Harnessing person-generated health data to accelerate patient-centered outcomes research: the Crohn’s and Colitis Foundation of America PCORnet Patient Powered Research Network (CCFA Partners)

The Crohn’s and Colitis Foundation of America Partners Patient-Powered Research Network (PPRN) seeks to advance and accelerate comparative effectiveness and translational research in inflammatory bowel diseases (IBDs). Our IBD-focused PCORnet PPRN has been designed to overcome the major obstacles that have limited patient-centered outcomes research in IBD by providing the technical infrastructure, patient governance, and patient-driven functionality needed to: 1) identify, prioritize, and undertake a patient-centered research agenda through sharing person-generated health data; 2) develop and test patient and provider-focused tools that utilize individual patient data to improve health behaviors and inform health care decisions and, ultimately, outcomes; and 3) rapidly disseminate new knowledge to patients, enabling them to improve their health. The Crohn’s and Colitis Foundation of America Partners PPRN has fostered the development of a community of citizen scientists in IBD; created a portal that will recruit, retain, and engage members and encourage partnerships with external scientists; and produced an efficient infrastructure for identifying, screening, and contacting network members for participation in research.

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Designing clinical trials in paediatric inflammatory bowel diseases: a PIBDnet commentary

Gut ◽

10.1136/gutjnl-2018-317987 ◽

2019 ◽

Vol 69 (1) ◽

pp. 32-41 ◽

Cited By ~ 2

Author(s):

Dan Turner ◽

Anne M Griffiths ◽

David Wilson ◽

Diane R Mould ◽

Robert N Baldassano ◽

...

Keyword(s):

Clinical Trials ◽

A Priori ◽

Time Lag ◽

Drug Approval ◽

Research Network ◽

Eligibility Criteria ◽

Writing Group ◽

Bowel Diseases ◽

Inflammatory Bowel ◽

Data Extrapolation

IntroductionThe optimal trial design for assessing novel therapies in paediatric IBD (PIBD) is a subject of intense ongoing global discussions and debate among the different stakeholders. However, there is a consensus that the current situation in which most medications used in children with IBD are prescribed as off-label without sufficient paediatric data is unacceptable. Shortening the time lag between adult and paediatric approval of drugs is of the upmost importance. In this position paper we aimed to provide guidance from the global clinical research network (Pediatric Inflammatory Bowel Disease Network, PIBDnet) for designing clinical trials in PIBD in order to facilitate drug approval for children.MethodsA writing group has been established by PIBDnet and topics were assigned to different members. After an iterative process of revisions among the writing group and one face-to-face meeting, all statements have reached consensus of >80% as defined a priori. Next, all core members of PIBDnet voted on the statements, reaching consensus of >80% on all statements. Comments from the members were incorporated in the text.ResultsThe commentary includes 18 statements for guiding data extrapolation from adults, eligibility criteria to PIBD trials, use of placebo, dosing, endpoints and recommendations for feasible trials. Controversial issues have been highlighted in the text.ConclusionThe viewpoints expressed in this paper could assist planning clinical trials in PIBD which are both of high quality and ethical, while remaining pragmatic.

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Frailty in inflammatory bowel diseases: an emerging concept

Therapeutic Advances in Gastroenterology ◽

10.1177/17562848211025474 ◽

2021 ◽

Vol 14 ◽

pp. 175628482110254

Author(s):

Bharati Kochar ◽

Ariela R. Orkaby ◽

Ashwin N. Ananthakrishnan ◽

Christine S. Ritchie

Keyword(s):

Older Adults ◽

Inflammatory Bowel Diseases ◽

Conceptual Models ◽

Younger Adults ◽

Inflammatory Conditions ◽

Immune Mediated ◽

Bowel Diseases ◽

Inflammatory Bowel ◽

The Relationship ◽

Improve Health

Inflammatory bowel diseases (IBD), consisting of Crohn’s disease and ulcerative colitis, are chronic remitting, relapsing inflammatory conditions of the gastrointestinal tract. While traditionally a disease of younger ages, the number of older adults with IBD is rising rapidly. Patients with IBD often experience geriatric syndromes at earlier ages. Older adults with IBD have poorer disease and treatment-related outcomes compared with younger adults with IBD. Applying the principles of geriatrics to understanding a chronic disease in older adults may improve health span. Better tools are needed to stratify IBD patients who are at high risk for adverse events. Frailty is a geriatric construct that may approximate biologic age. Frailty is a complex, multi-dimensional syndrome that leads to increased vulnerability to stress and decline of reserve across multiple physiologic systems. In this review, we present the leading conceptual models of frailty and discuss the applications of frailty in immune-mediated diseases. We also review chronic conditions where frailty has been applied successfully as a tool for risk stratification. Finally, we discuss in the detail the growing body of literature highlighting the relationship between frailty and IBD, the epidemiology of frailty in IBD, and ramifications of frailty in IBD.

