Background
Methods
Development of the Q-QAT technique
Application of the Q-QAT technique in two RCTs
Setting - the RCTs
RCT1 | RCT2 | |
---|---|---|
Context | Elective procedure, not life-threatening | Life-threatening cancer |
Specialties | Surgery | Surgery and oncology |
Treatment groups | Standard surgery versus minimally invasive procedure | Chemotherapy plus either surgery or radiotherapy |
Centres for qualitative research | 1 | 3 |
Clinicians who provided audio-recordings | 3 surgeons; 1 research nurse | Centre 1: 4 surgeons, 2 oncologists |
Centre 2: 1 surgeon, 2 oncologists | ||
Centre 3: none | ||
Recruitment process | Treatment options and recruitment discussion by surgeon, in the same appointment as history-taking, diagnosis and examination. Sometimes follow-up by nurse | Dedicated appointments for treatment options and recruitment discussion. Separate appointments with surgeon and with oncologist |
Number of consultation audio-recordings obtained | 13 with surgeons | Total: 26 pairs |
8 with research nurse | (Centre 1: 19 pairs, Centre 2: 7 pairs, Centre 3: none) | |
Q-QAT applied to | 13 surgeon appointments | Total: 11 pairs |
(Centre 1: 7 pairs, Centre 2: 4 pairs) | ||
Number of interviews | 5 patient interviews | 18 interviews with 16 patients |
Unrecorded discussions with CI | (Centre 1: 9, Centre 2: 3, Centre 3: 4) | |
20 staff interviews | ||
(Centre 1: 10, Centre 2: 4, Centre 3: 6) | ||
Unrecorded discussions with CI |
Data collection
Data analysis: Q-QAT elements
Development of guidelines for future application of the Q-QAT technique
Results
Application of the Q-QAT technique in RCT1 and RCT2
Findings from RCT1
Patients | Recruiters | Total time | Surgery | Minimally invasive procedure | RCT |
---|---|---|---|---|---|
Patient 1 | Surgeon X | 12:54 | 00:35 | 00:48 | 00:56 |
Patient 2 | Surgeon X | 16:22 | 00:29 | 00:13 | 00:40 |
Patient 3 | Surgeon X | 18:51 | 01:13 | 01:10 | 00:28 |
Patient 4 | Surgeon X | 29:14 | 00:44 | 00:59 | 01:46 |
Patient 5 | Surgeon X | 19:59 | 00:43 | 01:45 | 01:06 |
Patient 6 | Surgeon Y | 11:28 | 00:53 | 00:52 | 01:42 |
Patient 7 | Surgeon Y | 17:43 | 00:31 | 01:29 | 03:08 |
Patient 8 | Surgeon Y | 12:46 | 00:48 | 01:08 | 01:35 |
Patient 9 | Surgeon Y | 15:33 | 00:32 | 01:03 | 02:09 |
Patient 10 | Surgeon Z | 12:15 | 00:00 | 05:02 | 02:32 |
Patient 11 | Surgeon Z | 08:58 | 02:00 | 02:46 | 02:10 |
Patient 12 | Surgeon Z | 24:16 | 02:20 | 05:06 | 02:39 |
Patient 13 | Surgeon Z | 21:09 | 00:56 | 02:13 | 03:03 |
Mean | 17:02 | 00:54 | 01:54 | 01:50 | |
Median | 16:22 | 00:44 | 01:10 | 01:46 | |
Range | 08:58 to 29:14 | 00:00 to 02:20 | 00:13 to 05:06 | 00:28 to 03:08 |
Surgeon Z: there are good things about T(a); there are good things about T(b).Surgeon Y: we know they both work perfectly well, it’s just that there’s different things to them. On the one hand, one has an anaesthetic, the other doesn’t. One, uh, you know, you’ve got to wear some bandages for longer, one you are left with (problem) for longer, but you haven’t had an anaesthetic, and there’s all these pros and cons, and we really don’t know whether one is better than the other.
Surgeon X: if you didn’t decide (on the treatment) or couldn’t decide which way you’d like to go with your choice, or you’re happy to leave your choice open to us, we are randomising people.
