Full-text Publications Research Articles

A Call to Strengthen Instructional Leadership to Support Learner Achievement During and Post COVID-19: A Systematic Literature Review Approach

The coronavirus disease 19 has dismantled the traditional approaches to school management of education, prompting an urgent need to maintain teaching and learning during and post the pandemic. This study thus calls for strengthening instructional leadership to improve learner performance during and post the pandemic. Instructional leadership is an emerging concept from education leadership; however, the literature on educational leadership functions is still in its infancy. Subsequently, there is a lack of a complete understanding of the role of the School Management Team and educators’ instructional practices in managing teaching and learning in education literature. Although the School Management Team should identify and improve instructional practices to help learners attain learning outcomes, this goal is hindered by a lack of compressive insight into the relationship between instructional leadership and learner achievement. The purpose of this Systematic Literature Review is to examine the instructional leadership roles of SMTs and educators as identified by academics and practitioners. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis reporting guidelines were adopted in the study. An electronic search identified 127 publications. After duplication, titles and abstracts were screened, and inclusion and exclusion criteria were considered; 27 full-text version publications were assessed. Findings revealed a comprehensive conceptual relationship between instructional leadership roles at different hierarchical levels and their influence on learner performance. This study contributes a synthesised literature review on strengthening instructional leadership to promote learner attainment. These findings have implications for policymakers interested in promoting learner performance through strengthened instructional leadership during and post the coronavirus.

Prognostic factors in patients with clinical stage I nonseminoma—beyond lymphovascular invasion: a systematic review

ObjectiveTo systematically evaluate evidence on prognostic factors for tumor recurrence in clinical stage I nonseminoma patients other than lymphovascular invasion (LVI).MethodsWe performed a systematic literature search in the biomedical databases Medline (via Ovid) and Cochrane Central Register of Controlled Trials (search period January 2010 to February 2021) for full text publications in English and German language, reporting on retro- or prospectively assessed prognostic factors for tumor recurrence in patients with stage I nonseminomatous germ cell tumors.ResultsOur literature search yielded eleven studies reporting on 20 potential prognostic factors. Results are based on cohort studies of mostly moderate to low quality. Five out of eight studies found a significant association of embryonal carcinoma (EC) in the primary tumor with relapse. Among the different risk definitions of embryonal carcinoma (presence, predominance, pure), presence of EC alone seems to be sufficient for prognostification. Interesting results were found for rete testis invasion, predominant yolk sac tumor, T-stage and history of cryptorchidism, but the sparse data situation does not justify their clinical use.ConclusionsNo additional factors that meet the prognostic value of LVI, especially when determined by immunohistochemistry, could be identified through our systematic search. The presence of EC might serve as a second, subordinate prognostic factor for clinical use as the data situation is less abundant than the one of LVI. Further efforts are necessary to optimize the use of these two prognostic factors and to evaluate and validate further potential factors with promising preliminary data.

Microglia as a Potential Target for Antidepressant: A Systematic Review on Preclinical studies

Depression is a heterogeneous disorder with more than one possible etiologies. Currently, studies are mostly focused on neuronal dysfunction, while the involvement of other brain cells, such as microglia, has not been widely explored. This review aimed to systematically review the studies reporting the effect of microglia inhibitors on depressive-like behavior in rodent models, to obtained a better understanding of the effectiveness of the intervention against depression. The PubMed database was explored from January 2011 to April 2021 with related keywords for full-text publications reporting antidepressant effects of microglial inhibitor in rodents. We identified 713 research publications, of which only 25 studies met the inclusion criteria and were included for analysis. Administration of antidepressant drugs/compounds that inhibit microglia was reported to be beneficial because it improved depression-like symptoms by reducing outcomes based on immobility, anhedonia, and locomotor activity. Microglia inactivation has been reported to occur through inhibition of the HMGB1/TLR4/NF-B and NLRP3/NF-κB pathways, as well as improved communication of microglia neurons through increased interaction of CX3CL1 with CX3CR1. These data indicated that the use of an agent inhibiting microglia activity is promising as a strategy in overcoming depression in humans.

