A systematic scoping review of study methodology for randomized controlled trials investigating probiotics in athletic and physically active populations

Background: The purported ergogenic and health effects of probiotics have been a topic of great intrigue among researchers, practitioners, and the lay public alike. There has also been an increased research focus within the realm of sports science and exercise medicine on the athletic gut microbiota. However, compared to other ergogenic aids and dietary supplements, probiotics present unique study challenges. The objectives of this systematic scoping review were to identify and characterize study methodologies of randomized controlled trials investigating supplementation with probiotics in athletes and physically active individuals. Methods: Four databases (MEDLINE, CINAHL, Cochrane CENTRAL, and Cochrane Database of Systematic Reviews) were searched for randomized controlled studies involving healthy athletes or physically active individuals. An intervention with probiotics and inclusion of a control and/or placebo group were essential. Only peer-reviewed articles in English were considered, and there were no date restrictions. Results were extracted and presented in tabular form to detail study protocols, characteristics, and outcomes. Bias in randomized controlled trials was determined with the RoB 2.0 tool. Results: A total of 45 studies were included in the review, with 35 using a parallel group design and 10 using a cross-over design. Approximately half the studies used a single probiotic and the other half a multi-strain preparation. The probiotic dose ranged from 2 × 108 to 1 × 1011 colony forming units daily, and the length of intervention was between 7 and 150 days. Fewer than half the studies directly assessed gastrointestinal symptoms, gut permeability, or the gut microbiota. The sex ratio of participants was heavily weighted toward males, and only 3 studies exclusively investigated females. Low-level adverse events were reported in only 2 studies, although the methodology of reporting varied widely. The risk of bias was generally low, although details on randomization were lacking in some studies. Conclusion: There is a substantial body of research on the effects of probiotic supplementation in healthy athletes and physically active individuals. Considerable heterogeneity in probiotic selection and dosage as well as outcome measures has made clinical and mechanistic interpretation challenging for both health care practitioners and researchers. Attention to issues of randomization of participants, treatments and interventions, selection of outcomes, demographics, and reporting of adverse events will facilitate more trustworthy interpretation of probiotic study results and inform evidence-based guidelines

Core outcome domains for early-phase clinical trials of sound-, psychology-, and pharmacology-based interventions to manage chronic subjective tinnitus in adults: the COMIT'ID study protocol for using a Delphi process and face-to-face meetings to establish consensus

Background: The reporting of outcomes in clinical trials of subjective tinnitus indicates that many different tinnitus-related complaints are of interest to investigators, from perceptual attributes of the sound (e.g. loudness) to psychosocial impacts (e.g. quality of life). Even when considering one type of intervention strategy for subjective tinnitus, there is no agreement about what is critically important for deciding whether a treatment is effective. The main purpose of this observational study is therefore to develop Core Outcome Domain Sets for the three different intervention strategies (sound, psychological, and pharmacological) for adults with chronic subjective tinnitus that should be measured and reported in every clinical trial of these interventions. Secondary objectives are to identify the strengths and limitations of our study design for recruiting and reducing attrition of participants, and to explore uptake of the core outcomes. Methods: The ‘Core Outcome Measures in Tinnitus: International Delphi’ (COMIT’ID) study will use a mixed methods approach that incorporates input from healthcare users at the pre-Delphi stage, a modified three round Delphi survey and final consensus meetings (one for each intervention). The meetings will generate recommendations by stakeholder representatives on agreed Core Outcome Domain Sets specific to each intervention. A subsequent step will establish a common cross-cutting Core Outcome Domain Set by identifying the common outcome domains included in all three intervention-specific Core Outcome Domain Sets. To address the secondary objectives, we will gather feedback from participants about their experience of taking part in the Delphi process. We aspire to conduct an observational cohort study to evaluate uptake of the core outcomes in published studies at 7 years following core outcome set publication. Discussion: The COMIT’ID study aims to develop a Core Outcome Domain Set that are agreed as critically important for deciding whether a treatment for subjective tinnitus is effective. Such a recommendation would help to standardise future clinical trials worldwide and so we will determine if participation increases use of the core outcome set in the long term. Trial registration: This project has been registered in the database of the Core Outcome Measures in Effectiveness Trials (COMET) initiative

What is the value and impact of quality and safety teams? A scoping review

<p>Abstract</p> <p>Background</p> <p>The purpose of this study was to conduct a scoping review of the literature about the establishment and impact of quality and safety team initiatives in acute care.</p> <p>Methods</p> <p>Studies were identified through electronic searches of Medline, Embase, CINAHL, PsycINFO, ABI Inform, Cochrane databases. Grey literature and bibliographies were also searched. Qualitative or quantitative studies that occurred in acute care, describing how quality and safety teams were established or implemented, the impact of teams, or the barriers and/or facilitators of teams were included. Two reviewers independently extracted data on study design, sample, interventions, and outcomes. Quality assessment of full text articles was done independently by two reviewers. Studies were categorized according to dimensions of quality.</p> <p>Results</p> <p>Of 6,674 articles identified, 99 were included in the study. The heterogeneity of studies and results reported precluded quantitative data analyses. Findings revealed limited information about attributes of successful and unsuccessful team initiatives, barriers and facilitators to team initiatives, unique or combined contribution of selected interventions, or how to effectively establish these teams.</p> <p>Conclusions</p> <p>Not unlike systematic reviews of quality improvement collaboratives, this broad review revealed that while teams reported a number of positive results, there are many methodological issues. This study is unique in utilizing traditional quality assessment and more novel methods of quality assessment and reporting of results (SQUIRE) to appraise studies. Rigorous design, evaluation, and reporting of quality and safety team initiatives are required.</p

