scholarly journals A systematic evaluation on reporting quality of modern studies on pulmonary heart valve implantation in large animals

2020 ◽  
Vol 31 (4) ◽  
pp. 437-445
Author(s):  
Marcelle Uiterwijk ◽  
Annemijn Vis ◽  
Iris de Brouwer ◽  
Debora van Urk ◽  
Jolanda Kluin

Abstract OBJECTIVES Before new heart valves can be implanted safely in humans, animal experiments have to be performed. These animal experiments have to be clearly designed, analysed and reported to assess the accuracy and importance of the findings. We aimed to provide an overview of the reporting and methodological quality of preclinical heart valve research. METHODS We conducted a systematic literature search on biological and mechanical pulmonary valve implantations in large animals. We used the Animals in Research: Reporting In Vivo Experiments (ARRIVE) guidelines to score the quality of reporting in each article. We compared the scores before and after the introduction of the ARRIVE guidelines (2010). RESULTS We screened 348 articles, of which 31 articles were included. The included articles reported a mean of 54.7% adequately scored ARRIVE items (95% confidence interval 52.2–57.3%). We did not identify a difference in reporting quality (54.7% vs 54.8%) between articles published before and after 2010. We found an unclear (lack of description) risk of selection bias, performance bias and detection bias. CONCLUSIONS The reporting quality of studies that implanted bioprosthetic or mechanical valves in the pulmonary position in the large animal model is not on the desired level. The introduction of the ARRIVE guidelines in 2010 did not improve the reporting quality in this field of research. Hereby, we want to emphasize the importance of clearly describing the methods and transparently reporting the results in animal experiments. This is of great importance for the safe translation of new heart valves to the clinic. Clinical trial registration number PROSPERO (CRD42019147895).

2021 ◽  
Vol 73 (7) ◽  
pp. 478-484
Author(s):  
Watcharit Anantakal ◽  
◽  
Somboon Thamtakerngkit ◽  
Vijarn Vachirawongsakorn ◽  
◽  
...  

Objective: To compare the heart valve circumference before and after 10% formalin fixation. Materials and Methods: The study analyzed 63 Thai human cadaveric hearts. Each heart valve circumference was separately measured in the fresh state by specifically designed equipment. After that, the hearts were fixed in 10% formalin for 3 days. Then each heart valve circumference was measured by the same equipment and by the thread and ruler technique. The results were analyzed using SPSS package to find the association between the heart valve circumference before and after formalin fixation. Results: This study showed that the average circumferences of the heart valve measured in the fresh state were 13.329 cm in the tricuspid valve, 10.617 cm in the mitral valve, 8.416 cm in the pulmonic valve, and 7.122 cm in the aortic valve. The average circumferences of the heart valve measured after 10% formalin fixation were 11.019 cm in the tricuspid valve, 8.714 cm in the mitral valve, 6.751 cm in the pulmonic valve, and 6.089 cm in the aortic valve. The average ratios of the heart valve circumference measured fresh and after 10% formalin fixation were 0.8267 in the tricuspid valve, 0.8235 in the mitral valve, 0.8050 in the pulmonic valve, and 0.8573 in the aortic valve. There were significant differences in the heart valve circumference between the fresh state and after formalin fixation (p < 0.001). Conclusion: This study revealed important information on the dimensional changes of all the formalin-fixed heart valves. We found that the heart valve shrank after formalin fixation, with the formalin-fixed hearts an estimated 0.8 times smaller than the fresh cadaveric hearts.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
Y Takewa ◽  
Y Nakayama ◽  
J Shimamura ◽  
N Katagiri ◽  
E Tatsumi

Abstract Background We are developing a novel autologous tissue-engineered heart valve with a unique in-body tissue engineering. This is expected to be a viable bioprosthesis keeping better biocompatibility. Purpose We developed a conduit-type valve without any foreign materials and tested the feasibility and long-term availability in large animal experiments. Methods We created plastic molds for Biovalves with 3D printer easily and quickly considering the recipient character. We embedded them in the subcutaneous spaces of adult goats about 2 months. After extracting the molds with the tissue en-block and removing the plastic molds only, Biovalve with tri-leaflets similar to those of the native valves were constituted from completely autologous connective tissues and fibroblasts. Total 21 conduit-type Biovalves were implanted in the apico-aortic bypass or the pulmonary artery of goats, (8 and 13, respectively). No anticoagurants were used after implantation. Results The valves were successfully implanted and showed smooth movement of the leaflets with a little regurgitation in angiogram, and the maximum duration reached to 3 years 7 months. Histological examination of the Biovalves showed the autologous cells covering the laminar surface of the valve leaflets as the endothelium and also getting inside to construct characteristic tissues like native leaflets. Conclusion The valves have a potential to be used for viable bioprosthetic valves and to keep better function and biocompatibility longer than current ones.


