Abstract
The objectives of this study are to illustrate the effects of immortal time bias (ITB) using an oncology outcomes database and quantify through simulations the magnitude and direction of ITB when different analytical techniques are used. A cohort of 11 626 women who received neoadjuvant chemotherapy and underwent mastectomy with pathologically positive lymph nodes were accrued from the National Cancer Database (2004-2008). Standard Cox regression, time-dependent (TD), and landmark models were used to compare overall survival in patients who did or did not receive postmastectomy radiation therapy (PMRT). Simulation studies showing ways to reduce the effect of ITB indicate that TD exposures should be included as variables in hazard-based analyses. Standard Cox regression models comparing overall survival in patients who did and did not receive PMRT showed a significant treatment effect (hazard ratio [HR]: 0.93, 95% confidence interval [CI]: 0.88-0.99). Time-dependent and landmark methods estimated no treatment effect with HR: 0.97, 95% CI: 0.92 to 1.03 and HR: 0.98, 95% CI, 0.92 to 1.04, respectively. In our simulation studies, the standard Cox regression model significantly overestimated treatment effects when no effect was pres...Continue Reading
References
May 10, 1969·Lancet·B J MessmerD A Cooley
Jul 1, 1971·Annals of Internal Medicine·D A ClarkD C Harrison
Nov 1, 1983·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·J R AndersonR D Gelber
Jul 1, 1997·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·B FisherN V Dimitrov
Feb 12, 1998·The New England Journal of Medicine·M OvergaardK Zedeler
May 21, 1999·Lancet·M OvergaardH T Mouridsen
Jun 3, 1999·Annual Review of Public Health·L D Fisher, D Y Lin
Sep 11, 2004·Journal of Clinical Epidemiology·Carl van WalravenGeorge A Wells
May 9, 2006·Statistics in Medicine·Ralf BenderMaria Blettner
Dec 7, 2007·American Journal of Epidemiology·Samy Suissa
May 19, 2011·Circulation. Cardiovascular Quality and Outcomes·Urania Dafni
Jul 13, 2011·Epidemiology·Ashley I NaimiDavid B Richardson
Feb 22, 2012·International Journal of Radiation Oncology, Biology, Physics·Henry S ParkJames B Yu
Jul 10, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Anita Giobbie-HurderMeredith M Regan
Jul 6, 2014·Birth Defects Research. Part A, Clinical and Molecular Teratology·Ilan MatokSamy Suissa
Sep 30, 2014·American Journal of Obstetrics and Gynecology·Sharon DanielAmalia Levy
Feb 6, 2016·Annals of Epidemiology·Caihua LiangDavid D Dore
May 18, 2016·Cancer Treatment Reviews·Janick WeberpalsHermann Brenner
Jun 29, 2016·Statistics in Medicine·Xiaojuan MiSoko Setoguchi
Jul 28, 2016·American Journal of Epidemiology·Mohammad Ehsanul KarimUNKNOWN Long-Term Benefits and Adverse Effects of Beta-Interferon for Multiple Sclerosis (BeAMS) Study Group
Nov 5, 2016·Journal of Critical Care·Mark Jones, Robert Fowler
Dec 28, 2017·International Journal of Radiation Oncology, Biology, Physics·Nisha OhriChiaojung Jillian Tsai
Citations
Mar 10, 2020·Diseases of the Colon and Rectum·Sunil V PatelTimothy Hanna
Apr 30, 2020·Anesthesiology·Ehab FaragDaniel I Sessler
May 28, 2020·Journal of Clinical Pharmacy and Therapeutics·Sarah BitarNelly Agrinier
Apr 3, 2020·Journal of the National Cancer Institute·Rikki A CanniotoChristine B Ambrosone
Jul 21, 2020·Acta Oncologica·Mehran YusufNeal Dunlap
Apr 8, 2020·The British Journal of Surgery·A Z de BoerE Bastiaannet
Aug 25, 2020·International Journal of Cancer. Journal International Du Cancer·Fei WangXiao-Ou Shu
Mar 4, 2020·Breast Cancer Research and Treatment·Irene E G van HellemondUNKNOWN Dutch Breast Cancer Research Group (BOOG)
May 10, 2020·Diseases of the Colon and Rectum·Sunil V PatelTimothy Hanna
Nov 11, 2020·Journal of Gastrointestinal Surgery : Official Journal of the Society for Surgery of the Alimentary Tract·Michael J CavnarRonald P DeMatteo
Jan 8, 2021·BMC Cardiovascular Disorders·Christian FischerRafael Mikolajczyk
Jan 2, 2021·Seminars in Arthritis and Rheumatism·Devin AbrahamiSamy Suissa
Aug 14, 2019·International Journal of Radiation Oncology, Biology, Physics·Neil B NewmanLisa A Kachnic
Jul 24, 2020·HPB : the Official Journal of the International Hepato Pancreato Biliary Association·Roberto J VidriTimothy L Fitzgerald
Mar 10, 2021·Clinical Lung Cancer·Bernardo H L GoulartScott D Ramsey
Apr 15, 2021·Annals of Surgical Oncology·Mehran B YusufNeal Dunlap
Apr 24, 2021·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Daichi FujimotoNobuyuki Yamamoto
May 11, 2021·European Journal of Clinical Pharmacology·Sarah BitarNelly Agrinier
May 27, 2021·Liver International : Official Journal of the International Association for the Study of the Liver·Abdel Aziz ShaheenMark G Swain
Jun 27, 2021·Bone·Ioanna PapathanasiouAspasia Tsezou
Jul 14, 2021·The Journal of Arthroplasty·Dirk R LarsonHilal Maradit Kremers
Sep 1, 2021·The Journal of Dermatology·Tai-Li ChenChung-Hsing Chang
Oct 2, 2021·BMC Medical Research Methodology·Rebecca EvansChris A Rogers
Sep 8, 2021·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Ted A Gooley
Sep 30, 2021·Cancer Epidemiology, Biomarkers & Prevention : a Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology·Omonefe O OmofumaSusan E Steck