Procedural management of early pregnancy loss in different hospital settings: a cost-consequence analysis for the USA

Introduction

Background

Early pregnancy loss (EPL), defined as a nonviable, intrauterine pregnancy within 12 weeks and 6 days, occurs in approximately 10% to 20% of clinically-recognized pregnancies (1,2). Options for the management of EPL include expectant management, allowing the pregnancy tissue to pass on its own, or active treatment. In the latter, medication management is used to induce the expulsion of the pregnancy tissue and procedural management involves active evacuation in a procedure called uterine aspiration (1,3). In the past, uterine evacuation was performed using a sharp curettage but current ACOG guidelines now recommend to only use a suction curettage in the form of an electric or manual vacuum aspirator (1). Medication management for EPL can be considered in patients without infection, hemorrhage, severe anemia, or bleeding disorders who want to shorten the time to complete expulsion but want to avoid procedural treatment (1). Procedural treatment has long been the traditional approach for EPL and should be used for urgent, high-risk patients who present with hemorrhage, hemodynamic instability, or signs of infection and may be the preferable treatment option for those patients with comorbidities such as severe anemia, bleeding disorders, or cardiovascular disease (1). Other patients may choose procedural treatment instead of expectant or medication management because it provides a more immediate resolution with less follow up. There is no evidence that any of the three management options result in different long-term outcomes and in patients without medical complications or symptoms requiring urgent evacuation, treatment plans may be largely decided by patient preference (1,3).

Rationale and knowledge gap

Procedural management may be the better choice for patients who desire rapid resolution of their pregnancy loss. It is highly effective with a 97% success rate and requires less follow up (1,4). Patients looking for treatment of EPL may present initially either to an outpatient clinic or the emergency room (ER) of a hospital. Benson et al. identified that patients who present to the ER are less likely to receive active treatment (i.e., procedural or medication management) in comparison to those presenting to an outpatient clinic, indicating that barriers to active management exist when presenting to the ER (3). In the United States (US), roughly 900,000 patients who require treatment of EPL are presenting to the ER per year (3). Outcomes and patient satisfaction are associated with the patients’ ability to choose the treatment plan that is right for them (5,6).

When considering procedural management for patients presenting to the ER, a major barrier may be associated cost and time constraints (1,7). Procedural management is traditionally performed in the operating room (OR) using general anesthesia. In the OR, a shortage of staff and room availability can lead to long wait times and high costs for treatment (1,8). Previous work, however, has shown lower acuity settings to be equally safe and viable options (9-11). Studies suggest the office setting for procedural management, which could also be located in a hospital, can reduce overall treatment costs while still maintaining patient satisfaction (9,10). Furthermore, not undergoing general anesthesia may be preferable to some patients (12).

Procedural management is performed with a vacuum aspirator, either electric (EVA) or manual (MVA). Both devices have been found to be equally safe and effective and are well accepted by patients and providers (13-15). The use of the MVA has allowed for expansion of EPL care outside of the OR given its convenience and ease of use and storage (16). In addition, upfront costs for the MVA are lower than the EVA, suggesting benefits from a cost-savings perspective for hospital systems (16).

Objective

The objective was to perform a health-economic assessment to compare the current costs, hospital-resource time, and times to treatment completion associated with the site of service for procedural management within the hospital for patients presenting to the ER or in-facility office. Our aim is to support hospital administrators in establishing and informing further options for EPL management within the hospital, enabling better patient treatment and more patient-led decision making. Considering those patients for whom the OR (high-acuity setting) or the in-facility office and ER (low-acuity settings) can be considered equally safe when performing uterine aspiration from a medical perspective, we provide an evaluation of economic and resource factors that may motivate hospitals to extend their current treatment options. We present this article in accordance with the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) reporting checklist (available at https://jhmhp.amegroups.com/article/view/10.21037/jhmhp-24-45/rc) (17).

