In their randomized controlled trial, Pinsker et al. (2018) explored trends in self-efficacy to quit and smoking urges in homeless individuals with a smoking habit. Pinsker et al. (2018) point out that the levels of self-efficacy and the severity of smoking urges change significantly during the smoking cessation treatment. This observation renders measuring self-efficacy and smoking urges at a single point practically inefficient. Therefore, the questions that the study asks are as follows:
- How do smoking characteristics such as smoking urges, self-efficacy to quit, self-efficacy to abstain from smoking, and confidence to quit change over the course of therapy?
- How do such factors as the treatment group, age, gender, and race impact the trends in smoking characteristics in homeless smokers?
Pinsker et al. (2018) recruited 430 participants from eight emergency shelters and transitional sites located in the Twin Cities of Minneapolis and St. Paul, Minnesota, between May 2009 to August 2010. Eligibility criteria were current homelessness and having resided in the Twin Cities for at least half a year. Smokers were defined as individuals who were smoking at least one cigarette per day during the previous week and had smoked at least one-hundred cigarettes over their lifetime.
Apart from that, participants needed to be of age: 18 years or older, willing to use nicotine patches for eight weeks, and ready to partake in counseling sessions. Pinsker et al. (2018) excluded pregnant women, individuals with serious intellectual impairment and suicidal ideation, and those who were adhering to some other tobacco cessation aid. Homeless individuals with serious medical issues and psychotic symptoms were not eligible for participating in the study. Pinsker et al. (2018) made sure to obtain informed consent from all participants.
At the beginning of the study, participants were randomized and assigned to control and intervention groups. Participants in both groups were receiving similar smoking cessation aid: 21 mg nicotine patches for eight weeks.
The only difference between the two groups was that participants that were subject to intervention also received individual counseling sessions. The said sessions lasted for 15-20 minutes each and focused on accountability promotion, positive encouragement, and nicotine replacement therapy adherence. The counseling of control participants was limited to a one-time group advice session that lasted 10-15 minutes. Pinsker et al. (2018) measured the aforementioned smoking characteristics at one, two, four, six, and eight weeks; a follow-up was administered at 26 weeks after the start of the treatment.
Intrinsic and extrinsic self-efficacy to refrain from smoking were evaluated at the beginning of the study, after week eight, and week 26, using the Smoking Self-Efficacy Questionnaire. The two kinds of efficacies were measured by presenting twelve situations with intrinsic and extrinsic triggers (for example: feeling depressed vs. being around people who smoke). The confidence to quit was assessed by asking participants to describe their determination and intent on a scale from one to ten.
Lastly, Pinsker et al. (2018) employed the Questionnaire of Smoking Urges (QSU-Brief) to understand the nature of smoking urges in participants. Later, the researchers used general linear models with unstructured covariance patterns to compare the results. Intrinsic and extrinsic self-efficacy in both control and intervention participants increased throughout the treatment. Racial minorities showed better results than their white counterparts and expressed more confidence to quit.
The internal validity of a study evaluates to which extent collected evidence supports the initial claim. Confirming internal validity requires the assessment of many aspects such as sampling, setup, and outcome comparisons. Regarding sampling, Pinsker et al. (2018) do not explain the randomization procedure used for their study. The only fact that is known to the reader is that the patients indeed were randomly assigned to control and intervention groups.
The lack of detailed explanation might be a threat to validity due to the unclarity of the method. Further, it is not exactly clear whether the groups (control and intervention) were similar at the start of the trial. The only explanation that Pinsker et al. (2018) provide is the same eligibility and exclusion criteria mentioned above. However, it is impossible to tell whether the groups represented gender, races, and ages equally after randomization.
Since Pinsker et al. (2018) wanted to pinpoint the effect of smoking counseling on smoking homeless participants, they needed to adjust all other treatment factors. It is said that both control and intervention participants were receiving nicotine replacement therapy (21 mg nicotine patches for eight weeks). Besides, the schedule for measurements was the same: one, two, four, six, and eight weeks during the intervention and a follow-up at the 26th week since the beginning of the research. Therefore, it is possible to conclude that both groups were treated equally, safe for the tested intervention.
