Hatala et al used a scoring system for evaluating the methodology of clinical trials. The authors are from McMaster University in Canada.
Parameters used to evaluate the clinical trial methodology:
(1) randomization
(2) follow-up
(3) blinding of outcome assessors
(4) intention-to-treat analysis
(5) inclusion and exclusion criteria specified
(6) co-intervention
(7) compliance
(8) blinding of patients
(9) defined outcome measures
where:
• 7 of the 9 items are similar to those used in the methodologic score of Heyland et al (above).
|
Parameter |
Finding |
Points |
|
randomization |
complete concealment of randomization |
2 |
|
|
partial concealment |
1 |
|
|
clearly manipulation |
0 |
|
|
not stated |
0 |
|
follow-up |
> 80% of randomly assigned patients accounted for in any of the outcome assessments |
2 |
|
|
<= 80% patients accounted for |
0 |
|
blinding of outcome assessors |
assessors blinded to all outcome assessments |
2 |
|
|
assessors blinded for some outcome assessments |
1 |
|
|
assessors not blinded |
0 |
|
intention-to-treat analysis |
intention to treat analysis used |
1 |
|
|
other analysis used |
0 |
|
inclusion and exclusion criteria specified |
criteria specified |
1 |
|
|
criteria not specified |
0 |
|
co-intervention |
other interventions equally distributed between groups |
1 |
|
|
other interventions not equally distributed between groups |
0 |
|
compliance |
length of treatment recorded |
1 |
|
|
length of treatment not recorded |
0 |
|
blinding of patients |
patients blinded |
1 |
|
|
patients not blinded |
0 |
|
defined outcome measures |
defined outcome measures present |
1 |
|
|
no defined outcome measures |
0 |
where:
• Follow-up scoring mentions > 80% and < 80%, but = 80% not specified.
score =
= SUM(points for all 9 parameters) / 12
Interpretation:
• minimum score: 0
• maximum score: 1.0
• The higher the score, the better the clinical trial quality.
ICD-10: ,
