Table 1

Characteristics of the patient populations and recruitment approaches (n=300)

Characteristicn (%)
Recruitment location*
 Low-income country16 (5.3)
 Lower-middle-income country33 (11.0)
 Upper-middle-income country56 (18.7)
 High-income country202 (67.3)
Exclusion of patients with chronic diseases
 Yes205 (68.3)
 No59 (19.7)
 Unclear36 (12.0)
Recruitment strategy
 Standard299 (99.7)
 Not standard1 (0.3)
Time to decide whether to enrol
 Limited1 (0.3)
 Not reported299 (99.7)
Who first approached the patient
 Child’s clinician8 (2.7)
 Researcher or clinician unknown to patient28 (9.3)
 Other15 (5.0)
 Not reported249 (83.0)
Consent obtained and reported
 Yes275 (91.7)
 No25 (8.3)
Who obtained consent
 Child’s clinician2 (0.7)
 Researcher or clinician unknown to patient31 (10.3)
 Other6 (2.0)
 Not reported261 (87.0)
How consent was provided
 Parental permission149 (49.7)
 Parental permission and participant assent117 (39.0)
 Consent of a mature minor4 (1.3)
 Not reported30 (10.0)
Patients/families involved in trial design/conduct
 Reported9 (3.0)
 Not reported291 (97.0)
Source of recruitment†
 Inpatients74 (24.7)
 Outpatients51 (17.0)
 Clinician’s office38 (12.7)
 School70 (23.3)
 Community44 (14.7)
 Other14 (4.7)
 Unclear or not reported56 (18.7)
Primary diagnostic category‡
 Mental and behavioural disorders50 (16.7)
 Infectious and parasitic disease39 (13.0)
 Respiratory system30 (10.0)
 Conditions originating in the perinatal period28 (9.3)
 Endocrine, nutritional and metabolic diseases25 (8.3)
 Oral health19 (6.3)
 Factors influencing health status and contact with health services13 (4.3)
 Digestive system10 (3.3)
 Blood, blood forming organs and immune mechanism7 (2.3)
 Congenital malformations, deformations and chromosomal abnormalities7 (2.3)
 Nervous system7 (2.3)
 Eye and adnexa5 (1.7)
 Ear and mastoid process4 (1.3)
 Injury, poisoning and consequences of external causes4 (1.3)
 Circulatory system3 (1.0)
 External causes of morbidity and mortality3 (1.0)
 Genitourinary system3 (1.0)
 Musculoskeletal system and connective tissue3 (1.0)
 Neoplasms3 (1.0)
 Pregnancy, childbirth and the puerperium2 (0.7)
 Skin and subcutaneous tissue2 (0.7)
 Other33 (11.0)
  • *Defined according to the World Bank income classification, 2019 fiscal year.20 Some trials recruited from more than one category.

  • †Total exceeds 300 because some trials reported multiple sources.

  • ‡Defined according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision (2010).18 These data have been previously reported, but are shown here for context.9