns after hysterectomy. Clinical and other participant characteristics were compared across the classes.ResultsThree latent classes were identified among the 459 participants (422 of whom completed questionnaires at 12 months): "High Regret" (7.4%), women with a high regret score at baseline that did not improve over time; "Decreasing Regret" (13.3%), women with high baseline levels of regret but whose regret scores improved over time; and "Least Regret" (79.3%), women with the lowest baseline regret scores that remained low after surgery. These classes did not vary with respect to indication for surgery, clinical characteristics, age, or body mass index. Disproportionately more African American women (adjusted odds ratio: 1.99, 95% CI: 1.01-3.9) were in the "Decreasing Regret" versus "Least Regret" classes. Baseline satisfaction varied between the classes, with the "Least Regret" group having higher baseline satisfaction with their decision. Women with "Decreasing Regret" reported worse financial toxicity associated with surgery versus women in the "Least Regret" class (adjusted odds ratio: 0.95, 95% CI: 0.92-0.99).ConclusionsFor some women, decisional regret may worsen after hysterectomy. More often, initial regret lessens over time. Future studies that identify factors strongly associated with self-reported regret could lead to improved counseling about postsurgical expectations.

Dataset Information

Hysterectomy Practice Patterns in the Postmorcellation Era.

Objective

Methods

Results

Conclusion

Publications

Hysterectomy Practice Patterns in the Postmorcellation Era.

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