ImproveCareNow Retrospective_Research


ICN Research Explained: The association between erythema nodosum and pyoderma gangrenosum and pediatric inflammatory bowel disease

The objectives of this study are to estimate rates and identify factors associated with erythema nodosum (EN) and pyoderma gangrenosum (PG) in pediatric patients with inflammatory bowel disease (IBD).


Missing Data Handling Methods in External Control Arms for Pediatric IBD trials

A:

Principal Investigator: Disha Subramaniam, PhD Student / Digestive Disease Pre-doctoral Fellow, University of North Carolina at Chapel Hill

Purpose:
This work will be the first to evaluate multiple approaches to addressing missing outcome data in an external control arm for pediatric Crohn's disease, ultimately aiming inform innovations in pediatric IBD trials to get much-needed
treatments to children who need them.

Aims:

  1. Aim 1: To describe and visualize patterns of key variable missingness in the component categories of the Pediatric Crohn's Disease Activity Index (PCDAI) in a cohort constructed from real-world registry data to serve as an external control to the treatment arm of a prior randomized trial in pediatric Crohn's disease
  2. Aim 2: To assess the bias and precision of common statistical approaches to handle missing PCDAI component data in a modified pediatric Crohn's disease trial data set that incorporates realistic patterns of key variable missingness based on a matched registry-based external control cohort

Study Start Date: December 15, 2024

Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.

Contact: [email protected] 


Frequency and implication of silent Crohn's disease

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Purpose: Crohn's disease causes chronic bowel inflammation which can lead to strictures, fistulas, growth stunting, and other complications if inadequately controlled. We typically monitor inflammation via symptoms and laboratory monitoring. In the absence of symptoms, elevated inflammatory markers (erythrocyte sedimentation rates, c-reactive protein) is sometimes referred to as "silent Crohn's disease". It is unclear how often silent Crohn's disease occurs, or what the implications are. There is some evidence in adults that silent Crohn's disease is associated with increased risk of hospitalization. This has not been evaluated in children.

Specific Aims:

1. Determine the frequency of silent Crohn's disease in children with Crohn's disease in the ImproveCareNow
Network registry.
2. Determine the association between silent Crohn's disease and risk of disease-related complications including
strictures, fistulas, perianal disease, and short stature.

Contact: Jeremy Adler


Use of Non-FDA Approved Biologics and Small Molecule Medications in Pediatric Patients with Inflammatory Bowel Disease

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Principal Investigator: Steven Steiner, MD – Riley Hospital for Children

Purpose:
The selected medication for IBD depends primarily on the severity of active disease, the patient's tolerance, observed clinical response, and cost. Timely access to selected medications is critical to prevent complications from untreated disease such as strictures, infection, or need for surgical intervention. Of the approximately 13 biologics/small molecules approved for adult IBD, only 2 are currently approved in children: infliximab and adalimumab.

Pediatric patients often receive non-FDA approved biologics/small molecules with prior authorization after failing other FDA-approved medications or if they present with severe disease that necessitates urgent use of a non-FDA approved medication.

Aims:

  1. Identify the number/ percentage of patients who were exposed to a biologic/small molecule without FDA approval
  2. Identify the number/ percentage of patients who were exposed to specific number of biologic/small molecule without FDA approval (i.e. # exposed to 1 drug, # exposed to 2 drugs, etc.)
  3. Identify the average age of first exposure to non-FDA approved biologic/small molecule
  4. Identify the time from diagnosis toto first exposure to non-FDA approved biologic/small molecule (will consider time to second, third exposure as well)
  5. Identify variations, if any, of non-FDA approved biologic/small molecule medication use within gender and race/ethnicity subgroups

Funding Source (Year Awarded): 2022 - IU Pediatric GI Departmental Funding during fellowship

Study Period: July 2023 – June 2025

Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.

Contact: [email protected] 


Characteristics of pediatric Crohn’s disease patients unable to achieve remission within the first two years of being diagnosed

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Purpose: This study aims to determine the predictive variables of pediatric CD patients who do not reach remission within two years of diagnosis. 

