Impact of red and processed meat and fibre intake on treatment outcomes among patients with chronic inflammatory diseases: protocol for a prospective cohort study of prognostic factors and personalised medicine
IntroductionChronic inflammatory diseases (CIDs) are frequently treated with biological medications, specifically tumour necrosis factor inhibitors (TNFi)). These medications inhibit the pro-inflammatory molecule TNF alpha, which has been strongly implicated in the aetiology of these diseases. Up to...
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| creator | Christensen, Robin Heitmann, Berit L Andersen, Karina Winther Nielsen, Ole Haagen Sørensen, Signe Bek Jawhara, Mohamad Bygum, Anette Hvid, Lone Grauslund, Jakob Wied, Jimmi Glerup, Henning Fredberg, Ulrich Villadsen, Jan Alexander Kjær, Søren Geill Fallingborg, Jan Moghadd, Seyed A G R Knudsen, Torben Brodersen, Jacob Frøjk, Jesper Dahlerup, Jens Frederik Bojesen, Anders Bo Sorensen, Grith Lykke Thiel, Steffen Færgeman, Nils J Brandslund, Ivan Bennike, Tue Bjerg Stensballe, Allan Schmidt, Erik Berg Franke, Andre Ellinghaus, David Rosenstiel, Philip Raes, Jeroen Boye, Mette Werner, Lars Nielsen, Charlotte Lindgaard Munk, Heidi Lausten Nexøe, Anders Bathum Ellingsen, Torkell Holmskov, Uffe Kjeldsen, Jens Andersen, Vibeke |
| description | IntroductionChronic inflammatory diseases (CIDs) are frequently treated with biological medications, specifically tumour necrosis factor inhibitors (TNFi)). These medications inhibit the pro-inflammatory molecule TNF alpha, which has been strongly implicated in the aetiology of these diseases. Up to one-third of patients do not, however, respond to biologics, and lifestyle factors are assumed to affect treatment outcomes. Little is known about the effects of dietary lifestyle as a prognostic factor that may enable personalised medicine. The primary outcome of this multidisciplinary collaborative study will be to identify dietary lifestyle factors that support optimal treatment outcomes.Methods and analysisThis prospective cohort study will enrol 320 patients with CID who are prescribed a TNFi between June 2017 and March 2019. Included among the patients with CID will be patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis), rheumatic disorders (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis, hidradenitis suppurativa) and non-infectious uveitis. At baseline (pretreatment), patient characteristics will be assessed using patient-reported outcome measures, clinical assessments of disease activity, quality of life and lifestyle, in addition to registry data on comorbidity and concomitant medication(s). In accordance with current Danish standards, follow-up will be conducted 14–16 weeks after treatment initiation. For each disease, evaluation of successful treatment response will be based on established primary and secondary endpoints, including disease-specific core outcome sets. The major outcome of the analyses will be to detect variability in treatment effectiveness between patients with different lifestyle characteristics.Ethics and disseminationThe principle goal of this project is to improve the quality of life of patients suffering from CID by providing evidence to support dietary and other lifestyle recommendations that may improve clinical outcomes. The study is approved by the Ethics Committee (S-20160124) and the Danish Data Protecting Agency (2008-58-035). Study findings will be disseminated through peer-reviewed journals, patient associations and presentations at international conferences.Trial registration numberNCT03173144; Pre-results. |
| doi_str_mv | 10.1136/bmjopen-2017-018166 |
| format | Article |
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These medications inhibit the pro-inflammatory molecule TNF alpha, which has been strongly implicated in the aetiology of these diseases. Up to one-third of patients do not, however, respond to biologics, and lifestyle factors are assumed to affect treatment outcomes. Little is known about the effects of dietary lifestyle as a prognostic factor that may enable personalised medicine. The primary outcome of this multidisciplinary collaborative study will be to identify dietary lifestyle factors that support optimal treatment outcomes.Methods and analysisThis prospective cohort study will enrol 320 patients with CID who are prescribed a TNFi between June 2017 and March 2019. Included among the patients with CID will be patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis), rheumatic disorders (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis, hidradenitis