In the context of China and other Asian countries (e.g., India), performing a complete informed consent procedure is necessary for any emergency.11,12 Although a prior study revealed the common occurrence of failure to provide timely informed consent in these countries,11 there is less evidence regarding the modifiable factors associated with informed consent delay, which restricts the potential to reduce delays in emergency treatment. Taking advantage of a nationally representative population-based retrospective cohort, we were able to identify significant factors associated with the informed consent delay time in patients with STEMI, including older age, minority ethnicities, unemployment, a married status, URBMI, atypical symptoms, comorbidities, and transfer modes of EMS, transfer-in, and in-hospital onset. Despite adjustment for covariates, we observed that prolongation of the informed consent procedure was positively associated with the door-to-balloon time.
We explored the potential mechanisms underlying the association between the significant factors and informed consent delay. We found that informed consent delay was more likely to occur in older patients, which is consistent with a previous study.25 Because of the special social culture in China, the major consent signers are not patients but their relatives.11 Even relevant laws and regulations do not stipulate that medical personnel should obtain consent from the patients themselves first.22 Instead, family members are commonly given equal or greater right to providing informed consent as that given the patients.22 As a deep-rooted system of philosophy, Confucianism subtly steers Chinese people to more highly value the opinions of the whole family than of the individual.12 Older patients usually come to the hospital with their relatives, and the relatives make decisions on behalf of the patients. However, it is generally difficult for family members to achieve consensus within a limited time,13,26 which influences the informed consent delay. This difficulty can be attributed to deteriorating doctor–patient relationships and other patient-related factors,23,31 such as a low socioeconomic level (e.g., low education attainment and unemployment). Moreover, older patients might have other comorbidities, causing their relatives to require a long time to assess the risk of treatment before making a decision. This is supported by our study in that patients with STEMI who had comorbidities were more likely to have informed consent delay.
Our study also showed that compared with single patients with STEMI, married patients had a higher likelihood of deferring consent. As mentioned above, medical decisions are usually made by patients’ relatives in China. Married patients’ own family members and their spouse’s family members generally make decisions together. In such cases, disagreement more frequently occurs, resulting in a delay in obtaining informed consent.32 Further exploration of how patients’ marriage status influences the informed consent procedure is warranted.
Our results showed that patients of ethnic minorities were more likely to have delayed informed consent compared with ethnic Han patients. This is in line with a report from the American National Cardiovascular Data Registry, which found that treatment delays among non-English-speakers were caused by not providing consent in a timely manner because of culture bias and language barriers.25 Because most patients of ethnic minorities in China speak their own language rather than Mandarin, they might have difficulties in communicating with healthcare workers. Minority culture is also an indispensable factor that contributes to patients’ preferences and influences their decision-making.25 It is advisable to use simple and everyday language while informing patients of ethnic minorities. Undoubtedly, determining the reason behind patients’ hesitation is important to guide them to quickly make decisions.
In terms of medical insurance, patients who had URBMI more frequently had delayed informed consent. Patients with URBMI are urban residents, indicating that their socioeconomic level and understanding of disease might be better than that of patients with NRCMS, who are more rural. As a result, patients with URBMI may have a strong sense of self-determination and prefer to spend time thinking independently. In addition, medical paternalism, in which priority is given to the physician’s decision, is more prevalent among rural populations. Informed consent procedures involve patients and medical personnel, and shared decision-making is ideal for both parties; emergency care patients are in even greater need of physicians’ expertise. The present findings implicate that physicians should respect patients’ autonomy and join in decision-making rather than be a complete bystander or dominator.
Moreover, our results suggested that intermittent chest pain and chest pain relief were positively associated with the informed consent delay time. Because these are atypical symptoms of STEMI that do not seem to critically endanger patients, they might be considered less risky. In fact, patients with life-threatening manifestations require immediate emergency treatment, and preparation for such treatment could be started early before the informed consent signature is obtained. Thus, patients and their relatives tend to spend more time evaluating risks and giving consent. This finding is of practical significance in the sense that regardless of the severity of the disease, early reperfusion increases treatment effectiveness; it also provides suggestive evidence that physicians should help patients to recognize the diversity of STEMI manifestations and the benefits of timely reperfusion while providing medical information to the patients or their relatives.