Facilitating Faculty Engagement in Teaching with Technology

Members of a SoTL Faculty Learning Community will describe initiatives at their institution to support and encourage faculty in the use of instructional technology as they design and deliver courses. The goals of the session are to provide participants with information about strategies for engaging faculty with teaching technology, identify barriers to faculty engagement in online teaching, and show far-reaching benefits of a Faculty Learning Community structure. Session attendees will be asked to engage in discussions as the panel reviews data on the effect of technology on student learning, describes how a move to Desire2Learn provided an opportunity to train faculty in online course design, summarizes results of surveys assessing faculty needs for technology and attitudes about the effectiveness of online education, and describes the goals and plans of a faculty learning community that is providing support for the development of online courses

A systematic scoping review of study methodology for randomized controlled trials investigating probiotics in athletic and physically active populations

Background: The purported ergogenic and health effects of probiotics have been a topic of great intrigue among researchers, practitioners, and the lay public alike. There has also been an increased research focus within the realm of sports science and exercise medicine on the athletic gut microbiota. However, compared to other ergogenic aids and dietary supplements, probiotics present unique study challenges. The objectives of this systematic scoping review were to identify and characterize study methodologies of randomized controlled trials investigating supplementation with probiotics in athletes and physically active individuals. Methods: Four databases (MEDLINE, CINAHL, Cochrane CENTRAL, and Cochrane Database of Systematic Reviews) were searched for randomized controlled studies involving healthy athletes or physically active individuals. An intervention with probiotics and inclusion of a control and/or placebo group were essential. Only peer-reviewed articles in English were considered, and there were no date restrictions. Results were extracted and presented in tabular form to detail study protocols, characteristics, and outcomes. Bias in randomized controlled trials was determined with the RoB 2.0 tool. Results: A total of 45 studies were included in the review, with 35 using a parallel group design and 10 using a cross-over design. Approximately half the studies used a single probiotic and the other half a multi-strain preparation. The probiotic dose ranged from 2 × 108 to 1 × 1011 colony forming units daily, and the length of intervention was between 7 and 150 days. Fewer than half the studies directly assessed gastrointestinal symptoms, gut permeability, or the gut microbiota. The sex ratio of participants was heavily weighted toward males, and only 3 studies exclusively investigated females. Low-level adverse events were reported in only 2 studies, although the methodology of reporting varied widely. The risk of bias was generally low, although details on randomization were lacking in some studies. Conclusion: There is a substantial body of research on the effects of probiotic supplementation in healthy athletes and physically active individuals. Considerable heterogeneity in probiotic selection and dosage as well as outcome measures has made clinical and mechanistic interpretation challenging for both health care practitioners and researchers. Attention to issues of randomization of participants, treatments and interventions, selection of outcomes, demographics, and reporting of adverse events will facilitate more trustworthy interpretation of probiotic study results and inform evidence-based guidelines

Borrelia burgdorferi complement regulator-acquiring surface protein 2 does not contribute to complement resistance or host infectivity.

Borrelia burgdorferi, the pathogen of Lyme disease, cycles in nature through Ixodes ticks and mammalian hosts. At least five Complement Regulator-Acquiring Surface Proteins (BbCRASPs) are produced by B. burgdorferi, which are thought to assist spirochetes in host immune evasion. Recent studies established that BbCRASP-2 is preferentially expressed in mammals, and elicits robust antibody response in infected hosts, including humans. We show that BbCRASP-2 is ubiquitously expressed in diverse murine tissues, but not in ticks, reinforcing a role of BbCRASP-2 in conferring B. burgdorferi defense against persistent host immune threats, such as complement. BbCRASP-2 immunization, however, fails to protect mice from B. burgdorferi infection and does not modify disease, as reflected by the development of arthritis. An infectious BbCRASP-2 mutant was generated, therefore, to examine the precise role of the gene product in spirochete infectivity. Similar to wild type B. burgdorferi, BbCRASP-2 mutants remain insensitive to complement-mediated killing in vitro, retain full murine infectivity and induce arthritis. Quantitative RT-PCR assessment indicates that survivability of BbCRASP-2-deficient B. burgdorferi is not due to altered expression of other BbCRASPs. Together, these results suggest that the function of a selectively expressed B. burgdorferi gene, BbCRASP-2, is not essential for complement resistance or infectivity in the murine host