suppurativa) and non-infectious uveitis. At baseline (pretreatment), patient characteristics will be assessed using patient-reported outcome measures, clinical assessments of disease activity, quality of life and lifestyle, in addition to registry data on comorbidity and concomitant medication(s). In accordance with current Danish standards, follow-up will be conducted 14–16 weeks after treatment initiation. For each disease, evaluation of successful treatment response will be based on established primary and secondary endpoints, including disease-specific core outcome sets. The major outcome of the analyses will be to detect variability in treatment effectiveness between patients with different lifestyle characteristics.Ethics and disseminationThe principle goal of this project is to improve the quality of life of patients suffering from CID by providing evidence to support dietary and other lifestyle recommendations that may improve clinical outcomes. The study is approved by the Ethics Committee (S-20160124) and the Danish Data Protecting Agency (2008-58-035). Study findings will be disseminated through peer-reviewed journals, patient associations and presentations at international conferences.Trial registration numberNCT03173144; Pre-results.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2017-018166</identifier><identifier>PMID: 29439003</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Arthritis ; Chronic Disease ; Cohort analysis ; Crohn's disease ; Diet ; Dietary fiber ; Dietary Fiber - administration & dosage ; Health risk assessment ; Humans ; Immunotherapy ; Inflammation ; Inflammatory bowel disease ; Inflammatory Bowel Diseases - therapy ; Inflammatory diseases ; Life Style ; Meat ; Meat Products - adverse effects ; Medical Management ; Medical prognosis ; Patient Reported Outcome Measures ; Precision Medicine ; Prognosis ; Prospective Studies ; Psoriasis ; Quality of Life ; Red Meat - adverse effects ; Research Design ; Rheumatic Diseases - therapy ; Rheumatoid arthritis ; Skin diseases ; Skin Diseases - therapy ; Systematic review ; Tumor Necrosis Factor-alpha - antagonists & inhibitors ; Tumor necrosis factor-TNF ; Uveitis - therapy</subject><ispartof>BMJ open, 2018-02, Vol.8 (2), p.e018166-e018166</ispartof><rights>Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.</rights><rights>2018 Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. 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 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>Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b472t-dff00dc71b56a23239437a826d30b6651b79154e0bf5b389102b6f11e3d5ce723</citedby><cites>FETCH-LOGICAL-b472t-dff00dc71b56a23239437a826d30b6651b79154e0bf5b389102b6f11e3d5ce723</cites><orcidid>0000-0002-0127-2863 ; 0000-0002-6600-0631</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://bmjopen.bmj.com/content/8/2/e018166.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://bmjopen.bmj.com/content/8/2/e018166.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27526,27527,27901,27902,53766,53768,77343,77374</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29439003$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Christensen, Robin</creatorcontrib><creatorcontrib>Heitmann, Berit L</creatorcontrib><creatorcontrib>Andersen, Karina Winther</creatorcontrib><creatorcontrib>Nielsen, Ole Haagen</creatorcontrib><creatorcontrib>Sørensen, Signe Bek</creatorcontrib><creatorcontrib>Jawhara, Mohamad</creatorcontrib><creatorcontrib>Bygum, Anette</creatorcontrib><creatorcontrib>Hvid, Lone</creatorcontrib><creatorcontrib>Grauslund, Jakob</creatorcontrib><creatorcontrib>Wied, Jimmi</creatorcontrib><creatorcontrib>Glerup, Henning</creatorcontrib><creatorcontrib>Fredberg, Ulrich</creatorcontrib><creatorcontrib>Villadsen, Jan Alexander</creatorcontrib><creatorcontrib>Kjær, Søren Geill</creatorcontrib><creatorcontrib>Fallingborg, Jan</creatorcontrib><creatorcontrib>Moghadd, Seyed A G R</creatorcontrib><creatorcontrib>Knudsen, Torben</creatorcontrib><creatorcontrib>Brodersen, Jacob</creatorcontrib><creatorcontrib>Frøjk, Jesper</creatorcontrib><creatorcontrib>Dahlerup, Jens Frederik</creatorcontrib><creatorcontrib>Bojesen, Anders Bo</creatorcontrib><creatorcontrib>Sorensen, Grith Lykke</creatorcontrib><creatorcontrib>Thiel, Steffen</creatorcontrib><creatorcontrib>Færgeman, Nils J</creatorcontrib><creatorcontrib>Brandslund, Ivan</creatorcontrib><creatorcontrib>Bennike, Tue Bjerg</creatorcontrib><creatorcontrib>Stensballe, Allan</creatorcontrib><creatorcontrib>Schmidt, Erik