Barriers to patients recruitment
Patients received in consultation by health professionals mostly correspond to the target population of our study, however several difficulties relative to recruitment were reported, which can be grouped into four categories:
Exclusion criteria (lack of French language skills, a high income, a center policy that results in patients being mostly already treated, under legal guardianship),
Difficulties to evaluate eligibility criteria (detecting social benefits/ low SEP),
Problems inherent to the patient (hospitalized, geographical distance),
And finally, some health professionals’ preconceived idea that the desire to stop smoking is not a priority for smokers with low SEP, and quitting is perceived as more challenging among this population.
This last point calls for vigilance regarding the prejudices that some health professionals might have relative to what the patient thinks is a priority for him/her.
Although health professionals agreed that smoking cessation is a priority for their low-SEP patients, some comments indicated otherwise.
A study based on the National Health Interview Survey (NHIS) of 2001 in the US [
19], revealed that assistance with smoking cessation was less frequently reported by patients with high or mid-levels of disadvantage compared to those with low levels. Levels of disadvantage were scored depending on education, income, and health insurance. The authors explain this by the fact that patients in these situations are those among whom prevalences of smoking and associated comorbidities are the highest. Thus, health care professionals may feel that they are less likely to be successful in quitting. In addition, the facilities that provide care for this patient population are often in busy, under-staffed environments, which limit the smoking cessation treatments.
A systematic review on perceived barriers to smoking cessation among vulnerable groups reports cases where health professionals discourage smoking cessation because they were concerned about their mental health, or because they thought smoking was their only source of pleasure [
20]. Several studies cited in this review highlight lack of support to quit from health professionals [
20]. These results based on a systematic review of the literature suggest that some health professionals might have the preconception that disadvantaged patients have other “higher priority” problems and that quitting smoking could add to or exacerbate them.
Finally, health professionals report that smokers with low SEP have inherent difficulties in smoking cessation. Withdrawal is perceived as more complicated, as is smoking cessation initiation or participation in a study. Follow-up and adherence to care are also perceived as more difficult for these patients.
A literature review on barriers faced by low SEP patients to smoking cessation reports a lower ability to reach smoking cessation support because of low mobility, low social support, and a tendency to perceive it as inappropriate or inaccessible [
21].
Participation of health professionals in a research intervention
Health professionals did not report high satisfaction with their participation in the study. They mostly did not report gaining more information about NRT and e-cigarettes, discussing smoking cessation more often, or changing their perception concerning the desire to quit among low SEP populations. However, one of the goals of the study is to prove that giving free cessation tools to these patients according to their own choice would lead to greater success in quitting smoking. The professionals most convinced that this intervention would allow them to better help their patients, or would allow a better adherence to the care of their patients, were the smoking cessation specialists and the medical doctors.
The most frequently cited barriers and constraints related to participating in the study were the lack of time combined with the already present heavy workload. Indeed, since the investigating centers are public hospitals or health centers, the lack of staff and the influx of patients beyond capacity can make research take second place to care. Consultations must be quick and efficient in order to see as many patients as possible, and the addition of time that is not strictly necessary is perceived as burdening and therefore denied. The SESMAT qualitative survey [
22] asked physicians about work difficulty. The results highlight physicians’ frustration over chronic extensive workload (quantity, time, lack of recognition), administrative burden and lack of time. Since these issues are already present in everyday life, the addition of a research intervention can represent a constraint rather than a motivation.
Health professionals may also have been uncomfortable by the content of some questions in the questionnaire, such as questions on socio-economic background by fear of stigma. They reported that it could be complicated to submit it into the middle of a specific appointment, and that it may strain the already fragile therapeutic alliance with low SEP patients. Moreover, due to lack of time, sometimes these questionnaires replaced routine questioning that the professional would have liked to carry out. Thus, it may be considered more relevant to separate the time of care and the time of research by avoiding integrating the data collection in the consultation. In addition, they may be apprehensive about patients’ reluctance to participate in research. Patients may experience it as a “test”, and this may weaken the physician-patient trust relationship. Finally, health care professionals are sometimes not well trained in research and may be afraid of making errors and distorting the study.
Our results are consistent with a qualitative study on perceptions of recruiters in six Randomized Control Trials (RCTs) [
23]. Doctors struggled to balance their roles as recruiters and clinicians, leading to conflicts with clinical practice, uncertainty about the best treatment, and willingness to recruit patients. Nurses also faced conflicts between their roles as caring clinical nurses, patient advocates, and recruiters/scientists, causing considerable discomfort and difficulty. Organizational difficulties, lack of eligible patients, and patients’ strong treatment preferences were identified as recruitment barriers, but they were not straightforward and were often reinforced by recruiters’ views. Recruiters’ discomfort and difficulty were significant, leading to low morale and poor recruitment levels, as they had conflicts between carrying out research and ensuring individual patients’ best interests, and strong treatment preferences or clinical instincts that made them uncomfortable recruiting patients outside their comfort zone.
Our results highlight the desire of some health professionals to separate research time from clinical practice time. However, the aim of this pragmatic research, and therefore of the pragmatic trial, was to integrate research into routine, so that the intervention would be as close as possible to real-life conditions. This is so the intervention could be more easily generalized outside the research context.
Some professionals did have positive feedback on the integration of the intervention into their medical practice: it allowed them to refocus on patient preferences and thus improve their patient-centered approach to care. The co-construction of interventions with the target audience is indeed a criterion of effectiveness according to a synthesis of the literature conducted by Guignard et al. on smoking cessation interventions in low SEP patients [
24]. The value of relying on patient preference has already been explained in the STOP study protocol justification [
16].
A qualitative study asked key stakeholders about the challenges raised by pragmatic trials [
25]. It was noted that the difference between research, quality improvement, and practice is sometimes unclear. The boundary is also not well defined for the patient during the consultation time (the point at which one moves from care to research). This may explain why the health professionals in our study would prefer to separate the two components. Moreover, it is requested to compare the intervention to usual care. which can differ between each patient, and between each caregiver. Therefore the difference between the intervention and usual care may vary within the same study. The workload generated by the administrative aspect of the research would then seem disproportionate, for a lesser addition to the usual care given.
Finally, in real life, health professionals are confronted with specific problems while treating low SEP patients. This is why a pragmatic trial specifically tailored to this population has been set up. However, these same issues recur as barriers to the implementation of the research, which illustrates all the complexity of pragmatic trials not just those targeting individuals with lown SEP.