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REVIEW ARTICLE
Year : 2015  |  Volume : 18  |  Issue : 7  |  Page : 46-56

"Because I want to be informed, to be part of the decision-making": Patients' insights on informed consent practices by healthcare professionals in South Africa


Programme of Bio and Research Ethics and Medical Law, School of Nursing and Public Health, Nelson R Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa

Date of Web Publication1-Dec-2015

Correspondence Address:
S C Chima
Programme of Bio and Research Ethics and Medical Law, School of Nursing and Public Health, Nelson R Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban
South Africa
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/1119-3077.170833

Rights and Permissions
   Abstract 


Background: Informed consent (IC) is a legally enforceable right in South Africa based on constitutionally protected rights to bodily integrity and well-being. In terms of the law, patients cannot be involved in medical treatment or research without IC. Healthcare providers must inform patients about diagnosis, risks, benefits, treatment options, and right of refusal in a language patients understand based their literacy level. This study reports an empirical study on patients' perceptions of IC as practiced by doctors and nurses in South Africa.
Materials and Methods: A cross-sectional study, using a bilingual semi-structured questionnaire was conducted among patients attending randomly selected public hospitals in eThekwini Metropolitan Municipality (Durban), KwaZulu-Natal province. Competent patients or legal surrogates were eligible for inclusion. IC was obtained from all participants.
Results: Four hundred and four participants completed questionnaires of which 68% were female. The median age of participants was 35 years (range 11–91 years). Most respondents spoke IsiZulu (55%), were single (56%), unemployed (66%), and with secondary school education (69%). Patients were generally informed about the diagnosis (81%), risks (57%), and benefits of treatment (61%). Few were informed about treatment options (41%), recommended treatment (28%), and right of refusal (25%). IC was obtained verbally in 73% of cases. Patients favored disclosure of all material risks (78%) and few consulted surrogates before decision-making (76%). There was an association between participant's age and knowledge of the age of consent (P = 0.005). Most patients were satisfied with information disclosed (91%) and did not feel coerced. Some were afraid to ask questions for fear of losing free treatment (8%).
Conclusion: This study reveals that South African patients are aware of the right to IC, but many were vulnerable due to indigence. Barriers to IC include poverty, language, and low educational level. South African patients prefer disclosure of all material risks, better communication skills by healthcare workers, and a shift toward informed or shared healthcare decision-making.

Keywords: Africa, doctors, healthcare decision-making, hospitals, informed consent, insights, nurses, patients


How to cite this article:
Chima S C. "Because I want to be informed, to be part of the decision-making": Patients' insights on informed consent practices by healthcare professionals in South Africa. Niger J Clin Pract 2015;18, Suppl S1:46-56

How to cite this URL:
Chima S C. "Because I want to be informed, to be part of the decision-making": Patients' insights on informed consent practices by healthcare professionals in South Africa. Niger J Clin Pract [serial online] 2015 [cited 2020 Aug 8];18, Suppl S1:46-56. Available from: http://www.njcponline.com/text.asp?2015/18/7/46/170833




   Introduction Top


The above direct quotation from a patient (because I want to be informed; to be part of the decision-making); desiring full disclosure prior to giving consent to medical treatment, reflects the changing face of modern medical practice from the paternalistic notion of "doctor knows best" to informed or shared decision-making. According to other patients:

"Because I want to know what the options are, and weigh them myself."

"Because I want to know what is going to happen or why; I also look up info on the internet." These statements from knowledgeable and inquisitive patients who approach healthcare professionals imbued with consumer rights, rather than passive recipients of benevolent healthcare, has made contemporary medical practice a more contested and ethically challenging enterprise.

According to the World Medical Association:[1]

Until recently, physicians generally considered themselves accountable only to themselves, to their colleagues in the medical profession and for religious believers, to God. Nowadays, they have additional accountabilities to their patients, to third parties such as hospitals and managed healthcare organizations, to medical licensing and regulatory authorities, and often to courts of law. These different accountabilities can conflict with one another.

