Informed consent for invasive procedures in the emergency department

Feinstein, Max M.; Adegboye, Janet; Niforatos, Joshua D.; Pescatore, Richard

doi:10.1016/j.ajem.2020.01.035

Cited by 9 publications

(16 citation statements)

References 21 publications

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“…Preserving the rights and welfare of patients is at the forefront of human subjects protections in trauma research 18. Traditional informed consent indicates that adequate dialogue has occurred between a potential participant and a researcher 19–21. However, previous trauma research demonstrates that severely injured trauma patients can seldom provide consent at the time of injury, and an LAR is often unavailable, in which case EFIC is necessary to recruit a representative sample 22.…”

Section: Discussionmentioning

confidence: 99%

Regulatory challenges in conducting human subjects research in emergency settings: the National Trauma Research Action Plan (NTRAP) scoping review

Villarreal

Price

Moreno

et al. 2023

Trauma Surg Acute Care Open

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The complexity of the care environment, the emergent nature, and the severity of patient injury make conducting clinical trauma research challenging. These challenges hamper the ability to investigate potentially life-saving research that aims to deliver pharmacotherapeutics, test medical devices, and develop technologies that may improve patient survival and recovery. Regulations intended to protect research subjects impede scientific advancements needed to treat the critically ill and injured and balancing these regulatory priorities is challenging in the acute setting. This scoping review attempted to systematically identify what regulations are challenging in conducting trauma and emergency research. A systematic search of PubMed was performed to identify studies published between 2007 and 2020, from which 289 articles that address regulatory challenges in conducting research in emergency settings were included. Data were extracted and summarized using descriptive statistics and a narrative synthesis of the results. The review is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. Most articles identified were editorial/commentary (31%) and published in the USA (49%). Regulatory factors addressed in the papers were categorized under 15 regulatory challenge areas: informed consent (78%), research ethics (65%), institutional review board (55%), human subjects protection (54%), enrollment (53%), exception from informed consent (51%), legally authorized representative (50%), patient safety (41%), community consultation (40%), waiver of informed consent (40%), recruitment challenges (39%), patient perception (30%), liability (15%), participant incentives (13%), and common rule (11%). We identified several regulatory barriers to conducting trauma and emergency research. This summary will support the development of best practices for investigators and funding agencies.

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Section: Discussionmentioning

confidence: 99%

Regulatory challenges in conducting human subjects research in emergency settings: the National Trauma Research Action Plan (NTRAP) scoping review

Villarreal

Price

Moreno

et al. 2023

Trauma Surg Acute Care Open

View full text Add to dashboard Cite

show abstract

“…However, because of patients' poor understanding of medical information and fragile trust in clinicians or medical institutions, patients commonly hesitate to make decisions. 19,23 Thus, medical workers should pay attention to their communication skills and avoid medical terminology in the transfer of knowledge. Physicians' expertise, empathy, and respect for patients may help to build trust between them.…”

Section: Discussionmentioning

confidence: 99%

“…According to United States law and the American Medical Association Code of Medical Ethics, clinicians may provide necessary medical care in emergency situations without expressed consent when a patient is incapacitated (i.e., unconscious) and waiting to obtain consent would increase the risk to the life or health of the patient. [16][17][18][19] The National Health Service Constitution for England also states that if a patient is unable to make decisions and does not have a lasting power of attorney but requires emergency treatment to save his or her life, it is lawful to provide treatment without prior consent as soon as the healthcare professionals believe that it is in the patient's best interests. 20 This decision is universally accepted as a "waiver of informed consent" or "exception from informed consent" in emergency care.…”

Section: Introductionmentioning

confidence: 99%

Exploring the delay in the informed consent procedures of patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: Is it worth the wait?

