Miller 2011.
Methods | This was a 2‐arm, parallel group RCT The RCT phase lasted 12 weeks, followed by a 12‐week observational follow‐up phase with no treatment |
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Participants | The trial included 21 participants with moderate to severe HS, defined as Hurley stage II or III, for at least 6 months | |
Interventions | 2 groups randomised in a 1:2 ratio (placebo:active):
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Outcomes |
Primary outcomes
Secondary outcomes
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Notes | The study did not reach its recruitment target of 30 participants because the study medication exceeded its expiry date Abbott, manufacturers of adalimumab, provided the active drug, placebo, and computer randomisation. No salary was paid to the investigators or to the department performing the study |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The random sequence generation was computer generated |
Allocation concealment (selection bias) | Unclear risk | Sequentially numbered containers were used, but the paper did not specify if the containers were opaque |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Identical syringes were used as well as the same dosing schedule. The adverse effects were unlikely to have caused unblinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Treating clinicians assessed the outcomes but were unlikely to be unblinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The trial undertook ITT analysis with LOCF and first observation carried backwards. The authors stated: "The combination of last observation carried forward and first observation carried backward ensures that for a given patient both missing values after the last observation as well as missing values prior to the first observation are imputed" |
Selective reporting (reporting bias) | Unclear risk | EudraCT: 2006‐005297‐48, but a search for the study was unsuccessful |
Other bias | High risk | Baseline disease severity was higher in the adalimumab group |