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Preclinical Experiments for Hypospadias Surgery: Systematic Review and Quality Assessment.

ABSTRACT: 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.

SUBMITTER: Abbas TO

PROVIDER: S-EPMC8386350 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveUsing the AMSTAR tool, this study evaluated the quality of systematic reviews (SRs) that assessed the efficacy of bariatric surgery in diabetic patients. We aimed to identify studies that can be used as clinical references.MethodsMedline (via PubMed), EMBASE, Epistemonikos, Web of Science, Cochrane Library, CBM, CNKI, and Wanfang Data were systematically searched from inception to December 31, 2017. Two reviewers independently selected SRs and extracted data. Disagreements were solved by discussions or through consultation with a third reviewer. Reviewers extracted data (characteristics of included SRs, e.g., publication year, language, and number of authors) into the predefined tables in the Microsoft Excel 2013 sheet. Data were visualized using the forest plot in RevMan 5.3 software.ResultsA total of 64 SRs were included. The average AMSTAR score was 7.4 ± 1.7. AMSTAR scores of 7 (n = 21, 32.8%) and 8 (n = 14, 28.1%) were most common. The AMSTAR scores of SRs published before 2016 (n = 46, 71.9%) were compared with SRs published after 2016 (n = 18, 28.1%), and no significant differences were observed (MD = -0.79, 95% confidence interval (CI) -1.65-0.07, P = 0.07). For SRs published in Chinese (n = 17, 26.6%) compared to those published in English (n = 47, 73.4%), the AMSTAR scores significantly differed (MD = 0.21, 95% CI (-0.55, 0.97), P = 0.59). For SRs published in China (n = 33, 51.6%) compared to those published outside of China (n = 31, 48.4%), significant differences in the AMSTAR scores were observed (MD = 1.10, 95% CI (0.29, 1.91), P = 0.008). For SRs with an author number ≤ 6 (n = 31, 48.4%) compared to SRs with authors ≥ 6 (n = 33, 51.6%), no significant differences were observed (MD = -0.36, 95% CI (-1.22, 0.50), P = 0.41). For high-quality SRs published after 2016 (n = 11, 17.2%) compared to other SRs (n = 53, 82.8%), statistically significant differences were noted (MD = 1.75, 95% CI (1.01, 2.49), P < 0.00001).ConclusionsThe number of SRs assessing the efficacy of bariatric surgery in diabetic patients is increasing by year, but only a small number meet the criteria to support guideline recommendations. Study protocols not being registered, grey literature not retrieved, incorporation of grey literature as exclusion criteria, and failure to evaluate publication bias and report a conflict of interest were the main causes of low AMSTAR scores.

Project description:BackgroundThere is growing interest in using patient-reported outcome measures to support value-based care in colorectal surgery. To draw valid conclusions regarding patient-reported outcomes data, measures with robust measurement properties are required.ObjectiveThe purpose of this study was to assess the use and quality of patient-reported outcome measures in colorectal surgery.Data sourcesThree major databases were searched for studies using patient-reported outcome measures in the context of colorectal surgery.Study selectionArticles that used patient-reported outcome measures as outcome for colorectal surgical intervention in a comparative effectiveness analysis were included. Exclusion criteria included articles older than 11 years, non-English language, age <18 years, fewer than 40 patients, case reports, review articles, and studies without comparison.Main outcome measuresThis was a quality assessment using a previously reported checklist of psychometric properties.ResultsFrom 2007 to 2018, 368 studies were deemed to meet inclusion criteria. These studies used 165 distinct patient-reported outcome measures. Thirty were used 5 or more times and were selected for quality assessment. Overall, the measures were generally high quality, with 21 (70%) scoring ≥14 on an 18-point scale. Notable weaknesses included management of missing data (14%) and description of literacy level (0%).LimitationsThe study was limited by its use of original articles for quality assessment. Measures were selected for quality analysis based on frequency of use rather than other factors, such as impact of the article or number of patients in the study.ConclusionsPatient-reported outcome measures are widely used in colorectal research. There was a wide range of measures available, and many were used only once. The most frequently used measures are generally high quality, but a majority lack details on how to deal with missing data and information on literacy levels. As the use of patient-reported outcome measures to assess colorectal surgical intervention increases, researchers and practitioners need to become more knowledgeable about the measures available and their quality.

Project description:Translation from preclinical animal research to clinical bedside has proven to be difficult to impossible in many fields of research (e.g. acute stroke, ALS and HIV vaccination development) with oncology showing particularly low translation rates (5% vs. 20% for cardiovascular diseases). Several investigations on published preclinical animal research have revealed that apart from plain species differences, translational problems can arise from low study quality (e.g. study design) or non-representative experimental conditions (e.g. treatment schedule). This review assessed the published experimental circumstances and quality of anti-angiogenic cancer drug development in 232 in vivo studies. The quality of study design was often insufficient; at least the information published about the experiments was not satisfactory in most cases. There was no quality improvement over time, with the exception of conflict of interest statements. This increase presumably arose mainly because journal guidelines request such statements more often recently. Visual inspection of data and a cluster analysis confirmed a trend described in literature that low study quality tends to overestimate study outcome. It was also found that experimental outcome was more favorable when a potential drug was investigated as the main focus of a study, compared to drugs that were used as comparison interventions. We assume that this effect arises from the frequent neglect of blinding investigators towards treatment arms and refer to it as hypothesis bias. In conclusion, the reporting and presumably also the experimental performance of animal studies in drug development for oncology suffer from similar shortcomings as other fields of research (such as stroke or ALS). We consider it necessary to enforce experimental quality and reporting that corresponds to the level of clinical studies. It seems that only clear journal guidelines or guidelines from licensing authorities, where failure to fulfill prevents publication or experimental license, can help to improve this situation.

Project description:BackgroundThe effectiveness of breast cancer screening is still under debate. Our objective was to systematically review studies assessing personalized breast cancer screening strategies based on women's individual risk and to conduct a risk of bias assessment.MethodsWe followed the standard methods of The Cochrane Collaboration and PRISMA declaration and searched the MEDLINE, EMBASE and Clinical Trials databases for studies published in English. The quality of the studies was assessed using the ISPOR-AMCP-NPC Questionnaire and The Cochrane Risk of Bias Tool. Two independent reviewers screened full texts and evaluated the risk of bias.ResultsOut of the 1533 initially retrieved citations, we included 13 studies. Three studies were randomized controlled trials, while nine were mathematical modeling studies, and one was an observational pilot study. The trials are in the recruitment phase and have not yet reported their results. All three trials used breast density and age to define risk groups, and two of them included family history, previous biopsies, and genetic information. Among the mathematical modeling studies, the main risk factors used to define risk groups were breast density, age, family history, and previous biopsies. Six studies used genetic information to define risk groups. The most common outcome measures were the gain in quality-adjusted life years (QALY), absolute costs, and incremental cost-effectiveness ratio (ICER), while the main outcome in the observational study was the detection rate. In all models, personalized screening strategies were shown to be effective. The randomized trials were of good quality. The modeling studies showed moderate risk of bias but there was wide variability across studies. The observational study showed a low risk of bias but its utility was moderate due to its pilot design and its relatively small scale.ConclusionsThere is some evidence of the effectiveness of screening personalization in terms of QUALYs and ICER from the modeling studies and the observational study. However, evidence is lacking on feasibility and acceptance by the target population.Review registrationPROSPERO: CRD42018110483.

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Preclinical Experiments for Hypospadias Surgery: Systematic Review and Quality Assessment.

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