Maimaitiming

Dong

et al. 2022

Preprint

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Objective:To investigated the factors associated with informed consent delay in patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) and the association between the delay and door-to-balloon time. Methods:We conducted a nationally representative retrospective cohort study using patient data reported by hospital-based chest pain centers from 1 January 2016 to 31 December 2020. Results: In total, 257,510 patients were enrolled in the analysis. Mean informed consent delay time was 22.4 minutes, accounting for 39.3% in door-to-balloon time. Older age (≥65 years) was significantly correlated with informed consent delay time (RR: 1.034, p=0.001). Compared with ethnic Han patients, the minority (RR: 1.146, p<0.001) had more likelihood to extend consent giving; compared with patients who were single, longer informed consent time was found in married patients (RR: 1.054, p=0.006). Patients with intermittent chest pain (RR: 1.034, p=0.011), and chest pain relief (RR: 1.085, p=0.005)were more likely to delay informed consent. As for transfer modes, EMS (RR: 1.063, p<0.001), transfer-in (RR: 1.820, p<0.001), and in-hospital onset (RR: 1.099, p=0.002) all had positive correlations with informed consent delay time compared to walk-in. Informed consent delay was significantly associated with prolonged door-to-balloon time (OR: 1.002, p<0.001). Conclusion: Informed consent delay provokes prolongation of emergency treatment delay, which potentially leads to poor outcome of STEMI patients. It is essential to shorten the delay time by identifying and intervening modifiable factors that are associated with shortening the informed consent procedure in China and other countries.

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“…However, due to patients' poor understanding of medical information and fragile trust in clinicians or medical institutions, patients commonly hesitate about making up their minds. 18,25 Thus, it is supposed that medical workers pay attention to their communication skills and avoid medical terminology in the transfer of knowledge. Physicians' expertise, empathy, and respect for the patients may help build trust between them.…”

Section: Discussionmentioning

confidence: 99%

Exploring the Delay in the Informed Consent Procedures of Patients with ST-Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention: Is It Worth the Wait?

Maimaitiming

Dong

et al. 2021

Preprint

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Background Failure to achieve timely informed consent is the most important predictors of prolonged in-hospital delay in China. It is critically serious among patients with ST-elevation myocardial infarction (STEMI), which is the deadliest and most time-sensitive acute cardiac event. Informed consent procedure always begins on ambulance before door still does not complete yet after the catheterization laboratory is ready for percutaneous coronary intervention (PCI), which results in delayed treatment and poor clinical outcomes. This study aimed to investigate the factors associated with informed consent delay in patients with STEMI undergoing PCI, and its influence on in-hospital mortality. Methods We conducted a national-representative retrospective cohort study, drawing patient data reported by hospital-based chest pain centers, of admission between January 2016 and June 2019. Using generalized linear mixed models and negative binomial regression, we estimated factors independently predicting informed consent delay time. The associations of informed consent delay time, door-to-balloon (D2B) time and in-hospital mortality were analyzed by logistic regression, adjusted for patient characteristics. Results A total of 263,219 patients were enrolled in the analysis. Informed consent delay occurred in 44.7% (117,672) patients, of whom the median delayed time was 18.6 minutes (SD = 22.2). Patients with sustainable chest pain (RR: 1.032, p = 0.010), intermittent chest pain (RR: 1.083, p < 0.001), and dyspnea (RR: 1.096, p = 0.001) were more likely to delay informed consent. Among transfer modes, walk-in (RR: 1.165, p < 0.001), transfer-in (RR: 1.122, p < 0.001), in-hospital onset (RR: 1.248, p < 0.001) significantly correlated with extended informed consent delay time. The age of 35–64 years (RR: 0.941, p = 0.010) had a negative association with informed consent delay time. Informed consent delay was significantly associated with prolonged D2B time (OR: 1.148, p < 0.001), whereas there was no significant association between informed consent delay and in-hospital mortality. Conclusion Informed consent delay provokes prolongation of door-to-balloon time, which contributes to in-hospital delay that endangers STEMI patients. For better management of STEMI patients in emergent situations, it is essential to reduce the time of informed consent obtaining through effective patient-physician communication, and care coordination within and between hospitals. Trial registration: Retrospectively registered.

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Informed consent for invasive procedures in the emergency department

Cited by 9 publications

References 21 publications

Regulatory challenges in conducting human subjects research in emergency settings: the National Trauma Research Action Plan (NTRAP) scoping review

Regulatory challenges in conducting human subjects research in emergency settings: the National Trauma Research Action Plan (NTRAP) scoping review

Exploring the delay in the informed consent procedures of patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: Is it worth the wait?

Exploring the Delay in the Informed Consent Procedures of Patients with ST-Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention: Is It Worth the Wait?

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