Table 2.
Directness of Evidence (DoE) | |
---|---|
Study design | CT, clinical trial PCS, prospective case series RCS, retrospective case series RCT, randomized control trial |
Indication for treatment Diagnosis |
Clearly reported, ● Not clearly reported, ○ |
Demographic data Age at treatment |
Individually reported, ● Means reported, ◑ Not reported, ○ |
Treatment approach NF used, dosage, route of administration |
Reported, ● Not reported, ○ |
Efficacy outcome measures
Pre and post treatment assessment |
Reported, ● Not reported, ○ |
Safety assessment
Quantifiable adverse events per patient If drug was attributed to reported adverse events |
Reported per patient or per event, ● Events reported but not quantified, ◑ Not reported, ○ |
Follow-up Duration of follow-up at the end of treatment for all tested individuals |
˃2 months, ● <2 months, ◑ not reported, ○ |
Overall DoE score |
High, ≥5 points Moderate, between 4–5 points Low, <4 |
Risk of Bias (RoB) | |
Randomization | Randomized or concealed, ● Not randomized or concealed, ○ |
Blinding | Blinding of patient, researcher, observer, ● Single blind, ◑ No blinding, ○ |
Standardization of treatment | All patients received the same therapy, ● Different types of NFs or dosage used, ◑ Dosage modified throughout trial, ○ |
Standardization of outcome measures | Identical outcome reports, ● Reported however not standardized, ◑ Not reported, ○ |
Standardization of follow up | Identical follow up for all patients, ● Reported however not standardized, ◑ Not reported, ○ |
Missing data | No missing data; missing data mentioned/quantified and Method of handling described, ● Missing data mentioned in study but method of handling Not described, ◑ Missing data not reported, ○ |
Overall RoB score |
Low, ≥5 points Moderate, between 4–5 points High, <4 |
Grading (● = 1 Point, ◑ = 0.5 Point, ○ = 0 Point).