scholarly journals Making genomic medicine evidence-based and patient-centered: a structured review and landscape analysis of comparative effectiveness research

2017 ◽  
Vol 19 (10) ◽  
pp. 1081-1091 ◽  
Author(s):  
Kathryn A. Phillips ◽  
Patricia A. Deverka ◽  
Harold C. Sox ◽  
Muin J. Khoury ◽  
Lewis G. Sandy ◽  
...  
2018 ◽  
Vol 4 (1) ◽  
Author(s):  
Evan Mayo-Wilson ◽  
Asieh Golozar ◽  
Terrie Cowley ◽  
Nicole Fusco ◽  
Gillian Gresham ◽  
...  

2011 ◽  
Vol 25 (3) ◽  
pp. 191-209 ◽  
Author(s):  
Maria C. Katapodi ◽  
Laurel L. Northouse

The increased demand for evidence-based health care practices calls for comparative effectiveness research (CER), namely the generation and synthesis of research evidence to compare the benefits and harms of alternative methods of care. A significant contribution of CER is the systematic identification and synthesis of available research studies on a specific topic. The purpose of this article is to provide an overview of methodological issues pertaining to systematic reviews and meta-analyses to be used by investigators with the purpose of conducting CER. A systematic review or meta-analysis is guided by a research protocol, which includes (a) the research question, (b) inclusion and exclusion criteria with respect to the target population and studies, © guidelines for obtaining relevant studies, (d) methods for data extraction and coding, (e) methods for data synthesis, and (f ) guidelines for reporting results and assessing for bias. This article presents an algorithm for generating evidence-based knowledge by systematically identifying, retrieving, and synthesizing large bodies of research studies. Recommendations for evaluating the strength of evidence, interpreting findings, and discussing clinical applicability are offered.


2020 ◽  
Vol 35 (S2) ◽  
pp. 875-881 ◽  
Author(s):  
Laura C. Esmail ◽  
Rebecca Barasky ◽  
Brian S. Mittman ◽  
David H. Hickam

Abstract Introduction Complex health interventions (CHIs) are increasingly studied in comparative effectiveness research (CER), and there is a need for improvements in CHI research practices. The Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee (MC) launched an effort in 2016 to develop formal guidance on this topic. Objective To develop a set of minimal standards for scientifically valid, transparent, and reproducible CER studies of CHIs. The standards are intended to apply to research examining a broad range of healthcare interventions including delivery system, behavior change, and other non-pharmacological interventions. Methods We conducted a literature review, reviewed existing methods guidance, and developed standards through an iterative process involving the MC, two panels of external research methods experts, and a 60-day public comment period. The final standards were approved by the PCORI MC and adopted by the PCORI Board of Governors on April 30, 2018. Results The final standards include the following: (1) fully describe the intervention and comparator and define their core functions, (2) specify the hypothesized causal pathways and their theoretical basis, (3) specify how adaptations to the form of the intervention and comparator will be allowed and recorded, (4) plan and describe a process evaluation, and (5) select patient outcomes informed by the causal pathway. Discussion The new standards offer three major contributions to research: (1) they provide a simple framework to help investigators address the major methodological features of a CHI study, (2) they emphasize the importance of the causal model and the need to understand how a CHI achieves its effects rather than simply measuring these effects, and (3) they require description of a CHI using the concepts of core functions and forms. While these standards apply formally to PCORI-funded CER studies, they have broad applicability.


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