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. 2017 May 12;2017(5):CD012661. doi: 10.1002/14651858.CD012661
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))