Due to recent controversies surrounding the ethics of healthcare decision-making, a central dilemma has arisen in modern medical practice which can be summarized as whether the principle of respect for autonomy should have priority over professional beneficence?[2] It has been argued that persistence with professional beneficence by doctors creates a culture of medical paternalism which does not fully respect patients' autonomy.[3] In these situations, the ethical principles of beneficence and respect for autonomy may conflict with one another, thereby creating a tension in the doctor-patient relationship.[1],[2],[3] To promote patients' autonomy it has been advocated by common law cases such as Canterbury v Spence [4] that:

The patients' right to self-determination can be effectively exercised only if the patient possesses enough information to enable an intelligent choice. True consent to what happens to one's self is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each… From these almost axiomatic considerations springs the need, and in turn the requirement, of a reasonable divulgence by physician to patient to make such a decision possible.

In view of the above, informed consent (IC) has become the legal and ethical "standard of care" for medical practice since the late 20th century. More recently, others have argued for shared decision-making rather than informed decision-making. Distinguishing informed decision-making as "an individual's overall process of gathering relevant information from both the clinician and other clinical and nonclinical sources with or without independent clarification of values."[5]

Whereas shared decision-making may be defined as a particular process of decision-making by the patient and clinician in which the patient:

  • Understands the risk or seriousness of the medical condition
  • Understands the medical procedure including the risks, benefits, alternatives, and uncertainties
  • Has weighed his or her personal values regarding the potential benefits and harms associated with the healthcare service
  • Has engaged in decision-making at a level at which he or she feels comfortable, and finally
  • Has come to a joint decision in association with the healthcare provider'. Advocates of shared decision-making argue that it promotes patient comprehension and autonomy, reduces unwanted medical procedures and malpractice claims, improves patient compliance, and decreases overall costs of healthcare service delivery.[5],[6],[7],[8]


Informed consent to medical treatment

In its ideal legal and ethical contexts, IC requires five key elements to establish validity. These key elements must include (i) competence, (ii) voluntariness, (iii) information disclosure, (iv) understanding of information disclosed, and (v) authorization or consent to the medical procedure or treatment.[9],[10] In medical practice, IC should ideally involve a conversation between a doctor or healthcare worker (HCW) and the patient, initiated by the healthcare professional. This conversation must involve complete transparency, engagement by both parties, continuity and may require evidence that it occurred, such as eyewitnesses or a signed consent form.[2],[9],[10] IC could be withdrawn at any time by the patient and maybe vitiated by any changes in material facts not previously communicated to, or approved by the patient.[2],[9],[10] In accordance with some state laws, any exculpatory statements intended to deny any claim rights of the individual giving consent in order to protect responsible parties are expressly forbidden and may nullify IC.[11] Further, valid consent in accordance with certain state regulations [10],[11] and case law, strongly require the absence of coercion, undue influence or deception, as demonstrated in the English case of Re T. [12],[13],[14] Here, a patient refusing blood transfusion because of coercion and undue influence by the mother who was a Jehovah's witness was held not to have consented freely because her will was overborne. Therefore, her refusal did not represent an independent choice. It has been observed that US courts have become increasingly reluctant to dismiss personal injury claims on the on the grounds that the victims consented to the injury causing risks. Therefore, these courts have disfavored consent-based defenses such as assumption of risk, and product warning as a form of defense against negligence or battery.[15]

