Frequently Asked Questions
What is a randomised controlled trial?
A randomised controlled trial (RCT) is a type of clinical trial. An RCT will try and make a fair comparison between one treatment compared to an alternative. This could be new treatments compared to current treatments, or a new treatment vs no treatment, or a dummy treatment also called a placebo (if there is no existing treatment).
Participants are recruited for the trial and then randomly assigned to one of two or more trial groups. This makes sure that participants in each group are comparable.
It is important that in an RCT, the two (or more) treatment groups of people in a trial are as similar as possible. This means the outcomes of the trial are less likely to be affected, or ‘biased’, by things like age or sex.
The NeuroSAFE trial participants are randomly assigned to two groups. One group will undergo Robot assisted radical prostatectomy (the current treatment), while the second group will also undergo the same procedure but with the additional NeuroSAFE Technique (the new treatment being investigated).
What does 'Blind or Blinding' mean?
In clinical trials it’s important to make sure that you are doing everything possible to minimise bias. This could mean controlling things that may effect your result, like age or sex, but human beings can also bias results. If the patient knows which group that have been assigned to, it could have a serious impact on the results of the trial. For example, if a patient found out they had received a placebo (a dummy tablet for example), they could be much more likely to say the treatment hadn’t worked. Or, if they found out they’d received the treatment under investigation, they might give falsely positive reports to try and help the trial!
The level or amount of blinding is different between trials. The NeuroSAFE trial is single-blinded, meaning the patients don’t know which group they’re in. Some studies are double-blinded, meaning the clinicians also don’t know which groups patients have been assigned to. There are even triple-blinded studies, there the researchers analysing the data are also kept in the dark!
What do I need to do as a Neurosafe participant?
If you choose to take part in the study, and meet the study’s inclusion criteria, your research nurse, trial practitioner or urologist will give you a Patient Information Sheet so you can read about the trial in more detail. Once you feel you fully understand the trial, and have had all your questions answered, your investigator will ask you to sign the consent form.
You will be allocated at random to either the standard radical prostatectomy arm of the trial, or the radical prostatectomy with NeuroSAFE technique arm.
As part of the normal care pathway, you will need to attend a pre-operative assessment clinic at the hospital as an out-patient at least 1-2 weeks before your surgery to assess your health.
On the day of your surgery, you will be admitted and the operation will be performed. You will not be informed as to whether you have had the NeuroSAFE technique (this blinding to treatment allocation is an important measure to prevent bias within the results).
After surgery, your care will be delivered as per local NHS hospital practice until three months post-surgery. Your routine appointments will then be coordinated and undertaken by the NeuroSAFE team.
For the purposes of the trial, you will have appointments at three months, six months, twelve months and twenty four months.
Preoperatively, and at each postoperative visit, you will be asked to complete four to five quality of life questionnaires about your physical health and wellbeing as part of the trial. You will also be given a health resource diary to assess resource use at these time points.
The research team will continue to track your health through your medical records for years three, four and five post-surgery.
what happens when the trial finishes?
When all the participants have completed the trial, we will compare how participants have responded to the two types of surgery, and assess how quality of life, recovery and out of pocket expenses have been affected by the surgery they have received. The particular outcomes that we are interested in improving and evaluating are quality of life, cancer recurrence, erectile function recovery and urinary continence. The research team will make the results of the trial available to the public when the trial is finished (participants will be anonymous).
Why am I filling out all these questionnaires?
As mentioned above, we want to look at a range of outcomes through the study, and the questionnaires are a vital part of that. Here’s how each questionnaire helps us look at different areas of our participants’ journeys:
‘The International Index of Erectile Function Questionnaire’ or ‘IIEF’
This is a multidimensional scale that tries to assess erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. It helps us assess eligibility before surgery, and helps us assess recovery afterwards. The full questionnaire gives us a score out of 75, but we can also use the first 5 questions (sometimes called the IIEF-5 score) which can give us a score out of 25. To demonstrate good erectile function and to be eligible for the trial, patients must have an IIEF-5 score of 22/25 or above.
The ‘International Consultation of Incontinence Questionnaire’ or ‘ICIQ’
This questionnaire not only assesses the level of urinary incontinence (if present) but also how any incontinence interferes with the participant’s every day life. This questionnaire also asks what particular activities or actions trigger episodes of incontinence.
To be eligible for the trial, all participants must be fully continent.
The ‘RAND-36’ item Health Survey
This health-related quality of life survey is one of the most widely used questionnaires across the world. The 36 questions assess eight different areas of health and quality of life: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy levels, pain, and general health perception.
This is a quick and simple questionnaire that can be used across a range of different trials. This survey asks 5 questions related to 5 separate dimensions of health: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, and anxiety and depression. It also asks the participant to score their health generally out of 100. This questionnaire can give researchers a good overview of the participant’s current on the day of questionnaire completion, but also allows us to measure changes in health status over time. This questionnaire can help us assess the impact of treatment on patients both individually and across the entire group.
The ‘Additional Erectile Function Questionnaire’
This short questionnaire helps clarify any devices, medication or other treatments that participants are using to assist with their erectile function. It is very important to be able be aware of which treatments are being used by which patients, to make sure our results are not effected.
The ‘Patient Healthcare Resource Diary’
This document tries to assess all the different ways participants and the NHS could be economically affected by receiving this treatment and participating in the trial. For example, it tries to take into account travel time and cost, trips to the GP or hospital, or any money lost by participants or their families due to sick leave or time taken off to care for them. This is an important element of trying to make sure the care we provide is as efficient as possible for everyone involved.
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