{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T02:44:34Z","timestamp":1778899474557,"version":"3.51.4"},"reference-count":94,"publisher":"Wiley","issue":"11","content-domain":{"domain":["wiley.com","cochranelibrary.com"],"crossmark-restriction":true},"short-container-title":[],"DOI":"10.1002\/14651858.cd016218","type":"journal-article","created":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T12:51:54Z","timestamp":1762779114000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Tolvaptan versus other interventions for hyponatraemia in people with cirrhosis"],"prefix":"10.1002","volume":"2025","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2593-9623","authenticated-orcid":false,"given":"K N","family":"Anila","sequence":"additional","affiliation":[{"name":"Department of GI Surgery and Solid Organ Transplantation; Amrita Institute of Medical Sciences & Research Centre; Kochi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nair S","family":"Saraswathy","sequence":"additional","affiliation":[{"name":"Department of GI Surgery and Solid Organ Transplantation; Amrita Institute of Medical Sciences & Research Centre; Kochi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0409-9066","authenticated-orcid":false,"given":"Zubair U","family":"Mohamed","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia and Intensive care; Amrita Institute of Medical Sciences & Research Centre, Kochi; Kochi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christi Titus","family":"Varghese","sequence":"additional","affiliation":[{"name":"Department of GI Surgery and Solid Organ Transplantation; Amrita Institute of Medical Sciences & Research Centre; Kochi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S T","family":"Binoj","sequence":"additional","affiliation":[{"name":"Department of GI Surgery and Solid Organ Transplantation; Amrita Institute of Medical Sciences & Research Centre; Kochi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Unnikrishnan","family":"Gopalakrishnan","sequence":"additional","affiliation":[{"name":"Department of GI Surgery and Solid Organ Transplantation; Amrita Institute of Medical Sciences & Research Centre; Kochi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dinesh","family":"Balakrishnan","sequence":"additional","affiliation":[{"name":"Department of GI Surgery and Solid Organ Transplantation; Amrita Institute of Medical Sciences & Research Centre; Kochi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arun","family":"Valsan","sequence":"additional","affiliation":[{"name":"Hepatology & Transplantation; Amrita Institute of Medical Sciences & Research Centre; Kochi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Surendran","family":"Sudhindran","sequence":"additional","affiliation":[{"name":"Department of GI Surgery and Solid Organ Transplantation; Amrita Institute of Medical Sciences & Research Centre; Kochi India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,11,10]]},"reference":[{"issue":"3","key":"10.1002\/14651858.CD016218-BIB0001|cit1","doi-asserted-by":"publisher","first-page":"397","DOI":"10.1016\/j.jhep.2010.05.004","article-title":"EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis","volume":"53","author":"European Association for the Study of the Liver","year":"2010","journal-title":"Journal of Hepatology"},{"issue":"2","key":"10.1002\/14651858.CD016218-BIB0002|cit2","doi-asserted-by":"publisher","first-page":"406","DOI":"10.1016\/j.jhep.2018.03.024","article-title":"EASL clinical practice guidelines for the management of patients with decompensated cirrhosis","volume":"69","author":"European Association for the Study of the Liver","year":"2018","journal-title":"Journal of Hepatology"},{"issue":"2","key":"10.1002\/14651858.CD016218-BIB0003|cit3","doi-asserted-by":"crossref","first-page":"149","DOI":"10.1016\/j.cld.2022.01.001","article-title":"Hyponatremia in cirrhosis","volume":"26","author":"Rondon-Berrios","year":"2022","journal-title":"Clinical Liver Disease"},{"issue":"3","key":"10.1002\/14651858.CD016218-BIB0004|cit4","doi-asserted-by":"crossref","first-page":"871","DOI":"10.1016\/j.jceh.2021.10.145","article-title":"Impact of hyponatremia on morbidity, mortality, and resource utilization in portal hypertensive ascites: a nationwide analysis","volume":"12","author":"Thuluvath","year":"2022","journal-title":"Journal