Nutrients ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 1583 ◽  
Author(s):  
Kamioka ◽  
Tsutani ◽  
Origasa ◽  
Yoshizaki ◽  
Kitayuguchi ◽  
...  

Background: In Japan, a new type of foods with health claims, called Foods with Function Claims (FFC), was introduced in April 2015 in order to make more products available that are clearly labeled with certain health functions. Regarding substantiating product effectiveness, scientific evidence for the proposed function claims must be explained by systematic reviews (SRs), but the quality of SRs was not clear. The objectives of this review were to assess the quality of SRs based on the FFC registered on the Consumer Affairs Agency (CAA) website in Japan, and to determine whether the CAA’s verification report in 2016 was associated with improvement in the quality of SRs. Methods: We evaluated the reporting quality of each SR by the AMSTAR checklist on methodological quality. We searched the database from 1 April to 31 October 2015 as the before-SR and from 1 July 2017 to 31 January 2018 as the after-SR. Results: Among the 104 SRs reviewed, 96 final products were included: 51 (53.1%) were supplements, 42 (43.8%) were processed foods without supplements, and 3 (3.1%) were fresh foods. Of the 104 SRs, 92 (88.5%) were qualitative reviews (i.e., without meta-analysis) and 12 (11.5%) performed a meta-analysis. The average quality score of before-SRs and after-SRs was 6.2 ± 1.8 and 5.0 ± 1.9, respectively, a statistically significant decrease (p < 0.001). Conclusion: Overall, the methodology and reporting quality of after-SRs based on the FFC were poorer than those of before-SRs. In particular, there were very poor descriptions and/or implementations of study selection and data extraction, search strategy, evaluation methods for risk of bias, assessment of publication bias, and formulating conclusions based on methodological rigor and scientific quality of the included studies.


2019 ◽  
Vol 43 (10) ◽  
pp. 2371-2378 ◽  
Author(s):  
Benjamin Speich ◽  
Kimberly A. Mc Cord ◽  
Arnav Agarwal ◽  
Viktoria Gloy ◽  
Dmitry Gryaznov ◽  
...  

Author(s):  
Rindu Rika Gamayuni

Abstract: In Indonesia local government, accrual based Government Accounting Standard (GAS) was started to be mandatorily applied in 2015, so this research aims to investigate to what extent the role of accrual GAS implementation toward quality of financial reporting and financial performance especially at local governments. Population of this study is Local Governments of districts/cities in Indonesia for Fiscal Year 2014 and Fiscal Year 2015, as many as 542 local governments (before and after the implementation of accrual base).  Sampling method uses probability sampling which is cluster sampling. In this case, the population is divided based on 34 province clusters, so the number of sample obtained is 242 local governments of districts/cities in Indonesia.  The hypothesis testing uses paired t test. The object of research is the financial reporting quality and financial performance. The results of this study provide empirical evidence that there is an increase in the quality of financial reporting after the application of accrual-based accounting at local governments in Indonesia, but have not proven the existence of the increased financial performance. There is no differences in financial performance before and after accrual based accounting implementation at local governments in Indonesia. This hyphothesis  was not supported due to the application of accrual basis accounting is still in the early stages of implementation (1 year) that still have constraints in limited human resources competencies, necessary adaptations or adjustments in the process of change. Local governments in Indonesia must apply accrual based accounting because it is proven that it increases financial report quality.  However, the system implementation in the beginning period found many obstacles so it needs continuous adjustment and learning in order to reach desirable goal. There is still a debate on how important is the implementation or adoption of accrual IPSAS in many countries, including Indonesia.  In Indonesia, the implementation of accrual based Government Accounting Standard (SAP/GAS) is new mandatory since 2015. The result of this research will give contribution to the theory, that there is significant influence of implementation accrual based GAS to financial reporting quality, but no significant increase in financial performance (efficiency and effectiveness) at local government.  Therefore, this result study will be used to determine related policies about the implementation of accrual based GAS. Keywords: Accrual Based Accounting, Financial Reporting Quality, Financial Performance, Government


2017 ◽  
Author(s):  
Rajashree Yellur ◽  
Shabbeer Hassan

Improper reporting of diagnostic studies leads to an incorrect assessment of their clinical performance. STARD (Standards for Reporting of Diagnostic Accuracy Studies) checklist was launched in 2003 with the intention of improving reporting quality in diagnostic accuracy studies. The main aim of this study was to check the extent to which published diagnostic accuracy studies follow the 28-item STARD checklist. We conducted a literature survey of diagnostic studies published in Indian Journal of Medical Research (IJMR) between the years 1995-2013 for the evaluating their reporting quality by checking their adherence to STARD. Relevant studies (N=76) were retrieved from IJMR website and data extraction was performed by two authors simultaneously. A simple pre-post analysis found that there was no overall change in the reporting quality before and after STARD was released. Though some STARD items like description of participant sampling (χ2 = 5.712, p = 0.0169), clinical applicability of study findings (χ2 = 9.704, p = 0.0018) had a significant increase in post-STARD period. To take into account any underlying trend we conducted an interrupted time-series was done. We found a significant increase in the reporting quality after publication of STARD (β3 = 0.215 ± 0.068, p = 0.034). The overall reporting quality of diagnostic accuracy studies have improved since the introduction of STARD, however, error/defects in many sections remain as before.


