scholarly journals Quality of Reporting in Preclinical Urethral Tissue Engineering Studies: A Systematic Review to Assess Adherence to the ARRIVE Guidelines

Animals ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. 2456
Author(s):  
Tariq O. Abbas ◽  
Abubakr Elawad ◽  
Abdul Kareem Pullattayil S. ◽  
Cristian Pablo Pennisi

Preclinical research within the area of urethral tissue engineering has not yet been successfully translated into an efficient therapeutic option for patients. This gap could be attributed, in part, to inadequate design and reporting of the studies employing laboratory animals. In this study, a systematic review was conducted to investigate the quality of reporting in preclinical studies utilizing tissue engineering approaches for urethral repair. The scope was on studies performed in rabbits, published between January 2014 and March 2020. Quality assessment of the data was conducted according to the Animal Research: Reporting of in Vivo Experiments (ARRIVE) guidelines by the scoring of a 38-item checklist in different categories. A total of 28 articles that fulfilled the eligibility criteria were included in the study. The range of ARRIVE score was from 0 to 100, taking into consideration having reported the item in question or not. The mean checklist score was 53%. The items that attained the highest scores included the number of animals utilized, the size of control and experimental groups, and the definition of experimental outcomes. The least frequently reported items included the data regarding the experimental procedure, housing and husbandry, determination and justification of the number of animals, and reporting of adverse events. Surprisingly, full disclosure about ethical guidelines and animal protocol approval was missing in 54% of the studies. No paper stated the sample size estimation. Overall, our study found that a large number of studies display inadequate reporting of fundamental information and that the quality of reporting improved marginally over the study period. We encourage a comprehensive implementation of the ARRIVE guidelines in animal studies exploring tissue engineering for urethral repair, not only to facilitate effective translation of preclinical research findings into clinical therapies, but also to ensure compliance with ethical principles and to minimize unnecessary animal studies.

2020 ◽  
Vol 40 (4) ◽  
pp. 394-404
Author(s):  
Janusz Witowski ◽  
Dorota Sikorska ◽  
András Rudolf ◽  
Izabela Miechowicz ◽  
Julian Kamhieh-Milz ◽  
...  

The concerns about reproducibility and validity of animal studies are partly related to poor experimental design and reporting. Here, we undertook a scoping review of the literature to determine the extent and quality of reporting of animal studies on peritoneal dialysis (PD). Online databases were searched to identify 567 relevant original articles published between 1979 and 2018. These were analyzed with respect to bibliographic parameters and general aspects of animal experimentation. A subgroup of 120 studies was analyzed in detail in terms of the impact on the reporting quality of the Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines for animal studies. The number of animal studies on PD increased continuously over the years with a thematic shift toward long-term preservation of the peritoneum as a dialyzing organ. There were significant deficiencies in research design with the lack of sample size estimation, randomization, and blinding being the commonest shortcomings. The description of animal numbers, housing conditions, use of medication, and statistical analysis was incomplete. The introduction in 2010 of the ARRIVE guidelines produced very little improvement in the completeness of reporting regardless of journal impact factor. The animal studies on PD suffer from deficits in experimental protocols and transparent reporting. These drawbacks need to be corrected to ensure high-quality and much-needed animal research in PD.


2021 ◽  
Vol 9 ◽  
Author(s):  
Tariq O. Abbas ◽  
Abubakr Elawad ◽  
Amir Kareem ◽  
Abdul Kareem Pullattayil S ◽  
Mansour Ali ◽  
...  

Background: There is a steadily growing number of different reconstructive surgical procedures for hypospadias that were tested on animal models prior to their human application. However, the clinical translatability and reproducibility of the results encountered in preclinical urethral reconstruction experiments is considered poor, with significant factors contributing to the poor design and reporting of animal experiments. Our objective was to evaluate the quality of the design and reporting in published articles of urethral reconstructive preclinical studies.Methods: Both PubMed and EMBASE databases were searched for animal urethral repair experiments between January 2014 and September 2019. Internal quality (bias) was evaluated through several signaling questions arising from the Systematic Review Centre for Laboratory animal Experimentation (SYRCLE), while the quality of reporting was assessed by the Animal Research: Reporting of In vivo Experiments (ARRIVE) guidelines by scoring of a 20-item checklist.Results: A total of 638 articles were initially screened after the literature search. Employing the inclusion and exclusion criteria, 30 studies were chosen for full-text screening and 21 studies were considered eligible for the quality assessment. The mean score of the checklist was 66%. The elements that accomplished the highest grades included the number of animals utilized, the number in each investigational and control group, and the delineation of investigational conclusions. The items that were least commonly stated comprised information about the experimental method, housing and husbandry, rationalization of the number of animals, and reporting of adverse events. No paper stated the sample size estimation.Conclusion: We found that several critical experiment design principles were poorly reported, which hinders a rigorous appraisal of the scientific quality and reproducibility of the experiments. A comprehensive implementation of the ARRIVE guidelines in animal studies exploring urethral repair is necessary to facilitate the effective translation of preclinical research findings into clinical therapies.


