Comparison of Reporting and Transparency in Published Protocols and Publications in Umbrella Reviews: Scoping Review.

BACKGROUND: Inconsistencies between a protocol and its umbrella review (UR) may mislead readers about the importance of findings or lead to false-positive results. Furthermore, not documenting and explaining inconsistencies in the UR could reduce its transparency. To our knowledge, no study has examined the methodological consistency of the protocols with their URs and assessed the transparency of the URs when generating evidence. OBJECTIVE: This study aimed to investigate the inconsistency of protocols with their URs in the methodology and assess the transparency of the URs. METHODS: We searched medical-related electronic databases from their inception to January 1, 2022. We investigated inconsistencies between protocols and their publications and transparencies in the search strategy, inclusion criteria, methods of screening and data extraction, quality assessment, and statistical analysis. RESULTS: We included 31 protocols and 35 publications. For the search strategy, 39 inconsistencies between the protocols and their publications were found in 26 of the 35 (74%) URs, and 16 of these inconsistencies were indicated and explained. There were 84 inconsistencies between the protocols and their URs regarding the inclusion criteria in 31 of the 35 (89%) URs, and 29 of the inconsistencies were indicated and explained. Deviations from their protocols were found in 12 of the 32 (38%) URs reporting the methods of screening, 14 of the 30 (47%) URs reporting the methods of data extraction, and 11 of the 32 (34%) URs reporting the methods for quality assessment. Of the 35 URs, 6 (17%) were inconsistent with their protocols in terms of the tools for quality assessment; one-half (3/6, 50%) of them indicated and explained the deviations. As for the statistical analysis, 31 of the 35 (89%) URs generated 61 inconsistencies between the publications and their protocols, and 16 inconsistencies were indicated and explained. CONCLUSIONS: There was a high prevalence of inconsistencies between protocols and publications of URs, and more than one-half of the inconsistencies were not indicated and explained in the publications. Therefore, how to promote the transparency of URs will be a major part of future work.

Effectiveness of small-angle episiotomy on incisional laceration rate, suturing time, and incisional bleeding in primigravida: A meta-analysis.

Objective: To investigate the effect of small-angle lateral perineal incision on postoperative perineal rehabilitation in primiparous women. Method: The Cochrane Library, PubMed, Embase, CINAHL, CNKI, WanFang, VIP, and the Chinese Biomedical Literature Database were searched for randomized controlled trials (RCTs) on the effect of small-angle episiotomy on postoperative maternal perineal wound rehabilitation in puerpera until April 3, 2022. Two researchers independently performed literature screening, data extraction and evaluation of risk of bias in the included literature, and statistical analysis of the data was performed using RevMan 5.4 and Stata 12.0 software. Result: A total of 25 RCTs were included, with a total sample of 6,366 cases. Meta-analysis results showed that the use of small-angle episiotomy reduced incisional tearing [OR = 0.32, 95% CI (0.26, 0.39)], shortened incisional suture time [MD = -4.58 min, 95% CI (-6.02, -3.14)] and reduced incisional bleeding [MD = -19.08 mL, 95% CI (-19.53, -18.63)], with statistically significant differences (all p < 0.05). There was no significant difference in the rate of severe laceration between the two groups [OR = 2.32, 95% CI (0.70, 7.70), p > 0.05]. Conclusion: The use of a small-angle episiotomy during vaginal delivery can reduce the incision tear rate without increasing the incidence of severe perineal laceration, while shortening the incisional suturing time and reducing incisional bleeding. It can be used clinically according to birth canal conditions of the maternal, the intrauterine condition of the fetus and maternal needs. Systematic Review Registration: PROSPERO International Prospective Register of Systematic Reviews [CRD42022369698]; [https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=369698].

Quality and clinical applicability of recommendations for incontinence-associated dermatitis: A systematic review of guidelines and consensus statements.

AIMS AND OBJECTIVES: The aim of this study was to assess methodological quality of all currently available guidelines and consensus statements for IAD using the Appraisal of Guidelines, Research and Evaluation (AGREE) II and the AGREE Recommendation Excellence (AGREE-REX) instruments. BACKGROUND: Globally, incontinence-associated dermatitis (IAD) is a significant health challenge. IAD is a complex healthcare problem that reduces quality of life of patients, increases healthcare costs and prolongs hospital stays. Several guidelines and consensus statements are available for IAD. However, the quality of these guidelines and consensus statements remains unclear. DESIGN: A systematic review of guidelines and consensus statements. METHODS: Our study was undertaken using PRISMA guidelines. We searched seven electronic databases. Guidelines and consensus statements had to be published in English, Chinese or German languages. Five independent reviewers assessed the methodological quality of guidelines and consensus statements using the AGREE II and AGREE-REX instruments. Mean with standard deviation (SD) and median with interquartile range (IQR) were calculated for descriptive analyses. We generated bubble plots to describe the assessment results of each domain of each guideline and consensus statement. RESULTS: We included ten guidelines and consensus statements. The NICE guidelines, obtained the highest scores, fulfilled 86.11%-98.61% of criteria in AGREE II and 76.67%-91.11% for AGREE-REX. In the domains 'Stakeholder Involvement' (4.39 ± 1.64), 'Rigor of Development' (3.38 ± 1.86), 'Applicability' (3.62 ± 1.64), 'Editorial Independence' (3.91 ± 2.56) and 'Values and Preferences' (2.98 ± 1.41), the remaining guidelines and consensus statements showed deficiencies. CONCLUSIONS: Altogether, this study demonstrated that the currently available guidelines and consensus statements for IAD have room for methodological improvement. NICE guidelines on faecal incontinence and urinary incontinence have better quality. Remaining guidelines and consensus statements showed substantial methodological weaknesses, especially the domains of 'Stakeholder Involvement', 'Rigor of Development', 'Applicability', 'Editorial independence' and 'Values and Preferences'. This study was registered on INPLASY. (Registration number: INPLASY202190078). RELEVANCE TO CLINICAL PRACTICE: The currently available guidelines and consensus statements on IAD have room for methodological improvement.

