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 placebo (if there is no existing treatment).
Participants are recruited for the trial and then randomly assigned to one of 2 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 gender.
The NeuroSAFE trial participants are randomly assigned to 2 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 gender, 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, 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 ask you to sign the consent form.
You will be allocated at random to either the standard radical prostatectomy arm 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 at this point 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 3 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 3 months, 6 months, 12 months and 24 months.
Preoperatively and at each postoperative visit you will be asked to complete 4 to 5 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 your health care resource use, at these time points.
The research team will continue to track your health through your medical records for years 3, 4 and 5 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 (participants will be anonymous).
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