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. 2018 Dec 17;2018(12):CD013228. doi: 10.1002/14651858.CD013228
Trial ID Outcome High risk of bias (category A)a High risk of bias (category D)b High risk of bias (category E)c High risk of bias (category G)d
Altuntas 2003 All‐cause mortality No Yes No No
Severe hypoglycaemic episodes No Yes No No
All hypoglycaemic episodes Yes No No No
Other adverse events No Yes No No
Bastyr 2000 All‐cause mortality No No Yes No
Severe hypoglycaemic episodes No No No Yes
All hypoglycaemic episodes No No Yes No
HbA1c No No Yes No
Health‐related quality of life No Yes No No
Dailey 2004 N/A
Hermann 2013 All‐cause mortality No No Yes No
Severe hypoglycaemic episodes No No No Yes
NCT01650129 N/Ae
Pfützner 2013 All‐cause mortality No No Yes No
Severe hypoglycaemic episodes No Yes No No
All hypoglycaemic episodes No Yes No No
Rayman 2007 N/A
Ross 2001 Severe hypoglycaemic episodes No Yes No No
Other adverse events No No No Yes
Z012 1997 All‐cause mortality No Yes No No
Severe hypoglycaemic episodes No Yes No No
Other adverse events Yes No No No
Z014 1997 All‐cause mortality No Yes No No
Severe hypoglycaemic episodes No Yes No No
Other adverse events Yes No No No
aClear that outcome was measured and analysed; trial report states that outcome was analysed but reports only that result was not significant (Classification A, table 2, Kirkham 2010) bClear that outcome was measured and analysed; trial report states that outcome was analysed but report no results ( Classification D, table 2, Kirkham 2010) cClear that outcome was measured but was not necessarily analysed; judgement says likely to have been analysed but not reported because of non‐significant results (Classification E, table 2, Kirkham 2010) dUnclear whether outcome was measured; not mentioned, but clinical judgement says likely to have been measured and analysed but not reported on the basis of non‐significant results
(Classification G, table 2, Kirkham 2010) eNone of the data have been published, therefore assessment of risk of outcome reporting bias is not applicable.
N/A: not applicable; HbA1c: glycosylated haemoglobin A1c; ORBIT: Outcome Reporting Bias In Trials