Objective
We sought to evaluate the frequency of, and factors associated with, the use of 3 evidence-based interventions: antenatal corticosteroids for fetal lung maturity, progesterone for prevention of recurrent preterm birth, and magnesium sulfate for fetal neuroprotection.
Study Design
A self-administered survey was conducted from January through May 2011 among obstetricians from 21 hospitals that included 30 questions regarding their knowledge, attitudes, and practice of the 3 evidence-based interventions and the 14-item short version of the Team Climate for Innovation survey. Frequency of use of each intervention was ascertained from an obstetrical cohort of women between January 2010 and February 2011.
Results
A total of 329 obstetricians (74% response rate) who managed 16,946 deliveries within the obstetrical cohort participated in the survey. More than 90% of obstetricians reported that they incorporated each intervention into routine practice. Actual frequency of administration in women eligible for the treatments was 93% for corticosteroids, 39% for progesterone, and 71% for magnesium sulfate. Provider satisfaction with quality of treatment evidence was 97% for corticosteroids, 82% for progesterone, and 57% for magnesium sulfate. Obstetricians perceived that barriers to treatment were most frequent for progesterone (76%), 30% for magnesium sulfate, and 17% for corticosteroids. Progesterone use was more frequent among patients whose provider reported the quality of the evidence was above average to excellent compared with poor to average (42% vs 25%, respectively; P < .001), and they were satisfied with their knowledge of the intervention (41% vs 28%; P = .02), and was less common among patients whose provider reported barriers to hospital or pharmacy drug delivery (31% vs 42%; P = .01). Corticosteroid administration was more common among patients who delivered at hospitals with 24 hours a day–7 days a week maternal-fetal medicine specialist coverage (93% vs 84%; P = .046),
Conclusion
Obstetricians in Maternal-Fetal Medicine Units Network hospitals frequently use these evidence-based interventions; however, progesterone use was found to be related to their assessment of evidence quality. Neither progesterone nor the other interventions were associated with overall climate of innovation within a hospital as measured by the Team Climate for Innovation. National Institutes of Health Consensus Conference Statements may also have an impact on use; there is such a statement for antenatal corticosteroids but not for progesterone for preterm prevention or magnesium sulfate for fetal neuroprotection.
The translation of research into clinical practice is influenced by numerous factors that may facilitate or hinder its translation, including the quality of the evidence, methods of disseminating results, presence or absence of consensus statements, attitudes and behaviors of physicians, hospital climate, and costs. In an effort to improve on the translation of research into practice, the National Institutes of Health (NIH) created the Roadmap for Medical Research in 2002.
Traditional methods of disseminating information on new treatments in the obstetrical community include continuing education activities, lectures, and grand rounds. These methods have been described as ineffective at changing complex practices. More recently, it has been recognized that an organizational change, as well as individual provider knowledge, is needed to facilitate adoption of new treatments. The climate (hospital and team), the user (provider), and the intervention itself interact and affect the implementation process.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network, along with many other perinatal researchers, has provided evidence for therapies that aim to benefit pregnant women and their children. However, little is known about why some of the obstetrical evidence that has been produced is adopted and why some is not. We set out to evaluate factors associated with the adoption trends of 3 evidence-based obstetrical interventions at different stages of implementation within the MFMU Network hospitals. The interventions studied were antenatal corticosteroids injections for fetal lung maturity, progesterone injections for the prevention of recurrent preterm birth, and intravenous magnesium sulfate for cerebral palsy prevention.
Antenatal Corticosteroids
Treatment of women at risk of preterm delivery before 34 weeks with antenatal corticosteroids is a widely accepted practice. Liggins and Howie first introduced this therapy in 1972. It was further supported by a metaanalysis in 1990 and an NIH Consensus Conference Statement in 1994. This was followed by a second NIH Consensus Conference Statement in 2000 to make recommendations on repeat courses of antenatal steroids.
