About

Professor Cynthia Jan Coffman is associated with the Duke Center for Combinatorial Gene Regulation, which is an NIH Center of Excellence in Genomic Science. The center aims to make combinatorial studies of the function of regulatory elements and noncoding variants routine. Its goal is to develop the first systematic and comprehensive framework for determining the effects of combinations of regulatory elements on gene expression and downstream phenotypes. This work is expected to transform human disease studies by prioritizing thousands of genes for targeted study and drug design, and to advance the prediction of the pathogenicity of noncoding variants that have not been observed, which is crucial for whole genome sequencing studies of both rare and common diseases.

Research topics

• Medicine
• Psychology
• Internal medicine
• Political Science
• Computer Science
• Environmental health
• Clinical psychology
• Intensive care medicine
• Law
• Endocrinology
• Medical physics
• Pathology
• Psychiatry
• Physical therapy

Selected publications

• Baseline characteristics of Veterans from improving Veteran access to integrated management of back pain (AIM-Back) – an embedded pragmatic, cluster-randomized trial in the United States

  Pain Management · 2026-04-07

  articleOpen access

  OBJECTIVE: Describe baseline characteristics and representativeness of AIM-Back trial participants relative to Veterans with low back pain at participating clinics. METHODS: Veterans were referred to AIM-Back randomized care pathways and included 1) enrolled participants with data collected in the Electronic Health Record (EHR) by clinical staff with no consent required and 2) survey participants who provided informed consent with data collected via surveys by research staff. Descriptive statistics were reported. Participation to prevalence ratios (PPRs) were calculated for sex, age, race, and ethnicity by clinic to describe representativeness. RESULTS: = 799 of enrolled participants (44%) were also survey participants. More than 59% of Veterans of enrolled and survey participants had High Impact Chronic Pain and approximately 10% of enrolled participants had documented opioid use in the preceding year. Older Veterans (≥65 years) were underrepresented in the Referral cohort compared to those with LBP visits at clinics (PPRs < 0.8). CONCLUSIONS: These findings provide detailed insights for participants that will be included in future analyses of care pathway effectiveness. TRIAL REGISTRATION: NCT04411420.

  PublisherOA PDFDOI

• Sequenced Care Pathway vs Pain Navigator Pathway for Veterans With Low Back Pain

  JAMA Network Open · 2026-04-02

  articleOpen access

  Importance: Low back pain (LBP) is a leading cause of disability, and there is limited evidence from clinical practice to support the effectiveness of alternative care models. Objective: To compare a sequenced care pathway (SCP) with a pain navigator pathway (PNP) for patients with LBP. Design, Setting, and Participants: In this embedded cluster randomized clinical trial, 19 primary care clinics in the Veterans Health Administration were randomized to deliver 1 of 2 multimodal guideline-supported care pathways, with primary outcomes assessed in their electronic health records (EHRs) at 3 months. Between February 8, 2021 (first enrolled), and January 31, 2024 (last enrolled), 1817 participants were referred by primary care clinicians and attended an initial AIM-Back trial visit. A subset of 799 participants consented to complete additional questionnaires for secondary analyses (March 8, 2021 [first survey collected], to January 10, 2025 [final secondary outcome collected by survey]). Interventions: The SCP included pain education and modulation, physical activity coaching, risk stratification, and psychologically informed physical therapy. The PNP included shared decision-making and facilitated referrals to nondrug treatments. Main Outcomes and Measures: Pain interference and physical function were coprimary outcomes, assessed with the Patient-Reported Outcomes Measurement Information Systems 4-item Short Forms (PROMIS-SF; potential score range for pain interference, 41.6-75.6, where lower scores indicated less interference with daily activities due to pain; and potential score range for physical function, 22.5-57.0, where higher scores indicated higher physical functioning during daily activities). Secondary EHR outcomes included sleep disturbance and National Institutes of Health pain intensity, and survey outcomes included the coprimary outcomes and additional measures of pain, function, and quality of life. Analysis was performed in the intent-to-treat population. Results: There were 1817 enrolled participants (SCP, 811; PNP, 1006; mean [SD] age, 53.0 [15.7] years; 1597 men [87.9%]). At 3 months, 461 of 811 patients (56.8%) in the SCP group and 537 of 1006 (53.4%) in the PNP group had analyzable primary outcomes. The estimated baseline mean PROMIS-SF score was 63.2 points (97.5% CI, 62.7-63.6 points) for pain interference and 37.1 points (97.5% CI, 36.7-37.4 points) for physical function. The 3-month mean PROMIS-SF score for pain interference was 60.5 points (97.5% CI, 59.7-61.3 points) in the SCP group and 61.1 points (97.5% CI, 60.4-61.8 points) in the PNP group. The 3-month mean PROMIS-SF score for physical function was 39.1 points (97.5% CI, 38.4-39.7 points) in the SCP group and 38.5 points (97.5% CI, 37.8-39.1 points) in the PNP group. There was no SCP superiority, with estimated 3-month differences of -0.6 points (97.5% CI, -1.6 to 0.4 points) for pain interference and 0.6 points (97.5% CI, -0.3 to 1.5 points) for physical function. There were no pathway differences in secondary outcomes. Conclusion and Relevance: In this cluster randomized trial, the SCP was not superior for the primary outcomes of pain interference and physical function. Future research should consider designs that optimize pathway adherence, assess the effectiveness in other settings, and investigate patient-level factors indicative of a favorable response to the SCP or PNP. Trial Registration: ClinicalTrials.gov Identifier: NCT04411420.

