{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,28]],"date-time":"2026-02-28T02:01:11Z","timestamp":1772244071710,"version":"3.50.1"},"reference-count":14,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2023,1,23]],"date-time":"2023-01-23T00:00:00Z","timestamp":1674432000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health Research","doi-asserted-by":"publisher","award":["NIHR201466"],"award-info":[{"award-number":["NIHR201466"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["openresearch.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["NIHR Open Res"],"abstract":"<ns3:p>\n                    Background Malignant pleural effusion (MPE) is the build-up of pleural fluid in the space between the lung and chest wall due to advanced cancer. It is treated initially by large volume drainage (therapeutic aspiration). If the fluid reaccumulates, a definitive procedure is performed. There is wide variation in rate of reaccumulation. Patients with rapid reaccumulation often attend hospital as an emergency. Conversely, patients with slow reaccumulation do not need a definitive procedure and may experience cancelled or unnecessary procedures. This study aims to create and validate a multivariable prediction model to predict how quickly pleural fluid will reaccumulate in patients with MPE following therapeutic aspiration. Research question Can we predict how quickly pleural fluid will reaccumulate in patients with MPEs? Methods A total of 200 patients with known or suspected MPE attending for therapeutic aspiration will be recruited from 5\u201310 UK hospitals over 20 months. Patients will be enrolled prior to undergoing aspiration. Following this, they will undergo chest X-ray, which will be repeated one week later (treatment as usual). Rate of reaccumulation will be calculated based on change of size of the effusion seen on X-ray. Data will be collected on common clinical biomarkers\n                    <ns3:italic>e.g.<\/ns3:italic>\n                    , size of effusion on pre-aspiration chest X-ray, volume of fluid drained. This data will be analysed to create a clinical score. A further validation cohort of 40 patients will be enrolled in parallel with creation of the score. Anticipated impact The ability to predict rate of reaccumulation of MPE will enable patients and clinicians to make better informed treatment decisions. For patients with predicted rapid reaccumulation, a definitive procedure could be offered as first-line treatment, rather than a therapeutic aspiration. This will prevent emergency hospital admissions and decrease number of procedures. By contrast, patients whose effusions will recur slowly may avoid an unnecessary procedure.\n                  <\/ns3:p>","DOI":"10.3310\/nihropenres.13282.1","type":"journal-article","created":{"date-parts":[[2023,4,3]],"date-time":"2023-04-03T15:00:26Z","timestamp":1680534026000},"page":"5","update-policy":"https:\/\/doi.org\/10.3310\/nihropenres.crossmark-policy","source":"Crossref","is-referenced-by-count":5,"title":["Trial Protocol: Reaccumulation rate of pleural effusions after therapeutic aspiration: An observational cohort study to determine baseline factors associated with rate of pleural fluid reaccumulation following therapeutic aspiration in patients with malignant pleural effusion attending a pleural clinic (REPEAT)"],"prefix":"10.3310","volume":"3","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5903-3005","authenticated-orcid":false,"given":"Eleanor K.","family":"Mishra","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Allan","family":"Clark","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Magda","family":"Laskawiec-Szkonter","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicholas A.","family":"Maskell","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Najib M.","family":"Rahman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"6221","published-online":{"date-parts":[[2023,1,23]]},"reference":[{"key":"ref-1","doi-asserted-by":"publisher","first-page":"2383-9","DOI":"10.1001\/jama.2012.5535","article-title":"Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial.","volume":"307","author":"H Davies","year":"2012","journal-title":"JAMA."},{"key":"ref-2","doi-asserted-by":"publisher","first-page":"1431-5","DOI":"10.1378\/chest.128.3.1431","article-title":"Clinical efficacy and safety of thoracoscopic talc pleurodesis in malignant pleural effusions.","volume":"128","author":"S Kolschmann","year":"2005","journal-title":"Chest."},{"key":"ref-3","doi-asserted-by":"publisher","first-page":"221","DOI":"10.3389\/fphys.2014.00221","article-title":"Tight junction physiology of pleural mesothelium.","volume":"5","author":"A Markov","year":"2014","journal-title":"Front Physiol."},{"key":"ref-4","doi-asserted-by":"publisher","first-page":"1009-20","DOI":"10.3978\/j.issn.2072-1439.2015.05.20","article-title":"Switching off malignant pleural effusion formation-fantasy or future?","volume":"7","author":"M Spella","year":"2015","journal-title":"J Thorac Dis."},{"key":"ref-5","doi-asserted-by":"publisher","first-page":"e12978","DOI":"10.14814\/phy2.12978","article-title":"Systematic review and meta-analysis of vascular endothelial growth factor as a biomarker for malignant pleural effusions.","volume":"4","author":"E Fafliora","year":"2016","journal-title":"Physiol Rep."},{"key":"ref-6","doi-asserted-by":"publisher","first-page":"ii32-40","DOI":"10.1136\/thx.2010.136994","article-title":"Management of a malignant pleural effusion: British Thoracic Society Pleural Disease Guideline 2010.","volume":"65 Suppl 2","author":"M Roberts","year":"2010","journal-title":"Thorax."},{"key":"ref-7","doi-asserted-by":"publisher","first-page":"e0120827","DOI":"10.1371\/journal.pone.0120827","article-title":"Hospital admission of cancer patients: avoidable practice or necessary care?","volume":"10","author":"G Numico","year":"2015","journal-title":"PLoS One."