Introduction
It is important to understand how people feel about medical interventions, particularly in the case of behavioural issues, such as smoking cessation. People believe that they have direct insight into behavioural issues and behaviour change by virtue of their past and current experience and, therefore, need to feel that the treatment they are receiving is appropriate or they will not take it.
Methods
At week +1 (1 week after quit day) we asked participants to tell us their views on nicotine preloading. We did not ask similar questions to the control group. We used an open-ended question to ask participants for their views. However, to aid categorisation, the researcher collecting the data ticked one or more statements on a list of beliefs, attitudes and experiences that we had prepared and added to the case report form (CRF). This list was taken from qualitative interviews carried out in a previous study of preloading.17 In addition, we asked participants to rate the helpfulness of preloading and whether or not they would recommend this strategy to another person trying to quit smoking.
Results
The results are shown in Table 13. Overall, 87.2% found preloading to be helpful and 90.5% would recommend preloading to others. A mixed set of beliefs and experiences was reported, most of which reflected a generally positive view of the intervention.
| Question | Number (%) of participants (N = 727) |
|---|---|
| How helpful was the preloading intervention? | |
| Very helpful | 488 (67.13) |
| Slightly helpful | 146 (20.08) |
| Not very helpful | 76 (10.45) |
| Missing | 17 (2.34) |
| Would you recommend the preloading intervention to someone else? | |
| Yes | 658 (92.8) |
| No | 51 (7.02) |
| Unprompted responses to thoughts on preloading | Number (%) of participants mentioning response |
| Experience of smoking | |
| Did not feel urge to smoke | 225 (30.95) |
| Reduced smoking to control nausea | 41 (5.64) |
| Experienced nausea | 87 (11.97) |
| Felt no effect of preloading | 66 (9.08) |
| Lack of enjoyment when smoking | 253 (34.80) |
| Smoking rate reduced | 473 (65.06) |
| Smoking rate stayed the same | 69 (9.49) |
| Smoking rate increased | 16 (2.20) |
| Relief to stop smoking | 107 (14.72) |
| Smoking intolerable | 31 (4.26) |
| Ready to quit on quit day | 254 (34.94) |
| Nausea aided quit attempt | 50 (6.88) |
| Overall evaluation | |
| Helpful | 495 (68.09) |
| Disappointed with preloading | 38 (5.23) |
| Surprised asked to preload | 93 (12.79) |
| Continued patch use until quit day | 314 (43.19) |
| Discontinued patch use | 64 (8.80) |
| Belief nicotine not harmful | 4 (0.55) |
| Preloading is aversion therapy | 31 (4.26) |
| Worried about preloading | 62 (8.53) |
| Trusted guidance of research team | 198 (27.24) |
| Preloading dangerous | 14 (1.93) |
| Did not accept reason for preloading | 19 (2.61) |
| Aware of previous warnings not to preload | 41 (5.64) |
| Patch AEs | |
| Skin irritation | 122 (16.78) |
| Sleep disturbance | 125 (17.19) |
| Trouble getting patches to stay on | 86 (11.83) |
Discussion
Participants in this trial were generally happy to preload, reported it as a positive experience and would recommend the strategy to others.
This evaluation was only ever meant to give some overall sense of participants’ reactions to preloading and clearly this lacks depth. In particular, we did not record or note the verbatim thoughts of participants and, for practical reasons, the research team interpreted what participants said and ticked one or more boxes that they felt captured their thoughts. This process is likely to be somewhat inaccurate, depending on the interpretation in the moment of the conversation, as well as not capturing the full extent of participants’ thoughts. Nevertheless, in the absence of a full qualitative analysis, which was not planned nor funded, we believe that it reinforces data presented in Chapters 1 and 2. In particular, it suggests that preloading was well tolerated and that most participants perceived changes in their smoking as a result of preloading. In the preloading trial group, 65% of participants perceived the reduction in consumption and 35% felt that smoking was less enjoyable. These spontaneously reported effects reinforce what we captured quantitatively in the mediation analysis.
Conclusion
These limited reflections on participants’ feelings about preloading suggest that most participants found it helpful and that the large majority would recommend preloading.