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SMFM Special Report| Volume 217, ISSUE 4, PB2-B25, October 2017

Quality measures in high-risk pregnancies: Executive Summary of a Cooperative Workshop of the Society for Maternal-Fetal Medicine, National Institute of Child Health and Human Development, and the American College of Obstetricians and Gynecologists

      Providers perceive current obstetric quality measures as imperfect and insufficient. Our organizations convened a “Quality Measures in High-Risk Pregnancies Workshop.” The goals were to (1) review the current landscape regarding quality measures in obstetric conditions with increased risk for adverse maternal or fetal outcomes, (2) evaluate the available evidence for management of common obstetric conditions to identify those that may drive the highest impact on outcomes, quality, and value, (3) propose measures for high-risk obstetric conditions that reflect enhanced quality and efficiency, and (4) identify current research gaps, improve methods of data collection, and recommend means of change.
      The healthcare system is undergoing a major transformative change. In response to the provisions instituted under the Patient Protection and Affordable Care Act, there has been heightened impetus to control costs, increase coverage, and improve quality. Even before the enactment of the Patient Protection and Affordable Care Act, organizations have been working on issues of quality improvement. Most efforts thus far have focused on areas of cost and quality within populations covered by Medicare, which is an uncommon source of insurance coverage among obstetric patients, who are typically covered by either Medicaid or private insurers.
      Meanwhile, obstetric providers have grown increasingly frustrated with quality measures that poorly represent true provider and hospital quality.
      • Friedman A.M.
      • Ananth C.V.
      • Prendergast E.
      • D’Alton M.E.
      • Wright J.D.
      Evaluation of third-degree and fourth-degree laceration rates as quality indicators.
      • Howell E.A.
      • Zeitlin J.
      • Hebert P.L.
      • Balbierz A.
      • Egorova N.
      Association between hospital-level obstetric quality indicators and maternal and neonatal morbidity.
      Many obstetric providers perceive these measures as being fraught with inadequate risk adjustment, unclear attribution of care, burdensome data collection, and limited evidence that these measures result in actual quality improvement. Providers desire a healthcare system as described in the Institute of Medicine’s “Crossing the Quality Chasm” that is patient-centered, efficient, efficacious, equitable, safe, and timely.
      National Academy of Sciences, Institute of Medicine
      Crossing the quality chasm: a new health system for the 21st century.
      Accordingly, current efforts must therefore focus on how to encourage participation, cooperation, and collaborative advancement of all parties in the new “5 Ps of obstetrics” (patient, provider, programmer, payer, and place of service) in the development and implementation of ideal quality measures.
      The current United States healthcare system appears to deliver health care at high cost with mediocre results. In 2013, 17.1% of the United States gross domestic product was spent on health care, which is a percentage 50% above that spent by France (the next highest spender at 11.6% of gross domestic product) and almost double that of the United Kingdom at 8.8% of gross domestic product.
      • Squires D.
      • Anderson C.
      U.S. health care from a global perspective: spending, use of services, prices, and health in 13 countries.
      Our excess expenditures appear to be due in part to high use of diagnostic imaging and pharmaceutical costs.
      • Kanavos P.
      • Ferrario A.
      • Vandoros S.
      • Anderson G.F.
      Higher US branded drug prices and spending compared with other countries may stem partly from quick uptake of new drugs.

      International Federation of Health Plans. 2013 comparative price report: variation in medical and hospital prices by country. Available at: https://static1.squarespace.com/static/518a3cfee4b0a77d03a62c98/t/534fc9ebe4b05a88e5fbab70/1397737963288/2013+iFHP+FINAL+4+14+14.pdf. Accessed April 30, 2017.

      Despite these extraordinary overall costs, the United States has inferior outcomes in comparison to other high-income nations on several measures of population health that include life expectancy, maternal mortality rate, infant mortality rate, and the incidence of chronic diseases.
      Organization for Economic Cooperation and Development
      Health at a glance 2015: OECD indicators.
      • Osborn R.
      • Moulds D.
      • Squires D.
      • Doty M.M.
      • Anderson C.
      International survey of older adults finds shortcomings in access, coordination, and patient-centered care.
      • Kassebaum N.J.
      • Bertozzi-Villa A.
      • Coggeshall M.S.
      • et al.
      Global, regional, and national levels and causes of maternal mortality during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013.
      These statistics have spurred leaders throughout the entire healthcare community to address quality and value.
      Evaluations of quality of care typically are classified via three types of measures: structure, process, or outcome:
      Structural measures refer to the characteristics of the care provider or the place where the care is given. For the provider, these characteristics may include certification or educational background. Place or setting characteristics include structural elements, such as the presence and maintenance of equipment or staffing at a site of care. Structural measures are typically easier to capture than other types of measures and remain relatively stable; hence, they are often used by licensing and accrediting organizations. The assumption underlying structural quality measures is that enhancing structural elements at healthcare sites improves care. Although structural standards and improvements do not ensure quality, the lack of key structural elements may increase the difficulty of providing and sustaining high-quality care.
      Process measures focus on the series of events that take place during an episode of care and depend on the appropriateness of care, proficiency of providers, and timely provision of services. Process measures assume that appropriate care is more likely to result in excellent outcomes.
      Outcome measures evaluate whether healthcare goals were realized. Most outcome measures focus on the health status of the patient but can broadly include costs of care or patient satisfaction. Concerns regarding outcome measures often revolve around incorrect attribution of care and inadequate risk adjustment for factors beyond provider control, such as patient characteristics that predispose them to worse outcomes. At best, providers only control the process, which impacts but does not guarantee superior outcomes.
      None of the three categories of quality measures is considered inherently or continuously superior to another, and some investigators suggest that a simultaneous examination of measurements of different types allows a greater understanding of the quality environment.
      On February 3-4, 2016, the Society for Maternal-Fetal Medicine (SMFM), National Institute of Child Health and Human Development, and American College of Obstetricians and Gynecologists (ACOG) convened a “Quality Measures in High-Risk Pregnancies Workshop.” The goals were to (1) review the current landscape regarding quality measures in obstetric conditions with increased risk for adverse maternal or fetal outcomes, (2) evaluate the available evidence for management of common obstetric conditions to identify those that may drive the highest impact on outcomes, quality, and value, (3) propose measures for high-risk obstetric conditions that reflect enhanced quality and efficiency, and (4) identify current research gaps, improve methods of data collection, and recommend means of change.

      Workshop Design

      A workshop director and co-director were chosen by the SMFM leadership, and a steering committee was created to discuss the general topics and themes for production of quality measures for high-risk pregnancies. The committee held a series of conference calls during which topics to be considered at the workshop were chosen based on prevalence, increased level of maternal and fetal risk, existing variation in care, heightened economic burden, and primacy of the patient. Topics to be reviewed in breakout sessions at the workshop were chosen by the steering committee. Two facilitators per topic were chosen by the directors to assist in discussion of each topic. Clinical content experts were identified to review relevant evidence for clinical conditions to be examined within each topic. A series of conference calls were conducted before the workshop with the group facilitators, clinical experts, and directors. Call participants reviewed the framework for measuring quality and methods for review, and criteria for selection of appropriate indicators were outlined. For each subtopic, a content expert was chosen to perform a literature review and to lead the presentation of potential quality measures at the workshop. The group facilitators were charged with facilitating attendee participation during the workshop breakout sessions and to moderate discussion among workshop attendees regarding specific quality measure recommendations for each subtopic. Facilitators subsequently presented a summary of their respective breakout sessions to the entire group of workshop attendees for discussion and revision.
      The workshop preceded the 36th Annual Pregnancy Meeting of the Society for Maternal-Fetal Medicine. Attendance at the workshop was free, voluntary, multidisciplinary, and open. The workshop concluded with a discussion regarding current research, informational and personnel or organizational gaps, specific recommendations for research, and requirements in the future to enhance quality metrics for high-risk obstetrics and to improve future maternal healthcare quality. The measures recommended in this summary should continue to be evaluated, vetted, validated, and examined according to rigorous standards of measure development outlined by major organizations, including the Agency for Healthcare Research Quality and/or National Quality Forum.

      Results

      The steering committee selected the following topics and subtopics for discussion at the workshop:
      • 1.
        Preterm birth (screening and prevention, treatment, neonatal care)
      • 2.
        Cesarean delivery (cesarean birth rate measures, vaginal birth after cesarean [VBAC], infectious complications)
      • 3.
        Hypertension and preeclampsia (hypertensive crisis, magnesium sulfate prophylaxis, low-dose aspirin utilization, and postpartum follow-up)
      • 4.
        Hospital emergencies (venous thromboembolism [VTE], obstetric hemorrhage, and maternal sepsis)
      • 5.
        Outpatient care (obstetric ultrasonography and genetic testing)
      • 6.
        Information gaps and future research
      In the following sections, we present a brief overview of the topics, the quality measures discussed, and the measures that were recommended for further consideration. Table 1 lists the main measures discussed and the criteria used for recommendation for further consideration: importance, scientific acceptability, usability, and feasibility. Table 2 lists the 14 proposed measures that were recommended by consensus of the workshop attendees and measurement specifics, as appropriate.
      Table 1Principal workshop-proposed measures for participant consideration as a quality measure: rationale for inclusion or exclusion
      Proposed measuresImportanceScientific acceptabilityUsabilityFeasibilityRecommended for further consideration or development
      Preterm birth prevention (outpatient)
       Universal TVCL screeningYes

      Preterm birth occurs in 10% of pregnancies and is the leading cause of neonatal morbidity and death.
      Yes

      Identification of patients with short cervix ≤2.0 cm would provide opportunities for treatment.
      Yes

      Assists with medical decision-making.
      Unclear

      Difficult to abstract data from outpatient electronic health records
      No
       Primary TVCL vs transabdominal cervical length screeningYes

      Preterm birth occurs in 10% of pregnancies and is the leading cause of neonatal morbidity and death.
      Yes

      TVCL is the most accepted method.
      Yes

      Assists with medical decision-making.
      Unclear

      Study of training programs suggests variation in use of transabdominal vs transvaginal training for screening and some instances where transabdominal cervical length is adequate.
      No
       TVCL screening by Cervical Length Education and Review–certified sonographerUnclear

      Studies suggest standardized training and certification improves outcomes in other areas, but this has not been specifically evaluated for transvaginal ultrasound scans.
      Yes

      Short cervix is associated with increased risk preterm delivery; treatment and standardized training is available; there is no clear consensus about high-risk screening vs population screening.
      Unclear

      Perinatal Quality Foundation has database for status of sonographers and providers via the Cervical Length Education and Review program.
      Unclear

      Provider-level measure (not institutional); even with training, there are concerns about measurement reliability; access to outpatient records for data collection is not widely available.
      No
       Vaginal progesterone for women with short cervix ≤2.0 cm and <24 weeks of gestation and no history of spontaneous preterm birthYes

      Preterm birth occurs in 10% of pregnancies and is the leading cause of neonatal morbidity and death.
      Yes

      Studies suggest treatment is associated with reduction in preterm birth and is supported by ACOG and SMFM.
      Yes

      Measure of effective treatment and can monitor for under- or over-utilization.
      Unclear

      Provider-level measure would need to be done voluntarily or at the health plan level (eg, prescriptions for progesterone) that are linked to ultrasound findings.
      No
       Intramuscular progestins for women with history of spontaneous preterm birth at 20–36 6/7 weeks of gestationYes

      Preterm birth occurs in 10% of pregnancies and is the leading cause of neonatal morbidity and death.
      Yes

      History of preterm birth is a significant risk factor for recurrence; studies indicate prophylaxis is associated with reduction in recurrent preterm birth; prophylaxis is supported by ACOG and SMFM.
      Yes

      Measure of effective treatment that can monitor for under- or over-utilization.
      No

      Requires linkage with vital statistics data and insurance data for prescriptions
      No
       Cerclage for women with history of spontaneous preterm birth and TVCL <2.5 cm at <24 weeks of gestationYes

      Preterm birth occurs in 10% of pregnancies and is the leading cause of neonatal morbidity and death.
      Yes

      Studies suggest that ultrasound-indicated cerclage in women with a history of spontaneous preterm birth decreases risk of recurrent preterm birth.
      Yes

      Measure of effective treatment that can monitor for under- or over-utilization.
      No

