BMJ open
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Randomized Controlled Trial
Protocol for the TIDAL Melanoma Study: topical imiquimod or diphenylcyclopropenone for the management of cutaneous in-transit melanoma metastases-a phase II, single centre, randomised, pilot study.
Patients with in-transit melanoma metastases present a therapeutic challenge. Complete surgical excision of localised disease is considered as the gold standard; however, surgery is not always acceptable and alternatives are required. Treatment results reported using imiquimod and diphenylcyclopropenone (DPCP) suggest that topical immunotherapies can be used to successfully treat select patients with melanoma metastases. A phase II, randomised, single centre, pilot study was designed to assess the clinical efficacy and safety of DPCP and imiquimod for the treatment of superficial, cutaneous in-transit melanoma metastases. ⋯ Approval was obtained from the Human Research Ethics Committee at the participating centre, and recruitment has commenced. The results of this study will be submitted for formal publication within a peer-reviewed journal.
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Randomized Controlled Trial Multicenter Study
Bypassing nearest hospital for more distant neuroscience care in head-injured adults with suspected traumatic brain injury: findings of the head injury transportation straight to neurosurgery (HITS-NS) pilot cluster randomised trial.
Reconfiguration of trauma services, with direct transport of patients with traumatic brain injury (TBI) to specialist neuroscience centres (SNCs)-bypassing non-specialist acute hospitals (NSAHs), could improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) may worsen outcomes when compared with selective secondary transfer from nearest NSAH to SNC. We conducted a pilot cluster randomised controlled trial to determine the feasibility and plausibility of bypassing suspected patients with TBI -directly into SNCs-producing a measurable effect. ⋯ Bypassing patients with suspected TBI to SNCs gives an overtriage (false positive) ratio of 13:1 for neurosurgical intervention and 4:1 for TBI. A measurable effect from a full trial of early neuroscience care following bypass is therefore unlikely.
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Randomized Controlled Trial Multicenter Study
Stepwise strategy to improve Cervical Cancer Screening Adherence (SCAN-CC): automated text messages, phone calls and face-to-face interviews: protocol of a population-based randomised controlled trial.
Screening is highly effective for cervical cancer prevention and control. Population-based screening programmes are widely implemented in high-income countries, although adherence is often low. In Portugal, just over half of the women adhere to cervical cancer screening, contributing for greater mortality rates than in other European countries. The most effective adherence raising strategies are based on patient reminders, small/mass media and face-to-face educational programmes, but sequential interventions targeting the general population have seldom been evaluated. The aim of this study is to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organised cervical cancer screening: step 1a-customised text message invitation; step 1b-customised automated phone call invitation; step 2-secretary phone call; step 3-family health professional phone call and face-to-face appointment. ⋯ The study was approved by the Ethics Committee of the Northern Health Region Administration and National Data Protection Committee. Results will be disseminated through communications in scientific meetings and peer-reviewed journals.
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Randomized Controlled Trial Multicenter Study
Evolution of pain at 3 months by oral resveratrol in knee osteoarthritis (ARTHROL): protocol for a multicentre randomised double-blind placebo-controlled trial.
Osteoarthritis (OA) pathophysiology is driven in part by joint inflammation. Resveratrol has in vitro anti-inflammatory properties. We aim to assess the efficacy of oral resveratrol for knee pain at 3 months in people with knee OA. ⋯ The oral resveratrol in knee osteoarthritis (ARTHROL) trial has been authorised by the AgenceNationale de Sécurité du Médicament et des Produits de Santé and ethics were approved by the Comité deProtection des Personnes Île-de-France III. The findings of the study will be published in a peer-reviewed journal and disseminated at conferences. The design of ARTHROL will warrant the translation of its findings into clinical practice.
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Randomized Controlled Trial Multicenter Study
A cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of the GoActive intervention to increase physical activity among adolescents aged 13-14 years.
Adolescent physical activity promotion is rarely effective, despite adolescence being critical for preventing physical activity decline. Low adolescent physical activity is likely to last into adulthood, increasing health risks. The Get Others Active (GoActive) intervention is evidence-based and was developed iteratively with adolescents and teachers. This intervention aims to increase physical activity through increased peer support, self-efficacy, group cohesion, self-esteem and friendship quality, and is implemented using a tiered-leadership system. We previously established feasibility in one school and conducted a pilot randomised controlled trial (RCT) in three schools. ⋯ Ethical approval for the conduct of the study was gained from the University of Cambridge Psychology Research Ethics Committee. Given the lack of rigorously evaluated interventions, and the inclusion of objective measurement of physical activity, long-term follow-up and testing of causal pathways, the results of a CRCT of the effectiveness and cost-effectiveness of GoActive are expected to add substantially to the limited evidence on adolescent physical activity promotion. Workshops will be held with key stakeholders including students, parents, teachers, school governors and government representatives to discuss plans for wider dissemination of the intervention.