Andrew developed a quality score for evaluating the methodology of clinical trials using radiographic contrast material. The authors is from Oslo, Norway.
Parameters for the evaluation:
(1) aim of the trial
(2) study design (type, model, blinding)
(3) randomization
(4) patient material (size, inclusion. exclusion criteria)
(5) informed consent
(6) patients excluded
(7) contrast media and dosage
(8) injection and other relevant procedural conditions
(9) effect/side-effect parameters recorded
(10) statistical analysis of the results
(11) conclusion
|
Parameters |
Finding |
Points |
|
aim of the trial |
not defined |
0 |
|
|
not adequately defined |
1 |
|
|
relevant and well-defined |
2 |
|
study design |
poor (no comparative groups, etc.) |
0 |
|
|
inadequate (comparative, single blind or open) |
1 |
|
|
adequate (comparative, double blind) |
2 |
|
randomization |
none |
0 |
|
|
inadequate (or no randomization in not comparative studies) |
1 |
|
|
adequate (complete, block, stratified) |
2 |
|
patient material |
not defined |
0 |
|
|
inadequately defined |
1 |
|
|
well-defined |
2 |
|
informed consent |
not mentioned |
0 |
|
|
obtained |
1 |
|
|
obtained and specified where or by whom the information was given |
2 |
|
patients excluded |
not mentioned |
0 |
|
|
only number of exclusions mentioned |
1 |
|
|
stated with reason for exclusion |
2 |
|
|
stated no exclusion |
2 |
|
contrast media and dosage |
poorly defined |
0 |
|
|
inadequately described |
1 |
|
|
adequately described |
2 |
|
injection and other relevant procedural conditions |
not described |
0 |
|
|
poorly described |
0 |
|
|
inadequately described |
1 |
|
|
adequately described |
2 |
|
effects/side-effect parameters recorded |
not defined |
0 |
|
|
irrelevant |
0 |
|
|
partly relevant and partly defined |
1 |
|
|
relevant and well-defined |
2 |
|
statistical analysis of the results |
not performed (if possible) |
0 |
|
|
doubtful statistics |
1 |
|
|
performed with statement of adequate methods |
2 |
|
conclusion |
wrong |
0 |
|
|
irrelevant |
0 |
|
|
inadequate |
1 |
|
|
adequate |
2 |
from Table, page 56
where:
• Comparative, double blind design and randomization may not be necessary or needed in rare investigations. In these cases evaluate other features of the design in order to assign the proper points.
quality score =
= SUM(points for all 11 criteria)
Interpretation:
• minimum score: 0
• maximum score: 22
• The higher the score the better the score.
percent of ideal score =
= (quality score) / 22 * 100%
