Identification of potential carcinogenic and chemopreventive effects of prescription drugs: a protocol for a Norwegian registry-based study
IntroductionSurveillance of unintended effects of pharmaceuticals (pharmacovigilance or drug safety) is crucial, as knowledge of rare or late side effects is limited at the time of the introduction of new medications into the market. Side effects of drugs may involve increased or decreased risk of c...
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| creator | Andreassen, Bettina Kulle Støer, Nathalie C Martinsen, Jan Ivar Ursin, Giske Weiderpass, Elisabete Thoresen, G Hege Debernard, Karen Boldingh Karlstad, Øystein Pottegard, Anton Friis, Søren |
| description | IntroductionSurveillance of unintended effects of pharmaceuticals (pharmacovigilance or drug safety) is crucial, as knowledge of rare or late side effects is limited at the time of the introduction of new medications into the market. Side effects of drugs may involve increased or decreased risk of cancer, but these typically appear after a long induction period. This fact, together with low incidences of many cancer types, limits the usefulness of traditional pharmacovigilance strategies, primarily based on spontaneous reporting of adverse events, to identify associations between drug use and cancer risk. Postmarketing observational pharmacoepidemiological studies are therefore crucial in the evaluation of drug-cancer associations.Methods and analysisThe main data sources in this project will be the Norwegian Prescription Database and the Cancer Registry of Norway. The underlying statistical model will be based on a multiple nested case–control design including all adult (~200 000) incident cancer cases within the age-range 18–85 years from 2007 through 2015 in Norway as cases. 10 cancer-free population controls will be individually matched to these cases with respect to birth year, sex and index date (date of cancer diagnosis). Drug exposure will be modelled as chronic user/non-user by counting prescriptions, and cumulative use by summarising all dispensions’ daily defined doses over time. Conditional logistic regression models adjusted for comorbidity (National Patient Register), socioeconomic parameters (Statistics Norway), concomitant drug use and, for female cancers, reproduction data (Medical Birth Registry), will be applied to identify drug-use–cancer-risk associations.Ethics and disseminationThe study is approved by the regional ethical committee and the Norwegian data protection authority. Results of the initial screening step and analysis pipeline will be described in a key paper. Subsequent papers will report the evaluation of identified signals in replication studies. Results will be published in peer-reviewed journals, at scientific conferences and through press releases. |
| doi_str_mv | 10.1136/bmjopen-2018-028504 |
| format | Article |
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Side effects of drugs may involve increased or decreased risk of cancer, but these typically appear after a long induction period. This fact, together with low incidences of many cancer types, limits the usefulness of traditional pharmacovigilance strategies, primarily based on spontaneous reporting of adverse events, to identify associations between drug use and cancer risk. Postmarketing observational pharmacoepidemiological studies are therefore crucial in the evaluation of drug-cancer associations.Methods and analysisThe main data sources in this project will be the Norwegian Prescription Database and the Cancer Registry of Norway. The underlying statistical model will be based on a multiple nested case–control design including all adult (~200 000) incident cancer cases within the age-range 18–85 years from 2007 through 2015 in Norway as cases. 10 cancer-free population controls will be individually matched to these cases with respect to birth year, sex and index date (date of cancer diagnosis). Drug exposure will be modelled as chronic user/non-user by counting prescriptions, and cumulative use by summarising all dispensions’ daily defined doses over time. Conditional logistic regression models adjusted for comorbidity (National Patient Register), socioeconomic parameters (Statistics Norway), concomitant drug use and, for female cancers, reproduction data (Medical Birth Registry), will be applied to identify drug-use–cancer-risk associations.Ethics and disseminationThe study is approved by the regional ethical committee and the Norwegian data protection authority. Results of the initial screening step and analysis pipeline will be described in a key paper. Subsequent papers will report the evaluation of identified signals in replication studies. Results will be published in peer-reviewed journals, at scientific conferences and through press releases.