Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial
IntroductionStarting 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...
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| creator | Chen, Jilin Liu, Ying Chen, Xiangmei Sun, Xuefeng Li, Wei Yang, Wang Li, Ping Sun, Ximing Wang, Degang Jiang, Hongli Shi, Wei Liu, Wenhu Fu, Ping Ding, Xiaoqiang Chang, Ming Liu, Shuxin Yang, Xiao Cao, Ning Chen, Menghua Ni, Zhaohui Chen, Jing Sun, Shiren Liang, Xinling Wang, Huimin He, Yani Gao, Bihu Wang, Jianqin Hao, Lirong Liu, Jian Li, Suhua He, Qiang Liu, Hongmei Yi, Na Shao, Fengmin Jiao, Jundong Ma, Yuhuan Yao, Li Sun, Yi Li, Detian Szczech, Lynda Fang, Ming Odeh, Zach Lin, Hongli |
| description | IntroductionStarting 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 analysisA 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 disseminationEthical 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 scientifi |
| doi_str_mv | 10.1136/bmjopen-2018-023162 |
| format | Article |
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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 analysisA 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 disseminationEthical 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 numberClinicalTrial.gov. Registry (NCT03385902); pre-results.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2018-023162</identifier><identifier>PMID: 31501092</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Clinical medicine ; Clinical practice guidelines ; Diabetes ; Evidence-based medicine ; Heart failure ; Hemodialysis ; Kidney diseases ; Mathematics ; Medical prognosis ; Mortality ; Patients ; Quality of life ; Renal Medicine ; Systematic review</subject><ispartof>BMJ open, 2019-09, Vol.9 (9), p.e023162-e023162</ispartof><rights>Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2019 Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b538t-3466c497a7fe9505b28b48f2b8049e39a7e64e73100b72ce579a71bdb8bdf6a23</citedby><cites>FETCH-LOGICAL-b538t-3466c497a7fe9505b28b48f2b8049e39a7e64e73100b72ce579a71bdb8bdf6a23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://bmjopen.bmj.com/content/9/9/e023162.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://bmjopen.bmj.com/content/9/9/e023162.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,315,728,781,785,865,886,2103,27554,27555,27929,27930,53796,53798,77606,77637</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31501092$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chen, Jilin</creatorcontrib><creatorcontrib>Liu, Ying</creatorcontrib><creatorcontrib>Chen, Xiangmei</creatorcontrib><creatorcontrib>Sun, Xuefeng</creatorcontrib><creatorcontrib>Li, Wei</creatorcontrib><creatorcontrib>Yang, Wang</creatorcontrib><creatorcontrib>Li, Ping</creatorcontrib><creatorcontrib>Sun, Ximing</creatorcontrib><creatorcontrib>Wang, Degang</creatorcontrib><creatorcontrib>Jiang, Hongli</creatorcontrib><creatorcontrib>Shi, Wei</creatorcontrib><creatorcontrib>Liu, Wenhu</creatorcontrib><creatorcontrib>Fu, Ping</creatorcontrib><creatorcontrib>Ding, Xiaoqiang</creatorcontrib><creatorcontrib>Chang, Ming</creatorcontrib><creatorcontrib>Liu, Shuxin</creatorcontrib><creatorcontrib>Yang, Xiao</creatorcontrib><creatorcontrib>Cao, Ning</creatorcontrib><creatorcontrib>Chen, Menghua</creatorcontrib><creatorcontrib>Ni, Zhaohui</creatorcontrib><creatorcontrib>Chen, Jing</creatorcontrib><creatorcontrib>Sun, Shiren</creatorcontrib><creatorcontrib>Liang, Xinling</creatorcontrib><creatorcontrib>Wang, Huimin</creatorcontrib><creatorcontrib>He, Yani</creatorcontrib><creatorcontrib>Gao, Bihu</creatorcontrib><creatorcontrib>Wang, Jianqin</creatorcontrib><creatorcontrib>Hao, Lirong</creatorcontrib><creatorcontrib>Liu, Jian</creatorcontrib><creatorcontrib>Li, Suhua</creatorcontrib><creatorcontrib>He, Qiang</creatorcontrib><creatorcontrib>Liu, Hongmei</creatorcontrib><creatorcontrib>Yi, Na</creatorcontrib><creatorcontrib>Shao, Fengmin</creatorcontrib><creatorcontrib>Jiao, Jundong</creatorcontrib><creatorcontrib>Ma, Yuhuan</creatorcontrib><creatorcontrib>Yao, Li</creatorcontrib><creatorcontrib>Sun, Yi</creatorcontrib><creatorcontrib>Li, Detian</creatorcontrib><creatorcontrib>Szczech, Lynda</creatorcontrib><creatorcontrib>Fang, Ming</creatorcontrib><creatorcontrib>Odeh, Zach</creatorcontrib><creatorcontrib>Lin, Hongli</creatorcontrib><title>Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>IntroductionStarting 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 analysisA 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 disseminationEthical 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 numberClinicalTrial.gov. Registry (NCT03385902); pre-results.