Introduction
Methods
Recruitment to the qualitative study
Data collection
Analysis
Results
Participants
Patients and recruiters | |
---|---|
Trial participants | 27a |
Randomised to: | |
Antibiotic | 16 |
Methenamine | 12 |
Second interview conducted | 11b |
Randomised to: | |
Antibiotic | 5 |
Methenamine | 6 |
Interviewee unsuitable for trial | 1 |
Interviewee declined trialc | 1 |
Not contactable | 5 |
Recruiting staff | |
Research nurses | 7 |
Consultants | 2 |
Non-contactable | 5 |
Alerts to trial team
Views of the trial
Themes
Was the trial information comprehensive?
Why are patients willing participants?
Why may patients have reservations about the trial?
Reasons specific to trial | Other | ||
Aspects of trial medications involved | 4 | No reason given | 22 |
Blood tests | 1 | Not interested | 6 |
Washout | 7 | Moving out of area | 1 |
Extended follow-up period | 4 | Other health problems | 5 |
Inability to adhere to trial protocol | 2 | Feels well | 3 |
Why might patients consider dropping out?
Questions and quotation number | Interviewee response |
Was the trial information comprehensive? | |
Q1 | I just wondered whether, like, a pH test… once you know that you are on the Hiprex, whether a pH test might be useful to see how acidic your urine is……Because what I read was that a lot of doctors recommend taking a vitamin C tablet at the same time as the Hiprex - PAT1018 |
Q2 | Some women have heard about being on prophylactic, some of them have been on prophylactics already. But obviously, they understand it. I mean, you’re not having to teach them what prophylactic means and things like that, they all understand it. - RN1301 |
Q3 | I feel bad with it, it does affect your whole life. So I was more than happy to go for the trial and try and seek it out, for want of a better word. - PAT1101 |
Q4 | …on my second visit, when I went to collect the medicine, they said...um...they told me that if I had another infection, to go and see my GP. But I thought that this treatment would stop them altogether, so I was bit concerned about that at the beginning - PAT1008 |
Why are patients willing participants? | |
Q5 | I think a lot of people do not understand a UTI, they just kind of think waterworks. …But when it’s something, you know, basic things like walking. Walking, sleeping, sitting at work, having a conversation with people, when you have got that level of discomfort, it’s difficult to just carry on as normal, to be honest. So yes, it really does affect your quality of life - PAT1005 |
Q6 | I am at a stage now where I am actually prepared to try anything to try and rectify this, if possible - PAT1011 |
Q7 | As I say, I am pulling my hair out with this repeating occurrence with the infection and that so if I can do anything more hopefully-helpful - PAT1101 |
Q8 | So for me it was like, I would be getting medication anyway, so I can get the same medication and be slightly closer monitored for the problem I was having – PAT1009 |
Q9 | I thought if I can be part of research and get treatment and research can be done at the same time to sort of help women that are going through the same thing, I thought it’s a positive thing.- PAT1013 |
Q10 | I started taking these and I was a little bit concerned. So I actually got on the Internet and researched this and it actually says that it is an antibiotic. So I was a little bit confused. - PAT1005 |
Q11 | Well, I suppose I was worried about, what is this that I’m putting in my system? What effect is it having on me? Because when you read it turns into formaldehyde you’re like, “Oh my god is that actually good for me or not, I don’t know. - PAT1005 |
Q12 | Specifically in terms of the UTIs, I am already allergic to penicillin, so I can see the, you know, for me, the use of antibiotics is already quite limited. So I can see the benefit of trialling other ways, you know, for people like myself. - PAT1018 |
Q13 | I’m kind of glad that I was put on the antiseptic rather than antibiotic just because I know that obviously prolonged use of antibiotics, you can build up resistance to it - PAT1013 |
Why may patients have reservations about the trial? | |
Q14 | I do not think it’s healthy to take antibiotics for 12 months, I do not think the effect on your body is a positive one…. I just, I did not want to take them, I did not want to be selected for the route of antibiotics for 12 months. - PAT1014 |
Q15 | That it is a trial puts them off, just the fact that we are a trial or study. It makes them think they are trying something new or different - CO1102 |
Q16 | I have had some ladies that have said that since they have been to the hospital they have not had any urinary tract infections. So they’re not wanting to take part in the study just now because they’re quite, you know, everything’s going well for them and they do not feel the need to do anything extra at the moment. - RN1301 |
Q17 | They’re scared not to have their treatment because for them the prophylactic antibiotics may be working to a point. They don’t necessarily want to come off of them and not have treatment. - RN1101 |
Q18 | .”…. I think a lot of them would be rather hesitant to take on, or to stop, because actually for the first time in ages, they have got something that’s working. - CO1303 |
Q19 | For whatever reason, their lives are chaotic or they’re unwell. I mean, I have had quite a few women, there’s a couple of women that have been diagnosed with cancer. And they’re not wanting, they’re just like, “I can’t think about anything else right now.” RN1301 |
Why might patients consider dropping out? | |
Q20 | Interviewer: Would you have come off the trial if you were given the antibiotic, do you think? Patient: No, I don’t think I would have. I would have continued with it and given it a try but I think I would have been very open to, more open to saying, “Well, if this is not working I’m just coming off it,” whereas with this one I want to participate until the time is up if I can. – PAT1020: |
Q21 | One of my main concerns was that a year was a very long time to do a treatment……… my worry about the antibiotic was that maybe it was too long, and there might be some damage to the stomach lining. With such a heavy, it’s not heavy obviously, it’s a small dose but it’s for a long time. – PAT 1008 |
Q22 | I thought if I get the antibacterial, which I would have gone through, but if it made life not much better, it would have seemed a long drag. The year would have been a long year . – PAT1016 |
Q23 | One of the things that we have found for the ladies that have taken part in the study is trying to get their head around the system of sending back samples if they have a urinary tract infection. The process of the paperwork, the pods that they have to put the samples in, we have had a problem with that. I do not know whether the people declining do not want any additional hassle, additional visits, additional medication. - RN1302 |
Q24 | And we have had one lady already come off study, because she thought it would be a burden as well, after having initially being recruited. - RN1002 |
Q25 | The biggest inconvenience is getting it to the doctors…. because of the hours that I work, it impacts on my working life.... Because you have got to be there before a certain time so that the carrier can get it down to the hospital. – PAT1011FU |