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. 2017 Apr 13;8(5):1190–1201. doi: 10.1016/j.stemcr.2017.03.013

Table 3.

Completeness of Reporting in 23 Categories for 323a English-Language Publications of Novel Stem Cell Clinical Trials

Reporting Categoryb Completely Reported
n (% of Applicable Trials)
Partially Reported
n (% of Applicable Trials)
Not Reported
n (% of Applicable Trials)
Category Not Applicable
n
Background

Background/rationale 310 (93.1) 12 (3.6) 1 (0.3) 0

Methods

Interventions 310 (93.1) 12 (3.6) 1 (0.3) 0
Trial design 275 (82.6) 27 (8.1) 21 (6.3) 0
Primary outcome 266 (79.9) 54 (16.2) 3 (0.9) 0
Statistical methods 253 (76.0) 16 (4.8) 54 (16.2) 0
Participant criteria 246 (73.9) 57 (17.1) 19 (5.7) 0
Secondary outcome 201 (63.8) 43 (13.6) 71 (22.5) 8
Trial phase 183 (55.0) 1 (0.3) 139 (41.7) 0
Blinding 119 (55.6) 35 (16.4) 60 (28.0) 109
Randomization 116 (54.7) 54 (25.5) 42 (19.8) 111
Sample size 94 (28.2) 19 (5.7) 210 (63.1) 0

Results

Primary endpoint 295 (88.6) 14 (4.2) 14 (4.2) 0
Harms/side effects 232 (69.7) 11 (3.3) 80 (24.0) 0
Participant flow 200 (60.1) 87 (26.1) 36 (10.8) 0
Deaths 190 (57.1) 2 (0.6) 131 (39.3) 0
Recruitment period 168 (50.5) 5 (1.5) 150 (45.0) 0
Severity of harms 153 (45.9) 16 (4.8) 154 (46.2) 0

Conclusion

Generalizability 300 (90.1) 17 (5.1) 6 (1.8) 0
Interpretation 272 (81.7) 43 (12.9) 8 (2.4) 0
Limitations 191 (57.4) 66 (19.8) 66 (19.8) 0

Other

Protocol 295 (88.6) 7 (2.1) 21 (6.3) 0
Funding 276 (82.9) 5 (1.5) 42 (12.6) 0
Registration 244 (73.3) 6 (1.8) 73 (21.9) 0
a

Ten non-English-language publications were excluded from our analysis of completeness score. Percentages exclude trials with non-applicable reporting categories.

b

Reporting categories modified for early-phase clinical trials from CONSORT (Moher et al., 2010, Schulz et al., 2010).