Patients’ informed consent to medical services in Georgia

Introduction

Before a doctor provides any medical service to a patient (diagnostics, therapy, prophylaxis), his/her informed consent should be obtained. Informed consent requires a patient to be told and to understand the purpose, benefits and potential risks of a medical or surgical intervention and to then agree to receive the treatment. Informed consent generally requires the patient or responsible party to sign a statement confirming that they understand the risks and benefits of the procedure or treatment. ¹

A doctor should provide a patient with complete information on his/her disease as well as all possible methods of treatment; the patient retains the right to choose a medical treatment method or to refuse treatment. Even if patient’s opinion differs from that of a doctor, the doctor has to act in accordance with the patient’s decision. This paradigm is called ‘informed consent’; however, there is also a term called ‘shared decision-making between professional and patient’.^2,3

Formalised in 1948, the Universal Declaration of Human Rights recognises the inherent dignity and the equal and inalienable rights of all members of the human family. ⁴ Patients are an important issue for the health system, ⁵ and governments are required to implement various regulations. In this context, a need for the maximum awareness of patients is usually emphasised in the regulating rules which must reflect the fundamental principles of medical ethics where one of the key matters is a patient’s informed consent. ⁶

A requirement for patient’s consent to medical intervention was first formed in the 18th century in Great Britain. The term ‘voluntary consent’ appeared first during the late 1940s upon completion of the Nuremberg trials where voluntary participation in medical experiments was emphasised. ⁷ The Nuremberg Code (published in 1947) was expanded to establish a standard, which condemned Nazi scientists and doctors at the Nuremberg trials. Some authors believe that the term informed consent was first introduced into the judicial lexicon in 1957 in the written opinion of an appellate judge in California, ⁸ when a patient became disabled after he had been subjected to trans lumbar aortography. The patient applied to court and won: the court established that had the patient been informed of the complication he would not have consented to the procedure; therefore, his consent was not informed.

Informed consent replaces the traditional paternalistic doctor-patient relationship which governed the relationship between doctors and patients worldwide; the doctor decided the best choice for the patient and took full responsibility. The patient had a passive role, namely to follow advice and instructions given by the doctor. This has since been replaced by the ideal of informed consent by the patient, implying a joint decision when opting for treatment; patients and doctors share responsibility for patients’ health choices. Informed consent is important not only ethically and legally it also improves the care quality, patients’ understanding and cooperation and achieves better results and reduces errors.^9–12 A patient’s understanding of the procedure and possible complication also improves satisfaction, ¹³ trust between patients and health providers, and minimises litigation for medical procedures. ¹⁴

In clinical practice, important ethical problems arise when informed consent is not obtained properly or at all. Negligently failing to obtain informed consent is probably the most commonly breached fundamental patient’s right.

Studies show that, in some cases, patients who have ‘consented’ had no appropriate information on the medical service to be provided, so it was no more than a formality.^15–17

Surgery (a legalised battery) arguably requires a more rigorous informed consent process to achieve shared decision-making because the risks are higher compared with general medical care. This study aims to identify current problems and offers some solutions.

Methodology

This was a cross-sectional study conducted at three major hospitals in Tbilisi (Georgia). Responders were interviewed using a semi-structured questionnaire which was developed based on a review of relevant literature. It started on 15 October 2017 and ended on 25 December 2017. Surgical patients from major hospitals in Tbilisi were selected: 200 patients who had undergone surgery were enrolled. Interviews lasted about 30–45 min. The main limitation is that the survey was conducted only in Tbilisi due to lack of time. For statistical analysis of study data, SPSS was used and univariational and frequency cross-tabulation analysis was performed.

Social and demographic characteristics of the patients are represented in Table 1. Of the total in the study (n = 200), 68% (n = 136) were male. The largest group of patients by age was > 60 years (33%; n = 66). The majority of responders were married (69%, n = 138), with higher education (66%, n = 132). 43% were employed (n = 86).

OPEN IN VIEWER

Table 1.

Social and demographic characteristics of the patients.

	n	%
Gender
Male	136	68
Female	64	32
Age
18–30	10	5
31–40	28	14
41–50	42	21
51–60	54	27
60 and above	66	33
Marital status
Married	138	69
Single	30	15
Divorced	10	5
Widow	22	11
Education
Higher (University)	132	66
Incomplete Higher (University)	16	8
School	52	26
Incomplete school	0	0
Employment
Employed	86	43
Unemployed	44	22
Pensioner	70	35

Ethical issues of the study

The study was approved by the Ethics Committee of the Ilia State University. Research was carried out in accordance to ethical principles of scientific research, the Declaration of Helsinki. Prior to being involved in the survey, the selected individuals were given the informed consent forms and provided verbal consent to participate. The participants could choose to leave the survey at any time.

Results and discussion

The study found that all surgical patients (100%) stated that they had signed an informed consent form to express their consent to have any type of treatment during a period of hospitalisation. It demonstrates that patients regard the informed consent form as good, but just signing the informed consent form will not always mean that he/she is sufficiently informed by the doctor and is completely aware of his/her illness as well as the proposed surgical intervention, and this does not comply with medical ethics which require a patient to be informed on his/her health status as well as the planned interventions to the extent he/she is able to understand this, in compliance with a patient’s rights and professional ethics.