Leukocyte Telomere Length as a Molecular Biomarker of Coronary Heart Disease

Background. This work is a review of preclinical and clinical studies of the role of telomeres and telomerase in the development and progression of coronary heart disease (CHD). Materials and methods. A search for full-text publications (articles, reviews, meta-analyses, Cochrane reviews, and clinical cases) in English and Russian was carried out in the databases PubMed, Oxford University Press, Scopus, Web of Science, Springer, and E-library electronic library using keywords and their combinations. The search depth is 11 years (2010–2021). Results. The review suggests that the relative leukocyte telomere length (LTL) is associated with the development of socially significant and widespread cardiovascular diseases such as CHD and essential hypertension. At the same time, the interests of researchers are mainly focused on the study of the relative LTL in CHD. Conclusions. Despite the scientific and clinical significance of the analyzed studies of the relative length of human LTL as a biological marker of cardiovascular diseases, their implementation in real clinical practice is difficult due to differences in the design and methodology of the analyzed studies, as well as differences in the samples by gender, age, race, and ethnicity. The authors believe that clinical studies of the role of the relative length of leukocyte telomeres in adult patients with coronary heart disease are the most promising and require large multicenter studies with a unified design and methodology.

The Russian demography in 2010–2020: scientometric analysis according Elsevier data

The actuality of demographic research is permanently at high level both in Russia and in the world. The purpose of the study is to establish placement of studies and researchers in Russia on the world map of demographic science. The scientometric analysis was applied to the base of international quoting Scopus (Elsevier). The analysis of universe of discourse "Demography" was implemented using SciVal (Elsevier) on the basis of number of publications, number of viewing abstracts or full texts of publications, number of quoting, weighted-average impact-factor of journals. To compare trends according number of publications and quoting in the universe of discourse eLibrary data was used. The results of analysis demonstrated significant lagging of Russian publication activity on demography from countries-leaders on scientometric indices. At that, increased interest to Russian scientific results was established at the level of publications viewing. The most notable place in research of prominent topics in demography the Russian researchers assign to problematics of natality and inner migration. The number of directions targeting to ameliorate considered situation and to place the results of Russian demographic studies on world map of demographic science was proposed.

Issues of Safe Use of Plant-Based Food Supplements: A Review

Background: The widespread use of specialized food products, including plant-based dietary supplements, is determined by a rich variety of biologically active constituents. However, some plants containing such bioactive compounds as pulegone, menthofuran, estragole, methyleugenol, safrole, and thujone may cause adverse health effects. Objective: To review recent domestic and international scientific papers in order to substantiate the importance of regulating maximum permissible levels of monoterpene ketones (pulegone, menthofuran, and thujone) and alkenylbenzenes (estragole, methyleugenol, and safrole) in plant raw materials and plant-based nutritional supplements. Materials and methods: We used the keywords pulegone, menthofuran, methyleugenol, estragole, safrole, and thujone to search Scopus, Web of Science, PubMed, and RSCI abstract and citation databases and then applied information analysis and expert examination techniques to summarize research data published in Russian and English languages in 2001–2021. The initial sample consisted of 43 articles, of which 13 were excluded after initial screening. The selection criteria included availability of data on metabolism of the organic compounds in question, their levels in herbs and herbal teas, toxic effects on experimental animals, and potential adverse health effects in humans. We selected 30 full-text scientific publications and classified their data by the type of interventions. Results: The analysis of numerous studies of monoterpene ketones and alkenylbenzenes indicates a toxic effect of these groups of compounds on experimental animals. The International Agency for Research on Cancer (IARC) has classified pulegone, methyleugenol and safrole in Group 2B, which means that they are possibly carcinogenic to humans. Human health risks from plant-based alkenylbenzenes contained in dietary supplements are also demonstrated. Conclusion: Our findings prove the need to take appropriate risk management measures in order to limit the use of certain plant species containing high concentrations of biologically active substances posing threat to human health and to regulate their permissible levels in plant-based supplements.

