Peter Margolis

Cincinnati Children's Hospital Medical Center | CCHMC · Department of Pediatrics

Objectives HLA DQA1*05 has been associated with the development of anti-drug antibodies (ADA) to tumor necrosis factor antagonists (anti-TNF) and treatment failure among adults with Crohn’s disease (CD). However, findings from other studies have been inconsistent with limited pediatric data. Methods We analyzed banked serum from patients with CD <...

Background Higher drug levels and combination therapy with low-dose oral methotrexate (LD-MTX) may reduce anti-tumor necrosis factor (TNF) treatment failure in pediatric Crohn’s disease. We sought to (1) evaluate whether combination therapy with LD-MTX was associated with higher anti-TNF levels, (2) evaluate associations between anti-TNF levels and...

As the COVID-19 pandemic progressed, reliable, accessible, and equitable community-based testing strategies were sought that did not flood already overburdened hospitals and emergency departments. In Hamilton County, Ohio, home to ~800 000 people across urban, suburban, and rural areas, we sought to develop and optimize an accessible, equitable cou...

Introduction Patient engagement has historically referenced engagement in one's healthcare, with more recent definitions expanding patient engagement to encompass patient advocacy work in Learning Health Networks (LHNs). Efforts to conceptualize and define what patient engagement means—and what successful patient engagement means—are, however, lack...

Background and aims: Tumor Necrosis Factor inhibitors (TNFi), including infliximab and adalimumab, are a mainstay of pediatric Crohn's disease (PCD) therapy; however, non-response and loss of response is common. As combination therapy with methotrexate may improve response, we performed a multi-center, randomized, double-blind, placebo-controlled...

Prior studies of early antibiotic use and growth have shown mixed results, primarily on cross-sectional outcomes. This study examined the effect of oral antibiotics before age 24 months on growth trajectory at age 2–5 years. We captured oral antibiotic prescriptions and anthropometrics from electronic health records through PCORnet, for children wi...

Objective: To assess the odds of a psychiatric or neurodevelopmental diagnosis among youth with a diagnosis of gender dysphoria compared with matched controls in a large electronic health record dataset from six pediatric health systems, PEDSnet. We hypothesized that youth with gender dysphoria would have higher odds of having psychiatric and neur...

The SARS-CoV-2 virus emerged and spread quickly, leading to a pandemic within weeks of the first recognized cases. In this chapter, we describe a successful effort to develop and maintain situational awareness of COVID-19 presence and effects across Southwestern Ohio. Healthcare, public health, schools, and businesses organized and worked together...

Introduction Improving the U.S. healthcare system and health outcomes is one of the most pressing public health challenges of our time. Previously described Collaborative Learning Health Systems (CLHSs) are a promising approach to outcomes improvement. In order to fully realize this promise, a deeper understanding of this phenomenon is necessary....

Background Collaborative Learning Health Systems (CLHS) improve outcomes in part by facilitating collaboration among all stakeholders. One way to facilitate collaboration is by creating conditions for the production and sharing of medical and non‐medical resources (information, knowledge, and knowhow [IKK]) so anybody can get “what is needed, when...

Background Patient and Family Advisory Councils (PFACs) are an emerging mechanism to integrate patient and family voices into healthcare. One such PFAC is the Patient Advisory Council (PAC) of the ImproveCareNow (ICN) network, a learning health system dedicated to advancing the care of individuals with pediatric inflammatory bowel disease (IBD). Us...

Objective Using a nested, cluster-randomized trial, we tested the hypothesis that a shared decision-making intervention, as part of consent, would improve study-related knowledge. Methods We developed a shared decision-makingintervention then randomized sites in a clinical trial to intervention or control (standard consent). We collected participa...

Objectives To develop and evaluate the classification accuracy of a computable phenotype for pediatric Crohn's disease using electronic health record data from PEDSnet, a large, multi‐institutional research network and Learning Health System. Study Design Using clinician and informatician input, algorithms were developed using combinations of diag...

Background The vision of learning healthcare systems (LHSs) is attractive as a more effective model for health care services, but achieving the vision is complex. There is limited literature describing the processes needed to construct such multicomponent systems or to assess development. Methods We used the concept of a capability maturity matrix...

Background Collaborative learning health systems have demonstrated improved outcomes for a range of different chronic conditions. Patient and healthcare provider engagement in these systems is thought to be associated with improved outcomes. We have adapted an observational framework to measure, and track over time, engagement in ImproveCareNow, a...

Creating better value in health care service today is very challenging. The social pressure to do so is real for every health care system and its leadership. Real benefit has been achieved in manufacturing sector work by the use of “value‐chain” thinking, which assumes that the work is a series of linked processes necessary to make a product. For t...