Twelve-year global publications on small incision lenticule extraction: A bibliometric analysis.

Purpose: To analyze the development process of small incision lenticule extraction (SMILE) surgery in a 12-year period. Methods: We conducted a literature search for SMILE research from 2011 to 2022 using the Science Citation Index Expanded (SCIE) of the Web of Science Core Collection (WoSCC). The VOS viewer, and CiteSpace software were used to perform the bibliometric analysis. Publication language, annual growth trend, countries/regions and institutions, journals, keywords, references, and citation bursts were analyzed. Results: A total of 731 publications from 2011 to 2022 were retrieved. Annual publication records grew from two to more than 100 during this period. China had the highest number of publications (n = 326). Sixty-five keywords that appeared more than four times were classified into six clusters: femtosecond laser technology, dry eye, biomechanics, visual quality, complications, and hyperopia. Conclusion: The number of literatures has been growing rapidly in the past 12 years. Our study provides a deep insight into publications on SMILE for researchers and clinicians with bibliometric analysis for the first time.

Establishing a core outcome set for neurogenic bladder trials: study protocol for a scoping review and Delphi surveys.

BACKGROUND: Neurogenic bladder (NGB) is a chronic and disabling condition with a high prevalence rate, which can cause economic burden on patients and their families and reduce the quality of life of patients. Researchers have carried out a large number of clinical trials on the effectiveness and safety of different interventions for the treatment of NGB. The published clinical trials of NGB generally suffered from inconsistent and irregular reporting of outcome indicators. To facilitate future research studies of NGB, a core outcome set (COS) is required, which helps translate the results into high-quality evidence. METHODS AND ANALYSIS: This mixed-method project has four phases instrument: in phase 1, a scoping review of the literature to identify outcomes that have been reported in clinical trials and systematic reviews of clinical trials of interventions for NGB; in phase 2, a qualitative component using interviews to obtain the views of NGB patients, families, and their caregivers; in phase 3, Delphi survey among stakeholders to prioritize the core outcomes; and in phase 4, a face-to-face consensus meeting to discuss and agree on the final NBG COS. CONCLUSIONS: We will develop a COS that should be reported in future clinical trials of NGB. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials (COMET) Initiative database registration: http://www.comet-initiative.org/studies/details/1985 . Registered on 02 January 2022. INPLASY  INPLASY202210007.

Development of a Core Outcome Set in the Clinical Trials of Traditional Chinese Medicine for Stroke: A Study Protocol.

Introduction: Stroke, an acute cerebrovascular disease, is mainly caused by the sudden rupture or occlusion of blood vessels, and is subdivided into ischemic stroke and hemorrhagic stroke. It has become the second leading cause of death worldwide. In Chinese clinical practice, traditional Chinese medicine (TCM)/Integrative Medicine has been widely used for the treatment of stroke. Numerous randomized controlled trials (RCTs) of TCM/Integrative Medicine for stroke have been conducted to improve the efficacy and safety outcomes. However, their conclusions should be treated with caution because of the methodological quality defects in the clinical research. Pervasive inconsistencies are present in the outcomes collected and reported across these studies, which may lead to the pooling of discrepant data and preclude meta-analysis. The issue could be addressed by developing a core outcome set (COS). Aim: The aim of this study is to develop a COS in the clinical trials of TCM/Integrative Medicine in the treatment of stroke. Method and Analysis: A steering group will be set up to organize and guide the development of the COS. The study contains three phases: (I) development of an initial outcome list covering all relevant outcomes, via two steps: (i) systematic reviews of outcomes for clinical trials of TCM/ Integrative Medicine for stroke; (ii) semi-structured interviews with patients suffering from stroke; (II) conduction of three round of Delphi surveys with different stakeholder groups to prioritize important outcomes; (III) integration of outcomes into a core outcome set by a consensus meeting. Ethics and Dissemination: This study has been granted by the Ethics Committee of Tianjin University of Traditional Chinese Medicine (TJUTCM-EC20210003). When the COS is completed, we will publish it in an appropriate journal to promote further widespread use. Registration: This study has been registered at the Core Outcome Measures in Effectiveness Trials initiative, COMET database (Registration #1678).

