Objective
The purpose of this study was to describe health-related quality of life and satisfaction after global endometrial ablation in women with bleeding disorders and a systematic review of the literature.
Study Design
A follow-up survey was mailed to 36 patients with bleeding disorders and 110 reference patients (no coagulopathies) who underwent global endometrial ablation for menorrhagia. The survey included a generic (SF-12) and menorrhagia multi-attribute utility scale questionnaires.
Results
Ninety-six women (66%) responded. The total menorrhagia multiattribute utility scale score increased from 35-100 in bleeding disorder cohort ( P = .03) and from 48-100 in the reference cohort ( P < .001). Although postablation SF-12 mental domain scores were comparable in both cohorts (55 vs 55; P = .67), physical domain scores were lower in the bleeding disorder cohort (50 vs 56; P < .001). High satisfaction was reported by both cohorts (95% vs 84%; P = .60).
Conclusion
Global endometrial ablation improved health-related quality of life for women with bleeding disorders and had high satisfaction rates.
Excessive menstrual bleeding, in the setting of congenital or acquired coagulopathy, is an increasingly observed clinical challenge. This increase is attributable to the increased awareness of bleeding disorders in women with abnormal uterine bleeding and to the increased use of long-term anticoagulation therapy in women with thrombophilias and cardiac conditions. Regardless of the cause of bleeding, women with excessive menstruation often have secondary anemia and fatigue, and the bleeding at times can be socially incapacitating. Frequently, menorrhagia has a negative impact on health-related quality of life (HRQoL). For women with bleeding disorders, general health and quality of life may be further impaired by coexisting medical conditions.
Improving quality of life is an important goal in the treatment of menorrhagia. Global endometrial ablation (GEA) is an effective therapy for menorrhagia that is associated with long-term improvement in HRQoL in otherwise healthy women. We previously showed GEA was an effective treatment for menorrhagia for women with coagulopathies, with menstrual outcomes and postablation hysterectomy rates that were similar to those of women without known bleeding disorders. To date, no reports have described the HRQoL after GEA for women with bleeding disorders. The objective of this study was to describe the HRQoL and patient satisfaction rates after GEA in women with bleeding disorders. We also aimed to summarize the current evidence on the use of GEA in management of menorrhagia in this group of high-risk women.
Methods
The Mayo Clinic Institutional Review Board approved this study. This is a retrospective cohort study that was designed to evaluate the efficacy of GEA in the treatment of excessive menstrual bleeding in women with bleeding disorders, compared with women with no known diagnosis of bleeding disorders. The study included a mailed questionnaire that had been sent to a previously identified cohort of women who underwent GEA at Mayo Clinic (Rochester, MN) from January 1, 1998, through December 31, 2005.
Patient population (study cohorts)
The medical records-linkage system of Mayo Clinic was used to identify all women who underwent GEA. Ascertainment of the procedure was done using the International Classification of Diseases, Ninth Revision , Clinical Modification (ICD-9-CM) code 68.23 for endometrial ablation. A cohort that consisted of 2 groups was constructed: women with bleeding disorder (exposed cohort) and a random sample of women without known coagulation defects (reference cohort). The first cohort consisted of 41 women with acquired or congenital bleeding disorders: 2 women had type I von Willebrand disease; 5 women had acquired thrombocytopenia, and 34 women were receiving warfarin at the time of the procedure. The reference cohort included a group of 111 women.
Interventions
The 2 GEA methods that were used in our institution at the time of the study were ThermaChoice (Gynecare, Somerville, NJ) and NovaSure (Cytyc Surgical Products, Palo Alto, CA). Individual patient records were reviewed and allocated to 1 of the groups based on predefined criteria. Women were offered the procedure if an initial trial of medical therapy for menorrhagia had failed or if medical therapy was contraindicated and they had met the Food and Drug Administration-approved inclusion criteria for GEA. Before GEA, all women had a thorough clinical examination, a Papanicolaou test, endometrial sampling, pelvic ultrasonography, and office hysteroscopy if structural uterine lesions were suspected. Only women with benign polyps or submucous leiomyomas that did not distort the endometrial cavity or were <2 cm in size were offered endometrial ablation; removal was by curettage or ablation in situ. As is consistent with standard GEA practice, none of the women received hormonal or surgical pretreatment of the endometrium. Women who received anticoagulation were maintained with warfarin up to and through the surgical procedure.
Survey mailings
The survey was sent to patients through the Mayo Clinic Survey Research Center. The mailing included 2 questionnaires (described later) and the Health Insurance Portability and Accountability Act form for informed consent. To increase the response rate, the Survey Research Center sent a second mailing to nonresponders 1 month after the first mailing. Follow-up telephone calls were made to the remaining nonresponders 1 month after the second mailing.
