Table 2 study quality according to the Downs and Black instrument for success and complications
Baldwin et al. [25] | Bernie et al. [26] | Bird et al. [27] | Brooks et al. [28] | Calvert et al. [29] | Chen et al. [30] | Danuser et al. [31] | Desai et al. [14] | Fahad [32] | Garcia-Galisteo et al. [33] | Han et al. [22] | Hanske et al. [20] | Hemal et al. [34] | Klingler et al. [35] | Link et al. [36] | Lucas et al. [16] | Memon et al. [37] | Mohammed [38] | Olweny et al. [39] | Pahwa et al. [40] | Rivas et al. [15] | Simforoosh et al. [41] | Umari et al. [42] | Wang et al. [43] | Weise and Winfield [44] | Yanke et al. [21] | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Success | ||||||||||||||||||||||||||
Hypothesis/aim/objective clearly described | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | NA | 1 | 1 | NA | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 |
Main outcomes in Introduction or Methods | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | NA | 0 | 1 | NA | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Patient characteristics clearly described | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 1 | 1 | NA | 1 | 1 | NA | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 1 |
Interventions of interest clearly described | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | NA | 1 | 1 | NA | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 1 |
Principal confounders clearly described | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | 0 | 0 | NA | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 2 |
Main findings clearly described | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | NA | 0 | 0 | NA | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Estimates of random variability provided for main outcomes | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | NA | 1 | 1 | NA | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 1 |
All adverse events of intervention reported | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | NA | 1 | 1 | NA | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 0 |
Characteristics of patients lost to follow-up described | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | 0 | 0 | NA | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
Probability values reported for main outcomes | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | 0 | 0 | NA | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
Subjects asked to participate were representative of source population | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | NA | 1 | 1 | NA | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 1 | 1 |
Subjects prepared to participate were representative of source population | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | NA | 1 | 1 | NA | 1 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Location and delivery of study treatment was representative of source population | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | NA | 1 | 1 | NA | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Study participants blinded to treatment | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | 0 | 0 | NA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Blinded outcome assessment | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | 0 | 0 | NA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Any data dredging clearly described | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | 0 | 0 | NA | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Analyses adjust for differing lengths of follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | 0 | 0 | NA | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Appropriate statistical tests performed | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | NA | 0 | 0 | NA | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 1 |
Compliance with interventions was reliable | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | 1 | 1 | NA | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Outcome measures were reliable and valid | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | NA | 0 | 0 | NA | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 1 |
All participants recruited from the same source population | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 1 | NA | 1 | 1 | NA | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 1 |
All participants recruited over the same time period | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | NA | 0 | 1 | NA | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 1 |
Participants randomized to treatment(s) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | 0 | 0 | NA | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Allocation of treatment concealed from investigators and participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | 0 | 0 | NA | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Adequate adjustment for confounding | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | 0 | 0 | NA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Losses to follow-up taken into account | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | 0 | 0 | NA | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Study power | 2 | 1 | 5 | 3 | 4 | 5 | 4 | 2 | 2 | 3 | 3 | NA | 4 | 3 | NA | 5 | 4 | 3 | 2 | 4 | 4 | 4 | 3 | 5 | 3 | 5 |
Sum | 12 | 6 | 19 | 12 | 13 | 16 | 9 | 9 | 11 | 14 | 14 | NA | 14 | 15 | NA | 23 | 16 | 13 | 15 | 13 | 20 | 13 | 17 | 19 | 17 | 25 |
Complications | ||||||||||||||||||||||||||
Hypothesis/aim/objective clearly described | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | NA | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 |
Main outcomes in Introduction or Methods | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 1 | 1 | NA | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Patient characteristics clearly described | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | NA | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 1 |
Interventions of interest clearly described | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | NA | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 1 |
Principal confounders clearly described | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 1 | 1 | NA | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 2 |
Main findings clearly described | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 1 | NA | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Estimates of random variability provided for main outcomes | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | NA | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 1 |
All adverse events of intervention reported | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | NA | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 0 |
Characteristics of patients lost to follow-up described | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | NA | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
Probability values reported for main outcomes | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | NA | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
Subjects asked to participate were representative of source population | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | NA | 1 | 1 | 1 | 0 | 1 | 0 | 1 | 1 |
Subjects prepared to participate were representative of source population | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | NA | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Location and delivery of study treatment was representative of source population | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | NA | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Study participants blinded to treatment | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Blinded outcome assessment | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Any data dredging clearly described | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | NA | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Analyses adjust for differing lengths of follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | NA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Appropriate statistical tests performed | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | NA | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 1 |
Compliance with interventions was reliable | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | NA | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Outcome measures were reliable and valid | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 1 | NA | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 1 |
All participants recruited from the same source population | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | NA | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 1 |
All participants recruited over the same time period | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | NA | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 1 |
Participants randomized to treatment(s) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Allocation of treatment concealed from investigators and participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Adequate adjustment for confounding | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | NA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Losses to follow-up taken into account | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | NA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Study power | 2 | 1 | 5 | 3 | 4 | 5 | 4 | 2 | 2 | 3 | 3 | 5 | 4 | 3 | 1 | 5 | 4 | NA | 2 | 4 | 4 | 4 | 3 | 5 | 3 | 5 |
Sum | 12 | 6 | 19 | 12 | 13 | 16 | 9 | 9 | 11 | 14 | 14 | 23 | 14 | 15 | 12 | 23 | 16 | NA | 15 | 13 | 20 | 13 | 17 | 19 | 17 | 25 |