Epidural or intrathecal morphine for post-operative analgesia following laparoscopic endometriosis surgery

Background: Endometriosis is the development of endometrial glands or stroma outside the uterine cavity, in the pelvis, ovaries, and fallopian tubes. Laproscopy is the most common method used in management of endometriosis and it also eliminates endometriosis-related scar tissue, implants, and cysts. Epidural or intrathecal morphine is an effective way to alleviate post-operative pain after laparoscopic endometriosis surgery.Methods: Literature search was conducted in three electronic databases-Google Scholar, Cochrane (Controlled Trials Register), and PubMed (MEDLINE/Index Medicus). Postoperative pain, epidural and intrathecal morphine, laparoscopy surgery, patient-controlled analgesia (PCA), opioids, and morphine were the search criteria used.Results: After removing duplicate studies, the search yielded 106 results. Out of which50 full-text publications that matched the inclusion criterion were retrieved.Conclusion: Single intrathecal morphine injection is safe and effective in managing post-operative pain, however continuous epidural analgesia is risky and difficult to manage after laparoscopic endometriosis surgery.

Formation of the interdental papilla by surgical method

BACKGROUND: The loss of interdental gingival papillae or the presence of black triangles between the teeth is one of the important problems in aesthetic dentistry, along with the loss of teeth and violation of the integrity of the hard tissues of the tooth. These patients have aesthetic, phonetic disorders, and it is also possible that food gets stuck between the teeth, which causes discomfort in the oral cavity and leads to periodontal diseases. Currently, an increasing percentage of people with orthopedic structures have a recession of the interdental gum. To improve the predicted result, it is necessary to approach this problem in an interdisciplinary way.
 MATERIAL AND METHODS: The search for publications was conducted in four electronic databases: Pubmed, Google search, eLibrary and dissercat from 2006 to 2021. 157 full-text publications were analyzed, of which 40 publications were included in the systematic review.
 RESULTS: According to various studies, the restoration of the lost interdental papilla varies from 1.68 to 5 mm. Complete restoration of the interdental papilla occurs when using microsurgical methods of restoration of the interdental gum. The least injury to soft tissues leads to the best results and reduces the risk of complications.
 CONCLUSION: Restoration of the interdental papilla is a complex surgical manipulation where microsurgical instruments must be used. Any rupture or excessive injury of the isthmus of the interdental papilla leads to a violation of blood supply, which leads to necrosis of the graft and aesthetic dissatisfaction.

Photovoice methodology in social work research

In recent decades, there has been a growing interest in the use of such a visual research method as photovoice. This article aims to characterize photovoice as a research methodology in social work. The study analyzed 30 full-text English-language publications, most of which were written by US researchers. The analysis of publications was based on the following criteria: (1) the general purpose of the photo voice as a methodology of research in social work and its philosophy; (2) stages and procedures for the use of photovoice, the role of researchers and other research participants; (3) examples of the use of photo voice in foreign social work; (4) the advantages and limitations of photovoice identified by researchers who have used this methodology in theirresearch. Photovoice is a participatory and reflective method of research in social work. Its main tasks include: to encourage research participants to express their own opinions; to form critical consciousness through group discussion; achieve policy change. Photovoice is based on: feminist theory; critical pedagogy; participatory approach to documentary photography. It uses transformational or emancipatory frameworks of analysis that focus on social change. The use of photovoice involves compliance with a number of successive stages, some of which may be repeated: the preparatory stage; introductory group session; work of research participants on photo collection; group discussion; preparation of the report; discussion of results; organization of an exhibition of works; conveying information to those on whom decision-making depends. Photovoice is used to study the needs of various vulnerable groups, especially those who are discriminated and whose voice is often ignored. This reflective method can also be useful in studying various aspects of social work practice.

Children living with long-term conditions and their experiences of partnership in nursing care: An integrative systematic review.

