Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review

Armstrong, Stephanie; Langlois, Adèle; Laparidou, Despina; Dixon, Mark; Appleton, Jason P.; Bath, Philip M; Snooks, Helen; Siriwardena, A Niroshan

doi:10.1186/s12874-017-0423-4

Cited by 19 publications

(21 citation statements)

References 27 publications

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“…Research ethics committees consider that this approach is less stressful and gives more time for potential participants to consider taking part in research 54–56. Gaining consent from patients to participate in prehospital research must recognise the cognitive effect of emergency care 57. Patients’ inability to remember the emergency clearly reinforces the argument that they are unable to give truly informed consent when experiencing the emotional and physical trauma of a crisis.…”

Section: Discussionmentioning

confidence: 99%

Is fascia iliaca compartment block administered by paramedics for suspected hip fracture acceptable to patients? A qualitative study

et al. 2019

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ObjectiveTo explore patients’ experience of receiving pain relief injection for suspected hip fracture from paramedics at the location of the injury.DesignQualitative interviews within a feasibility trial about an alternative to routine prehospital pain management for patients with suspected hip fracture.SettingPatients treated by paramedics in the catchment area of one emergency department in South Wales.ParticipantsSix patients and one carer of a patient who received fascia iliaca compartment block (FICB).InterventionFICB administered to patients with suspected hip fracture by trained paramedics. We randomly allocated eligible patients to FICB—a local anaesthetic injection directly into the hip region—or usual care—most commonly morphine—using audited scratch cards.OutcomesAcceptability and experience of receiving FICB, assessed through interview data. We audio-recorded, with participants’ consent, and conducted thematic analysis of interview transcripts. The analysis team comprised two researchers, one paramedic and one lay member.ResultsPatients had little or no memory of being offered, consenting to or receiving FICB. They recalled the reassuring manner and high quality of care received. They accepted FICB without question. Partial or confused memory characterised experience of subsequent hospital care until surgery. They said their priorities when calling for emergency help were to receive effective care. After hospital treatment, they wanted to regain their health and mobility and resume the quality of life they experienced before their injury.ConclusionsThis study did not raise any concerns about the acceptability of FICB administered at the scene of injury by paramedics to people with suspected hip fracture. It adds to existing evidence about patient and carer experience of on-scene care for people with suspected hip fracture. Further research is needed to assess safety, effectiveness and cost effectiveness of this health technology in a new setting.Trial registration numberNCT60065373.

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Section: Discussionmentioning

confidence: 99%

Is fascia iliaca compartment block administered by paramedics for suspected hip fracture acceptable to patients? A qualitative study

et al. 2019

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“…Manchester University NHS Foundation Trust sponsors the study. Our consent procedure has been informed by prior experience within our national network of ambulance services, initial feedback from patient and public representatives (who have agreed with concern that judgement may be clouded in this acute situation) and the experience of AS in the Wellcome-funded ‘Network Exploring Ethics in Ambulance Trials (NEAT)’ project 13…”

Section: Methods and Analysismentioning

confidence: 99%

PRe-hospital Evaluation of Sensitive TrOponin (PRESTO) Study: multicentre prospective diagnostic accuracy study protocol

et al. 2019

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IntroductionWithin the UK, chest pain is one of the most common reasons for emergency (999) ambulance calls and the most common reason for emergency hospital admission. Diagnosing acute coronary syndromes (ACS) in a patient with chest pain in the prehospital setting by a paramedic is challenging. The Troponin-only Manchester Acute Coronary Syndromes (T-MACS) decision rule is a validated tool used in the emergency department (ED) to stratify patients with suspected ACS following a single blood test.We are seeking to evaluate the diagnostic accuracy of the T-MACS decision aid algorithm to ‘rule out’ ACS when used in the prehospital environment with point-of-care troponin assays. If successful, this could allow paramedics to immediately rule out ACS for patients in the ‘very low risk’ group and avoid the need for transport to the ED, while also risk stratifying other patients using a single blood sample taken in the prehospital setting.Methods and analysisWe will recruit patients who call emergency (999) ambulance services where the responding paramedic suspects cardiac chest pain. The data required to apply T-MACS will be prospectively recorded by paramedics who are responding to each patient. Paramedics will be required to draw a venous blood sample at the time of arrival to the patient. Blood samples will later be tested in batches for cardiac troponin, using commercially available troponin assays. The primary outcome will be a diagnosis of acute myocardial infarction, established at the time of initial hospital admission. The secondary outcomes will include any major adverse cardiac events within 30 days of enrolment.Ethics and disseminationThe study obtained approval from the National Research Ethics Service (reference: 18/ES/0101) and the Health Research Authority. We will publish our findings in a high impact general medical journal.Trial registration numberRegistration number: ClinicalTrials.gov, study ID: NCT03561051

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“…A systematic review of prehospital trials highlighted capacity and consent as being particularly challenging [9]. Patients in the prehospital setting are often incapable of giving consent and are therefore a vulnerable population [3, 10–12].…”

Section: Introductionmentioning

confidence: 99%

“…Due to the complexity of the setting, alternative consent models have been proposed [9]. Surrogate or proxy consent is a common approach whereby the surrogate is asked to act in the ‘best interests’ of the patient [8, 11, 18].…”

Section: Introductionmentioning

confidence: 99%

Ethical considerations in prehospital ambulance based research: qualitative interview study of expert informants

et al. 2019

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BackgroundPrehospital ambulance based research has unique ethical considerations due to urgency, time limitations and the locations involved. We sought to explore these issues through interviews with experts in this research field.MethodsWe undertook semi-structured interviews with expert informants, primarily based in the UK, seeking their views and experiences of ethics in ambulance based clinical research. Participants were questioned regarding their experiences of ambulance based research, their opinions on current regulations and guidelines, and views about their general ethical considerations. Participants were chosen because they were actively involved in, or in their expert capacity (e.g. law) expressed an interest in, ambulance based research.ResultsFourteen participants were interviewed including principal investigators, researchers, ethicists and medical lawyers. Five major themes were identified: Capacity, Consent, Clinical Considerations, Consultation and Regulation. Questions regarding consent and capacity were foremost in the discussions as all participants highlighted these as areas for concern. The challenges and use of multiple consent models reflected the complexity of research in this environment. The clinical theme referred to the role of paramedics in research and how research involving ambulance services is increasingly informing improvements to patient care and outcomes and reducing the burden on hospital services. Most felt that, although current regulations were fit for purpose, more specific guidance on implementing these in the ambulance setting would be beneficial. This related closely to the theme of consultation, which examined the key role of ethics committees and other regulatory bodies, as well as public engagement.ConclusionsBy interviewing experts in research or ethics in this setting we were able to identify key concerns and highlight areas for future development such as improved guidance.

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Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review

Cited by 19 publications

References 27 publications

Is fascia iliaca compartment block administered by paramedics for suspected hip fracture acceptable to patients? A qualitative study

Is fascia iliaca compartment block administered by paramedics for suspected hip fracture acceptable to patients? A qualitative study

PRe-hospital Evaluation of Sensitive TrOponin (PRESTO) Study: multicentre prospective diagnostic accuracy study protocol

Ethical considerations in prehospital ambulance based research: qualitative interview study of expert informants

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