Objective
The objective of this study was to estimate the economic consequences of expanding options for early pregnancy loss (EPL) treatment beyond expectant management and operating room surgical evacuation (usual care).
Study Design
We constructed a decision model using a hypothetical cohort of women undergoing EPL management within a 30 day horizon. Treatment options under the usual care arm include expectant management and surgical uterine evacuation in an operating room (OR). Treatment options under the expanded care arm included all evidence-based safe and effective treatment options for EPL: expectant management, misoprostol treatment, surgical uterine evacuation in an office setting, and surgical uterine evacuation in an OR. Probabilities of entering various treatment pathways were based on previously published observational studies.
Results
The cost per case was US $241.29 lower for women undergoing treatment in the expanded care model as compared with the usual care model (US $1033.29 per case vs US $1274.58 per case, expanded care and usual care, respectively). The model was the most sensitive to the failure rate of the expectant management arm, the cost of the OR surgical procedure, the proportion of women undergoing an OR surgical procedure under usual care, and the additional cost per patient associated with implementing and using the expanded care model.
Conclusion
This study demonstrates that expanding women’s treatment options for EPL beyond what is typically available can result in lower direct medical expenditures.
See related editorial, page 125
Approximately 25% of women will experience an early pregnancy loss (EPL) during their lifetime. Although there are evidence-based alternatives, such as treatment with misoprostol or office-based surgical evacuations, women are often offered surgical evacuation only in an operating room (OR) or expectant management. Given that many women prefer to avoid the OR and surgical management in an OR is more costly than other approaches, increasing access to alternative treatment approaches could have meaningful economic implications.
EPL treatment approaches are all reasonably effective but differ significantly in process. In most circumstances, EPL treatment decision making can be based on both clinical nuances and patient preferences. Existing studies comparing the cost of EPL treatment approaches consistently show that uterine evacuation in an OR is more expensive than the alternative approaches; however, these studies do not adequately account for clinical circumstances or patient preferences, which influence uptake, adherence, service use, and ultimately treatment efficacy, all critically important in cost estimates but often overlooked. A good example of this problem is the observation that treatment of EPL with misoprostol is significantly less effective in clinical practice than in clinical trials because of an unwillingness of many women to adhere to the treatment protocol.
Perhaps a better approach is to consider what would happen to medical expenditures if we enabled more women (and providers) to choose alternatives to surgical evacuation in an OR by simply adding other treatment options. The objective of this study was to estimate the economic consequences of expanding office-based EPL treatment options (medical and surgical) to women experiencing EPL beyond OR uterine evacuations and expectant management alone.
Materials and Methods
To simulate how expanding available treatment options for EPL management might have an impact on medical expenditures, we constructed a decision model using a hypothetical cohort of women undergoing EPL management within a 30 day horizon ( Figure 1 ). This study received exempt status from the University of Michigan Institutional Review Board (no. HUM00013643).
Treatment options under the usual care arm included expectant management and surgical uterine evacuation in an OR. We estimated the proportion of women entering each treatment branch under usual care using our previous work examining statewide practice patterns. Treatment options under the expanded care arm included expectant management, misoprostol treatment, surgical uterine evacuation in an office setting, and surgical uterine evacuation in an OR.
The proportion of the women entering each treatment branch in the expanded care model was derived from observed treatment patterns within our own health system during a time frame when all treatment options were routinely offered to the patients experiencing EPL (January 2010 through December 2012). The proportions entering each treatment arm were estimated using health system administrative claims data and a previously validated classification scheme.
Within both care models, all women using health services with the principal diagnosis of EPL are considered. Therefore, our hypothetical cohort included not only women with asymptomatic EPL but also those women presenting with complete or incomplete tissue passage and those with clinical indications for urgent OR evacuation. By using this approach, we accounted for the clinical nuances that influenced treatment decisions in this setting, including patient and provider treatment preferences and specific clinical circumstances encountered in real practice. For instance, women undergoing surgical evacuation in the OR because of anesthesia preference or because of urgent clinical circumstances would be included in our OR uterine evacuation arm.
Within the health system upon which we based treatment allocation in the expanded care model, women are cared for by a range of provider types, including obstetrician-gynecologists, family medicine physicians, midwives, and nurse practitioners. Expectant management refers to waiting for spontaneous passage of the pregnancy tissue without intervention. Evaluation is typically limited to office or emergency room visits, ultrasound(s), and laboratory tests. Medical management refers to treatment with misoprostol.