</description><subject>Clinical medicine</subject><subject>Clinical practice guidelines</subject><subject>Diabetes</subject><subject>Evidence-based medicine</subject><subject>Heart failure</subject><subject>Hemodialysis</subject><subject>Kidney diseases</subject><subject>Mathematics</subject><subject>Medical prognosis</subject><subject>Mortality</subject><subject>Patients</subject><subject>Quality of life</subject><subject>Renal Medicine</subject><subject>Systematic 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Jilin ; Liu, Ying ; Chen, Xiangmei ; Sun, Xuefeng ; Li, Wei ; Yang, Wang ; Li, Ping ; Sun, Ximing ; Wang, Degang ; Jiang, Hongli ; Shi, Wei ; Liu, Wenhu ; Fu, Ping ; Ding, Xiaoqiang ; Chang, Ming ; Liu, Shuxin ; Yang, Xiao ; Cao, Ning ; Chen, Menghua ; Ni, Zhaohui ; Chen, Jing ; Sun, Shiren ; Liang, Xinling ; Wang, Huimin ; He, Yani ; Gao, Bihu ; Wang, Jianqin ; Hao, Lirong ; Liu, Jian ; Li, Suhua ; He, Qiang ; Liu, Hongmei ; Yi, Na ; Shao, Fengmin ; Jiao, Jundong ; Ma, Yuhuan ; Yao, Li ; Sun, Yi ; Li, Detian ; Szczech, Lynda ; Fang, Ming ; Odeh, Zach ; Lin, Hongli</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b538t-3466c497a7fe9505b28b48f2b8049e39a7e64e73100b72ce579a71bdb8bdf6a23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Clinical medicine</topic><topic>Clinical practice guidelines</topic><topic>Diabetes</topic><topic>Evidence-based medicine</topic><topic>Heart 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Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chen, Jilin</au><au>Liu, Ying</au><au>Chen, Xiangmei</au><au>Sun, Xuefeng</au><au>Li, Wei</au><au>Yang, Wang</au><au>Li, Ping</au><au>Sun, Ximing</au><au>Wang, Degang</au><au>Jiang, Hongli</au><au>Shi, Wei</au><au>Liu, Wenhu</au><au>Fu, Ping</au><au>Ding, Xiaoqiang</au><au>Chang, Ming</au><au>Liu, Shuxin</au><au>Yang, Xiao</au><au>Cao, Ning</au><au>Chen, Menghua</au><au>Ni, Zhaohui</au><au>Chen, Jing</au><au>Sun, Shiren</au><au>Liang, Xinling</au><au>Wang, Huimin</au><au>He, Yani</au><au>Gao, Bihu</au><au>Wang, Jianqin</au><au>Hao, Lirong</au><au>Liu, Jian</au><au>Li, Suhua</au><au>He, Qiang</au><au>Liu, Hongmei</au><au>Yi, Na</au><au>Shao, Fengmin</au><au>Jiao, Jundong</au><au>Ma, Yuhuan</au><au>Yao, Li</au><au>Sun, Yi</au><au>Li, Detian</au><au>Szczech, Lynda</au><au>Fang, Ming</au><au>Odeh, Zach</au><au>Lin, Hongli</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2019-09-01</date><risdate>2019</risdate><volume>9</volume><issue>9</issue><spage>e023162</spage><epage>e023162</epage><pages>e023162-e023162</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>IntroductionStarting 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 analysisA 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 disseminationEthical 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 numberClinicalTrial.gov. Registry (NCT03385902); pre-results.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>31501092</pmid><doi>10.1136/bmjopen-2018-023162</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2044-6055 |
| ispartof | BMJ open, 2019-09, Vol.9 (9), p.e023162-e023162 |
| issn | 2044-6055 2044-6055 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6738726 |
| source | BMJ Open Access Journals; DOAJ Directory of Open Access Journals; PubMed Central Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Clinical medicine Clinical practice guidelines Diabetes Evidence-based medicine Heart failure Hemodialysis Kidney diseases Mathematics Medical prognosis Mortality Patients Quality of life Renal Medicine Systematic review |
| title | Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial |
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