Heather Small, Aaron Ranasinghe, Jorge Mascaro, Robert Bonser,University Hospital Birmingham NHS Foundation Trust

Queen Elizabeth Hospital Birmingham

Introduction� 700,000 patients per annum attend Emergency Department (ED) in

the UK with chest pain

� Commonest 999 call - 30% admissions

� Vulnerable group – sudden onset, pain, anxiety, alone

� Research in ED – ethical dilemmas

Consent to research in the (ED) � Informed Consent (IC)

>24hrs, GCP-ICHGMC ‘no decision about me without me’

� Without IC Autonomy is questionedUnethical practicesHalt novel therapies

� Provisional Consent (PC) <24hrsRelationship - patient Next of Kin

Objective

� To explore the views of patients attitudes to participate in research when being admitted to hospital in the acute phase of chest pain

Methods

� 100 patients previously admitted to the ED with acute Chest Pain

� Cardiology CCU & Cardiac Surgery

� Standardised questionnaire

� Ethics Approval

Questionnaire� Provisional Consent

� Blood Sampling

� Next of Kin

� Lack of Capacity

� Death

� Data

Informed Consent

92% preferred contact for IC during their hospital admission

54% patient only43% patient and NOK

Figure 1

Figure 2

Venesection

� Ninety-three percent of patients supported provisional consent prior blood sample analysis

� 98% accepted storage of samples until IC

� After IC analysis for blood samples for novel biomarkers was acceptable by 97%

• Lack of capacity – 80.4% agreed the researcher could contact their NOK for IC

• Death - Prior to or after IC 78.4% of patients would allow their NOK - IC for analysis of blood samples and review medical notes

Lack of Capacity & Death

Data� 99% content for us access their medical notes – confidential

� 97% supported an ‘expert team’ review scans/x-rays

� 97% agreed to long term outcomes to be tracked via their GP or Office of National Statistics

Summary

� Patients supported research in acute phase of admission with provisional consent and later formal informed consent by themselves or NOK

� Data useful for research in this population of patients

� Patient and Public Involvement

References

� Goodacre S, Cross E, Arnold J, Angelini K, Capewell, The health care burden of acute chest pain.Heat 2005February;91:229-230 doi:10:1136/hrt.2003.027599

� International Conference of Harmonisation – Good Clinical Practice

� Design and implementation of a stand alone chest pain evaluation centre within an academic emergency department .Winchester DE, Stomp D, Shifrin RY, Jois P CritPathw Cardiolo 2012 Sept 11(3): 123-7 doi10:10.1097/HPCOB013e31825d28b9.0

� Rugiomez A, Rodriguez LA, Wallander MA et al,Chest Pain in general practice: Incidence co-morbidity and mortalityFram.PactApr;23(2):167-74.Epub 2006 Feb3

� Clinical research without consent in adults in the emergency setting: A review of patient and public views.Lecoutrier J, Rodgers H, Ford GA, Rapley T, Stobbart Louw SJ,Murtagh MJ,BMC Med Ethics 2008 Apr 29.9.doi10:1186/1472-6939-9