Survey tools
HRQoL was evaluated with the use of 2 validated tools. The first tool was the menorrhagia multiattribute utility scale (MMAUS), which is a menorrhagia-specific HRQoL questionnaire that was developed and validated by Shaw et al in 1998. The second tool was a general HRQoL questionnaire (SF-12; QualityMetric Incorporated, Lincoln, RI). In addition, patients were asked to grade their satisfaction with the treatment on a 5-point scale with the following values: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, and very dissatisfied. Finally, patients were asked to report retrospectively their preprocedure and postprocedure menstrual blood loss, any need for further therapy, current use of anticoagulation medication, use of any contraceptives, and any incident pregnancy or procedure-related complications. Menstrual blood loss was evaluated indirectly by consideration of the number of days of bleeding and spotting per month and pad or tampon counts during the heaviest day of bleeding. Long-term was specified as 3 years in this study.
Database search
To identify previous studies of endometrial ablation in women with congenital and acquired coagulation disorders, we performed a systematic search of the MEDLINE, EMBASE, Cochrane Systematic Reviews, CENTRAL, Web of Science, and Scopus databases from inception through December 31, 2008. Search terms included those referring to heavy menstrual bleeding, coagulation disorders, and anticoagulant therapy.
Statistical analysis
Baseline characteristics were expressed as mean (SD) for normally distributed data, median (range) for skewed data, and as number and percentage of patients for categoric values. Differences between the 2 groups were assessed with the Student t test, Wilcoxon rank sum test, χ 2 test, or Fisher’s exact test, as appropriate. A complete case analysis was performed. The primary outcome was the change in total MMAUS score in women with bleeding disorders, compared with the reference group. Using a 2-sided t test with a type I error level of 0.05, 38 patients (at least 19 per group) would have 85% power to detect a difference between the 2 groups of 10 points on a scale of 100, assuming a common standard deviation of 10 (nQuery Advisor v.4.0; Statistic Solutions, Saugus, MA). All statistical analyses in this study were performed with JMP software (version 6.0.0; SAS Institute Inc, Cary, NC).
Results
Of 152 women who were identified in the original cohort, the questionnaire was sent to 146 women: 36 with bleeding disorders and 110 without bleeding disorders (reference group). Six women were deceased at the time of the first mailing (5 women from the bleeding disorders group and 1 from the reference group). The causes of death in the bleeding disorders group were leukemia (n = 2 women), cardiac disease (n = 2 women), and chronic liver disease (n = 1 woman). In the reference group, the death was the result of a motor vehicle accident. The median time between treatment and the survey mailing was 33 months (range, 14.6–57.9 months) for women with bleeding disorders and 30.7 months (range, 10.2–68.5 months) for the reference group ( P = .49).
Survey response
Ninety-six women (66%) completed the survey. Response rates were similar for both groups: 25 of 36 women (69%) responded from the bleeding disorders group, and 71 of 110 women (65%) responded from the reference group ( P = .53). To evaluate the potential bias between responders and nonresponders, we used the available baseline data from patient records to compare the groups. There were no significant differences between the 96 responders and 50 nonresponders when we compared age at the time of procedure, parity, body mass index, uterine length, amount and pattern of bleeding, or duration of follow-up after GEA ( Table 1 ). Three returned surveys were excluded because patients did not sign the informed consent form. The final analysis included 93 women: 23 women with bleeding disorders and 70 patients without coagulopathies.
| Characteristic | Responders (n = 96) | Nonresponders (n = 50) | P value |
|---|---|---|---|
| Age at the procedure, y a | 44.2 (40.0–48.1) | 45.0 (39.5–47.5) | .78 b |
| Parity, n a | 2 (2–3) | 3 (2–3) | .06 b |
| Body mass index (kg/m 2 ) a | 28.7 (22.7–31.0) | 28.5 (24.5–32.8) | .21 b |
| Cardiovascular disease, n | 15 (16%) | 9 (18%) | .71 c |
| Hypothyroidism, n | 12 (13%) | 8 (16%) | .56 c |
| Malignancy, n | 3 (3%) | 2 (4%) | > .99 d |
| Pretreatment bleeding, d a | 7 (6–10) | 7 (7–10) | .58 b |
| Hemoglobin, g/dL a | 12.1 (10.9–13.0) | 12.1 (11.0–13.1) | .63 b |
| Uterine length: uterine sounding, cm a | 9 (8–10) | 9 (8–10) | .66 b |
| Follow-up, mo a | 25.2 (12.4–41.6) | 25.9 (13.0–38.9) | .58 b |
| Type of global endometrial ablation, n | .72 c | ||
| Thermal balloon ablation | 46 (48%) | 25 (50%) | |
| Bipolar radiofrequency ablation | 50 (52%) | 25 (50%) |
a Data are presented as median (interquartile range);
HRQoL and satisfaction rate
Patients in both groups reported considerable improvement in menorrhagia-specific HRQoL. There was no significant difference between cohorts with respect to improvement of the total MMAUS score ( Figure 1 ). The domain-specific scores were also comparable ( Table 2 ). No significant difference between groups was observed for median SF-12 mental scores ( P = .67). However, SF-12 physical scores were significantly lower in women with bleeding disorders ( P < .001). Ninety-five percent of women with bleeding disorders reported that they were “very satisfied” or “somewhat satisfied,” whereas 84% in the reference group indicated satisfaction ( P = .60; Figure 2 ).
