Trial reportAlimentary pharmacology & therapeutics2019
Longitudinal non-adherence predicts treatment escalation in paediatric ulcerative colitis.
Trial report in Alimentary pharmacology & therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01536535 (Multicenter Open-label Study Evaluating the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine to Treat Children and Adolescents With Newly Diagnosed Ulcerative Colitis.), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Multicenter Open-label Study Evaluating the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine to Treat Children and Adolescents With Newly Diagnosed Ulcerative Colitis.
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Medication adherence and influencing factors in children and adolescents with attention deficit hyperactivity disorder (ADHD): a systematic review and meta-analysis.Frontiers in pharmacology · 2026Pooled it
- Management of paediatric ulcerative colitis, part 1: Ambulatory care-An updated evidence-based consensus guideline from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition and the European Crohn's and Colitis Organisation.Journal of pediatric gastroenterology and nutrition · 2025Guideline
- Transition Failure in Pediatric Inflammatory Bowel Disease: An Underrecognized Determinant of Long-Term Outcomes.Children (Basel, Switzerland) · 2026Review
- "You Can Lead a Horse to Water, but You Can't Make It Drink". Gastroenterology Healthcare Professionals' Perceptions of Reasons for Patient Non-Adherence to Inflammatory Bowel Disease Prescribed Medication: A Qualitative Study.Patient preference and adherence · 2026Article
- What the Patient Thinks and What the Patient Does: Placebo, Nocebo, and Therapy Adherence in Ulcerative Colitis.Journal of clinical medicine · 2025Review
- "I Probably Am Being a Naughty Boy, But…" Reasons for Non-Adherence to Prescribed Medication, as Perceived by People Living with Inflammatory Bowel Disease: A Qualitative Study.Patient preference and adherence · 2025Article
- Ethical considerations in using sensors to remotely assess pediatric health behaviors.The American psychologist · 2024Article
- Accelerating digital health literacy for the treatment of growth disorders: The impact of a massive open online course.Frontiers in public health · 2023Article
- Significant advantages for first line treatment with TNF-alpha inhibitors in pediatric patients with inflammatory bowel disease - Data from the multicenter CEDATA-GPGE registry study.Frontiers in pediatrics · 2022Article
- The Impact of COVID-19 on Pediatric Adherence and Self-Management.Journal of pediatric psychology · 2020Review
- A Micro-longitudinal Approach to Measuring Medication Adherence in Pediatric Inflammatory Bowel Diseases.Journal of pediatric gastroenterology and nutrition · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
backgroundMedication 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.
aimsTo 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
methodsPROTECT (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).
resultsAmong 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.
conclusionsNon-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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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.