Background
Safety warnings about power morcellation in 2014 considerably changed hysterectomy practice, especially for laparoscopic supracervical hysterectomy that typically requires morcellation to remove the corpus uteri while preserving the cervix. Hospitals might vary in how they respond to safety warnings and altered hysterectomy procedures to avoid use of power morcellation. However, there has been little data on how hospitals differ in their practice changes.
Objective
This study aimed to examine whether hospitals varied in their use of laparoscopic supracervical hysterectomy after safety warnings about power morcellation and compare the risk of surgical complications at hospitals that had different response trajectories in use of laparoscopic supracervical hysterectomy.
Study Design
This was a retrospective analysis of data from the New York Statewide Planning and Research Cooperative System and the State Inpatient Databases and State Ambulatory Surgery and Services Databases from 14 other states. We identified women aged ≥18 years undergoing hysterectomy for benign indications in the hospital inpatient and outpatient settings from October 1, 2013 to September 30, 2015. We calculated a risk-adjusted utilization rate of laparoscopic supracervical hysterectomy for each hospital in each calendar quarter after accounting for patient clinical risk factors. Applying a growth mixture modeling approach, we identified distinct groups of hospitals that exhibited different trajectories of using laparoscopic supracervical hysterectomy over time. Within each trajectory group, we compared patients’ risk of surgical complications in the prewarning (2013Q4–2014Q1), transition (2014Q2–2014Q4), and postwarning (2015Q1–2015Q3) period using multivariable regressions.
Results
Among 212,146 women undergoing benign hysterectomy at 511 hospitals, the use of laparoscopic supracervical hysterectomy decreased from 15.1% in 2013Q4 to 6.2% in 2015Q3. The use of laparoscopic supracervical hysterectomy at these 511 hospitals exhibited 4 distinct trajectory patterns: persistent low use (mean risk-adjusted utilization rate of laparoscopic supracervical hysterectomy changed from 2.8% in 2013Q4 to 0.6% in 2015Q3), decreased medium use (17.0% to 6.9%), decreased high use (51.4% to 24.2%), and rapid abandonment (30.5% to 0.8%). In the meantime, use of open abdominal hysterectomy increased by 2.1, 4.1, 7.8, and 11.8 percentage points between the prewarning and postwarning periods in these 4 trajectory groups, respectively. Compared with the prewarning period, the risk of major complications in the postwarning period decreased among patients at “persistent low use” hospitals (adjusted odds ratio, 0.88; 95% confidence interval, 0.81–0.94). In contrast, the risk of major complications increased among patients at “rapid abandonment” hospitals (adjusted odds ratio, 1.48; 95% confidence interval, 1.11–1.98), and the risk of minor complications increased among patients at “decreased high use” hospitals (adjusted odds ratio, 1.31; 95% confidence interval, 1.01–1.72).
Conclusion
Hospitals varied in their use of laparoscopic supracervical hysterectomy after safety warnings about power morcellation. Complication risk increased at hospitals that shifted considerably toward open abdominal hysterectomy.
Introduction
The safety of uterine power morcellation, a technique once commonly used in gynecologic surgery, has been scrutinized in recent years. The US Food and Drug Administration (FDA) issued a warning in April 2014, cautioning that uterine power morcellation may inadvertently disseminate cancer cells if patients have undiagnosed uterine malignancies, leading to upstaging and compromised survival. The FDA further requested in November 2014 that laparoscopic power morcellators should include a boxed warning about this safety concern. These actions led to important changes in the practice of hysterectomies.
Why was this study conducted?
Safety warnings about power morcellation have changed hysterectomy practice; however, there were little data on whether hospitals differed in their responses and what impact this had on patient outcomes.
Key findings
There were distinct groups of hospitals that differed considerably in how they reduced use of laparoscopic supracervical hysterectomy over time. Hospitals in these distinct groups also varied in how much they shifted hysterectomy to an open abdominal approach. Complication risk decreased at hospitals that had minimal shifts to open abdominal hysterectomy but increased at hospitals that had large shifts to open abdominal hysterectomy.
What does this add to what is known?
It is important to understand heterogeneity in hospital practice and the implications for patient safety.
Several studies reported a shift away from laparoscopic hysterectomies, especially laparoscopic supracervical hysterectomy (LSH)—which typically requires morcellation to remove the corpus uteri laparoscopically while preserving the cervix. However, data on how hospitals vary in their practice changes are sparse. Hospital variation in management of hysterectomy (eg, surgical route, concomitant adnexal procedures, and patient outcomes) is well documented. Because uncontained power morcellation can be avoided by utilizing contained power morcellation, alternative types of minimally invasive hysterectomy, or open abdominal hysterectomy, hospitals may differ considerably in their responses.
