From: N-of-1 trials in the clinical care of patients in developing countries: a systematic review
Author (date) | Sources of risk of bias | |||||||
---|---|---|---|---|---|---|---|---|
Selection bias (random sequence generation) | Selection bias (allocation concealment) | Reporting bias (incomplete outcome data) | Reporting bias (selective reporting) | Performance bias (blinding of participants and clinicians) | Inadequate cycles (risk of error – especially type 2) | Appropriateness of treatment for design | Appropriate washout period | |
Huang, et al., (2014) [32] | Low Method of random sequence generation is describe. | Low Independent pharmacist assigned treatments | Low All outcome data are reported | Low All outcome data are reported | Low Method of blinding is adequately described | Low 3 cycles were conducted | Unclear Biochemical and pharmacokinetic information of the TM is not known | Low risk Adequate washout period based on preliminary study |
Yuhong, et al., (2012) [33] | Low Method of random sequence generation is described | Low Independent pharmacist assigned treatments | Low Acceptable reasons for missing data are given | Low All outcome data are reported | Unclear Method of blinding is not adequately described | Low 3 cycles were conducted | Unclear Biochemical and pharmacokinetic information of the TM is not known | High 2 days of washout period decided speculatively |
Wang et al., (2010) [35] | Low Method of random sequence generation is described | Low Independent pharmacist assigned treatments | Low Acceptable reasons for missing data are given | Low All outcome data are reported | Low Method of blinding is adequately described | Low 3 cycles were conducted | Unclear Biochemical and pharmacokinetic information of the TM is not known | High The length of washout period is not well justified |
Yu, et al., (2012) [36] | Low Method of random sequence generation is described | Unclear The independence of the person who assigned treatments is not well described | Low All outcome data are reported | Low All outcome data are reported | High Method of blinding is not adequately described | Low 3 cycles were conducted | Unclear Biochemical and pharmacokinetic information of the TM is not known | High The length of washout period is not well justified |
Zhang, et al., (2012) [37] | Low Method of random sequence generation is described | Unclear The independence of the person who assigned treatments is not well described | Low All outcome data are reported | Low All outcome data are reported | High Method of blinding is not adequately described | Low 3 cycles were conducted | Unclear Biochemical and pharmacokinetic information of the TM is not known | High The length of washout period is not well justified |
Louly, et al., (2009) [34] | Low Method of random sequence generation is described | Low Treatment assigned by a researcher who had no contact with the patient or result | Low All outcome data are reported | Low All outcome data are reported | Low Method of blinding is adequately described | Low 3 cycles were conducted | Low The design is suitable for tramadol | Low Adequate washout period |