Communicating Risks: Consent for Lumbar Puncture

The goal of this randomized control trial is to compare the effect of visual aids on the recall of probabilistic risks in healthy participants. The main questions it aims to answer are: Will participants consented using a consent process incorporating visual aids recall the consent process better? Will participants consented with a consent process incorporating visual aids have higher acceptability if a hypothetical, simulated complication were to occur? Is this method of consent (visual aids) usable, appropriate and acceptable? Participants will be required to watch a brief video containing information on how a lumbar puncture is performed as well as the associated risks. Participants in the intervention group will receive information in the form of various visual aids (e.g. anatomical diagrams, paling palettes and paling perspective scales). The audio narration and information provided in both groups is identical. Participants will be tested on their knowledge of the procedure Participants will be asked to rate their response to a series of procedure specific statements and statements from other validated scales. Researchers will compare the control and intervention group to see if there is improvement in the recall of information and which consent process is more acceptable, appropriate and usable.

Background: Informed consent is an essential process in clinical decision-making, through which healthcare providers educate patients about the benefits, risks and alternatives of a given procedure or intervention in a descriptive way. An accurate understanding of the numerical information pertaining to risk is important because individuals perceive probability differently while also having different thresholds for what they would consider an unacceptable. This is vital for shared decision making to ensure that patients only undergo procedures or treatments where their understanding of the risks is in line with their personal level of acceptability. Aid tools have been employed to elaborate and communicate probabilistic risk information in areas such as screening (1). To the best of our knowledge there are no studies which evaluate the application of such visual aids on probabilistic information in surgical patients. Objectives: Our study aims to explore the effectiveness of visual aids to help communicate statistical information during the informed consent of a common clinical procedure: a lumbar puncture. We compare the effectiveness of this enhanced consent process against a typical consent method without visual aids Methods: Healthy participants were recruited within our institution and randomized using Qualtrics to complete a questionnaire containing either the control video or intervention video. Both videos contained identical audio narration however the intervention video included additional visual aids. Status: Recruitment of participants has been completed and the study has been written-up and submitted for publication and presentations.

Upon clicking the link to the study questionnaire, participants were randomized to either receive the control or intervention questionnaire. This was done through Qualtrics (Qualtrics, Provo, UT) built-in randomization.

Investigators were blind as to which arm participants were allocated to as the randomization and intervention/control exposure occurs after participants open the link to the study questionnaire. The same link would allocate participants to either the control/intervention group. Outcomes were assessed within the questionnaire without any human input No care providers were present in this study

Video with audio narration containing information provided in the standard informed consent process for a lumbar puncture

Video with identical audio narration (to the control) containing information provided in the standard informed consent process for a lumbar puncture. The video also received statistical information in the form of visual aids; anatomy diagrams, Paling diagrams and Paling scales

The visual aids used included: An anatomical diagram illustrating how a lumbar puncture is carried out Paling palette, diagram illustrating the number of individuals affected by a particular condition Paling perspective scale, diagram comparing the risk of an event occurring in comparison to other 'everyday' risks

Audio narration of a video containing text information relating to the lumbar puncture procedure (including risks) and an image of a consent form

Inclusion Criteria: Healthy individuals Above 18 years old No underlying cognitive impairment Exclusion Criteria: Individuals with prior experience receiving, performing or observing a lumbar puncture Lacks capacity Hospitalized individuals

Coyle M, Gillies K. A systematic review of risk communication in clinical trials: How does it influence decisions to participate and what are the best methods to improve understanding in a trial context? PLoS One. 2020 Nov 16;15(11):e0242239. doi: 10.1371/journal.pone.0242239. eCollection 2020.