{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T17:02:05Z","timestamp":1753894925318,"version":"3.41.2"},"reference-count":26,"publisher":"Becaris Publishing Limited","funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research and Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Comp. Eff. Res."],"abstract":"<jats:p>\n            <jats:bold>Aim:<\/jats:bold>\n            To evaluate the performance of the multiple imputation (MI) method for estimating clinical effectiveness in pediatric Crohn's disease in the ImproveCareNow registry; to address the analytical challenge of missing data.\n            <jats:bold>Materials &amp; methods:<\/jats:bold>\n            Simulation studies were performed by creating missing datasets based on fully observed data from patients with moderate-to-severe Crohn's disease treated with non-ustekinumab biologics. MI was used to impute sPCDAI remission statuses in each simulated dataset.\n            <jats:bold>Results:<\/jats:bold>\n            The true remission rate (75.1% [95%\u00a0CI: 72.6%, 77.5%]) was underestimated without imputation (72.6% [71.8%, 73.3%]). With MI, the estimate was 74.8% (74.4%, 75.2%).\n            <jats:bold>Conclusion:<\/jats:bold>\n            MI reduced nonresponse bias and improved the validity, reliability, and efficiency of real-world registry data to estimate remission rate in pediatric patients with Crohn's disease.\n          <\/jats:p>","DOI":"10.57264\/cer-2022-0136","type":"journal-article","created":{"date-parts":[[2023,2,17]],"date-time":"2023-02-17T17:39:14Z","timestamp":1676655554000},"source":"Crossref","is-referenced-by-count":2,"title":["Using multiple imputation of real-world data to estimate clinical remission in pediatric inflammatory bowel disease"],"prefix":"10.57264","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5796-3404","authenticated-orcid":false,"given":"Nanhua","family":"Zhang","sequence":"first","affiliation":[{"name":"Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA"},{"name":"University of Cincinnati, Cincinnati, OH 45229, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4096-3210","authenticated-orcid":false,"given":"Chunyan","family":"Liu","sequence":"additional","affiliation":[{"name":"Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7461-3905","authenticated-orcid":false,"given":"Steven J","family":"Steiner","sequence":"additional","affiliation":[{"name":"Riley Hospital for Children\/Indiana University School of Medicine, Indianapolis, IN 46202, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6253-0133","authenticated-orcid":false,"given":"Richard B","family":"Colletti","sequence":"additional","affiliation":[{"name":"University of Vermont College of Medicine, Department of Pediatrics, Burlington, VT 05405, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2337-1923","authenticated-orcid":false,"given":"Robert","family":"Baldassano","sequence":"additional","affiliation":[{"name":"The Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3936-8788","authenticated-orcid":false,"given":"Shiran","family":"Chen","sequence":"additional","affiliation":[{"name":"Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7765-7439","authenticated-orcid":false,"given":"Stanley","family":"Cohen","sequence":"additional","affiliation":[{"name":"GI Care For Kids, Atlanta, GA 30342, USA"},{"name":"Morehouse School of Medicine, Atlanta, GA 30310, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0469-6856","authenticated-orcid":false,"given":"Michael D","family":"Kappelman","sequence":"additional","affiliation":[{"name":"University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5534-7891","authenticated-orcid":false,"given":"Shehzad","family":"Saeed","sequence":"additional","affiliation":[{"name":"Dayton Children's Hospital\/Wright State University, Dayton, OH 45404, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9482-6350","authenticated-orcid":false,"given":"Laurie S","family":"Conklin","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, LLC, Spring House, PA 19477, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4789-1595","authenticated-orcid":false,"given":"Richard","family":"Strauss","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, LLC, Spring House, PA 19477, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1689-1173","authenticated-orcid":false,"given":"Sheri","family":"Volger","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, LLC, Spring House, PA 19477, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eileen","family":"King","sequence":"additional","affiliation":[{"name":"Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA"},{"name":"University of Cincinnati, Cincinnati, OH 45229, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kim Hung","family":"Lo","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, LLC, Spring House, PA 19477, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"36897","published-online":{"date-parts":[[2023,2,17]]},"reference":[{"key":"e_1_3_7_3_2","unstructured":"United States Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Oncology Center of Excellence. Real-world data: assessing registries to support regulatory decision-making for drug and biological products: draft guidance for industry (2021). Available at: www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/real-world-data-assessing-registries-support-regulatory-decision-making-drug-and-biological-products (Accessed: 12 July 2022)."},{"key":"e_1_3_7_4_2","unstructured":"United States Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Oncology Center of Excellence. Real-world data: assessing electronic health records and medical claims data to support regulatory decision-making for drug and biological products: draft guidance for industry (2021). Available at: www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/real-world-data-assessing-electronic-health-records-and-medical-claims-data-support-regulatory (Accessed: 12 July 2022)."},{"key":"e_1_3_7_5_2","unstructured":"European Medicines Agency. Guideline on registry-based studies (2021). Available at: www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-registry-based-studies_en-0.pdf (Accessed: 12 July 2022)."},{"issue":"2","key":"e_1_3_7_6_2","doi-asserted-by":"crossref","first-page":"331","DOI":"10.1093\/ecco-jcc\/jjab140","article-title":"Impact of drug approval pathways for paediatric inflammatory bowel disease","volume":"16","author":"Crowley E","year":"2021","unstructured":"Crowley E, Ma C, Andic M, Feagan BG, Griffiths AM, Jairath V. Impact of drug approval pathways for paediatric inflammatory bowel disease. J. Crohns Colitis. 16(2), 331\u2013335 (2021).","journal-title":"J. Crohns Colitis."},{"issue":"10","key":"e_1_3_7_7_2","doi-asserted-by":"crossref","first-page":"1063","DOI":"10.3748\/wjg.v24.i10.1063","article-title":"Inflammatory bowel disease registries for collection of patient iron parameters in Europe","volume":"24","author":"Halfvarson J","year":"2018","unstructured":"Halfvarson J, Cummings F, Grip O, Savoye G. Inflammatory bowel disease registries for collection of patient iron parameters in Europe. World J. Gastroenterol. 24(10), 1063\u20131071 (2018).","journal-title":"World J. Gastroenterol."},{"key":"e_1_3_7_8_2","doi-asserted-by":"crossref","DOI":"10.1002\/9780470316696","volume-title":"Multiple Imputation for Nonresponse in Surveys.","author":"Rubin DB","year":"1987","unstructured":"Rubin DB. Multiple Imputation for Nonresponse in Surveys. 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Bowel Dis."},{"issue":"4","key":"e_1_3_7_14_2","doi-asserted-by":"crossref","first-page":"416","DOI":"10.1097\/01.mpg.0000183350.46795.42","article-title":"Evaluation of the pediatric Crohn disease activity index: a prospective multicenter experience","volume":"41","author":"Hyams J","year":"2005","unstructured":"Hyams J, Markowitz J, Otley A Evaluation of the pediatric Crohn disease activity index: a prospective multicenter experience. J. Pediatr. Gastroenterol. Nutr. 41(4), 416\u2013421 (2005).","journal-title":"J. Pediatr. Gastroenterol. Nutr."},{"issue":"1","key":"e_1_3_7_15_2","doi-asserted-by":"crossref","first-page":"90","DOI":"10.1097\/00005176-200301000-00017","article-title":"A critical assessment of items on the pediatric Crohn's disease activity index","volume":"36","author":"Loonen HJ","year":"2003","unstructured":"Loonen HJ, Griffiths AM, Merkus MP, Derkx HH. A critical assessment of items on the pediatric Crohn's disease activity index. J. Pediatr. Gastroenterol. 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