In the context of China’s health system, performing a complete informed consent procedure is necessary for any emergency.11,12 However, a study that explored the factors of delay in D2B time among the Asian population showed that the failure to provide timely informed consent was one of the predictors of prolonged D2B time, which commonly occurs in China and India.11 That is because prolongation of informed consent procedure would delay the activation of catheterization laboratory, further impacting D2B time. To our knowledge, this is the first quantitative research that analyses nationally representative data to explores the factors associated with informed consent delay in patients with STEMI. The findings of our study could be worthwhile for an improvement in STEMI care.
One of our principal findings is that informed consent delay was significantly associated with the prolongation of D2B time, namely in-hospital delay. This finding is compatible with other studies.11,23,24 In our study, approximately half of the patients postponed consent, and D2B time was prolonged over 10.0 minutes when the delay occurred. Shavadia et al., point out that every 10-min delay in initiating catheterization correlates with increasing door-to-device time,23 which would make D2B time far away from the recommended time of 90 minutes. This would inevitably give rise to a longer delay of PCI, because with the postponement of consent, patients might get worse, meaning that PCI needs more time. Thus, it highlights the importance of informed consent time related to pre-activation of catheterization laboratory.
In clinical practice, Chinese doctors are merely responsible for the provision of medical information, while patients are left alone to make decisions. 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.18 Furthermore, clinicians should join patients in decision-making, to help patients quickly make better understand the emergency and risks, to induce patients to quickly make an optimal choice. To improve the informed consent procedure, it is advisable to give more weight to humanistic training in medical education, such as communication skills and professionalism.12
Moreover, the results suggested that sustainable chest pain, intermittent chat pain and dyspnea were significantly related to informed consent delay, which contributed to an increase in delay times. As they are non-typical symptoms of STEMI that seem not to critically endanger the patients, they might be considered less risky. Patients and their relatives, therefore, tend to spend more time in making decisions. Inversely, cardiogenic shock, heart failure, malignant arrhythmia and cardiac arrest, which are typical symptoms of STEMI, were proven to have no significant correlations with informed consent delay time. This indicates that if patients were in more serious conditions, they would less likely to delay informed consent. From the perspective of patients and their relatives, these clinical manifestations are more threatening so that there were no statistically significant differences between patients with and without such typical symptoms. Furthermore, it was observed that once there was a postponement among patients with these symptoms, the delay time of them is much longer than that of patients whose condition is not so critical. One reason for it is that the higher the level of emergency, the greater the risks involved in a medical intervention responding to it. Therefore, patients and their relatives need more time to evaluate the risks and give consent. There may be an urgent need for the patients to recognize the diversity of STEMI manifestations and the benefits of timely reperfusion. Regardless of the severity of the disease, early reperfusion increases treatment effectiveness. Physicians have to emphasize the time-sensitive nature of STEMI therapy while providing medical information to patients or their relatives.
Compared with EMS, other transport modes significantly lengthen the informed consent delay time. As for patients who walk into hospitals, it is presumed that their condition was relatively stable or their symptoms were less typical and critical, resulting in a lower risk consciousness to the disease.26 Additionally, patients who called for an ambulance had pre-hospital communication with healthcare workers about the conditions and treatment. As a result, it takes less time to understand PCI therapy and its risks when they were in the hospitals, indicating that it would bquicker to obtain their consent. Concerning patients who were transferred into hospitals, they had gone through the process of discharge and re-admission. Such patients had already experienced a long period of early delay, high time cost and high cost of making risky decisions,27,28 which may lead to hesitations in signing informed consent. It may also be because the symptoms of these patients were more serious, once there was a delay in informed consent obtaining, the delay time is much longer, given that patients and their relatives need more time to evaluate the risks and give consent. As for patients who had onset in the hospitals, their conditions were more complex, since they might have comorbidities and complications. This required them to sign multiple informed consent forms, causing a prolongation in doctor-patient communication and slowness in signature.
Hence, to shorten the informed consent delay time amongst patients whose transport modes were walk-in, transferred-in and in-hospital onset, several suggestions are offered. First, raising the risk consciousness of patients is fundamental. Clinicians should explain the information clearly in a way that patients could understand the message they acquire and allow them to realize the importance of timely reperfusion. Showing empathy is crucial to enable the patients to feel like more than just a number them, and to increase their confidence in the physicians.18 Second, strengthening collaboration among different healthcare institutions could be beneficial to omit overlapped processes for medical history taking. Once patients decide to transfer to another hospital, the transfer-out hospital should take the initiative to contact the transfer-in hospital and inform the patient’s conditions. It is warranted to develop incentive mechanisms for care coordination between different healthcare institutions,28 and government support would play an important role in intensifying the care coordination within healthcare system.24 Last, enhancing cooperation among different departments of hospitals is also recommended. In this way, times spent in the repetitive collection of medical information from the patients with comorbidities and complications could be saved.
What is noteworthy, patients aged 35–64 years were less likely to have informed consent delay than those aged 18–34 years. Owing to special social culture of China, the major consent signers are not patients but their relatives.11 Chinese value the opinions of the whole family, while it is generally difficult for family members to achieve consensus in a limited time,17 which influences the informed consent obtaining. Nevertheless, the group of 35–64 years old may be prone to having comparatively greater autonomy that make their own decisions, meaning that the time taken to reach an agreement among their families is shorter than other groups. Further research is needed to explore the differences in informed consent procedures among STEMI patients with different demographic characteristics.
In addition, the impact of informed consent delay on in-hospital mortality is not dominant, which is compatible with prior studies.29,30 However, a large number of previous studies have confirmed that D2B time is positively correlated with in-hospital mortality. 4,9,23,31In our study, the informed consent delay positively correlated with D2B time, which still indirectly reflects the effect of informed consent delay on in-hospital mortality to a certain extent. However, in-hospital mortality of STEMI patients depends on multiple factors,30,32 such as demographics, severity of coronary disease, medical history, technical access, postoperative complications. Thus, it is unconvincing to independently explore the association between informed consent delay and in-hospital mortality. Follow-up studies with prospective randomized studies are warranted to confirm the net effect of informed consent delay on in-hospital mortality.
Several limitations should be considered. First and foremost, as limited access to patients’ information, other social-demographic factors, such as medical history, economic status, educational attainment, were not analyzed. Still though, previous qualitative studies have investigated the contribution of these elements to informed consent delay. Besides, it is believed that data available in CPC Database were utilized in maximum to predict the factors related to informed consent delay. Second, although under-aged participants occupy a certain proportion and may exert an influence on the results, they were excluded from the study. The informed consent procedure of under-aged patients is rather complex as their relatives can be surrogate signers. Their condition requires a separate discussion. Last, regional differences in information disclosure, catheterization laboratory activation processes and PCI therapy and their influence on consent obtaining timing and clinical outcomes were not evaluated within our analysis. In the process of medical treatment, there are inevitably differences between accredited CPCs hospitals. Nevertheless, our study represents hospitals from multiple geographic regions, which could minimize the bias resulted from disparities, ensuring the reliability of our findings.