ABSTRACTBACKGROUND: Patients with multiple chronic conditions (MCC) are the largest consumers ofhealthcare in the US. Randomized controlled trials (RCT) of clinical effectiveness have notsufficiently studied these patients, while observational studies inherently produce biasedestimates of clinical effectiveness. There are substantial disparities in health and healthcare forpersons with MCC, particularly those with combinations of diabetes mellitus type II (DM),coronary artery disease (CAD) and chronic kidney disease (CKD). The effectiveness of statintherapy for preventing heart attacks and strokes remains unknown in populations with MCC.Furthermore, there is insufficient research done on how to best utilize existing data to studyMCC in order to obtain answers that can assist these patients and their clinicians in healthcaredecision-making.OBJECTIVE AND SPECIFIC AIM: The objective of this study is to help improve the utility ofsystematic review with meta-analysis as a method for studying the impact of MCC on clinicaleffectiveness. The specific aim of this project is to test the predictive value of systematicreview with meta- analysis as a method for quantifying the impact of MCC on theclinical effectiveness of statin therapy for preventing heart attacks and strokes inpatients with CAD, DM and CKD.METHODS: This study proposes to use systematic review with meta-analysis to identify,select and critically appraise relevant research studies, to synthesize the data from thesestudies in an effort to make recommendations for best practice, and to identify gaps in theliterature that can lead to better-informed research for patients with MCC. A systematic reviewwill be done to examine the impact of having MCC on the clinical effectiveness of statins forthe prevention of heart attacks and strokes. AHRQ guidelines will be implemented to find,assess and synthesize the evidence from all studies, including both experimental andobservational designs, which are relevant to the research question. Data from the includedstudies will be combined statistically to produce several meta-analyses. Meta-regression,subgroup, sensitivity and cumulative analyses will be performed to create quantitativemeasures of the impact of having different combinations of MCC on the effectiveness of statintherapy.PROJECTED OUTCOMES: The primary outcome of this project will be to determine how wellsystematic review with meta-analysis can help quantify the impact of having MCC on clinicaleffectiveness. A secondary outcome will be the quantification of this impact for theeffectiveness of statin therapy, which represents one of the most widely prescribed treatmentsin the US. This study's recommendations will guide researchers on how to utilize systematicreview with meta-analysis to analyze existing data on patients with other MCC. This will helpreduce the need to conduct additional expensive and large experimental or observationalstudies, thereby rapidly improving clinical decision-making and speeding up the implementationof evidence into practice for these populations with special care needs.
|Effective start/end date||9/30/16 → 9/29/17|
- Agency for Healthcare Research and Quality (AHRQ)