FOCUS GROUP TOPIC GUIDE

Introductions

Thank everyone for coming and introduce yourself, distribute consent forms for completion.

Once seated and commencing the audio-recording, ask each person to introduce themselves by their first name.

Setting context

The purpose of today's focus group is to identify what key information participants want to have available in a results summary of a Phase III trial that they have taken part in.

Explain what is meant by a Phase III trial; these are trials run to assess the effectiveness of the new intervention and typically have 300–3000 participants taking part. They aim to determine how effective a drug or surgical intervention is compared to another drug or intervention and in some trials more than two treatments are compared. For example, in PROSPECT, it was actually two randomized-controlled trials comparing standard (native tissue) repair alone with standard repair augmented with either a synthetic mesh (the mesh trial) or a biological graft (the graft trial) for prolapse surgery in women.

During the focus group

Start off by asking participants to talk about their experience of participating in PROSPECT.

Do you remember receiving the results of the trial?

What stood out for you from the results/what do you remember?

Was there anything else you wanted to know; if yes, where from?

Was the information presented in a way that was understandable?

We sent the results by post in the form of a newsletter, how did you find this? Would you have liked a link to more information? Would you have preferred it delivered differently, for example, face to face or the internet?

Interactive exercise

We are now going to complete an interactive exercise; some questions require you to rank items and others are yes/no questions. Introduction to the ranking exercise: It is a bit like voting in the local elections when you need to rank your first choice of candidate, your second choice of candidate and so on. Rather than using a voting slip, we will be using some handheld devices to complete this.

For the warmup exercise: First, can everyone chose their favourite destination by selecting A, B or C on your device. OK—has everyone done this now. Now select your second favourite destination. Then, the least favourite.

Following the exercise

If someone would have liked results in person, prompt to find out who they would like to receive the results from and in what setting: doctor (1 on 1), nurse, researcher at a patient coffee morning and so forth.

For any discrepancies in order of importance (example two items have been given same waiting) for Question 1, use the printed 10 individual items to explore with the group if on review they would change their responses and why.

Second part of focus group

Did receiving the results of PROSPECT make you feel that you were part of the research and that your input/time was recognized, why/why not?

Based on your experience in PROSPECT and receiving the results of the study, would you take part in future research and what has influenced your opinion on this?

Can you think of any situations where you would not want to receive the results? Would you have liked a choice about receiving the results?

Was there anything else you would like to add?

If discussions veer into PROSPECT-specific concerns, highlight that the purpose of the focus group is about trial feedback in general and not to provide any further information about the PROSPECT trial.

Closing the focus group and reflecting the PROSPECT results

Now that you have seen the PROSPECT results newsletter again today and following our discussions today, was it how you remembered? Was there anything that you had not remembered about the results?

Thank the participants for their time. Confirm that the statements and comments made today will be anonymized (i.e., study numbers and not names of individuals will be used in the interpreting of the data). Ask them if they would like to receive the results of this project and in what format.

There are different types of clinical trials. Some test new medicines or vaccines, some look at new combinations of existing treatments or look at delivering an existing treatment in a different way and whether it will make it more effective or reduce any side effects. Drug trials are probably the most familiar type of trial for many people, but clinical trials are not always about just testing medicines. They can be used to test other ‘interventions’ aimed at changing a person's behaviour or lifestyle (for exercise habits). Trials of different surgical procedures are not as common as drug trials. Surgical trials may, for example, compare different types of operations, or they may compare surgery with a nonsurgical treatment.

In VUE, they compared different operations for prolapse in women with or without a womb. There were two studies within VUE. -

Uterine trial (women with womb): Vaginal hysterectomy compared with an operation to suspend the uterus without removing it, and

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Vault trial: Suspending the vault from below (the vaginal route) compared with suspending it via the abdomen (tummy).

For the purpose of today, we are not going to be discussing the VUE results, but I would like to find out about your experiences of taking part in a trial like VUE and your views on receiving results from trials like VUE.

What do you remember being told when you consented to take part in VUE?

If they do not mention results—ask them if they remember that.

What kind of information would you like to see in a results summary? You will need some prompts here as example items—what were the overall findings? link to published paper? What to do if you have questions? (use ‘What else’ as a continuous prompt).

What way would you like it delivered? Some examples include by post, email, podcast (video of the researcher explaining the results) or meeting with the researcher.

Now, we are going to complete a set of ranking activities; the first is based on information you we expect to receive in a trial results summary or newsletter. Could you order these items based on what you think is the most or the least important?

Time to allow participant to complete Question 1.

Discuss how these items compare to what the participant has identified as important based on earlier discussions.

Ask the participant why he or she chose that item as the most important.

Ask the participant why he or she chose that item as the least important.

Now, I would like you to complete another activity exercise based on the most to the least preferred way of receiving trial results.

Time to allow participant to complete Question 2

Now that we have looked into what information you would want to be included in trial results and how you would want it delivered, can you think of any situations where you might not want to receive the results for study? For example, what about in cases of bereavement? Should the family still find out the results of the trial?

Do you think it is important that you are asked when you first agree to take part in a study if you would like to receive the results and how you would want it delivered to you?

This study is all about receiving results -would you like to receive the results from this student project? Also, how would you like it delivered to you?

Finally, the information provided today will be used by the VUE team to better prepare the trial results summary for participants. This will be sent out in Spring next year.