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. 2016 Nov 26;17(12):1981. doi: 10.3390/ijms17121981

Table 2.

Legend critical appraisal. Assessment per item for critical appraisal of selected studies.

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).