Informed consent and patients' rights

Patient's rights may be defined as a combination of claims, liberties, powers, and immunities that ensure the protection of the patient's dignity and moral autonomy.[9] This definition forms the core claims which patients may have against clinicians and defines the duties of clinicians to patients. Patient rights ensure access to data and information, protection from most kinds of unconsented activities. It suggests that patients may do no wrong by choosing to accept or refuse any recommended medical intervention.[9] Wear et al. have described patient's rights and IC as enabling and empowering a patient population that has traditionally been largely powerless and mute in the face of medical expertise and authority.[16] In this way, patient's rights while remaining based on the legal autonomy model also extends beyond the confines of any particular legal system.[15],[16] Patient's rights during medical treatment and research have only risen to prominence in the later part of the 20th century, especially after the reported abuses of human subjects of biomedical research [17],[18],[19] and the moral conflicts between respect for autonomy and professional beneficence.[1],[2] Further, recent advances in biomedical technology have also led to a constant rethinking of the rights of individuals utilizing the beneficial aspects of modern science.[20] Prior to these recent evolutions in bioethics and medical practice, with subsequent challenges to the status quo, the rights of patients have previously been based on medical paternalism.[3] Patient's right was solely dependent on the goodwill of doctors and the presumption that doctors would act in the best interests of the patients.[1],[2],[3] With revelations of physician/researcher abuses; however, and ongoing unethical research,[16],[17],[18],[19] ethicists and legal scholars began to question whether it was still appropriate for a patient to rely entirely on the judgment of doctors, and if not, how patients should be involved in the healthcare decision-making process?[21] Further, as medical practice has become more industrialized and sophisticated, patients have become consumers of healthcare services rather than involuntary participants in the healthcare decision-making process, raising the questions about consumer rights.[15],[16],[20],[21] One aspect of the recognition of the moral autonomy of the patient has been the recognition of the need for adequate information disclosure, which would enable the patient to accept, reject or choose between different medical therapies as first recognized in cases such as Canterbury v Spence [4] or as debated by the House of Lords in the English case of Sidaway. [22] Another aspect of this debate has been whether to persist with the "reasonable doctor standard" as established in Bolam [21] or to follow the "prudent patient standard" as suggested by Lord Scarman in Sidaway.[22] Information disclosure is an important aspect of enhancing the patient's moral autonomy and ability to choose. As suggested by Mclean, its potential invasiveness and its social and political potential make it an area ripe for rights discourse.[23] Debates in this area have, therefore, focused on several issues including whether the doctors' duty to disclose based on the patients' right to receive information can be tested independently of patient understanding.[23]

However, if the patient is unable to understand, what is the point of disclosure? Therefore is there a duty imposed on clinicians to ensure patient understanding prior to providing IC? There might also be issues with the rationality of patient's decision-making, with regards competence and incapacitated patients, minors, and other vulnerable members of society.[3],[23] In light of the above, questions about competence, information disclosure, understanding, and rights of vulnerable population groups have dominated contemporary debate on patient's rights, respect for autonomy and IC.[18],[19],[20],[21],[22],[23] Some have questioned whether providing information about risks, benefits, and alternatives actually improve patients' decision-making.[15] Schuck identified two obligations imposed on the doctors by these requirements. First, the fiduciary duty of care, i.e. the duty imposed on doctors to put patients' interests above their own. Second, the problems associated with cost and resource allocation since the obligation on full information disclosure may increase the burden on healthcare resources.[15] Others have argued that shared decision-making may decrease healthcare costs for well-informed patients.[5],[6],[7],[8] These observations suggest IC should also be viewed in terms of cost-effectiveness.[15] Therefore, there may be need to reconceptualize IC to suit the particular geographical or sociocultural environment involved.[6] For example, there may be a need to reduce consent procedures in "minimal risk" research or treatment while providing more information in "high-risk" situations. Further, not all patients require the same level of information disclosure, either due to personal choice or cultural belief systems.[24],[25],[26],[27] For example, it has been reported that among certain South Asian populations the disclosure of negative information may be considered harmful,[24] while some Nigerian African population groups are averse to negative information disclosure due to religious beliefs.[25],[26] Consequently, one can argue that IC needs to be viewed as a normative variable, not an empirical constant, due to its cultural plasticity.[9],[10],[15] Therefore, effective implementation of IC should allow for cultural belief systems and differences in regional or geographical medical practice.[15],[24],[25],[26],[27] However, the protections enshrined in the UNESCO Convention on Bioethics and the Universal Declaration of Human Rights among other instruments is emphatic about an acceptable IC.[28]