Notably, there have been 3 metaanalyses further disseminating information on this topic. Namely, the Cochrane Collaboration in 2006, which was an extensive document to assess the effects of maternal antenatal corticosteroids on the mother, the fetus, the neonate, and the child; the Cochrane Collaboration in 2007, which evaluated the effectiveness and safety of repeat courses of corticosteorids; and the Cochrane Collaboration in 2008, which elaborated on the effects of various types and dosing regimens of corticosteroids.
Progesterone
Treating women who experienced a prior spontaneous delivery with progesterone in the current pregnancy has been studied over the past 3 decades. In 1975 Johnson et al published one of the first randomized clinical trials on the topic and concluded that this therapy may be beneficial but that further studies and long-term follow-up are needed. In 2003, 2 major randomized clinical trials revealed further support for this treatment. Da Fonseca et al published a report on the efficacy of vaginal progesterone in preventing recurrent preterm delivery, and Meis et al published the MFMU Network trial of 17α-hydroxyprogesterone caproate injections, which showed a reduction in the risk of recurrent preterm deliveries.
Since then there have been several randomized clinical trials using various forms of progesterone delivery: vaginal gel, oral micronized gelatin capsules, vaginal micronized capsules, vaginal suppositories, and intramuscular agents, all of which showed some benefit to this therapy. Several systematic review articles and metaanalyses similarly concluded a reduced risk of recurrent preterm delivery with the use of progestogens. The American College Of Obstetricians and Gynecologists Committee Opinion in 2008 and subsequently the Practice Bulletin, Prediction and prevention of preterm birth, further supported this practice based on the evidence.
Progesterone
Treating women who experienced a prior spontaneous delivery with progesterone in the current pregnancy has been studied over the past 3 decades. In 1975 Johnson et al published one of the first randomized clinical trials on the topic and concluded that this therapy may be beneficial but that further studies and long-term follow-up are needed. In 2003, 2 major randomized clinical trials revealed further support for this treatment. Da Fonseca et al published a report on the efficacy of vaginal progesterone in preventing recurrent preterm delivery, and Meis et al published the MFMU Network trial of 17α-hydroxyprogesterone caproate injections, which showed a reduction in the risk of recurrent preterm deliveries.
Since then there have been several randomized clinical trials using various forms of progesterone delivery: vaginal gel, oral micronized gelatin capsules, vaginal micronized capsules, vaginal suppositories, and intramuscular agents, all of which showed some benefit to this therapy. Several systematic review articles and metaanalyses similarly concluded a reduced risk of recurrent preterm delivery with the use of progestogens. The American College Of Obstetricians and Gynecologists Committee Opinion in 2008 and subsequently the Practice Bulletin, Prediction and prevention of preterm birth, further supported this practice based on the evidence.
Magnesium Sulfate
In 1992, Kuban et al published an epidemiological study to assess the perinatal risk factors associated with intraventricular hemorrhage in the newborn and found that mothers who received magnesium sulfate had babies with a lower incidence of intraventricular hemorrhage. This was followed by a case-control study by Nelson and Grether in 1995 showing that magnesium sulfate treatment is associated with a reduced risk of cerebral palsy among very low-birthweight infants.
Several observation studies were published since then, some showing benefit and some negating the benefit. These were followed by several randomized clinical trials and subsequent systematic reviews with a metaanalysis of eligible trials, which concluded that this therapy has a neuroprotective effect on the fetus. Despite additional support for this therapy from several clinical practice guideline documents and committee opinions, the optimal regimen for balancing effectiveness and adverse effects to the mother and fetus remained unclear.
Materials and Methods
A survey was conducted among obstetricians from January 2011 through May 2011 at 21 hospitals in the MFMU Network, and the survey data were linked to data abstracted from medical charts of deliveries occurring from January 2010 until February 2011, at the same 21 hospitals, of patients delivered by the survey responders. The online, self-administered survey included questions regarding the responder’s knowledge of 3 obstetrical interventions, their satisfaction with the evidence, and the barriers to the use of these interventions.
