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Decision making about anti-TNF therapy: A pilot trial of a shared decision-making intervention.
Lipstein, EA, Brinkman, WB, Zhang, Y, Hommel, KA, Ittenbach, RF, Liu, C, Denson, LA
Patient education and counseling. 2022;(5):1075-1081
Abstract
OBJECTIVE We conducted a pre-post pilot trial to determine the feasibility and acceptability of a multi-component intervention (pre-clinic letter, shared decision making cards and follow-up phone call) designed to facilitate SDM in pediatric inflammatory bowel disease (IBD). METHODS We recruited physicians (n = 11) caring for IBD patients and families (n = 36) expected to discuss anti-tumor necrosis treatment. We measured feasibility and acceptability of the intervention, observed SDM, perceived SDM, decision conflict, and regret. Medical records were used to assess clinical outcomes, time to decision and adherence. We compared all outcomes between the usual care and intervention study arms. RESULTS Two out of three intervention components were feasible. Visit length increased significantly in the intervention arm. Parents and patients rated the intervention as acceptable, as did most physicians. The intervention was associated with a higher-level of observed SDM. There was no difference perceived SDM, decision conflict, regret or quality of life outcomes between arms. Physician global assessment improved over time in the intervention arm. CONCLUSIONS This pilot trial provides important guidance for developing a larger scale trial of a modified intervention. PRACTICE IMPLICATIONS Overall, our intervention shows promise in supporting SDM and engaging both parents and patients in pediatric IBD decisions.
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The Impact of COVID-19 on Pediatric Adherence and Self-Management.
Plevinsky, JM, Young, MA, Carmody, JK, Durkin, LK, Gamwell, KL, Klages, KL, Ghosh, S, Hommel, KA
Journal of pediatric psychology. 2020;(9):977-982
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Abstract
The COVID-19 pandemic has presented unique circumstances that have the potential to both positively and negatively affect pediatric adherence and self-management in youth with chronic medical conditions. The following paper discusses how these circumstances (e.g., stay-at-home orders, school closures, changes in pediatric healthcare delivery) impact disease management at the individual, family, community, and healthcare system levels. We also discuss how barriers to pediatric adherence and self-management exacerbated by the pandemic may disproportionately affect underserved and vulnerable populations, potentially resulting in greater health disparities. Given the potential for widespread challenges to pediatric disease management during the pandemic, ongoing monitoring and promotion of adherence and self-management is critical. Technology offers several opportunities for this via telemedicine, electronic monitoring, and mobile apps. Moreover, pediatric psychologists are uniquely equipped to develop and implement adherence-promotion efforts to support youth and their families in achieving and sustaining optimal disease management as the current public health situation continues to evolve. Research efforts addressing the short- and long-term impact of the pandemic on pediatric adherence and self-management are needed to identify both risk and resilience factors affecting disease management and subsequent health outcomes during this unprecedented time.
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Longitudinal non-adherence predicts treatment escalation in paediatric ulcerative colitis.
Carmody, JK, Plevinsky, J, Peugh, JL, Denson, LA, Hyams, JS, Lobato, D, LeLeiko, NS, Hommel, KA
Alimentary pharmacology & therapeutics. 2019;(8):911-918
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BACKGROUND Medication non-adherence in paediatric ulcerative colitis (UC) has been associated with negative health outcomes including flares in disease activity. However, no studies to date have examined longitudinal adherence to maintenance medication in a prospective controlled trial. AIMS To determine whether objectively measured adherence to standardised mesalazine (mesalamine) therapy over time was related to remission at 52 weeks and the need for treatment escalation in newly diagnosed paediatric patients with UC METHODS PROTECT (NCT01536535) was a prospective, inception cohort, multi-site study of paediatric patients aged 4-17 years with newly diagnosed UC followed for 52 weeks. Patients received standardised mesalazine, with pre-established criteria for escalation to thiopurines or anti-TNFα inhibitors. Patients used pill bottles with electronic caps to monitor mesalazine adherence. We tested whether longitudinal adherence to mesalazine predicted steroid-free remission at week 52 (i.e. quiescent disease on mesalazine alone with no corticosteroids ≥4 weeks prior) and need for treatment escalation (i.e. introduction of immunomodulators, calcineurin-inhibitors or anti-TNFα inhibitors). RESULTS Among 268 patients, average mesalazine adherence trajectories did not predict week 52 steroid-free remission. Declining adherence over time strongly predicted treatment escalation (β = -.037, P = .001). By month 6, adherence rate ≤85.7% was associated with treatment escalation. CONCLUSIONS Non-adherence may have affected therapeutic efficacy of standardised mesalazine, thereby contributing to need for treatment escalation. Routine adherence monitoring for at least 6 months following treatment initiation and addressing adherence difficulties early in the disease course are recommended.
