Background
Methods
Participants
Interventions
Behavioural support vs self-help
Short vs standard length reduction programmes
Adjuvant pharmacotherapy
Randomisation sequence generation, allocation concealment, implementation
Follow up and blinding
Qualitative interview data collection
Outcomes
Sample size
Statistical methods
Results
Quantitative process measures
Monthly recruitment rates and randomisation
Baseline characteristics
Behavioural/Standard
n = 17 | Self Help/Standard
n = 17 | Behavioural/Short
n = 19 | Self Help/Short
n = 15 | |
---|---|---|---|---|
Age yrs, mean (SD) | 44 (12.3) | 44 (16.5) | 44 (12.0) | 43 (13.1) |
Male, n (%) | 11 (65) | 7 (41) | 6 (32) | 10 (67) |
Ethnicity, n (%) | ||||
White | 7 (35) | 8 (47) | 11 (58) | 6 (40) |
Other | 9 | 7 | 5 | 7 |
Missing | 0 | 0 | 0 | 1 |
Age started regular smoking, mean (SD), n | 16 (3.0), 16 | 17 (5.0), 14 | 16 (2.3), 16 | 17 (2.6), 14 |
Have you ever made a serious quit attempt, n (%) | ||||
Yes | 12 (71) | 12 (71) | 12 (63) | 11 (73) |
No | 4 (24) | 2 (12) | 4 (21) | 3 (20) |
Missing | 1 (5) | 3 (17) | 3 (16) | 1 (7) |
FTND, mean (SD) | 5 (2.3), 16 | 6 (1.7), 15 | 6 (2.8), 16 | 6 (2.5), 14 |
Cigarettes per day, mean (SD) | 17 (8.2) | 23 (8.2) | 20 (9.1) | 17 (6.5) |
CO, mean (SD), n | 17 (8.4), 17 | 19 (11.2), 17 | 19 (10.4), 18 | 17 (8.7), 15 |
Reasons for cutting down, n (%) | ||||
I want to cut down as a way to stop | 9 (53) | 8 (47) | 10 (42) | 11 (73) |
I want to cut down as a way to smoke less | 7 (42) | 7 (41) | 6 (32) | 3 (20) |
I’m not sure why I want to cut down | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Missing | 1 (5) | 2 (12) | 3 (16) | 1 (7) |
Highest educational qualification | ||||
Secondary school (up to age 15/16) | 7 (41) | 4 (24) | 7 (37) | 6 (40) |
Sixth form (up to age 18/19) | 4 (24) | 2 (12) | 1 (5) | 1 (7) |
Professional or technical qualification/diploma after school | 0 (0) | 1 (6) | 1 (5) | 0 (0) |
University/polytechnic degree course | 0 (0) | 2 (12) | 0 (0) | 1 (7) |
Still in full time education | 1 (6) | 2 (12) | 2 (11) | 3 (20) |
None of the above | 4 (24) | 4 (24) | 5 (26) | 3 (20) |
Missing | 1 (6) | 2 (12) | 3 (16) | 1 (7) |
Fidelity to randomisation
Fidelity of the pharmacist to the treatment conditions
Behavioural Support/Standard
n = 17 | Behavioural Support/Short
n = 19 | |||||
---|---|---|---|---|---|---|
n attending | Week after baseline as specified by protocol | Actual attendance time (weeks) median (range) | n attending | Week after baseline as specified by protocol | Actual attendance time (weeks) median (range) | |
Visit 1 | 17 | 0 | 0 | 19 | 0 | 0 |
Visit 2 | 11 | 2 | 2 (1, 6) | 15 | 1 | 1.3 (1, 9) |
Visit 3 | 9 | 6 | 5.4 (2, 9) | 12 | 2 | 2.1 (2, 17) |
Visit 4 | 8 | 10 | 9.4 (3, 48) | 10 | 3 | 3.4 (3, 7) |
Visit 5 | 7 | 16 | 14 (4, 52) | 7 | 4 | 5 (4, 8) |
Visit 6 | 6 | 22 | 21.7 (5, 59) | 5 | 6 | 7 (6, 11) |
Visit 7 | 4 | 28 | 27.4 (6, 64) | 5 | 8 | 8.7 (7, 18) |
Visit 8 | 2 | 34 | 7.5 (7, 8) | 4 | 16 | 17.5 (11, 27) |
Behavioural
n = 36 | Self Helpa
n = 32 | |||||||
---|---|---|---|---|---|---|---|---|
Visit | n | Last visit target met
n (%) | New target set n (%) | Method recorded
n (%) | n | Last visit target met
n (%) | New target set n (%) | Method recorded
n (%) |
1 | 36 | 31 (86) | 36 (100) | 32 | 9 (28) | 23 (72) | ||
2 | 26 | 26 (100) | 26 (100) | 24 (92) | 17 | 8 (47) | 10 (59) | 10 (59) |
3 | 21 | 21 (100) | 18 (86) | 19 (90) | 14 | 7 (50) | 2 (14) | 6 (43) |
4 | 28 | 18 (100) | 17 (94) | 16 (89) | 9 | 4 (44) | 2 (22) | 4 (44) |
5 | 14 | 14 (100) | 13 (93) | 13 (93) | 7 | 5 (71) | 1 (14) | 2 (29) |
6 | 11 | 11 (100) | 11 (100) | 5 (45) | 5 | 4 (80) | 2 (40) | 2 (40) |
7 | 9 | 9 (100) | 8 (89) | 7 (78) | 4 | 4 (100) | 0 (0) | 1 (25) |
8 | 6 | 6 (100) | 2 (33) | 4 (67) | 3 | 3 (100) | 0 (0) | 0 (0) |
Contamination in the self-help arm
NRT use
Follow-up
Qualitative process measures - pharmacists
Views about the programme (Table 4)
“I think people don’t come at the moment because they think that they’re going to be pressurised… you know and a lot of finger pointing…so I think it is a good idea to have a programme that… allows very heavy smokers…to reduce first, before they quit, and that might help them more. ” PH01
