CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials

Family Health International, Research Triangle Park, North Carolina, United States of America.
Journal of Pharmacology and Pharmacotherapeutics 07/2010; 1(2):100-7. DOI: 10.4103/0976-500X.72352
Source: PubMed


The CONSORT (Consolidated Standards of Reporting Trials) statement is used worldwide to improve the reporting of randomized, controlled trials. Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience.

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    • "In randomized clinical trials (RCTs), for example, there are strict rules regarding intention-to-treat analyses, which are often complemented with additional approaches , such as per protocol analysis or modeling the complier average causal effect to account for noncompli- ance. The CONsolidated Standards of Reporting Trials (CON- SORT) [6] and Strengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines [7] provide helpful indications of broad relevance in human subjects research but are too broad to address several specific methodological difficulties in dementia research. Topicspecific guidelines building on STROBE have proven useful in several domains, such as genetic association studies [8]. "
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    ABSTRACT: Clinical and population research on dementia and related neurologic conditions, including Alzheimer's disease, faces several unique methodological challenges. Progress to identify preventive and therapeutic strategies rests on valid and rigorous analytic approaches, but the research literature reflects little consensus on "best practices." We present findings from a large scientific working group on research methods for clinical and population studies of dementia, which identified five categories of methodological challenges as follows: (1) attrition/sample selection, including selective survival; (2) measurement, including uncertainty in diagnostic criteria, measurement error in neuropsychological assessments, and practice or retest effects; (3) specification of longitudinal models when participants are followed for months, years, or even decades; (4) time-varying measurements; and (5) high-dimensional data. We explain why each challenge is important in dementia research and how it could compromise the translation of research findings into effective prevention or care strategies. We advance a checklist of potential sources of bias that should be routinely addressed when reporting dementia research.
    Alzheimer's & dementia: the journal of the Alzheimer's Association 09/2015; 11(9):1098-1109. DOI:10.1016/j.jalz.2015.06.1885 · 12.41 Impact Factor
    • "These specifications also challenge researchers to prioritize consideration of external validity in the formative development process, with the goal of developing interventions that will be usable and effective in the authentic settings for which they are ultimately intended. Although high quality methodological standards have been specified (and debated) for studies of intervention efficacy (e.g., Odom et al., 2005; Schulz, Altman, & Moher, 2010; What Works Clearinghouse, 2013), no widely disseminated or accepted standards for high quality intervention development research are available. Our Goal 2 development grant yielded sufficiently convincing evidence of the usability and feasibility of the intervention and its promise for promoting student change to lead to a successful application for Goal 3 funding from IES. "
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    ABSTRACT: Despite an emphasis on identifying evidence-based practices among researchers and using evidence-based practices among professionals in the field of education, there are still problems with uptake and implementation in real-world settings. This lack of diffusion of practices is evident in educational programming for children with autism spectrum disorder (ASD). One solution is to use an iterative process to develop interventions in which researchers work in collaboration with the end users to test and refine interventions. However, there are very few guidelines for developing feasible and effective interventions through these iterative processes. This article provides a description of the iterative process used to develop the Advancing Social-Communication and Play (ASAP) intervention, a supplemental program designed for public preschool classrooms serving students with ASD, and examples of how data from the sequence of iterative design studies shaped the intervention development. The research team offers guidelines for other researchers looking to engage in intervention development using an iterative process in the context of partnerships with end users, including suggestions for planning and executing an intervention development grant.
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    • "Ethical 19 approval was obtained from the local Human Research Ethics Committee and the protocol was 20 written in accordance with the standards set by the Declaration of Helsinki. This study is a 21 randomized controlled trial with two parallel groups, which followed the CONSORT 22 recommendation (Schulz et al. 2010). "
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    ABSTRACT: This study analyzed the effect of four weeks of jumping interval training (JIT), included in endurance training, on neuromuscular and physiological parameters. Eighteen recreational runners, randomized in control and experimental group, performed 40 min of running at 70% of velocity at peak oxygen uptake (vVO2peak), three times per week. Additionally, experimental group performed the JIT twice per week, consisted by four to six bouts of continuous vertical jumps (30s) with five-minute interval. Three days before and after training period the countermovement (CMJ) and continuous jump (CJ30), isokinetic and isometric evaluation of knee extensors/flexors, progressive maximal exercise and submaximal constant-load exercise were performed. The JIT provoked improvement in neuromuscular performance, indicated by increased jump height (JHCMJ) (4.7%; Effect Size, ES = 0.99) and power output (≈3.7%; ES ≈ 0.82) of CMJ and rate of torque development of knee extensors in isometric contraction (29.5%; ES = 1.02); anaerobic power and capacity, represented by the mean of JHINI (7.4%; ES = 0.8) and peak power output (PPOINI) (5.6%; ES = 0.73) of the first jumps of CJ30 and the mean of JHALL (10.2%, ES = 1.04) and PPOALL (9.5%, ES = 1.1) considering all jumps of CJ30; and aerobic power and capacity, represented by peak oxygen uptake - VO2peak (9.1%, ES = 1.28), vVO2peak (2.7%, ES = 1.11) and velocity corresponding to the onset of blood lactate accumulation - vOBLA (9.7%, ES = 1.23). These results suggest that the JIT included in traditional endurance training induces moderate-to-large effects on neuromuscular and physiological parameters.
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