Impact of a diagnostic strategy for appendicitis in children with acute abdominal pain in primary care: study protocol for a hybrid type 1 cluster randomised controlled trial
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Le résumé fourni par la source
BACKGROUND: Children with acute abdominal pain pose a diagnostic challenge for general practitioners (GPs), as it can be difficult to distinguish appendicitis from self-limiting conditions due to overlapping symptoms. To support GPs, a diagnostic strategy for appendicitis was developed that integrates an externally validated prediction rule with C-reactive protein point-of-care testing (CRP POCT) and risk-based management advice. This study will compare the impact of this diagnostic strategy to usual care in children with acute abdominal pain in primary care in terms of: (i) clinical effectiveness, (ii) cost-effectiveness, and (iii) implementation potential. METHODS: We will conduct a pragmatic, hybrid type 1 effectiveness-implementation, cluster randomised controlled trial in Dutch general practice. Children aged 4-18 years with acute (≤ 7 days) abdominal pain will be included. GP practices will be randomly allocated to either: (i) use of the diagnostic strategy for appendicitis, or (ii) usual care. In the intervention group, children are stratified into low, medium, or high risk for appendicitis based on a seven-item prediction rule including symptoms and signs. Management advice is tailored to appendicitis risk: safety netting for low-risk, immediate referral for high-risk, or CRP POCT for medium-risk (CRP < 10 mg/L: safety netting; CRP 10-50 mg/L: reassessment or immediate referral (based on GPs' clinical judgement and parent/child preference); CRP ≥ 50 mg/L: immediate referral). The primary outcome is referral efficiency (proportion of non-referrals amongst patients with no appendicitis during 30 days follow-up). Secondary outcomes include safety, proportion of children with CRP POCT, proportion of children with planned reassessment, child anxiety, patient satisfaction, quality of life, and costs. A parallel process evaluation will assess implementation outcomes, including the reach, adoption, implementation, and maintenance of the diagnostic strategy. We aim to include 566 children without appendicitis to determine an improvement of efficiency from 88% to 95%. DISCUSSION: We hypothesise that use of the diagnostic strategy will reduce referrals without increasing delayed diagnoses of appendicitis, compared to usual care in children presenting with acute abdominal pain in primary care. This may ultimately result in better patient outcomes, lower costs, and reduced health care resource use. TRIAL REGISTRATION: ClinicalTrials.gov: NCT06762275 (registration date: 2024/12/03).
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Impact of a diagnostic strategy for appendicitis in children with acute abdominal pain in primary care: study protocol for a hybrid type 1 cluster randomised controlled trial
- Date Crossref
- 13/08/2026
- Éditeur
- Springer Science and Business Media LLC
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University Medical Center Groningen Department of Epidemiology pays non établi dans la noticeÉtablissement de santé
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Utrecht University pays non établi dans la noticeUniversité ou école supérieure
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University Medical Center Utrecht Department of General Practice & Nursing Science pays non établi dans la noticeÉtablissement de santé
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Leiden University Medical Center Department of Public Health and Primary Care pays non établi dans la noticeOrganisme public
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University of Applied Sciences Leiden pays non établi dans la noticeUniversité ou école supérieure
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Hanoi Open University pays non établi dans la noticeUniversité ou école supérieure
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Amsterdam University Medical Centers Department of Surgery pays non établi dans la noticeÉtablissement de santé
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University of Amsterdam pays non établi dans la noticeUniversité ou école supérieure
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Martini Ziekenhuis pays non établi dans la noticeÉtablissement de santé
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Wilhelmina Children's Hospital pays non établi dans la noticeÉtablissement de santé
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Hanze University of Applied Sciences Allied Health Care and Nursing pays non établi dans la noticeUniversité ou école supérieure
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University of Groningen Department of Primary- and Long-term Care pays non établi dans la noticeUniversité ou école supérieure
Department of Epidemiology — University Medical Center Groningen, Utrecht University et Department of General Practice & Nursing Science — University Medical Center Utrecht, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.