SECTION I: PRE-MEETING (-30 min)

SECTION I: PRE-MEETING (-30 min)

A. Materials and supplies for focus groups

Please make sure you have the following items in the room:

1. Sign-in sheet

2. Consent forms (one copy for participants, one copy for the team) 3. Information sheet for each participant

4. Demographic form for each participant 5. Pencils/pen for each participant

6. Focus Group Discussion Guide for each Facilitator 7. 2 recording devices

8. Batteries for recording devices 9. Notebook for note-taking 10. Refreshments

Hand out consent forms to the participants and questionnaire upon participant arrival.

Allow a couple of minutes for the participants to settle in.

SECTION II: INTRODUCTION (30 min)

A. Welcome (A-D (approx. 20 min))

Welcome participants into the room and guide them to their seats. Make sure everyone signs the consent form and are happy to proceed.

A.1. Introduce yourself and all the facilitators in the room.

A.2. Review the following:

 Who we are and what we’re trying to do:

“This focus group is the first stage of a wider study that aims to understand the type of information and resources paediatric neurologists/neurosurgeons would ideally like to have to discuss options with parents who are making choices about surgical

interventions that involves a novel neurotechnology for a child who has drug resistant epilepsy (DRE).”

 What will be done with this information

“Our discussion today, together with other focus groups scheduled for the following months, will inform the development of a survey called a discrete choice experiment which allows us to understand people’s preferences for different aspects of treatments.

To do this we need to break down decisions into their key features, which are called attributes in a discrete choice experiment. Examples of attributes are risks, benefits, cost,

how a treatment is given etc. In the discrete choice experiment, people will make a series of repeated choices between two treatments described by different levels of these

‘attributes’; for example, the levels of a risk attribute may be low, medium or high.”

“In this project, we are doing both questionnaires and focus group discussions. The reason for using both of these tools is that we can get more in-depth information from a smaller group of people in focus groups. This allows us to understand the context behind the answers given in the written survey and helps us explore topics in more detail than we can do in a written survey.”

B. Explanation of the process

“Focus groups dynamics

 We learn from you (positive and negative remarks are acceptable)

 Not trying to achieve consensus, we’re gathering information

 No virtue in long lists: we’re looking for priorities

Logistics

 The focus group will last about one hour and half. In the interest of discussion all items we’ll be doing some time-keeping and may ask for the discussion to move forward. We have approximately 5-6 broad areas of discussion so we will be limited on how long we can spend on each area. If you have further remarks that you were not able to

communicate, we would love to hear from you (stay around after the focus group or email)

 Help yourself to refreshments Ground Rules

 Everyone should participate

 Only use first names

 Information provided in the focus group must be kept confidential

 Stay with the group and please don’t have side conversations

 Turn off cell phones if possible”

************ TURN ON RECORDER *************

C. Consent (read aloud)

“Participation in this focus group is completely voluntary and it is up to you to decide whether or not to take part. If you agree to take part, you will need to sign an informed consent form before we can begin. If anyone has not yet signed, please do so now. You may leave at any point of the focus group. If you do not want to participate in the focus group, please feel free to leave now. “

D. Ask participants to complete demographics form

E. Final Remarks before discussion starts

Ask the group if there are any questions before we get started, and address those questions.

F. Warm-up questions (approx. 10 min)

1. Familiarity with neurotechnological interventions

Start with a statement about how there is a discussion about novel surgical treatment of epilepsy in children with DRE.

“The outcomes and complications of conventional epilepsy surgery, especially temporal

lobectomy, have been well studied, however, the short- and long-term efficacy and side effects of both newer and novel interventions for DRE, and openness to their adoption are less

understood. Moreover, unlike novel pharmaceutical treatments, these interventions are less likely to be put through the rigors of a randomized controlled trial, nor are the outcomes of adult trials clearly generalizable to children.”

QUESTION: “How familiar are you with the neurotechnological interventions outlined in the info sheet?”

Probes:

 Can you give an example of a time you adopted a novel or new neurotechnological intervention to treat DRE?

 Which ones from the list in the info sheet have you used? Why?

 Which ones have you never used? Why?

2. Perceived role in decision

QUESTION: “How do you perceive your role in discussing and recommending a new neurotechnological intervention (either new to your institution or novel`)?”

QUESTION: “What characteristics would be important when considering whether to recommend a new intervention?” PROMPT: Recommend to your clinical group? Institution? Parents?

Probes:

 Medical history

 Preferences, if any

 Age of the patient

 Willingness to have child undergo

 Medical coverage

 Risk

 Evidence for efficacy

 Invasiveness

 Cost (to institution/parents)

 Novelty

Section III: DISCUSSION (60 min)

A. Clinical aspects (approx. 25 min) QUESTIONS:

1. What is the probability of success at which you would consider recommending a novel neurotechnological interventions compared to standard treatment?

2. What is the magnitude of benefit that would outweigh the potential side effects and risks of the intervention? Probe: Invasiveness

3. Are you more likely to consider a novel invasive or non-invasive neurotechnology if it’s being studied in the context of a well-designed trial?

4. What other information about the treatment would be important to you when considering whether to recommend neurotechnological interventions?

5. What factors influence you when you adopt a novel neurotechnological intervention? I.e.

trusted peers, conferences, scientific literature, device manufacturer representatives 6. What information about the patient and family would you want to know when

considering recommending neurotechnological interventions?

B. Life values (approx. 15 min)

“Medical decision making is rarely only about clinical outcomes. The values of the clinician, the caregivers, the institution and the health system itself might also influence decisions”.

QUESTION: “Do you perceive there to be trade-offs to be made between your clinical

assessment, practices and guidelines at the institution in which you work, and the things that patients, their parents/caregivers and families might be taking into account when you

QUESTION: “What do you find are the main trade-offs that need to be made?”

Probes:

 Quality of life

 Value of life

 Disability

 Cultural and religious beliefs

 Life goals

 Parenthood

 Finances

 Social conditions

 Interpersonal relationships

 Expectations

 Distance from treating center

QUESTION: “How do you take these factors in account?”

C. Resource use (approx. 15 min)

Intro: A lot of these neurotechnological interventions are expensive. Some will require the patient to attend follow-up visits and undergoing further testing or procedures.

QUESTION: “Do you ever take into account cost or resource use aspects in your decision?”

Probes:

 What costs are considered? Individual vs societal perspective

 What kind of information do you seek to help take these perspectives into account?

D. Open question (approx. 5 min)

QUESTION: “Are there any other factors you consider when making a decision that we didn’t cover today?”

Section IV: CLOSING REMARKS

“That concludes our focus group. Thank you so much for coming and sharing your thoughts and opinions with us. “