The survey also included questions regarding the team climate at each hospital, ascertained using the validated 14 item short version of the Team Climate for Innovation (TCI) survey, which is based on West and Farr’s 4 factor theory of group innovation with team activities. The TCI survey has been used to predict success or failure of quality improvement strategies in several countries and industries. Ouwens et al assessed the TCI survey in the health care industry among hospital teams and found it to be a valid, reliable, and discriminating self-report measure of team climate in hospital teams.
The 4 groups of questions in the TCI address vision (team members are committed to clear and realistic objectives), participative safety (team members interact in a participative and interpersonally nonthreatening climate), task orientation (team members are committed to high standards and are prepared for basic questions and apprised of weaknesses), and support for innovation (there is support for innovation attempts and cooperation to develop and apply new ideas).
To be eligible for the survey, providers had to be a general obstetrician or maternal-fetal medicine specialist and actively involved in patient deliveries at 1 of the 21 participating hospitals. Eligibility was ascertained from an obstetrical cohort (described below) of delivery data. The obstetrical cohort data were accessed to identify obstetrical providers who had a minimum of 5 deliveries in the cohort over a 6 month period (January 2010 through June 2010). From the initial list of 760 potentially eligible obstetricians, 467 providers were randomly chosen by the data coordinating center that assigned each a masked identification. These masked identifications along with a unique user name and password were incorporated in a cover letter that explained the purpose and anonymous nature of the survey and that completion of the survey would be considered consent for study participation. The institutional review board at each participating institution approved the study.
The proportion of patients eligible for the 3 treatments of interest and the proportion of eligible patients who actually received the treatment were ascertained for each obstetrician using the Assessment of Perinatal Excellence (APEX) study conducted by the Eunice Kennedy Shriver NICHD MFMU network. The APEX study was designed to develop quality measures for intrapartum obstetrical care and was approved by the institutional review board at each participating institution under a waiver of informed consent. Full details of the study design have been previously published.
For this analysis, only patients who were delivered by one of the attending providers participating in the survey were included. For each treatment being studied, we identified all patients eligible to receive the treatment. We defined women eligible for receiving antenatal corticosteroids as those who delivered on the labor and delivery floor at less than 34 weeks’ gestation and delivered 4 or more hours after admission. Women eligible for progesterone were those who delivered on the labor and delivery floor with a singleton pregnancy, had a history of a preterm birth in a prior pregnancy, had at least 2 prenatal care visits, and had a pregnancy that was dated by a first- or second-trimester ultrasound or had assisted reproductive technology (as a proxy of receiving prenatal care before the third trimester). Among the women meeting these initial criteria for eligibility of progesterone, if progesterone was received, the previous pregnancy was assumed to have been spontaneous (the population eligible for progesterone); otherwise, the prenatal records were reabstracted to determine whether the previous preterm birth was spontaneous and to determine whether the patient received progesterone. Women eligible for magnesium sulfate were those without gestational hypertension or preeclampsia (because they may receive magnesium sulfate for seizure prophylaxis), who delivered on the labor and delivery floor before 32 weeks of gestation, and who delivered 4 or more hours after admission. Within each subcohort of women eligible for the treatment under study, the primary outcome was whether the patient received the treatment.
Data were analyzed at the patient level. The χ 2 test or the Fisher exact test, when appropriate, was used to assess univariate differences. Multivariable analysis was used to determine which patient, attending physician, and hospital factors were independently associated with the use of each of the interventions. Model selection and internal validation was performed using k-fold cross-validation in which the cohort was randomly divided into 10 equal parts and logistic regression models, using backward selection, were generated using every possible combination of 9 of the 10 sets. Variables with P < .05 were retained, and each of the 10 subsamples was used for validation. All tests were 2 tailed and P < .05 was used to denote statistical significance. No imputation for missing data was performed and no adjustments were made for multiple comparisons. Analyses were performed using SAS software (SAS Institute Inc, Cary, NC).