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Choline Supplementation With a Structured Lipid in Children With Cystic Fibrosis: A Randomized Placebo-Controlled Trial.
Schall, JI, Mascarenhas, MR, Maqbool, A, Dougherty, KA, Elci, O, Wang, DJ, Altes, TA, Hommel, KA, Shaw, W, Moore, J, et al
Journal of pediatric gastroenterology and nutrition. 2016;(4):618-26
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BACKGROUND Choline depletion is seen in cystic fibrosis (CF) and pancreatic insufficiency in spite of enzyme treatment and may result in liver, fatty acid, and muscle abnormalities. This study evaluated the efficacy and safety of an easily absorbed choline-rich structured lipid (LYM-X-SORB™ [LXS]) to improve choline status. METHODS Children with CF and pancreatic insufficiency were randomized to LXS or placebo in a 12-month double blind trial. Dietary choline intake, plasma cholines, plasma and fecal phospholipids, coefficient of fat absorption, pulmonary function, growth status, body composition, and safety measures were assessed. Magnetic resonance spectroscopy for calf muscle choline and liver fat were assessed in a subgroup and compared with a healthy comparison group matched for age, sex, and body size. RESULTS A total of 110 subjects were enrolled (age 10.4 ± 3.0 years). Baseline dietary choline, 88% recommended, increased 3-fold in the LXS group. Plasma choline, betaine, and dimethylglycine increased in the LXS but not placebo (P = 0.007). Plasma lysophosphatidylcholine and phosphatidylcholine increased, and fecal phosphatidylcholine/phosphatidylethanolamine ratio decreased (P ≤ 0.05) in LXS only, accompanied by a 6% coefficient of fat absorption increase (P = 0.001). Children with CF had higher liver fat than healthy children and depleted calf muscle choline at baseline. Muscle choline concentration increased in LXS and was associated with improvement in plasma choline status. No relevant changes in safety measures were evident. CONCLUSIONS LXS had improved choline intake, plasma choline status, and muscle choline stores compared with placebo group. The choline-rich supplement was safe, accepted by participants, and improved choline status in children with CF.
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Treatment regimen adherence in pediatric gastroenterology.
Hommel, KA, Mackner, LM, Denson, LA, Crandall, WV
Journal of pediatric gastroenterology and nutrition. 2008;(5):526-43
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OBJECTIVE To review and critically evaluate the extant research pertaining to adherence in pediatric gastroenterological diseases, particularly inflammatory bowel disease and celiac disease, and to provide recommendations for future research development. MATERIALS AND METHODS A literature search with no date restriction was conducted using PubMed and PsychInfo electronic databases and bibliographies of relevant articles. RESULTS Adherence rates in inflammatory bowel disease and celiac disease range considerably from 16% to 62% and 5% to 70%, respectively, across treatments and assessment method; nonadherence frequency was generally not reported. Measures used to assess adherence included self-report, interview, diet record, and bioassay methods, and each measure demonstrated strengths and limitations. Limited evidence suggests that adherence in both disease populations is related to patient and family behavioral factors and that nonadherence is related to poor disease outcome. Treatment outcome research for nonadherence is scant in the current literature. CONCLUSIONS Future research should focus on refining assessment method, examining adherence and concomitant behavioral factors longitudinally, testing theoretical models of adherence, and developing efficacious treatments for nonadherence.