  PublisherDOI

• Comparing Approaches to Support Implementation of a Hospital Walking Program: Evidence from a Cluster Randomized Trial

  Journal of General Internal Medicine · 2026-02-26

  articleSenior author
  PublisherDOI

• Discharge Information and Support for Patients Discharged from the Emergency Department: Results from a Randomized Controlled Trial

  UNC Libraries · 2026-02-21

  articleOpen access
  PublisherDOI

• Sequenced Care Pathway vs Pain Navigator Pathway for Veterans With Low Back Pain

  UNC Libraries · 2026-04-11

  articleOpen access

  Importance: Low back pain (LBP) is a leading cause of disability, and there is limited evidence from clinical practice to support the effectiveness of alternative care models. Objective: To compare a sequenced care pathway (SCP) with a pain navigator pathway (PNP) for patients with LBP. Design, Setting, and Participants: In this embedded cluster randomized clinical trial, 19 primary care clinics in the Veterans Health Administration were randomized to deliver 1 of 2 multimodal guideline-supported care pathways, with primary outcomes assessed in their electronic health records (EHRs) at 3 months. Between February 8, 2021 (first enrolled), and January 31, 2024 (last enrolled), 1817 participants were referred by primary care clinicians and attended an initial AIM-Back trial visit. A subset of 799 participants consented to complete additional questionnaires for secondary analyses (March 8, 2021 [first survey collected], to January 10, 2025 [final secondary outcome collected by survey]). Interventions: The SCP included pain education and modulation, physical activity coaching, risk stratification, and psychologically informed physical therapy. The PNP included shared decision-making and facilitated referrals to nondrug treatments. Main Outcomes and Measures: Pain interference and physical function were coprimary outcomes, assessed with the Patient-Reported Outcomes Measurement Information Systems 4-item Short Forms (PROMIS-SF; potential score range for pain interference, 41.6-75.6, where lower scores indicated less interference with daily activities due to pain; and potential score range for physical function, 22.5-57.0, where higher scores indicated higher physical functioning during daily activities). Secondary EHR outcomes included sleep disturbance and National Institutes of Health pain intensity, and survey outcomes included the coprimary outcomes and additional measures of pain, function, and quality of life. Analysis was performed in the intent-to-treat population. Results: There were 1817 enrolled participants (SCP, 811; PNP, 1006; mean [SD] age, 53.0 [15.7] years; 1597 men [87.9%]). At 3 months, 461 of 811 patients (56.8%) in the SCP group and 537 of 1006 (53.4%) in the PNP group had analyzable primary outcomes. The estimated baseline mean PROMIS-SF score was 63.2 points (97.5% CI, 62.7-63.6 points) for pain interference and 37.1 points (97.5% CI, 36.7-37.4 points) for physical function. The 3-month mean PROMIS-SF score for pain interference was 60.5 points (97.5% CI, 59.7-61.3 points) in the SCP group and 61.1 points (97.5% CI, 60.4-61.8 points) in the PNP group. The 3-month mean PROMIS-SF score for physical function was 39.1 points (97.5% CI, 38.4-39.7 points) in the SCP group and 38.5 points (97.5% CI, 37.8-39.1 points) in the PNP group. There was no SCP superiority, with estimated 3-month differences of -0.6 points (97.5% CI, -1.6 to 0.4 points) for pain interference and 0.6 points (97.5% CI, -0.3 to 1.5 points) for physical function. There were no pathway differences in secondary outcomes. Conclusion and Relevance: In this cluster randomized trial, the SCP was not superior for the primary outcomes of pain interference and physical function. Future research should consider designs that optimize pathway adherence, assess the effectiveness in other settings, and investigate patient-level factors indicative of a favorable response to the SCP or PNP. Trial Registration: ClinicalTrials.gov Identifier: NCT04411420.

