Principal findings
In our analysis of adverse maternal and neonatal outcomes in 55 Ontario hospitals enrolled in the MOREOB program prior to 2012, we found no evidence of improvements in either of the composite indices after MOREOB implementation. In fact, there was a small increase in the occurrence of adverse events as captured by the mAOI. In subanalyses with individual components of the composite indices, we found small but statistically significant increased odds of maternal unanticipated operative procedures, 4th degree tears, and NICU admission; on the other hand, we found evidence of non-statistically significant decreases in neonatal birth trauma and maternal blood transfusion.
Comparison with previous studies
Two previous studies have assessed the effect of the implementation of the MORE
OB program. In the first study, implementation of the MORE
OB program in Alberta hospitals was associated with a reduction in 3rd and 4th degree perineal tears and decreases in maternal length of stay and neonatal morbidity [
11]. However there were limitations to this study, including the analysis which was vulnerable to confounding by the underlying secular trend, as well as the short follow-up time period. In the Alberta study only 2.8% of deliveries occurred post-Module 3, whereas in our study 39% of deliveries occurred post-Module 3. Using a multiple baseline interrupted time series (ITS) design, the second study assessed the effect of MORE
OB implementation on mandatory reportable events collected by a Canadian healthcare liability insurer [
10]. In that study, the authors reported a decrease of 4 mandatory reportable events at 3 years after MORE
OB implementation (95% CI:-0.5 to 8.1) and a decrease of 8 mandatory reportable events at 6 years post-implementation (95% CI: 1.4 to 15.1). However, this study included a smaller number of Ontario hospitals, 34, whereas the current study included 55 Ontario hospitals.
Other obstetric patient safety programs have been evaluated with mixed results. A recently published rapid review included 10 randomized controlled trials (RCT) and reported that “provider education and other quality improvement strategy combinations targeting healthcare providers may improve the safety of women and their newborns during childbirth” [
7]. In an evaluation of a program implemented at an American hospital from 2004 to 2006, it was reported that the program was associated with a decrease in the AOI [
5], as well as a decrease in the number of liability claims and associated payments [
4]. The nine elements of the program included items such as the development of new protocols and guidelines, the hiring of an Obstetric Safety Nurse, the implementation of an Obstetric Patient Safety Committee, the involvement of Obstetric Hospitalists to provide 24-h, 7-day per week in-house coverage, as well as team training and an electronic fetal heart rate certification program [
4,
5]. However, this program was implemented at one hospital, and a simple pre/post linear regression analysis was used, making it difficult to draw conclusions about what the wider impact of such a program would be. An RCT carried out at 15 American hospitals assessing the effect of a teamwork training program on the AOI reported no effect of the program on this outcome [
6]. Based on the literature to date, it is difficult to conclude what elements of an obstetric patient safety program might be most likely to improve effectiveness.
Strengths and weaknesses
In our analytical approach, we allowed for a gradient effect of MORE
OB implementation (from the first to the final module) but thereafter, the effect of the MORE
OB program was assumed to be stable. An alternative approach may have allowed for either a gradual decay or further gradual improvements after completion of all modules, using, for example, an ITS approach with segmented regression analysis allowing for both a step change and a slope change. However, the staggered implementation of the MORE
OB program, combined with the lengthy and variable amount of time required for hospitals to complete the program, precluded the use of an ITS approach. In a classical ITS analysis, the estimated pre-implementation trend (secular trend) is used to predict what the outcome event rate would have been at the end of the study, had the intervention not been implemented (the counterfactual estimate) [
12‐
14]. With a long separation, using the secular trend to predict a counterfactual estimate is risky due to projection far outside the observed range of the data.
