Trials (TRIALS)

Publisher: BioMed Central Ltd, BioMed Central

Journal description

Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported. The impact factor shown relates to articles published in CCTCVM during 2003-4. Making all its content open access and not retaining copyright, Trials offers a way to make data both freely available and highly visible to trialists worldwide; this will benefit the impact of your publication among peers and society. The journal has unrestricted space and takes advantage of all the technical possibilities available for electronic publishing. To date, journals have focused on reporting the results of trials, with very little coverage of why and how they are conducted. Reports of trials have been restricted both by authors and editors - both parties often select only a subset of the outcomes measured, while the latter often impose word limits on the articles published making it difficult to communicate the lessons learnt from conducting the trial, let alone include adequate details of how the trial was conducted. The Internet offers both unlimited space and interactivity, and we are keen to harness these attributes. For instance, trialists will be able to provide the detail required to be a true scientific record and do more to make the article's message comprehensible to a variety of reader groups. They will also be able to communicate not only all outcome measures, as well as varying analyses and interpretations, but also in-depth descriptions of what they did and what they learnt. This sharing of direct experience is fundamental to improving the quality and conduct of trials worldwide.

Current impact factor: 1.73

Impact Factor Rankings

2016 Impact Factor Available summer 2017
2014 / 2015 Impact Factor 1.731
2013 Impact Factor 2.117
2012 Impact Factor 2.206
2011 Impact Factor 2.496
2010 Impact Factor 2.08
2009 Impact Factor 2.02
2008 Impact Factor 1.743
2007 Impact Factor 1.438
2006 Impact Factor

Impact factor over time

Impact factor
Year

Additional details

5-year impact 2.16
Cited half-life 3.40
Immediacy index 0.30
Eigenfactor 0.02
Article influence 0.86
Website Trials website
Other titles Trials journal
ISSN 1745-6215
OCLC 63290284
Material type Document, Periodical, Internet resource
Document type Internet Resource, Computer File, Journal / Magazine / Newspaper

Publisher details

BioMed Central

  • Pre-print
    • Author can archive a pre-print version
  • Post-print
    • Author can archive a post-print version
  • Conditions
    • Publisher's version/PDF may be used
    • Eligible UK authors may deposit in OpenDepot
    • Creative Commons Attribution License
    • Copy of License must accompany any deposit.
    • All titles are open access journals
    • 'BioMed Central' is an imprint of 'Springer Verlag (Germany)'
  • Classification
    green