To describe the experiences of nursing care and partnership nursing as expressed by children living with long-term conditions. Children with long-term conditions have higher rates of hospitalisations and adverse events in hospital, yet little is known about their experiences of nursing care. How children perceive partnership in care with their families and nurses is of interest in the achievement of safe and effective care DESIGN: An integrative review following Joanna Briggs Institute protocols for systematic reviews. An integrative review was chosen following Joanna Briggs Institute protocols for systematic reviews. A total of 5150 articles were screened, with 251 full-text publications reviewed. A total of 21 studies were included, three mixed-method studies and 18 qualitative studies. This review has been reported as per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Four integrated findings were identified: "Children are aware of their surroundings and needs," "Children value positive communication," "Children want to be recognised as an individual in the triadic relationship, and this can be done through nurses using tailored play;" and "Children seek a shared decision-making process." Children wanted to be seen as an individual in Children and Young People's nursing as well as a child who craves security, fun and comfort, both from their families and nursing staff. Children described observing partnership between nursing staff and parents but felt uninvolved, with some children craving more knowledge and power to better understand their long-term condition. Further research is required on how Children and Young People's nursing staff can better support children and empower them to be active members in the shared decision-making process if the child wishes to be involved.

Mapping of research publications on corona virus disease (COVID-19) in PubMed database

The purpose of this paper is to find out the publications pertaining to “Corona Virus” available in PubMed database. PubMed database provides links to Full Text publications available with publishers and also Free Full Text publications. The data for the study were extracted from Pub Med database using the search term “Corona Virus”. Totally, 18659 publications pertaining to “Corona Virus” during 2010 to 2020 were retrieved. Out of 18659 publications, 57.90% of publications in Full Text with link to publications. The result shows that 89.43% of the publications were available in the form of “Articles” and 98.37% of publiations were listed under “Medline Journals”. Among four subject categories, the highest number of publications has been classified under subject “Cancer”. English is a dominating language, since, 96.78% of publications were published in English.COVID-19 disease is originated only in December 2019, within the very short span of time, the researchers and authors are rapidly involved in various research activities in order to investigate the factors for COVID-19. Perhaps, the research findings are published at regular and interval to speed up the research and also to encourage the researchers.

Potential applications of medicinal herbs and phytochemicals in oral and dental health: Status quo and future perspectives.

Herbal therapies are utilized to treat a broad diversity of diseases all over the globe. Although no clinical studies have been conducted to demonstrate the antibacterial, antimicrobial, and antiplaque characteristics of these plants, this does not imply that they are ineffectual as periodontal treatments or anti-cariogenic drugs. However, there is a scarcity of research confirming their efficacy and worth. Herbs are utilized in dentistry as antimicrobial, antineoplastic, antiseptic, antioxidant, and analgesics agents as well as for the elimination of bad breath. In addition, the application of herbal agents in tissue engineering improved the regeneration of oral and dental tissues. This study reviews the application of medicinal herbs for the treatment of dental and oral diseases in different aspects. This article focuses on current developments in the use of medicinal herbs and phytochemicals in oral and dental health. An extensive literature review was conducted via an Internet database, mostly PubMed. The articles included full-text publications written in English without any restrictions on a date. Plants have been suggested, as an alternate remedy for oral-dental problems, and this vocation needs long-term dependability. More research on herbal medicine potential as pharmaceutical sources and/or therapies is needed.

Review of long-term results and possible mechanisms of their improvement in patients after surgical treatment of congenital heart defects

