TABLE III.
Section | Number or Factor | Score |
Part A* | ||
1. Study size: no. of subjects (no.) | >60 | 10 |
41-60 | 7 | |
20-40 | 4 | |
<20 or not stated | 0 | |
2. Mean follow-up (mo) | >24 | 5 |
12-24 | 2 | |
<12, not stated, or unclear | 0 | |
3. No. of different surgical procedures included in each reported outcome | 1 surgical procedure only | 10 |
More than 1 surgical procedure, but >90% of subjects undergoing the 1 procedure | 7 | |
Not stated, unclear, or <90% of subjects undergoing the 1 procedure | 0 | |
4. Type of study | Randomized controlled trial | 15 |
Prospective cohort study | 10 | |
Retrospective cohort study | 0 | |
5. Diagnostic certainty | In all | 5 |
In ≥80% | 3 | |
In <80%, not stated, or unclear | 0 | |
6. Description of surgical procedure | Adequate (technique stated and necessary details of that type of procedure given) | 10 |
Fair (technique only stated without elaboration) | 5 | |
Inadequate, not stated, or unclear | 0 | |
7. Description of postoperative rehabilitation | Well described with >80% of patients complying | 5 |
Well described with 60-80% of patients complying | 3 | |
Not well described | 0 | |
Part B† | ||
1. Outcome criteria | Outcome measures clearly defined | 2 |
Timing of outcome assessment clearly stated (e.g., at best outcome after surgery or at the time of follow-up) | 2 | |
Use of outcome criteria that have reported good reliability | 3 | |
Use of outcome with good sensitivity | 3 | |
2. Procedure for assessing outcomes | Subjects recruited (results not taken from surgeon’s files) | 5 |
Investigator independent of surgeon | 4 | |
Written assessment | 3 | |
3. Description of subject selection process | Selection criteria reported and unbiased | 5 |
Recruitment rate reported >80% | 5 | |
Eligible subjects not included in the study satisfactorily accounted for or 100% recruitment | 5 |
Only 1 score to be given for each of the 7 sections.
Scores may be given for each option in each of the 3 sections if applicable.