Study | Clearly stated aim | Inclusion of consecutive patients | Prospective collection of data | Endpoints appropriate to the aim of the study | Unbiased assessment of the study endpoint | Follow-up period appropriate to the aim of the study | Loss to follow-up less than 5% | Prospective calculation of the study size | Additional criteria in the case of comparative study | Overall Score | |||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First author (year) | Adequate control group | Contemporary groups | Baseline equivalence of groups | Adequate statistical analyses | |||||||||
Aprato et al. (2021) | 2 | 2 | 0 | 2 | 0 | 1 | 2 | 0 | 2 | 1 | 2 | 2 | 16/24 |
Brumback et al. (1992) | 2 | 2 | 2 | 2 | 2 | 1 | 1 | 0 | 2 | 2 | 0 | 1 | 17/24 |
Kao et al. (1993) | 1 | 0 | 0 | 2 | 0 | 1 | 2 | 0 | – | – | – | – | 6/16 |
Mallet et al. (2005) | 2 | 2 | 0 | 2 | 0 | 2 | 1 | 0 | 2 | 2 | 2 | 2 | 17/24 |
Parulekar et al. (2021) | 0 | 2 | 0 | 2 | 0 | 2 | 2 | 0 | – | – | – | – | 8/16 |
Peterson et al. (1985) | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 0 | – | – | – | – | 8/16 |
Rajbabu et al. (2007) | 0 | 2 | 0 | 2 | 0 | 2 | 2 | 0 | – | – | – | – | 8/16 |
Coelho et al. (2008) | 2 | 2 | 0 | 2 | 0 | 2 | 2 | 0 | – | – | – | – | 10/16 |
Rose et al. (2007) | 2 | 2 | 2 | 2 | 0 | 0 | 2 | 0 | – | – | – | – | 10/16 |
Hofmann et al. (1982) | 2 | 0 | 0 | 2 | 0 | 1 | 2 | 0 | – | – | – | – | 7/16 |
Summary Statistics | Mean ± SD (range) global score for 3 comparative studies = 16.7 ± 0.6 (16– 17) | Mean ± SD global score for 7 noncomparative studies = 8.1 ± 1.5 (6–10) |