of Clinical & Experimental Hepatology"},{"key":"10.1002\/14651858.CD016218-BIB0005|cit5","first-page":"1014","article-title":"Diagnosis, evaluation, and management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome: 2021 practice guidance by the American Association for the Study of Liver Diseases","volume":"1","author":"Runyon","year":"2021","journal-title":"Hepatology"},{"issue":"1","key":"10.1002\/14651858.CD016218-BIB0006|cit6","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1007\/s12072-018-09923-2","article-title":"Management of ascites and related complications in cirrhosis: 2019 practice guidelines by the Chinese Society of Hepatology","volume":"13","author":"Xu","year":"2019","journal-title":"Hepatology International"},{"issue":"7","key":"10.1002\/14651858.CD016218-BIB0007|cit7","doi-asserted-by":"publisher","first-page":"593","DOI":"10.1007\/s00535-021-01788-x","article-title":"Evidence-based clinical practice guidelines for liver cirrhosis","volume":"56","author":"Yoshiji","year":"2021","journal-title":"Journal of Gastroenterology"},{"issue":"9930","key":"10.1002\/14651858.CD016218-BIB0008|cit8","doi-asserted-by":"publisher","first-page":"1749\u201361","DOI":"10.1016\/S0140-6736(14)60121-5","article-title":"Liver cirrhosis","volume":"383","author":"Tsochatzis","year":"2014","journal-title":"Lancet"},{"issue":"2","key":"10.1002\/14651858.CD016218-BIB0009|cit9","doi-asserted-by":"crossref","first-page":"112","DOI":"10.1038\/s41575-021-00520-7","article-title":"Cirrhosis-associated immune dysfunction","volume":"19","author":"Albillos","year":"2022","journal-title":"Nature Reviews Gastroenterology & Hepatology"},{"issue":"10","key":"10.1002\/14651858.CD016218-BIB0010|cit10","doi-asserted-by":"publisher","first-page":"1041","DOI":"10.1080\/17474124.2023.2267421","article-title":"Efficacy and safety of tolvaptan in cirrhotic patients: a systematic review and meta-analysis of randomized controlled trials","volume":"17","author":"Chai","year":"2023","journal-title":"Expert Review of Gastroenterology & Hepatology"},{"issue":"11","key":"10.1002\/14651858.CD016218-BIB0011|cit11","doi-asserted-by":"publisher","first-page":"3197","DOI":"10.3748\/wjg.v21.i11.3197","article-title":"Hyponatremia in cirrhosis: pathophysiology and management","volume":"21","author":"John","year":"2015","journal-title":"World Journal of Gastroenterology"},{"issue":"24","key":"10.1002\/14651858.CD016218-BIB0012|cit12","doi-asserted-by":"publisher","first-page":"1535","DOI":"10.1056\/nejm198606123142402","article-title":"Osmotic demyelination syndrome following correction of hyponatraemia","volume":"314","author":"Sterns","year":"1986","journal-title":"New England Journal of Medicine"},{"key":"10.1002\/14651858.CD016218-BIB0013|cit13","doi-asserted-by":"publisher","first-page":"279","DOI":"10.4103\/1319-3767.141686.","article-title":"Ascites and spontaneous bacterial peritonitis: recommendations from two United States centers","volume":"20","author":"Sundaram","year":"2014","journal-title":"Saudi Journal of Gastroenterology"},{"issue":"2","key":"10.1002\/14651858.CD016218-BIB0014|cit14","doi-asserted-by":"publisher","first-page":"1014","DOI":"10.1002\/hep.31884","article-title":"Diagnosis, evaluation, and management of ascites, spontaneous bacterial peritonitis and hepatorenal syndrome: 2021 Practice Guidance by the American Association for the Study of Liver Diseases","volume":"74","author":"Biggins","year":"2021","journal-title":"Hepatology"},{"issue":"20","key":"10.1002\/14651858.CD016218-BIB0015|cit15","doi-asserted-by":"publisher","first-page":"2099","DOI":"10.1056\/NEJMoa065181","article-title":"Tolvaptan, a selective oral vasopressin V2-receptor antagonist, for hyponatremia","volume":"355","author":"Schrier","year":"2006","journal-title":"New England Journal of Medicine"},{"issue":"12","key":"10.1002\/14651858.CD016218-BIB0016|cit16","doi-asserted-by":"publisher","first-page":"2124","DOI":"10.1038\/sj.ki.5000432","article-title":"Vasopressin receptor antagonists","volume":"69","author":"Greenberg","year":"2006","journal-title":"Kidney International"},{"issue":"10 Suppl 1","key":"10.1002\/14651858.CD016218-BIB0017|cit17","doi-asserted-by":"publisher","first-page":"S1\u201342","DOI":"10.1016\/j.amjmed.2013.07.006","article-title":"Diagnosis, evaluation, and