2019 ◽  
Vol 12 (1) ◽  
pp. 71-80
Author(s):  
Ilya Alexandrovich Soynov ◽  
Irina Yurievna Zhuravleva ◽  
Yuriy Yurievich Kulyabin ◽  
Nataliya Romanova Nichay ◽  
Tatyana Pavlovna Timchenko ◽  
...  

The “ideal” graft for forming outflow ways is a big issue in reconstructive heart valve surgery. For today, this question is a field of interest especially in pediatric cardiac surgery, because the existing prosthesis are exposed to aggressive degenerative processes due to metabolic features, and also do not have the growth potential. Therefore, repetitive graft reimplantation gradually increases risk of surgery and greatly reduce the quality of patient’s life. Tissue engineering is a new perspective approach in surgery of congenital and heart valve diseases, which may help overcome limitations of existing and provide the new opportunities for surgical correction. This review highlights current trends in development of tissue-engineered heart valves and grafts, and existing limitations and potential solutions are discussed.


2016 ◽  
Author(s):  
Yali Liu ◽  
Yuchen Feng ◽  
Lili Zhang ◽  
Xiaohuan Feng ◽  
Qin Feng ◽  
...  

Objective: The aim of this study was to use the Animals in Research: Reporting In Vivo Experiments (ARRIVE) guidelines to evaluate the quality of reporting of recent gastric cancer animal experiments. Materials and Methods: A literature search of studies was performed using the Chinese Biomedical Literature Database, Chinese Journal Full-text Database, Chinese Scientific Journal Full-text Database, and Wanfang Database from January 2010 to December 2012. We extracted data using pre-prepared Excel data-extraction forms. Reporting quality was evaluated based on the ARRIVE guidelines. Results: Of the 1816 studies that were identified by our search, 170 were subjected to quantitative analysis using the ARRIVE guidelines. The results of the evaluation based on the ARRIVE guidelines were that 132 studies (77.61%) provided an accurate and concise description of baseline conditions and clinical conditions. Only 2 (1.18%) papers provided relevant certificates of ethical review or institutional guidelines, and 2 (1.18%) papers provided an explanation of animal experiments requiring algorithms and formulas for sample size. Forty-seven (27.65%) studies described in detail how animals were assigned to each experimental group, including the randomization procedure, 2 (1.18%) reported whether blinding was used, and 15 (8.82%) evaluated the limitations of the study. Conclusions: The reporting quality of recent animal experiments of gastric cancer is inadequate. We should improve not only the quality of the methodology but also the reporting quality of the animal experiments.


2020 ◽  
Author(s):  
Bing Zhao ◽  
Yanbiao Jiang ◽  
Ting Zhang ◽  
Zhizhong Shang ◽  
Weiyi Zhang ◽  
...  

Abstract Objective To retrospectively evaluate the reporting quality of animal experiments published in Chinese journals adhering to the Animals Research: Reporting of In Vivo Experiments (ARRIVE) guidelines. Methods The databases CNKI, WanFang, VIP, and CBM were searched from inception until July 2018. Two appropriately-trained. reviewers screened and extracted articles independently. The ARRIVE guidelines were used to assess the quality of the published reports of animal experiments. The compliance rate of every item was analyzed relative to the different dates of publication. Results A total of 4342 studies were finally included, of which 73.03% had been cited ≤ 5 times. Only 29.04% (1261/4342) were published in journals listed in the Chinese Science Citation Database. The results indicate that the compliance rate of around half of the sub-items (51.3%, 20/39) was less than 50% and 65.0% (13/20) was less than 10%. Conclusions The reporting quality of animal experiments in Chinese journals is generally at a low to moderate level. Due to the publication of the ARRIVE guidelines in 2010, the compliance rate of the majority of items in the ARRIVE guidelines has improved to some extent. However, less attention has been paid to the ethics and welfare of experimental animals, and a number of specific items in the Methods, Results, and Discussion sections continue to not be reported in sufficient detail. Therefore, it is necessary to popularize the ARRIVE guidelines, advocate researchers to adhere to them in the future, and in particular promote the use of the guidelines in specialized journals, in order that the design, implementation, and reporting of animal experiments is promoted, to ultimately improve their quality.


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