|
“I think there is definitely a place for it…it would be able to help a lot more people than I was presently because the stop smoking services is very strict really… whereas at least with [the reduction programme] they can approach it gradually” PH06
|
“I think it’s quite important to establish that when you set out with a reduction scheme, you’re on…what I think is dodgy grounds because the patients thinks… “well I can reduce…and they don’t, they don’t see that final goal as quickly, whilst the cessation scheme is more likely… I think just as long as…it’s set out from the beginning that you’re going to reduce to quit, then I think…it can be valuable part of the NHS.“ PH15
|
“With the Self Help… I think it just depends on the person…how much enthusiasm they’ve got for it…if they’ve got… to do it themselves and make their own decisions, I don’t think that motivated them at all“ PH04
|
“I think it’s the smoke free period without a doubt [that is the best approach]. The timer method is only suitable for, very small proportion of the population. And even then, it doesn’t actually deter people, it might actually work the opposite way, and people may be used to then smoking every hour. Or every hour and a half, they make it the habit, that, ‘Oh God… I need to smoke now.” PH07
|
“When you are helping the person, behavioural support, it was more satisfying than…just tell them to go… do it themselves…”PH10
|
“I think, the one to be left on their own to do everything would have been…not appropriate, I think they really needed the support.”PH12
|
“It was a very thin line between ‘I am giving you support now,’ where ‘I’m not giving you support now.’ Now where do you stop, giving that support…You can even sit down with the guy and say, yeah try here, try here, do this, like we do with NRT product. But you can’t give him support…it’s a very thin line between, now I’m giving him support… and kind of messing with the study, where does my role stop, where can I say, nope, I can’t give you any more support past this point.” PH16
|
Recruitment methods (Table 5)
“People that came in and inquired about smoking patches and… inquired about what they could do for smoking, I would offer them [the reduction] programme alongside the [cessation] programme” PH01
|
“We’ve had the posters around the window, we’ve tried moving it about to different locations thinking it would maybe catch their eye better at different locations, we’ve also when people come into enquire about stop smoking we do ask them would you like to cut down or are you looking to just… quit altogether” PH2
|
“I know there was one GP he would send these letters out…we only got like four people ring us out of the whole lot. And only…one of them turned up out of the four. So, it just didn’t get people on as much as you’d hoped.” PH04
|
“We put up a poster in all the waiting rooms in surgeries, we put posters up in pharmacy, and people who were coming in, we were asking them if they wanted to give up smoking or did they want to reduce smoking. So, those are the main [recruitment] methods we used.” PH06
|
“We get a lot of referral from our GP, as well as…approaching patients… I gave it as a dual option, they could go for? the reduction method or they could go for the straight NRT approach.” PH08
|
“the record I keep of the, over the years of stop smoking service, I rang them up and I said, were they still smoking and, would they be interested, and also when we had some customer who came in and we asked them would you like to join this programme, when they bought a prescription and we’d normally ask them if they smoke, or even if they buy a cough mixture ….we targeted about fifteen people.. all of them, declined…we gave out lots of cards… I dropped it in the local surgeries as well but we didn’t get anything back from the surgeries. No referrals or nothing.” PH10
|
