PMID- 36003555
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220826
IS  - 2666-2736 (Electronic)
IS  - 2666-2736 (Linking)
VI  - 6
DP  - 2021 Jun
TI  - Harmonization of adverse events monitoring following thoracic surgery: Pursuit of 
      a common language and methodology.
PG  - 250-256
LID - 10.1016/j.xjon.2021.03.021 [doi]
AB  - OBJECTIVE: Thoracic surgery carries significant risk of postoperative adverse 
      events (AEs). Multiple international recording systems are used to define and 
      collect AEs following thoracic surgery procedures. We hypothesized that a 
      simple-yet-ubiquitous approach to AE documentation could be developed to allow 
      universal data entry into separate international databases. METHODS: AE 
      definitions of the Canadian Association of Thoracic Surgeons (CATS) system and 4 
      international databases were matched and compared. This consisted of reviewing 
      the definition of each AE as described by their respective database and assessing 
      compatibility with the CATS system. We developed a single set of 4 drop-down 
      menus to enable clear classification and facilitated data entry, using 3 
      single-select mandatory lists and 1 multiselect optional list classifying type 
      and severity of these events. RESULTS: The CATS data elements were harmonized 
      (ie, perfect or good) with 100% (European Society of Thoracic Surgeons), 89% 
      (Society of Thoracic Surgeons), 74% (Esophagectomy Complications Consensus 
      Group), and 73% (National Surgical Quality Improvement Program) of respective 
      data elements. The addition of 17 AEs and 2 complication modifiers to the CATS 
      system was implemented to achieve complete harmonization. Consequently, 100% of 
      AE data elements currently included in all 4 international databases are 
      perfectly or well-harmonized with the revised 4-choice drop down menu. 
      CONCLUSIONS: We describe a framework for a ubiquitously applicable approach to AE 
      monitoring following thoracic surgery harmonized with AE definitions of all major 
      thoracic international associations. Use of this AE collection framework allows 
      for comprehensive evaluation of both the incidence and severity of all AEs after 
      thoracic surgery along with quality indicators.
CI  - (c) 2021 The Author(s).
FAU - Sigler, Gregory
AU  - Sigler G
AD  - Division of General Surgery, Department of Surgery, University of Ottawa, Ottawa, 
      Ontario, Canada.
AD  - Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, 
      Canada.
FAU - Anstee, Caitlin
AU  - Anstee C
AD  - Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, 
      Canada.
AD  - Division of Thoracic Surgery, Department of Surgery, University of Ottawa, 
      Ottawa, Ontario, Canada.
FAU - Seely, Andrew J E
AU  - Seely AJE
AD  - Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, 
      Canada.
AD  - Division of Thoracic Surgery, Department of Surgery, University of Ottawa, 
      Ottawa, Ontario, Canada.
LA  - eng
PT  - Journal Article
DEP - 20210402
PL  - Netherlands
TA  - JTCVS Open
JT  - JTCVS open
JID - 101768541
PMC - PMC9390191
OTO - NOTNLM
OT  - AE, adverse event
OT  - CATS, Canadian Association of Thoracic Surgeons
OT  - Clavien-Dindo model
OT  - ECCG, Esophagectomy Complications Consensus Group
OT  - ESTS, European Society of Thoracic Surgeons
OT  - NSQIP, National Surgical Quality Improvement Program
OT  - STS, Society of Thoracic Surgeons
OT  - TM&M, Thoracic Morbidity and Mortality
OT  - adverse event monitoring
OT  - harmonization
OT  - thoracic surgery
EDAT- 2021/04/02 00:00
MHDA- 2021/04/02 00:01
PMCR- 2021/04/02
CRDT- 2022/08/25 02:22
PHST- 2021/03/29 00:00 [received]
PHST- 2021/03/29 00:00 [accepted]
PHST- 2022/08/25 02:22 [entrez]
PHST- 2021/04/02 00:00 [pubmed]
PHST- 2021/04/02 00:01 [medline]
PHST- 2021/04/02 00:00 [pmc-release]
AID - S2666-2736(21)00078-4 [pii]
AID - 10.1016/j.xjon.2021.03.021 [doi]
PST - epublish
SO  - JTCVS Open. 2021 Apr 2;6:250-256. doi: 10.1016/j.xjon.2021.03.021. eCollection 
      2021 Jun.