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2018-028504</identifier><identifier>PMID: 30962244</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Ambulatory care ; Antineoplastic Agents - adverse effects ; Antineoplastic Agents - therapeutic use ; Basale medisinske, odontologiske og veterinærmedisinske fag: 710 ; Basic medical, dental and veterinary science disciplines: 710 ; Cancer therapies ; Carcinogens ; Case-Control Studies ; Comorbidity ; Female ; Health risk assessment ; Health surveillance ; Humans ; Identification ; Information Storage and Retrieval ; Male ; Medical disciplines: 700 ; Medical screening ; Medisinske Fag: 700 ; Methods ; Middle Aged ; Mortality ; Oncology ; Pharmaceuticals ; Pharmacoepidemiology - methods ; Population ; Prescription drugs ; Product Surveillance, Postmarketing - methods ; Prostate cancer ; Public health ; Socioeconomic factors ; VDP ; Young Adult</subject><ispartof>BMJ open, 2019-04, Vol.9 (4), p.e028504-e028504</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>info:eu-repo/semantics/openAccess</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-b534t-d584b2797b6fc57b8686995bcbff1c16c42b8e7e4a4f41cbf7f08d92453d40773</citedby><cites>FETCH-LOGICAL-b534t-d584b2797b6fc57b8686995bcbff1c16c42b8e7e4a4f41cbf7f08d92453d40773</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://bmjopen.bmj.com/content/9/4/e028504.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://bmjopen.bmj.com/content/9/4/e028504.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,314,550,723,776,780,860,881,26546,27528,27529,27903,27904,53770,53772,77348,77379</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30962244$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:141144355$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Andreassen, Bettina Kulle</creatorcontrib><creatorcontrib>Støer, Nathalie C</creatorcontrib><creatorcontrib>Martinsen, Jan Ivar</creatorcontrib><creatorcontrib>Ursin, Giske</creatorcontrib><creatorcontrib>Weiderpass, Elisabete</creatorcontrib><creatorcontrib>Thoresen, G Hege</creatorcontrib><creatorcontrib>Debernard, Karen Boldingh</creatorcontrib><creatorcontrib>Karlstad, Øystein</creatorcontrib><creatorcontrib>Pottegard, Anton</creatorcontrib><creatorcontrib>Friis, Søren</creatorcontrib><title>Identification of potential carcinogenic and chemopreventive effects of prescription drugs: a protocol for a Norwegian registry-based study</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>IntroductionSurveillance of unintended effects of pharmaceuticals (pharmacovigilance or drug safety) is crucial, as knowledge of rare or late side effects is limited at the time of the introduction of new medications into the market. Side effects of drugs may involve increased or decreased risk of cancer, but these typically appear after a long induction period. This fact, together with low incidences of many cancer types, limits the usefulness of traditional pharmacovigilance strategies, primarily based on spontaneous reporting of adverse events, to identify associations between drug use and cancer risk. Postmarketing observational pharmacoepidemiological studies are therefore crucial in the evaluation of drug-cancer associations.Methods and analysisThe main data sources in this project will be the Norwegian Prescription Database and the Cancer Registry of Norway. The underlying statistical model will be based on a multiple nested case–control design including all adult (~200 000) incident cancer cases within the age-range 18–85 years from 2007 through 2015 in Norway as cases. 10 cancer-free population controls will be individually matched to these cases with respect to birth year, sex and index date (date of cancer diagnosis). Drug exposure will be modelled as chronic user/non-user by counting prescriptions, and cumulative use by summarising all dispensions’ daily defined doses over time. Conditional logistic regression models adjusted for comorbidity (National Patient Register), socioeconomic parameters (Statistics Norway), concomitant drug use and, for female cancers, reproduction data (Medical Birth Registry), will be applied to identify drug-use–cancer-risk associations.Ethics and disseminationThe study is approved by the regional ethical committee and the Norwegian data protection authority. Results of the initial screening step and analysis pipeline will be described in a key paper. Subsequent papers will report the evaluation of identified signals in replication studies. Results will be published in peer-reviewed journals, at scientific conferences and through press releases.