“we tried as much as possible to promote it, the posters and the little cards inside the things and stuff… it was mainly just anybody who…came to us to say that they noticed the poster … I say ‘look we offer two schemes… there’s one that you can…just … cut down, or there’s one that you can stop altogether, what would you prefer” PH15
|
Barriers to recruitment and continued engagement with the programme (Table 6)
“the initial consultation takes a bit of time… and because people haven’t been on this programme before, it’s a lot of information to go through whereas the other form [for cessation], a lot of people come in and re-sign up… it’s been running for years so they know all about it, and this is new so, they’ve just a bit more time to get their head around it and explain everything to them and get my head around it as well…What I don’t like about it at the moment is the fact that the whole paperwork and the structure for it is different to the other service…[if] the paperwork was similar, it would be a lot easier… this is all quite new and then… you’re slapping around trying to get the different paperwork and sometimes I think you… just leave it to the patients to come back…if I could… get an appointment from them there and then and get a telephone number…I think that maybe would’ve been a better thing to do. ”PH01
|
“I think when you try and explain the structured method to them…smoking every so many minutes…I think they look at you a little bit funny… I think they expect to go on the programme and just use the programme to reduce the number of cigarettes themselves and then when you sit and explain all the structure to them it sort of baffled them a little bit” PH01
|
“I think because of the staffing issues as you’ve seen and the fact of the length of the interviews as well for the first few appointments that’s probably a put off… but with a lot of our patients they’ve not really actively come in and seek to cut down, I think when they come in they’ve made up their minds they want to quit, they want to go all the way… so I think that’s probably the biggest hurdle we’ve had.” PH02
|
“It was hard to get people on. … they know there is a stop smoking course, and they will come because they want to stop smoking today, but I don’t think a lot of people wake up saying, “I want to cut down…I did ask people, even the people that came in… “Oh, I want to stop smoking” I’d tell them that we were doing the reduction or to stop smoking and they say, “I want to stop smoking, not the reduction.” PH04
|
“I mean, the cessation programme is short and you have to stop by the second week; whereas this, you get people who go up and down, up and down over the longer period, you know…I think if they had like a barrier, say, ‘By this time you have to have stopped or cut down to this much’, then, I think they will try a bit harder…they knew that they can go up and down and you know it wouldn’t really matter, I think that’s when that probably took advantage of.” PH04
|
“During the period that it was running we actually managed to recruit about ten people into the stop smoking service, but when I offered… those same people the choice of joining the Redpharm study, they all declined and the reason they declined was because when they were given the choice about being supported or not supported, they didn’t want to take the risk, of being not supported.” PH06
|
“the reason [that we had difficulty recruiting] I think is it’s a very highly ethnic area and English language isn’t number one medium so with the paper work and the whole bulk that came with it, it was very difficult to explain it to them how the programme worked. So we had initial interest but then nobody carried on… when I explained it further they weren’t really interested because of the technicalities of it…English isn’t their number one language…to explain something that is fairly complex to them it took my time and takes their time …I know trials you have all these technicalities that have to be followed but if it was the programme though we could just go straight into it without the issues surrounding it I think it would work definitely… I did try and recruit, well the initial recruitment as in speaking to them and I also offered them our PCT programme [cessation], which is the standard 12 week programme and they’d rather go for that one.” PH08
