Phenotypes and Outcomes Workgroup


Phenotypes and Outcomes Workgroup Membership


Concato, John
Goulet, Joseph


Workgroup Co-Chairs – Qualifications and Experience

John Concato MD, MPH is Director of the VA Cooperative Studies Program Clinical Epidemiology Research Center (CERC) and Professor of Medicine at the Yale School of Medicine.  As a general internist and clinical epidemiologist, he has conducted research on a range of topics in both patient care and methodology, such as evaluating the effectiveness of medical interventions, identifying sources of bias in patient-oriented research, and assessing limitations of popular methods of statistical analysis.  Representative studies have focused on prostate cancer as a clinical topic, assessing comorbidity in patient-oriented research, and using multivariable analysis as a statistical technique.  These topics have important interrelationships, when (for example) a need exists to accurately conceptualize, measure and analyze comorbidity as a competing cause of death among men with prostate cancer.  Other work has compared the results of observational studies and randomized trials, disputing prior suggestions of a simple “research design hierarchy.”  More recent CERC-based research involves projects in genomic medicine, including the Million Veteran Program (MVP), as part of the VA Cooperative Studies Program and VA Genomic Medicine Program.

Joseph Goulet, MS, PhD is Associate Professor of Emergency Medicine and Director of the Methodology and Biostatistics core of the Pain Research, Informatics Multi-morbidities and Education (PRIME) Center.  He has extensive experience in the design and analysis of studies using VA data, and in leading teams of statisticians and clinical researchers in the conduct of VA health services research.  He has extensive experience in finding and validating key data elements in the VA Electronic Health Record (EHR) needed for wide variety of clinical research questions.  He led a DoD funded study examining the response of veterans in mild TBI to the Defense and Veterans Pain Rating Scale (DVPRS).  He was a member of the Population Research Working Group of the National Pain Strategy (NPS) Oversight Panel that developed and promulgated measure of pain to be used in national health interview surveys and large electronic health care databases.  Of relevance, he led a research project to examine methods to identify and compare the use of complementary and integrative health (CIH) approaches for chronic pain in VA and Kaiser-Permanente (KP) electronic and administrative data sources, and he is currently collaborating with Kerns and Brandt and colleagues at KP and Group Health Research Institute to develop standards for use of the EHR to measure core constructs relevant to the NPS (e.g. definitions of chronic pain, high impact chronic pain).  Dr. Goulet has worked extensively with existing VA based cohort studies, including the Veterans Aging Cohort Study (VACS) to develop algorithms for phenotype ascertainment.


Workgroup Goals

  • Identify reliable and clinically meaningful phenotypes among participants, for use in examining important treatment effect moderators and for enhanced understanding of study results.
  • Promote harmonization of measurement approaches, when feasible, especially for key outcomes proposed.
  • Provide a forum for discussing analytic, technical, and regulatory issues that arise related to harmonization of measurement approaches.