treatment of hyponatremia: expert panel recommendations","volume":"126","author":"Verbalis","year":"2013","journal-title":"American Journal of Medicine"},{"issue":"4","key":"10.1002\/14651858.CD016218-BIB0018|cit18","doi-asserted-by":"publisher","first-page":"335\u20137","DOI":"10.3350\/kjhep.2011.17.4.335","article-title":"The use of vaptan in hyponatremic patients with liver cirrhosis","volume":"17","author":"Choe","year":"2011","journal-title":"Korean Journal of Hepatology"},{"key":"10.1002\/14651858.CD016218-BIB0019|cit19","unstructured":"NDA 22-275 (hyponatremia) https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2009\/022275s000_OtherR.pdf"},{"issue":"9624","key":"10.1002\/14651858.CD016218-BIB0020|cit20","doi-asserted-by":"publisher","first-page":"1624","DOI":"10.1016\/S0140-6736(08)60695-9","article-title":"Non-peptide arginine-vasopressin antagonists: the vaptans","volume":"371","author":"Decaux","year":"2008","journal-title":"Lancet"},{"issue":"11","key":"10.1002\/14651858.CD016218-BIB0021|cit21","doi-asserted-by":"publisher","first-page":"2153","DOI":"10.1007\/s11255-014-0839-2","article-title":"Hyponatremia: pathophysiology, classification, manifestations, and management","volume":"46","author":"Rondon-Berrios","year":"2014","journal-title":"International Urology and Nephrology"},{"key":"10.1002\/14651858.CD016218-BIB0022|cit22","unstructured":"Prescribing information: [SAMSCA]. Reference ID. 3289766. Otsuka Pharmaceutical Co., Ltd. (MD): FDA; 2013 [cited 2025 JAN 17] Available from https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2013\/022275s009lbl.pdf"},{"issue":"3","key":"10.1002\/14651858.CD016218-BIB0023|cit23","doi-asserted-by":"publisher","first-page":"182","DOI":"10.4103\/2278-330X.136811","article-title":"Tolvaptan","volume":"3","author":"Rangarajan","year":"2014","journal-title":"South Asian Journal of Cancer"},{"key":"10.1002\/14651858.CD016218-BIB0024|cit24","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1007\/978-3-031-27119-9_2","volume-title":"Hydro Saline Metabolism. Endocrinology","author":"Mantovani","year":"2023"},{"issue":"2","key":"10.1002\/14651858.CD016218-BIB0025|cit25","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD010202.pub3","article-title":"The roles of vasopressin and its receptors: V1a, V1b, and V2 in health and disease","author":"Thibonnier","year":"2020","journal-title":"Cochrane Database of Systematic Reviews"},{"issue":"18","key":"10.1002\/14651858.CD016218-BIB0026|cit26","doi-asserted-by":"publisher","first-page":"1847","DOI":"10.1056\/NEJMp058006","article-title":"Hyperactive vasopressin receptors and disturbed water homeostasis","volume":"352","author":"Knoers","year":"2005","journal-title":"New England Journal of Medicine"},{"issue":"1","key":"10.1002\/14651858.CD016218-BIB0027|cit27","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1111\/j.1527-3466.2007.00001.x","article-title":"Tolvaptan, an orally active vasopressin V2-receptor antagonist\u2014pharmacology and clinical trials","volume":"25","author":"Miyazaki","year":"2007","journal-title":"Cardiovascular Drug Reviews"},{"issue":"3","key":"10.1002\/14651858.CD016218-BIB0028|cit28","doi-asserted-by":"publisher","first-page":"157","DOI":"10.1055\/s-0029-1212091","article-title":"Nonpeptide vasopressin antagonists: a new group of hormone blockers entering the scene","volume":"107","author":"Mayinger","year":"1999","journal-title":"Experimental and Clinical Endocrinology & Diabetes"},{"issue":"3","key":"10.1002\/14651858.CD016218-BIB0029|cit29","doi-asserted-by":"publisher","first-page":"14","DOI":"10.2165\/00003495-199100413-00004","article-title":"Clinical pharmacology of loop diuretics","volume":"41","author":"Brater","year":"1991","journal-title":"Drugs"},{"issue":"1","key":"10.1002\/14651858.CD016218-BIB0030|cit30","doi-asserted-by":"publisher","first-page":"5582","DOI":"10.3390\/ijms22115582","article-title":"Management of cirrhotic ascites under the add-on administration of tolvaptan","volume":"22","author":"Adachi","year":"2021","journal-title":"International Journal of Molecular Sciences"},{"issue":"1","key":"10.1002\/14651858.CD016218-BIB0031|cit31","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1016\/j.xkme.2019.09.004","article-title":"Equivalent efficacy and decreased rate of overcorrection in patients with