An umbrella review of Lianhua Qingwen combined with Western medicine for the treatment of coronavirus disease 2019.

Lianhua Qingwen combined with Western medicine (LHQW+WM) has been proposed as a viable treatment for coronavirus disease 2019 (COVID-19). Interestingly, umbrella reviews of systematic reviews (SRs), which provide the most comprehensive evidence, are the best evidence in evidence-based medicine. Therefore, an umbrella review of SRs that summarizes and evaluates the efficacy of LHQW+WM for COVID-19 is urgently required. Methods: Overall, 6 databases were used to conduct a comprehensive literature search from inception to January 22, 2022. The corrected covered area (CCA) was used to analyze the overlapping between SRs. Meta-analysis was conducted when that of the included SRs was inappropriate. A MeaSurement Tool to Assess Systematic Reviews (AMSTAR-2) was also employed to assess the quality of the included SRs. Results: In total, 12 SRs were identified, which included 12 unique primary studies. The included SRs ranged in quality from moderate to critically low and had an extremely high CCA (36.4%). Compared to conventional treatment, LHQW+WM showed efficacy concerning fatigue recovery [risk ratio (RR) = 1.69, 95% confidence interval (CI): 1.04-2.73, n = 2, I2 = 0%], cough recovery (RR = 1.65, 95% CI: 1.09-2.51, n = 3, I2 = 39.1%), and overall effective rates (RR = 1.17, 95% CI: 1.07-1.28, n = 3, I2 = 17.5%). Conclusion: LHQW+WM may improve the clinical symptoms of patients with COVID-19; however, the results should be interpreted cautiously because of the rigorous processes in the included SRs. Graphical abstract: http://links.lww.com/AHM/A32.

Early Diagnosis of Occult Blood of Colorectal Cancer Based on Nano-Colloidal Gold Sandwich Immunochromatography.

The development of science and technology has deepened people's understanding of cancer, changing the management of malignant tumors in the medical field. Given the common precancerous characteristics of colorectal cancer (CRC), researchers studied early CRC screening. The complexity of traditional diagnostics forced medical staff to speed up CRC innovation early screening methods. Here, we prepared nano-colloidal gold raw materials with different particle sizes (15 and 30 nm) and observed the morphological characteristics and properties of the materials. Simultaneously, the nanocolloidal gold double antibody sandwich kit was designed through the optimum pH value and protein content screening experiment. The results of clinical enteroscopy confirmed the important guiding significance of the equipment in early CRC screening.

Amber codon is genetically unstable in generation of premature termination codon (PTC)-harbouring Foot-and-mouth disease virus (FMDV) via genetic code expansion.

The foot-and-mouth disease virus (FMDV) is the causative agent of FMD, a highly infectious and devastating viral disease of domestic and wild cloven-hoofed animals. FMD affects livestock and animal products' national and international trade, causing severe economic losses and social consequences. Currently, inactivated vaccines play a vital role in FMD control, but they have several limitations. The genetic code expansion technology provides powerful strategies for generating premature termination codon (PTC)-harbouring virus as a live but replication-incompetent viral vaccine. However, this technology has not been explored for the design and development of new FMD vaccines. In this study, we first expanded the genetic code of the FMDV genome via a transgenic cell line containing an orthogonal translation machinery. We demonstrated that the transgenic cells stably integrated the orthogonal pyltRNA/pylRS pair into the genome and enabled efficient, homogeneous incorporation of unnatural amino acids into target proteins in mammalian cells. Next, we constructed 129 single-PTC FMDV mutants and four dual-PTC FMDV mutants after considering the tolerance, location, and potential functions of those mutated sites. Amber stop codons individually substituted the selected amino acid codons in four viral proteins (3D, L, VP1, and VP4) of FMDV. We successfully rescued PTC-FMDV mutants, but the amber codon unexpectedly showed a highly degree of mutation rate during PTC-FMDV packaging and replication. Our findings highlight that the genetic code expansion technology for the generation of PTC-FMD vaccines needs to be further improved and that the genetic stability of amber codons during the packaging and replication of FMDV is a concern.

Quantitative analysis of neovascular permeability in glioma by dynamic contrast-enhanced MR imaging.

This study was designed to quantitatively analyse neovascular permeability in glioma by dynamic contrast-enhanced MRI (DCE-MRI). Forty-four patients with glioma were included in this study. The highest value of volume transfer constant (K(trans)) and volume of extravascular extracellular space per unit volume of tissue (V(e)) were obtained and the differences in K(trans) and V(e) between low-grade glioma (LGG) and high-grade glioma (HGG) were analyzed. The correlations between K(trans), V(e) and glioma grade were performed. Receiver operating characteristic (ROC) curve analyses were conducted. The values of K(trans) and V(e) of LGG were significantly lower than those of HGG. The correlation analysis demonstrated statistically significant relationships between K(trans) and glioma grade, between V(e) and glioma grade, and between K(trans) and V(e). The ROC curve analyses of K(trans) (0.035/min) and V(e) (0.130) for differentiating LGG from HGG were statistically significant. Thus, DCE-MRI can be used to estimate neovascular permeability and for pre-operative grading of glioma.