      Requires linkage with vital statistics data and chart abstraction of inpatient and outpatient data
      No
      Preterm birth treatment (inpatient)
       Use of TVCL screening for women with threatened preterm birth (contractions) between 23 0/7 and 33 6/7 weeks of gestationYes

      Threatened preterm birth is common, and determining true labor from false labor is a diagnostic challenge.
      Yes

      Presence of long cervix (≥3.0 cm) is helpful in the determination of who is not at high risk for preterm birth.
      Unclear

      Good for negative predictive value; improves efficiency of care for women at low risk (cervical length, ≥3.0 cm); not as helpful (discriminatory if cervical length is <3.0 cm) with low positive predictive value.
      Unclear

      Chart abstraction required; no standard protocol exists for treatment; main benefit is efficiency for low-risk women.
      No
       Antenatal corticosteroid administration at 24 0/7 to 33 6/7 weeks of gestationYes

      This is the current standard advocated by societies and is the current quality metric.
      Yes

      Absence of timing of steroid administration limits this measure’s true effectiveness.
      YesYes

      Currently in use
      Yes

      Continue current measure as balancing measure (Joint Commission PC-03 [Perinatal Care Measure Set-03], National Quality Foundation).
       Optimal timing of corticosteroids within 7 days of delivery (first or second course) between 24 0/7 and 33 6/7 weeks of gestationYes

      Current variation in performance (only 20% of women receive treatment within 7 days of delivery)
      Yes

      Increased respiratory distress syndrome if exposure is >7 days.
      Unclear

      Data suggest timing better (more reliable) for maternal indications than fetal indications.
      Unclear

      Concern that current success might decrease if clinician waits to try to optimize time; currently, chart abstraction is to dichotomous yes/no; enhanced measure would require date/time of dose and delivery date/time and slightly more intensive chart abstraction.
      Yes

      Develop as an “enhanced measure.”
       Magnesium sulfate neuroprotection at 24–32 weeks of gestationYes

      Current standard of ACOG and SMFM
      Yes

      Meta-analyses demonstrate decreased moderate-severe cerebral palsy or death.
      Unclear

      Rare outcome, multifactorial causes
      Unclear

      Some concern exists about proper provider attribution.
      No
       NICU accepting VLBW deliveries provide care to an adequate volume of VLBW neonates (>100 VLBW infants per year)Yes

      Increased deregionalization in some areas leads to decreased experience and cost, with replication of service and equipment in some centers.
      Yes

      Increased neonatal mortality rates in low- volume NICUs
      YesUnclear

      Contradictory financial incentives for delivery and care of VLBW neonate, regardless of outcomes; may harm areas with limited NICUs for immediate transfer.
      No
       VLBW infant delivered at birthing center, level I or II NICUYes

      Measure of poor quality if infant is delivered at birthing center, level I and II NICU; variation because of access or financial incentives
      Yes

      Delivery in level III NICU associated with reduction in neonatal mortality rates.
      Yes

      Differences are clinically meaningful.
      Yes

      Cooperative transfer agreements in effect
      Yes

      Modification of current measure (National Quality Foundation)
      Hypertension/preeclampsia
       Low-dose aspirin for prevention of preeclampsiaYes

      Preeclampsia occurs in 6–8% of pregnancies and is associated with significant maternal neonatal morbidity/death.
      Yes

      Evidence indicates reduction in adverse outcomes, minimal harms;

      endorsed by ACOG and United States Preventive Services Task Force.
      Unclear

      Needs consensus regarding “at risk” women; ACOG and United States Preventive Services Task Force differ.
      Unclear

      Requires additional data field in inpatient record for electronic medical record abstraction.
      Yes

      As recommended by ACOG Task Force on Hypertension in Pregnancy (Table 2; footnote a).
       Hypertension/preeclampsia treatment (inpatient)
       Magnesium sulfate for prevention of eclampsia in delivering or postpartum women with preeclampsia with severe featuresYes

      Significant cause of maternal morbidity and death.
      Yes

      Studies indicate decreased rate of seizures with prophylaxis.
      YesYes

      Chart abstraction or electronic health records
      Yes
       Treatment of severe sustained and unresolved hypertension in pregnancy within 30 minutes (systolic blood pressure >160 mm Hg or diastolic blood pressure>110 mm Hg)Yes

      Elevated blood pressure is a significant cause of maternal morbidity and death.
      Yes

      Studies based on maternal death reviews suggest delay in diagnosis and treatment is associated with increased mortality rates.
      Yes

      Protocols decrease mortality rates from intraventricular hemorrhage.
      Yes

      Standard treatment protocol allows implementation and immediate treatment; may be difficult to abstract data in electronic medical record systems.
      Yes

      Other blood pressure thresholds and time intervals to treatment were also discussed.
       Documentation of care transition and education after delivery for women with gestational hypertension, preeclampsia, or eclampsiaYes

      Elevated blood pressure persists postpartum in 6–34% of women.
      Yes

      Follow-up and treatment, if needed, can reduce morbidity and lifetime risk of subsequent morbidity.
      Unclear

      Documentation of referral at time of discharge vs

      postpartum visit within 7–14 days with appropriate treatment or referral
      Unclear

      Chart audit for documentation of referral or follow-up evaluation; not linked to outcome; confirmed postpartum visit could be done with administrative data at system level; requires additional specific data field in inpatient record for electronic health record abstraction for referral and education.
      Yes

      Accepted for documented appointment or care transition and patient education before hospital discharge.
      Cesarean delivery
       Total cesarean delivery rateYes

      Significant variation across hospitals and providers
      Unclear

      No consensus regarding medically indicated cesarean deliveries; variable operative vaginal delivery skills are dependent on clinician experience; needs adjustment for case mix.
      Unclear

      Needs adjustment for case mix for comparisons
      Unclear

      Case mix adjustment could be burdensome.
      No
       Nulliparous, term, singleton, vertex delivery rateYes

      Significant variation across hospitals and providers
      Unclear

      Specified denominator accounts for risk adjustment; significant maternal and neonatal morbidities are associated with cesarean delivery; clinicians are not in agreement about limited exclusions; not sensitive to patient preferences.
      Yes

      May not be adequate for larger-volume hospitals or regional centers with patients at increased risk for cesarean delivery.
      Yes

      Currently being monitored
      Yes
       SMFM cesarean delivery rateYes

      Significant variation across hospitals and providers
      Unclear

      Enhanced denominator accounts for more significant risk adjustment; coding not validated across centers; does not account for parity; significant maternal and neonatal morbidities are associated with cesarean delivery.
      Yes

      Allows for a larger population to be measured because of lack of exclusion of multiparous women, which may improve usage; decreased month-to-month variability in smaller hospitals.
      Yes

      However, increases burden of measurement by including more data extraction.
      No

      Not currently recommended, but needs further research; may be better for evaluation of maternal-fetal medicine subspecialists.
       VBAC/TOLAC
      • 1.
        VBAC rate
      • 2.
        VBAC success
      Yes

      Twelve percent of women have had a previous cesarean delivery and are candidates for VBAC; VBAC success approaches 70% in appropriate candidates.
      Yes

      VBAC rates inversely are correlated with total cesarean rates; repeat cesarean deliveries are associated with increased morbidity over time; VBAC counseling influences uptake of attempted trial of labor.
      Unclear

      VBAC rate depends on access; many hospitals do not meet standards or have chosen not to offer VBAC for risk management reasons; potential for downstream complications if incentivized for VBAC success.
      Yes

      Can use administrative data for VBAC rate and VBAC success rate.
      No
       TOLAC counselingYes

      Accepted by major organizations
      Unclear

      Concern exists about monitoring the content of information for TOLAC counseling.
      Unclear

      TOLAC counseling does not address content, shared decision-making, or language differences.
      Unclear

      Requires extensive chart audit and documentation; dichotomous (yes/no) does not address usability.
      No
       Antibiotic prophylaxis for cesarean deliveryUnclear

      Possible low incidence of current noncompliance with therapy;

      no current data was found regarding variation in prophylaxis.
      Yes

      Infection is fourth leading cause of maternal death in the United States; perioperative antibiotics decrease infectious morbidity.
      Yes

      Differences between prophylaxis pre- vs post-incision are clinically meaningful.
      Yes

      Use existing hospital infrastructure for surgical prophylaxis.
      Yes
      Hospital-based emergencies
       Venous thromboembolism risk assessmentYes

      Venous thromboembolism is a leading cause of death in the United States and has significant long-term sequela.
      Yes

      Multiple protocols, evidence addresses primary prevention for patients at increased risk; pregnancy is risk factor, yet no clinical trials: re: prevention in pregnancy.
      Unclear

      International population-based cohort studies demonstrate improved maternal outcomes (decreased mortality rate).
      Yes

      Current infrastructure for risk assessment and monitoring has been implemented widely in hospitals for nonpregnant medical and surgical populations.
      Yes

      All pregnant women should undergo venous thromboembolism risk assessment and receive treatment if at increased risk; recommend tracking of prophylaxis rates, harms (wound infection, heparin- induced thrombocytopenia, hemorrhage) for further analysis.
       Obstetric hemorrhage (≥4 units transfused)Yes

      Obstetric hemorrhage a leading cause of maternal death in United States;

      significant racial disparity
      Yes

      Death reviews demonstrate that some instances are preventable.
      Unclear

      Concerns about attribution and withholding transfusions because of fear of penalty
      Yes

      Caution regarding regionalized “accreta centers”; consider exclusion of diagnosis of placental invasion abnormalities, clotting abnormalities, trauma, sickle cell disease, amniotic fluid embolus.
      No
       Total packed red blood cells per 1000 deliveriesYes

      Obstetric hemorrhage is a leading cause of maternal death in United States;

      significant racial disparity.
      Yes

      Death reviews demonstrate that some instances are preventable; the benchmark number of transfused units is known (estimated range of 40–60/1000 deliveries).
      Yes

      Relative benchmark known
      Yes

      Caution regarding regionalized “accreta centers”; consider exclusion of diagnosis of placental invasion abnormalities, abruption, trauma, sickle cell disease, amniotic fluid embolus.
      Yes
       Presence of obstetric hemorrhage protocolYes

      Obstetric hemorrhage is a leading cause of maternal death in United States;

      significant racial disparity.
      Unclear

      Death reviews demonstrate some instances are preventable; studies that relate to presence of protocols show inconsistent results.
      Yes

      Protocols in place in many larger centers
      Yes

      Ease of measurement
      No
       Sepsis bundle in all hospital systems that perform obstetricsYes

      Fourth leading cause of maternal death and accounts for 5% of maternal intensive care unit admissions.
      Yes

      Sepsis bundle associated with decreased mortality rates.
      Yes

      Early recognition and treatment associated with decreased mortality rate.
      Yes

      But need modified scoring systems to identify pregnant women at increased risk.
      Yes

      Also recommend hospital-based internal quality review for initiation of management protocol and in-person provider evaluation in <3 hours from suspicion of diagnosis.
      Obstetric ultrasonography and genetics
       AccreditationYes

      Many centers with no minimal standards.
      Yes

      Studies demonstrate improved image quality and completeness in accredited units.
      YesYes

      Low cost
      Yes
       Prenatal detection of congenital cardiac anomaliesYes

      Cardiac anomalies are the most common major congenital defect; anomalies occur in approximately 1% of births.
      Yes

      One fourth of congenital heart defects require early surgery and management in a tertiary care center.
      Yes

      Knowledge before delivery could impact decision-making and outcomes.
      Yes

      Current postnatal screening programs allow for identification of missed diagnosis and over-diagnosis.
      Yes

      Requires a neonatal O2 saturation screening program.
       FGR detectionYes

      Incidence 5–7%
      Yes

      FGR is associated with significant morbidity and death.
      Unclear

      Several FGR definitions; no treatment options that change course; different management strategies for follow-up evaluation
      Unclear

      Needs consensus agreement on definition and trials to demonstrate effective management protocols with improved outcomes.
      No
       Doppler assessment of umbilical artery in newborn infants who weigh <5% for gestational ageYes

      In agreement with current standard by ACOG and SMFM for use with FGR.
      Yes

      Reduction in mortality rates and morbidity
      Yes

      Knowledge could impact decision-making and outcomes.
      Unclear

      Requires time- consuming chart audits from outpatient and inpatient sites.
      No
       Aneuploidy screening or diagnosis offered to women <24 weeks of gestation at first visitYes