syndrome of inappropriate secretion of antidiuretic hormone given very low-dose tolvaptan","volume":"2","author":"Hanna","year":"2019","journal-title":"Kidney Medicine"},{"issue":"1","key":"10.1002\/14651858.CD016218-BIB0032|cit32","doi-asserted-by":"publisher","first-page":"137","DOI":"10.1186\/s12876-018-0857-0","article-title":"Tolvaptan treatment improves survival of cirrhotic patients with ascites and hyponatremia","volume":"18","author":"Wang","year":"2018","journal-title":"BMC Gastroenterology"},{"issue":"4","key":"10.1002\/14651858.CD016218-BIB0033|cit33","doi-asserted-by":"publisher","first-page":"320","DOI":"10.1159\/000503559","article-title":"Response to tolvaptan improves overall survival in cirrhotic patients with refractory ascites: meta-analysis of randomized controlled trials","volume":"38","author":"Bellos","year":"2020","journal-title":"Digestive Diseases and Sciences"},{"issue":"5","key":"10.1002\/14651858.CD016218-BIB0034|cit34","doi-asserted-by":"publisher","first-page":"761\u201371","DOI":"10.1111\/cen.13315","article-title":"A systematic review of known interventions for the treatment of chronic nonhypovolaemic hypotonic hyponatraemia and a meta-analysis of the vaptans","volume":"86","author":"Bhandari","year":"2017","journal-title":"Clinical Endocrinology"},{"issue":"10","key":"10.1002\/14651858.CD016218-BIB0035|cit35","doi-asserted-by":"publisher","first-page":"1365","DOI":"10.3389\/fphar.2019.01365","article-title":"Impact of vaptans on clinical outcomes in cirrhosis patients: a meta-analysis of randomized controlled trials","volume":"20","author":"Li","year":"2019","journal-title":"Frontiers in Pharmacology"},{"key":"10.1002\/14651858.CD016218-BIB0036|cit36","unstructured":"Sterns RH Overview of the treatment of hyponatremia in adults https:\/\/www.uptodate.com\/contents\/overview-of-the-treatment-of-hyponatremia-in-adults"},{"issue":"3","key":"10.1002\/14651858.CD016218-BIB0037|cit37","doi-asserted-by":"publisher","first-page":"571","DOI":"10.1016\/j.jhep.2011.08.020","article-title":"Tolvaptan, an oral vasopressin antagonist, in the treatment of hyponatremia in cirrhosis","volume":"56","author":"C\u00e1rdenas","year":"2012","journal-title":"Journal of Hepatology"},{"issue":"7","key":"10.1002\/14651858.CD016218-BIB0038|cit38","doi-asserted-by":"publisher","first-page":"619\u201326","DOI":"10.1111\/apt.12025","article-title":"The safety and efficacy of vaptans (tolvaptan, satavaptan and lixivaptan) in cirrhosis with ascites or hyponatraemia: a meta-analysis","volume":"36","author":"Dahl","year":"2012","journal-title":"Alimentary Pharmacology and Therapeutics"},{"issue":"3","key":"10.1002\/14651858.CD016218-BIB0039|cit39","doi-asserted-by":"publisher","first-page":"398","DOI":"10.14218\/JCTH.2021.00227","article-title":"Racial and Health Disparities among Cirrhosis-related Hospitalizations in the USA","volume":"10","author":"Singal","year":"2022","journal-title":"Journal of Clinical and Translational Hepatology"},{"key":"10.1002\/14651858.CD016218-BIB0040|cit40","unstructured":"Higgins JP Lasserson T Thomas J Flemyng E Churchill R Methodological Expectations of Cochrane Intervention Reviews. Cochrane: London, Version August 2023 Available from https:\/\/community.cochrane.org\/mecir-manual"},{"key":"10.1002\/14651858.CD016218-BIB0041|cit41","doi-asserted-by":"publisher","first-page":"n71","DOI":"10.1136\/bmj.n71","article-title":"The PRISMA 2020 statement: an updated guideline for reporting systematic reviews","volume":"372","author":"Page","year":"2020","journal-title":"BMJ"},{"key":"10.1002\/14651858.CD016218-BIB0042|cit42","doi-asserted-by":"publisher","first-page":"n160","DOI":"10.1136\/bmj.n160","article-title":"PRISMA 2020 explanation and elaboration: updated guidance and exemplars for reporting systematic reviews","volume":"372","author":"Page","year":"2021","journal-title":"BMJ"},{"key":"10.1002\/14651858.CD016218-BIB0043|cit43","unstructured":"Higgins JP Eldridge S Li T Chapter 23: Including variants on randomized trials (chapter last updated October 2019). In: Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 6.5 (updated August 2024). Cochrane, 2024 Available from https:\/\/cochrane.org\/handbook"},{"key":"10.1002\/14651858.CD016218-BIB0044|cit44","unstructured":"International Council for Harmonisation of technical requirements