Tailoring Systematic Reviews to Meet Critical Priorities in Maternal Health Presented by Meera Viswanathan, Ph.D. RTI International Presented at The 135th Annual Meeting of the American Public Health Association Washington, DC, November 3–7, 2007 3040 Cornwallis Road ■ P.O. Box 12194 ■ Research Triangle Park, NC 27709 Phone 919-316-3930 Fax 919-541-7384 e-mail viswanathan@rti.org RTI International is a trade name of Research Triangle Institute

Current Practice for Selecting Topics for Systematic Reviews AHRQ topics often generated by professional societies; Cochrane reviews by individual reviewers Topic nominations can be motivated by Search for evidence to review ongoing changes in clinical practice Publication of unexpected trial or observational data Incremental approach Requires clear specification of Patient, Intervention, Comparators, Outcomes, Timing, and Setting (PICOTS)

Rethinking Systematic Review Resources on Maternal Health: why should we care? Systematic reviews can have substantial impact on practice physician guidelines quality of care initiatives Time- and resource-intensive efforts AHRQ reviews are funded by public dollars

Reframing Maternal Health Priorities for Systematic Reviews TABLE 1—Maternal Morbidity During Labor and Delivery: National Hospital Discharge Survey, 1993–1997 Women Giving 95% Confidence Estimated Type of Morbidity Birth, % Interval Annual No.a Obstetric complications Hemorrhage Antepartum 1.6 1.47, 1.73 61 208 Postpartum 2.0 1.79, 2.18 75 729 Preeclampsia and eclampsia All 3.0 2.79, 3.23 115 001 Severe preeclampsia 0.6 0.56, 0.70 24 084 Eclampsia 0.1 0.06, 0.13 3 660 Transient hypertension of pregnancy 2.1 1.89, 2.27 79 205 Obstetric trauma 3rd/4th-degree laceration or hematoma 5.0 4.61, 5.28 188 803 4th-degree laceration 1.7 1.50, 1.81 63 112 Other obstetric trauma 3.8 3.49, 4.09 146 133 Ruptured uterus 0.1 0.07, 0.11 3 365 Infection Genitourinary infection 2.7 2.42, 2.96 102 744 Amnionitis 1.9 1.74, 2.10 73 252 Other infection 1.5 1.32, 1.72 57 922 Fever 1.1 0.95, 1.31 43 127 Major puerperal infection 0.8 0.69, 0.88 30 118 Postpartum fever of unknown origin 0.3 0.29, 0.40 13 280 Sepsis < 0.1 0.01, 0.04 931 Other Other puerperal complication 0.9 0.8, 1.1 35 884 Other major obstetric complication 0.4 0.33, 0.45 14 807 Anesthesia complication 0.4 0.28, 0.42 13 422 Wound complication 0.3 0.22, 0.29 9 701 Deep venous thrombosis < 0.1 0.02, 0.06 1 500 Gestational liver disease < 0.1 0.03, 0.06 1 797 Late vomiting < 0.1 0.01, 0.04 977 Pulmonary or amniotic embolism < 0.1 0.01, 0.03 607 Cerebrovascular accident < 0.1 0.01, 0.01 340 Gestational diabetes (abnormal GTT) 2.8 2.58, 2.94 105 377 Preexisting medical conditions Chronic hypertension 1.5 1.37, 1.67 57 914 Cardiac disease 0.9 0.78, 0.94 32 884 Asthma 0.7 0.59, 0.78 25 977 Diabetes (excluding abnormal GTT) 0.6 0.54, 0.73 24 126 Renal disease 0.1 0.06, 0.11 3 282 Obstetric complications, total 28.6 27.7, 29.5 1 091 188 Preexisting medical conditions, total 4.1 3.8, 4.3 155 335 Any morbidity, excluding cesarean 30.7 29.81, 31.71 1 173 846 Cesarean delivery 21.8 20.87, 22.77 842 997 Total morbidity 43.0 42.54, 43.68 1 663 873 Note. The total sample of deliveries was 154 001. Individual women were counted only once, no matter how many complications they had. Therefore, summary prevalence estimates are not the sum of the individual types of morbidity listed but represent the percentage of women with at least 1 reported morbidity within a given category. GTT = glucose tolerance test. aBased on total US births (n = 19 081 038). TABLE 1—Maternal Morbidity During Labor and Delivery: National Hospital Discharge Survey, 1993–1997 Women Giving 95% Confidence Estimated Type of Morbidity Birth, % Interval Annual No.a Obstetric complications Hemorrhage Antepartum 1.6 1.47, 1.73 61 208 Postpartum 2.0 1.79, 2.18 75 729 Preeclampsia and eclampsia All 3.0 2.79, 3.23 115 001 Severe preeclampsia 0.6 0.56, 0.70 24 084 Eclampsia 0.1 0.06, 0.13 3 660 Transient hypertension of pregnancy 2.1 1.89, 2.27 79 205 Obstetric trauma 3rd/4th-degree laceration or hematoma 5.0 4.61, 5.28 188 803 4th-degree laceration 1.7 1.50, 1.81 63 112 Other obstetric trauma 3.8 3.49, 4.09 146 133 Ruptured uterus 0.1 0.07, 0.11 3 365 Infection Genitourinary infection 2.7 2.42, 2.96 102 744 Amnionitis 1.9 1.74, 2.10 73 252 Other infection 1.5 1.32, 1.72 57 922 Fever 1.1 0.95, 1.31 43 127 Major puerperal infection 0.8 0.69, 0.88 30 118 Postpartum fever of unknown origin 0.3 0.29, 0.40 13 280 Sepsis < 0.1 0.01, 0.04 931 Other Other puerperal complication 0.9 0.8, 1.1 35 884 Other major obstetric complication 0.4 0.33, 0.45 14 807 Anesthesia complication 0.4 0.28, 0.42 13 422 Wound complication 0.3 0.22, 0.29 9 701 Deep venous thrombosis < 0.1 0.02, 0.06 1 500 Gestational liver disease < 0.1 0.03, 0.06 1 797 Late vomiting < 0.1 0.01, 0.04 977 Pulmonary or amniotic embolism < 0.1 0.01, 0.03 607 Cerebrovascular accident < 0.1 0.01, 0.01 340 Gestational diabetes (abnormal GTT) 2.8 2.58, 2.94 105 377 Preexisting medical conditions Chronic hypertension 1.5 1.37, 1.67 57 914 Cardiac disease 0.9 0.78, 0.94 32 884 Asthma 0.7 0.59, 0.78 25 977 Diabetes (excluding abnormal GTT) 0.6 0.54, 0.73 24 126 Renal disease 0.1 0.06, 0.11 3 282 Obstetric complications, total 28.6 27.7, 29.5 1 091 188 Preexisting medical conditions, total 4.1 3.8, 4.3 155 335 Any morbidity, excluding cesarean 30.7 29.81, 31.71 1 173 846 Cesarean delivery 21.8 20.87, 22.77 842 997 Total morbidity 43.0 42.54, 43.68 1 663 873 Note. The total sample of deliveries was 154 001. Individual women were counted only once, no matter how many complications they had. Therefore, summary prevalence estimates are not the sum of the individual types of morbidity listed but represent the percentage of women with at least 1 reported morbidity within a given category. GTT = glucose tolerance test. aBased on total US births (n = 19 081 038). Reframing Maternal Health Priorities for Systematic Reviews Morbidity and mortality Cross-cutting issues Cost Other?

