Comparative study on the evaluation of patient's satisfaction on esophagogastroduodenoscopy and colonoscopy between a pre-filled and standard hand-written consent form in Hospital Kuala Lipis.

INTRODUCTION: Informed consent is the patient's selfdetermination authorization of a choice made by themself before any intervention is performed by the health care provider. It should be a structured process that includes the disclosure of relevant procedural information, benefit, risk, and other treatment option. MATERIALS AND METHODS: An open-label static group comparison experimental design was conducted in a singlecentred study starting from April 2021 until January 2022 among patients who were going for OGDS and Colonoscopy at Hospital Kuala Lipis. The patients were stratified by 2-by- 2 randomization to either the standard hand-written prefilled consent forms. The satisfaction was assessed using Gastrointestinal Endoscopy Satisfaction Questionnaire version 2. The difference in the satisfaction was analyzed using multifactorial ANOVA. RESULTS: The percentage score of satisfaction on the endoscopic procedure using pre-filled was significantly higher than standard form consents (mean difference: 18.36 (95%CI: 14.15, 22.58)) and the effect size was large (partial ή = 0.399). The difference in percentage score of satisfaction was associated with gender (p = 0.003) and medical officers' years of working experience (p < 0.001). CONCLUSION: The pre-filled consent form fulfils the ethical and legal aspects of the informed consent process and should be used in endoscopic and other invasive procedures in Malaysia. It is suggested that a formal training, exposure to course in communication skills, breaking bad news on patient consent among junior doctors need to be taken to improve patients' satisfaction of the endoscopic procedure to make them more satisfied.