Results
The majority of hospitals that participated in this study were teaching hospitals (19 of 21) and located in an urban setting (19 urban, 2 suburban, and 0 rural of 21). Most of the hospitals had 24 hours a day, 7 days a week availability of maternal-fetal medicine specialists (19 of 21), in-house obstetric attending physician (laborist or otherwise) (18 of 21), neonatology services (17 of 21), and obstetric anesthesia services (18 of 21).
The median number of deliveries captured in APEX at the study hospitals was 4074. Of the 467 randomly selected providers, 443 remained eligible (ie, still delivering at the hospital at the time the survey was implemented), and 329 of the 443 (74%) completed the survey. Almost all invited maternal-fetal medicine specialists participated in the survey (92%), and the majority of obstetricians participated (70%). The 329 participating obstetricians performed 16,946 of the deliveries in the APEX observational cohort.
The patient characteristics of those cared for by physicians participating in the survey, compared with those whose physicians remained eligible but did not respond or refused participation in the survey, differed ( Table 1 ). APEX patients included in this study were more ethnically diverse, more high risk, more likely to have been delivered by a maternal-fetal medicine specialist, more likely delivered at a teaching hospital, and more likely to have used magnesium sulfate if eligible for that treatment, compared with APEX patients delivered by an obstetrician who did not respond or refused participation in the survey.
| Characteristics of the study population | Delivered by an obstetrician who participated in the survey (n = 16,946), n (%) | Delivered by an obstetrician who refused participation in the survey (n = 4525), n (%) | P value |
|---|---|---|---|
| Age, y | < .001 | ||
| <20 | 1355 (8.0) | 267 (5.9) | |
| 20–34.9 | 12,728 (75.1) | 3617 (79.9) | |
| ≥35 | 2863 (16.9) | 641 (14.2) | |
| Race/ethnicity a | < .001 | ||
| Non-Hispanic white | 6814 (40.2) | 3025 (66.9) | |
| Non-Hispanic black | 3893 (23.0) | 539 (11.9) | |
| Non-Hispanic Asian | 1067 (6.3) | 195 (4.3) | |
| Hispanic | 4066 (24.0) | 625 (13.8) | |
| Other or not documented | 1106 (6.5) | 141 (3.1) | |
| Insurance status | < .001 | ||
| Uninsured or self-pay | 1983 (11.8) | 315 (7.0) | |
| Government assisted | 7383 (43.7) | 1155 (25.6) | |
| Private | 7513 (44.5) | 3043 (67.4) | |
| Prenatal care | 15,642 (97.7) | 4273 (98.6) | < .001 |
| Multiple gestation | 476 (2.8) | 98 (2.2) | .02 |
| Premature rupture of the membranes | 917 (5.5) | 171 (3.8) | < .001 |
| Eligible for ACS b | 500 (3.0) | 96 (2.1) | .003 |
| ACS use among those eligible for ACS | 463 (92.6) | 84 (87.5) | .10 |
| Eligible for PROG c | 753 (4.4) | e | |
| Eligible for MG d | 181 (1.1) | 35 (0.8) | .08 |
| MG use among those eligible for MG | 129 (71.3) | 13 (37.1) | < .001 |
| Gestational age at delivery, wks (first born in multifetal) | < .001 | ||
| 23 0 to 33 6 | 859 (5.1) | 146 (3.2) | |
| 34 0 to 36 6 | 1448 (8.5) | 343 (7.6) | |
| 37 0 to 41 6 | 14,600 (86.2) | 4029 (89.0) | |
| ≥42 0 | 39 (0.2) | 7 (0.2) | |
| Specialty of patient’s attending at delivery | < .001 | ||
| General obstetrics | 12,717 (75.0) | 4392 (97.1) | |
| Maternal-fetal medicine | 4229 (25.0) | 133 (2.9) | |
| Years since patient’s attending physician at delivery graduated medical or midwifery school | < .001 | ||
| 0–9.9 (includes no attending at delivery) | 3443 (20.6) | 499 (11.0) | |
