Missing data on 3-month modified Rankin Scale may influence results of functional outcome after intravenous thrombolysis in observational studies

Journal of Thrombosis and Thrombolysis, Nov 2016

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Missing data on 3-month modified Rankin Scale may influence results of functional outcome after intravenous thrombolysis in observational studies

Missing data on 3-month modified Rankin Scale may influence results of functional outcome after intravenous thrombolysis in observational studies Stefano Forlivesi 0 1 Manuel Cappellari 0 1 Paolo Bovi 0 1 Dear Editor 0 1 0 Stroke Unit, Azienda Ospedaliera Universitaria Integrata Verona , Piazzale Aristide Stefani 1, 37126 Verona , Italy 1 & Stefano Forlivesi 1. SITS (Safe Implementation of Treatments in Stroke) International. SITS-Thrombolysis registry, http://www.sitsinternational.org/regis tries/sits-thrombolysis/. 31 May 2016 2. SITS (Safe Implementation of Treatments in Stroke) International. SITS database, https://db.sitsinternational.org/intranet/sitsdata base/sitscountry_IT/sitshospital_VER/. 31 May 2016 3. Ahmed N, Kellert L, Lees KR, Mikulik R, Tatlisumak T, Toni D (2013) Results of intravenous thrombolysis 4.5 to 6 hours and updated results within 3-4.5 hours of onset of acute ischemic stroke recorded in the Safe Implementation of Treatment in Stroke International Stroke Thrombolysis Register (SITS-ISTR): an observational study. JAMA Neurol 70:837-844 4. Wardlaw JM, Murray V, Berge E, Del Zoppo GJ (2014) Thrombolysis for acute ischaemic stroke. Cochrane Database Syst Rev 7(CD000213) - The Safe Implementation of Treatments in Stroke (SITS)Thrombolysis is an internet-based registry, which currently includes more than one hundred thousand thrombolysed patients from about 1400 centers all over the world [1]. As of May 31 2016, 57.8 % of the registered patients resulted functionally independent [modified Rankin Scale (mRS) B 2] at 3 months after intravenous thrombolysis (IVT), but data on 3-month mRS were missing in a significant proportion (24 %) of the registered patients [2]. A recent analysis on 29,618 patients registered in the SITS-Thrombolysis reported functional independence at 3 months in 14,148/23,987 (59 %) patients, and missing data on 3-month mRS in 5631 (19 %) patients [3]. On the other hand, a systematic review of randomized controlled trials (RCTs) on IVT reported a lower proportion of thrombolysed patients (1611/3483, 46.3 %) who were functionally independent at the end of follow-up [4]. We speculate that missing data in observational studies are responsible of overestimation of the proportion of patients with 3-month mRS B 2 after IVT. We analyzed data prospectively collected from 207 consecutive stroke patients treated with IVT at the Stroke Unit, Azienda Ospedaliera Universitaria Integrata Verona, from January 1 to December 31, 2015. Since a significant proportion of patients (29 %) did not attend the 3-month scheduled follow-up visit or telephonic interview, we went to the missing patients’ residence to assess 3-month mRS and we were able to get data from 54/60 (90 %) missing patients. Of these patients only 20/54


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Missing data on 3-month modified Rankin Scale may influence results of functional outcome after intravenous thrombolysis in observational studies, Journal of Thrombosis and Thrombolysis, 2016, DOI: 10.1007/s11239-016-1392-x