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Ambulatory care</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Basale medisinske, odontologiske og veterinærmedisinske fag: 710</subject><subject>Basic medical, dental and veterinary science disciplines: 710</subject><subject>Cancer therapies</subject><subject>Carcinogens</subject><subject>Case-Control Studies</subject><subject>Comorbidity</subject><subject>Female</subject><subject>Health risk assessment</subject><subject>Health surveillance</subject><subject>Humans</subject><subject>Identification</subject><subject>Information Storage and Retrieval</subject><subject>Male</subject><subject>Medical disciplines: 700</subject><subject>Medical screening</subject><subject>Medisinske Fag: 700</subject><subject>Methods</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Oncology</subject><subject>Pharmaceuticals</subject><subject>Pharmacoepidemiology - methods</subject><subject>Population</subject><subject>Prescription drugs</subject><subject>Product Surveillance, Postmarketing - methods</subject><subject>Prostate cancer</subject><subject>Public health</subject><subject>Socioeconomic factors</subject><subject>VDP</subject><subject>Young Adult</subject><issn>2044-6055</issn><issn>2044-6055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>3HK</sourceid><sourceid>D8T</sourceid><recordid>eNqNks1u1DAUhSMEolXpEyBBJDZsUvzvhAUSqvipVMEG1pbjXE89JHawk6nmGXhpnMm0almRje17v3Oca52ieInRBcZUvGuHbRjBVwThukKk5og9KU4JYqwSiPOnD_YnxXlKW5Q_xhvOyfPihKJGEMLYafHnqgM_OeuMnlzwZbDlGKalpPvS6GicDxvwzpTad6W5gSGMEXYLsIMSrAUzpYMqQjLRjQeXLs6b9L7UuRqmYEJf2hDz8VuIt7Bx2pcxL2mK-6rVCboyTXO3f1E8s7pPcH5cz4qfnz_9uPxaXX__cnX58bpqOWVT1fGatUQ2shXWcNnWohZNw1vTWosNFoaRtgYJTDPLcK5Ki-quIYzTjiEp6VlRrb7pFsa5VWN0g457FbRTx9KvvAPFaiRonfkPK587A3QmDx91_0j2uOPdjdqEnRIcIcpFNni9GuQHSpPzyoeoFc5NqbBEFGfi7fGKGH7PkCY1uGSg77WHMCdFCBKEIkpJRt_8g27DHH1-sIWSCAt8mJHeXRlSimDvfxcjtSRIHROklgSpNUFZ9erhpPeau7xk4GIFsvq_HP8CN23U9w</recordid><startdate>20190408</startdate><enddate>20190408</enddate><creator>Andreassen, Bettina Kulle</creator><creator>Støer, Nathalie C</creator><creator>Martinsen, Jan Ivar</creator><creator>Ursin, Giske</creator><creator>Weiderpass, Elisabete</creator><creator>Thoresen, G Hege</creator><creator>Debernard, Karen Boldingh</creator><creator>Karlstad, Øystein</creator><creator>Pottegard, Anton</creator><creator>Friis, Søren</creator><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>9YT</scope><scope>ACMMV</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>3HK</scope><scope>5PM</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>D8T</scope><scope>ZZAVC</scope></search><sort><creationdate>20190408</creationdate><title>Identification of potential carcinogenic and chemopreventive effects of prescription drugs: a protocol for a Norwegian registry-based study</title><author>Andreassen, Bettina Kulle ; Støer, Nathalie C ; Martinsen, Jan Ivar ; Ursin, Giske ; Weiderpass, Elisabete ; Thoresen, G Hege ; Debernard, Karen Boldingh ; Karlstad, Øystein ; Pottegard, Anton ; Friis, Søren</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b534t-d584b2797b6fc57b8686995bcbff1c16c42b8e7e4a4f41cbf7f08d92453d40773</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Ambulatory care</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Basale medisinske, odontologiske og veterinærmedisinske fag: 710</topic><topic>Basic medical, dental and veterinary science disciplines: 710</topic><topic>Cancer therapies</topic><topic>Carcinogens</topic><topic>Case-Control Studies</topic><topic>Comorbidity</topic><topic>Female</topic><topic>Health risk assessment</topic><topic>Health surveillance</topic><topic>Humans</topic><topic>Identification</topic><topic>Information Storage and Retrieval</topic><topic>Male</topic><topic>Medical disciplines: 700</topic><topic>Medical screening</topic><topic>Medisinske Fag: 700</topic><topic>Methods</topic><topic>Middle Aged</topic><topic>Mortality</topic><topic>Oncology</topic><topic>Pharmaceuticals</topic><topic>Pharmacoepidemiology - methods</topic><topic>Population</topic><topic>Prescription drugs</topic><topic>Product Surveillance, Postmarketing - methods</topic><topic>Prostate cancer</topic><topic>Public health</topic><topic>Socioeconomic factors</topic><topic>VDP</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Andreassen, Bettina Kulle</creatorcontrib><creatorcontrib>Støer, Nathalie C</creatorcontrib><creatorcontrib>Martinsen, Jan Ivar</creatorcontrib><creatorcontrib>Ursin, Giske</creatorcontrib><creatorcontrib>Weiderpass, Elisabete</creatorcontrib><creatorcontrib>Thoresen, G Hege</creatorcontrib><creatorcontrib>Debernard, Karen