Highlights. Congenital heart disease (CHD) is estimated to occur nearly in one per 100 newborns and a third of these babies are in need of corrective procedures. There is a downward trend in mortality associated with advances in surgical treatment and perioperative care. An increasing number of patients with corrected CHD are accumulating in the population. This article provides a literary review of the current state of long-term outcomes of CHD corrections and possible mechanisms for improving late outcomes.Abstract The article analyzes the literature on long-term results of surgical treatment of congenital heart defects and possible mechanisms for their improvement. The bibliographic method was used. The analysis of domestic and foreign literary sources with a search depth of 20 years is carried out. The criteria for including publications were: access to full-text publications, original research, scientific and review articles. Exclusion criteria: abstracts and summaries of publications. The following search queries were formulated for the review: in English: late outcomes of corrections of congenital heart defects, in Russian: long-term results of corrections of congenital heart defects, long-term results after corrections of congenital heart defects. The used search engines are Science Direct, PubMed, Cyberleninka, E-library. The analysis of the literary data showed that the volume and duration of patients’ observation that underwent surgical correction of congenital heart defects remain controversial. In world and domestic practice modern digital technologies are used for the purpose of patients remote monitoring. Remote monitoring programs in the Russian Federation are used for such socially significant diseases as diabetes mellitus, bronchial asthma, as well as cardiac rehabilitation of adult patients. There are no similar programs for patients with congenital heart defects. There is a problem of patients remote monitoring after congenital heart defects surgical treatment. In Russia today there is no any comprehensive program for remote monitoring of children after congenital heart disease surgical correction. We believe that a universal remote monitoring system for managing this group of patients must be created.

Depression and anxiety prevalence in people with cystic fibrosis and their caregivers: a systematic review and meta-analysis

BackgroundPrevalence of depression and anxiety in people with cystic fibrosis (PwCF) and their caregivers is high, however, results have been inconsistent. This systematic review and meta-analysis aimed to estimate the prevalence of depression and anxiety in PwCF and their caregivers and explore sources of heterogeneity.MethodMEDLINE, EMBASE, CINAHL plus and PsychINFO databases were searched from inception to January 2021. Studies were included if a specific psychometric tool (PT) to assess depression or anxiety (rather than quality of life) was used and did not involve a transitory patient state. Random-effects models were applied due to high anticipated heterogeneity and I2 estimates were calculated. Sources of heterogeneity were explored through subgroup comparisons. The presence of small-study effects was investigated visually using funnel plots and statistically using the Egger test.ResultsA total of 94 articles (48 full-text publications, 46 abstracts) were included. Depression prevalence in adolescents aged 12–18 years (n = 2386), adults (n = 9206) and caregivers (n = 6617) were 18.7% (95% CI 12.8–25.3%, I2 = 89.2%), 27.2% (95% CI 23.6–31%, I2 = 90.4%), and 32.8% (95% CI 27.9–37.9%, I2 = 90.3%), respectively. Anxiety prevalence in adolescents aged 12–18 years (n = 2142) was 26% (95% CI 19.6–33%, I2 = 86.4%), 28.4% (95% CI 25–31.9%, I2 = 85%) for adults (n = 8175), and 38.4% (95% CI 30.8–46.2%, I2 = 94.6%) for caregivers (n = 5931). Prevalence differed by the PT used and study location.DiscussionThis comprehensive analysis found the prevalence of depression and anxiety in PwCF and their caregivers to be high, supporting recommendations for regular screening. Choice of PT significantly influenced prevalence, indicating a need for future studies to identify the optimal PT for each CF population to identify those most at risk.

Do radiation oncologists publish what they present? An observational analysis of abstracts presented at the radiation oncology congresses in Turkey: A young radiation oncologists group study.

The publication rate of abstracts is a measure of the quality of scientific meetings. The present study aimed to determine the radiation oncologists' publication rates of abstracts presented at the National Radiation Oncology Congresses (UROK) and National Cancer Congresses (UKK) and identify the top journals that published these studies. We reviewed the abstracts presented at UROK and UKK, held between 2013 and 2017. To retrieve any publications originating from the presented abstracts, we searched the match terms in the public databases, including PubMed, Web of Science, Google Scholar, The Turkish Academic Network, and Information Center (ULAKBIM). We evaluated the articles' publication dates and peer-review history and noted the journals' impact factors. Three thousand seven hundred six abstracts were accepted for presentation; 1178 papers met the study criteria and were included in the analyses. There were 297 oral and 881 poster presentations. The overall publication rate was 18.9%. The median time to publication was 12 months. The studies were published in 94 scientific journals with a median impact factor of 1.28. Breast cancer and lung cancer studies had the highest publication rates among all subspecialties (15.2%). Retrospective studies had higher publication rates than those with other study designs (P < 0.0001). Almost 20% of abstracts presented at UROK and UKK were converted into full-text publications. Most of the abstracts achieved publication within 2 years from the presentation. Oral presentations had a significantly higher publication rate than poster presentations, reflecting their higher quality. The authors' affiliations and the study designs were among the significant factors that determine publication success.

