{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T12:59:23Z","timestamp":1783688363346,"version":"3.55.0"},"reference-count":36,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2020,11,21]],"date-time":"2020-11-21T00:00:00Z","timestamp":1605916800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2021,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>We evaluated the reproducibility of a study characterizing newly\u2010diagnosed multiple myeloma (MM) patients within an electronic health records (EHR) database using different analytic tools.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We reproduced the findings of a descriptive cohort study using an iterative two\u2010phase approach. In Phase I, a common protocol and statistical analysis plan (SAP) were implemented by independent investigators using the Aetion Evidence Platform\u00ae (AEP), a rapid\u2010cycle analytics tool, and SAS statistical software as a gold standard for statistical analyses. Using the UK Clinical Practice Research Datalink (CPRD) dataset, the study included patients newly diagnosed with MM within primary care setting and assessed baseline demographics, conditions, drug exposure, and laboratory procedures. Phase II incorporated analysis revisions based on our initial comparison of the Phase I findings. Reproducibility of findings was evaluate by calculating the match rate and absolute difference in prevalence between the SAS and AEP study results.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Phase I yielded slightly discrepant results, prompting amendments to SAP to add more clarity to operational decisions. After detailed specification of data and operational choices, exact concordance was achieved for the number of eligible patients (N = 2646), demographics, comorbidities (i.e., osteopenia, osteoporosis, cardiovascular disease [CVD], and hypertension), bone pain, skeletal\u2010related events, drug exposure, and laboratory investigations in the Phase II analyses.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In this reproducibility study, a rapid\u2010cycle analytics tool and traditional statistical software achieved near\u2010exact findings after detailed specification of data and operational choices. Transparency and communication of the study design, operational and analytical choices between independent investigators were critical to achieve this reproducibility.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5171","type":"journal-article","created":{"date-parts":[[2020,11,11]],"date-time":"2020-11-11T03:40:56Z","timestamp":1605066056000},"page":"248-256","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Real\u2010world reproducibility study characterizing patients newly diagnosed with multiple myeloma using Clinical Practice Research Datalink, a <scp>UK<\/scp>\u2010based electronic health records database"],"prefix":"10.1002","volume":"30","author":[{"given":"Anouchka","family":"Seesaghur","sequence":"first","affiliation":[{"name":"Department Center for Observational Research Amgen Ltd  Uxbridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natalia","family":"Petruski\u2010Ivleva","sequence":"additional","affiliation":[{"name":"Department Science Aetion, Inc  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victoria","family":"Banks","sequence":"additional","affiliation":[{"name":"Department Center for Observational Research Amgen Ltd  Uxbridge UK"},{"name":"VLB Contractors Ltd  Kent UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jocelyn Ruoyi","family":"Wang","sequence":"additional","affiliation":[{"name":"Department Science Aetion, Inc  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pattra","family":"Mattox","sequence":"additional","affiliation":[{"name":"Department Science Aetion, Inc  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edwin","family":"Hoeben","sequence":"additional","affiliation":[{"name":"Department Center for Observational Research Amgen Ltd  Uxbridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joe","family":"Maskell","sequence":"additional","affiliation":[{"name":"Department Center for Observational Research Amgen Ltd  Uxbridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Neasham","sequence":"additional","affiliation":[{"name":"Department Center for Observational Research Amgen Ltd  Uxbridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shannon L.","family":"Reynolds","sequence":"additional","affiliation":[{"name":"Department Science Aetion, Inc  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George","family":"Kafatos","sequence":"additional","affiliation":[{"name":"Department Center for Observational Research Amgen Ltd  Uxbridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,11,21]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1426"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsb1609216"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.329"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4295"},{"key":"e_1_2_10_6_1","unstructured":"WangSV SchneeweissS. Improving Transparency and Replicability of Healthcare Databases to Increase Credibility of \u201cReal World\u201d Evidence. BMJ Opinion.https:\/\/blogs.bmj.com\/bmj\/2017\/12\/15\/improving-transparency-and-replicability-of-healthcare-databases-to-increase-credibility-of-real-world-evidence\/. December 15 2017. Accessed November 8 2019."