      Current standard by ACOG and SMFM;

      required for equitable care
      Unclear

      Controversy exists regarding ideal test for high-risk and low-risk women.
      Unclear

      Appropriate counseling is an important component, but quality of counseling cannot be measured easily.
      No

      Would require chart audit of a large majority of pregnant women.
      No
       Percentage of high-risk women with documentation of genetic screening and testing optionsYes

      Current standard by ACOG and SMFM;

      required for equitable care
      Yes

      Trials support variations in outcomes based on adequate counseling.
      Yes

      Trials show that counseling leads to changes in test use and patient satisfaction.
      No

      Would require chart audit of a large majority of pregnant patients; components of adequate counseling are unclear.
      No
       Microarray analysis when a diagnostic invasive procedure is performed in the setting of fetal structural anomalyYes

      Current standard of societies
      Yes

      Enhanced detection of abnormality in this setting with microarray
      Yes

      May give important information not seen on routine karyotype; some problems exist with counseling of unknown variants.
      Yes

      Requires chart audit for data abstraction, but numbers would be limited.
      Yes
      ACOG, American College of Obstetricians and Gynecologists; FGR, fetal growth restriction; NICU, neonatal intensive care unit; SMFM, Society for Maternal-Fetal Medicine; TOLAC, trial of labor after cesarean delivery; TVCL, transvaginal cervical length; VBAC, vaginal birth after cesarean delivery; VLBW, very low birthweight.
      SMFM Publications Committee. Quality measures in high-risk pregnancies. Am J Obstet Gynecol 2017.
      Table 2Workshop attendee-recommended new quality measures January 2016: numerator and denominator (when appropriate)
      Recommended quality measureNumeratorDenominator
      Optimal antenatal corticosteroid administrationNo. of women who delivered liveborn infants between 24 0/7 and 33 6/7 weeks of gestation who received at least 1 dose of corticosteroids within 7 days of delivery; valid only for first or second courseNo. of women who delivered liveborn infants between 24 0/7 and 33 6/7 weeks of gestation
      Delivery of a very low birthweight liveborn infant at appropriate neonatal intensive care unit level of care (for measurement by birth centers and level I or II)Any liveborn infant at ≥24 weeks and <1500 g delivered at a birth center or a center with a level I or II neonatal intensive care unit whose mother presented and stayed at a center ≥24 hours before deliveryNo denominator proposed for consideration as a “serious reportable event,” case management category; serious reportable events are considered serious, largely preventable, and harmful clinical events
      Timely treatment of severe hypertension in pregnancyNo. of pregnant women ≥20 weeks of gestation or postpartum with a sustained and unresolved blood pressure measurement of systolic ≥160 mm Hg or diastolic ≥110 mm Hg who receive an antihypertensive agent within 30 minutesNo. of pregnant women ≥20 weeks gestation or postpartum with a sustained blood pressure measurement of systolic ≥160 mm Hg or diastolic ≥110 mm Hg
      Low-dose aspirin for prevention of preeclampsia
      American College of Obstetricians and Gynecologists recommendations for preeclampsia prevention with low-dose aspirin prophylaxis were updated in a practice advisory published in July 2016, after the workshop to include more groups for prophylaxis: history of preeclampsia, multifetal gestation, chronic hypertension, type 1 or 2 diabetes mellitus, renal disease, and autoimmune disease such as lupus or antiphospholipid syndrome (American College of Obstetricians and Gynecologists. Practice Advisory on low-dose aspirin and prevention of preeclampsia: Updated recommendations. July 11, 2016. Available at: http://www.acog.org/About-ACOG/News-Room/Practice-Advisories/Practice-Advisory-Low-Dose-Aspirin-and-Prevention-of-Preeclampsia-Updated-Recommendations. Accessed April 9, 2017)
      No. of women who delivered with a history of preeclampsia that required preterm delivery at <34 weeks or preeclampsia in >1 previous pregnancy and who received outpatient daily low-dose aspirin prophylaxis before deliveryNo. of women who delivered who had a history of preeclampsia that required preterm delivery at <34 weeks or preeclampsia in >1 previous pregnancy
      Magnesium sulfate for seizure prophylaxis in preeclampsia with severe featuresNo. of women who delivered with preeclampsia with severe features who receive magnesium sulfate seizure prophylaxisNo. of women who delivered with preeclampsia with severe features
      Follow-up evaluation and education of women with gestational hypertension or preeclampsiaNo. of women who delivered with a diagnosis of eclampsia, preeclampsia, or gestational hypertension who had combined documented care transition with a primary care provider and documented patient education on future cardiovascular and metabolic complications before hospital dischargeNo. of women who delivered with eclampsia, preeclampsia, or gestational hypertension
      Cesarean delivery rate
      Recent data on the Society for Maternal-Fetal Medicine displays possible improved utility vs nulliparous, term, singleton, vertex rate as a quality measure; further research should be monitored for this quality measure.
      No. of cesarean deliveries for nulliparous, term, singleton, vertex pregnanciesTotal no. of deliveries for nulliparous, term, singleton, vertex pregnancies
      Antibiotic prophylaxis for cesarean deliveryNo. of women who underwent cesarean delivery and received antibiotics before skin incisionNo. of women who underwent cesarean delivery
      Venous thromboembolism risk assessmentNo. of obstetric patients admitted to a hospital from documentation of pregnancy to 6 weeks postpartum who receive a venous thromboembolism assessment within 24 hours of admissionNo. of obstetric patients who were admitted to a hospital for >24 hours from documentation of pregnancy to 6 weeks postpartum
      Blood transfusion in pregnancy

      (adjust no. per 1000 deliveries)
      Total no. of units of red blood cells transfused during pregnancy and immediately postpartum, excluding cases of placental invasion (accreta/increta/percreta), sickle cell disease, trauma, preexisting bleeding disorder, and amniotic fluid embolusNo. of deliveries, excluding cases of placental invasion (accreta/increta/percreta), sickle cell disease, trauma, preexisting bleeding disorder, and amniotic fluid embolus
      Sepsis identification and treatmentAvailability of a protocol for identification and treatment of sepsis in pregnant women:

      categoric (yes/no)
      Not applicable
      Obstetric ultrasound accreditationAccreditation per nationally recognized standards that were assessed by a central organization with peer review for practices that perform obstetric ultrasonography; in addition, similarly recognized accreditation for maternal-fetal medicine practices that perform specialized detailed fetal anatomic sonography: categoric (yes/no)Not applicable
      Detection of clinically significant congenital heart defectsNo. of fetuses identified with a cardiac defect on second- or third-trimester ultrasound imaging (excluding echogenic intracardiac focus) in women who delivered at ≥24 0/7 weeks of gestation and whose neonate had a congenital heart defect that was diagnosed before discharge in centers with screening programs with neonatal O2 saturation monitoringNo. of women who had a second or third trimester ultrasound scan and who had an infant delivered at ≥24 0/7 weeks of gestation with a congenital heart defect discovered before discharge in centers with screening programs with neonatal O2 saturation monitoring
      Microarray analysis in the setting of fetal structural abnormality and performance of a diagnostic invasive procedureNo. of women with a fetal structural abnormality diagnosed on ultrasound imaging at <24 weeks of gestation who underwent a diagnostic invasive procedure for genetic testing (amniocentesis or chorionic villus sampling) and had microarray analysis performedNo. of women with a fetal structural abnormality diagnosed on ultrasound scan at <24 weeks of gestation who had a diagnostic invasive procedure for genetic testing (amniocentesis or chorionic villus sampling)
      N/A, not available.
      SMFM Publications Committee. Quality measures in high-risk pregnancies. Am J Obstet Gynecol 2017.
      a American College of Obstetricians and Gynecologists recommendations for preeclampsia prevention with low-dose aspirin prophylaxis were updated in a practice advisory published in July 2016, after the workshop to include more groups for prophylaxis: history of preeclampsia, multifetal gestation, chronic hypertension, type 1 or 2 diabetes mellitus, renal disease, and autoimmune disease such as lupus or antiphospholipid syndrome (American College of Obstetricians and Gynecologists. Practice Advisory on low-dose aspirin and prevention of preeclampsia: Updated recommendations. July 11, 2016. Available at: http://www.acog.org/About-ACOG/News-Room/Practice-Advisories/Practice-Advisory-Low-Dose-Aspirin-and-Prevention-of-Preeclampsia-Updated-Recommendations. Accessed April 9, 2017)
      b Recent data on the Society for Maternal-Fetal Medicine displays possible improved utility vs nulliparous, term, singleton, vertex rate as a quality measure; further research should be monitored for this quality measure.

      Preterm birth

      As the leading cause of neonatal death and disability, preterm birth affects almost 400,000 women in the United States annually. Additionally, preterm birth levies a substantial toll on the healthcare system: a preterm birth costs 12 times more than a term birth in combined maternal and immediate neonatal care.

      March of Dimes. Preterm birth: the financial impact on business. 2013. Available at: http://www.marchofdimes.org/materials/premature-birth-the-financial-impact-on-business.pdf. Accessed April 30, 2017.

      Despite recent decreases in preterm delivery rates, much of which appears to result from quality monitoring efforts that has led to a reduction of late preterm birth, the United States continues to have among the highest preterm birth rates in the developed world.
      • Hamilton B.E.
      • Martin J.A.
      • Osterman M.J.
      • Curtin S.C.
      Births: final data for 2013.
      • Beck S.
      • Wojdyla S.
      • Say L.
      • et al.
      The worldwide incidence of preterm birth: a systematic review of maternal mortality and morbidity.
      Moreover, despite preterm birth rates being a significant public health priority, disparities based on race and ethnicity have persisted for decades.
      • Spong C.Y.
      • Iams J.
      • Goldenberg R.
      • Hauck F.R.
      • Willinger M.
      Disparities in perinatal medicine preterm birth, stillbirth, and infant mortality.
      Further reduction in the preterm birth rate is challenging because of the multifactorial cause of preterm labor and the complex epidemiologic condition of idiopathic preterm birth.

      Screening and prevention

      Efforts to prevent preterm birth are complex and recently have been focused on cervical length measurement and subsequent interventions. Women with a previous spontaneous preterm birth are at increased risk of recurrent preterm birth.
      • Esplin M.S.
      • O’Brien E.
      • Fraser A.
      • et al.
      Estimating recurrence of spontaneous preterm delivery.
      Furthermore, short cervical length has long been associated with preterm birth.
      • Iams J.D.
      • Goldenberg R.L.
      • Meis P.J.
      • et al.
      The length of the cervix and the risk of spontaneous premature delivery: National Institute of Child Health and Human Development Maternal-Fetal Medicine Unit Network.
      Evidence suggests that women with a previous preterm birth who have a short cervix (<2.5 cm) demonstrated on transvaginal ultrasound scans benefit from cerclage placement.
      • Berghella V.
      • Rafael T.J.
      • Szychowski J.M.
      • Rust O.A.
      • Owen J.
      Cerclage for short cervix on ultrasonography in women with singleton gestations and previous preterm birth: a meta-analysis.
      • Owen J.
      • Hankins G.
      • Iams J.D.
      • et al.
      Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length.
      Similarly, randomized trials have supported the efficacy of vaginal progesterone in reducing the incidence of preterm birth in women with a short cervix.
      • Fonseca E.B.
      • Celik E.
      • Parra M.
      • Singh M.
      • Nicolaides K.H.
      Fetal Medicine Foundation Second Trimester Screening Group
      Progesterone and the risk of preterm birth among women with a short cervix.
      • Hassan S.S.
      • Romero R.
      • Vidyadhari D.
      • et al.
      Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial.
      Universal cervical length screening has been proposed as a means of identifying candidates for treatment to decrease the risk of preterm birth.
      • Son M.
      • Grobman W.A.
      • Ayala N.K.
      • Miller E.S.
      A universal mid-trimester transvaginal cervical length screening program and its associated reduced preterm birth rate.
      The workshop discussed several measures related to cervical length assessment that included identification of candidates for screening (universal vs high risk only), method of cervical length assessment (initial transvaginal sonographic screening vs transabdominal sonographic screening), and training standards for and certification in sonographic cervical length assessment. There is wide variation in the application of cervical length screening, despite continued efforts to develop consensus based on expert opinion regarding routine universal screening vs screening at-risk patients only. This variation is influenced by region, resources, and patient and provider preferences.
      • Khalifeh A.
      • Quist-Nelson J.
      • Berghella V.
      Universal cervical length screening for preterm birth prevention in the United States.
      Although transvaginal cervical length assessment is more accurate than transabdominal assessment, some research suggests improved efficiency based on a strategy of transvaginal evaluation contingent on the findings of transabdominal examination.
      • Hernandez-Andrade E.
      • Romero R.
      • Hussein Y.
      • et al.
      Transabdominal evaluation of uterine cervical length during pregnancy fails to identify a substantial number of women with a short cervix.
      • Friedman A.
      • Srinivas S.
      • Elovitz M.
      • Wang E.
      • Schwartz N.
      Can transabdominal ultrasound be used as a screening test for short cervical length?.
      Workshop attendees suspected that, because most practitioners perform initial cervical length screening transvaginally, little variation and only a limited opportunity exists for quality improvement with institution of a specific modality-based quality measure. Outpatient ultrasound reporting systems, which are used to document cervical length assessments, are often separate from other electronic health record (EHR) systems, which makes data collection difficult. Finally, training in cervical length assessment (and/or specific certification) was considered for inclusion as a structural quality measure but was not recommended because of inadequate current evidence of efficacy. Thus, at this time, the workshop consensus was that no measure related to cervical length assessment could be proposed.

