A retrospective observational study to investigate the effect of frailty on outcomes of older adults admitted with major trauma.

A protocol for a retrospective observational study to investigate the effect of frailty on outcomes of older adults admitted with major trauma. Patient data will be examined held within the Trauma and Audit Research Network (TARN) database, from 23 Major Trauma Centres in England, between April 2019 and March 2020. The two research questions are: 1) Is there any association between frailty and clinical outcomes in older people admitted with serious traumatic injuries? 2) Is there any association between a geriatrician review and clinical outcomes in an older people admitted with serious traumatic injuries? Patients 65 years old or over will be included. The primary outcome will be mortality as measured by time from hospital admission to death. Secondary outcomes will include day 30 mortality, post injury complications, and length of hospital stay. A mixed-effects multivariable Cox proportional hazards model will be used to analyse the data. A statistical analysis plan has been produced separately for each research question. 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 requirement. 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 publically 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. For and on behalf of the Study Sponsor O_TBL View this table: org.highwire.dtl.DTLVardef@18e4ccforg.highwire.dtl.DTLVardef@154e654org.highwire.dtl.DTLVardef@ddbe83org.highwire.dtl.DTLVardef@69943org.highwire.dtl.DTLVardef@1380f28_HPS_FORMAT_FIGEXP M_TBL C_TBL Key Study Contacts O_TBL View this table: org.highwire.dtl.DTLVardef@16b3beeorg.highwire.dtl.DTLVardef@12bb41forg.highwire.dtl.DTLVardef@3e6700org.highwire.dtl.DTLVardef@dc71c0org.highwire.dtl.DTLVardef@b00e56_HPS_FORMAT_FIGEXP M_TBL C_TBL Study Summary O_TBL View this table: org.highwire.dtl.DTLVardef@7d43f1org.highwire.dtl.DTLVardef@1f7bce9org.highwire.dtl.DTLVardef@1937d99org.highwire.dtl.DTLVardef@1ae13corg.highwire.dtl.DTLVardef@b95026_HPS_FORMAT_FIGEXP M_TBL C_TBL Plain Language SummaryThe majority of major injuries admitted to hospital are now in older people, with a fall from standing height being the most common reason for injury. Our study will look at older adults admitted to hospital with serious traumatic injuries across England and Wales. It will aim to work out firstly if there is an effect of frailty on peoples survival after injury. Frailty is the reserve a person has to cope with illness and is a measure of a person slowing down over time usually due to the collection of lots of health problems. Secondly, we will look at if being seen by an old age specialist (geriatrician) has an effect on a persons chances of surviving their injuries. The records we will look at are held collected routinely and held by a national database run by the Trauma and Audit Research Network (TARN) from the University of Manchester. They collect information from the 23 centres of major trauma excellence around the country and help researchers to work with them to access the anonymous data for specific research questions. We aim to use these results to help clinicians and health systems to improve how the fund and deliver care for older people. Funding and Support in Kind O_TBL View this table: org.highwire.dtl.DTLVardef@3d04b3org.highwire.dtl.DTLVardef@1ffbb49org.highwire.dtl.DTLVardef@60c2f4org.highwire.dtl.DTLVardef@9f54a8org.highwire.dtl.DTLVardef@6ee811_HPS_FORMAT_FIGEXP M_TBL C_TBL Role of Study Sponsor and FunderNorth Bristol Trust R&I - supporting the development of this work. No direct influence in any part of the work. TARN - supporting development of the work. Will have input into the development, analysis and write-up of the work. Study Steering Group O_TBL View this table: org.highwire.dtl.DTLVardef@145cceeorg.highwire.dtl.DTLVardef@1913ebcorg.highwire.dtl.DTLVardef@add06corg.highwire.dtl.DTLVardef@14ea160org.highwire.dtl.DTLVardef@144bacf_HPS_FORMAT_FIGEXP M_TBL C_TBL Protocol Contributors O_TBL View this table: org.highwire.dtl.DTLVardef@144a207org.highwire.dtl.DTLVardef@e9899aorg.highwire.dtl.DTLVardef@4907fcorg.highwire.dtl.DTLVardef@ab63cdorg.highwire.dtl.DTLVardef@253c97_HPS_FORMAT_FIGEXP M_TBL C_TBL No patients were involved in the development of the protocol. Study Flow Chart O_TBL View this table: org.highwire.dtl.DTLVardef@ace3bborg.highwire.dtl.DTLVardef@9b3b92org.highwire.dtl.DTLVardef@1642b13org.highwire.dtl.DTLVardef@1481209org.highwire.dtl.DTLVardef@983589_HPS_FORMAT_FIGEXP M_TBL C_TBL Study ProtocolA retrospective observational study to investigate the effect of frailty on outcomes of older adults admitted with major trauma.