BMJ open
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Randomized Controlled Trial
Tackling statin intolerance with n-of-1 trials (TaSINI) in primary care: protocol for a feasibility randomised trial to increase statin adherence.
Statins reduce the incidence of cardiovascular disease (CVD) and cause few adverse effects. Half of patients prescribed statins discontinue treatment due to perceived intolerance. Placebo-controlled (blinded) n-of-1 trials have shown people with perceived intolerance that the statin does not cause adverse events and most resume treatment. However, blinded n-of-1 trials are impractical to deliver in routine practice. Tackling Statin Intolerance using n-of-1 trials (TaSINI) will test the feasibility of a general practitioner (GP)-delivered behavioural intervention endorsing an unblinded n-of-1 trial to increase adherence to statins relative to usual care. ⋯ This study has been granted ethical approval by North of Scotland Research Ethics Service. The results will be written up for publication and show whether to progress to an effectiveness trial where the primary outcome would be differences in low-density lipoprotein concentration.
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Randomized Controlled Trial Multicenter Study Comparative Study
Proximal Femoral Nail Unlocked versus Locked (ProFNUL): a protocol for a multicentre, parallel-armed randomised controlled trial for the effect of femoral nail mode of lag screw locking and screw configuration in the treatment of intertrochanteric femur fractures.
Intertrochanteric fractures are common fragility injuries in the elderly. Surgical fixation using intramedullary devices are one of the widely used management options. To date, evidence demonstrating the effects of lag screw configuration and the mode of lag screw locking in these devices is lacking. The purpose of this study is to investigate whether the lag screw configuration (single vs integrated dual interlocking screw) and the mode of lag screw locking (static vs dynamic) of a femoral nail device result in differences in clinical and functional outcomes. ⋯ The Central Adelaide Local Health Network Human Research Ethics Committee has approved the protocol for this RCT (HREC/17/RAH/433). The results will be disseminated via peer-reviewed publications and presentations at relevant conferences.