2020 ◽  
Vol 4 (1) ◽  
pp. e100046 ◽  
Author(s):  
Jan Vollert ◽  
Esther Schenker ◽  
Malcolm Macleod ◽  
Anton Bespalov ◽  
Hanno Wuerbel ◽  
...  

Over the last two decades, awareness of the negative repercussions of flaws in the planning, conduct and reporting of preclinical research involving experimental animals has been growing. Several initiatives have set out to increase transparency and internal validity of preclinical studies, mostly publishing expert consensus and experience. While many of the points raised in these various guidelines are identical or similar, they differ in detail and rigour. Most of them focus on reporting, only few of them cover the planning and conduct of studies. The aim of this systematic review is to identify existing experimental design, conduct, analysis and reporting guidelines relating to preclinical animal research. A systematic search in PubMed, Embase and Web of Science retrieved 13 863 unique results. After screening these on title and abstract, 613 papers entered the full-text assessment stage, from which 60 papers were retained. From these, we extracted unique 58 recommendations on the planning, conduct and reporting of preclinical animal studies. Sample size calculations, adequate statistical methods, concealed and randomised allocation of animals to treatment, blinded outcome assessment and recording of animal flow through the experiment were recommended in more than half of the publications. While we consider these recommendations to be valuable, there is a striking lack of experimental evidence on their importance and relative effect on experiments and effect sizes.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Louise C. Burgess ◽  
Thomas W. Wainwright ◽  
Khara A. James ◽  
Johan von Heideken ◽  
Maura D. Iversen

Abstract Background Therapeutic exercise is recommended as a core treatment for hip osteoarthritis (HOA). Whilst it is widely accepted that exercise can improve pain and disability, optimal type and dose of exercise are yet to be agreed upon. This may, in part, be attributed to the wide variation and inadequate reporting of interventions within the literature. This study evaluates the quality of intervention reporting among trials of therapeutic exercise in HOA. Methods Randomised controlled trials (RCTs) were sourced in a systematic review, completed in August 2020. Two raters independently used the Template for Intervention Description and Replication (TIDieR) and Consensus on Exercise Reporting Template (CERT) to evaluate intervention reporting. Correlations between quality assessment scores and CERT and TIDieR scores evaluated the relationship between internal validity and external applicability. The year of publication was compared to the quality of reporting scores. Results Fourteen RCTs were included in the analysis. On average, studies were awarded 9.43 ± 1.95 out of 12 points for the TIDieR checklist (range 4–12) and 13.57 ± 4.01 out of 19 points for the CERT (range 5–19). Pearson’s correlation coefficient suggested that the quality of reporting had improved over time and that there was a fair, positive relationship between internal validity and external applicability. Discussion Whilst the quality of intervention reporting is improving, many RCTs of therapeutic exercise in HOA lack the detail necessary to allow accurate evaluation and replication. Researchers are encouraged to utilise the standardised reporting guidelines to increase the translation of effective interventions into clinical practice.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Moses M. Ngari ◽  
Susanne Schmitz ◽  
Christopher Maronga ◽  
Lazarus K. Mramba ◽  
Michel Vaillant

