CONSORT Group, CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann. Intern. Med. 152(11), 726-732

Family Health International, Research Triangle Park, North Carolina, USA.
Obstetrics and Gynecology (Impact Factor: 4.37). 05/2010; 115(5):1063-70. DOI: 10.1097/AOG.0b013e3181d9d421
Source: PubMed

ABSTRACT 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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    • "Items could be marked as yes, no, unclear or partial. Items were only marked as yes if they fully and explicitly met the detailed criteria laid out in the CONSORT standards [12]. Any initial disagreements regarding study quality were discussed until consensus was reached. "
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    ABSTRACT: Existing review required updating. To evaluate the effectiveness of physiotherapy exercise after discharge from hospital on function, walking, range of motion, quality of life and muscle strength, for patients following elective primary total hip arthroplasty for osteoarthritis. Systematic review from January 2007 to November 2013. AMED, CINAHL, EMBASE, MEDLINE, Kingsfund Database, and PEDro. Cochrane CENTRAL, BioMed Central (BMC), The Department of Health National Research Register and Clinical register. Searches were overseen by a librarian. Authors were contacted for missing information. No language restrictions were applied. Trials comparing physiotherapy exercise vs usual/standard care, or comparing two types of relevant exercise physiotherapy, following discharge from hospital after elective primary total hip replacement for osteoarthritis were reviewed. Functional activities of daily living, walking, quality of life, muscle strength and joint range of motion. Quality and risk of bias for studies were evaluated. Data were extracted and meta-analyses considered. 11 trials are included in the review. Trial quality was mixed. Newly included studies were assessed as having lower risk of bias than previous studies. Narrative review indicates that physiotherapy exercise after discharge following total hip replacement may potentially benefit patients in terms of function, walking and muscle strengthening. The overall quality and quantity of trials, and their diversity, prevented meta-analyses. Disappointingly, insufficient evidence still prevents the effectiveness of physiotherapy exercise following discharge to be determined for this patient group. High quality, adequately powered, trials with long term follow up are required. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
    Physiotherapy 01/2015; DOI:10.1016/ · 2.11 Impact Factor
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    • "RCT methodology requires the reporting of the system used to generate the random allocation sequence, as well as mentioning participant drop-out rates, means, SDs, effect sizes and associated confidence intervals. Although an important first step, this paper falls some way short of suggested recommendations for the reporting of RCTs (Schulz et al., 2010). "
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    ABSTRACT: Speech perception problems lead to many different forms of communication diffi-culties, and remediation for these prob-lems remains of critical interest. A recent study by Kraus et al. (2014b) published in the Journal of Neuroscience, used a ran-domized controlled trial (RCT) approach to identify how low intensity community-based musical enrichment for "at-risk chil-dren" improved neural discrimination of "ba/ga" syllables. In the study, forty-four children aged six to nine years from "gang reduction zones" received 2 hours of musical training each week arranged in two 1 hour sessions. A control group received a single year of training follow-ing a one year delay, whilst the experi-mental group received two full years of training without delay. They found that auditory brainstem responses (ABRs) to the "ba/ga" syllables were changed in the experimental group, but only after more than one year of training. ABRs were not changed in the control group, either following the delay or after the first full year of training. We endorse the use of a randomized control trial (RCT) to evaluate this educational programme, but argue that several additional crite-ria must be met before firm conclusions can be drawn about the benefits of the intervention. Kraus et al. argue their results provide evidence that "community music pro-grams may stave off certain language-based challenges" (Kraus et al., 2014b, p. 11915), but this claim is hard to sustain without behavioral data (e.g., of concomi-tant improvements in speech perception or literacy). For the current paper, it would be necessary to show group differences in behavior that relate to the educational program, and explore the ways that indi-vidual differences in neural and behavioral profiles vary with the speech and liter-acy measures. This is particularly impor-tant given that a meaningful musicianship advantage in speech perception can be hard to demonstrate, as the size of the advantage shown for musicians (com-pared to non-musicians) is small (<1 dB) (Parbery-Clark et al., 2009) and has not been consistently replicated (Fuller et al., 2014; Ruggles et al., 2014). We also note a more recent follow up study (Kraus et al., 2014a) shows no improvement in liter-acy skills associated with active musical engagement. There are other important issues: for example, Kraus et al. presented a single pair of synthesized "ba" and "ga" syllables 6000 times, at a rate of 4.35 repetitions per second, to each participant. No nat-urally occurring human speech sequences occur like this: speech tokens are never identical, and repetition itself is normally
    Frontiers in Human Neuroscience 12/2014; 34:11913-119181881. DOI:10.3389/fnhum.2014.00964 · 2.90 Impact Factor
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    • "This study was a parallel (1:1) randomized controlled trial of 800 women admitted to the postpartum unit of WakeMed Hospital between May 2011 and January 2012. The study protocol followed CONSORT guidelines and was approved by the Institutional Review Boards of the University of North Carolina and WakeMed Hospital [13]. WakeMed Hospital is a large private nonprofit hospital in Raleigh, North Carolina, with about 5000 deliveries annually. "
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    ABSTRACT: Objectives Short interpregnancy intervals are associated with adverse perinatal outcomes. Increased postpartum use of long-acting reversible contraception (LARC) could reduce short interpregnancy intervals. Therefore, the primary objective of our study was to evaluate if a postpartum educational script about LARC (LARC script) could increase postpartum LARC utilization at the 6-week postpartum visit. Study Design We completed a randomized-controlled trial (1:1) of 800 postpartum women in Raleigh, North Carolina. Women were recruited from the postpartum unit and randomized to receive (intervention) or not receive (control) the LARC script prior to hospital discharge. We conducted follow-up phone interviews to assess LARC use after their 6-week postpartum visit. We used Pearson’s Chi-squared test to compare LARC use between arms. Results Between May 2011 and January 2012, 400 women were randomized to each arm. Three-hundred sixty-nine women (92.3%) in each arm were successfully contacted after their 6-week postpartum visit. LARC use was reported by 17.6% and 13.3% of women in the intervention and control arms, respectively (p=0.103). Conclusions The LARC script did not increase LARC utilization at the 6-week postpartum visit. Future studies should evaluate interventions that address both educational and systematic barriers to postpartum LARC uptake. IMPLICATIONS Use of a postpartum educational script focused on the intrauterine device and contraceptive implant did not increase their utilization after the 6-week postpartum visit. Future studies should evaluate interventions that address both educational and systematic barriers to postpartum contraceptive uptake.
    Contraception 08/2014; 90(2). DOI:10.1016/j.contraception.2014.03.017 · 2.93 Impact Factor
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