      Treatment

      Randomized controlled trials and metaanalyses have demonstrated the effectiveness of progestins in decreasing preterm delivery in those women specifically identified to be at increased risk. Studies indicate that daily use of vaginal progesterone in women with a short cervix on transvaginal ultrasound scanning and no history of spontaneous preterm birth or intramuscular 17-OH progesterone injection weekly starting at 16 weeks of pregnancy for women with a history of spontaneous preterm birth are associated with a 30–40% decrease in the rate of preterm birth.
      • Fonseca E.B.
      • Celik E.
      • Parra M.
      • Singh M.
      • Nicolaides K.H.
      Fetal Medicine Foundation Second Trimester Screening Group
      Progesterone and the risk of preterm birth among women with a short cervix.
      • Hassan S.S.
      • Romero R.
      • Vidyadhari D.
      • et al.
      Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial.
      • Meis P.J.
      • Klebanoff M.
      • Thom E.
      • et al.
      Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate.
      Despite this evidence, workshop attendees verbalized concern about reliability of the required variables, specifically the identification of the denominator (women who are candidates for treatment based on either history or cervical length) and numerator (a reliable method of ascertaining treatment that is not overly burdensome with current EHR limitations). Adequate data collection currently is hindered often by fragmentation within the healthcare system because of limitation of data communication between prenatal providers and obstetric care institutions. New infrastructure for data collection and data abstraction would need to be designed to enable interconnectivity with inpatient and outpatient medical records and vital statistics data. This presently is feasible only in select health systems. Furthermore, barriers that impact acceptance and use of progestins may impede access for patients who are at risk of recurrent preterm birth.
      • Orsulak M.K.
      • Block-Abraham D.
      • Gee R.E.
      17α-hydroxyprogesterone caproate access in the Louisiana Medicaid population.
      Hence, the workshop attendees were unable to agree on measures that involve progesterone administration that could be applied reliably to all practice settings.

      Corticosteroids

      Currently, administration of corticosteroids for women at risk for delivery at 24–33 6/7 weeks of gestation is a quality measure published by the Joint Commission (PC [Perinatal Care]-03) and has achieved a high percentage of implementation. However, timing of corticosteroid administration is an important factor that has been overlooked in the Joint Commission’s current quality metric. Maximum benefit of corticosteroids as shown by a reduction in intubation or respiratory support is achieved when the first dose of corticosteroids is administered within 2–7 days of delivery.
      • Wilms F.F.
      • Vis J.Y.
      • Pattinaja D.A.
      • et al.
      Relationship between the time interval from antenatal corticosteroid administration until preterm birth and the occurrence of respiratory morbidity.
      • Peaceman A.M.
      • Bajaj K.
      • Kumar P.
      • Grobman W.A.
      The interval between a single course of antenatal steroids and delivery and its association with neonatal outcomes.
      Despite this evidence, only 20% of women receive these medications within this optimal period.
      • Adams T.M.
      • Kinzler W.L.
      • Chavez M.R.
      • Fazzari M.J.
      • Vintzileos A.M.
      Practice patterns in the timing of antenatal corticosteroids for fetal lung maturity.
      Antenatal corticosteroid administration is timed more ideally when the indication for preterm delivery is for maternal conditions rather than for fetal indications or spontaneous labor.
      • Adams T.M.
      • Kinzler W.L.
      • Chavez M.R.
      • Vintzileos A.M.
      The timing of administration of antenatal corticosteroids in women with indicated preterm birth.
      • Levin H.I.
      • Ananth C.V.
      • Benjamin-Boamah C.
      • Siddiq Z.
      • Son M.
      • Friedman A.M.
      Clinical indication and timing of antenatal corticosteroid administration at a single centre.
      Although determination of the timing of corticosteroid administration is complex and often affected by the clinical scenario, the attendees recommended the measure of corticosteroid administration within 7 days of a preterm delivery.
      The workshop attendees expressed concern that overall corticosteroid administration might decrease if the current quality measure of any administration before preterm birth is changed to indicate the timing of administration. Conceptually, balancing measures are used to examine whether design improvements in one part of a system lead to problems in other areas of care. Hence, workshop attendees suggested the continuation of the current measure (Joint Commission PC-03) for any administration as a balancing measure in addition to this new enhanced quality metric.
      Another concern raised was how to properly integrate the judicious administration of multiple courses of steroids within the newly quantified metric. Serial courses of corticosteroids have been associated with a reduction in birthweight, an increase in the number of small-for-gestational-age infants, and decreased head circumference.
      • Wapner R.J.
      • Sorokin Y.
      • Thom E.A.
      • et al.
      Single versus weekly courses of antenatal corticosteroids: evaluation of safety and efficacy. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.
      • Thorp J.A.
      • Jones P.G.
      • Knox E.
      • Clark R.H.
      Does antenatal corticosteroid therapy affect birth weight and head circumference?.
      • Murphy K.E.
      • Hannah M.E.
      • Willan A.R.
      • et al.
      Multiple courses of antenatal corticosteroids for preterm birth (MACS): a randomised controlled trial: MACS Collaborative Group.
      Conversely, a single rescue course of corticosteroids has been linked to significant reduction in the incidence of respiratory distress syndrome, need for surfactant therapy, and composite morbidity when administered to women with intact membranes at <34 0/7 weeks of gestation.
      • Garite T.J.
      • Kurtzman J.
      • Maurel K.
      • Clark R.
      Impact of a ‘rescue course’ of antenatal corticosteroids: a multicenter randomized placebo-controlled trial: Obstetrix Collaborative Research Network.
      The American College of Obstetricians and Gynecologists recommends the limitation of corticosteroid administration to 2 courses.
      American College of Obstetricians and Gynecologists
      Management of preterm labor: Practice Bulletin no. 171.
      Workshop attendees agreed that the new quality measure of corticosteroid treatment within 7 days of delivery should be limited to women who receive only their first or second course to account for ideal administration.

      Magnesium sulfate

      Magnesium sulfate has been shown to prevent moderate-to-severe cerebral palsy or death when administered to women at high risk for delivery at <32 weeks of gestation.
      • Rouse D.J.
      • Hirtz D.G.
      • Thom E.
      • et al.
      A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy.
      • Costantine M.M.
      • Weiner S.J.
      Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network
      Effects of antenatal exposure to magnesium sulfate on neuroprotection and mortality in preterm infants: a meta-analysis.
      The American College of Obstetricians and Gynecologists and SMFM support magnesium sulfate use for neuroprotection and released a patient safety checklist for proper administration.
      American College of Obstetricians and Gynecologists Committee on Obstetric Practice; Society for Maternal-Fetal Medicine
      Committee Opinion no. 455: Magnesium sulfate before anticipated preterm birth for neuroprotection.
      Patient safety checklist no. 7: magnesium sulfate before anticipated preterm birth for neuroprotection.
      Although deemed of high clinical importance, workshop attendees were concerned with data accuracy and burden of data abstraction regarding timing of administration and delivery. Because of these concerns, this measure was not recommended.

      Delivery at appropriate neonatal intensive care unit level of care

      Research has identified an association between outcomes for very low birthweight (VLBW) infants and the level of care of the neonatal intensive care unit (NICU) at the delivering hospital.
      • Paneth N.
      • Kiely J.L.
      • Wallenstein S.
      • Marcus M.
      • Pakter J.
      • Susser M.
      Newborn intensive care and neonatal mortality in low-birth-weight infants: a population study.
      • Bode M.M.
      • O’Shea T.M.
      • Metzguer K.R.
      • Stiles A.D.
      Perinatal regionalization and neonatal mortality in North Carolina, 1968-1994.
      For this reason, the proportion of newborn infants who weigh <1500 g who were delivered at hospitals with the appropriate level of neonatal care was also considered as a quality measure. The neonatal death rate is reduced by 3.4% with care at a large-volume NICU compared with lower volume centers, with a number needed to treat of 30 neonates to prevent a single death of a VLBW infant.
      • Chung J.H.
      • Phibbs C.S.
      • Boscardin W.J.
      • Kominski G.F.
      • Ortega A.N.
      • Needleman J.
      The effect of neonatal intensive care level and hospital volume on mortality of very low birth weight infants.
      Despite these data, multiple factors have led to deregionalization and proliferation of NICU beds, which include increasing availability of technology, community-based physician competition among neonatology subspecialists, and increasing favorability of Medicaid reimbursement because of shrinking commercial insurer payments.
      • Gould J.B.
      • Marks A.R.
      • Chavez G.
      Expansion of community-based perinatal care in California.
      The workshop attendees discussed a measure that would consider NICU volume but were unable to recommend it because of multiple factors that would limit its implementation, which include issues of proper attribution at the provider level vs hospital level and current financial pressures, which potentially reward the presence of NICU facilities and admissions. This makes the possible implementation of this measure difficult. There was universal agreement that intended delivery of a viable VLBW infant at a birthing center or a hospital with a level I or II NICU is suboptimal. Hence, workshop attendees recommended measurement of delivery of a viable VLBW infant at a birthing center or level I or II center in contrast to the preferred optimal delivery at a level III or IV NICU.

      Summary of recommended measures for preterm birth

      • 1.
        Antenatal corticosteroids initiated within 7 days of delivery to patients who delivered between 24 and 33 6/7 weeks of gestation
      • Balancing measure: Any administration of antenatal corticosteroids to patients delivering between 24 and 33 6/7 weeks of gestation (continuation of Joint Commission quality measure PC-03)
      • 2.
        Delivery of a viable liveborn VLBW infant at appropriate NICU level of care

      Hypertension and preeclampsia

      Preeclampsia is one of the leading causes of maternal and neonatal morbidity and death worldwide.
      • Ghulmiyyah L.
      • Sibai B.
      Maternal mortality from preeclampsia/eclampsia.
      Notably, the importance of quality care is signified by the reduction in complications that has occurred over the last several decades because of improvements in access to maternity care and effective management of this condition.
      • Ozimek J.A.
      • Eddins R.M.
      • Greene N.
      • et al.
      Opportunities for improvement in care among women with severe maternal morbidity.

      Hypertensive crisis

      Treatment of severe hypertension in pregnancy is an example of a protocol that clearly has improved outcomes. Use of an order set with automatic and rapid treatment for patients with a defined blood pressure elevation (systolic ≥160 mm Hg or diastolic ≥110 mm Hg) has resulted in the elimination of death from intracranial hemorrhage over a 5-year period that encompassed >1,256,000 deliveries.
      • Clark S.L.
      • Christmas J.T.
      • Frye D.R.
      • Meyers J.A.
      • Perlin J.B.
      Maternal mortality in the United States: predictability and the impact of protocols on fatal postcesarean pulmonary embolism and hypertension-related intracranial hemorrhage.
      The notable improvement in outcomes with this protocol led the workshop attendees to recommend a quality measure of the percentage of pregnant and postpartum women with sustained and unresolved blood pressure (systolic ≥160 mm Hg or diastolic ≥110 mm Hg) who receive treatment with an antihypertensive agent within 30 minutes of blood pressure elevation.