|
“Once you get about eight, nine people on it, it’s… too… time consuming, if it’s..a simple thing just filling the chart, sign it, away you go, it would’ve been easier for me. But… to keep you in behavioural support or, getting people in, saying look how’s it going,…it was time consuming….it just meant that I had to cap the number of people I could take on” PH07
|
“people didn’t have the understanding that it’s not offered everywhere, a lot of them thought, oh, we’ll go down road and we’ll do it there, or we’ll go closer to home and do it there… and a lot of them… whenever you hear research they think, oh we’re guinea pigs, what’s going happen are you going to give us special drugs, but apart from that, which was a small portion, there wasn’t any problems” PH0
|
“If you give people the choice between stopping smoking and reduction, they want to stop.” PH10
|
“The, paperwork is a problem to pharmacists. It’s a bit long and it takes a little long to fill…we’d rather to do it immediately you may try to give someone an appointment to come the next day, in doing so that person may not come so you may end up losing that, and that’s where I find a little bit of a problem. We’d like a shorter level--I know you’re going to collect statistics but, we have to think of a better way to be, to have less paperwork…I think the level of education of most people… possibly was not sufficient for them to understand in detail what this programme was doing to them…There is a big document…in the beginning, and there were, for the patient, the bigger documents that they signed in the beginning, I think some of them don’t like to sign documents, that’s another thing” PH10
|
“I mean, once they starting losing interest that was it, you know, even the behavioural support people, they would…once they got past the initial appointments, they were just coming in every so and so just to get patches and it’s just one of those things. I think they felt that they weren’t doing anything like on the programme or something…They started off well and after three to four weeks…it just went back up…they would come in and say, “Oh, we’re going to try and do this.” …but then they just go back to normal and then they wouldn’t turn up. So, they start at a level, they go down for a few weeks and then they go back up and then just disappear.“ PH04
|
“a lot of people left half way because maybe they didn’t see the point, or they didn’t understand the forms that they had to fill, and I can understand but most of them they’d not finished completely so only for four weeks, after that they were tired and they stopped. I have time for them when they come to the pharmacy, but I haven’t got time to start making phone calls” PH10
|
“when we mentioned to them it’s a year programme… they were a bit reluctant, initially when we say to them, look this is a good programme, you don’t have to quit…straight away, it’s a gradual process so they were impressed it, and then when I gave the information of the little bits, the first, will be about forty five minutes and then it’s for a year you have to really be committed to this programme, then they become reluctant, but the four people I talked to, who’d really benefit from it, they just declined on this, principle… if you were to roll this programme out you probably might need to reduce the number of questions that have been asked, and the… timeframe of the first session, probably needs … at least, fifteen minutes reduction. I think you can get comfortably half an hour somebody come to sit with you, but I think… then, it’s become like a barrier for them, for us to get them to sit twenty minutes in the first session when we do other stop smoking services, it’s already a task….so…”PH12
|
“after talking to the clients, all gave me that reason is that, this first interview’s too long for us and, we can’t give that much time. And, the other problem is, a lot of the clients here, their English is not, fluent English… we have to speak in their own languages, either in Bengali or, Urdu like that so that’s become, little bit hard.”PH12