Informed consent in South Africa

As previously reported,[10] IC before treatment is a constitutionally protected right in South Africa.[10] This has been demonstrated in landmark South African cases such as Stoffberg v Elliot 1923,[29] Esterhuizen v Administrator Transvaal 1957,[30] and more recent cases of Minister of Safety and Security v Xaba 2003[31] and Castell v DeGreef 1993.[32] Generally, South African Courts have defended the patients' right to bodily integrity and the need for full information disclosure prior involvement in any medical treatment or procedure. Failure to follow these guidelines may result in offending HCWs being found guilty of assault, battery, or negligence.[29],[30],[31],[32] Following the DeGreef case, it was suggested that South African Courts appear to have shifted from a "reasonable doctor standard" to the "prudent patient standard" in terms of information disclosure.[32],[33] Further, there was a shift in risk disclosure to the objective "material risks" standard which is based on what a reasonable patient would attach importance to, in arriving at a decision whether to accept or refuse a recommended treatment.[6],[10],[33] The National Health Act 2003 (NHA)[34] codified the requirements for IC before treatment by requiring that every healthcare provider before treating a patient must among other requirements disclose the following:

  • The range of diagnostic procedures and treatment options, generally, available to the user
  • The benefits, risks, and consequences, generally, associated with each option
  • The user's right to refuse health services and explain the implications, risks, obligations of such refusal
  • Finally, healthcare providers must give the user this information in a language that the user understands and in a manner which takes into account the user's level of literacy.[10],[33]


Other factors which may impact on the practice of IC in African communities include sociocultural issues such as language, education and literacy level, and other socioeconomic factors.[10],[24],[25],[26],[35],[36],[37],[38] South Africa is a multicultural middle-income country, with a population of around 54 million people [39] who speak eleven official languages.[39],[40],[41] The country has historical, sociocultural inequities resulting from apartheid which left a section of the local population marginalized with a high unemployment rate currently estimated at 25.5%.[39],[40],[41] Because of these inequities there is a dichotomy in the provision of healthcare service delivery with the majority indigent population, about 88% uninsured in KwaZulu-Natal province (KZN) using publicly funded healthcare services, while the minority affluent populace using privately funded healthcare services.[41] This has led to a situation whereby doctors may be unable to comply with the legal requirements of IC, especially in public hospitals.[10],[35],[36],[37] It has also been reported that there may be geographic and cultural barriers to the practice of IC even in developed countries such as the USA.[6],[27],[42],[43] This has led most international ethical guidelines to recommend that cultural factors and language must be taken into consideration when obtaining IC from patients, especially those in developing countries during biomedical research or treatment.[28],[44],[45],[46] Previously, I reported on the understanding and practice of IC by medical doctors in South African hospitals.[10] Here, I analyze and report patient's actual experiences, perceptions, and evaluation of the IC process at local public hospitals in eThekwini Metropolitan Municipality (Durban), South Africa. This study was conducted simultaneously with an interview of doctors and professional nurses practicing in KZN.[10]


   Materials and Methods Top


Objectives

The general objective of this study was to establish whether IC is obtained from patients prior to medical treatment in South African public hospitals. Specific objectives were to establish whether sufficient information is provided to patients. Whether patients understand the information provided, whether patients providing IC to treatment are generally competent to consent to such treatment, and to establish whether IC is obtained from patients voluntarily. Finally, whether IC provided by patients is truly valid and consistent with the requirements of the NHA.[34]

Study population and location

The study location and stratified random sampling of selected public hospitals and patient populations were previously described in detail.[10] Briefly, this study was conducted in the outpatient clinics and inpatient wards of selected public hospitals in eThekwini Metropolitan Municipality (Durban). Inclusion criteria were such that any patient attending the selected hospitals during the period of study (March–June 2012), who was willing to participate voluntarily, was eligible for inclusion in the study. Exclusion criteria were mental incapacity and absence of parent or guardian to provide consent for children below the age of consent in South Africa.

