Table 6

PPI specified within the outline application by condition and trial characteristics

InterventionPPI details in the outline applicationTotal
N=90 n (%)
p Value
YesNo
n (%)n (%)
Aim of intervention
 Treatment40 (54.1)34 (45.9)74 (82.2)0.66*
 Prevention8 (61.5)5 (38.5)41 (45.6)
 Diagnostic1 (33.3)2 (66.7)3 (3.3)
Nature of intervention†
 Drug16 (51.6)15 (48.4)31 (34.4)0.70
 Device7 (46.7)8 (53.3)15 (16.7)0.51
 Surgery4 (25.0)12 (75.0)16 (17.8)0.01
 Education6 (60.0)4 (40.0)10 (11.1)0.75*
 Behavioural11 (64.7)6 (35.3)17 (18.9)0.35
 Physical8 (72.7)3 (27.3)11 (12.2)0.19
Setting†
 Primary care10 (47.6)11 (52.4)21 (23.3)0.47
 Secondary care30 (56.6)23 (43.4)53 (58.9)0.62
 Emergency care4 (50.0)4 (50.0)8 (8.9)1.00*
 Community6 (50.0)6 (50.0)12 (13.3)0.77
 Social care4 (66.7)2 (33.3)6 (6.7)0.68*
 Tertiary4 (66.7)2 (33.3)6 (6.7)0.68*
Blinding
 Yes‡30 (69.8)13 (30.2)43 (47.8)0.01
 No19 (40.4)28 (59.6)47 (52.2)
Involved a placebo
 No placebo39 (51.3)37 (48.7)76(84.4)0.17
 Placebo§10 (71.4)4 (28.6)14 (15.6)
Received an active intervention
 Received Placebo only¶8 (88.9)1 (11.1)9 (10.0)0.04*
 Received an active intervention41 (50.6)40 (49.4)81 (90.0)
Recruitment at diagnosis
 Yes8 (33.3)16 (66.7)24 (26.7)0.02
 No41 (62.1)25 (37.9)66 (73.3)
Long-term condition
 Yes31 (60.8)20 (39.22)51 (56.7)0.17
 No17 (47.2)19 (52.8)36 (40)
Impact of condition on life expectancy
 None36 (57.1)27 (42.9)63 (70.0)0.72
 General shortening7 (50.0)7 (50.0)14 (15.6)
 Rapid mortality6 (46.2)7 (53.9)13 (14.4)
  • *Fishers exact test.

  • †Categories are not mutually exclusive.

  • ‡Includes 23 trials in which only the outcome assessor was blind.

  • §Five trials used a double-dummy technique.

  • ¶Groups receiving placebo did not receive an active intervention.

  • PPI, patient and public involvement.