Quality improvement initiatives have been developed to improve acute coronary syndrome (ACS) care largely in high-income country settings. We sought to synthesize the effect size and quality of evidence from randomized controlled trials (RCTs) and non-randomized studies for hospital-based ACS quality improvement interventions on clinical outcomes and process of care measures for their potential implementation in low- and middle-income country settings.
We conducted bibliometric search of databases and trial registers and hand searching in 2016 and performed an updated search in May 2018 and May 2019. We performed data extraction, risk of bias assessment, and quality of evidence assessments in duplicate. We assessed differences in outcomes by study design comparing RCTs to non-randomized quasi-experimental studies and by country income status. A meta-analysis was not feasible due to substantial, unexplained heterogeneity among the included studies and thus, we present a qualitative synthesis. We screened 5,858 records and included 32 studies (14 RCTs [n=109,763] and 18 non-randomized quasi-experimental studies [n=54,423]. In-hospital mortality ranged from 2.1%-4.8% in the intervention groups versus 3.3-5.1% in the control groups in 5 RCTs (n=55,942). Five RCTs (n=64,313) reported a 3.0%-31.0% higher rates of reperfusion for STEMI patients in the intervention groups. The effect sizes for in-hospital and discharge medical therapies in a majority of RCTs were 3.0%-10.0% higher in the intervention groups. There was no significant difference in 30-day mortality evaluated by 4 RCTs (n=42,384), which reported 2.5%-15.0% vs. 5.9-22% 30-day mortality rates in the intervention vs. control groups. In contrast, non-randomized quasi-experimental studies reported larger effect sizes compared to RCTs. There were no significant consistent differences in outcomes between high-income and middle-income countries. Low-income countries were not represented in any of the included studies.
Hospital-based ACS quality improvement interventions have a modest effect on process of care measures but not on clinical outcomes with expected differences by study design. Although quality improvement programs have an ongoing and important role for ACS quality of care in high-income country settings, further research will help to identify key components for contextualizing and implementing such interventions to new settings to achieve their desired effects.