for pharmaceuticals for human use (ICH) ICH Harmonised Guideline. Integrated addendum to ICH E6(R1): guideline for good clinical practice E6(R2); 2016 Available at https:\/\/database.ich.org\/sites\/default\/files\/E6_R2_Addendum.pdf"},{"issue":"2","key":"10.1002\/14651858.CD016218-BIB0045|cit45","doi-asserted-by":"publisher","first-page":"295\u2013300","DOI":"10.1136\/gut.45.2.295","article-title":"Development of a disease specific questionnaire to measure health related quality of life in patients with chronic liver disease","volume":"45","author":"Younossi","year":"1999","journal-title":"Gut"},{"issue":"8","key":"10.1002\/14651858.CD016218-BIB0046|cit46","doi-asserted-by":"publisher","first-page":"1469\u201381","DOI":"10.1023\/B:QURE.0000040797.17449.c0","article-title":"The Liver Disease Symptom Index 2.0: validation of a disease-specific questionnaire","volume":"13","author":"Plas","year":"2004","journal-title":"Quality of Life Research"},{"issue":"0","key":"10.1002\/14651858.CD016218-BIB0047|cit47","doi-asserted-by":"publisher","first-page":"92","DOI":"10.1186\/1477-7525-10-92.","article-title":"Review of patient-reported outcome measures in chronic hepatitis C","volume":"10","author":"Kleinman","year":"2012","journal-title":"Health and Quality of Life Outcomes"},{"issue":"6","key":"10.1002\/14651858.CD016218-BIB0048|cit48","doi-asserted-by":"publisher","first-page":"1788","DOI":"10.1097\/HEP.0000000000000480","article-title":"PROMIS Profile-29 is a valid instrument with distinct advantages over legacy instruments for measuring the quality of life in chronic liver disease","volume":"78","author":"Desai","year":"2023","journal-title":"Hepatology"},{"issue":"4","key":"10.1002\/14651858.CD016218-BIB0049|cit49","doi-asserted-by":"publisher","first-page":"232","DOI":"10.5114\/ceh.2018.80124","article-title":"Health-related quality of life in liver cirrhosis patients using SF-36 and CLDQ questionnaires","volume":"4","author":"Janani","year":"2018","journal-title":"Clinical and Experimental Hepatology"},{"issue":"2","key":"10.1002\/14651858.CD016218-BIB0050|cit50","doi-asserted-by":"publisher","first-page":"575","DOI":"10.1016\/j.jceh.2021.09.008","article-title":"Clinical Implications, Evaluation, and Management of Hyponatraemia in Cirrhosis","volume":"12","author":"Praharaj","year":"2022","journal-title":"Journal of Clinical and Experimental Hepatology"},{"issue":"1","key":"10.1002\/14651858.CD016218-BIB0051|cit51","doi-asserted-by":"publisher","first-page":"86","DOI":"10.1186\/s12882-017-0501-1","article-title":"Effect of tolvaptan on renal water and sodium excretion and blood pressure during nitric oxide inhibition: a dose-response study in healthy subjects","volume":"18","author":"Al Therwani","year":"2017","journal-title":"BMC Nephrology"},{"issue":"1","key":"10.1002\/14651858.CD016218-BIB0052|cit52","doi-asserted-by":"crossref","first-page":"87","DOI":"10.1186\/s40360-018-0277-3","article-title":"Impact of continued administration of tolvaptan on cirrhotic patients with ascites","volume":"19","author":"Kogiso","year":"2018","journal-title":"BMC Pharmacology Toxicology"},{"issue":"6","key":"10.1002\/14651858.CD016218-BIB0053|cit53","doi-asserted-by":"publisher","first-page":"2381","DOI":"10.1177\/030006051204000637","article-title":"The pharmacokinetics and pharmacodynamics of tolvaptan in patients with liver cirrhosis with insufficient response to conventional diuretics: a multicentre, double-blind, parallel-group, phase III study","volume":"40","author":"Sakaida","year":"2012","journal-title":"Journal of International Medical Research"},{"key":"10.1002\/14651858.CD016218-BIB0054|cit54","unstructured":"Lefebvre C Glanville J Briscoe S Featherstone R Littlewood A Chapter 4: Searching for and selecting studies (chapter last updated March 2025). In: Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editor(s). Cochrane Handbook for Systematic Reviews of Interventions version 6.5.1. Cochrane, 2025 Available from https:\/\/cochrane.org\/handbook"},{"issue":"1","key":"10.1002\/14651858.CD016218-BIB0055|cit55","doi-asserted-by":"publisher","first-page":"39","DOI":"10.1186\/s13643-020-01542-z","article-title":"PRISMA-S: an extension to the PRISMA Statement for Reporting Literature Searches in Systematic Reviews","volume":"10","author":"Rethlefsen","year":"2021","journal-title":"Systematic