Pinsker et al. (2018) do not state exactly how many people decided to leave the study at each stage and how many people made it to the follow-up at week 26. The only piece of information that the researchers provide is that after the fourth week, they could not access as many as 25% of the data. Pinsker et al. (2018) made the best out of the data available and did not input any values for those participants who had left the study. However, the researchers made some assumptions that might as well be dubious: for instance, they assumed that all the participants for whom there was no data available were smokers by week 26. On the other hand, Pinsker et al. (2018) acknowledged that the missing information was a significant limitation, which they mentioned in the discussion section.
The study was not double-blinded: both the researchers and the participants were aware of the treatment allocation. The researchers had to know the distinction between the control and intervention groups because they administered different types of counseling depending on the belongingness. Those in the control group only received standard care, as in one group advice session. Those in the intervention group were eligible for individual sessions. Since the outcome is subjective (smoking characteristics concern psychological concepts such as confidence and self-efficacy), the blinding of the outcome is critical.
93% of participants in both control and intervention groups did not quit smoking by the end of the trial (week 26). Pinsker et al. (2018) do not comment on whether the treatment groups showed different performance, therefore, it is assumed that the rate of cessation was equal for both control and intervention participants (LoBiondo-Wood & Haber, 2017). Therefore, the relative risk can be calculated as RR = 0.93/0.93 = 1, which shows that treatment had no effect.
Drawing on this computation, ARR (Absolute Risk Reduction) = 0.97 – 0.97 = 0.00 or 0% and RRR (Relative Risk Reduction) = 1 – 1 = 0. NTT is impossible to calculate because it would require division by zero. Hence, this study’s findings do not allow for making predictions as to how many years it would take for the intervention to be fully effective. The estimated effect was fairly precise as it employed confidence intervals (CI) at 95%. The values corresponding to the zero effect fell well outside the 95% CI, which implies that the result was statistically significant at the 0.05 level.
The major difference between my patients and the study participants is that Pinsker et al. (2018) recruited homeless people while I do not handle this demographic all that much in my practice. I believe that homelessness affects motivation, self-efficacy, and confidence significantly, which implies that the treatment of this type of patient should differ from those who have more stability in their lives. Upshur et al. (2015) and Deck and Platt (2015) state that homelessness can be seen as psychologically traumatizing. This, in turn, may be associated with lower levels of motivation, impaired long-term planning, and continuous psychological distress. Therefore, I am convinced that the counseling methods chosen by Pinsker et al. (2018) may only apply to the homeless.
The treatment is feasible in my setting as it requires medium organizational effort and minimal equipment (nicotine patches, phones, and computers). The biggest challenge that healthcare workers at my place may encounter is similar to the one faced by Pinsker et al. (2018): patients’ inability to adhere to the full course of treatment. Generally, nicotine replacement therapy is considered a safe choice; the same is valid for individual and group counseling (Wadgave & Nagesh, 2016). However, Lee and Farris (2017) show that nicotine patches can have some adverse effects such as nausea, itchiness, soreness, and headache. Based on these facts and observations, it is safe to conclude that the study by Pinsker et al. (2018) has limited applicability.
References
Deck, S. M., & Platt, P. A. (2015). Homelessness is traumatic: Abuse, victimization, and trauma histories of homeless men. Journal of Aggression, Maltreatment & Trauma, 24(9), 1022-1043. Web.
Lee, P. N., & Fariss, M. W. (2017). A systematic review of possible serious adverse health effects of nicotine replacement therapy. Archives of Toxicology, 91(4), 1565-1594. Web.
LoBiondo-Wood, G., & Haber, J. (2017). Nursing research-E-book: Methods and critical appraisal for evidence-based practice. Elsevier Health Sciences.
Pinsker, E. A., Hennrikus, D. J., Erickson, D. J., Call, K. T., Forster, J. L., & Okuyemi, K. S. (2018). Trends in self-efficacy to quit and smoking urges among homeless smokers participating in a smoking cessation RCT. Addictive Behaviors, 78, 43-50. Web.
Upshur, C., Weinreb, L., Bharel, M., Reed, G., & Frisard, C. (2015). A randomized control trial of a chronic care intervention for homeless women with alcohol use problems. Journal of Substance Abuse Treatment, 51, 19-29. Web.
Wadgave, U., & Nagesh, L. (2016). Nicotine replacement therapy: An overview. International Journal of Health Sciences, 10(3), 425. Web.