},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1633"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3968"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwx065"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwx066"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwj093"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyz034"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyv098"},{"issue":"10","key":"e_1_2_10_14_1","doi-asserted-by":"crossref","first-page":"1261","DOI":"10.2217\/fon-2015-0043","article-title":"Opportunities and challenges in leveraging electronic health record data in oncology","volume":"12","author":"Berger ML","year":"2016","journal-title":"Future Oncol"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djx187"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.3399\/bjgp10X483562"},{"key":"e_1_2_10_17_1","unstructured":"Cancer Research UK. Myeloma Statistics.https:\/\/www.cancerresearchuk.org\/health-professional\/cancer-statistics\/statistics-by-cancer-type\/myeloma#heading-Five. Accessed October 2019."},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(14)70442-5"},{"issue":"7","key":"e_1_2_10_19_1","doi-asserted-by":"crossref","first-page":"A672","DOI":"10.1016\/j.jval.2015.09.1977","article-title":"Retrospective cohort study using data from the UK Clinical Practice Research Datalink and hospital episode statistics to assess unplanned hospitalisation in patients with multiple myeloma","volume":"18","author":"Raluy\u2010Callado M","year":"2015","journal-title":"Value Health"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.3399\/bjgp15X683545"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(97)04248-7"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2125.1998.00701.x"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2017.3919"},{"key":"e_1_2_10_24_1","doi-asserted-by":"crossref","first-page":"827","DOI":"10.1002\/cpt.1577","article-title":"Choosing among common data models for real\u2010world data analyses fit for making decisions about the effectiveness of medical products CPT","volume":"107","author":"Schneeweiss S","year":"2019","journal-title":"Clin Pharm Ther"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-012-0009-3"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-014-0221-4"},{"key":"e_1_2_10_27_1","unstructured":"U.S. FDA: Guide for Industry and FDA Staff. Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data.https:\/\/www.fda.gov\/files\/drugs\/published\/Best\u2010Practices\u2010for\u2010Conducting\u2010and\u2010Reporting\u2010Pharmacoepidemiologic\u2010Safety\u2010Studies\u2010Using\u2010Electronic\u2010Healthcare\u2010Data\u2010Sets.pdf. May 2013. Accessed October 22 2020."},{"key":"e_1_2_10_28_1","unstructured":"European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) and European Medicines Agency (EMA). Guide of Methodological Standards in Pharmacoepidemology (Rev. 2).http:\/\/www.encepp.eu\/standards_and_guidances\/documents\/ENCePPGuideofMethStandardsinPE_Rev5.pdf. June 2013. Accessed October 22 2020."},{"key":"e_1_2_10_29_1","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1002\/pds.3891","article-title":"Guidelines for good pharmacoepidemiology practices (GPP)","volume":"25","author":"International Society for Pharmacoepidemiology","year":"2016","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"e_1_2_10_30_1","volume-title":"Developing a Protocol for Observational Comparative Effectiveness Research; A User's GUIDE","author":"Agency for Healthcare Research and Quality (AHRQ)","year":"2013"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-147-8-200710160-00010"},{"key":"e_1_2_10_32_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1001885"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.k3532"},{"key":"e_1_2_10_34_1","doi-asserted-by":"crossref","first-page":"1023","DOI":"10.1016\/j.jval.2017.08.3012","article-title":"Making real\u2010world evidence more useful for decision making","volume":"20","author":"Greenfield S","year":"2017","journal-title":"Value Health"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2017.08.3019"},{"key":"e_1_2_10_36_1","doi-asserted-by":"publisher","DOI":"10.7326\/M18-3079"},{"key":"e_1_2_10_37_1","unstructured":"Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT). Design Diagram Templates.www.repeatinitiative.org\/projects.html. Accessed October 22 2020."}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5171","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/pds.5171","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5171","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,3]],"date-time":"2023-09-03T18:16:08Z","timestamp":1693764968000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.5171"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,11,21]]},"references-count":36,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2021,2]]}},"alternative-id":["10.1002\/pds.5171"],"URL":"https:\/\/doi.org\/10.1002\/pds.5171","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,11,21]]},"assertion":[{"value":"2020-02-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-11-04","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-11-21","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}