Appendix C Study profiles of included studies Table 57: Study profiles of included studies on diagnostic accuracy of HbA1c testing for diagnosing diabetes with retinopathy as the reference standard Study and Diagnostic Quality Study population Inclusion/exclusion criteria Reference Index test Outcomes location level of assessment standard evidence and study design Massin High risk of N=733 people who were N=33 excluded because Retinal HbA1c FPG ROC Level III-2 ()Central bias as it recruited into longitudinal photographs not gradable; no photography by continuum continuum analysis, Western included study; n=237 had been other criteria described. non-mydriatic sensitivity France people with treated for diabetes or had retinal camera, all and longitudinal a diabetes-range FPG level graded by same specificity, cohort study, during the 9-year study observer AUC, recruited in treatment period; n=246 had IFG level according to predefined 1994–96 and effect likely. at any time during study; simplified and optimal followed up for n=249 with normal FPG Wisconsin cut-offs 9–10 years; No level during study. Average protocol. invited at applicability age at baseline 52 years. 10 years to concerns in No other descriptors participate in terms of provided. microvascular setting or examination. population. McCance () Level III-2 High risk of N=927 people but Excluded subjects with Ophthalmoscopic HbA1c FPG and ROC Gila River bias as it used participation rates not retinopathy or receiving insulin exam by continuum 2hPG analysis, Indian HbA1 as reported. Included subjects or oral hypoglycaemics; also physician. sensitivity, continuum community, measure for not described, other than excluded those with missing specificity, longitudinal Arizona, USA many being 25 years of age or blood glucose measures at predefined cohort study subjects, and older. Baseline measures baseline. and optimal that has been retinopathy from Jan 1982 to Nov 1991, cut-offs going since diagnosed by mean follow up of 4.5 years. 1965; all direct community ophthalmic members over examination; 5 years invited likely that to participate. quality of tests
Appendix C Study profiles of included studies Table 57: Study profiles of included studies on diagnostic accuracy of HbA1c testing for diagnosing diabetes with retinopathy as the reference standard Study and location Diagnostic level of evidence and study design Quality assessment Study population Inclusion/exclusion criteria Reference standard Index test Outcomes Massin ()Central Western France Level III-2 longitudinal cohort study, recruited in 1994–96 and followed up for 9–10 years; invited at 10 years to participate in microvascular examination. High risk of bias as it included people with treatment effect likely. No applicability concerns in terms of setting or population. N=733 people who were recruited into longitudinal study; n=237 had been treated for diabetes or had a diabetes-range FPG level during the 9-year study period; n=246 had IFG level at any time during study; n=249 with normal FPG level during study. Average age at baseline 52 years. No other descriptors provided. N=33 excluded because photographs not gradable; no other criteria described. Retinal photography by non-mydriatic retinal camera, all graded by same observer according to simplified Wisconsin protocol. HbA1c continuum FPG continuum ROC analysis, sensitivity and specificity, AUC, predefined and optimal cut-offs McCance () Gila River Indian community, Arizona, USA Level III-2 longitudinal cohort study that has been going since 1965; all community members over 5 years invited to participate. High risk of bias as it used HbA1 as measure for many subjects, and retinopathy diagnosed by direct ophthalmic examination; likely that quality of tests N=927 people but participation rates not reported. Included subjects not described, other than being 25 years of age or older. Baseline measures from Jan 1982 to Nov 1991, mean follow up of 4.5 years. Excluded subjects with retinopathy or receiving insulin or oral hypoglycaemics; also excluded those with missing blood glucose measures at baseline. Ophthalmoscopic exam by physician. HbA1c continuum FPG and 2hPG continuum ROC analysis, sensitivity, specificity, predefined and optimal cut-offs
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