REACH Replication Study to be Presented at DDW2013

Posted on 20 February 2013 by ImproveCareNow

Dr. Richard Colletti – Network Director for ImproveCareNow – announced today that an ImproveCareNow study has been accepted for oral presentation at Digestive Diseases Week in May. This is a highly innovative study done in collaboration with the Department of Biostatistics and Epidemiology of the University of Pennsylvania. It is a replication of the REACH study, and the first pediatric comparative effectiveness study of anti-TNF drugs.

Congratulations to Mike Kappelman, Wallace Crandall and the research team. And congratulations and thank you to all of the centers whose data made this study possible. More comparative effectiveness studies are planned.

Here is the abstract:

Kappelman MD, Bailey LC, Crandall WV, Zhang P, King E, Joffe M, Colletti RB, Forrest CB and the ImproveCareNow Network

Real-World Clinical and Comparative Effectiveness of Infliximab in Pediatric Crohn’s Disease

Background and Aims: Clinical trials in pediatric Crohn’s disease (CD) are difficult to recruit for, enroll highly selected subjects, and utilize standardized protocols. Thus, efficacy data from trials may not be generalizable to clinical practice. Studies of real-world clinical effectiveness are needed to fully evaluate evolving therapeutic options. We sought to use data from a multicenter clinical registry (the ImproveCareNow Network, ICN) to evaluate the clinical and comparative effectiveness of anti-TNFα biological therapy in children with moderate to severe CD.

Methods: ICN maintains a registry of medication use and clinical and laboratory data collected during pediatric gastroenterology outpatient IBD encounters (33 centers in this analysis). We identified a cohort of new users of infliximab and adalimumab with characteristics (selection criteria) similar to subjects enrolled in the REACH clinical trial. To evaluate clinical effectiveness, Pediatric Crohn’s Disease Activity Index (PCDAI) scores and corticosteroid use were evaluated at the visit closest to 10 weeks following induction. Missing data were estimated by multiple imputation. Response (PCDAI <30 and decrease by ≥ 15 points), remission (PCDAI < 10), and steroid-free status were determined. To evaluate comparative effectiveness, we performed a trial simulation comparing 6 month outcomes of remission and steroid-free remission, adjusting for disease severity and medication use for the 6 months before the start of the trial, among biologic initiators and non-biologic users, using Cox proportional hazards models and generalized estimating equations.

Results: 192 biologic initiators (53% male, mean age 14.9 years, mean PCDAI 39.7) were included in the analysis. Overall, 80% experienced response, 39% remission, and 33% steroid free status at week 10. Among those on concomitant immunomodulators, 82% experienced response and 48% experienced remission (REACH clinical trial 88% and 59% respectively). In the trial simulation, 198 biologic trials were compared with 1157 non-biologic trials. Biologics were associated with increased remission (hazard ratio 1.5, 95% CI 1.1-2.0) and steroid free remission (hazard ratio 2.0, 95% CI 1.5-2.7), with corresponding number needed to treat (NNT) of 7.8 and 5.3.

Discussion: The real-world clinical effectiveness of anti-TNFα biological therapy observed in a multi-center pediatric IBD network is similar to the efficacy estimates from the REACH clinical trial. Concomitant immunomodulator use is associated with increased effectiveness. Compared with conventional care, biological therapy is more effective at achieving remission, particularly steroid-free remission. The NNT can be used to guide clinical decision making regarding risks and benefits. These findings support the use of the ICN registry for comparative effectiveness research.

ICN Remission Rates: A Real Improvement

Posted on 29 January 2013 by ImproveCareNow

A control chart allows us to detect when there has been a significant change—a real improvement.

This graph shows that the remission rate has been increasing steadily since February 2012, and in August 2012 the remission rate crossed the dotted line (the upper control limit), indicating that a real improvement had occurred. It also shows that the average remission rate has increased from 60% in 2007, to 71% in 2008, to 75% in 2010, and to 77% in 2012. The ImproveCareNow Network will continue to apply the Model for Improvement and use QI tools to improve the remission rate to 80% or more.

Parental Guidance

Posted on 30 October 2012 by 2endibd

Having a child with IBD means many things. It means learning a new language, a new way of living, developing new family dynamics, gaining a new perspective, and seeking, desperately, to get guidance (and to give guidance). Also, it reinforces the notion, “You don’t know what you don’t know.” But, luckily at my child’s care center, and across the ImproveCareNow Network in which our care center is a participating member, guidance is available to parents and guidance is also sought from parents.

As I watch my child learn to live with Ulcerative Colitis, I learn too. So, not only does my parental guidance come from her medical team and other parents, it comes from my child as well. She guides me by letting me know I am being overprotective or questioning too much – how did you feel today? what was your level of stomach pain? how many times did you go to the bathroom? – and that sometimes it is best to just leave the UC inquisition for another day. When she is feeling good, she just wants to relish the moment and forget about UC. She guides me to live in the moment as she has learned to do and to appreciate the gift of now.

Parents as partners and teachers is important to a child’s medical team. Parental guidance is a must when communicating a child’s flare pattern as it is as unique as are our children. My daughter’s care team relies on me and my husband to guide them through her symptoms and health pattern so they can care for her better and deliver better outcomes. It cannot be “family-centered” care without the family participating as partners in a child’s care. Doctors cannot provide the best care for IBD kids without parental guidance.

As my child is a tween, my parental guidance to her during a medical visit is to model clear communications with her medical team. When my children were very young, I would always say before a doctor’s visit, “Doctors are like detectives, and we have to give them the clues to help them solve the mystery.” Teaching our children how to communicate with doctors is a necessity. With her teen years fast approaching and college around the corner (in my mind anyway), I must use my parental guidance to prepare my daughter for life-long medical care without me. I must model the behavior she needs to learn to do life with UC on her own, someday.

Even though my daughter is only a tween, her transition to being able to care for herself must begin now. While I want to be by her side through her IBD journey forever, the reality is I cannot do that. So I must not fail her by not preparing her or guiding her toward this kind of independence. We are very fortunate, our care center has a formal transition program from pediatric to adult GI care. It is just this type of guidance that I need to receive from them to do this right.

ImproveCareNow (ICN) made transitions a focus at their recent Learning Session in Chicago. Young adult patients, medical professionals and parents came together to bring their perspectives, provide their guidance for the many transitions children with IBD face and how to navigate them as smoothly as possible. Across the ICN Network, parental guidance is not only needed, it is valued. The ICN Parent Working Group (PWG) is proof of that – parents from ICN centers are coming together to guide one another and the ICN Network.

When a child is diagnosed with IBD, or any chronic disease, parental guidance is important. Why? Because family-centered care requires a circle of communication and guidance from all involved at different points on the journey. It is the needed model to resolve the issues and meet challenges of pediatric IBD. Without the many facets of “parental guidance”, our children will not live as well as they should with IBD. So not only is parental guidance important, I believe it is required.

A sweet review

Aside

In his recent post – Vermont Children’s Hits the “Sweet Spot” for Quality Medical Care – on Fletcher Allen’s Health Care Blog, Nathaniel White had this to say:

“It is my belief that the “sweet spot” for quality medical care lies somewhere between the laboratory and the bedside. Those truly talented healthcare providers are those who are able to blend the ever-evolving science of medicine with the art of taking care of patients.”

Nathaniel White is a medical assistant in Pediatric Gastroenterology at the Vermont Children’s Hospital at Fletcher Allen – one of 36 participating ImproveCareNow centers.