UK‐PDRG (RR) 1998.
Methods | G: random number tables C: central allocation Patients/doctors/assessors all unblinded Intention‐to‐treat | |
Participants | UK 104 patients from arm 3 (bromocriptine) re‐randomised 51 to selegiline; 53 to control Incl and excl criteria as for UK‐PDRG 2001 | |
Interventions | Treatment: selegiline 5 mg twice a day Control: no selegiline Both groups received levodopa | |
Outcomes | Deaths | |
Notes | Patients who initially could not tolerate bromocriptine were subsequently re‐randomised to selegiline or no selegiline Mean duration of FU: 6.8 years No washout | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "random number tables" |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was carried out by an independent coordinator" Quote: "the investigators telephoned the coordinator for the treatment code, which was subsequently confirmed in writing." |
Blinding (performance bias and detection bias) Doctors, All outcomes | High risk | Quote: “An open, randomised trial” Comment: Not blinded. Unlikely to bias mortality data but may influence other more subjective outcomes. |
Blinding (performance bias and detection bias) Patients, All outcomes | High risk | |
Blinding (performance bias and detection bias) Outcome assessors, All outcomes | High risk | |
Incomplete outcome data (attrition bias) Mortality | Low risk | Rx: 51 re‐randomised, 51 analysed C: 53 re‐randomised, 53 analysed No reasons for loss documented. |
Incomplete outcome data (attrition bias) Parkinsonian impairment & disability | Unclear risk | Outcome not assessed |
Incomplete outcome data (attrition bias) Participants requiring levodopa | Unclear risk | Outcome not assessed |
Incomplete outcome data (attrition bias) Motor fluctuations & dyskinesias | Unclear risk | Outcome not assessed |
Selective reporting (reporting bias) | Unclear risk | No protocol available. |
Other bias | Unclear risk | Quote: "sponsorship from Britannia Pharmaceuticals and Sandoz Products" |