Methods

Model design

A cost-consequence model was developed to compare the costs and consequences of procedural management of EPL in different hospital settings. The model starts after diagnosis and procedural management of the EPL was selected as appropriate by both provider and patient. Costs and consequences are reported from the perspective of an average hospital in the US. Three settings for performing uterine aspiration were investigated: the OR, which is the traditional setting, the ER, and the in-facility office. A 30-day time horizon was used as all model outcomes were accrued within this timeframe, ending with treatment success. This time horizon has also been explored by similar health-economic evaluations for the procedural management of EPL (10,18).

A decision tree was used to model the movement of the hypothetical patient cohort through the care pathway. Designed using Microsoft Excel^® (Microsoft Office, Redmond, USA), the model was developed as per good health-economic modeling practice according to the International Society for Pharmacoeconomic and Outcomes Research (ISPOR) (19-21).

Care pathway

A patient experiencing EPL may be symptomatic (e.g., vaginal bleeding or uterine cramping) where they may be more likely to present to an ER or asymptomatic where the EPL may be established during a routine visit in an office setting. Patients enter the presented model only after EPL has been diagnosed and the provider and patient have decided to pursue procedural management in the hospital; medication and expectant management of EPL are not a part of this investigation (Figure 1). The site of service for the initial visit was not considered in the model as this is dependent on external factors that cannot easily be controlled by hospital administration. In addition, hypothetical patients entering the model are considered “low risk” meaning that the patient’s vital signs are stable, they are not actively miscarrying when evaluated, and they present with no heavy bleeding or signs of infection, nor do they present with other medical complications that would necessitate urgent treatment (1). At the healthcare provider’s discretion, any of the three hospital settings (OR, ER, and in-facility office) would be considered safe to perform the uterine aspiration procedure for these “low risk” patients.

Figure 1 A schematic of a typical clinical care pathway for patients with EPL, represented as a decision tree. Only the part of the care pathway that is directly affected by patients who are eligible for any site of service for uterine aspiration are modeled in the presented economic assessment—as indicated by the states “Model entry” and “Model ends”. The care pathway was informed by published US studies and validated based on the experience of the clinical author from a US hospital in Philadelphia. OR, operating room; ER, emergency room; EPL, early pregnancy loss.

If a patient initially presented to the ER, they could receive uterine aspiration treatment on the same day in the ER, or the same day in an in-facility office or in the OR, if capacity is available (Figure 1). Otherwise, the patient is scheduled for treatment at a later day in the OR or the in-facility office with no scheduling available in the ER. When EPL was detected in an in-facility office, the patient has the option of treatment on the same day in the office or the patient is scheduled for treatment at a later day in the OR or in-facility office. If the patient’s treatment was scheduled, we used an average number of 5 days (range, 3–7 days) before the patient could have treatment, which is similar to times published in a Canadian study but slightly adjusted for longer times according to the clinical experience of A.O. (22). As the conservative choice, the same scheduling delay was used for both the OR and the in-facility office although it could potentially be shorter for the latter.

On the day of the procedure, the patient is taken through the standard preoperative preparations by the hospital staff. If the patient is going for an OR procedure, it is typical that an EVA is used (11,23). Conversely, in line with published data from settings outside of the OR, the MVA is used in the ER and in-facility office settings (11,16,23). In the OR, patients would receive general anesthesia, whereas in the ER or in-facility office, patients would receive local anesthesia. After the procedure, the patient is allowed a period of recovery before being discharged home. Staff preparation time, operative time, and postoperative recovery time were modeled to be setting specific (see Table 1).

A successful procedure is defined as the complete evacuation of the pregnancy tissue. After a complete evacuation, the patient may return for a related—but unplanned—ER visit, which is associated with extra costs and consequences. If the procedure is unsuccessful, the patient will wait for a repeat, scheduled procedure in the OR, reentering the model. A repeat procedure includes an additional cost for ultrasound at a use rate of 53.70%, according to Benson et al., 2021 (7). After the second procedure, the patient may again visit the ER for related complications. No further procedures were modeled due to the very low probability of requiring more than two procedures for a successful evacuation.

The care pathway from the decision for procedural management of EPL until successful evacuation (Figure 1) was informed by published studies on patients from the US and confirmed based on the clinical experience of A.O. from a hospital in Philadelphia, USA.