      Magnesium sulfate seizure prophylaxis

      The Magpie Trial showed a 58% reduction in the relative risk of eclampsia with magnesium sulfate treatment, with a number needed to treat of 63 to prevent a single case of eclampsia in women with preeclampsia with severe features.
      • Altman D.
      • Carroli G.
      • Duley L.
      • et al.
      Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial.
      Use of magnesium sulfate for cases of preeclampsia with severe features targets women at the greatest risk of eclampsia.
      • Smith J.M.
      • Lowe R.F.
      • Fullerton J.
      • Currie S.M.
      • Harris L.
      • Felker-Kantor E.
      An integrative review of the side effects related to the use of magnesium sulfate for pre-eclampsia and eclampsia management.
      Adopting magnesium sulfate seizure prophylaxis in preeclampsia with severe features as a quality measure is facilitated by the ease of abstraction from coding and EHR documentation. Because of the benefit of treatment and ease of measurement, a quality measure that would assess the percentage of women with preeclampsia with severe features who are receiving magnesium sulfate for seizure prophylaxis was recommended. The recommendation noted earlier should not be construed as a recommendation to defer the use of magnesium sulfate prophylaxis in cases of preeclampsia without severe features but instead as an acknowledgement of the need for prophylaxis in the clear majority of women with preeclampsia with severe features.

      Low-dose aspirin

      Prevention of hypertensive disease of pregnancy is the preferred approach and has been the subject of multiple trials with low-dose aspirin. The United States Preventive Services Task Force has released guidelines for use of low-dose aspirin to prevent preeclampsia, which increase use of this therapy by expansion of the patients whose condition is categorized at elevated risk for the development of this disorder.
      • Henderson J.T.
      • Whitlock E.P.
      • O’Conner E.
      • Senger C.A.
      • Thompson J.H.
      • Rowland M.G.
      Low-dose aspirin for the prevention of morbidity and mortality from preeclampsia: a systematic evidence review for the U.S. Preventive Services Task Force.
      In contrast, ACOG endorses a more restrained approach by recommending low-dose aspirin use for women with a medical history of early-onset preeclampsia and required preterm delivery at <34 0/7 weeks of gestation or who experienced preeclampsia in >1 previous pregnancy.
      ACOG Task Force on Hypertension in Pregnancy
      Hypertension in pregnancy: report of the American College of Obstetricians and Gynecologists’ Task Force on hypertension in pregnancy.
      Although the two sets of guidelines differ in the range of historic factors that require prophylaxis, both statements recommend the use of low-dose aspirin in at least some cases. Considering the somewhat conflicting nature of the guidelines at the time of the workshop, attendees suggested adoption of the more conservative ACOG recommendation of low-dose aspirin prophylaxis in pregnant women with a history of preeclampsia that required delivery at <34 weeks of gestation or preeclampsia in >1 previous pregnancy.

      Postpartum care of patients with preeclampsia

      Gestational hypertension and preeclampsia are associated with an increased long-term risk of cardiovascular disease. The risks of stroke, coronary artery disease, and peripheral artery disease are doubled in women who are diagnosed with preeclampsia; evidence of increased disease risk can be seen in as few as 8 years after a preeclampsia diagnosis.
      • Ray J.G.
      • Vermeulen M.J.
      • Schull M.J.
      • Redelmeier D.A.
      Cardiovascular health after maternal placental syndromes (CHAMPS): population-based retrospective cohort study.
      • Kestenbaum B.
      • Seliger S.L.
      • Easterling T.R.
      • et al.
      Cardiovascular and thromboembolic events following hypertensive pregnancy.
      Incidence of subsequent hypertension is also tripled, and the rate of diabetes mellitus has been observed to almost double in patients with a history of preeclampsia or gestational hypertension.
      • Brown M.C.
      • Best K.E.
      • Pearce M.S.
      • Waugh J.
      • Robson S.C.
      • Bell R.
      Cardiovascular disease risk in women with pre-eclampsia: systematic review and meta-analysis.
      • Callaway L.K.
      • Lawlor D.A.
      • O’Callaghan M.
      • Williams G.M.
      • Najman J.M.
      • McIntyre H.D.
      Diabetes mellitus in the 21 years after a pregnancy that was complicated by hypertension: findings from a prospective cohort study.
      The identification of pregnancy complications as a window to future disease is an opportunity to affect women’s health beyond pregnancy. Documentation at the time of discharge for postpartum follow-up by a primary care provider for care transition and documentation of patient education of risks of future cardiovascular and metabolic disease was recommended as a combined quality measure for women with gestational hypertension, preeclampsia, or eclampsia.

      Summary of recommended measures for hypertension and preeclampsia

      • 1.
        Proportion of pregnant women with sustained and unresolved blood pressure (systolic ≥160 or diastolic ≥110) who receive an antihypertensive agent within 30 minutes of continued blood pressure elevation
      • 2.
        Proportion of women with a history of preeclampsia that required delivery at <34 weeks of gestation or with a history of multiple pregnancies with preeclampsia who receive low-dose aspirin antepartum
      • 3.
        Proportion of women who delivered with preeclampsia with severe features who receive magnesium sulfate for seizure prophylaxis
      • 4.
        Proportion of postpartum women with a current diagnosis of gestational hypertension, preeclampsia, or eclampsia who have documented care transition with a primary care provider and documented patient education on future cardiovascular and metabolic complications before hospital discharge

      Cesarean delivery

      Cesarean delivery is the most common inpatient operation in the United States, yet rates and indications for this procedure vary widely among physicians, hospitals, and regions.
      • Nippita T.A.
      • Lee Y.Y.
      • Patterson J.A.
      • et al.
      Variation in hospital caesarean section rates and obstetric outcomes among nulliparae at term: a population-based cohort study.
      • Spong C.Y.
      • Berghella V.
      • Wenstrom K.D.
      • Mercer B.M.
      • Saade G.R.
      Preventing the first cesarean delivery: summary of a joint Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, and American College of Obstetricians and Gynecologists Workshop.
      Several quality measures for this common procedure were considered: cesarean delivery rate, VBAC rate, trial of labor after cesarean (TOLAC) counseling, and administration of preoperative antibiotics.

      Cesarean delivery rate

      The overall cesarean delivery rate does not measure quality because simple procedure frequency does not consider the case mix of the population being evaluated. Current assessment has focused on subpopulations with particular characteristics that are accessed readily from medical records in an effort to evaluate populations relatively homogenous in risk to bring objectivity to this measure. In discerning the factors that define these subpopulations, attention should be given to the ease of ascertaining the relevant data, reliability of the documentation and coding, frequency of their presence and magnitude of the causal effect on cesarean delivery, and their ability to reflect predelivery characteristics exclusively without contamination by postdelivery developments. Parity, for example, has a large effect on cesarean delivery rates because of its prevalence and attributable impact. Other prevalent factors that affect cesarean delivery rates and have been used to create more comparably measurable subpopulations are gestational age, fetal presentation, and presence of multiple gestations. Consideration of these factors have led to the creation of the “nulliparous, term, singleton, and vertex (NTSV) cesarean delivery rate.” Although measurement of the NTSV cesarean delivery rate focuses on a smaller population, this subgroup is still sufficiently large, possesses seemingly ample variation in outcome, and carries implications regarding route of delivery and maternal morbidity in future pregnancies.
      • Main E.K.
      • Moore D.
      • Farrell B.
      • et al.
      Is there a useful cesarean birth measure? Assessment of the nulliparous term singleton vertex cesarean birth rate as a tool for obstetric quality improvement.
      The NTSV rate has been criticized because it does not exclude all conditions that are clinically significant and preclude vaginal delivery, such as placenta previa, nor does it consider other maternal or fetal conditions that may lead to a higher rate of cesarean delivery. In comparison, a cesarean delivery rate developed by SMFM restricts the population by the exclusion of patients with additional risk factors that may lead to cesarean delivery.
      • Armstrong J.C.
      • Kozhimannil K.B.
      • McDermott P.
      • Saade G.R.
      • Srinivas S.K.
      Society for Maternal-Fetal Medicine Health Policy Committee
      Comparing variation in hospital rates of cesarean delivery among low-risk women using 3 different measures.
      However, workshop attendees expressed concern that, because of the low frequency of these diagnoses in most low-risk centers, the use of the SMFM cesarean delivery rate instead of the NTSV rate would be of limited advantage. Use of coding data may also affect accuracy and reliability of the SMFM cesarean delivery rate, because coding data has been shown to be unreliable in other obstetric scenarios.
      • Geller S.E.
      • Ahmed S.
      • Brown M.F.
      • Cox S.M.
      • Rosenberg D.
      • Kilpatrick S.J.
      International Classification of Diseases-9th revision coding for preeclampsia: how accurate is it?.
      • Korst L.M.
      • Gregory K.D.
      • Gornbein J.A.
      Elective primary cesarean delivery: accuracy of administrative data.
      In addition, the SMFM cesarean delivery rate does not account for the effects of parity. The California Maternal Data Center found a 4-fold difference in multiparous vs NTSV cesarean delivery rates.

      Main E, Castles A; California Maternal Quality Care Collaborative. A rational approach to reducing first-birth (NTSV) cesarean birth rates. Available at: http://www.hqinstitute.org/sites/main/files/file-attachments/ntsv_cs_reduction_san_diego.pdf. Accessed March 20, 2017.

      Because workshop attendees agreed that nulliparity should be considered a risk factor for cesarean delivery, measurement of the NTSV rate was considered preferable and recommended as a quality measure.
      Nevertheless, the SMFM cesarean delivery rate recently has been shown to compare favorably on several aspects to the NTSV rate, including lower month-to-month variability, which may be particularly important for use as a quality metric in hospitals with lower delivery volume.
      • Shields L.
      • Walker S.
      • Wiesner S.
      • et al.
      Cesarean section rates: side-by-side comparison of three national inpatient quality indicators. 37th Annual Meeting of the Society for Maternal-Fetal Medicine: The Pregnancy Meeting. 23 January 2017-28 January 2017.
      Recent efforts directing payment based on NTSV rates without consideration of the unintended consequences for the mother or infant have created concern.

      Main EK, Morton CH, Hopkins D, Giuliani G, Melsop K, Gould JB. Cesarean deliveries, outcomes, and opportunities for change in California: Toward a public agenda for maternity care safety and quality. 2011. Palo Alto, CA: California Maternal Quality Care Collaborative. Available at: https://www.cmqcc.org/resource/cesarean-deliveries-outcomes-and-opportunities-change-california-toward-public-agenda. Accessed May 3, 2017.

      Health Pacific Business Group on Health. Case study: Maternity payment and care redesign pilot. Published October 2015. Available at: http://www.pbgh.org/storage/documents/TMC_Case_Study_Oct_2015.pdf. Accessed May 3, 2017.

      For this reason, some workshop attendees suggested that the SMFM cesarean delivery rate may also provide an improved gauge for maternal-fetal medicine subspecialists or regional referral centers and called for further investigation to validate which cesarean delivery rate would provide the most representative assessment of quality.