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Lessons on Patient and Stakeholder Engagement Strategies for Pipeline to Proposal Awards

Ethnicity & Disease ◽

10.18865/ed.28.s2.303 ◽

2018 ◽

Vol 28 (Supp) ◽

pp. 303-310 ◽

Cited By ~ 1

Author(s):

Ashley Wennerstrom ◽

Benjamin F. Springgate ◽

Felica Jones ◽

Diana Meyers ◽

Norris Henderson ◽

...

Keyword(s):

Los Angeles ◽

Outcomes Research ◽

Technical Assistance ◽

African American Men ◽

Knowledge Exchange ◽

Lessons Learned ◽

Research Network ◽

Patient Centered ◽

Research Partnerships ◽

New Research

The Patient Centered Outcomes Research Institute (PCORI) supports patient-centered clinical comparative effectiveness research (CER) including health disparities and engagement portfolios. In 2013, PCORI launched the Pipeline to Proposal (P2P) mechanism to support development of novel patient- and stakeholder-centered partnerships focused on designing clinical CER funding proposals. By providing a tiered structure of successive small contracts and technical assistance, the P2P mechanism encourages development of new research partnerships among diverse stakeholders. As a comparatively new field, patient-centered outcomes research (PCOR) has few well-delineated methods for engaging patients and other non-scientists in effective teams with academics or clinicians to develop and implement rigorous, scientific research proposals. Community partnered participatory research (CPPR) provides a useful framework for structuring new partnerships.In this article we highlight the origins, development, and prospects of three current examples of funded P2P initiatives based in New Orleans and Los Angeles. We outline how these projects – Prisoner to Patient, the NOLA Partnership, and Resilience Among African American Men – use CPPR principles. We also describe how they have collaborated with, and contributed to, a two-way learning and knowledge exchange among members of the PCORI-funded Community and Patient Partnered Research Network. Lessons learned may be applicable to other groups planning to create new partnerships focused on implementing PCOR.Ethn Dis. 2018;28(Suppl 2):303- 310; doi:10.18865/ed.28.S2.303.

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The Patient-Centered Outcomes Research Network Antibiotics and Childhood Growth Study: Implementing Patient Data Linkage

Population Health Management ◽

10.1089/pop.2019.0089 ◽

2020 ◽

Vol 23 (6) ◽

pp. 438-444

Author(s):

Melanie Canterberry ◽

Alan F. Kaul ◽

Satyender Goel ◽

Pi-I Debby Lin ◽

Jason P. Block ◽

...

Keyword(s):

Outcomes Research ◽

Data Linkage ◽

Patient Data ◽

Research Network ◽

Growth Study ◽

Patient Centered ◽

Childhood Growth

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A Comprehensive Stakeholder Engagement Plan for the Patient Centered Outcomes Research Network (PCORnet) Bariatric Study

Surgery for Obesity and Related Diseases ◽

10.1016/j.soard.2016.08.339 ◽

2016 ◽

Vol 12 (7) ◽

pp. S194-S195

Author(s):

Karen Coleman ◽

Neely Williams ◽

Jane Anau ◽

Caroline Apovian ◽

Anita Courcoulas ◽

...

Keyword(s):

Outcomes Research ◽

Stakeholder Engagement ◽

Research Network ◽

Patient Centered

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Changes in Patient-Reported Outcomes With Vedolizumab Therapy in Patients With Inflammatory Bowel Diseases (IBD): Results From the IBD Partners Patient Powered Research Network

Crohn's & Colitis 360 ◽

10.1093/crocol/otz020 ◽

2019 ◽

Vol 1 (2) ◽

Author(s):

Millie D Long ◽

Christopher F Martin ◽

Wenli Chen ◽

Michelle Luo

Keyword(s):

Odds Ratio ◽

Patient Reported Outcomes ◽

Adjusted Odds Ratio ◽

Research Network ◽

Social Satisfaction ◽

Patient Reported ◽

Remission Rates ◽

Bowel Diseases ◽

Inflammatory Bowel

Abstract Background We described changes in patient-reported outcomes (PROs) with vedolizumab (VDZ) use in inflammatory bowel disease (IBD). Methods We included patients initiating VDZ with at least 6 months of follow-up in the IBD Partners cohort. We stratified by biologic naive (BN) or biologic exposed (BE) status. Outcomes included PROs. Results We included 380 patients with IBD. Remission rates at follow-up were higher for BN versus BE (65.1% vs 45.5%, P < 0.01). BN patients experienced significant improvements in social satisfaction (P < 0.01). BN status was associated with remission (adjusted odds ratio, 3.36; 95% confidence interval, 1.67–6.77). Conclusions Improvements in PROs were seen with VDZ, particularly in BN populations.

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