Study instruments

The main study instrument was a semi-structured questionnaire in English language, which was also translated into IsiZulu, the dominant language spoken by about 81% of the population of KZN.[47] Professional translation was done by the Department of IsiZulu studies, University of KZN. Questionnaires consisted of three sections. The first section collected sociodemographic data; the second part was designed to collect information on patient experiences of IC practices by healthcare providers during clinical encounters. The third part asked questions about patient's general knowledge, understanding, and opinions on IC. Participants were interviewed by three trained bilingual research assistants. Those who preferred were allowed to complete the questionnaire by themselves. Respondents had the option of completing questionnaires either in English or IsiZulu. The study was conducted in various hospital departments shown in [Figure 1].
Figure 1: Percentage of participants by clinical departments

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Study design and statistical analysis

Preliminary sample size for this study was calculated using a web-based sample size calculator, Raosoft ®.[48] Based on the formula for sample size and margin of error from Raosoft, a representative sample size of 385 ± 20 patients was calculated (95% confidence interval; P = 0.05). Data from questionnaires were transcribed directly into Statistical Package for Social Sciences (SPSS), IBM Corp. Armonk New York, NY.[49] The captured data were then checked for completeness and accuracy by both the principal investigator and a qualified biostatistician. Data were later analyzed using SPSS (version 21).[49] Descriptive statistics such as percentages, proportions, median mode, and interquartile range were used to summarize the data. Scores for comprehension, understanding, information disclosure, and voluntariness were worked out from the responses. Fisher's exact test was used to test for association between categorical variables and groups of patients. Pearson's Chi-squared test was used to test for differences in responses between patients and HCWs (doctors and nurses). One sample Kolmogorov–Smirnoff test was used to test for normal age distribution.

Ethical considerations

Ethical approval was obtained from a local Research Ethics Committee at the University of South Africa (UNISA). The study and biostatistics methodology was also reviewed and approved by the health research and knowledge management subcomponent of the KZN Department of Health. Approval was also obtained from the management of each of the hospitals included in the study. Finally, written IC was obtained from each respondent after full information disclosure prior to participation in the study.


   Results Top


Demographic characteristics

Four hundred and four valid questionnaires were completed by respondents with few missing data. The sociodemographic characteristics of participants are summarized in [Table 1] and [Table 2]. The majority of questionnaires were completed by the patients themselves (88.2%, 351/398), while the remainder were completed by surrogates including parents/guardians (8.2%, 33/398). Most participants were female (68.2%; 272/399), single (56%, 225/403), or married (37%, 149/403). The age of participants was not normally distributed (P < 0.001, median = 35.5 years; range = 11–91 years). Most of the participants were bilingual, IsiZulu speakers (55%, 222/403), English (49%, 195/403), IsiXhosa (8%, 32/403), and Afrikaans (2%, 9/403). Other minority languages spoken include Hindi, Tamil, Tswana, and Sesotho. The majority of patients had a secondary education (69%, 278/401), some tertiary education (16%, 65/401), primary education (12%, 49/401), and no education (2%, 9/401). Most respondents were unemployed (66%, 262/398), with (27%, 106/398) employed. The majority of participants reported no monthly income (56%, 227/404). Detailed earnings of participants are shown in [Figure 2].
Table 1: Demographic characteristics of respondents (n=404)

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Table 2: Secondary demographic and social stratification data (n=404)

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Figure 2: Monthly earnings of participants. *Salaries are shown in South African Rands (ZAR). 1$ (USD) ≥11.5 ZAR

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Information disclosure

The majority of patients/respondents reported that an HCW (doctor or nurse) explained the treatment or procedure to them (88%, 355/403). Information provided to patients included diagnosis (81%, 326/403), general risks (57%, 229/403), and benefits (61%, 245/403). Less than half were informed about treatment options, (41%, 165/403), recommended treatment (28%, 113/403), and the risks of refusing recommended treatment (25%, 99/403). Only 28%, (113/403) were given information about their right of refusal [Table 3].
Table 3: Information provided to patients by healthcare professionals prior to IC

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Time spent on information disclosure

Time spent by patients with doctors or other HCWs during a clinical encounter, including obtaining IC ranged from <5 min (15%, 58/399); 5–10 min (29%, 115/399); 10–20 min (23%, 91/399); 20–30 min (13%, 51/399) to >30 min (15%, 59/399) [Figure 3].
Figure 3: Time spent on informed consent/clinical encounter by healthcare workers

