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Increasing the management options for early pregnancy loss: the economics of miscarriage

      See related article, page 177
      Early pregnancy loss (EPL) represents a very common event, occurring in approximately one-third of all pregnancies
      • Wilcox A.J.
      • Weinberg C.R.
      • O'Connor J.F.
      • et al.
      Incidence of early loss of pregnancy.
      and experienced by one-fourth of all patients.
      • Creinin M.D.
      • Shwartz J.L.
      • Guido R.S.
      • Pymar H.C.
      Early pregnancy failure—current management concepts.
      Although all share a diagnosis of EPL, these patients represent a variety of clinical scenarios, ranging from asymptomatic patients diagnosed with anembryonic pregnancies on ultrasound to patients presenting to the emergency department with heavy bleeding in the midst of an incomplete abortion. Overall, EPL will impact roughly 1 million women each year in the United States.

      Ventura SJ, Curtin SC, Abma JC, Henshaw SK. Estimated pregnancy rates and rates of pregnancy outcomes for the United States, 1990-2008. Natl Vital Stat Rep: From the Centers for Disease Control and Prevention, Natl Center Health Stat, Natl Vital Stat Sys 2012;60:1-21.

      Given the variability in clinical presentation, a wide range of approaches are viewed as acceptable in managing these patients, including expectant management, medical management with the administration of misoprostol, and uterine evacuation. Uterine evacuation may occur via traditional dilation and suction curettage in the operating room setting (D&C), or as an outpatient with manual vacuum aspiration (MVA) of the uterine contents. Success rates for these interventions vary widely, dependent on the type of EPL experienced (for instance, incomplete abortion vs anembryonic pregnancy), the dose and route of misoprostol administered, and the length of time a patient is willing to be observed. Surgical evacuation by either MVA or D&C is typically 96-100% effective as an initial treatment.
      • Rausch M.
      • Lorch S.
      • Chung K.
      • Frederick M.
      • Zhang J.
      • Barnhart K.
      A cost-effectiveness analysis of surgical versus medical management of early pregnancy loss.
      • Zhang J.
      • Gilles J.M.
      • Barnhart K.
      • Creinin M.D.
      • Westhoff C.
      • Frederick M.M.
      A comparison of medical management with misoprostol and surgical management for early pregnancy failure.
      Medical management with vaginal misoprostol will result in a completed miscarriage in 60-90% of patients.
      • Rausch M.
      • Lorch S.
      • Chung K.
      • Frederick M.
      • Zhang J.
      • Barnhart K.
      A cost-effectiveness analysis of surgical versus medical management of early pregnancy loss.
      • Zhang J.
      • Gilles J.M.
      • Barnhart K.
      • Creinin M.D.
      • Westhoff C.
      • Frederick M.M.
      A comparison of medical management with misoprostol and surgical management for early pregnancy failure.
      • Muffley P.E.
      • Stitely M.L.
      • Gherman R.B.
      Early intrauterine pregnancy failure: a randomized trial of medical versus surgical treatment.
      • Kong G.W.
      • Lok I.H.
      • Yiu A.K.
      • Hui A.S.
      • Lai B.P.
      • Chung T.K.
      Clinical and psychological impact after surgical, medical or expectant management of first-trimester miscarriage—a randomised controlled trial.
      Expectant management has the greatest variation in success rates, ending in a completed miscarriage for 38-81% of patients.
      • Nanda K.
      • Peloggia A.
      • Grimes D.
      • Lopez L.
      • Nanda G.
      Expectant care versus surgical treatment for miscarriage.
      • Wieringa-De Waard M.
      • Hartman E.E.
      • Ankum W.M.
      • Reitsma J.B.
      • Bindels P.J.
      • Bonsel G.J.
      Expectant management versus surgical evacuation in first trimester miscarriage: health-related quality of life in randomized and non-randomized patients.
      • Luise C.
      • Jermy K.
      • May C.
      • Costello G.
      • Collins W.P.
      • Bourne T.H.
      Outcome of expectant management of spontaneous first trimester miscarriage: observational study.
      Although expectant management has been shown to increase overall days of bleeding and the risk of unscheduled surgical intervention or hospitalization,
      • Nanda K.
      • Peloggia A.
      • Grimes D.
      • Lopez L.
      • Nanda G.
      Expectant care versus surgical treatment for miscarriage.
      • Trinder J.
      • Brocklehurst P.
      • Porter R.
      • Read M.
      • Vyas S.
      • Smith L.
      Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial).
      patient satisfaction rates remain high for all approaches.
      • Kong G.W.