Publications in this journal


  • No preview · Article · Dec 2016 · Trials
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    ABSTRACT: Physical exercise reduces glucose levels and glucose variability in patients with type 2 diabetes. Acute inspiratory muscle exercise has been shown to reduce these parameters in a small group of patients with type 2 diabetes, but these results have yet to be confirmed in a well-designed study. The aim of this study is to investigate the effect of acute inspiratory muscle exercise on glucose levels, glucose variability, and cardiovascular autonomic function in patients with type 2 diabetes. This study will use a randomized clinical trial crossover design. A total of 14 subjects will be recruited and randomly allocated to two groups to perform acute inspiratory muscle loading at 2 % of maximal inspiratory pressure (PImax, placebo load) or 60 % of PImax (experimental load). Inspiratory muscle training could be a novel exercise modality to be used to decrease glucose levels and glucose variability. Trial registration ClinicalTrials.gov NCT02292810.
    Preview · Article · Dec 2016 · Trials
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    ABSTRACT: Background: Laparoscopy training has become an integral part of surgical education. Suturing and knot tying is a basic, yet inherent part of many laparoscopic operations, and should be mastered prior to operating on patients. One common and standardized suturing technique is the C-loop technique. In the standard training setting, on a box trainer, the trainee learns the psychomotor movements of the task and the laparoscopic visuospatial orientation simultaneously. Learning the psychomotor and visuospatial skills separately and sequentially may offer a more time-efficient alternative to the current standard of training. Methods: This is a monocentric, two-arm randomized controlled trial. The participants are medical students in their clinical years (third to sixth year) at Heidelberg University who have not previously partaken in a laparoscopic training course lasting more than 2 hours. A total of 54 students are randomized into one of two arms in a 1:1 ratio to sequential learning (group 1) or control (group 2). Both groups receive a standardized introduction to the training center, laparoscopic instruments, and C-loop technique. Group 1 learn the C-loop using a transparent shoebox, thus only learning the psychomotor skills. Once they reach proficiency, they then perform the same knot tying procedure on a box trainer with standard laparoscopic view, where they combine their psychomotor skills with the visuospatial orientation inherent to laparoscopy. Group 2 learn the C-loop using solely a box trainer with standard laparoscopic view until they reach proficiency. Trainees work in pairs and time is recorded for each attempt. The primary outcome is mean total training time for each group. Secondary endpoints include procedural and knot quality subscore differences. Tertiary endpoints include studying the influence of gender and video game experience on performance. Discussion: This study addresses whether the learning of the psychomotor and visuospatial aspects of laparoscopic suturing and knot tying is optimal sequentially or simultaneously, by assessing total training time, procedural, and knot quality differences between the two groups. It will improve the efficiency of future laparoscopic suturing courses and may serve as an indicator for laparoscopic training in a broader context, i.e., not only for suturing and knot tying. Trial registration: This trial was registered on 12 August 2015 with the trial registration number DRKS00008668.
    Preview · Article · Dec 2016 · Trials
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    ABSTRACT: The World Health Organization predicts that by 2030 diabetes will be the seventh leading cause of death in the world. Multiple studies have tried to determine if cinnamon is an effective treatment for diabetes. Cinnamon extract is an insulin sensitizer, protects mesangial cells, decreases inflammatory markers, and lowers glucose, lipids, and blood pressure in patients with type 2 diabetes, so we developed a protocol to study whether ingestion of water-soluble cinnamon extract prevents progression from pre-diabetes to diabetes. This is a randomized, double-blind, placebo-controlled trial comparing cinnamon extract versus placebo in subjects with pre-diabetes who have committed to participate in a lifestyle change program. The trial will be conducted at five sites and will include 428 subjects who take cinnamon extract or placebo for 1 year. Follow-up for these subjects will be for a total of 2 years (nine study visits). The primary outcomes to be assessed are 1) conversion of patients from pre-diabetes to diabetes and 2) impact of water-soluble cinnamon extract on hepatic transaminases, renal function, and QT interval on electrocardiogram. Secondary outcomes include changes in HbA1c, lipids, waist circumference, weight, blood pressure, and fasting plasma glucose. The trial protocol has been approved by the Institutional Review Board of the US Air Force 59th Medical Wing, Wilford Hall Ambulatory Surgical Center (Protocol FWH20110035H). Investigator-sponsored Investigational New Drug status (114078) was granted by the US Food and Drug Administration. This study will provide high-quality evidence of the efficacy of water-soluble cinnamon extract in conjunction with lifestyle intervention for preventing patients with pre-diabetes from converting to diabetes. Additionally, it will provide important safety information about water-soluble cinnamon extract. Trial registration ClinicalTrials.gov Identifier: NCT01301521, 18 February 2011.
    Preview · Article · Dec 2016 · Trials
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    ABSTRACT: Pragmatic cluster-randomised trials should seek to make unbiased estimates of effect and be reported according to CONSORT principles, and the study population should be representative of the target population. This is challenging when conducting trials amongst 'hidden' populations without a sample frame. We describe a pair-matched cluster-randomised trial of a combination HIV-prevention intervention to reduce the proportion of female sex workers (FSW) with a detectable HIV viral load in Zimbabwe, recruiting via respondent driven sampling (RDS). We will cross-sectionally survey approximately 200 FSW at baseline and at endline to characterise each of 14 sites. RDS is a variant of chain referral sampling and has been adapted to approximate random sampling. Primary analysis will use the 'RDS-2' method to estimate cluster summaries and will adapt Hayes and Moulton's '2-step' method to adjust effect estimates for individual-level confounders and further adjust for cluster baseline prevalence. We will adapt CONSORT to accommodate RDS. In the absence of observable refusal rates, we will compare the recruitment process between matched pairs. We will need to investigate whether cluster-specific recruitment or the intervention itself affects the accuracy of the RDS estimation process, potentially causing differential biases. To do this, we will calculate RDS-diagnostic statistics for each cluster at each time point and compare these statistics within matched pairs and time points. Sensitivity analyses will assess the impact of potential biases arising from assumptions made by the RDS-2 estimation. We are not aware of any other completed pragmatic cluster RCTs that are recruiting participants using RDS. Our statistical design and analysis approach seeks to transparently document participant recruitment and allow an assessment of the representativeness of the study to the target population, a key aspect of pragmatic trials. The challenges we have faced in the design of this trial are likely to be shared in other contexts aiming to serve the needs of legally and/or socially marginalised populations for which no sampling frame exists and especially when the social networks of participants are both the target of intervention and the means of recruitment. The trial was registered at Pan African Clinical Trials Registry (PACTR201312000722390) on 9 December 2013.
    Preview · Article · Dec 2016 · Trials