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Patients choice on risk disclosure

The majority of patients reported that they would prefer to receive information on "all the risks" associated with the treatment or procedure (78%, 304/391), while (6%, 22/391) said they would like to know only "some of the risks," another (6%, 22/391) preferred to know "none of the risks," while (11%, 43/391) answered "don't know." Relevant reasons given by patients for requesting full disclosure of material risks are shown in [Table 4]. Some respondents wanted to know the side-effects of the drugs because they were allergic to some medications or were concerned about the health effects on their children, pregnancy, or current health status. Those who preferred partial or none disclosure of risks gave varying reasons for their choices as shown in [Table 4].
Table 4: Selected verbatim responses from patient to questions on IC

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Undue pressure or coercion

When patients were asked whether they were advised that they could accept or reject the treatment or procedure, (42%, 153/370) answered "yes." When asked if they felt threatened or were afraid to say "no," (8%, 30/379) answered "yes," while (91%, 343/379) said "no." Patients', who said they were afraid to say "no," gave various reasons as detailed in [Table 4]. Some patients complained that they were afraid because the doctor was simply too rude or aggressive or that they would be asked why they were refusing help. When patients were asked if they were given any perverse incentive or persuaded to accept any particular treatment, 9 patients (2.4%, 9/377) answered "yes," while (97%, 365/377) said "no." Some of those who responded affirmatively said they were given some pills and money for bus fare. "They gave me money, and they said it was bus fare?" Another, "there are pills that they say we must take for them to see if they are working and they gave us R120." Another was persuaded by being told it would benefit her in the end.

Methods of obtaining consent

The majority of patients reported that consent was obtained "verbally" (73%, 274/374), "written" (19%, 71/374); while (5%, 19/374) said both methods were used. Information disclosure to patients was rendered using "words" in most cases (89%, 358/401). English language was used in (66%, 255/384) and IsiZulu (32%, 124/384). Methods used to enhance information disclosure included pictures (8%, 32/401); diagrams (5%, 21/401), and interpreters (3.5%, 14/401).

Understanding of information disclosed

The majority of participants said they understood the information provided (91%, 355/392), while about (8%, 31/392) answered "no." When asked if they asked any questions about their treatment (70%, 275/391) said "yes," while (29%, 113/391) said "no." Reasons for not asking questions about treatment elicited responses such as "Doctor knows best" or "I didn't know what to ask." Others said they were already familiar with their medical diagnosis or treatment regimen. Some complained that they did not have time to ask questions because the doctors were in a hurry or too busy. "The doctor was too fast he didn't give me time to ask, he didn't have time at all."

Voluntariness of consent

When patients were asked if the amount of information provided was enough, (74%, 290/391) answered "yes," while (24%, 92/391) said "no." When asked whether they made the treatment decision of their own free will, (95%, 348/366) respondents answered affirmatively. However, some respondents said they only followed orders from the doctor, with one stating: "The doctors tell you what needs to be done and you do it." When asked if they could change their mind if they did not like the recommended treatment, about (87%, 309/356) answered "yes," while (12%, 41/356) said "no." Several patients who stated that they could not change their mind said it was because they could not afford alternative treatment [Table 4]. There was no significant association between patients age and knowledge of the right of refusal (P = 0.334), educational level and the right of refusal (P = 0.404), or income and right of refusal (P = 0.480).

Involvement of surrogates in patients' decision-making

When patients were asked whether they sought assistance any other person before deciding to accept or reject recommended treatment. Most patients (76%, 274/363) said "no," while (24%, 86/363) said "yes." Of those who sought help from surrogates, (11%, 42/370) involved parents, (6%, 21/369) from another family member, (3%, 11/369), from a husband, (2.4%, 9/369) from a friend, about (1%, 4/369) from a wife, and <1% from a child. A few patients sought assistance from a doctor or nurse, the internet, or another patient. Most of those seeking assistance from parents did so because they were minors currently dependent on parents/guardians. Those seeking assistance from doctors or nurses felt that HCWs knew better or were seeking a second opinion.