In our setting, patients administer the misoprostol at home and are instructed to repeat the dose if significant bleeding does not occur in 48 hours. Patients are typically scheduled for a follow-up ultrasound in the gynecology clinic to confirm completion 7-10 days after misoprostol administration. During the medical management of EPL, services typically include office visits, emergency room visits, ultrasounds, and laboratory tests.
Women experiencing EPL may choose to undergo surgical uterine evacuation in either the OR or the office. Office-based surgical evacuations, which are performed by both obstetrician-gynecologists and a family medicine physician, are available 3 days per week. Moderate sedation is available and provided for about two-thirds of women opting for office-based surgical evacuation.
Women can be directly scheduled into the office surgery schedule after screening by their referring provider. Women with significant comorbidities, such as significant cardiac or pulmonary disease, bleeding disorders, severe anemia, or poorly controlled seizure disorder, may not be eligible for the clinic-based procedure.
Surgical uterine evacuations are also done in the operating room in which general anesthesia is available. The best surgical setting for individual patients is determined by the woman and her provider. Reasons for an OR-based uterine evacuation might include patient instability, medical or surgical risk factors, a need for deep sedation, or patient preference.
Women presenting to the emergency room (ER) with EPL have a range of treatment options available. They can be managed surgically in the ER or in the OR, medically managed with misoprostol, or referred to the clinic for follow-up.
Our decision models were constructed and analyzed using Precision Tree (Palisade Corp, Ithaca, NY). Probabilities of treatment outcomes and complications were identified from published clinical trials and systematic reviews. Our study sample includes all women who present to the health system with a principal diagnosis consistent with EPL, both symptomatic and asymptomatic.
This aspect of our study design was particularly important in our estimates of successful expectant management. Success rates for expectant management in published studies may underestimate the total proportion of women who spontaneously pass the pregnancy tissue because those who spontaneously and completely pass the gestational tissue prior to presenting for services are excluded. We also included women who were treated surgically in the ER. Because the proportion of women treated surgically in the emergency department was small (<5%), and the procedural charges were the same as the office procedure, we included these women in the office-based surgical evacuation arm.
We estimated costs using the cost data from the University of Michigan Health System Data Warehouse, Medicare reimbursement rates, and costs reported in other published analyses. First, we identified the median cost in our health system generated from all encounters associated with relevant diagnostic codes, such as International Classification of Diseases , ninth revision, Clinical Modification codes 632.xx or 634.xx, beginning with the first encounter and continuing for the following 30 days. Services included office visits, ultrasounds and surgical procedures, and we included facility, physician/provider, laboratory, and anesthesia-related costs.
Next, we calculated costs using Medicare reimbursement rates and typical service utilization using patterns observed in our health system and reported in the literature. Finally, we compared our estimates with those reported in other analyses.
Cost estimates generated by these 3 approaches were similar except that our office uterine evacuation estimate included charges related to intravenous sedation, which resulted in a cost estimate higher than reported in a similar setting. Thirty day costs generated from our data warehouse were used in our decision model. Cost per case was calculated for initial treatment and initial treatment plus 1 surgical evacuation in the OR for failures. Surgical evacuation for failure of initial treatment was assumed to be 100% effective.
Finally, because we recognized that the expanded care model may incur additional costs because of implementation activities (staff training or equipment) and additional counseling time to review treatment options, we included an implementation cost for each patient treated under expanded-care conditions. Model parameters are shown in the Table .
| Care model | Therapy | Fraction choosing therapy (range for sensitivity analysis) | Effectiveness (range for sensitivity analysis) | Cost estimate, US dollars (range for sensitivity analysis) |
|---|---|---|---|---|
| Usual care | ||||
| Expectant | 65% (60–70%) | 50% (44–56%) | 493.94 (370.46–617.43) | |
| OR evacuation | 35% (30–40%) | 98.5% (97–100%) | 1542.57 (1156.93–1928.21) | |
| Expanded care | ||||
| Expectant | 47% (40–50%) | 50% (44–56%) | 493.94 (370.46–617.43) | |
| Medication | 17% (5–7%) | First dose: 71% (60–85%) Second dose: 85% (80–90%) | 387.66 (290.75–484.58) | |
| Office evacuation | 20% (15–25%) | 98.5% (97–100%) | 600.56 (450.42–750.70) | |
| OR evacuation | 15% (12–18%) | 98.5% (97–100%) | 1542.57 (1156.93–1928.21) | |
| Implementation cost of expanded care model | 25.00 (10.00–250.00) | |||
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