Berg</creatorcontrib><creatorcontrib>Franke, Andre</creatorcontrib><creatorcontrib>Ellinghaus, David</creatorcontrib><creatorcontrib>Rosenstiel, Philip</creatorcontrib><creatorcontrib>Raes, Jeroen</creatorcontrib><creatorcontrib>Boye, Mette</creatorcontrib><creatorcontrib>Werner, Lars</creatorcontrib><creatorcontrib>Nielsen, Charlotte Lindgaard</creatorcontrib><creatorcontrib>Munk, Heidi Lausten</creatorcontrib><creatorcontrib>Nexøe, Anders Bathum</creatorcontrib><creatorcontrib>Ellingsen, Torkell</creatorcontrib><creatorcontrib>Holmskov, Uffe</creatorcontrib><creatorcontrib>Kjeldsen, Jens</creatorcontrib><creatorcontrib>Andersen, Vibeke</creatorcontrib><title>Impact of red and processed meat and fibre intake on treatment outcomes among patients with chronic inflammatory diseases: protocol for a prospective cohort study of prognostic factors and personalised medicine</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>IntroductionChronic inflammatory diseases (CIDs) are frequently treated with biological medications, specifically tumour necrosis factor inhibitors (TNFi)). These medications inhibit the pro-inflammatory molecule TNF alpha, which has been strongly implicated in the aetiology of these diseases. Up to one-third of patients do not, however, respond to biologics, and lifestyle factors are assumed to affect treatment outcomes. Little is known about the effects of dietary lifestyle as a prognostic factor that may enable personalised medicine. The primary outcome of this multidisciplinary collaborative study will be to identify dietary lifestyle factors that support optimal treatment outcomes.Methods and analysisThis prospective cohort study will enrol 320 patients with CID who are prescribed a TNFi between June 2017 and March 2019. Included among the patients with CID will be patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis), rheumatic disorders (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis, hidradenitis suppurativa) and non-infectious uveitis. At baseline (pretreatment), patient characteristics will be assessed using patient-reported outcome measures, clinical assessments of disease activity, quality of life and lifestyle, in addition to registry data on comorbidity and concomitant medication(s). In accordance with current Danish standards, follow-up will be conducted 14–16 weeks after treatment initiation. For each disease, evaluation of successful treatment response will be based on established primary and secondary endpoints, including disease-specific core outcome sets. The major outcome of the analyses will be to detect variability in treatment effectiveness between patients with different lifestyle characteristics.Ethics and disseminationThe principle goal of this project is to improve the quality of life of patients suffering from CID by providing evidence to support dietary and other lifestyle recommendations that may improve clinical outcomes. The study is approved by the Ethics Committee (S-20160124) and the Danish Data Protecting Agency (2008-58-035). Study findings will be disseminated through peer-reviewed journals, patient associations and presentations at international conferences.Trial registration numberNCT03173144; Pre-results.</description><subject>Arthritis</subject><subject>Chronic Disease</subject><subject>Cohort analysis</subject><subject>Crohn's disease</subject><subject>Diet</subject><subject>Dietary fiber</subject><subject>Dietary Fiber - administration & dosage</subject><subject>Health risk assessment</subject><subject>Humans</subject><subject>Immunotherapy</subject><subject>Inflammation</subject><subject>Inflammatory bowel disease</subject><subject>Inflammatory Bowel Diseases - therapy</subject><subject>Inflammatory diseases</subject><subject>Life Style</subject><subject>Meat</subject><subject>Meat Products - adverse effects</subject><subject>Medical Management</subject><subject>Medical prognosis</subject><subject>Patient Reported Outcome Measures</subject><subject>Precision Medicine</subject><subject>Prognosis</subject><subject>Prospective Studies</subject><subject>Psoriasis</subject><subject>Quality of Life</subject><subject>Red Meat - adverse effects</subject><subject>Research Design</subject><subject>Rheumatic Diseases - therapy</subject><subject>Rheumatoid arthritis</subject><subject>Skin diseases</subject><subject>Skin Diseases - therapy</subject><subject>Systematic review</subject><subject>Tumor Necrosis Factor-alpha - antagonists & inhibitors</subject><subject>Tumor necrosis factor-TNF</subject><subject>Uveitis - 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of red and processed meat and fibre intake on treatment outcomes