Evaluating a Clinical Prediction Rule and CRP Test to Improve Diagnosis of Acute Appendicitis in Children With Abdominal Pain in Primary Care
Led by University Medical Center Groningen · Updated on 2026-07-13
566
Participants Needed
1
Research Sites
47 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a diagnostic strategy to improve the identification of acute appendicitis AA in children aged 4 to 18 years who visit their general practitioner GP with acute abdominal pain. Early-stage AA is challenging to distinguish from other common causes like constipation or gastroenteritis. This study compares a clinical prediction rule cPR combined with a C-reactive protein point-of-care test CRP POCT to usual care to see if it improves referral efficiency without delaying diagnosis.
The study involves two groups one where GPs use the diagnostic strategy consisting of a cPR based on seven clinical signs and symptoms, followed by CRP POCT for medium-risk children and a control group where GPs provide care as usual following national guidelines without CRP testing. The cPR score guides decisions, with low-risk children receiving safety advice, high-risk children referred immediately, and medium-risk children receiving CRP testing to decide on referral or reassessment. The diagnostic strategy is integrated electronically for GPs to use during consultations.
Participants will be monitored over 30 days for referral efficiency and safety, with additional assessments at 3 months for anxiety, satisfaction, quality of life, and costs. Researchers will collect data on CRP testing use, planned reassessments, and clinical outcomes. The study uses a cluster randomized design involving multiple GP practices and includes a process evaluation of implementation. The primary outcome is the proportion of appropriate referrals, aiming to reduce unnecessary referrals while ensuring timely care for children with AA.
CONDITIONS
Brief Title
The Impact of a Diagnostic Strategy for Acute Appendicitis in Children With Acute Abdominal Pain in Primary Care
Research Team
G
Gea A. Holtman, Dr.
H
Huibert Burger, Dr.
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ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
Who Can Participate
Age: 4Years - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
Children aged 4 to 18 years with acute abdominal pain lasting 7 days or less who visit a general practitioner
You will not qualify if you...
History of appendectomy
Current pregnancy
Abdominal pain caused by trauma
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Strategy or Usual Care
Duration - 30 days
Participants either receive care using the diagnostic strategy with a clinical prediction rule and CRP blood test or usual care by their GP according to national guidelines.
Visits occur as part of routine GP consultations; some participants may have additional follow-up or reassessment visits.
Follow-up Assessments
Duration - Up to 3 months
Researchers assess referral outcomes, safety, child anxiety, satisfaction, quality of life, and healthcare costs at 30 days and 3 months after the initial visit.
Questionnaires and data collection at 30 days and 3 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Published Research Related To This Trial
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.
Esmee M Hogervorst, Roderick P Venekamp, Grietje E Knol-de Vries...