      Vaginal birth after cesarean delivery and trial of labor after cesarean delivery

      Scheduled repeat cesarean deliveries have become a major contributor to the overall cesarean delivery rate in the last decade.
      • Barber E.L.
      • Lundsberg L.S.
      • Belanger K.
      • et al.
      Indications contributing to the increasing cesarean delivery rate.
      Successful VBAC is associated with fewer immediate and long-term complications compared with a scheduled repeat cesarean delivery. Models that have examined cost and quality of life have shown dramatic savings of $164.2 million dollars and an improvement of 500 quality-adjusted life years per 100,000 women with VBAC success rates as low as 47.2%.
      • Gilbert S.A.
      • Grobman W.A.
      • Landon M.B.
      • et al.
      Lifetime cost-effectiveness of trial of labor after cesarean in the United States.
      Despite these benefits, concerns regarding possible unintended consequences of the use of the VBAC rate as a quality measure prevented its adoption. For example, many hospitals in the United States perform <1000 deliveries per year. These low-volume centers may not have the staff or experience to respond quickly in emergent scenarios associated with TOLAC, such as uterine rupture. In these low-volume hospitals without adequate resources, not performing TOLAC may be a better approach for optimal quality of care. An additional concern about the use of the VBAC rate as a quality measure is that it may not solely measure provider and facility performance but may also reflect patient preference and demographic factors that are associated with the choice of the procedure, such as maternal age, payer, and race, rather than actual quality.
      • Cheng E.R.
      • Declercq E.R.
      • Belanoff C.
      • et al.
      Racial and ethnic differences in the likelihood of vaginal birth after cesarean delivery.
      • Gregory K.D.
      • Fridman M.
      • Korst L.
      Trends and patterns of vaginal birth after cesarean availability in the United States.
      Workshop attendees also expressed concern that linking incentives to successful VBAC rates may influence provider behavior and result in missed signs of uterine rupture or slowed responses to adverse events. Furthermore, because of the rare occurrence of uterine rupture (0.7–0.9%),
      • Landon M.B.
      • Spong C.Y.
      • Thom E.
      • et al.
      Risk of uterine rupture with a trial of labor in women with multiple and single prior cesarean delivery.
      only the largest centers may have more than a few instances of uterine rupture annually. The small sample size at smaller institutions may not yield meaningful results with which to draw conclusions about adverse effects of TOLAC or quality and may instead reflect chance.
      To decrease cesarean delivery rates, some experts have called for more consistent and meaningful counseling regarding TOLAC. Hence, counseling for TOLAC has been suggested as a quality measure. However, multiple factors limit the use of TOLAC counseling as an adequate measure. Tracking the provision of counseling without evaluation of the content of the discussion does not assess the quality of counseling. The quality of counseling would be difficult to assess from administrative data because it depends on factors such as the information presented, discussion in the proper language for the patient, and whether counseling was appropriate for the patient’s health literacy level. Additionally, specific elements of counseling relevant to improved outcomes have not been established. Finally, assessment of chart documentation regarding TOLAC counseling has shown that patients who currently receive counseling had no increased knowledge of the risks and benefits, which is a finding that limits its use as an effective quality measure.
      • Friedman A.M.
      • Srinivas S.K.
      Is documentation of TOLAC counseling a good measure of quality of care?.

      Indications for cesarean delivery

      Workshop attendees also considered quality measures to assess the appropriateness of cesarean delivery by evaluating some of the most common indications. The SMFM–ACOG Obstetric Care Consensus document, “Safe Prevention of the Primary Cesarean Delivery,” includes recommendations for the appropriate length of time for diagnosis of prolonged latent phase, arrest of dilation, or failure to descend.
      American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine
      Obstetric Care Consensus no. 1: safe prevention of the primary cesarean delivery.
      Arrest of labor accounts for 35% of all primary cesarean deliveries and 41% of primary cesarean deliveries in nulliparous women. In primigravid women, 42.6% of cesarean deliveries for failure to progress were performed at <6 cm cervical dilation; 15% of cesarean deliveries for failure to descend were performed at <2 hours in the second stage of labor.
      • Boyle A.
      • Reddy U.M.
      • Landy H.J.
      • Huang C.C.
      • Driggers R.W.
      • Laughon S.K.
      Primary cesarean delivery in the United States.
      Twenty-three percent of all primary cesarean deliveries are related to the treatment of patients with nonreassuring fetal heart rate patterns
      • Barber E.L.
      • Lundsberg L.S.
      • Belanger K.
      • Pettker C.M.
      • Funai E.F.
      • Illuzzi J.L.
      Indications contributing to the increasing cesarean delivery rate.
      ; however, in one tertiary care center, ACOG recommendations regarding the use of scalp stimulation, acoustic stimulation, tocolytic agents, or amnioinfusion when indicated were implemented only in a limited manner.
      • Hendrix N.W.
      • Chauhan S.P.
      • Scardo J.A.
      • Ellings J.M.
      • Devoe L.D.
      Managing nonreassuring fetal heart rate patterns before cesarean delivery: compliance with ACOG recommendations.
      Although the ACOG–SMFM Obstetric Care Consensus document recommends tracking the rate of cesarean delivery for nonreassuring fetal heart rate, it does so only for purposes of providing individual physician feedback.
      American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine
      Obstetric Care Consensus no. 1: safe prevention of the primary cesarean delivery.
      The consensus of the workshop attendees was that the requirement for extensive chart review, lack of adjustment for case mix, and poor predictive capability and ambiguity of fetal heart tracing interpretation limits current widespread use of these measures for quality improvement outside of the previously established guidelines. Additionally, concerns were raised regarding unintended consequences of using rates of cesarean delivery because of nonreassuring fetal heart rate and possible unintended delay in delivery.

      Antibiotic prophylaxis

      Puerperal infection and sepsis is the fourth leading cause of maternal death in the United States. It is responsible for 11.6% of maternal deaths after a live birth and contributes significantly to increasing healthcare costs.
      • Chang J.
      • Elam-Evans L.D.
      • Berg C.J.
      • et al.
      Pregnancy-related mortality surveillance–United States, 1991-1999.
      Antibiotic prophylaxis for cesarean delivery reduces infection rates and its associated morbidity from endometritis, wound infection, and other complications by approximately 60% while also decreasing the length of hospital stay and overall treatment cost.
      • MacKeen A.D.
      • Packard R.E.
      • Ota E.
      • Berghella V.
      • Baxter J.K.
      Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing cesarean delivery.
      • Smaill F.M.
      • Grivell R.M.
      Antibiotic prophylaxis versus no prophylaxis for preventing infection after cesarean section.
      Compared with the historical approach of administering antibiotic prophylaxis after cord clamping, administration before skin incision has been shown to provide superior outcomes.
      • Chelmow D.
      • Hennesy M.
      • Evantash E.G.
      Prophylactic antibiotics for non-laboring patients with intact membranes undergoing cesarean delivery: an economic analysis.
      Workshop attendees therefore recommended the proportion of women who undergo cesarean deliveries who receive preincision antibiotic prophylaxis as a quality measure.

      Summary of recommended measures for cesarean delivery

      • 1.
        Cesarean delivery rate in NTSV patients
      • 2.
        Proportion of women with cesarean deliveries who receive antibiotics before skin incision

      Hospital-based emergencies

      Because of concerns regarding excessive rates of maternal mortality and morbidity and persistent healthcare disparities within the United States, the workshop evaluated opportunities for monitoring the quality of care that is provided during obstetric hospital-based emergency scenarios, which included VTE, obstetric hemorrhage, and sepsis.

      Venous thromboembolism

      VTE is one of the leading causes of pregnancy-related death in the United States.
      • Creanga A.A.
      • Berg C.J.
      • Syverson C.
      • Seed K.
      • Bruce F.C.
      • Callaghan W.M.
      Pregnancy-related mortality in the United States, 2006-2010.
      Beyond death, VTE also can trigger long-term sequelae that include recurrent VTE, postthrombotic syndrome, lung damage, and cardiovascular compromise. Postthrombotic syndrome alone has an estimated additional cost of $7000 per year per case in the United States.
      • MacDougall D.A.
      • Feliu A.L.
      • Boccuzzi S.J.
      • Lin J.
      Economic burden of deep-vein thrombosis, pulmonary embolism, and post-thrombotic syndrome.
      Because of the morbidity and mortality rates associated with VTE, primary prevention with pharmacologic or mechanical methods is recommended for women at increased risk.
      Multiple agencies, including the Agency for Healthcare Research Quality and the National Quality Forum, have evaluated the importance of VTE prophylaxis; however, the Joint Commission excluded the obstetric population from measurement. Within the obstetric population, there has been major disagreement in existing guidelines for prophylaxis. Based on various association guidelines, the percentage of pregnant women who should receive thromboprophylaxis range from 1% from ACOG, to 35% from the American College of Chest Physicians, and to 85% for the Royal College of Obstetricians and Gynaecologists.
      • Palmerola K.L.
      • D’Alton M.E.
      • Brock C.O.
      • Friedman A.M.
      A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines.
      Such wide variation in recommendations underscores the importance of the evaluation of outcomes and adverse effects of treatment before specific quality measures relating to VTE prophylaxis are made. Nonetheless, because of the increased risk of VTE in the obstetric population, workshop attendees recommended that some form of risk assessment should be performed for all antepartum, delivering, and postpartum patients within 24 hours of admission. Additionally, hospitals should consider monitoring for complications that are associated with pharmacologic prophylaxis, such as wound hematomas, heparin-induced thrombocytopenia, and hemorrhage.

      Obstetric hemorrhage

      Obstetric hemorrhage is one of the major causes of maternal morbidity and death in the United States.
      • Creanga A.A.
      • Berg C.J.
      • Syverson C.
      • Seed K.
      • Bruce F.C.
      • Callaghan W.M.
      Pregnancy-related mortality in the United States, 2006-2010.
      The incidence of obstetric hemorrhage varies greatly and is largely dependent on the criteria used for definition. Transfusion of ≥4 units of red blood cells has been used as a definition of severe obstetric hemorrhage and as a component in the definition of severe maternal morbidity.
      • Callaghan W.M.
      • Grobman W.A.
      • Kilpatrick S.J.
      • Main E.K.
      • D’Alton M.D.
      Facility-based identification of women with severe maternal morbidity: it’s time to start.
      Workshop attendees suggested that misinterpretation of this transfusion threshold as a quality measure or sentinel event has created confusion and concerns of improper attribution and disciplinary action instead of fulfilling its original intent as a trigger for institutional review and a means of fostering an environment of education and a culture of improvement.

      Severe maternal morbidity: clarification of the new joint commission sentinel event policy [statement]. Washington, DC: American College of Obstetricians and Gynecologists; Washington, DC: Association of Women’s Health, Obstetrics, and Neonatal Nurses; Oakbrook Terrace, IL: The Joint Commission; Washington, DC: Society for Maternal-Fetal Medicine. January 28, 2015. Available at: https://www.acog.org/About-ACOG/News-Room/Statements/2015/Severe-Maternal-Morbidity-Clarification-of-the-New-Joint-Commission-Sentinel-Event-Policy. Accessed May 25, 2016.

      Workshop attendees also noted that the use of this standard as a quality metric may make providers reluctant to transfuse beyond 3 units of packed red blood cells to thwart possible review. Workshop attendees therefore recommended that this measure exist only as means of internal performance improvement and education.
      As an alternative, the total number of packed red blood cells transfused per 1000 delivering women was recommended as a quality measure. This measure is easily identifiable from administrative data and has an expected baseline rate of 40–60 units per 1000 births at >20 weeks of gestation.

      Lyndon A, Lagrew D, Shields L, Main E, Cape V. Improving health care response to obstetric hemorrhage: a California Maternal Quality Care Collaborative toolkit to transform maternity care. Version 2.0. March 2015. Available at: https://www.cmqcc.org/resources-tool-kits/toolkits/ob-hemorrhage-toolkit. Accessed May 4, 2017.

      The final interpretation of this measure should include recognition that hospitals that serve as regional referral centers are expected to have increased transfusion rates in comparison with other sites and that regionalization is important in decreasing maternal morbidity and mortality rates.
      • Silver R.M.
      • Fox K.A.
      • Barton J.R.
      • et al.
      Center of excellence for placenta accreta.
      Ideally, placenta previa, placenta accreta, and other preexisting conditions that highly predispose patients for transfusion (such as trauma, sickle cell disease, amniotic fluid embolus, and preexisting bleeding disorders) should be considered exclusion criteria or factors for risk adjustment in quality measurement.
      It has been hypothesized that outcomes of obstetric hemorrhage improve with better preparedness. Despite this hypothesis, one study found that <50% of hospitals have massive transfusion protocols.
      • Bingham D.
      • Scheich B.
      • Byfield R.
      • Wilson B.
      • Bateman B.T.
      Postpartum hemorrhage preparedness elements vary among hospitals in New Jersey and Georgia.
      The use of a standardized protocol for obstetric hemorrhage has been associated with mixed results regarding blood loss and transfusion rates.
      • Shields L.E.
      • Smalarz K.
      • Reffigee L.
      • Mugg S.
      • Burdumy T.J.
      • Propst M.
      Comprehensive maternal hemorrhage protocols improve patient safety and reduce utilization of blood products.
      • Bailit J.L.
      • Grobman W.A.
      • McGee P.
      • et al.
      Does the presence of a condition-specific obstetric protocol lead to detectable improvements in pregnancy outcomes?.
      Because most evidence supports rapid treatment to prevent the sequelae of massive obstetric hemorrhage, the workshop attendees recommended that all hospital labor units develop the infrastructure to enable a prompt response to this emergent scenario as part of a coordinated treatment regimen. However, because of mixed results in outcomes, the proposed structural metric of the presence of an obstetric hemorrhage protocol as a quality measure was not recommended by workshop attendees.

