Pragmatic Trial of Health Care Technologies to Improve Adherence to Pediatric Asthma Treatment

Bender, Bruce G.; Cvietusa, Peter; Goodrich, Glenn K.; Lowe, Ryan; Nuanes, Heather; Rańd, Cynthia S.; Shetterly, Susan; Tacinas, Cathy; Vollmer, William M.; Wägner, Nicole; Wamboldt, Frederick S.; Xu, Stanley; Magid, David J.

doi:10.1001/jamapediatrics.2014.3280

Cited by 86 publications

(103 citation statements)

References 19 publications

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“…The asthma diary entry rate was exceptionally high (93.5% on average) in the present study. We also found that daily medication administration rates were relatively high relative to those of other reports (Bender et al, ; Otsuki et al, ), with 25 caregivers (55.6%) reporting total medication compliance and 20 (44.4%) describing being unable to achieve full compliance with medication regimens. It is important to note here; however, that a social desirability bias may have driven some participants to answer more favorably when asked about medication compliance or to complete diary entries.…”

Section: Discussionsupporting

confidence: 42%

Effects of maintaining web‐based diaries by caregivers on adherence to care regimens in preschoolers with asthma

Hashi

Tsukasaki

Nakamura

et al. 2019

Specialist Pediatric Nursing

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Background The objective of this pilot study was to assess the effects of maintaining web‐based diaries by the caregivers of preschoolers with asthma on the adherence to asthma care regimens, the recognition of asthma symptoms, and their perceived levels of parenting stress, quality of life, and family functioning. Design and Methods The caregivers of preschoolers with asthma completed a 4‐week web‐based diary and received weekly emails that depicted their children's asthma symptoms. We compared asthma symptoms from before and after the intervention. We analyzed demographic data, such as the caregivers’ age and education, and assessment scores from the Japanese Pediatric Asthma Control program (JPAC), Adherence with Asthma Management for Caregivers of Preschoolers (AAMCP), General Functioning subscale of the Family Assessment Device (GF‐FAD), Parenting Stress Index Short Form (PSI‐SF), and Quality of Life assessment scale for Caregivers of Asthmatic Children 24 (QOLCA‐24). Results A total of 45 participants were included in the analyses. The mean scores depicting asthma control were significantly improved postintervention (pre: 12.29 ± 2.65; post: 13.02 ± 2.01; t = −2.15, p = .037). Mean AAMCP scores postintervention (52.13 ± 6.25) were significantly greater than before (49.78 ± 7.20; t = −3.07; p = .004). Practice Implications Adherence to asthma care and the recognition of asthma symptoms improved following the use of a web‐based diary, making it a potential cost‐effective intervention for asthma patients and their families.

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Section: Discussionsupporting

confidence: 42%

Effects of maintaining web‐based diaries by caregivers on adherence to care regimens in preschoolers with asthma

Hashi

Tsukasaki

Nakamura

et al. 2019

Specialist Pediatric Nursing

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“…on May 11, 2018. by guest www.bloodjournal.org From better palatability may also improve adherence among pediatric patients and should be developed. Other methods to improve adherence, such as direct supervision or various reminder systems, 74 may be needed in patients with suboptimal responses to TKIs. Another factor that needs to be considered is the cumulative cost of TKI therapy in children who may need decades of treatment, although this may become less of an issue in the near future with the introduction of generic products.…”

Section: Pediatric CML May Require a Different Approach To Tki Treatmentmentioning

confidence: 99%

Pediatric chronic myeloid leukemia is a unique disease that requires a different approach

Hijiya

Schultz

Metzler

et al. 2016

Blood

167

176

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Chronic myelogenous leukemia (CML) in children is relatively rare. Because of a lack of robust clinical study evidence, management of CML in children is not standardized and often follows guidelines developed for adults. Children and young adults tend to have a more aggressive clinical presentation than older adults, and prognostic scores for adult CML do not apply to children. CML in children has been considered to have the same biology as in adults, but recent data indicate that some genetic differences exist in pediatric and adult CML. Because children with CML may receive tyrosine kinase inhibitor (TKI) therapy for many decades, and are exposed to TKIs during a period of active growth, morbidities in children with CML may be distinct from those in adults and require careful monitoring. Aggressive strategies, such as eradication of CML stem cells with limited duration and intensive regimens of chemotherapy and TKIs, may be more advantageous in children as a way to avoid lifelong exposure to TKIs and their associated adverse effects. Blood and marrow transplantation in pediatric CML is currently indicated only for recurrent progressive disease, and the acute and long-term toxicities of this option should be carefully evaluated against the complications associated with lifelong use of TKIs.

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“…Although pragmatic drug trials in children are generally lacking, recent interventional pragmatic trials provide some insight into trial execution. The Breathe Well study was a pragmatic interventional study designed to evaluate adherence in pediatric asthma by comparing usual care to speech recognition calls using personalized EHR information (eg, child's name and sex, physician name, medication name) when inhaled corticosteroid refills were due . The intervention resulted in a 25% increase in adherence (9% absolute difference); however, there was no observed difference in sick visits or β‐agonist use .…”

Section: Clinical Trial Optimizationmentioning

confidence: 99%

Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children

Balevic

Cohen‐Wolkowiez

2018

The Journal of Clinical Pharma

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Almost half of recent pediatric trials failed to achieve labeling indications, due in large part to inadequate study design. Therefore, innovative study methods are crucial to optimize trial design while also reducing the potential harms inherent with drug investigation. Several methods exist to optimize the amount of pharmacokinetic (PK) data collected from the smallest possible volume and with the fewest number of procedures, including the use of opportunistic and sparse sampling, alternative and non-invasive matrices, and micro-volume assays. In addition, large research networks using master protocols promote collaboration, reduce regulatory burden, and increase trial efficiency for both early- and late-phase trials. Large pragmatic trials that leverage electronic health records can capitalize on central management strategies to reduce costs, enroll patients with rare diseases on a large scale, and augment study generalizability. Further, trial efficiency and safety can be optimized through Bayesian adaptive techniques that permit planned protocol changes based on analyses of prior and accumulated data. In addition to these trial design features, advances in modeling and simulation have paved the way for systems-based and physiologically-based models that individualize pediatric dosing recommendations and support drug approval. Lastly, given the low prevalence of many pediatric diseases, collecting de-identified genetic and clinical data on a large scale is a potentially transformative way to augment clinical pharmacology research in children.

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Pragmatic Trial of Health Care Technologies to Improve Adherence to Pediatric Asthma Treatment

Abstract: clinicaltrials.gov Identifier: NCT00958932.

Cited by 86 publications

References 19 publications

Effects of maintaining web‐based diaries by caregivers on adherence to care regimens in preschoolers with asthma

Effects of maintaining web‐based diaries by caregivers on adherence to care regimens in preschoolers with asthma

Pediatric chronic myeloid leukemia is a unique disease that requires a different approach

Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children

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