A patient’s education about the diagnosis and methods of treatment of disease is the responsibility of the doctor. According to our study, 74% (n = 148) of patients stated that they were informed about surgery by their physician, while 26% (n = 52) of patients stated that they had been informed by physicians and nurses. Other studies show that information on interventions is mainly given by the physician. ¹⁸

When the patients were asked to write the name of the disease, only 56% (n = 112) knew their diagnosis for which they had been hospitalised, 44% (n = 88) did not know their precise diagnosis, and only 34% (n = 68) did not know what surgical intervention was planned (Table 2). This can be explained by the fact that most patients were highly educated to university level (66%, n = 132). Other studies show that the better educated patients were likely to be more correctly informed. ¹⁹

OPEN IN VIEWER

Table 2.

Answers to the questions of the patients.

	n	%
I signed a document to allow all kinds of treatments during the hospitalisation
Yes	200	100%
No	0	0
Who informed you about your surgery?
Physician	148	74
Nurse	0
Nobody gave information	0
Physician + Nurse	52	26
Please write the name of your condition
Knows	112	56
Does not know	0
Does not know exactly	88	44
Please write the name of the intervention
Knows	88	44
Does not know	44	22
Does not know exactly	68	34

When asked why informed consent from patients is necessary, most of them (78%) answered that it contributed to raising a level of trust between patients and doctors, and 91% of patients said informed consent would help to avoid potential risks. Furthermore, many patients believed that doctors were obliged to provide maximum information to patients (94%).

Of all the patients, 57% (n = 114) stated that they had received sufficient information on their diagnosis and methods of treatment. However, 26% (n = 52) of responders agreed only in part; 62% (n = 124) of patients received sufficient information on the need for surgery. Most (66%, n = 132) were adequately informed on the risks and benefits of alternative ways of treatment. Other studies show that only 73.9% of respondents were informed about the availability (or lack thereof) of alternative treatment options. ²⁰

In our study, 61% (n = 122) of the patients received sufficient information on duration of surgery; 58% (n = 116) of patients received sufficient information on potential risks during surgery; 67% (n = 134) of patients received sufficient information on potential risks after surgery; 59% (n = 118) of patients received sufficient information on post-surgery treatment; 68% (n = 136) of patients received sufficient information on duration of post-surgery hospitalisation (Table 3).

OPEN IN VIEWER

Table 3.

The answers of the patients participating in the study in the scope of the informed consent.

	Yes		Partially agree		No
	n	%	n	%	n	%
I was given sufficient information about the diagnosis and the treatment of my condition after the hospitalisation	114	57	52	26	34	17
I was given sufficient information that my problem could be solved by surgical treatment (surgery)	124	62	56	28	20	10
I was given sufficient information about the alternative treatment options to surgery and the benefits and the risks	132	66	50	25	18	9
I was given sufficient information about the time of the intervention	122	61	46	23	32	16
I was given sufficient information about the risks of this surgical intervention	116	58	42	21	42	21
I was given sufficient information about the probable risks after this surgical intervention	134	67	56	28	10	5
I was given sufficient information about the postoperative care	118	59	66	33	16	8
I was given sufficient information about the length of hospital stay after this surgical intervention	136	68	52	26	12	6

Certainly, treatment processes will be more effective when patients are fully informed before any surgical intervention. Doctors are obliged to explain to patients details of the surgical intervention, complications related to post-surgical periods, expected outcomes and expectations.

Sometimes a patient gives doctors a vote of confidence and signs an informed consent document only formally. In such cases, doctors are responsible for providing patients with all information in a manner that is understandable to avoid any false expectations that can lead to future complications at different stages of treatment.

Patient’s full awareness will deepen the confidence between doctors and patients and help patients to achieve a successful outcome. In order to reach the goals, it is necessary to raise the level of awareness of both doctors and patients.

With regard to the post-surgery period, long-lasting hospitalisation and rehabilitation process, patients were only partially informed (50%, 52% and 55%, respectively) indicating that understanding of post-surgery issues is lower in patients than pre-surgery issues, which means that doctors are more sensitive before surgery and with regard to any complications during surgery as compared with later.

Conclusion

The study shows that it is a precondition for patients to be adequately informed in order to participate in decision-making regarding their health, but that there are problems with the patient information processes. Informed consent administration for surgical care is still inadequate. Although it is difficult to achieve patients’ informed consent and complete understanding in practice, it is necessary to provide it. When conveying information to patients, more attention should be paid to raising their level of awareness. Patients need to be better informed about different treatment options, consequences of treatment refusal, costs of not continuing treatment and follow-ups after refusal of treatment. Doctors have to provide information to patients in a manner that is understandable to them. To achieve this goal, both verbal and other methods should be used including visual, videos and photographs, and medical personnel need to be better educated as to what constitutes informed consent and the importance of adhering to such requirements.