Trials
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Randomized Controlled Trial Multicenter Study
Recruiting to inpatient-based rehabilitation trials: lessons learned.
Effective recruitment is central to successful trials but is often problematic. This article reports the lessons learnt while recruiting stroke rehabilitation patients to a multi-centre randomised control trial. As intended, 94 participants were recruited from 12 inpatient stroke rehabilitation services in Northwest England over 12 months; however, recruitment rates were highly varied (from 0.6 to 2.5 participants per site per month) as were the nature of the stroke services and the personnel available. Consequently, bespoke recruitment procedures were needed at each site. As the assessment skills needed to screen for the selection criteria were specific to therapists, our most common strategy was for the hospital therapists to screen patients and make referrals directly to the trial team. However, we identified several strategies undertaken by the research nurse in the highest recruiting site that appeared to positively impact on recruitment. These strategies included involving the whole multidisciplinary team, being part of the stroke team, facilitating contact between the clinical and trial teams and using inclusive recruitment and watchful waiting strategies. Rehabilitation trials frequently require skilled assessments by therapists, rather than by doctors or nurses to identify potential participants. Thus, research support models need to include suitably skilled trial therapists. Recruitment can be enhanced by enthusiastic, regular and structured engagement with the entire stroke multidisciplinary team and by using inclusive recruitment and 'watchful waiting' strategies to identify and monitor potential participants.
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Randomized Controlled Trial Multicenter Study
WARRIOR-trial - is routine radiography following the 2-week initial follow-up in trauma patients with wrist and ankle fractures necessary: study protocol for a randomized controlled trial.
Extremity fractures such as wrist and ankle fractures are a common and costly healthcare problem. The management of these fractures depends on fracture type and loss of congruity of the joint, resulting in cast immobilization or operative treatment. Loss of congruity or displacement leading to uneven joint loading, osteoarthritis and an increased probability of a poor functional outcome should be identified within the first 2 weeks post-trauma, based upon radiographs to determine optimal treatment. After this period, routine radiographs are scheduled for monitoring the bone-healing process. Current protocols describe imaging at 1, 2, 6 and 12 weeks post-trauma. However, it is questionable whether routine radiography following the initial follow-up ( 2-weeks post-trauma) is cost effective. The aim of this study is to determine whether a modification of the radiographic follow-up protocol can be conducted with no worse outcome and less cost than the current standard of care for patients with a wrist or ankle fracture. ⋯ This study will provide data on (cost) effectiveness of routine radiography in the follow-up of wrist and ankle fractures, and could pave the way for a change in (inter)national protocols.
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Randomized Controlled Trial Multicenter Study
Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial.
Traumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis. ⋯ When completed, the trial aims to provide evidence on the efficacy and safety of erythropoietin in traumatic brain injury patients, and to provide clear guidance for clinicians in their management of this devastating condition.
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Randomized Controlled Trial Multicenter Study
The effects of stimulation of the autonomic nervous system via perioperative nutrition on postoperative ileus and anastomotic leakage following colorectal surgery (SANICS II trial): a study protocol for a double-blind randomized controlled trial.
Postoperative ileus and anastomotic leakage are important complications following colorectal surgery associated with short-term morbidity and mortality. Previous experimental and preclinical studies have shown that a short intervention with enriched enteral nutrition dampens inflammation via stimulation of the autonomic nervous system and thereby reduces postoperative ileus. Furthermore, early administration of enteral nutrition reduced anastomotic leakage. This study will investigate the effect of nutritional stimulation of the autonomic nervous system just before, during and early after colorectal surgery on inflammation, postoperative ileus and anastomotic leakage. ⋯ Activation of the autonomic nervous system via perioperative enteral feeding is expected to dampen the local and systemic inflammatory response. Consequently, postoperative ileus will be reduced as well as anastomotic leakage. The present study is the first to investigate the effects of enriched nutrition given shortly before, during and after surgery in a clinical setting.
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Randomized Controlled Trial Multicenter Study
Early exercise after spinal cord injury ('Switch-On'): study protocol for a randomised controlled trial.
Spinal cord injury (SCI) leads to a profound muscular atrophy, bone loss and bone fragility. While there is evidence that exercising paralysed muscles may lead to reversal of muscle atrophy in the chronic period after SCI, there is little evidence that exercise can prevent muscle changes early after injury. Moreover, whether exercise can prevent bone loss and microarchitectural decay is not clear. ⋯ The results of this trial will determine the relative effectiveness of a 12-week programme of FES-assisted cycling versus passive cycling in preventing muscle atrophy and maintaining skeletal integrity after spinal cord injury.