General knowledge of informed consent regulations by patients

When asked about the age of consent to treatment by children in South Africa, most respondents answered wrongly with (26%, 96/373) choosing, "15 years;" (33%, 122/373) chose "18 years;" (11%, 40/373) "21 years," while (6%, 21/373) did not know. Only (25%, 94/373) participants correctly answered "12 years." There was a statistically significant association between participant's age and knowledge of the age of consent in South Africa (P < 0.005). Older age groups were more likely to respond correctly. There was no association between educational level or income and knowledge of the age of consent (P = 0.080) and (P = 0.334), respectively.


   Discussion Top


This study assesses patients understanding and perceptions on the quality of IC as practiced by healthcare professionals (doctors and nurses) in an urban municipality in South Africa. Patients were generally satisfied with the level of information disclosure during medical treatment with about 74% expressing satisfaction regarding information disclosure. Patients also confirmed that doctors provided most of the information headings required by the NHA 2003,[34] including diagnosis, general risks, and benefits of treatment. This was consistent with a previous study on doctors practicing in the same region.[10] However, 25–41% of patients were not given information on the right of refusal, treatment options, recommended treatment, and risks of refusing recommended treatment. With regards to the understanding of information, over 90% of patients stated that they understood the information provided and about 70% said they were able to ask questions about their treatment. Although about 30% stated they were afraid to ask questions for fear of losing the free treatment provided in public hospitals since they were indigent and did not have any alternatives. This observation is consistent with a similar study in Kenya, where it was reported that patients were too timid or afraid to ask questions because of the fear of losing the benefits of free treatment provided during clinical trials or research.[38],[50] In terms of voluntariness of consent, the majority of patients reported making their decisions of their own free will, while those who sought assistance from surrogates reported the involvement of mostly family members, friends, and occasionally HCWs. Most patients reported the absence of coercion or undue influence with over 90% reporting that they were not afraid to say "no" if they felt uncomfortable with recommended treatment. This is somewhat unusual for developing country, especially in Africa, where cultural and family influences are thought to play a major role in healthcare decision-making as reported from studies in Nigeria [25],[26] and Kenya.[38],[50] This may indicate that South African patients are more aware of patient's rights and more sophisticated in terms of their understanding of IC when compared to patients from other developing countries in Africa and elsewhere.[25],[26],[38],[50] This may be a complement to the passage and wide publication of the NHA in South Africa and the patients' rights charter displayed by law in all public hospitals in South Africa. This observation may provide a good example to other countries in Africa, such as Nigeria, who are yet to pass or legally enforce healthcare laws in their own jurisdictions. While the Nigerian Health Act was passed into law in late 2014, its active implementation remains a future target.[51],[52] Most patients reported that there was no perverse influence on their decision-making such as financial inducement or threats, except few who reported being given money for "bus fare." The latter were probably patients involved in ongoing clinical trials that were financially compensated for participation, although the amount of 120 ZAR reported is less than the nationally recommended rate of 150 ZAR (≤15 USD) per day.[53] Time spent on IC as reported by most patients is within the range of 5–20 min as previously reported by doctors.[10] However, it is not clear from the patients account whether time spent with patients refers to time specifically spent on obtaining IC, or time spent on the entire clinical encounter. Probably the latter, since most doctors in the public hospitals are very busy with a large case load, thereby militating on time spent on IC as previously observed.[10] The timeframe of <20 min is also consistent with the entire clinical encounter as reported from other jurisdictions like the USA, where the estimated duration of an average primary care visit is 15 min.[5] Cultural factors impacting on IC in this population include the unemployment and poverty with over 65% unemployed and 56% reporting no monthly income in this cohort. Other cultural issues identified include language difficulties, with the majority of patients speaking IsiZulu or other African languages, while communication with HCWs on IC was predominantly in English language. Language as a barrier to IC was previously reported in other studies in South Africa [10],[35],[36] and the USA.[42],[43] However, this barrier did not seem to affect patient understanding with over 90% of respondents claiming they understood the information provided. There was some inconsistency with previous reports where doctors claimed that IC was obtained in writing in 51% of cases,[1] compared patients in this study who reported that IC was obtained verbally in over 75% of cases. Moreover, doctors reported giving patients information on the right of refusal in 65% of cases, while patients reported only 28%. Further, doctors reported using interpreters in 72% of cases when obtaining IC,[10] while patients reported that interpreters were involved in only 3.5% of clinical encounters. This inconsistency cannot be readily explained; however, it could be due to the practice of "cultural brokerage," whereby nurses maybe used to "translate, mediate, and negotiate on behalf of patients."[36],[54] In this situation the patient may not readily recognize or relate this to the use of interpreter while a doctor may report otherwise. Finally, patients showed a poor knowledge of the legal age for consent in South Africa, with only 25% identifying the current age of consent to routine treatment. Overall patients were satisfied with their encounter with healthcare professionals in this setting; however, they wanted to be involved in the healthcare decision-making process via informed decision-making.[5],[6],[7] This finding is consistent with reports from other parts of Africa such as Nigeria [55] and Kenya,[38],[50] as well as Greece [56] where were patients felt that while IC was important, they also wanted to be involved in decisions affecting their healthcare. It has been suggested by some American researchers that informed and shared decision-making are important elements of preventive medicine.[57],[58] Recommendations by patients on improving IC practices in the environment include improved communication skills by HCWs, with many patients complaining that doctors were too busy, rude, or aggressive while recommending that: "Bit more time spent with each patient will help," and "communicate better with patients." Others said, "doctors need to give all the important information without patients asking." Another, "I think nurses must try to spend more time explaining the treatment because sometimes they just right (write) in your card and you can hardly see what is written." And another, "I think they must be more careful with our documents, and they must also learn how to speak to patients." Finally, "I think they need to manage their time better."

