Patients' Comprehension and Internalization of Operative Consent Form

Informed Pre-operative Consent: Are We There Yet?

This is a prospective pilot study conducted within otolaryngology (ENT) clinics in a tertiary hospital between July and December 2016. 22 patients planned for common elective ENT operations were given a self-administered one-page survey on the same day after preoperative counselling. The investigators aim to identify if there are any associations between perceived and actual understanding of information given during pre-operative counselling and patient satisfaction with the process.

Study Overview

• Status: Completed
• Conditions: Informed Consent

Detailed Description

As above and in later sections.

• Study Type: Observational
• Enrollment (Actual): 22

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients planned for common elective ENT operations in a tertiary hospital between July and December 2016

Description

Inclusion Criteria:

• Planned for common elective ENT operations
• English-speaking
• Unaccompanied
• Counselled with the use of a structured surgery-specific consent form

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's perceived understanding of information given during pre-operative counselling (nominal score on questionnaire)	The score of how certain patients feel about information given during pre-operative counselling, as indicated on a self-administered questionnaire on the same day after pre-operative counselling	Through study completion, up to 6 months
Patient's actual understanding of information given during pre-operative counselling (numeric score on questionnaire)	The score of correct answers patients give to factual questions about their surgery, as indicated on a self-administered questionnaire on the same day after pre-operative counselling	Through study completion, up to 6 months
Patient's satisfaction with pre-operative counselling (nominal score on questionnaire)	The score of how satisfied patients are with pre-operative counselling, as indicated on a self-administered questionnaire on the same day after pre-operative counselling	Through study completion, up to 6 months

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Investigators: Principal Investigator: Tze Choong Charn, MRCS, Singhealth Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): December 31, 2016
• Study Completion (ACTUAL): December 31, 2016

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: November 8, 2020
• First Posted (ACTUAL): November 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 8, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2016/2638

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No