Reviews"},{"key":"10.1002\/14651858.CD016218-BIB0056|cit56","unstructured":"Lefebvre C Glanville J Briscoe S Featherstone R Littlewood A Technical Supplement to Chapter 4: Searching for and selecting studies (chapter last updated September 2024). In: Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 6.5 (updated August 2024). Cochrane, 2024 Available from https:\/\/cochrane.org\/handbook"},{"key":"10.1002\/14651858.CD016218-BIB0057|cit57","unstructured":"Higgins JP Thomas J Chandler J Cumpston M Li T Page MJ Cochrane Handbook for Systematic Reviews of Interventions, Version 6.5 (updated August 2024). Cochrane, 2024 Available from https:\/\/cochrane.org\/handbook"},{"key":"10.1002\/14651858.CD016218-BIB0058|cit58","unstructured":"Review Manager (RevMan) The Cochrane Collaboration 2025"},{"key":"10.1002\/14651858.CD016218-BIB0059|cit59","unstructured":"Covidence Veritas Health Innovation 2025"},{"key":"10.1002\/14651858.CD016218-BIB0060|cit60","unstructured":"WebPlotDigitizer Rohatgi A Automeris LLC"},{"key":"10.1002\/14651858.CD016218-BIB0061|cit61","doi-asserted-by":"publisher","first-page":"135","DOI":"10.1186\/1471-2288-14-135","article-title":"Estimating the sample mean and standard deviation from the sample size, median, range, and\/or interquartile range","volume":"14","author":"Wan","year":"2014","journal-title":"BMC Medical Research Methodology"},{"key":"10.1002\/14651858.CD016218-BIB0062|cit62","unstructured":"Higgins JP Savovi\u0107 J Page MJ Elbers RG Sterne JA Chapter 8: Assessing risk of bias in a randomised trial (chapter last updated October 2019). In: Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 6.5 (updated August 2024). Cochrane, 2024 Available from https:\/\/cochrane.org\/handbook"},{"key":"10.1002\/14651858.CD016218-BIB0063|cit63","doi-asserted-by":"publisher","first-page":"l4898","DOI":"10.1136\/bmj.l4898","article-title":"RoB 2: a revised tool for assessing risk of bias in randomised trials","volume":"366","author":"Sterne","year":"2019","journal-title":"BMJ"},{"key":"10.1002\/14651858.CD016218-BIB0064|cit64","unstructured":"Higgins JP Li T Deeks JJ Chapter 6: Choosing effect measures and computing estimates of effect (chapter last updated August 2023). In: Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 6.5 (updated August 2024). Cochrane, 2024 Available from https:\/\/cochrane.org\/handbook"},{"key":"10.1002\/14651858.CD016218-BIB0065|cit65","unstructured":"Deeks JJ Higgins JP Altman DG McKenzie JE Veroniki AA Chapter 10: Analysing data and undertaking meta-analyses (chapter last updated November 2024). In: Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 6.5 (updated August 2024). Cochrane, 2024 Available from https:\/\/cochrane.org\/handbook"},{"key":"10.1002\/14651858.CD016218-BIB0066|cit66","unstructured":"Sch\u00fcnemann HJ Vist GE Higgins JP Santesso N Deeks JJ Glasziou P Chapter 15: Interpreting results and drawing conclusions (chapter last updated August 2023). In: Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 6.5 (updated August 2024). Cochrane, 2024 Available from https:\/\/cochrane.org\/handbook"},{"issue":"6","key":"10.1002\/14651858.CD016218-BIB0067|cit67","doi-asserted-by":"crossref","first-page":"579","DOI":"10.1016\/j.jclinepi.2004.09.013","article-title":"Uncertainty method improved on best-worst case analysis in a binary meta-analysis","volume":"58","author":"Gamble","year":"2005","journal-title":"Journal of Clinical Epidemiology"},{"issue":"7211","key":"10.1002\/14651858.CD016218-BIB0068|cit68","doi-asserted-by":"publisher","first-page":"670","DOI":"10.1136\/bmj.319.7211.670","article-title":"What is meant by intention to treat analysis? Survey of published randomised controlled trials","volume":"319","author":"Hollis","year":"1999","journal-title":"BMJ"},{"key":"10.1002\/14651858.CD016218-BIB0069|cit69","unstructured":"Page MJ Higgins JP Sterne JA Chapter 13: Assessing risk of bias due to missing evidence in a meta-analysis (chapter last updated August 2024). In: Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 6.5 (updated August 2024). Cochrane, 2024 Available from https:\/\/cochrane.org\/handbook"},{"issue":"7109","key":"10.1002\/14651858.CD016218-BIB0070|cit70","doi-asserted-by":"publisher","first-page":"629","DOI":"10.1136\/bmj.315.7109.629","article-title":"Bias in