BACKGROUND Acute appendicitis (AA) in an early stage is difficult to distinguish from other (self-limiting) causes of acute abdominal pain (e.g. constipation and gastroenteritis), resulting in missing 19% of children with AA at first presentation in primary care and 70% of non-AA cases among referrals.
OBJECTIVE To evaluate the impact of the use of a diagnostic strategy for acute appendicitis (AA), which consists of a clinical prediction rule (cPR) including C-reactive protein point-of-care test (CRP POCT), on referral efficiency in children with acute abdominal pain in primary care, as compared to usual care.
STUDY DESIGN This is a cluster randomized controlled trial in primary care with a process evaluation. GPs in the intervention group will use an externally validated cPR based on symptoms and signs selectively followed by a CRP POCT in the medium risk group. GPs from general practices allocated to the control group will provide care and diagnosis as usual, i.e. following recommendations of the Dutch College of GPs guideline 'abdominal pain in children'.
STUDY POPULATION Children aged 4 to 18 years presenting to their general practitioner (GP) with acute abdominal pain.
OUTCOME MEASURES Primary outcome: referral efficiency (proportion non-referrals in non-AA patients during 30 days follow-up).
Secondary outcomes: safety (proportion of referrals in AA patients during the first consultation or planned reassessment), proportion of children with CRP-POCT, proportion of children with planned reassessment, child anxiety, parent or child satisfaction, quality of life, and costs.
None
A history of appendectomy
Current pregnancy
Traumatic cause of abdominal pain
Parallel
Diagnostic strategy
Diagnostic testGPs' use of an externally validated cPR followed by CRP-POCT in the medium risk group. See for details: Detailed description - Intervention.
Referral efficiency
The referral efficiency is defined as the proportion of non-referrals in patients without AA during 30 days follow-up (development of appendicitis beyond this period is extremely unlikely). This corresponds with the specificity of the diagnostic strategy. Medical records of the participating children in the GPs registry, including discharge letters (hospital data), will be screened by the researchers, in order to assess whether children were referred and whether they were or were not diagnosed with AA.
Safety
Safety is defined as the proportion of children with AA who are referred during the initial GP consultation or planned reassessment. This corresponds with the sensitivity of the diagnostic strategy. Medical records of the participating children in the GPs registry, including discharge letters (hospital data), will be screened by the researchers, in order to assess whether children were referred and whether they were or were not diagnosed with AA.
Proportion of children with CRP-POCT
Proportion of children with a CRP-POCT in primary care among all children per randomized group at baseline. The researchers will review data from the GP registry to identify whether a CRP-POCT was carried out for each child.
Proportion of children with planned reassessment
Proportion of children with planned reassessment in all children per randomized group at baseline. The researchers will use GP registry data to determine whether a reassessment was planned for each child. GPs will be explicitly instructed to document in the medical files whether a reassessment was planned or unplanned.
Anxiety of child ≥8 years according to the Dutch version of the State-Trait Anxiety Inventory for Children
Children ≥8 years will complete the Dutch version of the State-Trait Anxiety Inventory for Children (STAIC) questionnaire. It measures self-perceived anxiety in children based on two scales: state-anxiety and trait-anxiety. The Dutch version of the STAIC (Zelfbeoordelingsvragenlijst voor Kinderen (ZBV-K) Versie Nu) questionnaire consists only of the state-anxiety scale. The questionnaire consists of 20 statements involving the current state of mind of the child. The score ranges from 20 to 60. The higher the score, the higher the level of state-anxiety of the child.
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University Medical Center Groningen
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Leiden University Medical Center
Collaborator
UMC Utrecht
Collaborator