  PublisherDOI

• Novel approaches to recruiting clinical sites for embedded pragmatic clinical trials: Insights from the AIM-back trial

  Contemporary Clinical Trials Communications · 2025-04-11

  articleOpen access

  Background: Embedded pragmatic clinical trials (ePCTs) assess interventions in real-world settings. Best practices for recruiting clinical sites for ePCTs are unknown, especially for sites that aren't known to the study team or familiar with clinical research. We describe the site recruitment process for AIM-Back, an ePCT of two nonpharmacologic pathways for low back pain within the Veterans Health Administration (VA). Methods: During the planning phase of the AIM-Back trial, we aimed to recruit 18-20 sites. Eligible sites required provider capacity, administrative support, and geographic separation to avoid contamination. Our three-step approach involved: (1) lead (VA personnel) identification through existing VA contacts, data repositories of VA clinicians, and promotional outreach at events and listservs; (2) lead engagement via tailored communications emphasizing participation benefits; and (3) virtual meetings with administrators and clinicians. Results: We identified 184 leads across 53 VA healthcare systems. Leads from 40 systems responded to outreach, and recruitment meetings were conducted with 23 systems involving primary care, physical therapy, research staff, and leadership. We met our recruitment goal, securing participation agreements from 19 sites, with a median timeline from outreach to participation agreement of 3.7 months. Common reasons for non-participation included infrastructure and resource constraints, resistance to new clinical programs, and competing programs. Conclusion: AIM-Back's recruitment highlights ePCT site recruitment complexities for trials engaging new clinical research sites. Our innovative three-step recruitment approach provides an example for similarly designed trials. Future ePCTs should consider comprehensive recruitment strategies to ensure clinician buy-in, study feasibility, and broaden existing networks for completing ePCTs.

  PublisherDOI

• Exploration of heterogeneity of treatment effects across exercise-based interventions for knee osteoarthritis

  Osteoarthritis and Cartilage Open · 2025-01-23 · 5 citations

  articleOpen access

  Objective: Variability exists in the degree of improvement patients experience following exercise-based interventions (EBIs) for knee osteoarthritis (KOA), but understanding of this heterogeneity is limited. Using a machine learning approach, this study leveraged data from two randomized controlled trials (RCTs) to identify patient characteristics contributing to differential treatment effects. Design: The RCTs enrolled n ​= ​621 patients and evaluated three EBIs (group-based physical therapy (PT), individual PT, and a Stepped Exercise Program) and an education control group. The primary outcome was change in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline to end of treatment. Predictors included 25 demographic, clinical, and psychosocial characteristics. Three metalearners with three machine learning algorithms each and a simple interpretable model-based regression tree were used to identify subgroups with differential treatment effects. Fit was evaluated with holdout/validation data using root mean square error and mean absolute error. Results: The regression tree model outperformed all 9 metalearner models. Tree results suggested group-based PT yielded the largest improvement in mean WOMAC score. Only two subgroups were identified: baseline WOMAC score≤44 versus >44. Group-based PT was the optimal treatment regardless of baseline WOMAC score, but results were more ambiguous for patients with higher initial WOMAC score. For all 3 EBIs, patients with higher baseline WOMAC score made greater improvements. Conclusion: Results suggest individuals with moderate or greater KOA symptoms may benefit more from EBIs than those with less severe symptoms and that group-based PT is a promising approach for KOA.

  PublisherOA PDFDOI

• The Business Case for Family Caregiver Skills Training: Results From a Multisite Trial in the Veterans Health Care System

  Journal of the American Medical Directors Association · 2025-12-15

  letterOpen access
  PublisherOA PDFDOI

• Implementation Context of Outpatient Physical Therapy Clinics Preparing to Launch a New Evidence-Based Clinical Program for Knee Osteoarthritis: Findings From a National Multisite Implementation Trial

  Archives of Physical Medicine and Rehabilitation · 2025-10-12

  article
  PublisherDOI

• Changes in weight and physical function for older African American women in Take Off Pounds Sensibly (TOPS): Study protocol for a randomized clinical trial

  Contemporary Clinical Trials · 2025-01-18

  articleOpen accessSenior author
  PublisherOA PDFDOI

Frequent coauthors

• Kelli D. Allen

  320 shared

• Eugene Ž. Oddone

  Durham VA Health Care System

  219 shared

• Hayden B. Bosworth

  203 shared

• Susan N. Hastings

  Durham VA Health Care System

  203 shared

• William S. Yancy

  Duke University

  188 shared

• Corrine I. Voils

  William S. Middleton Memorial Veterans Hospital

  161 shared

• Courtney H. Van Houtven

  Duke University

  157 shared

• David Edelman

  Duke University

  147 shared