meta-analysis detected by a simple, graphical test","volume":"315","author":"Egger","year":"1997","journal-title":"BMJ"},{"issue":"11","key":"10.1002\/14651858.CD016218-BIB0071|cit71","doi-asserted-by":"publisher","first-page":"1539","DOI":"10.1002\/sim.1186","article-title":"Quantifying heterogeneity in a meta-analysis","volume":"21","author":"Higgins","year":"2002","journal-title":"Statistics in Medicine"},{"issue":"10","key":"10.1002\/14651858.CD016218-BIB0072|cit72","doi-asserted-by":"publisher","first-page":"1603","DOI":"10.1007\/s00134-018-5293-7","article-title":"Industry sponsorship and research outcome: systematic review with meta-analysis","volume":"44","author":"Lundh","year":"2018","journal-title":"Intensive Care Medicine"},{"key":"10.1002\/14651858.CD016218-BIB0073|cit73","unstructured":"meta: An R package for meta-analysis [software] Version 7.0-0 Schwarzer G Carpenter JR R\u00fccker G R Foundation for Statistical Computing 2025"},{"issue":"1","key":"10.1002\/14651858.CD016218-BIB0074|cit74","doi-asserted-by":"publisher","first-page":"56","DOI":"10.1016\/j.jclinepi.2013.08.005","article-title":"Applying an equity lens to interventions: using PROGRESS ensures consideration of socially stratifying factors to illuminate inequities in health","volume":"67","author":"O'Neill","year":"2014","journal-title":"Journal of Clinical Epidemiology"},{"key":"10.1002\/14651858.CD016218-BIB0075|cit75","unstructured":"Welch VA Petkovic J Jull J Hartling L Klassen T Kristjansson E Chapter 16: Equity and specific populations (chapter last updated October 2019). In: Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 6.5 (updated August 2024). Cochrane, 2024 Available from https:\/\/cochrane.org\/handbook"},{"key":"10.1002\/14651858.CD016218-BIB0076|cit76","unstructured":"Thorlund K Engstr\u00f8m J Wetterslev J Brok J Imberger G Gluud C User manual for Trial Sequential Analysis (TSA); 2nd edition. Copenhagen Trial Unit, 2017 Available from ctu.dk\/tsa\/learn-more"},{"key":"10.1002\/14651858.CD016218-BIB0077|cit77","unstructured":"TSA - Trial Sequential Analysis Copenhagen Trial Unit 2021"},{"issue":"1","key":"10.1002\/14651858.CD016218-BIB0078|cit78","doi-asserted-by":"publisher","first-page":"64","DOI":"10.1016\/j.jclinepi.2007.03.013","article-title":"Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis","volume":"61","author":"Wetterslev","year":"2008","journal-title":"Journal of Clinical Epidemiology"},{"issue":"1","key":"10.1002\/14651858.CD016218-BIB0079|cit79","doi-asserted-by":"publisher","first-page":"39","DOI":"10.1186\/s12874-017-0315-7","article-title":"Trial Sequential Analysis in systematic reviews with meta-analysis","volume":"17","author":"Wetterslev","year":"2017","journal-title":"BMC Medical Research Methodology"},{"key":"10.1002\/14651858.CD016218-BIB0080|cit80","doi-asserted-by":"publisher","first-page":"763","DOI":"10.1016\/j.jclinepi.2007.10.007","article-title":"Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analyses","volume":"61","author":"Brok","year":"2008","journal-title":"Journal of Clinical Epidemiology"},{"issue":"1","key":"10.1002\/14651858.CD016218-BIB0081|cit81","doi-asserted-by":"publisher","first-page":"287","DOI":"10.1093\/ije\/dyn188","article-title":"Apparently conclusive meta-analyses may be inconclusive \u2013 trial sequential analysis adjustment of random error risk due to repetitive testing of accumulating data in apparently conclusive neonatal meta-analyses","volume":"38","author":"Brok","year":"2009","journal-title":"International Journal of Epidemiology"},{"key":"10.1002\/14651858.CD016218-BIB0082|cit82","doi-asserted-by":"publisher","first-page":"57","DOI":"10.2147\/clep.s9242","article-title":"Interpreting meta-analysis according to the adequacy of sample size. An example using isoniazid chemoprophylaxis for tuberculosis in purified protein derivative negative HIV-infected individuals","volume":"2","author":"Thorlund","year":"2010","journal-title":"Clinical Epidemiology"},{"issue":"110","key":"10.1002\/14651858.CD016218-BIB0083|cit83","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/s13643-018-0770-1","article-title":"Assessing imprecision in Cochrane systematic reviews: a comparison of GRADE and Trial Sequential Analysis","volume":"7","author":"Castellini","year":"2018","journal-title":"Systematic