Key model assumptions

Every model must make assumptions to simplify clinical practice. Key model assumptions were as follows:

• It was assumed that there would be three days between the procedure and confirmation that the procedure was unsuccessful as there was no available data for this time period and we did need to model a time to completion without gaps. The same time period is consistently applied to all three arms of the model and fluctuations in evacuation success between settings were minor such that relative time differences remain comparable.
• Although differences exist in practice, it is assumed that the repeat procedure occurs in the OR when patients present to the hospital a second time because it was not possible to identify settings for repeat procedures. This assumption decreases modeling bias by assuming the most conservative (expensive) option.
• Cost data were only available for the in-facility office versus the OR. Therefore, it was assumed in the model base case that the cost of performing the procedure in the ER was equal to the cost for the in-facility office. As this may not be true in many hospitals, we incrementally increased the cost of the ER relative to the in-facility office in a scenario analysis.

Evacuation success is very high for procedural treatment of EPL, ranging from 96–98%, depending on the location (Table 1) and we assumed maximally one repeat procedure may be required (9,14,24). It is possible that published variations depending on the setting are due to typical fluctuations reported in clinical studies and that the site of service has no influence on evacuation success. Therefore, we performed a scenario analysis, setting evacuation success to 100% for each of the ER, the OR, and the in-facility office. This allows the reader to compare costs and consequences assuming success after only one round of treatment for any of the locations.

Patient population

The modeled patient population was a hypothetical cohort of patients who were diagnosed with EPL by a healthcare provider and consented to or preferred procedural management of EPL in any hospital setting after initial presentation and diagnosis. The model used published clinical data extracted from peer-reviewed studies as inputs, primarily from studies involving US patients. No primary, patient-level clinical data were processed; the analysis did not involve human subjects and therefore, ethical approval or patient consent was not required.

Model-input data

The model-input data were sourced from published literature. A structured literature search was performed in PubMed between July and August 2022 (Table S1). The search aimed to identify relevant efficacy, time, and cost data. To support the structured literature review, additional hand searches were performed. A comprehensive list of model-input data and their sources are given in Table 1. When data for the time inputs were available in the literature, these values were used, otherwise we relied on the clinical experience of A.O., who works as a gynecologist in a US hospital in Philadelphia that already offers treatment for EPL both in the ER and the outpatient setting, outside of the OR. Multiple data sources for the same input were combined using a weighted average approach.

All cost data within the model were in or inflated to 2,022 USD, using the consumer price index for Medicare services in the US (30). Due to the short time horizon, no discount rate was applied to any of the costs.

The cost of the vacuum aspirator (MVA or EVA) was included in the cost of the procedure by site of service. The patient time and the hospital-resource time included the modeled proportion of same-day and scheduled procedures.

Model outcomes

The model generated the total cost per patient for each of the hospital settings (OR, ER, and in-facility office). It also determined the cost difference between OR versus ER management and between OR versus in-facility office management. Other outcomes of the model included time to completion of EPL management and hospital-resource time across each setting. Time to completion was defined as the duration from the decision to proceed with procedural management until either an unscheduled ER visit occurred or until it became evident that such an ER visit was unnecessary. The time to repeat the procedure, if needed, was also included in estimating the time to completion. The hospital-resource time encompassed the total staff time required for each hospital setting for initial and repeat procedures.

Statistical analysis

Model outputs are reported as the average per patient in the base case. To investigate uncertainty of model outcomes, a probabilistic sensitivity analysis (PSA) was carried out by running 2,000 Monte Carlo simulations to test the robustness of all model results. Each input for the model has a mean value, used for the base-case calculations, and an underlying probability distribution and variance. The distribution was a normal, log-normal, gamma, or beta distribution for continuous, relative risk, cost, and probability inputs, respectively. The distribution underlying each input represents the uncertainty associated with that input. In summary, a potentially true value for the input could be drawn from anywhere on the distribution. If the variance of the input is small, then the distribution will be narrow and the range of possible true values for the input relatively limited. If the variance of the input is large, then the inverse is true: the distribution underlying the input will be wide and there are a large number of potentially true values for this input. A variance of 10% was assumed for clinical inputs, 30% for cost inputs, and 50% for time inputs, reflecting the differences in variations found in these categories of data.