The shift away from laparoscopic hysterectomy has raised concerns for a potential increase in surgical complications because abdominal hysterectomy has greater morbidity risk than laparoscopic hysterectomy. However, empirical evidence is mixed. Many studies have found no change in complications among hysterectomies overall, whereas some reported higher rates of complications in selected patient groups. , , This is likely because of heterogeneity in how practice changed across hospitals with varying degrees of reversion to abdominal hysterectomy, which could mask its impact on patient outcomes.
To better elucidate practice changes and safety implications, this study examined the hospital variation in the trajectory of LSH use after safety warnings about power morcellation. For hospitals that had different response trajectories, we compared their institutional characteristics, changes in reversion to abdominal hysterectomy, and risk of surgical complications.
Materials and Methods
Data and study population
This study used the State Inpatient Databases (SID) and State Ambulatory Surgery and Services Databases (SASD) from the Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project , and data from the New York Statewide Planning and Research Cooperative System (SPARCS). The SID, SASD, and SPARCS databases contained complete enumeration of all hospital inpatient and outpatient encounters in a given state-year regardless of payer. Patient sociodemographic characteristics and diagnosis- and procedure-related information were available for each encounter. We acquired SID and SASD from the following 14 states that documented both inpatient and outpatient procedures and hospital identifiers: Colorado, Florida, Iowa, Kentucky, Maryland, Minnesota, Nebraska, Nevada, New Jersey, North Carolina, Oregon, Utah, Vermont, and Wisconsin. Along with New York, these states span all 4 census regions and represent 31.8% of the US population.
We limited our sample to adult women who underwent a hysterectomy from October 1, 2013 to September 30, 2015. The fourth quarter of 2013 (2013Q4) served as the baseline because the potential role of power morcellation in spreading undiagnosed uterine cancer was first publicized in a Wall Street Journal article on December 18, 2013, and data in our sample suggested that use of LSH continued to increase until 2013Q4. We used data up to the third quarter of 2015 (2015Q3) to capture subsequent changes in practice. More recent quarters or years were excluded because the transition of the International Classification of Diseases (ICD) coding system from the 9th to the 10th revision in October 2015 could confound the measurement of changes in procedures and morbidities. Hysterectomies were identified using ICD-9 procedure codes and current procedural terminology (CPT) codes.
To focus on routine gynecologic patients with benign indications, we excluded women who underwent hysterectomy for obstetrical conditions, were admitted from the emergency department or were transferred in, had any cancer diagnosis, underwent a radical hysterectomy or pelvic exenteration, or had elevated risk of gynecologic cancer (endometrial hyperplasia, cervical dysplasia or other cervical abnormality, elevated CA125, genetic susceptibility to breast, ovarian or endometrial cancer). These eligibility criteria were determined on the basis of admission source and diagnosis and procedure codes. Hysterectomies performed at freestanding ambulatory surgery centers were excluded as we could not measure characteristics of these facilities. To ensure an adequate sample size for assessing each hospital’s practice and nonlinear trend in practice changes, we limited our analysis to hospitals that had data from the baseline quarter and at least 2 additional calendar quarters and had at least 10 eligible hysterectomies per quarter.
We linked hospitals in the SID, SASD, and SPARCS data to the 2014 American Hospital Association (AHA) annual survey database to measure institutional characteristics. The AHA annual survey data provided comprehensive measures of each hospital’s infrastructure, capacity, organization, and financial characteristics. This study was approved by the Yale Human Investigation Committee.
Measures
For each patient, we defined a binary indicator (yes or no) for whether she underwent an LSH, as opposed to other routes of hysterectomy. This categorization was based on ICD-9 procedure code 68.31 and CPT procedure codes 58541 to 58544.
We measured the occurrence of major and minor complications for each patient during the hospital stay. Major complications included in-hospital mortality, transfer-out, and severe morbidities (eg, sepsis, hemorrhage or blood transfusion, stroke, pulmonary or deep vein embolism). Minor complications included less severe outcomes, such as operative wound disruption, urinary tract infection, and nausea or vomiting. These conditions were determined on the basis of patients’ disposition status and diagnosis and procedure codes. ,
Patient clinical risk factors included age, surgical indication, smoking status, comorbidities, and concomitant procedures. Using diagnostic codes, we classified surgical indication into categories, such as uterine leiomyoma, menstrual disorders, genital prolapse, endometriosis, female pelvic inflammatory diseases, and postmenopausal bleeding. We measured the Elixhauser comorbidities , based on diagnosis codes. Common comorbidities (obesity, anemia, hypertension, diabetes, chronic pulmonary disease, hypothyroidism, and depression) were included as individual binary indicators (yes or no), whereas other comorbidities were accounted for using a count variable because of their low frequency. Using procedure codes, we constructed 2 additional binary indicators for whether the patient underwent any concomitant abdominopelvic surgery (yes or no) or concomitant other surgery (yes or no).