Surgeon Z: and if you go into the study, it would involve us opening an envelope at random so to speak and it will say treatment (a) or treatment (b). We then do the treatment and follow you up afterwards for 5 years to make sure.Patient 11: yeah, that’s interesting.Surgeon Z: it won’t involve a lot of visits or extra time (explains follow-up questionnaires for five lines). So the most important thing is that if you decide you’d rather have treatment (a) or you’d rather have treatment (b)…Patient 11: I’m pretty ambivalent really.Surgeon Z: yes, well just don’t make that decision in front of me today. And if you can’t make your mind up, consider the study, but if you don’t want to do the study ‘cause you’re thinking it might be too much bother, you don’t have to give us a reason, it will not alter the way we feel about you in anyway. It’s simple, you can walk away at any time.Patient 11: excellent.
Research Nurse (RN): after initial introductions) It’s just a follow-up call to see if you’ve had a chance to read through the information you were given about the treatment options.P8: I have yes.RN: yes. What would you like to do?P8: what I’ve decided I wanna do is, if possible is to have the operation if that’s alright.RN: okay, yes. I’ll let (surgeon’s) secretary know that.
Patient 11: he (surgeon) said you have to choose whether you want to have treatment (a) or whether you want to have treatment (b). And he explained them both and really they didn’t seem to make any difference. He seemed to think that at my age and my health that it wasn’t a problem having an anaesthetic, and I said well, I really am ambivalent. He said ‘no’, go home and read the paperwork and think about it. And don’t make a decision today. So I did that, I went home and then I decided I would go for treatment (b).
SP: did you have any opinion as to what treatment you might prefer before you went in for this initial consultation?Patient 4: no, I didn’t know anything about it to be quite honest.SP: so when did the fact that you preferred surgery kind of take shape do you think? During the consultation, after or?Patient 4: well, I came home and they sent me information or I had information about both of them, I think it was just reading that really, because at the consultation (surgeon) couldn’t, he explained both the treatments but he didn’t, I was disappointed that he couldn’t turn around and say to me, treatment (a) would be better for you or treatment (b) would be better for you. So although he explained both procedures to me, I didn’t really choose there and then what I was gonna have.SP: and did (surgeon) kind of explain why he was not able to choose one treatment for you?Patient 4: I don’t know, I can’t remember what he said, why he couldn’t, but I remember asking him but I can’t think what he said.
Patient 4: because I was eligible for both of them, I would benefit from either of the treatments, he said to me, and it would just be almost picked out of a hat.SP: was there any reason do you think for the treatment being chosen in that way?Patient 4: um, I’m not sure really. I don’t know.Patient 14: had there been an option where equal numbers of people said this was the way they wanted to go, I don’t see why they couldn’t have been in the trial, you know, they could have still been followed up, they could have still been kept under scrutiny and the results would still have been the same because there were the same number of people.
Findings from RCT2
Patients | Recruiters | Total time | Surgery | Radiotherapy | Trial |
---|---|---|---|---|---|
Patient 1 | Surgeon A | 28:54 | 02:41 | 03:01 | 08:01 |
Oncologist A | 37:34 | 00:10 | 08:48 | 03:15 | |
Patient 2 | Surgeon B | 35:27 | 02:23 | 02:05 | 03:20 |
Oncologist B | 15:31 | 00:10 | 00:41 | 00:00 | |
Patient 3 | Surgeon C | 41:00 | 03:00 | 01:59 | 05:44 |
Oncologist B | 25:30 | 00:10 | 04:59 | 01:20 | |
Patient 4 | Surgeon C | 17:30 | 00:30 | 00:15 | 01:30 |