Abstract Background Survival analyses methods (SAMs) are central to analysing time-to-event outcomes. Appropriate application and reporting of such methods are important to ensure correct interpretation of the data. In this study, we systematically review the application and reporting of SAMs in studies of tuberculosis (TB) patients in Africa. It is the first review to assess the application and reporting of SAMs in this context. Methods Systematic review of studies involving TB patients from Africa published between January 2010 and April 2020 in English language. Studies were eligible if they reported use of SAMs. Application and reporting of SAMs were evaluated based on seven author-defined criteria. Results Seventy-six studies were included with patient numbers ranging from 56 to 182,890. Forty-three (57%) studies involved a statistician/epidemiologist. The number of published papers per year applying SAMs increased from two in 2010 to 18 in 2019 (P = 0.004). Sample size estimation was not reported by 67 (88%) studies. A total of 22 (29%) studies did not report summary follow-up time. The survival function was commonly presented using Kaplan-Meier survival curves (n = 51, (67%) studies) and group comparisons were performed using log-rank tests (n = 44, (58%) studies). Sixty seven (91%), 3 (4.1%) and 4 (5.4%) studies reported Cox proportional hazard, competing risk and parametric survival regression models, respectively. A total of 37 (49%) studies had hierarchical clustering, of which 28 (76%) did not adjust for the clustering in the analysis. Reporting was adequate among 4.0, 1.3 and 6.6% studies for sample size estimation, plotting of survival curves and test of survival regression underlying assumptions, respectively. Forty-five (59%), 52 (68%) and 73 (96%) studies adequately reported comparison of survival curves, follow-up time and measures of effect, respectively. Conclusion The quality of reporting survival analyses remains inadequate despite its increasing application. Because similar reporting deficiencies may be common in other diseases in low- and middle-income countries, reporting guidelines, additional training, and more capacity building are needed along with more vigilance by reviewers and journal editors.


2017 ◽  
Vol 242 (18) ◽  
pp. 1772-1785 ◽  
Author(s):  
Stanislav Žiaran ◽  
Martina Galambošová ◽  
L'uboš Danišovič

The purpose of this article was to perform a systematic review of the recent literature on urethral tissue engineering. A total of 31 articles describing the use of tissue engineering for urethra reconstruction were included. The obtained results were discussed in three groups: cells, scaffolds, and clinical results of urethral reconstructions using these components. Stem cells of different origin were used in many experimental studies, but only autologous urothelial cells, fibroblasts, and keratinocytes were applied in clinical trials. Natural and synthetic scaffolds were studied in the context of urethral tissue engineering. The main advantage of synthetic ones is the fact that they can be obtained in unlimited amount and modified by different techniques, but scaffolds of natural origin normally contain chemical groups and bioactive proteins which increase the cell attachment and may promote the cell proliferation and differentiation. The most promising are smart scaffolds delivering different bioactive molecules or those that can be tubularized. In two clinical trials, only onlay-fashioned transplants were used for urethral reconstruction. However, the very promising results were obtained from animal studies where tubularized scaffolds, both non-seeded and cell-seeded, were applied. Impact statement The main goal of this article was to perform a systematic review of the recent literature on urethral tissue engineering. It summarizes the most recent information about cells, seeded or non-seeded scaffolds and clinical application with respect to regeneration of urethra.


2019 ◽  
Vol 20 (2) ◽  
pp. 199-216 ◽  
Author(s):  
C. B. Winder ◽  
J. M. Sargeant ◽  
D. Hu ◽  
C. Wang ◽  
D. F. Kelton ◽  
...  

AbstractA systematic review and network meta-analysis were conducted to assess the relative efficacy of antimicrobial therapy given to dairy cows at dry-off. Eligible studies were controlled trials assessing the use of antimicrobials compared to no treatment or an alternative treatment, and assessed one or more of the following outcomes: incidence of intramammary infection (IMI) at calving, incidence of IMI during the first 30 days in milk (DIM), or incidence of clinical mastitis during the first 30 DIM. Databases and conference proceedings were searched for relevant articles. The potential for bias was assessed using the Cochrane Risk of Bias 2.0 algorithm. From 3480 initially identified records, 45 trials had data extracted for one or more outcomes. Network meta-analysis was conducted for IMI at calving. The use of cephalosporins, cloxacillin, or penicillin with aminoglycoside significantly reduced the risk of new IMI at calving compared to non-treated controls (cephalosporins, RR = 0.37, 95% CI 0.23–0.65; cloxacillin, RR = 0.55, 95% CI 0.38–0.79; penicillin with aminoglycoside, RR = 0.42, 95% CI 0.26–0.72). Synthesis revealed challenges with a comparability of outcomes, replication of interventions, definitions of outcomes, and quality of reporting. The use of reporting guidelines, replication among interventions, and standardization of outcome definitions would increase the utility of primary research in this area.


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