The methodologic quality of a clinical study or trial can be evaluated by examining its design and implementation. A score based on the key parameters can be used to evaluate the study and to compare it with other similar studies.
Parameters:
(1) randomization
(2) blinding
(3) analysis
(4) patient selection
(5) comparability of groups at baseline
(6) extent of follow-up
(7) description of treatment protocol
(8) co-interventions
(9) description of outcomes
|
Parameter |
Finding |
Points |
|
randomization |
not concealed or not sure |
1 |
|
|
concealed randomization |
2 |
|
blinding |
not blinded |
0 |
|
|
adjudicators blinded |
2 |
|
analysis |
other |
0 |
|
|
intention to treat |
2 |
|
patient selection |
selected patients or unable to tell |
0 |
|
|
consecutive eligible patients |
1 |
|
comparability of groups at baseline |
no or not sure |
0 |
|
|
yes |
1 |
|
extent of follow-up |
< 100% |
0 |
|
|
100% |
1 |
|
treatment protocol |
poorly described |
0 |
|
|
reproducibly described |
1 |
|
co-interventions (extent to which interventions applied equally across groups) |
not described |
0 |
|
|
described but not equal or not sure |
1 |
|
|
well described and all equal |
2 |
|
outcomes |
not described |
0 |
|
|
partially described |
1 |
|
|
objectively defined |
2 |
Interpretation:
• minimum score: 0
• maximum score: 14
• The higher the score, the higher the quality in the study design and implementation.
ICD-10: ,