      Maternal sepsis

      The incidence of maternal sepsis in pregnancy is increasing in the United States. Research shows a doubling in the risk of sepsis-associated hospitalizations, an increase in diagnosis of severe sepsis, and similar increases in related deaths over a 10-year period.
      • Bauer M.E.
      • Bateman B.T.
      • Bauer S.T.
      • Shanks A.M.
      • Mhyre J.M.
      Maternal sepsis mortality and morbidity during hospitalization for delivery: Temporal trends and independent associations for severe sepsis.
      Currently, maternal sepsis is the fourth leading cause of maternal death in the United States and is responsible for 5% of intensive care unit admissions during pregnancy.
      • Chang J.
      • Elam-Evans L.D.
      • Berg C.J.
      • et al.
      Pregnancy-related mortality surveillance–United States, 1991-1999.
      • Pollock W.
      • Rose L.
      • Dennis C.L.
      Pregnant and postpartum admissions to the intensive care unit: a systematic review.
      Complications from sepsis have led to the formulation of management algorithms that are designed to improve early identification and care in nonpregnant populations.
      • Dellinger R.P.
      • Levy M.M.
      • Rhodes A.
      • et al.
      Surviving sepsis campaign: International guidelines for management of severe sepsis and septic shock, 2012.
      Protocols for sepsis management can be initiated through nurse-driven screening programs to expedite delivery of care.
      • Gatewood M.O.
      • Wemple M.
      • Greco S.
      • Kritek P.A.
      • Durvasula R.
      A quality improvement project to improve early sepsis care in the emergency department.
      Unfortunately, the variables and criteria used for early identification within a nonpregnant population of patients who are at risk for sepsis and systemic inflammatory response syndrome overestimate the risk of morbidity and death for the pregnant patient.
      • Lappen J.R.
      • Keene M.
      • Lore M.
      • Grobman W.A.
      • Gossett D.R.
      Existing models fail to predict sepsis in an obstetric population with intrauterine infection.
      A retrospective study has shown that a modified scoring system had high sensitivity, specificity, and negative predictive value for intensive care unit admission and may hold promise for future use in pregnant individuals, but this scoring system has not been validated and explicitly cannot be recommended currently.
      • Albright C.M.
      • Ali T.N.
      • Lopes V.
      • Rouse D.J.
      • Anderson B.L.
      The sepsis in obstetrics score: a model to identify risk of morbidity from sepsis in pregnancy.
      Once an individual has been identified to be at risk for sepsis, prompt treatment should be initiated. The components of different sepsis treatment bundles vary, but most protocols include key components such as identification and risk stratification by lactate level, early antibiotic therapy, and rapid administration of fluid therapy within 3 hours of diagnosis.
      • Dellinger R.P.
      • Levy M.M.
      • Rhodes A.
      • et al.
      Surviving sepsis campaign: International guidelines for management of severe sepsis and septic shock, 2012.
      • Albright C.M.
      • Ali T.N.
      • Lopes V.
      • Rouse D.J.
      • Anderson B.L.
      The sepsis in obstetrics score: a model to identify risk of morbidity from sepsis in pregnancy.
      • Rhee C.1
      • Murphy M.V.
      • Li L.
      • Platt R.
      • Klompas M.
      Centers for Disease Control and Prevention Epicenters Program
      Lactate testing in suspected sepsis: trends and predictors of failure to measure levels.
      • Sterling S.A.
      • Miller W.R.
      • Pryor J.
      • Puskarich M.A.
      • Jones A.E.
      The impact of timing of antibiotics on outcomes in severe sepsis and septic shock: a systematic review and meta-analysis.
      • Kramer R.D.
      • Cooke C.R.
      • Liu V.
      • Miller 3rd, R.R.
      • Iwashyna T.J.
      Variation in the contents of sepsis bundles and quality measures: a systematic review.
      Because the overall number of obstetric cases with septic complications at individual hospitals remains small, the use of outcome-based measures may be limiting; hence, the recommendation for a general management bundle protocol rather than specific outcome measures. The presence of a sepsis management bundle has been associated with a 25% decrease in mortality rates, decreased time in intensive care, and decreased lengths of hospital stays in nonpregnant patients.
      • Levy M.M.
      • Rhodes A.
      • Phillips G.S.
      • et al.
      Surviving Sepsis Campaign: association between performance metrics and outcomes in a 7.5-year study.
      Because of the improved outcomes with early identification and treatment of sepsis, the workshop attendees suggested the use of a sepsis bundle for pregnancy as a structural quality measure for institutions. Initiation of management within 3 hours of the diagnosis of suspected sepsis with a protocol and in-person provider evaluation was also recommended as an important hospital-based measure for internal quality review.

      Summary of recommended measures for hospital-based emergencies

      • 1.
        Proportion of obstetric patients who undergo VTE risk assessment within 24 hours of hospital admission
      • 2.
        Measurement of the total number of units of RBCs transfused per 1000 delivery hospital encounters, excluding cases of cases of placental invasion, (accreta/increta/percreta), sickle cell disease, trauma, pre-existing bleeding disorder, and amniotic fluid embolus
      • 3.
        Presence of a protocol for sepsis identification, evaluation, and treatment that includes pregnant patients

      Outpatient care: ultrasonography and genetics

      Quality measures currently focus almost exclusively on inpatient treatment because of formalized electronic medical record systems that facilitate data collection. However, the clear majority of patient-provider interactions for women with high-risk pregnancies occur within an outpatient setting. Medical decisions and procedures performed in the outpatient setting have tremendous effects on the cost of care and eventual patient outcomes in both the inpatient and outpatient spheres. For these reasons, the workshop considered measures for the ambulatory care setting, specifically for obstetric ultrasonography and genetic testing.

      Ultrasonography

      In the United States, an average of 4.55 ultrasound examinations are performed for each low-risk pregnancy.
      • O’Keeffe D.F.
      • Abuhamad A.
      Obstetric ultrasound utilization in the United States: data from various health plans.
      The number of obstetric ultrasounds examinations performed per pregnancy varies widely by state, which raises concern that factors other than standardized medical indications may be driving usage.
      • Iriye B.
      • Hancock L.
      • Hancock J.
      • Ghamsary M.
      Large variation in umbilical artery Doppler ultrasound (UAD) between MFM providers: results of the AMFMM RVU study.
      Specialized ultrasound examinations, such as umbilical artery Doppler (current procedural terminology [CPT] 76820) and specialized detailed fetal anatomic sonography (CPT 76811), have high variation in usage,
      • Iriye B.
      • Hancock L.
      • Hancock J.
      • Ghamsary M.
      Large variation in umbilical artery Doppler ultrasound (UAD) between MFM providers: results of the AMFMM RVU study.
      • Iriye B.
      • Hancock L.
      • Ghamsary M.
      • Hancock J.
      Second and third trimester ultrasound utilization in MFM practices: results of the AMFMM RVU study.
      but further study is needed to recommend usage thresholds for these procedures. However, eventual quality measures in this area are needed with the goal of reducing unnecessary usage and cost.

      Accreditation

      A lack of regulatory control within the field of obstetric ultrasound imaging has resulted in variation in quality and a high incidence of misdiagnosis. In the last decade, 40% of practices initially seeking accreditation for obstetric ultrasonography fell below minimal standards and guidelines.
      • Abuhamad A.Z.
      • Benacerraf B.R.
      • Woletz P.
      • Burke B.L.
      The accreditation of ultrasound practices: impact on compliance with minimum performance guidelines.
      Calls for accreditation have received limited attention because the incidence of congenital abnormality is low (approximately 3–5%); hence, even practices that do not meet accreditation standards will not miss abnormalities in the overall majority of patients, which makes it more difficult to make the case for accreditation. Potential benefits of ultrasonography accreditation include identification of weaknesses in practice, acceptance of recognized ultrasonography guidelines, standardization of personnel qualification and education, performance within safety criteria, and requirement of proper reporting and documentation standards. In practices that participate in an accreditation process, use of standardized imaging protocols for specific types of ultrasound examinations have been shown to improve the quality and consistency of images over time.
      • Abuhamad A.Z.
      • Benacerraf B.R.
      • Woletz P.
      • Burke B.L.
      The accreditation of ultrasound practices: impact on compliance with minimum performance guidelines.
      Thus, accreditation by a central body is suggested as a measure of ultrasound quality for all centers that provide obstetric ultrasonography services. Furthermore, accreditation for obstetric ultrasonography and for specialized detailed fetal anatomic sonography (CPT 76811) is recommended for all maternal-fetal medicine practices.

      Fetal anomaly detection

      The workshop attendees also considered the development of quality indicators for detection of major abnormalities with obstetric ultrasonography. The recognition of major fetal cardiac anomalies has a moderate-to-high rate of misdiagnosis and wide variation in ultrasound detection among sites.
      • Boyd P.A.
      • Tonks A.M.
      • Rankin J.
      • et al.
      Monitoring the prenatal detection of structural fetal congenital anomalies in England and Wales: register-based study.
      • Acherman R.J.
      • Evans W.N.
      • Luna C.F.
      • et al.
      Prenatal detection of congenital heart disease in southern Nevada: the need for universal fetal cardiac evaluation.
      Congenital heart disease is the leading cause of death from anomalies in the first year of life and affects approximately 1% of all pregnancies.
      • Van der Linde D.
      • Konings E.E.
      • Slager M.A.
      • et al.
      Birth prevalence of congenital heart disease worldwide: a systematic review and meta-analysis.
      • Roger V.L.
      • Go A.S.
      • Lloyd-Jones D.M.
      • et al.
      Heart disease and stroke statistics–2012 update: a report from the American Heart Association.
      Misdiagnosis is also associated with increased neonatal death and longer length of hospital stay.
      • Verheijen P.M.
      • Lisowski L.A.
      • Stoutenbeek P.
      • et al.
      Prenatal diagnosis of congenital heart disease affects preoperative acidosis in the newborn patient.
      • Holland B.J.
      • Myers J.A.
      • Woods Jr., C.R.
      Prenatal diagnosis of critical congenital heart disease reduces risk of death from cardiovascular compromise prior to planned neonatal cardiac surgery: a meta-analysis.
      Current recommendations call for screening of neonates with pulse oximetry, which may assist in the detection of 29.5% of cases of nonsyndromic congenital heart disease that are currently diagnosed >3 days after birth.
      • Peterson C.
      • Ailes E.
      • Riehle-Colarusso T.
      • et al.
      Late detection of critical congenital heart disease among US infants: Estimation of the potential impact of proposed universal screening using pulse oximetry.
      Neonatal oxygen saturation monitoring provides a means of hospital-based postnatal detection of congenital heart disease and allows the identification of missed diagnosis in patients with a previous second- or third-trimester ultrasound examination as a quality measure. The percentage of congenital heart defects that are detected before delivery in infants with a prenatal ultrasound examination after the first trimester is recommended as a quality measure. Hospitals should also track individual physician performance as a provider-based quality improvement program.

      Fetal growth restriction

      Intrauterine fetal growth restriction (FGR) is associated with a 360% increase in the rate of stillbirth and a 130% increase in the rate of neonatal death. Compared with prenatal diagnosis of FGR, lack of detection is associated with a 3-fold increase in fetal acidemia or seizure, neurologic damage, or death.
      • Lindqvist P.G.
      • Molin J.
      Does antenatal identification of small-for-gestational age fetuses significantly improve their outcome?.
      Prenatal detection of FGR allows Doppler assessment of the umbilical artery, which is associated with reductions in labor induction, cesarean delivery, and perinatal death.
      • Berkley E.
      • Chauhan S.P.
      • Abuhamad A.
      Society for Maternal-Fetal Medicine Publications Committee
      Doppler assessment of the fetus with intrauterine growth restriction.
      However, workshop attendees opted not to recommend a quality metric directed at detection of FGR because of multiple concerns. These include the feasibility of operationalizing ultrasound detection of FGR because of difficulties in postdelivery data capture and follow-up evaluation, poor detection rates of growth restriction by ultrasound scanning, lack of a reasonable consensus threshold for FGR, and coordination of data extraction for inpatient and outpatient sites.