Reviews"},{"issue":"1","key":"10.1002\/14651858.CD016218-BIB0084|cit84","doi-asserted-by":"publisher","first-page":"127","DOI":"10.1097\/CCM.0000000000004568","article-title":"Powering bias and clinically important treatment effects in randomized trials of critical illness","volume":"202","author":"Abrams","year":"2020","journal-title":"American Journal of Respiratory and Critical Care Medicine"},{"key":"10.1002\/14651858.CD016218-BIB0085|cit85","doi-asserted-by":"publisher","first-page":"120","DOI":"10.1186\/1471-2288-14-120","article-title":"Thresholds for statistical and clinical significance in systematic reviews with meta-analytic methods","volume":"14","author":"Jakobsen","year":"2014","journal-title":"BMC Medical Research Methodology"},{"key":"10.1002\/14651858.CD016218-BIB0086|cit86","doi-asserted-by":"publisher","first-page":"86","DOI":"10.1186\/1471-2288-9-86","article-title":"Estimating required information size by quantifying diversity in a random-effects meta-analysis","volume":"9","author":"Wetterslev","year":"2009","journal-title":"BMC Medical Research Methodology"},{"key":"10.1002\/14651858.CD016218-BIB0087|cit87","unstructured":"GRADEpro GDT McMaster University (developed by Evidence Prime) 2025"},{"key":"10.1002\/14651858.CD016218-BIB0088|cit88","unstructured":"Sch\u00fcnemann H Bro\u017cek J Guyatt G Oxman A Handbook for grading the quality of evidence and the strength of recommendations using the GRADE approach (updated October 2013). GRADE Working Group, 2013 Available from https:\/\/gdt.gradepro.org\/app\/handbook\/handbook.html"},{"key":"10.1002\/14651858.CD016218-BIB0089|cit89","unstructured":"Sch\u00fcnemann HJ Higgins JP Vist GE Glasziou P Akl EA Skoetz N Chapter 14: Completing \u2018Summary of Findings\u2019 tables and grading the certainty of the evidence (chapter last updated August 2023). In: Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 6.5 (updated August 2024). Cochrane, 2024 Available from https:\/\/cochrane.org\/handbook"},{"key":"10.1002\/14651858.CD016218-BIB0090|cit90","doi-asserted-by":"publisher","first-page":"216","DOI":"10.1016\/j.jclinepi.2022.07.014","article-title":"GRADE Guidance 34: update on rating imprecision using a minimally contextualized approach","volume":"150","author":"Zeng","year":"2022","journal-title":"Journal of Clinical Epidemiology"},{"key":"10.1002\/14651858.CD016218-BIB0091|cit91","doi-asserted-by":"publisher","first-page":"e081904","DOI":"10.1136\/bmj-2024-081904","article-title":"Core GRADE 2: choosing the target of certainty rating and assessing imprecision","volume":"389","author":"Guyatt","year":"2025","journal-title":"BMJ"},{"issue":"1","key":"10.1002\/14651858.CD016218-BIB0092|cit92","doi-asserted-by":"publisher","first-page":"65","DOI":"10.20473\/cimrj.v6i1.60741","article-title":"Tolvaptan improves refractory ascites and overall survival in cirrhosis: a meta-analysis","volume":"6","author":"Kalal","year":"2025","journal-title":"Current Internal Medicine Research and Practice Surabaya Journal"},{"issue":"5","key":"10.1002\/14651858.CD016218-BIB0093|cit93","doi-asserted-by":"publisher","first-page":"582\u201392","DOI":"10.1097\/00005650-200305000-00004","article-title":"Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation","volume":"41","author":"Norman","year":"2003","journal-title":"Medical Care"},{"key":"10.1002\/14651858.CD016218-BIB0094|cit94","unstructured":"Lasserson TJ Thomas J Higgins JP Chapter 1: Starting a review (chapter last updated August 2021). In: Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 6.5 (updated August 2024). Cochrane, 2024 Available from https:\/\/cochrane.org\/handbook"}],"container-title":["Cochrane Database of Systematic Reviews"],"original-title":[],"language":"en","deposited":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T12:52:07Z","timestamp":1762779127000},"score":1,"resource":{"primary":{"URL":"http:\/\/doi.wiley.com\/10.1002\/14651858.CD016218"}},"subtitle":[],"editor":[{"name":"Cochrane Central Editorial Service","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2025,11,10]]},"references-count":94,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2025,11]]}},"URL":"https:\/\/doi.org\/10.1002\/14651858.cd016218","relation":{},"ISSN":["1465-1858"],"issn-type":[{"value":"1465-1858","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,10]]}}}