Compared with walk-in, other transport modes significantly lengthened the informed consent delay time. A possible explanation is that patients who arrive at the hospital by EMS may have a relatively serious condition, resulting in a longer discussion to assess the risk of PCI therapy. Patients who are transferred to hospitals have already undergone the process of discharge and readmission. Such patients have already experienced a long period of early delay and a high cost of time and making critical decisions,33,34 which may lead to hesitations in signing informed consent. Additionally, because these patients’ symptoms are more critical and acute, the overall delay time is much longer once a delay in obtaining informed consent has occurred given that patients and their relatives need more time to evaluate the risks and give consent. The situations of patients with in-hospital onset are more complex because they might have comorbidities and complications. This requires them to sign multiple informed consent forms, prolonging doctor–patient communication and slowing obtainment of the signature.
Hence, several suggestions to shorten the informed consent delay time among patients whose transport modes are EMS, transfer-in, and in-hospital onset are offered as follows. First, raising the patients’ risk consciousness is fundamental. Clinicians should explain the information clearly in a way that patients can understand and allow them to realize the importance of timely reperfusion. Showing empathy is crucial to relieve their pressure and anxiety and increase their confidence in the physicians.23 Second, strengthening collaboration among different healthcare institutions could be beneficial to omit overlapping processes of medical history-taking. Once a patient has decided to transfer to another hospital, the transfer-out hospital should take the initiative to contact the transfer-in hospital and inform them of the patient’s condition. The development of incentive mechanisms for care coordination between different healthcare institutions is warranted,34 and government support would play an important role in intensifying the care coordination within the healthcare system.31 Finally, enhancing cooperation among different hospital departments is also recommended. This could help to reduce the time spent in repetitive collection of medical information from patients with comorbidities and complications.
In clinical practice, Chinese doctors are merely responsible for the provision of medical information, whereas patients are left alone to make decisions. 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.23 Again, clinicians should join patients in decision-making, help patients quickly understand the emergency and its risks, and induce patients to make an optimal choice within a limited time. 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.14
Another principal finding is that informed consent delay was significantly associated with prolongation of the door-to-balloon time, which potentially led to poor clinical outcomes.5,8,35,38 This finding is compatible with other studies.11,31,32 Shavadia et al.35 reported that every 10-minute delay in initiating catheterization was correlated with an increase in the door-to-device time, which lengthened the door-to-balloon time far beyond the recommended time of 90 minutes. This would inevitably give rise to a longer delay of PCI because with the postponement of consent, patients’ condition might worsen, resulting in a longer time required to complete PCI. This highlights the importance of the association between the informed consent time and pre-activation of the catheterization laboratory. Nonetheless, follow-up prospective randomized studies are warranted to confirm the net effect of informed consent delay on clinical outcomes.
Several limitations of this study should be acknowledged. First, because of limited access to patients’ information, we did not analyze other sociodemographic factors such as economic status and educational attainment. However, previous qualitative studies have investigated the contribution of these elements to informed consent delay. Additionally, we believe that the data available in the Database were maximally utilized to predict the factors related to informed consent delay. Second, although underage patients (< 18 years of age) constitute a certain proportion and may exert an influence on the results, they were excluded from the study. The informed consent procedure of underage patients is rather complex because their relatives can be surrogate signers. Their condition requires a separate discussion. Finally, regional differences in factors associated with a delayed informed consent time were not evaluated within our analysis. Nevertheless, our study employed generalized linear mixed models with a random-effect term for hospitals across geographic regions to account for clustering of hospitals, which may have minimized the bias resulting from disparities in regions and thus ensuring the reliability of our findings.