among patients with chronic inflammatory diseases: protocol for a prospective cohort study of prognostic factors and personalised medicine</title><author>Christensen, Robin ; Heitmann, Berit L ; Andersen, Karina Winther ; Nielsen, Ole Haagen ; Sørensen, Signe Bek ; Jawhara, Mohamad ; Bygum, Anette ; Hvid, Lone ; Grauslund, Jakob ; Wied, Jimmi ; Glerup, Henning ; Fredberg, Ulrich ; Villadsen, Jan Alexander ; Kjær, Søren Geill ; Fallingborg, Jan ; Moghadd, Seyed A G R ; Knudsen, Torben ; Brodersen, Jacob ; Frøjk, Jesper ; Dahlerup, Jens Frederik ; Bojesen, Anders Bo ; Sorensen, Grith Lykke ; Thiel, Steffen ; Færgeman, Nils J ; Brandslund, Ivan ; Bennike, Tue Bjerg ; Stensballe, Allan ; Schmidt, Erik Berg ; Franke, Andre ; Ellinghaus, David ; Rosenstiel, Philip ; Raes, Jeroen ; Boye, Mette ; Werner, Lars ; Nielsen, Charlotte Lindgaard ; Munk, Heidi Lausten ; Nexøe, Anders Bathum ; Ellingsen, Torkell ; Holmskov, Uffe ; 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Medicine</topic><topic>Prognosis</topic><topic>Prospective Studies</topic><topic>Psoriasis</topic><topic>Quality of Life</topic><topic>Red Meat - adverse effects</topic><topic>Research Design</topic><topic>Rheumatic Diseases - therapy</topic><topic>Rheumatoid arthritis</topic><topic>Skin diseases</topic><topic>Skin Diseases - therapy</topic><topic>Systematic review</topic><topic>Tumor Necrosis Factor-alpha - antagonists & inhibitors</topic><topic>Tumor necrosis factor-TNF</topic><topic>Uveitis - therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Christensen, Robin</creatorcontrib><creatorcontrib>Heitmann, Berit L</creatorcontrib><creatorcontrib>Andersen, Karina Winther</creatorcontrib><creatorcontrib>Nielsen, Ole Haagen</creatorcontrib><creatorcontrib>Sørensen, Signe Bek</creatorcontrib><creatorcontrib>Jawhara, Mohamad</creatorcontrib><creatorcontrib>Bygum, Anette</creatorcontrib><creatorcontrib>Hvid, Lone</creatorcontrib><creatorcontrib>Grauslund, Jakob</creatorcontrib><creatorcontrib>Wied, Jimmi</creatorcontrib><creatorcontrib>Glerup, Henning</creatorcontrib><creatorcontrib>Fredberg, Ulrich</creatorcontrib><creatorcontrib>Villadsen, Jan Alexander</creatorcontrib><creatorcontrib>Kjær, Søren Geill</creatorcontrib><creatorcontrib>Fallingborg, Jan</creatorcontrib><creatorcontrib>Moghadd, Seyed A G R</creatorcontrib><creatorcontrib>Knudsen, Torben</creatorcontrib><creatorcontrib>Brodersen, Jacob</creatorcontrib><creatorcontrib>Frøjk, Jesper</creatorcontrib><creatorcontrib>Dahlerup, Jens Frederik</creatorcontrib><creatorcontrib>Bojesen, Anders Bo</creatorcontrib><creatorcontrib>Sorensen, Grith Lykke</creatorcontrib><creatorcontrib>Thiel, Steffen</creatorcontrib><creatorcontrib>Færgeman, Nils J</creatorcontrib><creatorcontrib>Brandslund, Ivan</creatorcontrib><creatorcontrib>Bennike, Tue Bjerg</creatorcontrib><creatorcontrib>Stensballe, Allan</creatorcontrib><creatorcontrib>Schmidt, Erik Berg</creatorcontrib><creatorcontrib>Franke, Andre</creatorcontrib><creatorcontrib>Ellinghaus, David</creatorcontrib><creatorcontrib>Rosenstiel, Philip</creatorcontrib><creatorcontrib>Raes, Jeroen</creatorcontrib><creatorcontrib>Boye, Mette</creatorcontrib><creatorcontrib>Werner, Lars</creatorcontrib><creatorcontrib>Nielsen, Charlotte Lindgaard</creatorcontrib><creatorcontrib>Munk, Heidi Lausten</creatorcontrib><creatorcontrib>Nexøe, Anders Bathum</creatorcontrib><creatorcontrib>Ellingsen, Torkell</creatorcontrib><creatorcontrib>Holmskov, Uffe</creatorcontrib><creatorcontrib>Kjeldsen, Jens</creatorcontrib><creatorcontrib>Andersen, Vibeke</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni 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>ProQuest Psychology</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</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 Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Christensen, Robin</au><au>Heitmann, Berit L</au><au>Andersen, Karina Winther</au><au>Nielsen, Ole Haagen</au><au>Sørensen, Signe Bek</au><au>Jawhara, Mohamad</au><au>Bygum, Anette</au><au>Hvid, Lone</au><au>Grauslund, Jakob</au><au>Wied, Jimmi</au><au>Glerup, Henning</au><au>Fredberg, Ulrich</au><au>Villadsen, Jan Alexander</au><au>Kjær, Søren Geill</au><au>Fallingborg, Jan</au><au>Moghadd, Seyed A G R</au><au>Knudsen, Torben</au><au>Brodersen, Jacob</au><au>Frøjk, Jesper</au><au>Dahlerup, Jens Frederik</au><au>Bojesen, Anders Bo</au><au>Sorensen, Grith Lykke</au><au>Thiel, Steffen</au><au>Færgeman, Nils J</au><au>Brandslund, Ivan</au><au>Bennike, Tue Bjerg</au><au>Stensballe, Allan</au><au>Schmidt, Erik