Enhancing Scientific Foundations to Ensure Reproducibility

Hsieh, Terry; Vaickus, Max; Remick, Daniel G.

doi:10.1016/j.ajpath.2017.08.028

Cited by 16 publications

(14 citation statements)

References 31 publications

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“…The increasing awareness of the lack of proper reporting and reproducibility of preclinical studies [6][7][8][9][10] fueled concerns about the reliability of preclinical research as a predictor of human outcomes as a whole. 11,12 To this aim, the ARRIVE guidelines on reporting of preclinical studies were published in 2010.…”

Section: Discussionmentioning

confidence: 99%

Quantity and Reporting Quality of Kidney Research

Chatzimanouil¹,

Wilkens²,

Anders³

2018

JASN

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Background In 2004, researchers reported that the number of nephrology clinical trials was low and that the reporting quality of such trials was suboptimal. Furthermore, the number or quality of preclinical kidney-related studies has not been systematically evaluated. Methods We performed a systematic review of randomized clinical trials published in 1966-2017 (listed in the Cochrane Library) and preclinical studies published in 1945-2017 (listed in PubMed). For reporting quality analysis, we evaluated the final main paper of 118 clinical trial reports and 135 preclinical studies published in leading journals in 1996, 2006, and 2016 on the basis of criteria from the widely used CONSORT and ARRIVE guidelines. Results The annual number of reports of clinical kidney-related trials more than doubled between 2004 and 2014 along with reports in other medical disciplines. Hypertension remains the dominant focus of study, but ongoing trials also center on CKD, ESRD, and AKI. The reporting quality analysis revealed improvements, but deficits in reporting of clinical trial design, mode of randomization, and intention-totreat analysis remain. Annual numbers of kidney-related preclinical studies remained low between 1945 and 2017 compared with other disciplines. Reporting quality analysis of preclinical studies revealed substantial reporting deficits across all leading journals, with little improvement over the last 20 years, especially for group size calculations, defining primary versus secondary outcomes, and blinded analysis. Conclusions Nephrology studies keep increasing in number but still lag behind other medical disciplines, and the quality of data reporting in kidney research can be further improved.

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Section: Discussionmentioning

confidence: 99%

Quantity and Reporting Quality of Kidney Research

Chatzimanouil¹,

Wilkens²,

Anders³

2018

JASN

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“…This discrepancy in cellular response also demonstrates that caution must be taken when extrapolating data from similar studies utilizing differing strains of the same species. The different biological responsiveness/function of the same cell type in different strains of rat is becoming more apparent (Claassen, 1994) and, whilst not part of this investigation, it is known that sex (male or female) of the donor and/or recipient can impact on transplantation success in both ocular (Hopkinson et al, 2017) and non‐ocular scenarios (Hsieh, Vaickus, & Remick, 2018).…”

Section: Discussionmentioning

confidence: 99%

Plasma polymer surface modified expanded polytetrafluoroethylene promotes epithelial monolayer formation in vitro and can be transplanted into the dystrophic rat subretinal space

Shen

Kearns

Wong

et al. 2020

J Tissue Eng Regen Med

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The aim of this study was to evaluate whether the surface modification of expanded polytetrafluoroethylene (ePTFE) using an n‐heptylamine (HA) plasma polymer would allow for functional epithelial monolayer formation suitable for subretinal transplant into a non‐dystrophic rat model. Freshly isolated iris pigment epithelial (IPE) cells from two rat strains (Long Evans [LE] and Dark Agouti [DA]) were seeded onto HA, fibronectin‐coated n‐heptylamine modified (F‐HA) and unmodified ePFTE and fibronectin‐coated tissue culture (F‐TCPS) substrates. Both F‐HA ePTFE and F‐TCPS substrates enabled functional monolayer formation with both strains of rat. Without fibronectin coating, only LE IPE formed a monolayer on HA‐treated ePTFE. Functional assessment of both IPE strains on F‐HA ePTFE demonstrated uptake of POS that increased significantly with time that was greater than control F‐TCPS. Surgical optimization using Healon GV and mixtures of Healon GV: phosphate buffered saline (PBS) to induce retinal detachment demonstrated that only Healon GV:PBS allowed F‐HA ePTFE substrates to be successfully transplanted into the subretinal space of Royal College of Surgeons rats, where they remained flat beneath the neural retina for up to 4 weeks. No apparent substrate‐induced inflammatory response was observed by fundus microscopy or immunohistochemical analysis, indicating the potential of this substrate for future clinical applications.

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“…Despite not being hypothesis driven, both of these programs were supported to increase standardization. The NIH has also launched an initiative to improve the rigor of data and reproducibility of results (20, 21). Grant proposals are now expected to address data reproducibility in the research plan and a specific page needs to specify authentication of key resources.…”

Section: Initiatives For Standardization In Non-sepsis Preclinicalmentioning

confidence: 99%

Premise for Standardized Sepsis Models

Remick

Ayala

Chaudry

et al. 2019

Shock

Self Cite

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Sepsis morbidity and mortality exacts a toll on patients and contributes significantly to healthcare costs. Preclinical models of sepsis have been used to study disease pathogenesis and test new therapies, but divergent outcomes have been observed with the same treatment even when using the same sepsis model. Other disorders such as diabetes, cancer, malaria, obesity and cardiovascular diseases have used standardized, preclinical models that allow laboratories to compare results. Standardized models accelerate the pace of research and such models have been used to test new therapies or changes in treatment guidelines. The National Institutes of Health (NIH) mandated that investigators increase data reproducibility and the rigor of scientific experiments and has also issued research funding announcements about the development and refinement of standardized models. Our premise is that refinement and standardization of preclinical sepsis models may accelerate the development and testing of potential therapeutics for human sepsis, as has been the case with preclinical models for other disorders. As a first step towards creating standardized models, we suggest 1) standardizing the technical standards of the widely used cecal ligation and puncture model and 2) creating a list of appropriate organ injury and immune dysfunction parameters. Standardized sepsis models could enhance reproducibility and allow comparison of results between laboratories and may accelerate our understanding of the pathogenesis of sepsis.

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Enhancing Scientific Foundations to Ensure Reproducibility

Cited by 16 publications

References 31 publications

Quantity and Reporting Quality of Kidney Research

Quantity and Reporting Quality of Kidney Research

Plasma polymer surface modified expanded polytetrafluoroethylene promotes epithelial monolayer formation in vitro and can be transplanted into the dystrophic rat subretinal space

Premise for Standardized Sepsis Models

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