|
“…because we’re offering a smoking cessation scheme as well …I’d give them the option… about which one they wanted to go for, and they all seemed to go for the cessation scheme rather than the reduction scheme, so … didn’t really seem to work over here very well.” PH15
|
“The cessation scheme is quite straightforward, there’s a bit of paper, the patient comes in, you take a quick… CO reading, you discuss the plan with them, and they just literally come in week in week out to collect their NRT, keep an eye on them… I never really got to have a good, chance with the reduction scheme, but it looked complicated from the outset, that’s my initial view… it’s a randomised trial isn’t it…so obviously, it can’t be as straight forward as a cessation scheme but because of its nature I guess, it just seemed extremely complicated from the outset.” PH15
|
“they were..like, oh we’re here to stop, but we want a nine month course, and we want your support. And it’s like, well we can’t always, it depends, if you get that, in a raffle, kind of way. And a lot of people say, oh well we’ll go on another one then ’cause, eight to ten weeks we can do that, so we had a lot of problems with that especially around this area, with people didn’t understand that.” PH16
|
Desire to reduce
Length and complexity of initial consultation
Understanding of research
Length, complexity and administration of the programme
Qualitative process measures - participants (Table 7)
Recruitment |
“[The pharmacist] knew that I smoke anyway. So, he just suggested it to me as an idea, because I always buy patches from the pharmacy. So, he goes “Why not do it this way, because it would save you money and it would help you as well.” PPT1 |
“I went in and asked him because he got the thing on the door… about quitting there and to ask for advice there. And, I asked him. And, he says, “I’ll put your name down.”…And, that was it. And, it just sort of picked up from there.” PPT2 |
"Normally, what it is with these local chemists, they always have programmes running. And, I’ve been with him once before or twice before, I think, previously. But, he knows that I give in to temptation very quickly – the smoking part of it…I felt happy [that he offered me the programme], because …it’s actually not just like a face behind the counter…just give the medication and that’s it. He actually showed concern.” PPT3 |
“I [saw] the sign outside, I was sort of interested myself anyway” PPT4 |
“I was asked because I’ve been buying patches and stuff previously. So they obviously knew that I was trying to give up.” PPT5 |
Reactions to the programme |
“It was overall a good experience being on it because …I was buying patches before privately and they were costing too much. So, obviously when I found out about this scheme, it’s a one-off payment and then you’ve got like nine months as a free course thing so I took part of it and it did actually help me progress quite well actually. I’d been on 8 weekly programmes before, you see, and they haven't been successful. Whereas, this one …it’s got more time for me to quit…or to reduce, either way” PPT1 |
“Do you think that the programme worked for you overall? Yeah, it did. …and why was that? Well, you know, it just did. We just made our minds up well I did. And, I just stopped.”PPT2 |
“Do you think that the programme worked for you? It has. It actually made a lot of great improvement for myself. Again, I’ve cut down. Sadly, I haven’t completely quit but, I have actually cut down to between 2–3 a day; now, to maybe once every 2 days……and that’s without any patches or anything. So that’s actually… worked for me. It’s like I have a bit more…like a stronger hold on it.” PPT3 |
“Did you find it helpful that you didn’t have to stop completely? I did stop completely. The thing was I did stop completely, I didn’t sort of go smoke and…because, you were allowed to have a certain amount of cigarettes a week. But, from Day 1, I sort of went cold turkey and used the patches. And, I didn’t smoke.“PPT4 |
Motivation |