Specific Aims: This group of pediatric patients will be compared with CD patients who do go into remission within two years of diagnosis in order to find predictors of (non-) remission, correlations, define 'at risk' patients and asses it’s impact on treatment strategy (drugs, strategy and closer follow-up). 

Study Period: April 2023-December 2024

Contact: Gigi Veereman


Characteristics of pediatric ulcerative colitis patients unable to achieve remission within the first two years of being diagnosed

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Purpose: The purpose of this study is to determine the predictive variables for pediatric UC patients who do or do not reach remission within two years of diagnosis

Specific Aims:

This group of pediatric patients will be compared with UC patients who do go into remission within two years of diagnosis in order to find predictors of (non-) remission, correlations, define 'at risk' patients and asses it’s impact on treatment strategy (drugs, strategy and closer follow-up).

Study Period: April 2023-December 2024

Contact: Jonathan Van Hecke


Colectomy: Understanding clinical and variation in care delivery across ICN network

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Overall Study Question: Initial data review of the ICN registry has found that since 2014, nearly 600 patients have undergone colectomy. We suspect that deeper review of this patient population is likely to provide insight for clinical care in addition to identifying variation in care delivery across the ICN network, thus making this patient cohort important for further data analysis. Ultimately, this deeper evaluation could provide insight toward improving patient outcomes.

Specific Aims: We would like to review clinical variables including BMI prior to colectomy, medication exposures prior to colectomy, time from diagnosis to colectomy, incidence rates of colectomy among patients newly diagnosed with UC in ICN database.
We also suspect there could be variation in colectomy rates or treatment approaches across the collaborative between academic vs nonacademic center, regional variation, public vs commercial insurance, and possible trends of biological treatment prior to colectomy.

Study Period: starting in January 2023

Contact: Brendan Boyle and Sabina Ali


A data-driven approach for risk stratification and outcome prediction for PIBD

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Purpose: The purpose of this study is to build a risk prediction model for pediatric Crohn's disease to predict outcomes of sustained remission/flare, surgery, and hospitalization using data from ICN Registry and PCORnet.

Specific Aims:

  1. Leveraging longitudinal data from ICN registry and PCORnet, and previously developed methods in assessing and stratifying disease activities, this study proposes to apply data analytics and visualization to facilitate efficient decision support for personalized care and risk prediction in pediatric Crohn’s disease. We aim to develop a machine-learning based clinical pathway learning algorithm for pediatric Crohn’s disease that predicts for 3 outcomes of interests: (1) sustained remission/flare, (2) surgery, and (3) hospitalization. Stratifying patients by their risk levels using PCDAI and sPCDAI, we will infer the common disease progression trajectories that are unique to each patient subpopulation from data, which we further use for prediction of future patient states.

Start Date: March 2017

Contact: Yiye Zhang


Evaluating inequities in personalized care for children with IBD

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Purpose: The purpose of this study is to refine proactive TDM processes to personalize care in the ImproveCareNow (ICN) rapid Learning Health Network of >30,000 children and 110 care centers in an effective and equitable way.

Specific Aims:

  1. Describe variation in the use of anti-TNF therapy and TDM at the patient and practice levels.
  2. Assess whether anti-TNF drug monitoring is associated with health outcomes, and to determine the extent to which they are explained by patient and practice level factors.

Contact: Jennifer Dotson and Jasbir Dhaliwal


Risk Factors associated with colectomy for Ulcerative Colitis

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Purpose: The purpose of this study is to identify the risk factors that are most important in developing severe UC (PUCAI >65 and/or colectomy), so that they can be mitigated and more intensive therapy can be initiated earlier in order to avoid surgery.

Specific Aims:

  • Identify risk factors for colectomy and severe disease in UC. Search ICN database to identify patients with UC who required colectomy or had PUCAI>65. Identify top 10 risk factors patients had in common. Compare and contrast risk factors to a case control group of UC patients in the ICN database, marked by physician global assessment “quiescent” and in remission. Check for statistically significant differences among the risk factors between the two groups.
  • Identify the medications patients used in each group. Assess statistically if certain medications were used or not by patients who had colectomy or PUCAI > 65.

Contact: Gitit Tomer


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