Berg</au><au>Franke, Andre</au><au>Ellinghaus, David</au><au>Rosenstiel, Philip</au><au>Raes, Jeroen</au><au>Boye, Mette</au><au>Werner, Lars</au><au>Nielsen, Charlotte Lindgaard</au><au>Munk, Heidi Lausten</au><au>Nexøe, Anders Bathum</au><au>Ellingsen, Torkell</au><au>Holmskov, Uffe</au><au>Kjeldsen, Jens</au><au>Andersen, Vibeke</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Impact of red and processed meat and fibre intake on treatment outcomes among patients with chronic inflammatory diseases: protocol for a prospective cohort study of prognostic factors and personalised medicine</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2018-02-08</date><risdate>2018</risdate><volume>8</volume><issue>2</issue><spage>e018166</spage><epage>e018166</epage><pages>e018166-e018166</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>IntroductionChronic inflammatory diseases (CIDs) are frequently treated with biological medications, specifically tumour necrosis factor inhibitors (TNFi)). These medications inhibit the pro-inflammatory molecule TNF alpha, which has been strongly implicated in the aetiology of these diseases. Up to one-third of patients do not, however, respond to biologics, and lifestyle factors are assumed to affect treatment outcomes. Little is known about the effects of dietary lifestyle as a prognostic factor that may enable personalised medicine. The primary outcome of this multidisciplinary collaborative study will be to identify dietary lifestyle factors that support optimal treatment outcomes.Methods and analysisThis prospective cohort study will enrol 320 patients with CID who are prescribed a TNFi between June 2017 and March 2019. Included among the patients with CID will be patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis), rheumatic disorders (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis, hidradenitis suppurativa) and non-infectious uveitis. At baseline (pretreatment), patient characteristics will be assessed using patient-reported outcome measures, clinical assessments of disease activity, quality of life and lifestyle, in addition to registry data on comorbidity and concomitant medication(s). In accordance with current Danish standards, follow-up will be conducted 14–16 weeks after treatment initiation. For each disease, evaluation of successful treatment response will be based on established primary and secondary endpoints, including disease-specific core outcome sets. The major outcome of the analyses will be to detect variability in treatment effectiveness between patients with different lifestyle characteristics.Ethics and disseminationThe principle goal of this project is to improve the quality of life of patients suffering from CID by providing evidence to support dietary and other lifestyle recommendations that may improve clinical outcomes. The study is approved by the Ethics Committee (S-20160124) and the Danish Data Protecting Agency (2008-58-035). Study findings will be disseminated through peer-reviewed journals, patient associations and presentations at international conferences.Trial registration numberNCT03173144; Pre-results.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>29439003</pmid><doi>10.1136/bmjopen-2017-018166</doi><orcidid>https://orcid.org/0000-0002-0127-2863</orcidid><orcidid>https://orcid.org/0000-0002-6600-0631</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2044-6055 |
| ispartof | BMJ open, 2018-02, Vol.8 (2), p.e018166-e018166 |
| issn | 2044-6055 2044-6055 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5829767 |
| source | BMJ Open Access Journals; MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; PubMed Central Open Access |
| subjects | Arthritis Chronic Disease Cohort analysis Crohn's disease Diet Dietary fiber Dietary Fiber - administration & dosage Health risk assessment Humans Immunotherapy Inflammation Inflammatory bowel disease Inflammatory Bowel Diseases - therapy Inflammatory diseases Life Style Meat Meat Products - adverse effects Medical Management Medical prognosis Patient Reported Outcome Measures Precision Medicine Prognosis Prospective Studies Psoriasis Quality of Life Red Meat - adverse effects Research Design Rheumatic Diseases - therapy Rheumatoid arthritis Skin diseases Skin Diseases - therapy Systematic review Tumor Necrosis Factor-alpha - antagonists & inhibitors Tumor necrosis factor-TNF Uveitis - therapy |
| title | Impact of red and processed meat and fibre intake on treatment outcomes among patients with chronic inflammatory diseases: protocol for a prospective cohort study of prognostic factors and personalised medicine |
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