Patient Perspectives on Artificial Intelligence in Radiology | NCT05618860

Studies
Patient Perspectives on Artificial Intelligence in Radiology

NCT05618860

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Status

Unknown status

Last Update Posted

Nov 16, 2022Actual

Enrollment

175Estimated

Phase

Not provided

Conditions

Patients Waiting for Radiology Exams

Interventions

Questionnaire

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2022Estimated

Primary Completion Date

Aug 2023Estimated

Completion Date

Feb 2024Estimated

First Submitted Date

Oct 27, 2022

First Submission Date that Met QC Criteria

Nov 9, 2022

First Posted Date

Nov 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2022

Last Update Posted Date

Nov 16, 2022Actual

Name	Class
King's College London	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators will conduct a short questionnaire with patients who are waiting for radiology exams to understand their views on the use of artificial intelligence in radiology. The questionnaire will be anonymised and entirely optional. Results will be published in peer-reviewed publications and inform future implementation of AI in clinical radiology.

Detailed Description

The project entails a patient questionnaire. Patients will firstly be informed about the study via a member of the radiology care team. Informed consent will be obtained by a member of the team. Each participant will be assigned a unique identifier number upon recruitment. Aside from the signed consent form, no identifiable information or medical details will be collected. Consent documentation will be stored within a locked drawer in the research department of the radiology department in GSTT. The signed consent document will be kept entirely separate and will not be linked in any way to the questionnaire answers. The questionnaire data will therefore be anonymised data. A document containing the following items will be created on a GSTT computer and updated as the study progresses:

Participant Unique Identifier
Questionnaire Answers 5.2 Questionnaire When the study identifier number is assigned, it will be entered at the top of a paper questionnaire. The questionnaire is thus anonymised from the beginning of the study. The questionnaire will include demographic variables and questions with multiple choice responses corresponding to a Likert scale, which will be completed by the patient. This information will be transferred to an NHS computer in the radiology department in GSTT.

Survey data will not include identifiable information. A Gaussian Graphical Model will be inferred indicating conditional dependencies between demographic variables and participant responses. This will be performed using the desparsified Graphical LASSO method of Jankova, implemented via the R package SILGGM.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

175Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	eligible participants in the radiology department waiting rooms will be asked to complete a questionnaire after taking consent.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
This study aims to evaluate patient opinion regarding the use of artificial intelligence in radiology by completing a questionnaire	We aim to identify common concerns held by patients and to characterise the distribution of patient viewpoints regarding the use of artificial intelligence for radiology.This will allow identification of key issues from the patients' perspectives	6 months

Secondary Outcomes

Measure	Description	Time Frame
Quantification of patients' positivity towards AI technology in radiology by completing a questionnaire	This will facilitate understanding between expert and lay stakeholders on this issue.	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients presenting to the radiology department waiting area for an elective appointment will be eligible to participate.
Participants must be aged above 18 years.
Participants must have independent capacity to consent to the study.

Exclusion Criteria:

Inpatients or acute patients presenting to the radiology department waiting area.
Those who cannot complete informed consent.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients presenting to the radiology department waiting area for an elective appointment

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carolyn Horst	Contact	07809671293		Carolyn.horst@gstt.nhs.uk
Robert O'Shea	Contact	073 94761391		robert.1.oshea@kcl.ac.uk

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

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Browse Branches

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