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A randomized clinical trial of dietary calcium to improve bone accretion in children with juvenile rheumatoid arthritis.
Stark, LJ, Davis, AM, Janicke, DM, Mackner, LM, Hommel, KA, Bean, JA, Lovell, D, Heubi, JE, Kalkwarf, HJ
The Journal of pediatrics. 2006;(4):501-7
Abstract
OBJECTIVE To examine a behavioral intervention (BI) to increase calcium intake in children with juvenile rheumatoid arthritis (JRA) on calcium intake and bone mass 6 and 12 months after treatment. STUDY DESIGN A randomized trial compared a 6-session BI to a 3-session enhanced standard of care (ESC) with 49 children ages 4 to 10 years with JRA. Calcium intake was assessed via 3-day diet diaries. Total body bone mineral content (BMC), arms and legs BMC, and lumbar spine bone mineral density were assessed by dual energy x-ray absorptiometry. RESULTS BI maintained an average calcium intake of 1500 mg/d at 6- and 12-month follow-up. This was greater than their baseline level of 972 mg/d, but not greater than the intake of 1300 mg/day maintained by ESC (P=.09). The BI had a 4% and 2.9% greater gain in total body bone mineral content than ESC at 6 and 12 months, respectively (P=.005), and a 7.1% and 5.3% greater gain in arms and legs BMC at 6 and 12 months than ESC (P=.0007). CONCLUSIONS BI is effective in increasing calcium intake and BMC in children with JRA over a 12-month period.
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Prevention of osteoporosis: a randomized clinical trial to increase calcium intake in children with juvenile rheumatoid arthritis.
Stark, LJ, Janicke, DM, McGrath, AM, Mackner, LM, Hommel, KA, Lovell, D
Journal of pediatric psychology. 2005;(5):377-86
Abstract
OBJECTIVE To test the efficacy of a behavioral intervention (BI) compared to an enhanced standard of care (ESC) dietary counseling on increasing dietary calcium (Ca) intake in children with juvenile rheumatoid arthritis (JRA). METHODS Three-day food diaries collected at baseline and posttreatment were analyzed for Ca intake in 49 children with JRA randomly assigned to either BI or an ESC treatment. RESULTS Children in the BI (N = 25) demonstrated a significantly greater increase in average dietary Ca intake (M = 839) than children in the ESC (N = 24; M = 420) (F = 14.39; p < .001). Post hoc analysis revealed that children in both groups demonstrated significant gains in dietary Ca intake baseline to posttreatment. A significantly greater percentage of children in the BI (92%) attained the goal of 1500 mg/Ca at posttreatment compared to the ESC (17%), X2= 28.09; p < .001. CONCLUSIONS Behavioral intervention can have a positive impact on increasing dietary Ca intake. Future research will need to evaluate the maintenance of gains in dietary Ca intake following treatment cessation and the impact of increased Ca intake on bone mineral density.
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Randomized trial comparing two methods of increasing dietary calcium intake in children with inflammatory bowel disease.
Stark, LJ, Hommel, KA, Mackner, LM, Janicke, DM, Davis, AM, Pfefferkorn, M, Crandall, W, Heubi, J
Journal of pediatric gastroenterology and nutrition. 2005;(4):501-7
Abstract
OBJECTIVE To examine the efficacy of behavioral intervention compared with enhanced standard of care nutrition intervention on increasing dietary calcium intake of children with inflammatory bowel disease. METHOD Children aged 5 to 12 years old (N = 32) were randomly assigned to the behavioral intervention or enhanced standard of care conditions. Three-day food diaries collected on all participants at baseline and post-treatment were analyzed for dietary calcium intake. RESULTS Children in the behavioral intervention group achieved a significantly greater mean increase in dietary calcium intake (M= 984 mg) than children in the enhanced standard of care group (M = 274 mg) (P < 0.05). In the behavioral intervention group 81% of children achieved the daily calcium intake goal of 1500 mg/day compared with only 19% of children in the enhanced standard of care group, (P < 0.05). CONCLUSIONS Behavioral modification appears to be significantly more effective than nutrition education alone in modifying calcium intake in children with inflammatory bowel disease.