Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial Article Swipe
Ji‐Lin Chen
,
Ying Liu
,
Xiangmei Chen
,
Xuefeng Sun
,
Wei Li
,
Yang Wang
,
Ping Li
,
Xi‐Ming Sun
,
Degang Wang
,
Hongli Jiang
,
Wei Shi
,
Wenhu Liu
,
Ping Fu
,
Xiaoqiang Ding
,
Chang Ming
,
Shuxin Liu
,
Xiao Yang
,
Ning Cao
,
Menghua Chen
,
Zhaohui Ni
,
Jing Chen
,
Shiren Sun
,
Xinling Liang
,
Huimin Wang
,
Yani He
,
Bihu Gao
,
Jianqin Wang
,
Lirong Hao
,
Jian Liu
,
Suhua Li
,
Qiang He
,
Hongmei Liu
,
Na Yi
,
Fengmin Shao
,
Jundong Jiao
,
Yuhuan Ma
,
Li Yao
,
Yi Sun
,
Detian Li
,
Lynda A. Szczech
,
Ming Fang
,
Zach Odeh
,
Hongli Lin
·
YOU?
·
· 2019
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2018-023162
YOU?
·
· 2019
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2018-023162
Introduction Starting dialysis early or late both result in a low quality of life and a poor prognosis in patients undergoing haemodialysis. However, there remains no consensus on the optimal timing of dialysis initiation, mainly because of a lack of suitable methods to assess variations in dialysis initiation time. We have established a novel equation named DIFE (Dialysis Initiation based on Fuzzy-mathematics Equation) through a retrospective, multicentre clinical cohort study in China to determine the most suitable timing of dialysis initiation. The predictors of the DIFE include nine biochemical markers and clinical variables that together influence dialysis initiation. To externally validate the clinical accuracy of DIFE, we designed the assessment of DIFE (ADIFE) study as a prospective, open-label, multicentre, randomised controlled trial to assess the clinical outcomes among patients who initiate dialysis in an optimal start dialysis group and a late-start dialysis group, based on DIFE. Methods and analysis A total of 388 enrolled patients with end-stage renal disease will be randomised 1:1 to the optimal start dialysis group, with a DIFE value between 30 and 35, or the late-start dialysis group, with a DIFE value less than 30, using the Randomization and Trial Supply Management system. Participants will be assessed for changes in signs and symptoms, dialysis mode and parameters, biochemical and inflammatory markers, Subjective Global Assessment, Kidney Disease Quality of Life Short Form, Cognitive Assessment, medical costs, adverse events and concomitant medication at baseline, predialysis visiting stage and postdialysis visiting stage, every 12–24 weeks. The following data will be recorded on standardised online electronic case report forms. The primary endpoint is 3-year all-cause mortality. The secondary endpoints include non-fatal cerebrocardiovascular events, annual hospitalisation rate, quality of life, medical costs and haemodialysis related complications. Ethics and dissemination Ethical approval was obtained from the Ethics Committee of the First Affiliated Hospital of Dalian Medical University China (registration no: YJ-KY-2017–119) and the ethics committees of all participating centres. The final results of the ADIFE trial will be presented to the study sponsor, clinical researchers and the patient and public involvement reference group. Findings will be disseminated through peer-reviewed journals, Clinical Practice Guidelines and at scientific meetings. Trial registration number ClinicalTrial.gov. Registry ( NCT03385902 ); pre-results.
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- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1136/bmjopen-2018-023162
- https://bmjopen.bmj.com/content/bmjopen/9/9/e023162.full.pdf
- OA Status
- gold
- Cited By
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- References
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- Related Works
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- OpenAlex ID
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Raw OpenAlex JSON
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https://openalex.org/W2972432445Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1136/bmjopen-2018-023162Digital Object Identifier
- Title
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Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trialWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2019Year of publication
- Publication date
-
2019-09-01Full publication date if available
- Authors
-
Ji‐Lin Chen, Ying Liu, Xiangmei Chen, Xuefeng Sun, Wei Li, Yang Wang, Ping Li, Xi‐Ming Sun, Degang Wang, Hongli Jiang, Wei Shi, Wenhu Liu, Ping Fu, Xiaoqiang Ding, Chang Ming, Shuxin Liu, Xiao Yang, Ning Cao, Menghua Chen, Zhaohui Ni, Jing Chen, Shiren Sun, Xinling Liang, Huimin Wang, Yani He, Bihu Gao, Jianqin Wang, Lirong Hao, Jian Liu, Suhua Li, Qiang He, Hongmei Liu, Na Yi, Fengmin Shao, Jundong Jiao, Yuhuan Ma, Li Yao, Yi Sun, Detian Li, Lynda A. Szczech, Ming Fang, Zach Odeh, Hongli LinList of authors in order
- Landing page
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https://doi.org/10.1136/bmjopen-2018-023162Publisher landing page
- PDF URL
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https://bmjopen.bmj.com/content/bmjopen/9/9/e023162.full.pdfDirect link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
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goldOpen access status per OpenAlex
- OA URL
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https://bmjopen.bmj.com/content/bmjopen/9/9/e023162.full.pdfDirect OA link when available
- Concepts
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Medicine, Dialysis, Clinical trial, Hemodialysis, Quality of life (healthcare), Intensive care medicine, End stage renal disease, Randomized controlled trial, Internal medicine, NursingTop concepts (fields/topics) attached by OpenAlex
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2Total citation count in OpenAlex
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2024: 1, 2023: 1Per-year citation counts (last 5 years)
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41Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.markers, | 214 |
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| abstract_inverted_index.sponsor, | 330 |
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| corresponding_author_ids | https://openalex.org/A5085657697 |
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| institutions_distinct_count | 43 |
| corresponding_institution_ids | https://openalex.org/I191996457, https://openalex.org/I4210140813 |
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| sustainable_development_goals[0].display_name | No poverty |
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| citation_normalized_percentile.is_in_top_10_percent | False |