Mainz 2015.
Study characteristics | ||
Methods | RCT. Design: double‐blind, cross‐over design. Duration: 1st arm of 28 days followed by a 28‐day washout period and then alternative treatment for 28 days. Location: multicentre in Germany. |
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Participants | 69 people with CF. | |
Interventions |
Group 1: HS 6% via PariSinusTM. Group 2: IS via PariSinusTM. |
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Outcomes |
Primary outcome Sinonasal outcome test (SNOT‐20) upper airway symptoms or disease‐specific QOL. Secondary outcomes Rhinoscopy, rhinomanometry, cytokines in nasal lavage. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Stated but not defined. |
Allocation concealment (selection bias) | Unclear risk | This was stated but not described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No attempt was made to blind the taste of the HS solution. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Stated but not described in detail. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All drop outs clearly defined. |
Selective reporting (reporting bias) | Low risk | All outcomes that were stated were described. |
Other bias | Low risk | No other major source of bias detected. |