Contemporary clinical trials communications
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Contemp Clin Trials Commun · Sep 2017
ReviewThe over-representation of significant p values in abstracts compared to corresponding full texts: A systematic review of surgical randomized trials.
Abstracts are often the only read summaries of research findings, and it is essential that they accurately represent of the contents of the full text of the randomised control trial (RCT). We investigated whether outcomes in surgical trials were selectively reported in abstracts based on their statistical significance. ⋯ Data presented in abstracts is biased to statistically significant outcomes. Clinicians and policy makers should do not rely solely on information presented in abstracts for their decision-making.
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Contemp Clin Trials Commun · Sep 2017
Quality of abstracts of randomized control trials in five top pain journals: A systematic survey.
The reporting quality of abstracts of randomized control trials (RCTs) is inadequate despite the publication of consolidated standards of reporting trials extension for abstracts (CONSORT-A). We compared the reporting quality of abstracts in pain journals before and after the publication of CONSORT-A. ⋯ Abstract reporting for trials in pain literature was better in the post-CONSORT-A period, but there is room for improvement.
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Contemp Clin Trials Commun · Jun 2017
Age-related macular degeneration in a randomized controlled trial of low-dose aspirin: Rationale and study design of the ASPREE-AMD study.
Although aspirin therapy is used widely in older adults for prevention of cardiovascular disease, its impact on the incidence, progression and severity of age-related macular degeneration (AMD) is uncertain. The effect of low-dose aspirin on the course of AMD will be evaluated in this clinical trial. ⋯ The study findings will be of significant clinical and public interest due to a potential to identify a possible low cost therapy for preventing AMD worldwide and to determine risk/benefit balance of the aspirin usage by the AMD-affected elderly. The ASPREE-AMD study provides a unique opportunity to determine the effect of aspirin on AMD incidence and progression, by adding retinal imaging to an ongoing, large-scale primary prevention randomized clinical trial.
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Contemp Clin Trials Commun · Mar 2017
Corticosteroid injections compared to foot orthoses for plantar heel pain: protocol for the SOOTHE heel pain randomised trial.
Corticosteroid injections and foot orthoses are common interventions for plantar heel pain. Previous clinical trials have found that the effectiveness of these interventions differs over time, with corticosteroid injections being more effective in the short-term (i.e. 0-4 weeks) and foot orthoses more effective in the longer-term (i.e. 5-12 weeks). However, some of these trials have methodological weaknesses that could have caused confounding and bias, which may have led to over- or under-estimation of the effectiveness of these interventions. As a result, there is a need to compare the effectiveness of corticosteroid injections and foot orthoses in a robust clinical trial with an appropriate follow-up time. ⋯ This article describes the protocol for a pragmatic, parallel-group assessor-blinded randomised trial (Steroid injection versus foot orthoses (SOOTHE) heel pain trial). One hundred participants with plantar heel pain will be randomly allocated (i.e. two groups of approximately 50) to receive either an ultrasound-guided corticosteroid injection or prefabricated foot orthoses. Outcome measures will be obtained at baseline, 4, 8 and 12 weeks, with two primary endpoints at 4 and 12 weeks to reflect the hypothesised temporal effects of each intervention. The primary outcome measure will be the foot pain domain of the Foot Health Status Questionnaire.
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Contemp Clin Trials Commun · Dec 2016
Effects of a tele-prehabilitation program or an in-person prehabilitation program in surgical candidates awaiting total hip or knee arthroplasty: Protocol of a pilot single blind randomized controlled trial.
The accessibility for total joint arthroplasty often comes up against long wait lists, and may lead to deleterious effects for the awaiting patients. This pilot single blind randomized controlled trial aims to evaluate the impact of a telerehabilitation prehabilitation program before a hip or knee arthroplasty compared to in-person prehabilitation or to usual wait for surgery. ⋯ This pilot study is the first to evaluate the feasibility and the impact of a telerehabilitation prehabilitation program for patients awaiting a total joint arthroplasty. The results of this pilot-RCT will set the foundations for further research in the fields of rehabilitation and tele-medicine for patients suffering from lower limb osteoarthritis.