  • No preview · Article · Dec 2016 · Trials
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    ABSTRACT: Barriers to recovering the excess treatment costs associated with health research from local organisations in the United Kingdom can increase research costs, delay completion of high- quality studies and risk disenfranchising health trusts and patients from participation. The authors demonstrate how the process for recovering excess treatment costs at a local National Health Service (NHS) trust level in a multicentre study was inconsistent and resulted in excess effort and cost to the research budget. An innovative example of how an organisation acting as a broker between commissioners and researchers facilitated a more timely excess treatment cost agreement is highlighted. Trial registration Current Controlled Trials ISRCTN68798818, registered on 18 February 2014.
    No preview · Article · Dec 2016 · Trials
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    ABSTRACT: Painful spinal metastases have been treated with conventional radiotherapy for decades, but one-third of the patients have insufficient pain relief after treatment and one-fifth need retreatment. Stereotactic radiotherapy is a method to increase the dose in the spinal metastases with a potentially longer lasting palliative effect without increasing the side effects of the treatment and thereby is expected to improve the quality of life significantly. This study is a multicenter prospective randomized clinical trial comparing conventional radiotherapy (1 x 8Gy) with stereotactic radiotherapy (1 x 20Gy) for pain reduction and quality of life in patients with painful spinal metastases. A total of 386 patients will be randomized between the two treatment groups. Besides pain measured by the Dutch Brief Pain Inventory, quality of life and cost-effectiveness also will be measured. The primary outcome is pain reduction at 6 weeks after treatment. Secondary outcomes will be the time to pain response, duration of pain relief, health-related quality of life and toxicity, as well as cost-effectiveness. This study investigates whether stereotactic radiotherapy with dose escalation for symptomatic spinal metastases can lead to improved pain reduction as compared to conventional radiotherapy without an increase of treatment-related side effects. These results will contribute to the optimization and individualization of the treatment for the patient. Trial registration ClinicalTrials.gov identifier NCT02407795 (March 31, 2015).
    Preview · Article · Dec 2016 · Trials
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    ABSTRACT: Knee osteoarthritis (KOA) is a major public health issue causing chronic disability as well as a burden on healthcare resources. In China, a herbal drug tablet has been used as an effective and conventional therapy to alleviate clinical symptoms caused by KOA. However, evidence gathered from systematic reviews or randomized controlled trials that validated herbal drugs for the management of osteoarthritic pain is weak. The purpose of this study is to explore the efficacy and safety of the Shaoyao Shujin tablet for the management of KOA in a short-term study. This trial is a multicenter randomized, double-blind, placebo-controlled study. A total of 276 patients will be randomized into 3 groups: (1) the high-dose Shaoyao Shujin tablet group (HD group), (2) the low-dose Shaoyao Shujin tablet group (LD group), and (3) the placebo tablet group (control group). In the three groups, four tablets will be administered three times per day for 6 weeks. Follow-up will be at regular intervals during a 10-week period with the Western Ontario and McMaster Universities Index (WOMAC) score, visual analog scale (VAS) score, and rescue medication use assessed as outcome measures. This study will provide clinical evidence on the efficacy and safety of the Shaoyao Shujin tablet in treating KOA. Trial registration Chinese Cochrane Center ChiCTR-IPR-15006194, registered 4 April 2015.
    Preview · Article · Dec 2016 · Trials