Domains |
Signalling items |
Risk of bias ratings |
1. Study participation |
(a) Adequate participation in study by eligible individuals |
Relationship between PF and outcome ‐ |
(b) Description of target population |
High: very likely to be different for participants and eligible non‐participants |
(c) Description of baseline study sample |
Moderate: may be different for participants and eligible non‐participants |
(d) Adequate description of recruitment process |
Low: unlikely to be different for participants and eligible non‐participants |
(e) Adequate description of period and place of recruitment |
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(f) Adequate description of inclusion/exclusion criteria |
2. Study attrition |
(a) Adequate response rate for study participants |
Relationship between PF and outcome ‐ |
(b) Description of process for collecting information on participants who dropped out |
High: very likely to be different for completing and non‐completing participants |
(c) Reasons for loss to follow‐up provided |
Moderate: may be different for completing and non‐completing participants |
(d) Adequate description of participants lost to follow‐up |
Low: unlikely be different for completing and non‐completing participants |
(e) No important differences between participants who completed the study and those who dropped out |
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3. Prognostic factor (PF) measurement |
(a) Clear definition of PF provided |
Measurement of PF ‐ |
(b) Method of PF measurement is adequately valid and reliable |
High: very likely to be different for different levels of outcome of interest |
(c) Continuous variables are reported |
Moderate: may be different for different levels of outcome of interest |
(d) Method and setting of measurement of PF is identical for all participants |
Low: unlikely to be different for different levels of outcome of interest |
(e) Adequate proportion of study sample has complete data for PF |
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(f) Appropriate methods of imputation used for missing PF data |
4. Outcome measurement |
(a) Clear definition of outcome provided |
High: outcome measurement very likely to be different related to baseline level of PF |
(b) Method of outcome measurement is adequately valid and reliable |
Moderate: outcome measurement may be different related to baseline level of PF |
(c) Method and setting of outcome measurement is identical for all participants |
Low: outcome measurement unlikely to be different related to baseline level of PF |
5. Adjustment for other prognostic factors |
(a) All other important PFs measured |
Observed effect of PF on outcome ‐ |
(b) Clear definitions of important PFs measured provided |
High: very likely to be distorted by another factor related to PF and outcome |
(c) Measurement of all important PFs adequately valid and reliable |
Moderate: may be distorted by another factor related to PF and outcome |
(d) Measurement and setting of PF measurement identical for all participants |
Low: unlikely to be distorted by another factor related to PF and outcome |
(e) Appropriate methods are used to deal with missing values of PFs |
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(f) Important PFs accounted for in study design |
(g) Important PFs accounted for in analysis |
6. Statistical analysis and reporting |
(a) Sufficient presentation of data to assess adequacy of analytic strategy |
Reported results ‐ |
(b) Strategy for model building appropriate and based on a conceptual framework or model |
High: very likely to be spurious or biased related to analysis or reporting |
(c) Selected statistical model adequate for design of study |
Moderate: may be spurious or biased related to analysis or reporting |
(d) No selective reporting of results |
Low: unlikely to be spurious or biased related to analysis or reporting |