During PSA, each input of the model was varied. To achieve this, the distribution underlying each input was represented as a cumulative distribution function (CDF). In the CDF, the lowest potentially true value of the input is represented by zero and the highest potentially true value of the input is represented by one. The mean, or base case, value of the input is 0.5 in the CDF. With the CDF for each input parameter available, a random number with a uniform distribution between zero and one is drawn separately for each input. To ensure randomness of the input and that the results can be replicated, a seeded Mersenne-Twister algorithm is used for generating the random number. This random number is used as the cumulative probability from which to draw a potentially true value from the CDF of the input parameter. In this way, each input has a “new” value drawn during PSA and each run of the PSA provides a “new”, potentially true result that fits with the uncertainty in model-input parameters. By repeating the PSA multiple times, in this case 2,000 times, a large range of potentially true results is created. These results may not be normally distributed and so are summarized by the 95% credible interval (CrI). This is the range of results with the bottom and top 2.5% of results (outliers) removed. It can be thought of as if the model was run with unique input parameters from 2,000 hospitals, giving a range of results that could be realistically expected. If the range does not cross zero, e.g., all results in the 95% CrI are positive or all are negative, then the outcome is considered statistically significant. The outcome of the PSA was reported as the median difference of the model base case and the 95% CrI of the difference comparing either the ER to the OR or the in-facility office to the OR.

One-way sensitivity analysis was used to identify the model inputs with the greatest impact on the model outputs. For this, each model input was changed by 20%. However, for the probability of evacuation success, the upper percentage increase could not be estimated as it is not logically valid to increase beyond 100% success. The five most impactful inputs were reported. Model results comparing the ER to the OR were used as the basis for the one-way sensitivity analysis. As the main model inputs for the ER and the in-facility office were similar, a one-way sensitivity analysis of in-facility office versus OR was not necessary.

Results

The model estimated that the total cost of care per patient for each hospital setting was as follows: $3,498 for the OR, $1,842 for the ER, and $1,800 for the in-facility office (Table 2). Moving procedural management from the OR to the ER or the in-facility office may save approximately $1,656 and approximately $1,698, respectively. This represents a reduction in costs of 47–49% in comparison to the OR setting.

The longest time to completion was 5.01 days for the OR, followed by 1.67 days for the in-facility office, and 0.35 days for the ER. Changing the site of service from the OR could reduce time to completion by 3.33 days when the in-facility office is used and by 4.66 days when the ER is used.

The model estimated that patients spend more time in hospital if managed in the ER setting (214 minutes) than in the OR (157 minutes) or in the in-facility office (91 minutes) settings (Table 2). This time includes planned and unplanned hospital visits and the additional time accrued for repeat procedures. Regarding hospital-resource time, the most time was expended in the OR setting (Table 2). The OR was associated with 306 minutes of hospital-resource time. The ER was associated with 88 minutes and finally, the in-facility office was associated with 75 minutes of hospital-resource time.

Sensitivity and scenario analyses

The results of the PSA are reported in Table 3. Median cost savings in comparison to the OR were $1,648 (95% CrI: $1,555–$1,735) for the ER and $1,743 (95% CrI: $1,647–$1,839) for the in-facility office. The model implies that approximately halving treatment costs when performing the procedure outside of the OR is likely. Time outputs are also improved in all settings except that the time in hospital is likely longer when the treatment takes place in the ER.

The results of the one-way sensitivity analysis are presented as tornado diagrams that show the inputs that most influence cost and time (Figure 2). The inputs that had the most influence on the model results were the probability of complete evacuation success, probability of same-day procedure, cost of procedure, and waiting time before a scheduled procedure.

Figure 2 One-way sensitivity analysis of OR versus ER procedure showing top five influential parameters affecting (A) cost and (B) time to completion and patient time in hospital. Upper and lower values represent the percentage increase and decrease compared to the base-case results respectively, when the parameters are varied. OR, operating room; ER, emergency room.

The first scenario analysis was done on the cost of procedural management in the ER setting. There was no cost available from the literature, so a conservative assumption was that ER had equal costs to the in-facility office. The result of the scenario analysis showed that the ER is cost-saving when compared to the OR up until costs of the ER are double those of the base case. This is logical because the OR cost input is roughly double that of the ER cost that we used in the base case.