Oncologist B | 12:52 | 00:34 | 02:15 | 00:40 | |
Patient 5 | Surgeon B | 42:05 | 00:25 | 01:20 | 05:45 |
Oncologist B | 20:07 | 00:00 | 03:23 | 00:30 | |
Patient 6 | Surgeon A | 12:59 | 02:24 | 00:10 | 00:50 |
Oncologist B | 09:14 | 00:50 | 00:10 | 00:00 | |
Patient 7 | Surgeon D | 18:11 | 01:05 | 00:00 | 04:06 |
Oncologist B | 33:08 | 00:10 | 04:30 | 01:23 | |
Centre 1 Total | Mean | 25:00 | 01:02 | 02:24 | 02:36 |
Median | 22:49 | 00:32 | 02:02 | 01:26 | |
Range | 09:14 to 42:05 | 00:00 to 03:00 | 00:00 to 08:48 | 00:00 to 08:01 | |
Centre 1 Surgeons | Mean | 28:01 | 02:32 | 01:16 | 04:11 |
Median | 28:54 | 02:23 | 01:20 | 04:06 | |
Range | 12:59 to 42:05 | 00:25 to 03:00 | 00:00 to 03:01 | 00:50 to 08:01 | |
Centre 1 Oncologists | Mean | 22:00 | 00:18 | 03:32 | 01:01 |
Median | 20:07 | 00:10 | 03:23 | 00:40 | |
Range | 09:14 to 37:34 | 00:00 to 00:50 | 00:10 to 08:48 | 00:00 to 03:15 |
Patients | Recruiters | Total time | Surgery | Radiotherapy | Trial |
---|---|---|---|---|---|
Patient 8 | Surgeon E | 31:00 | 04:50 | 01.15 | 02:55 |
Oncologist C | 38:02 | 00:10 | 12:38 | 02:00 | |
Patient 9 | Surgeon E | 28:02 | 03:11 | 01:57 | 05:35 |
Oncologist C | 31:00 | 00:15 | 14:14 | 01:05 | |
Patient 10 | Surgeon E | 38:10 | 03:20 | 00:00 | 03:32 |
Oncologist C | 33:31 | 00:15 | 00:00 | 00:00 | |
Patient 11 | Surgeon E | 28:02 | 01:19 | 00:20 | 01:05 |
Oncologist D | 33:46 | 01:26 | 00:52 | 02:49 | |
Centre 2 Total | Mean | 32:42 | 01:51 | 03:55 | 02:23 |
Median | 34:31 | 01:23 | 01:04 | 02:25 | |
Range | 28:02 to 38:10 | 00:10 to 04:50 | 00:00 to 14:14 | 00:00 to 05:35 | |
Centre 2 Surgeon | Mean | 31:19 | 03:10 | 00:53 | 03:17 |
Median | 29:31 | 03:16 | 00:48 | 03:14 | |
Range | 28:02 to 38:10 | 01:19 to 04:50 | 00:00 to 01:57 | 01:05 to 05:35 | |
Centre 2 Oncologists | Mean | 34:05 | 00:32 | 06:56 | 01:29 |
Median | 33:39 | 00:15 | 06:45 | 01:33 | |
Range | 31:00 to 38:02 | 00:10 to 01:26 | 00:00 to 14:14 | 00:00 to 02:49 |
Oncologist B, Centre 1: it’s a very difficult decision and there isn’t a right and a wrong answer and some people have very clear ideas about what they want to do, whether it should be an operation, they want to have it cut out. Other people, the thought of the operation is just so frightening they opt for the radiotherapy treatment. But for us, we don’t know which of these treatments is - is better.Oncologist C, Centre 2: getting back to what you said before about eradicating it (tumour) was your word I think, the problem if you think about it with, and especially in radiotherapy is partly that we do the treatment and then when you finish you have a scan. You can still see where the tumour is or where it’s been ‘cause it’s, then takes time for it to shrink and as it shrinks, the area that was treated becomes inflamed and then scarred and you look at the scans after this sort of treatment and you’re always looking at it and thinking, ‘is there still tumour there or is there not?’ and it’s difficult sometimes to assess response after radiotherapy (three more lines about assessing the scans). Whereas at least with surgery, as you say, once it’s cut out, that’s the end of it hopefully and then the scans that we do are slightly different - they’re to look to see if there’s any sign of it coming back and you have scans in the future, er, er, yeah, so it is, some people do feel that that they want to have it cut out and that - they feel that that’s gonna be the end of it.Surgeon E, Centre 2: now, the upside of the chemotherapy and the radiotherapy is of course you don’t need a very big operation. The upside of surgery is that of course we actually physically remove the cancerous area and we are able to look at it under the microscope and see exactly what the nature of it is and, and so on, but the evidence that we have is that the two techniques are similar, but we don’t know whether they’re exactly the same and that is why we’re doing the study.