      Genetic counseling and testing

      Controversy exists regarding quality measures for genetic counseling services. The American College of Medical Genetics states that there are no clear baseline measures that are nationally accepted, user driven, and rigorously developed.
      • Zellerino B.C.
      • Milligan S.A.
      • Gray J.R.
      • Williams M.S.
      • Brooks R.
      Identification and prioritization of quality indicators in clinical genetics: an international survey.
      Additionally, measurement of quality in prenatal genetic testing is difficult for several reasons: lack of current consensus regarding ideal protocols, rapid changes in testing technologies, and significant variation in testing implementation because of patient preference. Emerging technologies are introduced rapidly, with inadequate studies from a population, health system, or cost-effectiveness perspective. Because fetuses with an anatomic abnormality noted on ultrasound imaging are at a higher risk of chromosomal abnormality, there is general agreement that invasive diagnostic testing is recommended. In women who undergo amniocentesis, other-than-common benign copy number variants are found in 8.1% of women with ultrasound-detected anomalies vs 3.6% of those without ultrasound-detected anomalies.
      • Donnelly J.C.
      • Platt L.D.
      • Rebarber A.
      • Zachary J.
      • Grobman W.A.
      • Wapner R.J.
      Association of copy number variants with specific ultrasonographically detected fetal anomalies.
      Additionally, a review of several large-scale studies reported clinically significant deletions or duplications in 6.5% of cases with abnormal ultrasound findings, despite these cases having normal karyotypes.
      • Callaway J.L.
      • Shaffer L.G.
      • Chitty L.S.
      • Rosenfeld J.A.
      • Crolla J.A.
      The clinical utility of microarray technologies applied to prenatal cytogenetics in the presence of a normal conventional karyotype: a review of the literature.
      Workshop members therefore suggested a quality measure for the performance of chromosomal microarray analysis in the setting of a fetal structural anomaly when invasive diagnostic testing is performed.

      Summary of recommended measures for outpatient care: ultrasonography and genetics

      • 1.
        Performance accreditation for practices that perform obstetric ultrasound per nationally recognized standards as assessed by a central organization with peer review; performance accreditation within maternal-fetal medicine practices that provide specialized detailed fetal anatomic sonography (CPT 76811) per nationally recognized standards as assessed by a central organization with peer review
      • 2.
        Rate of prenatal second- and third-trimester ultrasound detection of clinically significant congenital heart defects in centers with neonatal screening programs
      • 3.
        Proportion of women who receive microarray analysis at the time of diagnostic prenatal testing in the setting of fetal structural abnormality

      Information gaps and future research

      A major objective for the workshop was to coalesce expert efforts on quality improvement and thereby examine the available evidence, evaluate the current landscape within obstetrics, and develop measures that would drive high impact on outcomes, quality, and value. The workshop organizers understood that many of the proposed quality measures may be difficult to implement initially because of deficiencies in system infrastructure that supports data collection or measurement, lack of integration of electronic records between ambulatory and hospital services, and insufficient provider influence in the fields of quality measurement and informatics. Reviews of maternal deaths have found that a significant proportion of cases may have preventable causes.
      • Mitchell C.
      • Lawton E.
      • Morton C.
      • McCain C.
      • Holtby S.
      • Main E.
      California Pregnancy-Associated Mortality Review: mixed methods approach for improved case identification, cause of death analyses and translation of findings.
      The Alliance for Innovation on Maternal Health has set a goal to prevent 100,000 cases of severe maternal morbidity and 1000 cases of maternal death over a period of 4 years.

      American College of Obstetricians and Gynecologists. Leading health organizations launch state-based care programs through the Alliance for Innovation on Maternal Health. June 4, 2015. Available at: http://www.acog.org/About-ACOG/News-Room/News-Releases/2015/Leading-Health-Organizations-Launch-State-Based-Care-Programs-Through-theAIM-on-Maternal-Health. Accessed June 12, 2017.

      Dissemination of patient safety bundles and efforts for quality improvement via efforts led by the California Maternal Quality Care Collaborative have produced a concomitant statewide 60% reduction in maternal mortality rates since 2006.

      California Department of Public Health, Center for Family Health, Maternal, Child and Adolescent Health Division, April 2013. Maternal mortality rate. Available at: https://archive.cdph.ca.gov/data/statistics/Documents/2013MaternalMortalityRates-SlideSet%20for%20MCAH%20Website.pdf. Accessed June 12, 2017.

      The efforts of state-based perinatal quality collaboratives, which were formed as networks of providers and health professionals, can assist in the improvement of quality care for women and their children. The recent launch of the National Network of Perinatal Quality Collaboratives holds promise as a means for sharing best practices, lessons on implementation, and the formation of an initial infrastructure for networking and support.
      The identification and construction of quality measures should move forward under the impetus to provide improvement over punishment. Production of quality measures, which includes those provided by this workshop, must be examined rigorously, and possible balancing measures must be kept in mind to avoid unintended consequences of inappropriate rewards or penalties. Measures should present low burden and affordability to providers and hospitals or outpatient clinics. For actual quality to be measured, more effective measures eventually will require appropriate risk adjustment. The development of measures should connect peers and involved parties as teams to avoid the burden and possible consequences of unnecessary or flawed measure development.
      Currently, our inability to obtain sufficient data because of inadequate data systems is a significant limitation to quality measurement efforts. The workshop organizers and attendees understood that many useful quality measures cannot be implemented because of a lack of current system infrastructure and standardized documentation elements. EHRs are omnipresent but frequently lack enhancements that promote meaningful functionality, efficiency, system interoperability, and readily available data abstraction capability. Furthermore, decisions regarding the purchase and implementation of EHR systems frequently are made on the basis of cost, presumed clinical need, and institutional revenue generation, sometimes at the expense of data reporting and analytic capability. Clinicians are entering information geared towards documentation of clinical care rather than data generation and abstraction needs. The often unstructured information entered by providers provides a comprehensible story for patient care but is inadequate for reporting and data functions. Conversely, structured data entered for the purposes of reporting are often inadequate for use in logical documentation of patient care. In addition, there is a lack of data standardization that makes information dissimilar across individual sites of care.
      Current efforts at a standardized medical record system have started with the Medical Quality Improvement Program that is now being implemented at the University of Rochester and a community hospital system. This system is based on similar efforts in anesthesia that have been overseen by the Anesthesia Quality Institute. In the system administered by the Anesthesia Quality Institute, data entry is performed by providers for approximately 20% of all anesthesia cases in the United States. This database supplies provider benchmarks, continuous improvement monitoring, and performance analysis. The Medical Quality Improvement Program seeks to provide a national clinical data registry focused on maternal and neonatal outcomes created by doctors and nurses. Although efforts like the Medical Quality Improvement Program are to be applauded, they are likely to engender resistance for several reasons. Most deliveries take place in hospitals that perform <1000 deliveries per year. In addition, these hospitals often use lower quality EHRs, have fewer support personnel, and lack financial resources to assist with implementation, updates, and support.
      Clearly, multiple efforts are needed to improve the measurement of obstetric quality. A significant component in this effort would be the formation of a national birth certificate system. The current system of individual state certificates introduces variability in data elements and collection, therefore impeding meaningful progress. A national birth certificate would simplify data entry requirements from EHR vendors and would enable the standardized upload of data entry from both inpatient and outpatient systems. A national birth certificate with standardization of data entry could allow major improvement through linking medication exposures, specific interventions, and obstetric history directly to the care of the woman and neonate. Additionally, it would allow real-time evaluation of these interventions, thereby facilitating and accelerating data collection and evaluation that could immediately improve care, decrease maternal and neonatal morbidity, and save lives.
      Current measures to assess patient satisfaction within healthcare systems are generic, flawed, and do not address the specific issues associated with maternity care that account for >4 million births and > 20% of all hospital discharges. Consumer Assessment of Healthcare Providers and Systems surveys must address specific pain care issues that are unique to childbirth and provide specificity for pain control in settings of vaginal birth vs cesarean delivery. Current Consumer Assessment of Healthcare Providers and Systems questions focus on care in the last 12 months instead of the episode of maternity care. Survey questions should acknowledge the possible use of advanced practitioners or alternative birthing centers instead of focusing solely on physicians and hospitals. In addition, the availability of the questionnaires in English only prevents a large proportion of the maternity population from being adequately sampled. Hence, a specific Consumer Assessment of Healthcare Providers and Systems survey centered on maternity care for facilities, providers, and health plans is recommended.
      To facilitate our attempts at quality improvement, we will need multifaceted efforts. EHR vendors and the major societies in obstetrics will need to work together to improve record usability and efficiency, while incorporating the needs for workflow improvement. A balance will need to be struck between structured data and textual documentation with endorsement of set standards. Further research in quality improvement and informatics is required, and these topics should be part of the standard medical training curriculum. The current gaps stress the need for clinical physician informaticians who can assist with EHR design and data quality improvement to help with quality improvement efforts.

      Summary of recommended measures for information gaps and future research

      • 1.
        Systematic efforts to develop more physician informaticians in our field who are experts on EHR design, data quality/governance, and quality and performance improvement
      • 2.
        Development of a national birth certificate system with mandatory data entry from inpatient and outpatient EHR systems
      • 3.
        Partnership with EHR vendors to meet usability and efficiency needs while incorporating workflows that collect accurate and usable clinical data
      • 4.
        Strong support of clinical standardization and registry development in obstetrics
      • 5.
        Research into understanding the proper balance of discrete structured data to textual documentation and endorsement and training to those standards
      • 6.
        Endorsement of regulatory standards for data quality and governance
      • 7.
        Initiation of efforts to make quality improvement and informatics a part of the standard training curriculum for students, residents, and fellows (along with training for current faculty)
      • 8.
        Encouragement of research and publications in quality improvement and informatics
      • 9.
        Formation and use of specific maternity-care–based Consumer Assessment of Healthcare Providers and Systems surveys for facilities, providers, and health plans

      Comment

      This workshop brought together our multiple organizations, clinicians, and researchers to suggest and make progress towards the realization of meaningful quality measures for high-risk obstetric conditions. In conjunction with applicable providers, we must take a more consistent role in measure development, research, analysis, validation, and refinement. Our hope is that the measures suggested within this document serve a basis for quality assessment and are considered a framework for future validation and inclusion in obstetric quality programs. Research on these and other quality measures is needed to identify ideal quality goals, prevent unintended consequences, and improve risk-specific measure adjustment for measure refinement. Partnerships between providers, patients, EHR vendors, payers, hospital systems, and governmental agencies are needed to provide cost-efficient solutions with the connectivity, interoperability, and mandated information to improve care consistently and provide transparency and accountability. To achieve these goals, the formation of an ongoing task force or committee with commitment to quality measure refinement, validation, research, and reform that involves obstetric providers and major organizations is recommended.

      Acknowledgments

      The authors, SMFM, and ACOG thank the workshop participants (facilitators, topic experts, and contributing ACOG and NICHD representatives) for their invaluable contributions to this project: Alfred Z. Abuhamad, Ann Borders, Jennifer Bailit, Michael A. Belfort, Vincenzo Berghella, Debra Bingham, Sean C. Blackwell, Alison G. Cahill, Aaron B. Caughey, Suneet P. Chuhan, Judith Chung, Steven L. Clark, Lorraine Dugoff, Michael Foley, Alexander M. Friedman, Edmund Funai, Henry L. Galan, Cynthia Gyamfi-Bannerman, Stephen Hasley, David C. Lagrew, Michael C. Lu, Elliott K. Main, James N. Martin Jr, Brian M. Mercer, Michael Nageotte, Mary E. Norton, Daniel O’Keeffe, Luis D. Pacheco, Christian M. Pettker, Uma M. Reddy, Anthony Sciscione, Baha M. Sibai, Sindhu K. Srinivas, Alan T. Tita, Reva Winkler, and Christopher M. Zahn.

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      Linked Article

      • October 2017 (vol. 217, no. 4, page B22)
        American Journal of Obstetrics & GynecologyVol. 218Issue 5
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          Iriye BK, Gregory KD, Saade GR, et al. Quality measures in high-risk pregnancies: Executive Summary of a Cooperative Workshop of the Society for Maternal–Fetal Medicine, National Institute of Child Health and Human Development, and the American College of Obstetricians and Gynecologists. Am J Obstet Gynecol 2017;217:B2-25.
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