Search

Soon Nan Wee,1,* Christian Liman,1,* Heidi C Waters,2 Christy R Houle,3 Miguel Renteria,1 Sankha S Mukherjee,1 Subina Surendran,1 Joshua Marcovici,1 Malaak Brubaker,2 Stine Rasmussen Meehan,4 Anne de Jong-Laird,2 A John Rush,5– 7 Joydeep Sarkar1 1Holmusk Technologies, Inc, New York, NY, USA; 2Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ, USA; 3Lundbeck, Deerfield, IL, USA; 4H. Lundbeck A/S, Valby, Denmark; 5Department of Psychiatry, Duke-National University of Singapore, Singapore, Singapore; 6Department of Psychiatry, Duke University School of Medicine, Durham, NC, USA; 7Health Sciences Center, Texas Tech University, Odessa, TX, USA*These authors contributed equally to this workCorrespondence: Heidi C Waters, Otsuka Pharmaceutical Development & Commercialization, Inc, 508 Carnegie Center Drive, Princeton, NJ, 08540, USA, Tel +1 609 535 9626, Email heidi.waters@otsuka-us.comPurpose: Life engagement encompasses concepts such as life fulfillment, well-being, and participation in meaningful activities, encompassing cognitive, physical, social, and emotional dimensions. Patients with MDD experience impaired functioning across multiple domains of life engagement and have ranked concepts related to life engagement and fulfillment as important predictors of treatment success. Post-hoc analyses of three clinical trials of patients with MDD treated adjunctively with brexpiprazole have reported a significantly greater improvement in life engagement. This study investigated improvements in life engagement among patients with MDD following initiation of brexpiprazole treatment using a real-world dataset.Patients and Methods: Information was extracted from semi-structured clinical notes of the Mental Status Examination (MSE) of patients in a real-world setting to develop an outcome measure for quantifying life engagement of psychiatric patients. Measures of life engagement and its four sub-domains (emotional, physical, social, and cognitive) were calculated at each clinical visit for 624 adult patients with MDD during the 6 months following brexpiprazole initiation. Paired t-tests assessed differences between the index event and time periods within 6 months of the index event. Kaplan–Meier survival analyses were used to quantify the improvement in life engagement scores following brexpiprazole initiation.Results: The study identified 54 clinical features associated with life engagement. Statistically significant improvements were observed from as early as 1 month following brexpiprazole initiation, with 20.6%, 37.9%, and 53.9% of the patients demonstrating improved life engagement scores within 1, 3, and 6 months, respectively. The improvements were particularly apparent for the emotional and social sub-domains.Conclusion: The results of this study provide evidence of improved life engagement following brexpiprazole initiation in a real-world dataset.Keywords: brexpiprazole, major depressive disorder, real-world evidence, mental status examination, life engagement

Background: Real world data on clinical outcomes and quality of care for patients with coronary artery disease (CAD) are fragmented. We describe the rationale and design of the Singapore Cardiovascular Longitudinal Outcomes Database (SingCLOUD). Methods and Results: We designed a health data grid to integrate clinical, administrative, laboratory, procedural, prescription and financial data from all public-funded hospitals and primary care clinics, which provide 80% of health care in Singapore. Here, we explain our approach to harmonize real-world data from diverse electronic medical and non-medical platforms to develop a robust and longitudinal dataset. We present pilot data on patients with myocardial infarction (MI) treated with percutaneous coronary intervention (PCI) between 2012 and 2014. The initial data set had 53,395 patients. Of these, 35,203 had CAD confirmed on coronary angiography, of whom 21,521 had PCI. Eventually, limiting to 2012-2014, 3,819 patients had MI with PCI, while 5,989 had MI. Compared with the quality improvement registry, Singapore Cardiac Data Bank, which had 189 fields for analysis, the SingCLOUD platform generated an additional 313 additional data fields, and was able to identify an additional 250 heart failure events, 664 major adverse cardiovascular events at 2 years, and low-density lipoprotein levels to 1 year for 3,747 patients. Conclusions: By integrating multiple incongruent data sources, SINGCLOUD enables in-depth analysis of real-world cardiovascular "big data".