Charting the course from abstract to published article.

Abstracts act as short, efficient sources of new information. This intentional brevity potentially diminishes scientific reliability of described findings. The authors' objective was to 1) determine the proportion of abstracts submitted to the American Association of Neurological Surgeons (AANS) annual meeting that subsequently are published in peer-reviewed journals, 2) assess AANS abstract publications for publication bias, and 3) assess AANS abstract publications for differing results. The authors screened all abstracts from the annual 2012 AANS meeting and identified their corresponding full-text publication, if applicable, by searching PubMed/MEDLINE. The abstract and subsequent publication were analyzed for result type (positive or negative) and differences in results. Overall, 49.3% of abstracts were published as papers. Many (18.1%) of these published papers differed in message from their original abstract. Publication bias exists, with positive abstracts being 40% more likely to be published than negative abstracts. The top journals in which the full-text articles were published were Journal of Neurosurgery (13.1%), Neurosurgery (7.3%), and World Neurosurgery (5.4%). Here, the authors demonstrate that alone, abstracts are not reliable sources of information. Many abstracts ultimately remain unpublished; therefore, they do not attain a level of scientific scrutiny that merits alteration of clinical care. Furthermore, many that are published have differing results or conclusions. In addition, positive publication bias exists, as positive abstracts are more likely to be published than negative abstracts.

Effects of Flywheel Resistance Training on Sprinting and Change of Direction Performance in Elite Adolescent Football Players

Background: Numerous studies have reported accelerated muscle hypertrophy, strength, and power adaptations following chronic bouts of isoinertial Flywheel Resistance Training (FRT). These factors contribute to Change of Direction (CoD) speed and sprinting performance, which are key determinants of performance in football. Progression through to the senior elite level dictates the necessity to develop these qualities in adolescent populations. Aim: To determine whether ≥ 4 weeks' FRT enhances CoD and sprinting performance in adolescent football players versus traditional strength training. Methods: PubMed and SPORT Discus electronic databases were used in February 2021. The search strategy identified randomised controlled trials, randomised crossover trials, and controlled non-randomised, full-text peer-reviewed publications written in English. Study quality was assessed by conducting a modified Downs and Black checklist. Results: A total of 21 studies were found, and following the removal of duplicates and studies based on title and abstract screening, eight studies remained. Following eligibility screening, three studies were included in the systematic review. A total of 67 subjects participated in the included studies. FRT training provides evidence that sprint performance over distances from 10 to 40-m can be improved (effect sizes: 10m = -1.8 ± 2.4%); 20m (ES = 0.37); 30m (ES = -1.5 ± 1.1%); 40m (ES = -1.1 ± 1.0%); and flying 10m (ES = 0.77) and that FRT induces significant improvements in CoD (different distances and for dominant and non-dominant limbs) compared to a control condition where subjects continued with their football training. Conclusion: Although the included studies suggest that 10-27 weeks' FRT may improve CoD and sprint performance in adolescent football players, paucity in the available literature makes such a conclusion premature. Further research in the area would ideally account for the device, moment of inertia, and transfer mechanism.

