Table 3.

Satisfaction of CONSORT adverse event reporting recommendations

CONSORT AE reporting recommendations	All intervention types N=107	Pharmacologic N=54	Non-pharmacologic N=53
	Articles, N (% of column)
1) Title or abstract: If the study collected data on harms and benefits, the title or abstract should so state.	39 (36)	35 (65)	4 (8)
2) Introduction: If the trial addresses both harms and benefits, the introduction should so state.	21 (20)	20 (37)	1 (2)
3) Methods: List addressed adverse events with definitions for each (with attention, when relevant, to grading, expected versus unexpected events, reference to standardized and validated definitions, and description of new definitions).	13 (12)	10 (19)	3 (6)
4) Methods: Clarify how harms-related information was collected (mode of data collection, timing, attribution methods, intensity of ascertainment, and harms-related monitoring and stopping rules, if pertinent).	42 (39)	33 (61)	9 (17)
5) Methods: Describe plans for presenting and analyzing information on harms (including coding, handling of recurrent events, specification of timing issues, handling of continuous measures, and any statistical analyses).	10 (9)	8 (15)	2 (4)
6) Results: Describe for each arm the participant withdrawals that are due to harms and their experiences with the allocated treatment.	43 (40)	34 (63)	9 (17)
7) Results: Provide the denominators for analyses on harms.	38 (36)	30 (56)	8 (15)
8) Results: Present the absolute risk per arm and per adverse event type, grade, and seriousness and present appropriate metrics for recurrent events, continuous variables, and scale variables, whenever pertinent.	50 (47)	38 (70)	12 (23)
9) Results: Describe any subgroup analyses and exploratory analyses for harms.	9 (8)	9 (17)	0 (0)
10) Discussion: Provide a balanced discussion of benefits and harms with emphasis o3).n study limitations, generalizability, and other sources of information on harms.	37 (35)	32 (59)	5 (9)
CONSORT: Consolidated Standards of Reporting Trials