Potential limitations of this study include the fact that it was carried out in and urban metropolitan municipality in South Africa (Durban), with an arguably better educated and more knowledgeable population group by South African standards. It is possible that a similar study in a rural location in KZN may yield a different result as reported elsewhere, although accurate sociodemographic data for proper comparison was not provided another study from rural KZN.[36] It is also unclear whether a study in a more cosmopolitan South African city such as Cape Town or Johannesburg with different population demographics may or may not produce a different result. It is possible that similar studies on patients utilizing private healthcare services may produce a different result because it has been suggested that doctors in private healthcare setting in Greece are more likely to provide detailed information to patients.[56]


   Conclusion Top


This study confirms that majority of patients utilizing South African public hospitals are vulnerable because of their indigence and lack of alternative means of obtaining healthcare. This study also shows that despite their evident vulnerability, most patients in Africa are generally aware of their right to information disclosure, human rights, and dignity in healthcare. Patients want to be informed and participate in informed or shared healthcare decision-making. This study supports previous reports by doctors and patients regarding the IC practices in South Africa, although there were some areas of inconsistency in actual practice with patients and doctors differing on the content and methodology of information disclosure. The major cultural factors militating against IC include language barriers, poverty, and poor communication skills by HCWs. One can conclude that there is a need to further educate patients and HCWs on patients' rights, the legal requirements of IC, with improved communication skills and training CPD of HCWs in ethics and medical law. This will enhance the doctor-patient relationship, patient's rights, and human dignity. Future research should focus on informed and shared healthcare decision-making in order to improve preventive healthcare services in Africa.

Acknowledgments

This paper is derived in part from a research project entitled "An investigation of IC in clinical practice in South Africa," which is being completed as a thesis for the award of the LLD (Doctor of Laws) degree at the UNISA.

I also acknowledge the management of King Edward VIII Hospital, Durban, as well as the management of all the participating hospitals, and the Health research and knowledge management subcomponent of the KZN Department of Health for giving ethical approval for the study.

Financial support and sponsorship

Institutional research support, University of KwaZulu-Natal, South Africa.

Conflicts of interest

There are no conflicts of interest.

 
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    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]


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