Methodology Core Finds the Optimal Study Design for Your Innovative Research Idea

figure 1. Methodolic approaches to clinical priority areas

The VERITY Methodology Core addresses many complex methodologies that researchers encounter when studying rheumatic and musculoskeletal (MSK) disorders. These conditions persist for decades and have a profound impact on the patient’s quality of life. Epidemiologic studies to identify persons at high risk for these disorders and to identify factors leading to worse prognoses merit a high priority, and clinical trials to establish treatment efficacy are even more crucial. Both types of studies must account for the complexity of the phenotype and longevity of the clinical course. Furthermore, they must address the balance between efficacy and toxicity in treatments for rheumatic and MSK disorders.

The mission of the VERITY Methodology Core is to link innovative ideas with rigorous study designs, state-of-the-art trials and assistance with methods development, data management, statistical analyses, HIPAA regulations and reporting of findings. Core faculty and staff possess methodologic expertise in patient-centered research, comparative effectiveness studies, cost-effectiveness studies, behavioral interventions and randomized controlled trials. The Methodology Core faculty are adept at matching clinical questions to appropriate study designs and outcomes, at developing and implementing statistical analysis plans and at optimizing data management systems and data collection methods.

An example of the Methodology Core’s work involves Jason Young, a medical student who requested assistance in designing a study to better understand patterns of opioid prescription after orthopedic surgery. VERITY Methodology Core faculty, including Dr. Elena Losina, PhD, and statistician Swastina Shrestha, MS, helped Mr. Young to develop a series of vignettes that described orthopedic procedures performed in patients of varied age and gender. They also helped him to develop an analysis plan. Mr. Young conducted the study by presenting vignettes to orthopedic residents from Haiti, the Netherlands and the United States. After the data was collected and given to the VERITY Methodology Core, Ms. Shrestha performed statistical analyses summarizing study results, and she helped Mr. Young to compile the tables and statistical analysis section for a manuscript.

The VERITY Methodology Core is led by Dr. Losina, the Robert W. Lovett Professor of Orthopedic Surgery at Harvard Medical School, and director of the PIVOT Center and a co-director of the OrACORe Center at Brigham and Women’s Hospital. Associate Director of the VERITY Methodology Core is Jeffrey N. Katz, MD, MSc, director of the Brigham’s OrACORe Center and Professor of Medicine and Orthopedic Surgery at Harvard Medical School. Dr. Losina and Dr. Katz have assembled a talented team to form the VERITY Methodology Core. Each individual brings a wealth of experience and can offer support in many areas.

To learn more about the resources of the VERITY Methodology Core, visit http://www.verityresearch.org/.

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