1. Quality assessment of included studies.
Study | Allocation | Concealment | Study groups | Eligibility | Blinding | Attrition | Delphi list | Jadad score | Comment |
Kasseroller 1998 | random allocation; method of sequence generation not reported | unclear | no information on comparability of study groups regarding risk factors at baseline | eligibility criteria specified; number of eligible patients not stated | patient: yes; care provider: yes; outcome assessor: yes ‐ unblinding of treatment status after end of intervention | 3 dropouts | 1‐0‐0‐1‐1‐1‐1‐0‐0 | 1‐1‐1 | Selection bias possible: allocation concealment unclear, no information on distribution of risk factors at baseline. Observer/detection bias possible: no control procedure reported whether blinding was successful, details on outcome assessment not reported Performance bias possible: concomitant treatment not sufficiently described |
Mücke 2007 | random allocation; method of sequence generation not reported | serially numbered, sealed, opaque envelopes | no information on comparability of study groups regarding risk factors at baseline | eligibility criteria specified; number of eligible patients not stated | patient: no; care provider: no; outcome assessor: no | dropouts / withdrawals not reported in most recent publications | ‐‐ | ‐‐ | Preliminary results of an ongoing study (Delphi List and Jadad Score will be given when final report is available) Selection bias unlikely, but possible: allocation concealment adequate, but no information on distribution of risk factors for outcome. Observer/detection bias possible: no blinding. Performance bias possible: concomitant treatment unclear |
Zimmermann 2005 | random allocation; method of sequence generation not reported | unclear | no information on comparability of study groups regarding risk factors at baseline | eligibility criteria specified; number of eligible patients not stated | patient: unclear; care provider: unclear; outcome assessor: unclear | no dropouts or withdrawals | 1‐0‐0‐1‐0‐0‐0‐0‐0 | 1‐1‐1 | Selection bias possible: allocation concealment unclear, information on distribution of risk factors at baseline. Observer/detection bias possible: study was reported as double‐blinded ‐ informed consent form, however, contained information on intervention status, reliability and validity of outcome assessment unclear. Performance bias possible: concomitant treatment not sufficiently described. Randomisation and blinding unclear: informed consent form for participants contains the sentence "you have been allocated to the group receiving selenium supplements", while study is reported as double‐blinded |