      • Lok I.H.
      • Yiu A.K.
      • Hui A.S.
      • Lai B.P.
      • Chung T.K.
      Clinical and psychological impact after surgical, medical or expectant management of first-trimester miscarriage—a randomised controlled trial.
      • Nanda K.
      • Peloggia A.
      • Grimes D.
      • Lopez L.
      • Nanda G.
      Expectant care versus surgical treatment for miscarriage.
      • Weeks A.
      • Alia G.
      • Blum J.
      • et al.
      A randomized trial of misoprostol compared with manual vacuum aspiration for incomplete abortion.
      • Graziosi G.C.
      • Bruinse H.W.
      • Reuwer P.J.
      • van Kessel P.H.
      • Westerweel P.E.
      • Mol B.W.
      Misoprostol versus curettage in women with early pregnancy failure: impact on women's health-related quality of life: a randomized controlled trial.
      Obviously, a patient’s presentation may strongly dictate management—at times, surgical evacuation in the operating room may be required for a patient with profound bleeding. However, most patients with EPL are not diagnosed in the midst of an acute episode requiring immediate surgical intervention. Most patients are candidates for any of the previously mentioned therapies. With so many acceptable approaches to this clinical problem, other factors merit consideration before selecting a management course. One is patient preference. Despite lower overall success rates when compared with surgical evacuation, patient satisfaction rates are consistently high for both medical and expectant management.
      • Nanda K.
      • Peloggia A.
      • Grimes D.
      • Lopez L.
      • Nanda G.
      Expectant care versus surgical treatment for miscarriage.
      • Weeks A.
      • Alia G.
      • Blum J.
      • et al.
      A randomized trial of misoprostol compared with manual vacuum aspiration for incomplete abortion.
      • Graziosi G.C.
      • Bruinse H.W.
      • Reuwer P.J.
      • van Kessel P.H.
      • Westerweel P.E.
      • Mol B.W.
      Misoprostol versus curettage in women with early pregnancy failure: impact on women's health-related quality of life: a randomized controlled trial.
      Inherent risks are involved in surgical evacuation, including bleeding, discomfort, cervical laceration, uterine perforation, and potential risks of anesthesia. Patients may feel intimidated by the operating room setting, or simply prefer the privacy of managing their pregnancy loss at home. Some patients may even worry that more active management represents a potential risk to their health.
      • Kong G.W.
      • Lok I.H.
      • Yiu A.K.
      • Hui A.S.
      • Lai B.P.
      • Chung T.K.
      Clinical and psychological impact after surgical, medical or expectant management of first-trimester miscarriage—a randomised controlled trial.
      These varied interventions are also associated with significantly different costs. Although costs are rarely appreciated in the individual patient encounter, the overall costs of managing patients with EPL are significant and should at least be considered. Overall costs have consistently been highest for the patients managed in the operating room setting.
      • Rausch M.
      • Lorch S.
      • Chung K.
      • Frederick M.
      • Zhang J.
      • Barnhart K.
      A cost-effectiveness analysis of surgical versus medical management of early pregnancy loss.
      • You J.H.
      • Chung T.K.
      Expectant, medical or surgical treatment for spontaneous abortion in first trimester of pregnancy: a cost analysis.
      • Petrou S.
      • Trinder J.
      • Brocklehurst P.
      • Smith L.
      Economic evaluation of alternative management methods of first-trimester miscarriage based on results from the MIST trial.
      Petrou et al
      • Petrou S.
      • Trinder J.
      • Brocklehurst P.
      • Smith L.
      Economic evaluation of alternative management methods of first-trimester miscarriage based on results from the MIST trial.
      found the costs of both medical and surgical management to be higher than expectant management, although in their review all surgical evacuations were performed in the operating room. In a cost-effectiveness analysis of surgical vs medical management of EPL, Rausch et al
      • Rausch M.
      • Lorch S.
      • Chung K.
      • Frederick M.
      • Zhang J.
      • Barnhart K.
      A cost-effectiveness analysis of surgical versus medical management of early pregnancy loss.
      confirmed the higher cost of surgical evacuation in the operating room. However, they also demonstrated that surgical evacuation performed by MVA was $202 cheaper when compared with medical management using 800 μg vaginal misoprostol, because of the increased costs associated with managing misoprostol failures. Their study confirmed what is likely a common consensus among practitioners—that surgery was more effective, and less costly, under certain circumstances such as (1) surgery is performed as an outpatient; (2) the probability of medically treated women needing extra office visits it high; (3) the costs of outpatient visits are high; and (4) the success of medical management is low.
