Table 1

Publication and trial characteristics (N = 300)

Study Characteristic

N (%)


Continent of corresponding author

Africa

11 (3.7)

Asia

58 (19.3)

Australia

16 (5.3)

Europe (excluding UK)

91 (30.3)

North America

87 (29.0)

South America

7 (2.3)

United Kingdom

30 (10.0)


Type of journal

General medical journal

19 (6.3)

Specialty medical journal

166 (55.3)

General pediatric journal

45 (15.0)

Specialty pediatric journal

70 (23.3)


Study design

RCT parallel

269 (89.7)

RCT crossover

19 (6.3)

RCT factorial

5 (1.7)

Other

7 (2.3)


Study type

Efficacy/Superiority

248 (82.7)

Equivalence

9 (3.0)

Non-inferiority

13 (4.3)

Not declared

2 (0.7)

None of the above

25 (8.3)

Unclear

3 (1.0)


Nature of intervention

Drug

121 (40.3)

Vaccine

16 (5.3)

Natural health product

26 (8.7)

Device

44 (14.7)

Other

93 (31.0)


Placebo-controlled

90 (30.0)


Number of centres

Multicentre

105 (35.0)

Single Centre

179 (59.7)

Unclear

16 (5.3)


Sample size

Mean (SD)

785.2 (5837.3)

Median (range), IQR

83 (6 - 71,799), 10 - 7079


Data Monitoring Committee established

14 (4.7)


Any adverse events reported

129 (43.0)


Funding source

Declared

194 (64.7)

Industry Sponsored

67/194 (34.5)


Primary outcome explicitly reported

123 (41.0)


At least one statistically significant outcome

230 (76.7)


Intervention favored

Treatment

189 (63.0)

Control

19 (6.3)

Neither

92 (30.7)


Common primary diagnostic categories

Acute Respiratory Infections

17 (5.7)

Airways

14 (4.7)

Anaesthesia

18 (6.0)

Developmental, Psychosocial, and Learning Problems

20 (6.7)

Ear, Nose, and Throat Disorders

10 (3.3)

Infectious Disease

19 (6.3)

Metabolic and Endocrine Disorders

15 (5.0)

Neonatal

28 (9.3)

Oral Health

23 (7.7)

Public Health

16 (5.3)


Hamm et al. BMC Pediatrics 2010 10:96   doi:10.1186/1471-2431-10-96

Open Data