A second scenario analysis was performed to evaluate costs and consequences when assuming 100% evacuation success at each location, i.e., assuming only one round of uterine aspiration treatment for all patients. Costs were $3,422 for the OR and reduced to $1,703 (−$1,719 reduction in costs) for both the ER and in-facility office. Time to completion was 4.83 days for the OR, 0.15 days for the ER, and 1.45 days for the in-facility office. Time in hospital was 154 min for the OR, 210 min for the ER, and 88 min for the in-facility office. Hospital-resource time was 300 min for the OR, 77 min for the ER, and 67 min for the in-facility office. These results are not substantially different to the model base case except for a slight increase in cost savings in the lower acuity settings (ER and in-facility office) and an obvious decrease in the average days until completion in all settings.

Discussion

About 1.6% of all visits to a hospital ER in the US were reported as patients experiencing bleeding during early pregnancy, a potential sign of EPL (7). Between 2006 and 2016, this corresponded to roughly 900,000 patients of all ER visits for EPL-related care per year (7). Over 80% of these patients may not be receiving active treatment for EPL, significantly more patients than those first presenting to outpatient clinics (3). In addition, patients presenting to the ER are more likely to be vulnerable and from marginalized communities (31).

When considering procedural management, 14% of privately insured patients underwent uterine aspiration after first presenting to the ER in comparison to 24% of patients first presenting to outpatient clinics (3). With a ten percentage-point difference, barriers to procedural management for patients presenting to the ER are likely. The traditional approach to receiving procedural management is for the patient to be scheduled for surgery in the OR (1,8). Aging demographics combined with an increased demand for OR resources and a continued growth of surgical treatments means that OR time and resources constitute a critical and scarce resource in the hospital—it is also of ethical importance to optimize OR use (32).

In our health-economic analysis, moving the management of EPL away from the OR may halve expenses with a magnitude of over $1,500 cost decrease and a significant decrease in time spent using hospital resources. To the best of our knowledge, and according to our structured literature review, this is the first economic analysis to compare patient and staff time in addition to costs through the complete care pathway. Although other studies have investigated moving procedural treatment of EPL to a lower acuity setting (10,18,26), our study is the only one to compare three possible treatment locations within the hospital—the OR, an in-facility office, or directly in the ER. The presented decrease in costs are supported by the previous health-economic literature (10,18,26).

The presented model only considers direct costs to hospitals when providing treatment. Decreasing expenses when moving to a lower acuity setting is unsurprising, and one must also consider reimbursement structures and charges made directly to the patient when estimating overall changes in hospital revenue. Although we do not have data showcasing differences in reimbursement depending on hospital location, only two Current Procedural Terminology (CPT) codes are available for reimbursing procedural treatment of EPL (CPT 59820 for the treatment of a missed abortion and CPT 59812 for the treatment of an incomplete abortion) (33). Facility payments for these codes do not differ between the sites of service within a hospital—only additional services offered at each location could potentially be reimbursed on top. These are unlikely to cover the entire difference of over $1,500 between the OR and the two other lower acuity settings. For example, in the OR one could charge for anesthesia but then one needs to have an anesthesiologist present when anesthesia may not be required. In addition, moving lower acuity procedures such as uterine aspiration out of the OR increases the opportunity for OR resources to be used for higher acuity surgeries that can be charged at higher rates, called opportunity costs. When considering costs that are passed on to patients, reducing out-of-pocket costs for patients who can choose a lower acuity setting may increase healthcare equity by making procedural management more affordable.

The model indicated that the total time to completion could be reduced by approximately 3 to 5 days when procedural treatment was performed outside of the OR with procedures being performed on the same day as the diagnosis in the ER. The need to schedule a procedure in the OR, which would depend on the availability and patient-fasting requirements, contributes to the long time to completion for the OR (11). There is supporting evidence that moving procedural management to a lower acuity setting reduces overall patient wait times (8,11,26). The downside of the ER is that patients spend the longest time in the hospital, with the model estimating a total of one hour longer in the hospital in comparison to the OR and two additional hours in comparison to the in-facility office. ER management may still be desirable for patients who would prefer a resolution before discharge, regardless of the challenges posed by the ER (31).