Maternal Mortality Issues Pregnancy-related mortality ratio in the U.S. not declined since 1982 Pregnancy-related mortality ratio in the U.S.: 11.5 Range for industrialized countries 8 – 13 Pregnancy-related mortality likely underestimated when derived from death certificate data Racial and ethnic disparities persist Black women have a 4-fold higher risk

Prevalence of maternal morbidity during childbirth (1993-1997) Third- and fourth-degree lacerations: 5.0% Other obstetric traumas including cervical lacerations and pelvic trauma: 3.8% Preeclampsia and eclampsia: 3.0% Gestational diabetes: 2.8% Genitourinary infections: 2.7% Postpartum hemorrhages: 2.0% Amnionitis: 2.0% Cesarean delivery: 21.8% Danel, I.; Berg, C.; Johnson, C. H., and Atrash, H. Magnitude of maternal morbidity during labor and delivery: United States, 1993-1997. Am J Public Health. 2003 Apr; 93( 4), p. 632.

Prevention of Adverse Events versus Reduction of Harms Events on morbidity-to-mortality continuum could be due to Pre-existing conditions Childbirth Harms associated with childbirth-related interventions Potentially preventable adverse events associated with childbirth include fetal malpresentation, perineal trauma, infection associated with premature rupture of membranes, etc. Harms associated with childbirth-related interventions include hyperstimulation from labor induction, hypotension from anesthesia, anal sphincter injury from episiotomy, etc.

Systematic Review Priorities in the Intrapartum Period Review strategies to reduce morbidity and mortality Focus on prevention of childbirth-related adverse events as well as reduction of harms from childbirth-related intervention Identify interventions to address persistent disparities in health outcomes

Methods: inclusion criteria Medline search of MeSH term “Delivery, obstetric” only items with abstracts English published in the last 5 years (Jan 2002 to Jan 2007) meta-analysis or systematic review female humans 488 abstracts Inclusion criteria Identifiable as systematic review Relevant to interventions in the intrapartum period

Methods: exclusions 108 potential includes 99 available as full-text articles 35 excluded on full-text review No quality appraisal: 12 Duplicates: 4 Exclusions for content: 19 interventions without comparators, outcomes independent of interventions, not associated with interventions in the intrapartum period

Systematic Review Content

Systematic Reviews on Childbirth-related Interventions

Systematic Reviews on Prevention of Adverse Events

Systematic Reviews on Diagnosis/Prognosis

Analysis of Disparities None address racial disparities in health outcomes Sub-analyses generally based on anticipated risk factors maternal age obesity

Systematic Review Methods Adverse events and harms are rare and may not be reported in sufficient numbers in small trials Half the included reviews concluded that their included studies were underpowered to address adverse events 69 percent of systematic reviews chose to limit their inclusion criteria to randomized trials

Considerations for the Future Include large observational studies to address rare adverse events and harms Address issues of quality in observational studies Explicitly seek evidence on interventions addressing racial and ethnic disparities in maternal morbidity and mortality