Hospital characteristics included teaching status, urban or rural location, type of ownership, affiliation with a multihospital system, annual volume, and patient composition. Annual volume was measured on the basis of a hospital’s average annual number of benign hysterectomies that met sample eligibility criteria in our study period. Patient composition measured the proportion of a hospital’s eligible hysterectomies where the patients were racial or ethnic minorities (ie, non-white); where Medicaid, self-pay or no charge was the primary source of payment (ie, safety-net proportion); and where the patients’ income (based on zip code medium household income) was in the highest quartile.
Statistical analysis
We estimated a patient’s likelihood of undergoing LSH (yes or no) using logistic regression via the generalized estimating equation (GEE) approach to account for clustering of data by hospital while adjusting for patient age, surgical indication, smoking status, comorbidities, concomitant procedures, and indicators of calendar quarter. From this model, we calculated a risk-adjusted rate of LSH use for each hospital in each calendar quarter by dividing its observed number of LSHs by expected number of LSHs (conditional on its patient characteristics) and then multiplying by the sample overall observed rate of LSH use in the corresponding calendar quarter ( Additional Technical Detail ).
Using these risk-adjusted rates of LSH use, we applied a growth mixture modeling technique to identify distinct hospital groups that exhibited different trajectories of LSH use ( Additional Technical Detail ). Trajectories were modeled as a function of time, that is, number of calendar quarters since baseline. The highest order polynomial term of time (eg, quadratic or cubic function of time) that was statistically significant determined the shape of each trajectory. We evaluated models with an increasing number of trajectories and selected the optimal number of trajectories based on the Bayesian information criterion and posterior probability of trajectory group membership (ie, the probability that a hospital belonged to a given trajectory based on its observed data). Each hospital was assigned to the trajectory group for which it had the maximum posterior probability of membership. We then compared hospital characteristics across the different trajectory groups using chi-square test for categorical variables and Wilcoxon rank-sum test for continuous variables. Further pairwise comparisons were performed by adjusting for multiple comparison.
In addition, we examined changes in patients’ risk of complications over time. Because the FDA released warnings about power morcellation in April and November 2014, we defined 2013Q4 to 2014Q1 as the prewarning period, 2014Q2 to 2014Q4 as the transition period, and 2015Q1 to 2015Q3 as the postwarning period. Within each trajectory group, we compared the risk of major and minor complications among these time periods, first using chi-square tests and then using logistic regressions via the GEE approach, accounting for patients’ clinical risk factors and clustering of hysterectomies by hospital. In addition, using similar analyses, we examined changes in complication risk among a subset of women who underwent hysterectomy for uterine leiomyoma—the patient population that was the focus of the FDA warnings.
P values below .05 were considered statistically significant. Analyses were performed using Analyses were performed using SAS (version 9.4; SAS Institute Inc, Cary, NC).
Results
Sample characteristics
A total of 212,146 women from 511 hospitals met the sample eligibility criteria (mean age, 46.9 years; standard deviation, 10.5). Uterine leiomyoma (58.4%), menstrual disorder (50.9%), and endometriosis (31.1%) were the most common indications (categories not mutually exclusive) ( Table 1 ). Most hysterectomies (62.7%) were outpatient procedures. In the overall sample, the use of LSH decreased from 15.1% of benign hysterectomies in 2013Q4 to 6.2% in 2015Q3.