Background Collaborative learning health systems (CLHSs) enable patients, clinicians, researchers, and others to collaborate at scale to improve outcomes and generate new knowledge. An organizational framework to facilitate this collaboration is the actor‐oriented architecture, composed of (a) actors (people, organizations, and databases) with the...

Objective: To implement a quality improvement based system to measure and improve data quality in an observational clinical registry to support a Learning Healthcare System. Data source: ImproveCareNow Network registry, which as of September 2019 contained data from 314,250 visits of 43,305 pediatric Inflammatory Bowel Disease (IBD) patients at...

Optimising short- and long-term outcomes for children and patients with CHD depends on continued scientific discovery and translation to clinical improvements in a coordinated effort by multiple stakeholders. Several challenges remain for clinicians, researchers, administrators, patients, and families seeking continuous scientific and clinical adva...

BACKGROUND Mobile health (mHealth) technology has potential to make pediatric chronic care more collaborative, continuous, data driven and thus, more effective. OBJECTIVE This study evaluated the feasibility, acceptability and short-term impact of Orchestra, an electronic health record-linked technology platform and delivery system intervention su...

Background Mobile health (mHealth) technology has the potential to support the Chronic Care Model’s vision of closed feedback loops and patient-clinician partnerships. Objective This study aims to evaluate the feasibility, acceptability, and short-term impact of an electronic health record–linked mHealth platform (Orchestra) supporting patient and...

Objective: Electronic medication lists may be useful in clinical decision support and research, but their accuracy is not well described. Our aim was to assess the completeness of the medication list compared to the clinical narrative in the electronic health record. Methods: We reviewed charts of 30 patients with inflammatory bowel disease (IBD...

Background: Our health care system fails to deliver necessary results, and incremental system improvements will not deliver needed change. Learning health systems (LHSs) are seen as a means to accelerate outcomes, improve care delivery, and further clinical research; yet, few such systems exist. We describe the process of codesigning, with all rel...

The US National Academy of Sciences has called for the development of a Learning Healthcare System in which patients and clinicians work together to choose care, based on best evidence, and to drive discovery as a natural outgrowth of every clinical encounter to ensure innovation, quality and value at the point of care. However, the vision of a Lea...

Background: The importance of a holistic approach with a comprehensive multidisciplinary team, including nutritional and psychosocial support, is becoming well recognised as a key contributor to optimal care in paediatric inflammatory bowel disease [IBD]. The Paediatric committee of ECCO [P-ECCO] aimed to determine important components that would...

This study investigates the relation of the incidence of georeferenced tweets related to respiratory illness to the incidence of influenza-like illness (ILI) in the emergency department (ED) and urgent care clinics (UCCs) of a large pediatric hospital. We collected (1) tweets in English originating in our hospital’s primary service area between 11/...

Health services research suggests that health care could perform a great deal better than it does today. To improve the care of patients requires more than knowledge; achievement of improvements requires the application of the principles of continuous quality improvement. One of the barriers to quality improvement is unnecessary variation in care....

Background: Pediatric chronic illness care models are traditionally organized around acute episodes of care and may not meet the needs of patients and their families. Interventions that extend the patient-clinician interaction beyond the health care visit, allow for asynchronous and bidirectional feedback loops that span visits and daily life, and...

BACKGROUND Network-based Learning Health Systems that facilitate patient, clinician and researcher collaboration are emerging as a means to improve health and the healthcare system. The first step to engaging in a network is becoming aware that one exists. OBJECTIVE Our objective was to determine whether an Internet-based communication campaign wi...

Background Healthcare improvement work benefits from diverse stakeholder participation. Great strides are being made towards formal collaborative relationships with patients and their caregivers. But how will we know if these overtures evolve into true partnerships? Reliable methods for tracking participation are needed to understand and enumerate...

Standardization of Inflammatory Bowel Disease (IBD) care through participation in the ImproveCareNow (ICN) Network has improved outcomes for pediatric patients with IBD, but under the current care model, our improvements have plateaued. Current ICN model care guidelines recommend health supervision visits every six months. We identified a gap in ou...

Introduction: Improving symptoms for patients with chronic illness is difficult due to poor recall and imprecise assessments of therapeutic response to inform treatment decisions. Daily variation in symptoms may obscure subtle improvement or lead to erroneous associations between symptom changes and alteration in medication or dietary regimens. Th...

Background: Assessment of Inflammatory bowel disease (IBD) is complicated by day-to-day variation in symptoms. Management is further challenged by incomplete symptom recall and lack of data about how patients are feeling between visits. We designed a personalized learning system (PLS) to allow patients to work with their providers to track symptoms...