| 10–14.9 | 3553 (21.3) | 657 (14.5) | |
| 15–19.9 | 3225 (19.3) | 804 (17.8) | |
| 20–24.9 | 2580 (15.5) | 779 (17.2) | |
| ≥25 | 3878 (23.3) | 1786 (39.5) | |
| Maternal-fetal medicine availability 24/7 | 14,045 (82.9) | 3671 (81.1) | .006 |
| Obstetrics residents on labor and delivery | 16,413 (96.9) | 3788 (83.7) | <.001 |
a Race/ethnicity was reported in the chart
b Patients eligible for antenatal corticosteroid for fetal lung maturity were those who delivered in the labor and delivery department before 34 weeks of gestation and delivered 4 or more hours after admission
c Patients eligible for progesterone for the prevention of preterm birth were those who delivered in the labor and delivery department with a singleton pregnancy, with a history of a prior spontaneous preterm delivery, who had at least 2 prenatal care visits, and whose pregnancy was dated by a first- or second-trimester ultrasound or had assisted reproductive technology
d Patients eligible for magnesium sulfate for neuroprotection were those who delivered in the labor and delivery department before 32 weeks of gestation, did not have gestational hypertension or preeclampsia, and delivered 4 or more hours after admission
Table 2 describes the providers’ satisfaction with their knowledge about the treatment, their satisfaction with the evidence for each treatment, and the actual frequency of each treatment. More than 90% of the providers reported incorporating each of the treatments into practice. Actual use in eligible patients was high for antenatal corticosteroids (93%), but it was 71% for the magnesium sulfate and only 39% for the progesterone treatment. Provider satisfaction with quality of treatment evidence was 97% for antenatal corticosteroids, 82% for progesterone, and 57% for magnesium sulfate. Providers were asked whether barriers existed that prevented better use of the interventions. Seventy-six percent of providers reported barriers for progesterone, 30% for magnesium sulfate, and 17% for antenatal corticosteroids. Specific barriers cited are presented in Table 2 .
| Variable | Antenatal corticosteroid for fetal lung maturity, n (%) | Progesterone for prevention of preterm birth, n (%) | Magnesium sulfate for neuroprotection, n (%) |
|---|---|---|---|
| Provider stated that they prescribe intervention in practice (intent) | 16,812 (99.2) | 16,375 (96.6) | 15,490 (91.4) |
| Provider was satisfied with their knowledge of the intervention | 16,373 (96.6) | 14,292 (84.4) | 11,126 (65.7) |
| Provider rated the quality of the evidence for the intervention as above average to excellent | 16,446 (97.1) | 13,788 (81.6) | 9528 (57.4) |
| Provider perceived barriers to their patients’ receiving the intervention | 2875 (17.1) | 12,913 (76.4) | 4996 (30.1) |
| Financial | 142 (0.8) | 7408 (43.8) | 100 (0.6) |
| Fear of birth defects | 536 (3.2) | 1430 (8.5) | 236 (1.4) |
| Fear of side effects | a | a | 3945 (23.7) |
| Fear of injections | 1440 (8.6) | 6929 (41.0) | a |
| Difficulty with hospital or pharmacy drug delivery | 272 (1.6) | 4185 (24.8) | 74 (0.4) |
| Difficulty arranging injection | a | 4250 (25.1) | a |
| Poor compliance | 531 (3.2) | 3588 (21.2) | a |
| Poor patient understanding of drug benefits | 791 (4.7) | 2322 (13.7) | 2184 (13.1) |
| Actual frequency of treatment in patients eligible for the treatment (practice) | 463 (92.6) | 292 (38.8) | 129 (71.3) |
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