[Ref.] | Inc/Exc# | Truly randomised¶ | Groups comparable+ | Intervention clear§ | Comparable careƒ | Blinding## | Outcomes | Follow-up appropriate§§ | ITTƒƒ | Total### | |
Clear¶¶ | Appropriate++ | ||||||||||
18 | 1 | 0.5 | 0.5 | 1 | 0 | 1 | 1 | 0.33 | 1 | 0 | 6.33 |
20 | 1 | 0.5 | 0.5 | 1 | 0 | 1 | 1 | 0.67 | 1 | 0 | 6.67 |
19 | 1 | 1 | 0.5 | 1 | 0 | 1 | 1 | 0.67 | 1 | 1 | 8.17 |
12 | 1 | 0.5 | 0.5 | 1 | 0 | 1 | 1 | 0.67 | 1 | 0 | 6.67 |
9 | 1 | 0.5 | 0.5 | 1 | 0 | 0.67 | 1 | 0.67 | 1 | 0 | 6.34 |
16 | 1 | 0.5 | 0 | 1 | 0 | 1 | 1 | 0.67 | 1 | 0.5 | 6.67 |
15 | 0.5 | 1 | 0.5 | 1 | 0 | 0 | 1 | 0.33 | 1 | 1 | 6.33 |
17 | 1 | 0.5 | 1 | 1 | 0 | 0.67 | 0.5 | 0.33 | 1 | 0 | 6 |
10 | 1 | 1 | 0.5 | 1 | 0 | 0.67 | 1 | 0.67 | 1 | 0 | 6.84 |
21 | 1 | 0.5 | 0.5 | 1 | 0 | 0.67 | 1 | 0.33 | 1 | 0 | 6 |
11 | 1 | 0.5 | 1 | 1 | 0 | 1 | 1 | 0.67 | 1 | 1 | 8.17 |
14 | 1 | 0.5 | 0.5 | 1 | 0 | 1 | 1 | 0.67 | 1 | 1 | 7.67 |
13 | 1 | 0.5 | 0.5 | 1 | 0 | 1 | 1 | 0.33 | 1 | 1 | 7.33 |
Inc: inclusion; Exc: exclusion; ITT: intention to treat. #: 1: clearly defined; 0.5: inadequately defined; ¶: 1: yes (clearly described, including concealed potential allocation); 0.5: unclear; +: 1: yes; 0.5: inadequately described; 0: obvious differences; §: 1: interventions clearly defined and applied via standardised protocol; 0: intervention poorly or not defined; ƒ: 1: care programmes, other than trial options, identical; 0.5: clear but trivial differences; 0: not mentioned or important differences; ##: 1: patients, treatment providers and outcome assessors blinded to treatment group; 0.67: two of three blinded; 0.33: one of three blinded; 0: no blinding or not mentioned; ¶¶: 1: outcomes clearly defined; 0.5: inadequately defined; 0: not defined; ++: 1: outcomes include clinical success, mortality and length of stay; 0.67: includes any two; 0.33: includes any one; 0: none; §§: 1: follow-up active and of appropriate duration (>3 weeks); 0.5: active, inadequate duration; 0: not active or not defined; ƒƒ: 1: outcomes of patients who withdrew described and included in ITT analysis; 0.5: inadequately described; 0: no mention or obvious differences; ###: maximum 10. Adapted from 8.