Surgeon E, Centre 2: the chemotherapy sensitises the tumour and then the radiotherapy blasts it and tries to- to- to- kill it. And there have been some very good results when we do this form of treatment but they’ve never ever been compared with what has been in - over many years, the gold standard treatment which is, with, with an operation
Patient 2: I mean, what is the trial? That’s what I’m trying to get at.Surgeon B, Centre 1: the trial is, we would enter you into this trial and the trial would choose the option for you.Patient 2: does the trial, is it something else that’s going to start before we actually get the treatment?Surgeon B: no. Er, n- n- n- not quite. The treatment is either chemotherapy and surgery or chemotherapy and radiotherapy, and if you agree to enter this trial, we would choose - well, the study would choose one of those options for you, at random.Patient 2: yeah, but what have I got to do for the trial, this is the point, is what I’m trying to get at.Surgeon B: you would have that treatment, whichever one the trial chose for you.Patient 2: no, I don’t think I’m getting this. This word trial to me seems to be a completely wrong word. It’s not a trial, it’s actually what you’re gonna get. It’s the actual treatment, isn’t it?
Surgeon G, Centre 1: we can certainly stir up and reinforce a patient’s bias very easily with a throw away comment like the aim of the surgery is to cut out your cancer and that could ruin everything from the point of view of a balanced randomised trial.Oncologist B, Centre 1: there was someone who used to work here who used to say ‘well I can cut away your tumour or they can shrink it with radiotherapy’, so the word you use matters a lot because ‘shrink’ gives the impression that you’re not going to get rid of it, whereas to cut it out means you’ve taken it away, gives you the impression that you’re definitely cured.
Oncologist E, Centre 2: it is the case though that historically because we’ve had such a strong surgical lead to the MDT (Multi-Disciplinary Team meeting), we’ve got a long history of surgery for that group of patients (…) I think that it’s not because we think surgery is better, it’s just that we’ve more experience and that it’s been a gold standard here for so long.
Patient 14, Centre 1: so having chemo and radiotherapy, there’s no guarantee with any of it, but in my mind, you’re just trying to shrink the tumour and there is no guarantee that you will do it with that, but with surgery you’re physically cutting it out.
Patient 4, Centre 1: once or twice I thought is he (oncologist) trying to persuade you to go for the radiotherapy and chemotherapy, that was the impression I got, but I don’t know. (CW: what did he say that made you think that?). Patient 4: well he sort of elaborated on it a bit more rather than about the operation. I had a feeling he was leaning towards that way. (CW: and when you were with (surgeon) did you feel was leaning towards the surgery?) Patient 4: no, (surgeon) explained what surgery would be, what radiotherapy would be, and said really the decision will be yours.
Patient 2, Centre 1: my honest opinion was between them there was a little bit of competition, and that can put you off a little bit. There shouldn’t be competition in that sort of a way (…) they might not think so themselves but there is, yeah. Obviously the surgeon thinks he’s the better man, the other one thinks he’s the better man.Patient 14, Centre 1: I know that there is historically an antipathy between oncology and surgery, different aspects of looking at things.Patient 17, Centre 2: I got the impression, and you can take it whichever way you like, that they knew what they were doing with their job and the other, they weren’t quite interested in the other side, if you know what I mean.
Guidelines for applying the Q-QAT method
Coding categories | Content |
---|---|
(a) Trial group 1, Trial group 2 and so on | Time spent by recruiter and patient discussing: |
Intervention types | |
Intervention processes | |
Intervention outcomes | |
(Content of each RCT treatment group to be defined for each randomised controlled trial (RCT)) | |
(b) Trial | Time spent by recruiter and patient discussing: |
RCT design | |
Rationale for RCT | |
Patient eligibility | |
Processes involved in trial participation, including randomisation, informed consent, study documentation and procedures | |
(c) Total length of appointment | Time spent by recruiter and patient discussing: |
Everything - from start to finish of appointment | |
(d) Balancing | Time spent by recruiter and patient discussing: |
Need for intervention when not in context of RCT | |
All other intervention options available when not in context of RCT | |
Eligibility for any treatment when not in context of RCT | |
Discussion of interventions involving comparisons, when not in the context of the RCT | |
(e) TTFMT | Time elapsed before first mention of RCT |
(Time to first mention of RCT) | |
(f) Other | Time spent by recruiter and patient discussing: |
All other issues, including current state of health, history-taking, | |
test results, diagnosis, examination, and general non-RCT or | |
intervention talk |