A long-term prospective cohort study of seriously injured older trauma patients

A protocol for a prospective observational cohort study to investigate the effect of frailty on long-term outcomes in older adults admitted with trauma. Patients aged 65 years and older admitted to the Severn Major Trauma Centre at North Bristol NHS Trust in England between November 2018 and September 2019, will be followed up at 4-years. The objective is to determine if there is an association between Clinical Frailty Scale and mortality at 4 years after admission to hospital with a traumatic injury. The primary outcome will be mortality as measured by time from hospital admission to death. Analyses will be adjusted for other factors shown to be associated with mortality, using a mixed-effects multivariable Cox proportional hazards model. Protocol Version O_TBL View this table: org.highwire.dtl.DTLVardef@1d9f91corg.highwire.dtl.DTLVardef@171baf0org.highwire.dtl.DTLVardef@1a7ed8forg.highwire.dtl.DTLVardef@1dd7752org.highwire.dtl.DTLVardef@c4c732_HPS_FORMAT_FIGEXP M_TBL C_TBL Signature PageThe undersigned confirm that the following protocol has been agreed and accepted and that the Chief Investigator agrees to conduct the study in compliance with the approved protocol and will adhere to the principles outlined in the Declaration of Helsinki, the Sponsors SOPs, and other regulatory requirements. I agree to ensure that the confidential information contained in this document will not be used for any other purpose other than the evaluation or conduct of the investigation without the prior written consent of the Sponsor I also confirm that I will make the findings of the study publicly available through publication or other dissemination tools without any unnecessary delay and that an honest, accurate and transparent account of the study will be given; and that any discrepancies from the study as planned in this protocol will be explained. Chief Investigator O_FIG O_LINKSMALLFIG WIDTH=200 HEIGHT=43 SRC="FIGDIR/small/22278578v1_ufig1.gif" ALT="Figure 1"> View larger version (7K): org.highwire.dtl.DTLVardef@f1c8f0org.highwire.dtl.DTLVardef@1bf3d77org.highwire.dtl.DTLVardef@5c7260org.highwire.dtl.DTLVardef@1591da2_HPS_FORMAT_FIGEXP M_FIG C_FIG Key Study Contacts O_TBL View this table: org.highwire.dtl.DTLVardef@1a8b2deorg.highwire.dtl.DTLVardef@77243dorg.highwire.dtl.DTLVardef@1ec306borg.highwire.dtl.DTLVardef@15ed12corg.highwire.dtl.DTLVardef@1f6c65c_HPS_FORMAT_FIGEXP M_TBL C_TBL Study Summary O_TBL View this table: org.highwire.dtl.DTLVardef@58e1ccorg.highwire.dtl.DTLVardef@1502283org.highwire.dtl.DTLVardef@9f33dorg.highwire.dtl.DTLVardef@14051d1org.highwire.dtl.DTLVardef@1bba966_HPS_FORMAT_FIGEXP M_TBL C_TBL Funding and Support in Kind O_TBL View this table: org.highwire.dtl.DTLVardef@16e9cbeorg.highwire.dtl.DTLVardef@f4a7b6org.highwire.dtl.DTLVardef@2eb8e3org.highwire.dtl.DTLVardef@16c54b7org.highwire.dtl.DTLVardef@12dec59_HPS_FORMAT_FIGEXP M_TBL C_TBL Roles and ResponsibilitiesO_ST_ABSProtocol ContributorsC_ST_ABS O_TBL View this table: org.highwire.dtl.DTLVardef@1f7ced8org.highwire.dtl.DTLVardef@2ccf18org.highwire.dtl.DTLVardef@1d05cdborg.highwire.dtl.DTLVardef@803a13org.highwire.dtl.DTLVardef@64ef18_HPS_FORMAT_FIGEXP M_TBL C_TBL Study Flow Chart O_TBL View this table: org.highwire.dtl.DTLVardef@8d4b54org.highwire.dtl.DTLVardef@4c98e7org.highwire.dtl.DTLVardef@caa572org.highwire.dtl.DTLVardef@33e3e0org.highwire.dtl.DTLVardef@b59fd9_HPS_FORMAT_FIGEXP M_TBL C_TBL