Boldingh</creatorcontrib><creatorcontrib>Karlstad, Øystein</creatorcontrib><creatorcontrib>Pottegard, Anton</creatorcontrib><creatorcontrib>Friis, Søren</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>NORA - Norwegian Open Research Archives</collection><collection>PubMed Central (Full Participant titles)</collection><collection>SwePub</collection><collection>SwePub Articles</collection><collection>SWEPUB Freely available online</collection><collection>SwePub Articles full text</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Andreassen, Bettina Kulle</au><au>Støer, Nathalie C</au><au>Martinsen, Jan Ivar</au><au>Ursin, Giske</au><au>Weiderpass, Elisabete</au><au>Thoresen, G Hege</au><au>Debernard, Karen Boldingh</au><au>Karlstad, Øystein</au><au>Pottegard, Anton</au><au>Friis, Søren</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Identification of potential carcinogenic and chemopreventive effects of prescription drugs: a protocol for a Norwegian registry-based study</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2019-04-08</date><risdate>2019</risdate><volume>9</volume><issue>4</issue><spage>e028504</spage><epage>e028504</epage><pages>e028504-e028504</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>IntroductionSurveillance of unintended effects of pharmaceuticals (pharmacovigilance or drug safety) is crucial, as knowledge of rare or late side effects is limited at the time of the introduction of new medications into the market. Side effects of drugs may involve increased or decreased risk of cancer, but these typically appear after a long induction period. This fact, together with low incidences of many cancer types, limits the usefulness of traditional pharmacovigilance strategies, primarily based on spontaneous reporting of adverse events, to identify associations between drug use and cancer risk. Postmarketing observational pharmacoepidemiological studies are therefore crucial in the evaluation of drug-cancer associations.Methods and analysisThe main data sources in this project will be the Norwegian Prescription Database and the Cancer Registry of Norway. The underlying statistical model will be based on a multiple nested case–control design including all adult (~200 000) incident cancer cases within the age-range 18–85 years from 2007 through 2015 in Norway as cases. 10 cancer-free population controls will be individually matched to these cases with respect to birth year, sex and index date (date of cancer diagnosis). Drug exposure will be modelled as chronic user/non-user by counting prescriptions, and cumulative use by summarising all dispensions’ daily defined doses over time. Conditional logistic regression models adjusted for comorbidity (National Patient Register), socioeconomic parameters (Statistics Norway), concomitant drug use and, for female cancers, reproduction data (Medical Birth Registry), will be applied to identify drug-use–cancer-risk associations.Ethics and disseminationThe study is approved by the regional ethical committee and the Norwegian data protection authority. Results of the initial screening step and analysis pipeline will be described in a key paper. Subsequent papers will report the evaluation of identified signals in replication studies. Results will be published in peer-reviewed journals, at scientific conferences and through press releases.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>30962244</pmid><doi>10.1136/bmjopen-2018-028504</doi><oa>free_for_read</oa></addata></record> |
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| source | BMJ Open Access Journals; MEDLINE; NORA - Norwegian Open Research Archives; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; SWEPUB Freely available online; PubMed Central Open Access; PubMed Central |
| subjects | Adolescent Adult Aged Aged, 80 and over Ambulatory care Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use Basale medisinske, odontologiske og veterinærmedisinske fag: 710 Basic medical, dental and veterinary science disciplines: 710 Cancer therapies Carcinogens Case-Control Studies Comorbidity Female Health risk assessment Health surveillance Humans Identification Information Storage and Retrieval Male Medical disciplines: 700 Medical screening Medisinske Fag: 700 Methods Middle Aged Mortality Oncology Pharmaceuticals Pharmacoepidemiology - methods Population Prescription drugs Product Surveillance, Postmarketing - methods Prostate cancer Public health Socioeconomic factors VDP Young Adult |
| title | Identification of potential carcinogenic and chemopreventive effects of prescription drugs: a protocol for a Norwegian registry-based study |
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