Research Proposal- E-cigarettes In COPD Smokers.

Posted: January 12th, 2023

Research Proposal- E-cigarettes In COPD Smokers.

Background

COPD is a debilitating illness that involves inflammation and remodeling of the lungs and airway resulting in poor pulmonary functioning, cor pulmonale, failure of the respiratory system, and even death. According to Polosa et al. (2016), by the year 2030, COPD will be the 3^rd cause of death globally. In the advanced form, COPD has a huge economic burden on the healthcare system. For instance, in the US, its direct and indirect costs are approximately $29.5 billion and $20.4billion respectively. In the UK, currently, existing evidence reveals that the direct costs of managing a patient are £819 yearly (Polosa et al., 2016). Research Proposal- E-cigarettes In COPD Smokers.

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The distinguishing airway inflammatory response that occurs in COPD is due to tobacco smoking, which has contributed to about 15-20% of a COPD diagnosis in smokers (Polosa et al., 2018). Besides, both COPD ex-smokers and smokers are potentially at risk of DM cancers, and cardiovascular illnesses. Therefore, it is vital to improving the prognosis of COPD patients smoking cessation. Cessation decreases the rate of yearly declines in lung function, improves the overall health status, and reduces the extent or severity of respiratory symptoms. According to Lee et al. (2018), cessation also lessens the risks of complications and deaths of CV diseases and other tobacco-associated illnesses. Therefore, it is extremely necessary to incorporate cessation when managing COPD smokers.

The FDA permitted the use of NRT, varenicline, and bupropion combined with counseling as the best cessation strategy. Although these strategies have demonstrated effectiveness in promoting abstinence in COPD smokers, their rates of relapse. Unsuccessful quitting attempts and frequent relapses are even more common in COPD patients due to high pack-years, lack of motivation to quit, high nicotine dependence, and a high risk of depressive symptoms. Due to the poor patient response to cessation efforts, it is necessary to improve the quit rates. Thus the need for more efficient and effective cessation interventions. Research Proposal- E-cigarettes In COPD Smokers.

Purpose Statement

The recommended therapies used currently for smoking cessation especially NRT seem to be ineffective COPD patients since most of them require ongoing support and long-term treatment regimens for long-term abstinence. Besides, patients who develop physical dependence have difficulties in discontinuing nicotine completely. Existing research recommends ECs use as a perfect method to promote cessation in this patient population. When compared to conventional cigarettes, ECs are not only popular but also highly efficacious and effective in reducing tobacco smoking (Polosa et al., 2016). They are competitively cheaper, do not burn, and sustains the smoking experience.

It is anticipated that reducing the consumption of conventional cigarettes by changing to ECs should result in significant health benefits. According to a National Health Interview Survey conducted in 2015, the researchers found that using ECs among patients with COPD was more reliant in preventing relapse to tobacco smoking (Polosa et al., 2018). Patients who used ECs gained health-wise and their respiratory symptoms improved significantly. Research Proposal- E-cigarettes In COPD Smokers.

This paper aims at determining the effectiveness of ECs e-cigarettes compared to NRT in cessation among patients with COPD. Although e-cigarettes also contain nicotine, a potent psycho-stimulant that should be avoided in young people, in conventional cigarette smoking, the combustion of tobacco chemicals rather than nicotine, is the major cause of tobacco-associated illnesses and complications. Healthcare providers need to be more concerned about the damage related to the potentially dangerous components generated after smoking tobacco rather than the combustion of nicotine per se.

Theoretical/Conceptual Framework

The theory of goal attainment by Imogene King will provide a conceptual framework for this study. While drawing on the interaction that occurs between its major concepts of social, personal and interpersonal systems, this theory will be used to determine the attainment of smoking cessation goals after participants’ mutually setting goals and formulating plans for smoking cessation (Adib-Hajbaghery & Tahmouresi, 2018). It will also help to determine possible interpersonal, social and personal reasons that can prevent or inspire the attainment of goals. Research Proposal- E-cigarettes In COPD Smokers.

In this context, a goal is described as an expected outcome that participants organize their behaviors towards attaining and can be differentiated from aspirations, which participants would like to occur, but might not be pursuing directly(Adib-Hajbaghery & Tahmouresi, 2018). In the case of smoking cessation, the ultimate aspiration will be to never to smoke again. The probable goal will be not to smoke again. Research Proposal- E-cigarettes In COPD Smokers.

Literature Review

According to the study by Polosa et al. (2018), very few studies have explored how ECs affect the health of patients with COPD. They conducted a study to assess the long-term respiratory symptoms of patients with COPD who either eased or significantly reduced using conventional cigarettes with ECs. In a prospective research design of a sample of 44 patients with COPD, the researchers: re-evaluated the physical activity (6MWD), spirometric indices, COPD exacerbations, conventional use of cigarettes in EC COPD users, and conducted subjective assessments using CAT scores. The researchers compared the baseline measurements with outcome data during follow-up visits (12, 24, and 36 months) before switching to ECs. Polosa et al. (2018) used sex and age-matched regular smoking patients with COPD who did not use ECs as the control group.