| Patient characteristics | n (%) |
|---|---|
| Age (y) | |
| 18–34 | 18,466 (8.7) |
| 35–44 | 76,649 (36.1) |
| 45–54 | 78,799 (37.1) |
| 55–64 | 21,115 (10.0) |
| ≥65 | 17,117 (8.1) |
| Race and ethnicity a | |
| Non-Hispanic White | 117,213 (62.1) |
| Non-Hispanic Black | 35,391 (18.7) |
| Hispanic | 18,675 (9.9) |
| Other | 9240 (4.9) |
| Unknown | 8297 (4.4) |
| Primary payer | |
| Private insurance | 153,631 (72.4) |
| Medicare | 21,201 (10.0) |
| Medicaid | 27,308 (12.9) |
| Self-pay | 3410 (1.6) |
| Other payer | 5063 (2.4) |
| No charge | 1277 (0.6) |
| Unknown | 256 (0.1) |
| Household income (based on zip code) | |
| Lowest quartile | 47,311 (22.3) |
| Lower middle quartile | 56,123 (26.5) |
| Upper middle quartile | 53,344 (25.1) |
| Highest quartile | 52,711 (24.8) |
| Unknown | 2657 (1.3) |
| Surgical indication b | |
| Uterine leiomyoma | 123,809 (58.4) |
| Other disorders of corpus uteri | 29,559 (13.9) |
| Menstrual disorder | 107,997 (50.9) |
| Endometriosis | 66,040 (31.1) |
| Genital prolapse | 39,957 (18.8) |
| Inflammatory diseases of female pelvic organs | 61,547 (29.0) |
| Disorders of ovary or fallopian tube | 61,092 (28.8) |
| Noninflammatory disorders of the cervix | 5029 (2.4) |
| Postmenopausal bleeding | 7629 (3.6) |
| Other menopausal disorder | 2817 (1.3) |
| Urinary incontinence | 21,782 (10.3) |
| Abdominal pain | 2318 (1.1) |
| Abdominal or pelvic mass | 1401 (0.7) |
| Other female genital disorders | 42,498 (20.0) |
| Setting | |
| Inpatient | 79,057 (37.3) |
| Outpatient | 133,089 (62.7) |
| Concomitant abdominopelvic procedure | 21,769 (10.3) |
| Concomitant other procedure | 1370 (0.6) |
| Smoking | 35,189 (16.6) |
| Comorbidities | |
| Hypertension | 48,907 (23.1) |
| Diabetes | 14,635 (6.9) |
| Anemia | 31,799 (15.0) |
| Obesity | 27,515 (13.0) |
| Chronic pulmonary disease | 20,583 (9.7) |
| Hypothyroidism | 17,188 (8.1) |
| Depression | 16,780 (7.9) |
a A total of 23,330 cases had missing data. Race and ethnicity were not available in some state-years
b Surgical indications were not mutually exclusive. A patient could have more than 1 indication.
All 511 hospitals had at least 10 eligible patients in every calendar quarter from 2013Q4 to 2015Q3. These hospitals were diverse in characteristics: 55.4% were teaching institutions, 11.9% were in rural areas, and 75.3% had private nonprofit ownership ( Table 2 ). Their median annual volume of eligible benign hysterectomies was 155 (interquartile range, 100–266).
| Hospital characteristics | Overall sample (N=511) | Persistent low use (n=246) | Decreased medium use (n=199) | Decreased high use (n=48) | Rapid abandonment (n=18) | P value |
|---|---|---|---|---|---|---|
| Teaching status | .001 a | |||||
| Yes | 283 (55.4) | 118 (48.0) | 131 (65.8) | 27 (56.3) | 7 (38.9) | |
| No | 228 (44.6) | 128 (52.0) | 68 (34.2) | 21 (43.8) | 11 (61.1) | |
| Location | .004 b | |||||
| Urban | 450 (88.1) | 205 (83.3) | 188 (94.5) | 42 (87.5) | 15 (83.3) | |
| Rural | 61 (11.9) | 41 (16.7) | 11 (5.5) | 6 (12.5) | 3 (16.7) | |
| Type of ownership | .19 | |||||
| Government (nonfederal) | 53 (10.4) | 31 (12.6) | 19 (9.5) | 3 (6.3) | 0 (0.0) | |
| Private nonprofit | 385 (75.3) | 173 (70.3) | 158 (79.4) | 38 (79.2) | 16 (88.9) | |
| Private for profit | 73 (14.3) | 42 (17.1) | 22 (11.1) | 7 (14.6) | 2 (11.1) | |
| Affiliation with a multihospital system | .13 | |||||
| Yes | 388 (75.9) | 180 (73.2) | 157 (78.9) | 40 (83.3) | 11 (61.1) | |
| No | 123 (24.1) | 66 (26.8) | 42 (21.1) | 8 (16.7) | 7 (38.9) | |
| Annual volume (number of eligible benign hysterectomies) | 155 (100–266) | 136 (90–202) | 229 (116–363) | 151 (100–261) | 114 (83–151) | <.001 c |
| Percentage of patients that were racial or ethnic minorities d | 26.6 (11.7–49.0) | 23.4 (9.3–45.1) | 27.6 (14.2–49.0) | 26.2 (17.2–52.5) | 26.5 (12.8–61.7) | .16 |
| Percentage of patients with Medicaid or were uninsured or no charge | 15.0 (7.4–24.5) | 18.1 (10.0–27.4) | 12.0 (5.6–20.6) | 11.9 (4.7–22.1) | 13.0 (8.3–19.5) | <.001 e |
| Percentage of patients in the highest income quartile | 12.9 (2.6–36.7) | 6.7 (0.7–19.2) | 21.1 (7.4–43.9) | 26.1 (2.9–61.3) | 17.3 (1.9–68.2) | <.001 f |
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