Efforts to ensure effective participation of patients in healthcare are called by many names-patient centredness, patient engagement, patient experience. Improvement initiatives in this domain often resemble the efforts of manufacturers to engage consumers in designing and marketing products. Services, however, are fundamentally different than prod...

Introduction: We collaborated with the ImproveCareNow Network to create a proof-of-concept architecture for a network-based Learning Health System. This collaboration involved transitioning an existing registry to one that is linked to the electronic health record (EHR), enabling a "data in once" strategy. We sought to automate a series of reports...

In this paper we compare the social network structure of people talking about Crohn's disease, Cystic Fibrosis, and Type 1 diabetes on Facebook and Twitter. We find that the Crohn's community's contributors are most emotional on Facebook and Twitter and most negative on Twitter, while the T1D community's communication network structure is most cohe...

Efforts to ensure effective participation of patients in healthcare are called by many names – patient centeredness, patient engagement, patient experience. Improvement initiatives in this domain often resemble the efforts of manufacturers to engage consumers in designing and marketing products. Services, however, are fundamentally different than p...

Through Improve Care Now, a quality improvement and research collaborative for pediatric patients with inflammatory bowel disease, our clinic piloted the feasibility and acceptability of patient-facing electronic technology to enhance engagement: This article qualitatively describes our experience piloting the. technology. Participants included 36...

Except for a few conditions, pediatric disorders are rare diseases. Because of this, no single institution has enough patients to generate adequate sample sizes to produce generalizable knowledge. Aggregating electronic clinical data from millions of children across many pediatric institutions holds the promise of producing sufficiently large data...

Objectives: ImproveCareNow (ICN) is the largest pediatric learning health system in the nation and started as a quality improvement collaborative. To test the feasibility and validity of using ICN data for clinical research, we evaluated the effectiveness of anti-tumor necrosis factor-α (anti-TNFα) agents in the management of pediatric Crohn disea...

A learning health system (LHS) integrates research done in routine care settings, structured data capture during every encounter, and quality improvement processes to rapidly implement advances in new knowledge, all with active and meaningful patient participation. While disease-specific pediatric LHSs have shown tremendous impact on improved clini...

Background Children with juvenile idiopathic arthritis (JIA) do not receive optimal care. There is wide variation in selection of treatment, adherence with published guidelines, and the use of evidence-based care delivery processes. Improving the quality of care for JIA by decreasing these existing wide variations is essential to improve long term...

Physicians deliver about half of indicated care, and patients do about half of what it takes to stay healthy, despite the best intentions and tireless efforts of both physicians and patients. The learning healthcare system (LHS) has been proposed as a solution. As envisioned by the Institute of Medicine, an LHS would “generate and apply the best ev...

This paper introduces Collaborative Innovation Networks as an engine for self-organizing disruptive innovation. It is illustrated by the metaphor of the bee swarm through four lessons from the beehive: “centralized leadership – rotating leaders – waggle dance – attraction pheromone” as key principles for managing self-organizing teams of creators....

A learning health system enables patients, clinicians, and researchers to work together to choose care based on the best evidence, drive discovery as a natural outgrowth of patient care, and ensure innovation, quality, safety, and value in health care; all in a more real-time fashion. Our paper describes how goal-directed design (GDD) methods were...

Despite significant gains by pediatric collaborative improvement networks, the overall US system of chronic illness care does not work well. A new paradigm is needed: a Collaborative Chronic Care Network (C3N). A C3N is a network-based production system that harnesses the collective intelligence of patients, clinicians, and researchers and distribu...

Moving significant therapeutic discoveries beyond early biomedical translation or T1 science and into practice involves: (1) T2 science, identifying "the right treatment for the right patient in the right way at the right time" (eg, patient-centered outcomes research) and tools to implement this knowledge (eg, guidelines, registries); and (2) T3 st...

Presentation Quality Improvement (QI) research may be defined as “the design, development and evaluation of complex interventions aimed at the re-design of health care systems to produce improved outcomes”. The challenge of QI lies in bridging the gap between knowing what needs to happen at an individual patient level and implementing this at a sys...

Biomedical innovation has improved prevention, diagnosis, and treatment resulting in reduction in mortality for most diseases. However, health and health care disparities remain across the lifespan because these advances have not been matched by advances in delivering care, patient engagement, adherence, or access to these advanced care strategies....

Objective: To develop and evaluate a system for reliable and efficient individualized risk-based monitoring of cholesterol and 11 other tests after kidney transplantation in children. Methods: We identified system components that drive reliable individualized monitoring and used quality improvement methods to develop and implement interventions,...

Health services research suggests that health care could perform a great deal better than it does today. To improve the care of patients requires more than knowledge; achievement of improvements requires the application of the principles of continuous quality improvement. One of the barriers to quality improvement is unnecessary variation in care....