When compared to baseline data in the intervention group (EC users), Polosa et al. (2018) found a significant decline in conventional cigarette users. Although they found no changes in pulmonary function patients in the intervention group showed a huge improvement in exacerbation rates, CAT scores, and 6MWD (p<0.01). Although the findings of this study were not statistically significant, it was clinically significant in supporting ECs use to promote cessation and improve COPD smokers’ health status. A key limitation of this study is that the researchers used a very small patient cohort (44) which requires a lot of caution during interpretation.

Polosa et al. (2016) acknowledge electronic cigarettes as an alternative method to help patients diagnosed with COPD to either quit smoking or reduce tobacco consumption. However, the researchers’ highlight that, there lacks adequate evidence on how ECs use in COPD smokers affects their health status, and if regular EC use promotes improvement in objective and subjective outcomes. Their study purposed to establish the changes in the subjective and objective COPD outcomes among COPD patients who ceased smoking or significantly reduced tobacco smoking after converting to ECs use. Research Proposal- E-cigarettes In COPD Smokers.

In a retrospective research design, Polosa et al. (2016) reviewed charts of COPD patients to identify those who used ECs daily in at least two follow-up visits. They used regular smokers with COPD as the control group. Based on the findings, there was a huge reduction in tobacco smoking in COPD patients who used ECs 2.3 to -1.8 (±1; p = 0.002), to 1.4 (±0.9; p < 0.001). The researchers also noted reduced rates of COPD exacerbations in the intervention group (ECs users) than the reference group. To add on, in the intervention group, participants’ ability to engage in physical activities and COPD symptoms has some statistical improvement. The findings emphasize on using ECs for long-term smoking cessation in COPD smokers. However, since the researchers used self-reported data to assess smoking cessation among participants, it may have a high likelihood of recall bias. Research Proposal- E-cigarettes In COPD Smokers.

Tobacco smoking causes high incidences of complications (Lee et al., 2018). It is for this reason that ECs are alternatively used as a cessation method. Therefore, they conducted a study whose purpose was to establish the acceptability and feasibility of ECs when compared to the nicotine patch. In randomized controlled research design, Lee et al. (2018) randomized 30 patients to an intervention (EC n=20) or a control group (nicotine patch n=10). The participants received brief counseling and referred to a smokers’ Helpline in California. The rates of cessation established through the amount of exhaled carbon monoxide were the primary outcome while the secondary outcome was lung function, smoking habits, product satisfaction, and adverse effects. Research Proposal- E-cigarettes In COPD Smokers. The researchers found a similar rate of cessation in both groups but in the intervention group, FEV1- 592 ml and FEV1/FVC ratio- 40.1 % was more than in the reference group. Although the findings supported the long-term ECs use in cessation when compared to nicotine patches, Lee et al. (2018) did not mention whether the population sampled had COPD and there was inconsistency in behavior support that was given to participants in both groups. Research Proposal- E-cigarettes In COPD Smokers.

Research Question

Broad Research Question

What is the effectiveness of E-cigarettes for cessation in COPD smokers?

Specific Research Questions

What motivates COPD smokers to quit smoking?
What are the reasons for relapse in COPD smokers?
What smoking-cessation methods do COPD smokers prefer?

Independent variable	Conceptual Meaning/Operational Method
Mode of smoking cessation	Method to stop smoking tobacco
Motivations to quit smoking	Reasons to stop tobacco consumption.
Reasons for relapse	Going back to regular tobacco smoking
Dependent
Smoking cessation	Process of discontinuing tobacco smoking

Methods

Research Design

The researcher will use a qualitative research design as it is the most appropriate in capturing the participant’s experiences through semi-structured interviews and focus groups. Focused groups promote the interaction of participants. Semi-structured interviews enhance a more detailed understanding of the investigated issue. Since the latter will be in the form of narratives, participants will be able to express their opinions freely.

The study will take place between May 2020 and July 2020. Purposive sampling of patients diagnosed with COPD for interviews and focused groups will be recruited through the respiratory clinic. An advertisement placed at the respiratory clinic announcement board will address those who are willing to take part regardless of race, religion, or ethnicity. Nurses and GPs in other departments will inform patients of the opportunity to take part in the study. Trough focused-groups and interviews, the researcher will seek to understand and categorize participants’ opinions on motivations to quit, reasons for relapse, and methods to quit. Outcome data will be analyzed through descriptive qualitative methods. Research Proposal- E-cigarettes In COPD Smokers.

