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Table 2 Registration, timeliness of registration, and primary outcome non-discordance among clinical trials published in 10 high-impact US medical specialty society journals, stratified by journal

From: Adherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals

 

Total (column %)

Registration

Timeliness of registrationa

Primary outcome comparisone

Primary outcome results

Unregistered (%)b

Overall chi-squared p value

Retrospective (%)c

Overall chi-squared p value

Retrospective after initial primary outcome ascertainment (%)c, d

Overall chi-squared p value

Non-discordant (%)c

Overall chi-squared p value

Favorable (%)f

Overall chi-squared p value

Total

486 (100)

47 (9.7)

< 0.001

99 (22.6)

0.21

67 (15.3)

0.004

249 (56.7)

.049

282 (66.4)

0.11

AJP

52 (10.7)

6 (11.5)

15 (32.6)

14 (30.4)

17 (37.0)

45 (86.5)

AJRCCM

51 (10.5)

4 (7.8)

7 (14.9)

7 (14.9)

28 (59.6)

29 (60.4)

AON

37 (7.6)

16 (43.2)

5 (23.8)

3 (14.3)

8 (38.1)

24 (72.7)

Blood

52 (10.7)

0 (0.0)

9 (17.3)

4 (7.7)

26 (50.0)

23 (60.5)

Gast.

53 (10.9)

1 (1.9)

7 (13.4)

7 (13.5)

30 (57.7)

30 (68.2)

Hep.

50 (10.3)

7 (14.0)

9 (20.9)

4 (9.3)

27 (62.8)

21 (60.0)

JACI

51 (10.5)

7 (13.7)

12 (27.3)

5 (11.4)

25 (56.8)

27 (64.3)

JCO

51 (10.5)

0 (0.0)

10 (19.6)

4 (7.8)

35 (68.6)

28 (57.1)

JACC

50 (10.3)

4 (8.0)

16 (34.8)

15 (32.6)

34 (73.9)

30 (66.7)

JASN

39 (8.0)

2 (5.1)

9 (24.3)

4 (10.8)

19 (51.4)

25 (64.1)

  1. aAmong 439 registered trials, we could not determine timeliness of registration for 2 (1 published in Gastroenterology and the other in JCO), as enrollment start date was missing from registrations. We excluded these 2 trials from analyses of association pertaining to overall timeliness of registration and timeliness of registration relative to initial primary outcome ascertainment
  2. bPercentages are expressed as fraction of total trials in each row
  3. cPercentages are expressed as fraction of registered trials in each row
  4. dDue to the nature of the primary outcome (i.e., median survival), we could not determine if retrospective registration occurred after initial primary outcome ascertainment in 8 cases: 1 in Blood; 1 in Hepatology; 2 in JACI; and 4 in JCO. These trials were excluded from analyses of association pertaining to timeliness of registration relative to initial primary outcome ascertainment
  5. e26 of 439 registered trials did not have a primary outcome designated in their publication and were, therefore, excluded from analyses of association pertaining to primary outcome concordance
  6. fPercentages are expressed as fraction of trials in each journal for which primary outcome favorability could be judged (row totals not shown)
  7. Abbreviations: AJP American Journal of Psychiatry, AJRCCM American Journal of Respiratory and Critical Care Medicine, AON Annals of Neurology, Gast. Gastroenterology, Hep. Hepatology, JACI Journal of Allergy and Clinical Immunology, JCO Journal of Clinical Oncology, JACC Journal of the American College of Cardiology, JASN Journal of the American Society of Nephrology
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