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A time-based weighting approach is proposed using the ratio of observed-to-expected follow-up duration within the Prentice-Williams-Peterson Gap Time model. The method is evaluated via simulations and applied to a double-blinded trial on calcium supplementation for preeclampsia prevention. Results show lower bias and improved precision, with smaller standard errors and a more conservative hazard ratio for hypertension family history.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/adjusting-for-truncated-study-duration-in-recurrent-event-analysis-a-weighting-approach-for-clinical-trials/455315/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/adjusting-for-truncated-study-duration-in-recurrent-event-analysis-a-weighting-approach-for-clinical-trials/455315.png","ImageObject",300,407,{"name":92,"@type":93},"OmBimo","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-30","2026-09-30",true,{"@type":102,"interactionType":103,"userInteractionCount":14},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"Why does truncated follow-up create bias in recurrent event analysis?","Question",{"text":112,"@type":113},"Truncation from early dropout or study termination breaks the fixed follow-up structure, which can bias risk estimates and reduce precision, often underestimating event risks.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"What weighting approach is proposed in this paper?",{"text":117,"@type":113},"The paper proposes time-based weighting using the ratio of observed-to-expected follow-up duration in the Prentice-Williams-Peterson Gap Time (PWP-GT) model.",{"name":119,"@type":110,"acceptedAnswer":120},"How was the method evaluated and what were the key findings?",{"text":121,"@type":113},"The method was assessed through simulations and then applied to a double-blinded clinical trial. Weighted analysis showed lower bias and improved precision, with smaller standard errors and a more conservative hazard ratio for hypertension family history.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},455315,1792216847,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":14,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":44,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":144,"preview_page_count":4},962090893581,"https://ap-avatar.wpscdn.com/davatar_276721f389ce27ea32af1340a28f341c","OPEN ACCESS  \nCitation: Michael Raj A J, Thomas T, Dwarkanath P (2026) Adjusting for truncated study duration in recurrent event analysis: A weighting approach for clinical trials. PLoSOne 21(1): e0339887. [https://doi.org/10.1371/](https://doi.org/10.1371/)[ ](https://doi.org/10.1371/)[journal.pone.0339887](journal.pone.0339887)  \nEditor: Farshid Danesh, Islamic World Science & Technology Monitoring and Citation Institute (ISC), IRAN, ISLAMIC REPUBLIC OF  \nReceived: July 11, 2025  \nAccepted: December 13, 2025  \nPublished: January 7, 2026  \nPeer Review History: PLOS recognizes the benefits of transparency in the peer review process; therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. The editorial history of this article is available here: [https://doi.org/10.1371/journal](https://doi.org/10.1371/journal). pone.0339887  \nCopyright: © 2026 Michael Raj A et al. This isan open access article distributed under the terms of the Creative Commons Attribution  License, which permits unrestricted use,  \nRESEARCH ARTICLE  \nAdjusting for truncated study duration in recurrent event analysis: A weighting approach for clinical trials  \nJohn Michael Raj A1,2, Tinku Thomas2*, Pratibha Dwarkanath3  \n1 Center for Doctoral Studies, Manipal Academy of Higher Education, Manipal, India, 2 Department of Biostatistics, St. John’s Medical college, Bangalore, India, 3 Division of Nutrition, St. John’s Research Institute, Bangalore, India  \n* tinku.sarah@sjri. res. in  \nAbstract  \nBackground  \nIn recurrent event analysis with fixed follow-up intervals, truncated follow-up due to early dropout or study termination introduces bias and reduces precision in risk estimates, particularly in clinical trials where shorter observation periods may underestimate event risks.  \nMethods  \nWe propose a time-based weighting approach using the ratio of observed-toexpected follow-up duration in the Prentice-Williams-Peterson Gap Time (PWP-GT) model. The method was evaluated in simulations and applied to a double-blinded trial (N = 4000) comparing 500 mg vs. 1500 mg daily calcium supplementation for preeclampsia prevention. For demonstration of the problem and application of the weighting method, drug non-adherence at follow-up visits was considered as therecurrent event.  \nResults  \nSimulations showed the weighted PWP-GT model had lower bias (1 .0% vs. 1.3%) and improved precision compared to the unweighted model, with coverage probabilities >94% . In the trial data, weighting yielded smaller standard errors and amore conservative hazard ratio for hypertension family history (weighted HR = 1. 14, SE = 0.054 vs. unweighted HR = 1.23, SE = 0.065) .  \nConclusion  \nUnaccounted truncated follow-up in recurrent event studies can bias the risk estimation if unaccounted for. Our findings demonstrate that total time-based weighting  \nPLOS One | [https://doi.org/10.1371/journal.pone.0339887](https://doi.org/10.1371/journal.pone.0339887) January 7, 2026 1 / 9  \ndistribution, and reproduction in any medium, provided the original author and source are credited.  \nData availability statement: The dataset used for demonstration in this manuscript is derived from a third-party randomized controlled trial: Dwarkanath P, Muhihi A, Sudfeld CR, Wylie BJ, Wang M, Perumal N, et al. Two Randomized Trials of Low-Dose Calcium Supplementation in Pregnancy. N Engl J Med. 2024;390(2):143–53 . The authors do not own the rights to share these data; all data-sharing rights remain exclusively with the study Principal Investigator (PI) . As detailed in the original publication’s data-sharing policy, complete de-identified patient-level data from the trial may be made available to qualified researchers. Access is granted only upon formal request to the PI, accompanied by a research proposal and the necessary approvals from the Institutional Ethics Committee (IEC) and other relevant regulatory authorities. The PI details, as ","cbCaipIMCpuUWiTk","https://ap.wps.com/l/cbCaipIMCpuUWiTk","pdf",550488,"English","# Abstract\n## Background\n## Methods\n## Results\n## Conclusion\n# Introduction\n## Cox model and recurrent events\n## Informative censoring and bias\n# Funding and competing interests\n# Data availability and abbreviations","[{\"question\":\"Why does truncated follow-up create bias in recurrent event analysis?\",\"answer\":\"Truncation from early dropout or study termination breaks the fixed follow-up structure, which can bias risk estimates and reduce precision, often underestimating event risks.\"},{\"question\":\"What weighting approach is proposed in this paper?\",\"answer\":\"The paper proposes time-based weighting using the ratio of observed-to-expected follow-up duration in the Prentice-Williams-Peterson Gap Time (PWP-GT) model.\"},{\"question\":\"How was the method evaluated and what were the key findings?\",\"answer\":\"The method was assessed through simulations and then applied to a double-blinded clinical trial. Weighted analysis showed lower bias and improved precision, with smaller standard errors and a more conservative hazard ratio for hypertension family history.\"}]","Adjusting for Truncated Study Duration in Recurrent Event Analysis - A Weighting Approach for Clinical Trials | PDF",1790742595,23]