Selection (max 3 points) |
Representativeness of the sample |
1—Truly representative of the average target population (all subjects or random sampling) |
1—Somewhat representative of the average target population (not random sampling, but based on solid sampling strategies) |
0—Small or biased subgroup of potential respondents |
0—No description of the sampling strategy |
|
Sample size |
1—Justified and satisfactory |
|
0—Not justified |
|
|
Non-response rate |
1—Response rate is satisfactory (> 70%) |
|
0—Response rate is unsatisfactory (<70%) |
0—No description of response rate |
|
Comparability (max 2 points) |
Comparability of participants |
1—Study controls for the single most important factor |
1—Study controls for any additional factors |
0—Non-responders differ from responders in important ways |
|
|
Outcome (max 4 points) |
Validity of outcomes |
1—Independent blind assessment of behavior |
1—Medical record review |
0—Self-report |
0—No description |
|
Ascertainment of the exposure (risk factor) |
2—Validated measurement tool |
1—Non-validated tool but tool available or described |
0—Non-validated measurement tool and not described |
|
|
Statistical test |
1—Statistical test is clearly described and appropriate, includes confidence intervals and probability level |
|
0—Statistical test is not appropriate, not described, or incomplete |
|
|
Selection (max 3 points) |
Is the case definition adequate? |
1—Yes, with independent validation |
|
0—Yes, with record linkage or based on self-report |
0—No description |
|
Representativeness of the cases |
1—Consecutive or obviously representative series of cases |
|
0—Potential for selection biases or not stated |
|
|
Selection of controls |
1—Community controls |
|
0—Hospital controls |
0—No description |
|
Definition of controls |
1—No history of disease (endpoint) |
|
0—No description of source |
|
|
Comparability (max 2 points) |
Comparability of cases and controls on the basis of the design or analysis |
1—Study controls for the single most important factor |
1—Study controls for any additional factors |
|
|
|
Exposure (max 3 points) |
Ascertainment of the exposure |
1—Secure record |
1—Structured interview where blind to case/control status |
0—Interview not blinded to case/control status |
0—Written self-report or medical record only |
0 – No description |
Same method of ascertainment for cases and controls |
1—Yes |
|
0—No |
|
|
Non-response rate |
1—Same rate for both groups |
|
0—Non-respondents described |
0—Rate different and no designation |
|
Selection (max 4 points) |
Representativeness of the exposed cohort |
1—Truly representative of the average population within the studied community |
1—Somewhat representative of the average population within the community |
0—Selected group of uses (nurses, volunteers) |
0—No description of how the cohort was selected |
|
Selection of the non-exposed cohort |
1—Drawn from the same community as the exposed cohort |
|
0—Drawn from a different source as the exposed cohort |
0—No description of the source of the non-exposed cohort |
|
Ascertainment of exposure: |
1—Secure record (medical records) |
|
0—Self-report |
0—No description |
|
Demonstration that outcome of interest was not present at start of study |
1—Yes |
|
0—No |
|
|
Comparability (max 2 points) |
Comparability of cohorts on the basis of the design or analysis |
1—Study controls for the single most important factor |
1—Study controls for any additional factors |
|
|
|
Outcome (max 3 points) |
Assessment of outcome |
1—Independent blind assessment |
1—Record linkage |
0—Self-report |
0—No description |
|
Was follow-up long enough for outcomes to occur? |
1—Yes |
|
0—No |
|
|
Adequacy of follow up of cohorts |
1—Complete follow-up (all subjects accounted for) |
1—Subjects lost to follow-up but unlikely to introduce bias (more than 80% retention) or adequate description of those lost to follow-up |
0—Follow up Rate < 80% and no description of those lost to follow-up |
0—No description of follow up rate |
|