While the staggered implementation of the MORE
OB program, which occurred over an 8 year period, presented analytic challenges, it also provided an advantage, in that our results are less likely to be confounded by concurrent interventions or local policy changes. Using our multivariable model, we were essentially able to compare outcomes from all hospitals after implementation of the program to their own pre-implementation outcomes as well as to the outcomes from other hospitals who had not yet implemented the program at the same calendar time. As well, the use of previously developed and used [
5,
6,
18‐
20] indicators for adverse maternal and neonatal outcomes, the mAOI and WAOS, further strengthens our results. Given the multifaceted nature of the MORE
OB program, we considered that indicators capturing multiple components of maternal/newborn care would be more appropriate. Further, aggregation of the components helps to address the rarity of these adverse outcomes in the Canadian healthcare setting. And, given that it had been used for research carried out in Canada [
19], this allows for the comparison between our estimates and what has been reported elsewhere. The AOI rate reported by Hutcheon et al. of 5.7% is lower than the 6.8% that we report here, and the WAOS we report is also higher (4.9 versus 1.9). It is not entirely clear why these rates would differ inter-provincially across Canada, and given the severity of these outcomes, this might highlight an area for further research.
We believe using composite indices as the primary outcomes was the most appropriate choice however it is possible that this masks the effect of the program on specific maternal-newborn outcomes that were not assessed by our study. As well, our analysis was limited to the data elements available in the DAD hospitalization database, and therefore we had to use a modified version of the AOI, which did not include elements such as Apgar score or 3rd degree perineal tears. Data quality is carefully managed and documented by CIHI [
27], and we made every attempt to identify any outstanding data quality issues including examining the study outcomes over time and by hospital site, and liaising with CIHI when issues were identified. Yet, it is possible that unidentified changes to coding or data quality remain. Also, the occurrence of maternal and neonatal adverse outcomes is affected by a host of factors unrelated to participation in a program such as the MORE
OB, such as maternal age, parity and comorbidity. We attempted to account for this by including hospital level of care, birth volume and a maternal comorbidity index in our models however, it is possible that unmeasured confounding remains. An additional limitation was the lack of clinical performance measures in this evaluation, such as compliance with guidelines, safety reports, or documentation of near misses. Further, changes to workplace culture were not assessed. It has previously been reported that participation in MORE
OB improved workplace culture and increased knowledge [
8], and it is difficult to understand how improvements to workplace culture would not result in improvements to patient outcomes. Inclusion of objective measures of behavior such as those described above, along with assessments of workplace culture might help to shed light on this issue in future studies.
Possible explanations and implications for policymakers
It is perhaps not surprising that we were unable to detect an impact of the MORE
OB program on a composite indicator of adverse maternal and neonatal outcomes. In this evaluation, which is one component of a larger mixed-methods evaluation of the MORE
OB program, we only measured adverse outcomes. Although these are important outcomes from the perspective of patients, hospitals and policymakers, they cannot fully capture other aspects of MORE
OB training related to improved communication, improvements in safety culture and increases in knowledge. Our mixed-methods evaluation of the MORE
OB program also assessed individual participant responses, including care providers’ views about the program, changes in their levels of knowledge, and their assessments of the culture change within their organizations. Our findings from that study suggest that the MORE
OB program had a positive impact on these factors. It is well-established that clinical behavior and practice change takes time to become entrenched [
28,
29]. As well, when a hospital embarks on the 3-year commitment to implement the MORE
OB program, they must also find strategies to sustain the activities and practice changes once their dedicated funding for the program runs out. If the activities and practice changes are not firmly established and culture change is temporary, there may be no detectable net benefit of the program on clinical adverse outcomes over time. The MORE
OB program does attempt to mitigate this effect, in that it is not just an educational program, rather every attempt is made to embed the program within the culture of each institution. A dedicated core team in each hospital carries out ongoing activities related to the program [
9].
Unanswered questions and future research
Improving patient safety and reducing adverse maternal and neonatal outcomes remain issues of critical importance in obstetrics, and our study demonstrates some of the important challenges associated with this area of research. Our study also demonstrates the critical nature of large datasets and long follow-up, which is especially important when studies are carried out in high-resource settings where adverse outcomes are rare. Great care is also needed in the selection of appropriate research and analytical methods. Future studies should look at the effect of obstetrical safety programs on other adverse outcomes such as near misses, as well as including objective measures of behavior change.