the same study. concern. 33% male; disease, chronic gastrointestinal disease, history of alcohol or drug Applicable to 2012b: n=780, mean abuse (n=91); n=330 excluded due to population in age 45 ± years, missing data. Total n=1,019. Also question; 42% male (exclusions excluded if positive to hepatitis C or high-risk not described). B, or if anaemic, but numbers not population in provided. Study on pre-diabetes Italy. excluded people found to have diabetes from analysis. Low risk of Patients with high risk Included patients with hypertension, 6.0%≥ 5.6 mmol/L≥ FPG 3x3 table, Cavagnolli () Level III-2 ≥6.5% bias. of diabetes referred family history of hypertension, HbA1c FPG ≥7.0 ROC Porto Alegre, Study of (unclear where from) diabetes or cardiovascular disease. <6.5% <7.0 mmol/L; analysis Brazil subjects Few for OGT tests, all Excluded participants with conditions referred to applicability 7.8 mmol/L≥ 2hPG Brazilians with 84% known to interfere with HbA1c results hospital clinical concerns; 2hPG ≥11.1 white, 39% males. (e.g. anaemia, variant haemoglobin). pathology Brazilian <11.1 mmol/L department for study but OGT tests. majority of subjects of European descent. Cut-offs appropriate. Table 59: Study profiles of included studies on diagnostic accuracy of HbA1c testing for diagnosing diabetes: studies not included in meta-analysis but providing diagnostic accuracy data Study and Diagnostic Quality Study population Inclusion/exclusion criteria HbA1c HbA1c Reference Reference Outcomes location level of assessment cut-off— cut-off— standard standard evidence and diabetes (FPG cut-off(s): study design and/or OGT (FPG and/or OGT
the same study. concern. Applicable to population in question; high-risk population in Italy. 33% male; 2012b: n=780, mean age 45 ± years, 42% male (exclusions not described). disease, chronic gastrointestinal disease, history of alcohol or drug abuse (n=91); n=330 excluded due to missing data. Total n=1,019. Also excluded if positive to hepatitis C or B, or if anaemic, but numbers not provided. Study on pre-diabetes excluded people found to have diabetes from analysis. Cavagnolli () Porto Alegre, Brazil Level III-2 Study of subjects referred to hospital clinical pathology department for OGT tests. Low risk of bias. Few applicability concerns; Brazilian study but majority of subjects of European descent. Cut-offs appropriate. Patients with high risk of diabetes referred (unclear where from) for OGT tests, all Brazilians with 84% white, 39% males. Included patients with hypertension, family history of hypertension, diabetes or cardiovascular disease. Excluded participants with conditions known to interfere with HbA1c results (e.g. anaemia, variant haemoglobin). 6.0%≥ HbA1c <6.5% ≥6.5% 5.6 mmol/L≥ FPG <7.0 mmol/L; 7.8 mmol/L≥ 2hPG <11.1 mmol/L FPG ≥7.0 2hPG ≥11.1 3x3 table, ROC analysis Table 59: Study profiles of included studies on diagnostic accuracy of HbA1c testing for diagnosing diabetes: studies not included in meta-analysis but providing diagnostic accuracy data Study and location Diagnostic level of evidence and study design Quality assessment Study population Inclusion/exclusion criteria HbA1c cut-off— HbA1c cut-off— diabetes Reference standard (FPG and/or OGT Reference standard cut-off(s): (FPG and/or OGT Outcomes
1267-FinalContractedAssessmentReport-accessible.DOCX