Miao 2012.
Study characteristics | ||
Methods | Single‐centre RCT with 1‐year follow‐up | |
Participants | Estimated sample size: 184 Number randomised: 70 Inclusion criteria
Exclusion criteria
|
|
Interventions | ET plus CMT versus CMT alone | |
Outcomes | Primary outcomes
Secondary outcomes
|
|
Funding source | Funded by the Research Fund of Capital Medical Development (2007–2069). | |
Notes | Clinical Trial Registration URL: www.chictr.org/en/ Unique identifier: ChiCTR‐TRC‐12001989 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The randomisation numbers were produced by Randlist software (Version 1.2 \Seed: [1497369600]; http://www.randomisation.net), 4 numbers as a block." |
Allocation concealment (selection bias) | Low risk | Quote: "Patients were randomised to either the PTAS or medical group." Comment: the study used software that carried out allocations in a closed environment, and nobody knew the allocation until after enrolment had been confirmed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | As the 2 treatments were very different, blinding of participants and personnel was not possible. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Investigators who did not participate in the enrolment of the patients and were blinded to the treatment assignment..." |
Incomplete outcome data (attrition bias) All outcomes | High risk | There was a high rate of loss to 1‐year follow‐up (49/70, 30%), and 19.4% of participants randomised to the ET group refused ET. |
Selective reporting (reporting bias) | Low risk | All study outcomes were prespecified in the registered information. |
Other bias | High risk | The study was stopped early; results of an interim analysis showed similar safety and efficacy for CMT and ET. However, the final results could have changed if recruitment had continued. |