Domain |
Signalling items |
Authors' judgement for 'yes' |
1. Study participation |
(a) Adequate participation in study by eligible individuals |
The sampling frame and recruitment are adequately described, including methods to identify the sample sufficient to limit potential bias (number and type used, e.g. referral patterns in health care) |
(b) Description of target population |
Source population for cohort with diabetic retinopathy (DR) is clearly described |
(c) Description of baseline study sample |
Number of people with DR at baseline is clearly described |
(d) Adequate description of recruitment process |
Way of establishing the source population, selection criteria and key characteristics of the source population clearly described |
(e) Adequate description of period and place of recruitment |
Time period and place of recruitment for both baseline and follow‐up examinations are clearly described |
(f) Adequate description of inclusion/exclusion criteria |
Definition of DR and other inclusion and exclusion criteria clearly defined |
Domain overall risk of bias |
High: most items are answered with 'no'; Low: all items answered with 'yes'; Moderate: most items are answered with 'unclear' |
2. Study attrition |
(a) Adequate response rate for study participants |
Response rate (i.e., proportion of study sample completing the study and providing outcome data) is adequate |
(b) Description of process for collecting information on participants who dropped out |
Attempts to collect information on participants who dropped out are described (e.g. telephone contact, mail, registers) |
(c) Reasons for loss to follow‐up provided |
Reasons on participants who dropped out are reported |
(d) Adequate description of participants lost to follow‐up |
Key characteristics of participants lost to follow‐up are described |
(e) No important differences between participants who completed the study and those who dropped out |
Study authors described differences between participants completing the study and those who did not as not important or information provided to judge the differences |
Domain overall risk of bias |
High: most items are answered with 'no'; Low: all items answered with 'yes'; Moderate: most items are answered with 'unclear' |
3. Prognostic factor measurement |
(a) Clear definition of prognostic factor (PF) provided |
Measurements for prognostic factors (PFs) are provided |
(b) Method of PF measurement is adequately valid and reliable |
Measurements techniques for prognostic factors are described and likely to be valid and reliable, e.g., standardised, repeated |
(c) Continuous variables are reported |
Standard categories for prognostic factors / cut‐offs |
(d) Method and setting of measurement of PF is identical for all participants |
Measurements of PFs are the same for all study participants |
(e) Adequate proportion of study sample has complete data for PF |
Adequate proportion of the study sample has complete data for PF variable |
(f) Appropriate methods of imputation used for missing PF data |
Appropriate methods of imputation are used for missing PF data |
Domain overall risk of bias |
High: most items are answered with 'no'; Low: all items answered with 'yes'; Moderate: most items are answered with 'unclear' |
4. Outcome measurement |
a) Clear definition of outcome provided |
Measurement of proliferative diabetic retinopathy(PDR)/high‐risk characteristics (HRC) is defined |
(b) Method of outcome measurement is adequately valid and reliable |
Measurement of PDR/HRC has to be a part of a diagnostic assessment |
(c) Method and setting of outcome measurement is identical for all participants |
Measurements of PDR/HRC are the same for all study participants |
Domain overall risk of bias |
High: most items are answered with 'no'; Low: all items answered with 'yes'; Moderate: most items are answered with 'unclear' |
5. Adjustment for other prognostic factors |
(a) All other important PFs measured |
Important confounders are: HbA1c and duration of DM |
b) Clear definitions of important PFs measured provided |
Measurement of confounders has to be clearly described |
(c) Measurement of all important PFs adequately valid and reliable |
Measurement of confounders is valid and reliable |
(d) Measurement and setting of PF measurement identical for all participants |
Measurements of confounders are the same for all study participants |
(e) Appropriate methods are used to deal with missing values of PFs |
Strategy to impute missing confounder data is described |
(f) Important PFs accounted for in study design |
Methods section of the publication describes strategy to account for confounders |
(g) Important PFs accounted for in analysis |
Important confounders are accounted for in multivariable logistic regression and Cox proportional hazards models |
Domain overall risk of bias |
High: most items are answered with 'no'; Low: all items answered with 'yes'; Moderate: most items are answered with 'unclear' |
6. Statistical analysis and reporting |
(a) Sufficient presentation of data to assess adequacy of analytic strategy |
Mean or median values, including confidence intervals or standard errors or standard deviations provided |
(b) Strategy for model building appropriate and based on a conceptual framework or model |
The selected statistical model is adequate for the design of the study |
(c) Selected statistical model adequate for design of study |
Mainly incidence rates, uni‐ and multivariate logistic regression, Cox proportional hazard model |
(d) No selective reporting of results |
There is no selective reporting of results |
Domain overall risk of bias |
High: most items are answered with 'no'; Low: all items answered with 'yes'; Moderate: most items are answered with 'unclear' |