It is important to note that there are not only cost and resource factors influencing the decision about where a patient is treated for EPL. A patient might only remain in the location of their initial presentation for procedural treatment if they present without medical complications or symptoms requiring urgent evacuation; a decision that remains at the discretion of the healthcare provider. High-risk patients may be sent to the ER if they presented in an office or to the OR for immediate treatment. Although outcomes of this health-economic analysis can generally only influence decisions made for (or by) the subset of low-risk patients who would be eligible for any of the locations investigated, presented costs and times also apply if the decision about the site of service was made due to medical factors rather than personal preference—where a higher acuity setting is medically required. With 900,000 patients presenting to the ER requiring treatment of EPL per year (3), reducing expenses for uterine aspiration in just a subset of patients should have an impact on total hospital spending and allow hospitals to optimize the use of OR resources. Expanding the site of service for procedural treatment would allow low-risk patients more flexibility to choose the management option for EPL that is right for them, increasing treatment satisfaction (5,6,34).

Limitations

Models are always an abstraction from real-life practice, and as such, it is not possible for a model to reflect the many different hospital pathways in the US. Moreover, multiple sources were used for the model inputs, creating bias as the studies were completed in different institutions with different inclusion and exclusion criteria. Due to a lack of data in the literature, patient wait time, postoperative recovery time, staff preparation time, and the hospital staff required for each procedure were provided from individual clinical experience in a specific field of practice. Owing to the heterogeneity of the healthcare system in the US, the wait times and hospital-resource time may not reflect reality in many hospitals.

The model was built on several assumptions, which weaken the conclusion of the model results. One of the assumptions was that the cost of procedural management with the MVA in the ER would be equivalent to the cost of the same procedure in the in-facility office. This assumption was made due to a lack of data on the cost of the procedure in the ER. Hence, a scenario analysis was done to account for this limitation. In a previous economic analysis (11), it was assumed that the EVA was used in the OR—and not the MVA, although it is possible to use the MVA in the OR. In our analysis, we also made this assumption, since the EVA is known to be frequently used in the OR and we did not identify data on how often the MVA is used instead. Since it was not possible to know which proportion of patients might have had their repeat procedures in the ER or an in-facility office, the conservative assumption in terms of costs was made that all repeat procedures took place in the OR using the EVA. This means that the ER and in-facility office settings may even see a further reduction in costs if the repeat procedures would be offered in the same setting as the primary procedure. In addition, we added a scenario analysis where we assumed 100% evacuation success after the first treatment such that outcomes can be compared when only one round of treatment is considered. Conclusions made about cost and time savings were still valid in this scenario.

Conclusions

Procedural management of EPL in the OR is more costly and time-consuming for the hospital when compared to the ER and the in-facility office settings. Patient’s waiting time, staff time, and time to completion may also be reduced if they are managed in the ER and the in-facility office settings. Results may provide additional evidence-based information to support patients in deciding on treatment options and to encourage a move to providing lower acuity and more accessible options for procedural management.

Acknowledgments

We thank Antonia Bosworth Smith for support in compiling the manuscript.

Funding: This work was funded by HPSRx.

Footnote

Reporting Checklist: The authors have completed the CHEERS reporting checklist. Available at https://jhmhp.amegroups.com/article/view/10.21037/jhmhp-24-45/rc

Peer Review File: Available at https://jhmhp.amegroups.com/article/view/10.21037/jhmhp-24-45/prf

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jhmhp.amegroups.com/article/view/10.21037/jhmhp-24-45/coif). U.S., S.J.S., M.C. and J.H. are employees and R.S. is the owner of Coreva Scientific GmbH & Co. KG. Coreva Scientific received consultancy fees for performing, analyzing, and communicating the work presented here. A.O. is a clinical trainer for Organon and received consulting fees for reviewing the work presented here. The authors have no other conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The economic model uses hypothetical patient cohorts with data derived from previously published research. IRB and informed consent are waived as this study involves no human subjects.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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