Dataset Information

Effect of informed consent on patients undergoing gastrointestinal surgery and living donor liver transplantation and on their relatives in a developing country.

ABSTRACT:

Background

Informed consent is a systematic process for obtaining permission before conducting a healthcare intervention. In a developing country, gaining informed consent is generally perceived to be a ritual only to comply with legal requirements. The present study examined this by assessing the process of informed consent in patients undergoing gastrointestinal surgery or living donor liver transplantation (LDLT) and their relatives, based on their comprehension and overall satisfaction, in India.

Methods

All patients undergoing any gastrointestinal surgery or LDLT procedure between August 2015 and July 2016 and their relatives were included, and were administered a structured questionnaire 5 days after the procedure.

Results

The majority of patients (94·2 per cent) could recall the nature of their disease, the surgery performed (81·6 per cent) and anticipated complications (55·6 per cent). Among their relatives, these proportions were 97·8, 87·3 and 58·5 per cent respectively. Recall was associated with age, occupation and education among both patients and relatives. Patients undergoing LDLT, their donors and their relatives had better recall than those who had other gastrointestinal procedures (P < 0·001). Many patients found the process of informed consent useful and reassuring.

Conclusion

The details and risks of an operation were understood by most of the patients, especially those undergoing liver transplantation. Patients from developing countries can generally understand 'informed consent', and value it.

SUBMITTER: Ray S

PROVIDER: S-EPMC5989942 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundInformed consent is an ethical and legal requirement for research involving human participants. However, few studies have evaluated the process, particularly in Africa. Participants in a case control study designed to identify correlates of immune protection against tuberculosis (TB) in South Africa. This study was in turn nested in a large TB vaccine efficacy trial. The aim of the study was to evaluate the quality of consent in the case control study, and to identify factors that may influence the quality of consent. Cross-sectional study conducted over a 4 month period.MethodsConsent was obtained from parents of trial participants. These parents were asked to complete a questionnaire that contained questions about the key elements of informed consent (voluntary participation, confidentiality, the main risks and benefits, etc.). The recall (success in selecting the correct answers) and understanding (correctness of interpretation of statements presented) were measured.ResultsThe majority of the 192 subjects interviewed obtained scores greater than 75% for both the recall and understanding sections. The median score for recall was 66%; interquartile range (IQR) = 55%-77% and for understanding 75% (IQR = 50%-87%). Most (79%) were aware of the risks and 64% knew that they participated voluntarily. Participants who had completed Grade 7 at school and higher were more likely (OR = 4.94; 95% CI = 1.57 - 15.55) to obtain scores greater than 75% for recall than those who did not. Participants who were consented by professional nurses who had worked for more than two years in research were also more likely (OR = 2.62; 95% CI = 1.35-5.07) to obtain such scores for recall than those who were not.ConclusionNotwithstanding the constraints in a developing country, in a population with low levels of literacy and education, the quality of informed consent found in this study could be considered as building blocks for establishing acceptable standards for public health research. Education level of respondents and experience of research staff taking the consent were associated with good quality informed consent.

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