“Did the offer to join the programme…increase or affect your motivation in any way to try and quit or reduce your smoking? Increased it, because I knew that it was there in place and I could take part in it. I had an opportunity so I worked for it… PPT1 |
“You’ve got some support, haven’t you? If you tried to do it on your own, you’ve got no support. Whereas, if you’re doing it like with… any pharmacy… you start to get educated. You could go in and have a chat and you’d get it all sorted…. It gives you, you know, another incentive to keep going.”PPT2 |
“It’s monitored on a weekly basis. Yeah, that was an incentive really. It’s monitored. Normally, the other ones don’t really get monitored. It gives you a greater incentive to not to smoke. And, especially, when you see the carbon coming down and down every week or when it hits zero” PPT4 |
“When you first joined the programme, did it help your motivation? They did a bit, yeah, of course, you’d have to go through all the process of filling in forms… and talking about it and they ask you all the necessary questions … “What have you tried and have you tried this or have you tried that?” And all the details about how you manage…with those things that you tried and I thought, “Oh, yeah, I will give it another go.” But it didn’t last long, I’m afraid, now” PPT5 |
ID | Treatment | Gender | Smoking status | How recruited |
---|---|---|---|---|
PPT1 | Standard/ Self-help | F | Quit on the programme but had relapsed by time of interview | Known smoker to pharmacist – pharmacist asked if she wanted to join the programme |
PPT2 | Standard/ Behavioural | F | Quit on the programme and still abstinent at interview | Saw the poster advertising programme to quit and asked to be enrolled |
PPT3 | Standard/ Self-help | M | Reduced on the programme, and this was maintained at interview | Known smoker to pharmacist – pharmacist asked if she wanted to join the programme |
PPT4 | Short/Behavioural | M | Quit on the programme and still abstinent at interview | Saw the poster advertising programme to quit and asked to be enrolled |
PPT5 | Short/Self-help | M | Unsuccessful | Known smoker to pharmacist – pharmacist asked if she wanted to join the programme |
Quantitative efficacy measures
Smoking cessation outcomes
Outcome | Short length programme (n = 34) | Standard length programme (n = 34) | ||
---|---|---|---|---|
RR (95%CI) | RD (95% CI) | |||
Any sustained reduction (n) | 4 | 2 | 2.00 (0.46, 8.95) | 0.06 (−0.09, 0.22) |
>50% sustained reduction (n) | 3 | 1 | 3.00 (0.45, 20.44) | 0.06 (−0.07, 0.20) |
Floating 4 week cessation (n) | 3 | 3 | 1.00 (0.24, 4.10) | 0.00 (−0.16, 0.16) |
Floating 6 months cessation (n) | 0 | 0 | N/A | N/A |
Mean difference (SD) | P | |||
Mean (SD) change in cpd baseline – 12 months (baseline carried forward) | −2.29 (7.9) | −2.26 (5.4) | −0.03 (1.65) | 0.98 |
Mean (SD) change in cpd baseline – 12 months (last observation carried forward) | −6.24 (8.81) | −8.41 (9.22) | 2.17 (2.19) | 0.32 |
Median (range) change in cpd baseline – 12 months (baseline carried forward) | 0 (−30, 20) | 0 (−20, 0) | ||
Median (range) change in cpd baseline – 12 months (last observation carried forward) | −5 (−30, 20) | −8 (−35, 18) |
Outcome | Behavioural support (n = 36) | Self - help (n = 32) | ||
---|---|---|---|---|
RR (95% CI) | RD (95% CI) | |||
Any sustained reduction (n) | 4 | 2 | 1.78 (0.41, 7.97) | 0.05 (−0.11, 0.2) |
>50% sustained reduction (n) | 3 | 1 | 2.67 (0.4, 18.19) | 0.05 (−0.09, 0.19) |
Floating 4 week cessation (n) | 2 | 4 | 0.44 (0.10, 1.95) | −0.07 (−0.24, 0.08) |
Floating 6 months cessation (n) | 0 | 0 | N/A | N/A |
Mean difference (SD) | P | |||
Mean (SD) change in cpd baseline – 12 months (baseline carried forward) | −1.58 (7.2) | −3.36 (6.14) | 1.48 (1.64) | 0.37 |
Mean (SD) change in cpd baseline – 12 months (last observation carried forward) | −7.31 (8.98) | −7.34 (9.21) | 0.04 (2.21) | 0.98 |
Median (range) change in cpd baseline – 12 months (baseline carried forward) | 0 (−30, 20) | 0 (−21, 0) | ||
Median (range) change in cpd baseline – 12 months (last observation carried forward) | −5.5 (−30, 20) | −7 (−35, 18) |