Woodfield 2005.
Methods | Double‐blind, randomised controlled 'N‐of‐1' trial, set in New Zealand | |
Participants | 13 elderly participants (median age 75 years), suffering at least 2 cramps per week | |
Interventions | 2‐week washout period followed by 3 x 4‐week treatment blocks in which participants are randomised to either placebo or quinine sulphate (200 to 300 mg) for 2 weeks and then the other treatment for 2 weeks | |
Outcomes | Cramp number, cramp days | |
Notes | General practices in New Zealand | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomly assigned to one of eight possible treatment sequences..."; "...copy of the randomisations code..." Comment: probably done as description suggests centrally‐organised randomisation codes |
Allocation concealment (selection bias) | Low risk | Quote: "A sealed copy of the randomisation code..."; " A master copy of the randomisation codes was also held by the research supervisor..." Comment: probably done |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "Both the patients and the researcher interacting with them and conducting the analyses were blinded..." Comment: adequate double‐blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Full explanation provided for the 3 drop‐outs |
Selective reporting (reporting bias) | Low risk | All outcomes measured that were described in the initial protocol were addressed in the analysis |
Other bias | Unclear risk | Participants continued with their most recent dose of quinine, thus this varied between participants |
RCT: randomised controlled trial