},{"key":"ref-8","doi-asserted-by":"publisher","first-page":"e002515","DOI":"10.1136\/bmjopen-2012-002515","article-title":"Are emergency admissions in palliative cancer care always necessary? Results from a descriptive study.","volume":"3","author":"M Hjermstad","year":"2013","journal-title":"BMJ Open."},{"key":"ref-9","doi-asserted-by":"publisher","first-page":"226-33","DOI":"10.1016\/j.clon.2008.12.006","article-title":"Oncological emergency admissions to the Norfolk and Norwich University Hospital: an audit of current arrangements and patient satisfaction.","volume":"21","author":"M Yates","year":"2009","journal-title":"Clin Oncol (R Coll Radiol)."},{"key":"ref-10","doi-asserted-by":"publisher","first-page":"76-82","DOI":"10.1111\/resp.13362","article-title":"Risk factors for pleural effusion recurrence in patients with malignancy.","volume":"24","author":"H Grosu","year":"2019","journal-title":"Respirology."},{"key":"ref-11","doi-asserted-by":"publisher","first-page":"3109-16","DOI":"10.1007\/s00520-013-1895-3","article-title":"Comparison of modified Borg scale and visual analog scale dyspnea scores in predicting re-intervention after drainage of malignant pleural effusion.","volume":"21","author":"R Boshuizen","year":"2013","journal-title":"Support Care Cancer."},{"key":"ref-12","doi-asserted-by":"publisher","first-page":"2641-53","DOI":"10.1001\/jama.2015.16840","article-title":"Effect of Opioids vs NSAIDs and Larger vs Smaller Chest Tube Size on Pain Control and Pleurodesis Efficacy Among Patients With Malignant Pleural Effusion: The TIME1 Randomized Clinical Trial.","volume":"314","author":"N Rahman","year":"2015","journal-title":"JAMA."},{"key":"ref-14","doi-asserted-by":"publisher","first-page":"649-56","DOI":"10.1097\/00000421-198212000-00014","article-title":"Toxicity and response criteria of the Eastern Cooperative Oncology Group.","volume":"5","author":"M Oken","year":"1982","journal-title":"Am J Clin Oncol."},{"key":"ref-15","doi-asserted-by":"publisher","first-page":"1727-36","DOI":"10.1007\/s11136-011-9903-x","article-title":"Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L).","volume":"20","author":"M Herdman","year":"2011","journal-title":"Qual Life Res."}],"container-title":["NIHR Open Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/3-5\/v1\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/3-5\/v1\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/3-5\/v1\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,16]],"date-time":"2024-05-16T10:10:16Z","timestamp":1715854216000},"score":1,"resource":{"primary":{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/3-5\/v1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,1,23]]},"references-count":14,"URL":"https:\/\/doi.org\/10.3310\/nihropenres.13282.1","relation":{"has-review":[{"id-type":"doi","id":"10.3310\/nihropenres.14402.r29817","asserted-by":"subject"},{"id-type":"doi","id":"10.3310\/nihropenres.14402.r30279","asserted-by":"subject"},{"id-type":"doi","id":"10.3310\/nihropenres.14402.r30273","asserted-by":"subject"},{"id-type":"doi","id":"10.3310\/nihropenres.14402.r30273","asserted-by":"object"},{"id-type":"doi","id":"10.3310\/nihropenres.14402.r30279","asserted-by":"object"},{"id-type":"doi","id":"10.3310\/nihropenres.14402.r29817","asserted-by":"object"}]},"ISSN":["2633-4402"],"issn-type":[{"value":"2633-4402","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,1,23]]},"assertion":[{"value":"Indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/3-5\/v1#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.3310\/nihropenres.14402.r29817, Andrea Ban Yu-Lin, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, 12 Jul 2023, version 1, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/3-5\/v1#referee-response-29817","order":0,"name":"referee-response-29817","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Eleanor Mishra<\/b>; \n<i>Posted: 20 Jul 2023<\/i>; Thank you for your review. I'm pleased to say that we have recently completed recruitment and are now working on completing follow up and cleaning data for this study.  1. Re. inclusion criteria: patients had to be attending for therapeutic aspiration (large volume drainage) of their effusion to prevent enrolment of patients with minimal effusions.  2. Patients with bilateral effusions were included in the study. In this instance, clinicians would chose which side to drain (usually the larger) and document this on the CRF.  3. Patients with loculated effusions are included in the study. This would be visible on the study ultrasound and documented on the CRF.  4. The criteria for diagnosis of an MPE is the final diagnosis from the clinician, including both malignant cells on cytology and a clinical diagnosis in the absence of cytology\/histology.&nbsp;  Thanks again for your feedback. I hope to have results of this study at the end of the year.","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/3-5\/v1#referee-comment-3263","order":1,"name":"referee-comment-3263","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.3310\/nihropenres.14402.r30273, Apostolos G Pappas, National and Kapodistrian University of Athens, Athens, 18 Sep 2023, version 1, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/3-5\/v1#referee-response-30273","order":2,"name":"referee-response-30273","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.3310\/nihropenres.14402.r30279, Neslihan Ozcelik, Faculty of Medicine, Chest Disease, Recep Tayyip Erdogan University, Rize, 09 Oct 2023, version 1, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/3-5\/v1#referee-response-30279","order":3,"name":"referee-response-30279","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This project is funded by the National Institute for Health and Care Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number NIHR201466). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.","order":4,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}