      In this issue of the journal, Dalton and colleagues
      • Dalton V.K.
      • Liang A.
      • Hutton D.W.
      • Zochkowski M.
      • Fendrick A.M.
      Beyond usual care: the economic consequences of expanding treatment options in early pregnancy loss.
      attempt to answer the question of costs in a more comprehensive fashion. Instead of comparing costs between 2 groups of patients randomized to one approach or another, the authors constructed a decision model following a hypothetical cohort of patients with EPL through a 30-day time period. These hypothetical patients were allocated into 2 separate treatment arms—‘usual care,’ including expectant management and surgical evacuation in the operating room, and ‘expanded care,’ which included all currently available and accepted treatments for EPL (expectant management, medical management with misoprostol, MVA in the office setting, and surgical evacuation the operating room). Patients were allocated into each treatment branch based on the authors’ prior work revealing treatment patterns within their own state and healthcare system.
      • Dalton V.K.
      • Harris L.H.
      • Clark S.J.
      • Cohn L.
      • Guire K.
      • Fendrick A.M.
      Treatment patterns for early pregnancy failure in Michigan.
      Patients failing their initial treatment were assumed to undergo a surgical evacuation in the operating room. The authors’ assessment of cost was quite comprehensive, including potential office visits, ultrasounds, surgical procedures, costs associated with provider or facility charges, laboratory charges, and the administration of anesthesia. They even considered the costs associated with implementation of the expanded care approach, accounting for additional training, counseling time, and necessary equipment.
      The results are dramatic. Expanding treatment options was expected to decrease initial use of D&C in the operating room—the most expensive option—from 35% to 15% of patients. Overall, expanding treatment options resulted in a savings of $241 per case, or roughly 19% less when compared with the costs of usual treatment. Although the authors compared cost estimates from their own data warehouse and found them comparable to Medicare reimbursement rates and other published analyses, one could argue these cost estimates may not generalize to other practice settings. It is just as likely, though, that the authors’ analysis could represent an underestimation of the actual savings. The authors assumed that all patients with an initial treatment failure would undergo D&C in the operating room, when many may choose administration of misoprostol or an office-based MVA. The study also accounted for their regional practice of using intravenous sedation for office-based MVAs, an intervention that is also costly and may not be necessary, at least in many patients.
      Given the wide range of acceptable options that exist for the management of EPL, it remains perplexing that patients are routinely only offered either expectant management or surgical evacuation in the operating room setting. Our beliefs about patient preferences, and our own training in miscarriage management, are likely barriers to offering all acceptable options.
      • Dalton V.K.
      • Harris L.H.
      • Gold K.J.
      • et al.
      Provider knowledge, attitudes, and treatment preferences for early pregnancy failure.
      • Wallace R.R.
      • Goodman S.
      • Freedman L.R.
      • Dalton V.K.
      • Harris L.H.
      Counseling women with early pregnancy failure: utilizing evidence, preserving preference.
      We should not let our biases cloud our counseling. In a study of health-related quality of life (HRQL) scores in randomized and nonrandomized patients undergoing expectant management or D&C for EPL, Wieringa-De Waard et al
      • Wieringa-De Waard M.
      • Hartman E.E.
      • Ankum W.M.
      • Reitsma J.B.
      • Bindels P.J.
      • Bonsel G.J.
      Expectant management versus surgical evacuation in first trimester miscarriage: health-related quality of life in randomized and non-randomized patients.
      found that patients randomized to surgery had lower HRQL scores than those randomized to expectant management. These differences, however, disappeared in the nonrandomized patients who were managed according to their own preference. Clearly, a patient’s HRQL experience depends on their ability to select their treatment—satisfaction should only increase if we are able to provide patients with all available treatment options.
      The authors should be commended for creating a cost-analysis that provides a more realistic cost representation for practices where all EPL treatment options are available. Although not all providers may by skilled in performing MVAs, misoprostol administration should be within the scope of every practice. Additional studies reviewing costs of 3 treatments—expectant management, misoprostol administration, and surgical evacuation in the operating room—may provide results more generalizable to practices where MVAs are not readily available. Nonetheless, Dalton and her colleagues
      • Dalton V.K.
      • Liang A.
      • Hutton D.W.
      • Zochkowski M.
      • Fendrick A.M.
      Beyond usual care: the economic consequences of expanding treatment options in early pregnancy loss.
      have advanced our understanding of the financial implications that result from decisions regarding EPL management. Increasing access to a patient’s preferred treatment is not only good patient care, but appears to be cost-saving as well.

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