Background Interest in the use of social network analysis (SNA) in healthcare research has increased, but there has been little methodological research on how to choose the name generators that are often used to collect primary data on the social connection between individuals for SNA. Objective We sought to determine a minimum set of name generato...

Background: Experience suggests that differences in context produce variability in the effectiveness of quality improvement (QI) interventions. However, little is known about which contextual factors affect success or how they exert influence. Purpose: Using the Model for Understanding Success in Quality (MUSIQ), we perform exploratory quantitat...

Unintended variation in the care of patients with Crohn disease (CD) and ulcerative colitis (UC) may prevent achievement of optimal outcomes. We sought to improve chronic care delivery and outcomes for children with inflammatory bowel disease by using network-based quality improvement methods. By using a modified Breakthrough Series collaborative s...

In this paper we describe a longitudinal analysis of the evolution of a team of medical researchers who are trying to establish a COIN consisting of patients of a chronic disease, family members of patients, doctors, and researchers. The data analysis is based on an e-mail archive consisting of the full mailboxes of the six project leaders covering...

The Institute of Medicine's publications, To Err is Human and Crossing the Quality Chasm, publicized the widespread deficits in healthcare quality. The quality of care in inflammatory bowel disease (IBD) has not been comprehensively evaluated, in part due to a lack of well-established IBD measures of quality. Quality can be measured for evaluation,...

BACKGROUND Quality improvement (QI) efforts have become widespread in healthcare, however there is significant variability in their success. Differences in context are thought to be responsible for some of the variability seen. To develop a conceptual model that can be used by organisations and QI researchers to understand and optimise contextual f...

To use quality-improvement (QI) methods to develop and test a multimodal intervention to improve hand-hygiene compliance among health care workers (HCWs) to >90%. We used a quasi-experimental staggered intervention that was conducted on 2 similar general pediatric units within a 475-bed tertiary children's hospital. Compliance was defined as accept...

Catheter-associated bloodstream infections (CA-BSIs) are associated with increased morbidity and mortality. Previous investigations have reported outbreaks of CA-BSI temporally associated with the use of needleless connector valves or similar devices. We observed an unexpected increase in the rate of CA-BSI at our institution during August 2009. We...

Unlabelled: There is significant variation in diagnostic testing and treatment for inflammatory bowel disease. Quality improvement science methods can help address unwarranted variations in care and outcomes. Methods: The ImproveCareNow Network was established under the sponsorship of the North American Society for Pediatric Gastroenterology, He...

Practical and objective instruments to assess pediatric Crohn's disease (CD) activity are required for observational research and quality improvement. The objectives were: 1) to determine the feasibility of completing the Pediatric Crohn's Disease Activity Index (PCDAI) and the Abbreviated PCDAI (APCDAI); and 2) to create a Short PCDAI by retaining...

The mixed results of success among QI initiatives may be due to differences in the context of these initiatives. The business and health care literature was systematically reviewed to identify contextual factors that might influence QI success; to categorize, summarize, and synthesize these factors; and to understand the current stage of developmen...

We examined and characterized variation among NICUs in the use of vitamin A supplementation for the prevention of bronchopulmonary dysplasia in extremely low birth weight infants. An historical cohort study of extremely low birth weight infants admitted within 7 days after birth to NICUs participating in the Pediatric Health Information System data...

Improving Performance in Practice (IPIP) is a large system intervention designed to align efforts and motivate the creation of a tiered system of improvement at the national, state, practice, and patient levels, assisting primary-care physicians and their practice teams to assess and measurably improve the quality of care for chronic illness and pr...

Despite the magnitude of the problem of catheter-associated bloodstream infections (CA-BSIs) in children, relatively little research has been performed to identify effective strategies to reduce these complications. In this study, we aimed to develop and evaluate effective catheter-care practices to reduce pediatric CA-BSIs. Our study was a multi-i...

Upgrading primary care is key to realizing the promise of health care reform to improve access and quality while reducing costs. Promising models, such as the patient-centered medical home and new measurement systems for detecting better population outcomes, require primary care clinicians to develop innovative ways of organizing care. Because new...

The opportunity to mobilize linkages between quality improvement (QI) and research is at an early stage. This article describes some of the opportunities for and challenges of integrating QI and more traditional forms of clinical research to achieve broad improvements in medical care. The authors suggest that such integration would include more act...

Variation in medical care can be a barrier to improving clinical outcomes. We aim to describe the variation in care of Crohn disease as provided by a broad sample of pediatric gastroenterologists. Two hundred forty-six Crohn disease patients of 93 pediatric gastroenterologists from 48 practice sites starting treatment with either thiopurine or infl...