Pathogenicity Factors of Vibrio Vulnificus: A Review

Introduction: Vibrio vulnificus is an opportunistic microorganism that is part of the natural flora of the coastal marine environment. Consumption of seafood containing V. vulnificus can result in a severe, lightning-fast systemic infection in humans, which can, in its turn, lead to sepsis and even death in susceptible people. Infections caused by V. vulnificus have been reported in various climate zones around the world. Thus, the understanding of factors contributing to pathogenicity of this bacterium in its natural habitat can help develop new methods of disease prevention, diagnosis and treatment. Objective: To overview and systematize pathogenicity factors of V. vulnificus described in literary sources. Materials and methods: We used data analysis techniques to review scientific studies published in Russian and English in such abstract and citation databases as Scopus, PubMed, Russian Science Citation Index, and on information portals in 1976–2020. The main selection criterion was availability of information on the study of pathogenicity factors of V. vulnificus in the papers. Sixty full-text publications meeting the above criteria were chosen. Results: This review presents the latest achievements in the study of determinants contributing to the pathogenicity of V. vulnificus and examines their roles in pathogenesis. It has been shown that this microorganism, like most pathogens, requires coordinated work of many pathogenicity factors to cause infection. Most of them perform only an auxiliary function in pathogenesis and serve mainly for survival in the environment. However, in the absence of pathogenicity factors such as cytolysins VVH and MARTX, which cause tissue necrosis in the small intestine with subsequent dissemination into the bloodstream and other tissues, V. vulnificus is unable to cause intestinal infection. Conclusion: The understanding of the determinants contributing the most to the infection is extremely important when analyzing strains circulating in the country and assessing the risks of diseases in humans exposed to this pathogen.

A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols

ObjectivesAvailability of randomized controlled trial (RCT) protocols is essential for the interpretation of trial results and research transparency. Study Design and SettingIn this study, we determined the availability of RCT protocols approved in Switzerland, Canada, Germany, and the United Kingdom in 2012. For these RCTs, we searched PubMed, Google Scholar, Scopus, and trial registries for publicly available protocols and corresponding full-text publications of results. We determined the proportion of RCTs with (1) publicly available protocols, (2) publications citing the protocol, and (3) registries providing a link to the protocol. A multivariable logistic regression model explored factors associated with protocol availability. ResultsThree hundred twenty-six RCTs were included, of which 118 (36.2%) made their protocol publicly available; 56 (47.6% 56 of 118) provided as a peer-reviewed publication and 48 (40.7%, 48 of 118) provided as supplementary material. A total of 90.9% (100 of 110) of the protocols were cited in the main publication, and 55.9% (66 of 118) were linked in the clinical trial registry. Larger sample size (>500; odds ratio [OR] = 5.90, 95% confidence interval [CI], 2.75–13.31) and investigator sponsorship (OR = 1.99, 95% CI, 1.11–3.59) were associated with increased protocol availability. Most protocols were made available shortly before the publication of the main results. ConclusionRCT protocols should be made available at an early stage of the trial.

The Effects of Berry Polyphenols on the Gut Microbiota and Blood Pressure: A Systematic Review of Randomized Clinical Trials in Humans.

Berry consumption has beneficial effects on blood pressure. Intestinal microbiota transform berry phytochemicals into more bioactive forms. Thus, we performed a systematic review of randomized clinical trials to determine whether berry polyphenols in foods, extracts or supplements have effects on both the profile of gut microbiota and systolic and diastolic blood pressure in humans. PubMed, Cochrane Library, Scopus, and CAB s (EBSCOhost) were searched for randomized clinical trials in humans published from 1 January 2011 to 29 October 2021. Search results were imported into Covidence for screening and data extraction by two blinded reviewers, who also performed bias assessment independently. The literature search identified 216 publications; after duplicates were removed, 168 publications were screened with 12 full-text publications assessed for eligibility. Ultimately three randomized clinical trials in humans met the eligibility criteria. One randomized clinical trial showed a low risk of bias while the other two randomized clinical trials included low, high or unclear risk of bias. Together the randomized clinical trials showed that berry consumption (Aronia berry, strawberries, raspberries, cloudberries and bilberries) for 8–12 weeks had no significant effect on both blood pressure and the gut microbiota. More randomized clinical trials are needed to determine the effects of berry consumption on the profile of gut microbiota and blood pressure in humans.