Patient Experience of Consent for Cancer Surgery in Light of Recent Changes to UK Law- a Questionnaire Study

Audit of Informed Consent of Patients Undergoing Surgery

Since the 2015 Montgomery vs Lanarkshire Health Board ruling, the consent process in the UK has had to change. In practice, this means that doctors must ask themselves whether the patient knows about the material risks of the treatment being proposed, alternatives to the treatment, and whether reasonable care has been taken to ensure the patient actually knows this. This study aims to determine patients' perspectives of consent for major cancer surgery in light of the Lanarkshire ruling.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction
• Intervention / Treatment: Other: Survey

Detailed Description

A patient satisfaction survey was administered to patients who had undergone urological, gynaecological, colorectal, and plastic surgical procedures at a specialised cancer centre where changes to consent processes in light of the Lanarkshire ruling had been implemented.

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • The Christie NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing surgery during a 6 week period at The Christie NHS Foundation Trust

Description

Inclusion Criteria:

• All patients who have been admitted and undergone surgery within a 6 week period between April - June 2018.

Exclusion Criteria:

• Any patient who could not complete the survey questionnaire i.e. English was not their first language or to unwell to complete.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients understanding of the risks associated with the procedure they will be having and the alternatives available to them was assessed using a study specific questionnaire.	Was the patient made aware by the clinical care team of the risks associated with their procedure and the alternatives available to them. Were they able to make an informed choice. This will be measured using a patient questionnaire	6 weeks
Patients views and feelings regarding their experiences in relation to support from healthcare professionals was assessed using a study specific patient questionnaire.	Did patients feel that healthcare professionals provided them with sufficient information and support to make an informed decision in respect of their procedure. This will be measured using a questionnaire completed by patients.	6 week

Collaborators and Investigators

• Sponsor: The Christie NHS Foundation Trust
• Investigators: Principal Investigator: Omer Aziz, The Christie NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): August 10, 2018

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 18/2117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data with other researchers.

Drug and device information, study documents

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