Characteristic | n (%) |
Recruitment location* | |
Low-income country | 16 (5.3) |
Lower-middle-income country | 33 (11.0) |
Upper-middle-income country | 56 (18.7) |
High-income country | 202 (67.3) |
Exclusion of patients with chronic diseases | |
Yes | 205 (68.3) |
No | 59 (19.7) |
Unclear | 36 (12.0) |
Recruitment strategy | |
Standard | 299 (99.7) |
Not standard | 1 (0.3) |
Time to decide whether to enrol | |
Limited | 1 (0.3) |
Not reported | 299 (99.7) |
Who first approached the patient | |
Child’s clinician | 8 (2.7) |
Researcher or clinician unknown to patient | 28 (9.3) |
Other | 15 (5.0) |
Not reported | 249 (83.0) |
Consent obtained and reported | |
Yes | 275 (91.7) |
No | 25 (8.3) |
Who obtained consent | |
Child’s clinician | 2 (0.7) |
Researcher or clinician unknown to patient | 31 (10.3) |
Other | 6 (2.0) |
Not reported | 261 (87.0) |
How consent was provided | |
Parental permission | 149 (49.7) |
Parental permission and participant assent | 117 (39.0) |
Consent of a mature minor | 4 (1.3) |
Not reported | 30 (10.0) |
Patients/families involved in trial design/conduct | |
Reported | 9 (3.0) |
Not reported | 291 (97.0) |
Source of recruitment† | |
Inpatients | 74 (24.7) |
Outpatients | 51 (17.0) |
Clinician’s office | 38 (12.7) |
School | 70 (23.3) |
Community | 44 (14.7) |
Other | 14 (4.7) |
Unclear or not reported | 56 (18.7) |
Primary diagnostic category‡ | |
Mental and behavioural disorders | 50 (16.7) |
Infectious and parasitic disease | 39 (13.0) |
Respiratory system | 30 (10.0) |
Conditions originating in the perinatal period | 28 (9.3) |
Endocrine, nutritional and metabolic diseases | 25 (8.3) |
Oral health | 19 (6.3) |
Factors influencing health status and contact with health services | 13 (4.3) |
Digestive system | 10 (3.3) |
Blood, blood forming organs and immune mechanism | 7 (2.3) |
Congenital malformations, deformations and chromosomal abnormalities | 7 (2.3) |
Nervous system | 7 (2.3) |
Eye and adnexa | 5 (1.7) |
Ear and mastoid process | 4 (1.3) |
Injury, poisoning and consequences of external causes | 4 (1.3) |
Circulatory system | 3 (1.0) |
External causes of morbidity and mortality | 3 (1.0) |
Genitourinary system | 3 (1.0) |
Musculoskeletal system and connective tissue | 3 (1.0) |
Neoplasms | 3 (1.0) |
Pregnancy, childbirth and the puerperium | 2 (0.7) |
Skin and subcutaneous tissue | 2 (0.7) |
Other | 33 (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