| Trial ID | |
| Signalling question | Authors' judgement for 'yes' |
| Study participation (STP) ‐ yes/noa/unclearb/NAc | |
| a. Adequate participation in the study by eligible persons | NA: usually participants with intermediate hyperglycaemia or with no diabetes at baseline are selected from a greater cohort on another research question (e.g. cardiovascular risk factors in elderly people) |
| b. Description of the source population or population of interest | Source population for cohort with intermediate hyperglycaemia is clearly described |
| c. Description of the baseline study sample | Number of people with intermediate hyperglycaemia at baseline is clearly described |
| d. Adequate description of the sampling frame and recruitment | Way of how the source population was established, selection criteria and key characteristics of the source population clearly described |
| e. Adequate description of the 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 and exclusion criteria | Definiton of people with normoglycaemia, intermediate hyperglycaemia or diabetes mellitus and description of other in‐ and exclusion criteria |
| STP risk of bias rating (high/low/unclear) |
High: majority of items is answered with 'no'; Low: all items answered with 'yes'; Unclear: majority of items is answered with 'unclear Note: potentially a single item may introduce a high risk of bias, depending on study specifics |
| Study attrition (STA) ‐ yes/no/unclear | |
| a. Adequate response rate for study participants | NA: usually participants with intermediate hyperglycaemia or with no diabetes at baseline are selected from a greater cohort (e.g. all obese people) |
| b. Description of attempts to collect 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 are provided | Reasons on participants who dropped out are available (e.g. deceased participants between baseline and follow‐up, participants moving to another location) |
| d. Adequate description of participants lost to follow‐up | Key elements of participants lost to follow‐up are described (age, sex, glucose status at baseline, body mass index) |
| e. There are no important differences between participants who completed the study and those who did not | Study authors describe differences between participants completing the study and those who did not as not important or information provided to judge the differences |
| STA risk of bias rating (high/low/unclear) |
High: majority of items is answered with 'no'; Low: all items answered with 'yes'; Unclear: majority of items is answered with 'unclear Note: potentially a single item may introduce a high risk of bias, depending on study specifics |
| Prognostic factor measurement (PFM) ‐ yes/no/unclear/NA | |
| a. A clear definition or description of the PF is provided | Measurements for intermediate hyperglycaemia are provided (e.g. IFG, IGT, elevated HbA1c) |
| b. Method of PF measurement is adequately valid and reliable | Ideally measurements for intermediate hyperglycaemia are repeated to ensure diagnosis, single measurements are accepted as well; technique for glucose measurement or HbA1c measurement described |
| c. Continuous variables are reported or appropriate cut points are used | Standard categories for intermediate hyperglycaemia (FPG 5.6‐6.9 mmol/L (IFG5.6), FPG 6.1‐6.9 mmol/L (IFG6.1), 2‐hr PG 7.8‐<11.0 mmol/L (IGT), HbA1c 6.0‐6.4% (HbA1c6.0), HbA1c 5.7‐6.4% (HbA1c5.7)) |
| d. The method and setting of measurement of PF is the same for all study participants | Measurements of intermediate hyperglycaemia are the same for all study participants |
| e. Adequate proportion of the study sample has complete data for the PF | NA: usually participants with intermediate hyperglycaemia or with no diabetes at baseline are selected from a greater cohort (e.g. proportion 100% because study focused on IGT‐subcohort) |
| f. Appropriate methods of imputation are used for missing PF data | NA: missing laboratory measurements for intermediate hyperglycaemia cannot be reliably imputed |
| PFM risk of bias rating (high/low/unclear) |
High: majority of items is answered with 'no'; Low: all items answered with 'yes'; Unclear: majority of items is answered with 'unclear Note: potentially a single item may introduce a high risk of bias, depending on study specifics |
| Outcome measurement (OM) ‐ yes/no/unclear/NA | |
| a. A clear definition of the outcome is provided | Measurement of type 2 diabetes mellitus has to be defined |
| b. Method of outcome measurement used is adequately valid and reliable | Measurement of type 2 diabetes mellitus: a glucose (FPG, PG) or HbA1c measurement has to be a part of the diagnosis (self‐reported diabetes alone will not be accepted) |
| c. The method and setting of outcome measurement is the same for all study participants | Measurements of type 2 diabetes mellitus are the same for all study participants |
| OM rating (high/low/unclear) |
High: majority of items is answered with 'no'; Low: all items answered with 'yes'; Unclear: majority of items is answered with 'unclear Note: potentially a single item may introduce a high risk of bias, depending on study specifics |
| Study confounding (SC) ‐ yes/no/unclear/NA | |
| a. All important confounders are measured | Important confounders are: age, sex, family history of diabetes, ethnicity, body mass index, blood pressure and hypertension, smoking and drinking status, socioeconomic status, comedications and comorbidities, physical activity |
| b. Clear definitions of the important confounders measured are provided | Measurement of confounders has to be clearly described |
| c. Measurement of all important confounders is adequately valid and reliable | Measurement of confounders is valid and reliable |
| d. The method and setting of confounding measurement are the same for all study participants | Measurements of confounders are the same for all study participants |
| e. Appropriate methods are used if imputation is used for missing confounder data | Strategy to impute missing confounder data is described |
| f. Important potential confounders are accounted for in the study design | Methods section of the publication describes strategy to account for confounders |
| g. Important potential confounders are accounted for in the analysis | Important confounders are accounted for in multivariate logistic regression and Cox proportional hazards models |
| SC risk of bias rating (high/low/unclear) |
High: majority of items is answered with 'no'; Low: all items answered with 'yes'; Unclear: majority of items is answered with 'unclear Note: potentially a single item may introduce a high risk of bias, depending on study specifics |
| Statistical analysis and reporting (SAR) ‐ yes/no/unclear/NA | |
| a. Sufficient presentation of data to assess the adequacy of the analytic strategy | Mean or median values, including confidence intervals or standard errors or standard deviations |
| b. Strategy for model building is appropriate and is based on a conceptual framework or model | NA: we do not anticipate conceptual frameworks or explicit model building strategies for this type of research question (focusing on one prognostic factor only) |
| c. The selected statistical model is adequate for the design of the study | Mainly incidence rates, uni‐ and multivariate logistic regression, Cox proportional hazard model |
| d. There is no selective reporting of results | NA: development of type 2 diabetes mellitus and potentially regression to normoglycaemia from intermediate hyperglycaemia are the only outcomes; if missing the study will be excluded |
| SAR risk of bias rating (high/low/unclear) |
High: majority of items is answered with 'no'; Low: all items answered with 'yes'; Unclear: majority of items is answered with 'unclear Note: potentially a single item may introduce a high risk of bias, depending on study specifics |
|
aNo: no or no relevant information to answer the signalling question bUnclear: not enough information to answer signalling question with yes or no cNA (not applicable): signalling question not appropriate for this type of prognostic review FPG: fasting plasma glucose; HbA1c: glycosylated haemoglobin A1c; IFG: impaired fasting glucose; IGT: impaired glucose tolerance; PG: post‐load glucose (after an oral glucose tolerance test (OGTT)) | |