Sample

Target population-The study will only incorporate patients diagnosed with COPD who currently smoke or previously smoked within the last 6 months attending the respiratory clinic.

Accessible sample– COPD patients attending the respiratory clinic who use ECs for smoking cessation as the intervention group and those who use NRT as the control group.

Sampling Procedure, Inclusion and Exclusion Criteria

Purposive sampling of participants drawn from a sample of patients diagnosed with COPD attending the respiratory clinic enrolled for smoking cessation programs using either ECs or NRT. The inclusion criteria will be patients aged 18 years or older and enrolled in a smoking cessation program within the last 6 months. The exclusion criteria will be patients aged less than 18 years old and enrolled in less than 6 months into a smoking cessation program. Research Proposal- E-cigarettes In COPD Smokers.

Ethical Considerations

Participation will be voluntary and before taking part in the study, the researcher will provide comprehensive details about the study to all the willing participants. In particular, information that will be shared include the objective of the study, how outcomes of the study will be shared with participants, and how the findings will be used. Those who decide to take part will sign an informed consent that will also help to safeguard their anonymity and maintain confidentiality (Fineout-Overholt & Melnyk, 2005).

Setting

The study will take place in the outpatient setting of a respiratory clinic in a large metropolitan hospital. Advertisements will be placed and disseminated to general practitioners, nurses, and patients in other departments of the metropolitan hospital and will address anyone willing to take part in the study.

Instrumentation

A smoking cessation questionnaire will be designed and administered to participants through focused groups and semi-structured interviews. This questionnaire will assess and analyze the following participant factors: motivations/reasons to quit, social improvement/nonsmoker identity, the effectiveness of methods to quit, adverse outcomes, treatment barriers, reasons for relapse. Research Proposal- E-cigarettes In COPD Smokers.

Reliability and Validity

To increase the reliability of the population and findings, the researcher will use a consistent environment to conduct focus groups and interviews (Polit & Beck, 2008). To increase the validity, a multidisciplinary team will assess the Smoking Cessation Questionnaire (SAQ) for data collection as well as help in data analysis. The team will also help in analyzing data to reduce the likelihood of bias from the researcher. Research Proposal- E-cigarettes In COPD Smokers.

Data Analysis

A multidisciplinary team comprising of the researcher, a physician, and a therapist will analyze the results through descriptive qualitative methods. The analysis of the data collected through semi-structured interviews will aim at establishing an honest descriptive summary of the findings. Transcripts analysis will aim at identifying meaning units that define participants: reasons for smoking relapse, motivations for smoking, and methods of smoking cessation.

Summary

The only common cause of COPD is cigarette smoking. According to WHO, 15-20% of cigarette smokers usually develop COPD, and currently, up to 37% of patients with COPD are still smokers. Since all patients diagnosed with COPD smoke or smoked in the past, they are at the potential risk of DM, cancers, and cardiovascular illnesses such as coronary artery disease and ultimately, a higher CVD mortality rate. Research indicates that cessation in COPD smokers improves the quality of life and changes the clinical course of COPD by primarily reducing all-cause mortality and the rate of decline in lung function. While NRT has been associated with high relapses among COPD patients who want to quit smoking, ECs have proven to be more reliant in preventing relapses with health benefits and significant improvement in respiratory symptoms.

This study aims at determining how effective ECs are, compared to NRT for cessation in COPD smokers. It uses the PMT theory as a framework to examine the motivations for cessation, reasons for cessation, and methods of cessation among COPD smokers. When compared to NRT, the literature review findings recommend ECs use as a long-term cessation method in COPD smokers. The study will take place in the outpatient setting of a respiratory clinic in a large metropolitan hospital. It will include a purposive sample of patients with COPD on follow-up at the clinic enrolled in smoking cessation programs with either ECs or NRT. Data will be collected through semi-structured interviews and focus groups using a smoking cessation questionnaire and analyzed through descriptive qualitative methods. Research Proposal- E-cigarettes In COPD Smokers.

References

Fineout-Overholt, E., & Melnyk, B. M. (2019). Evidence-Based Practice in Nursing and Healthcare: A guide to best practice. Wolters Kluwer

Lee, S. M., Tenney, R., Wallace, A. W., & Arjomandi, M. (2018). E-cigarettes versus nicotine patches for perioperative smoking cessation: a pilot randomized trial. PeerJ, 6, e5609. Research Proposal- E-cigarettes In COPD Smokers. https://doi.org/10.7717/peerj.5609

Polit, D. F., & Beck, C. T. (2017). Nursing research: Generating and assessing evidence for nursing practice. Lippincott Williams & Wilkins.

Polosa, R., Morjaria, J. B., Caponnetto, P., Prosperini, U., Russo, C., Pennisi, A., & Bruno, C. M. (2016). Evidence for harm reduction in COPD smokers who switch to electronic cigarettes. Respiratory Research, 17(1), 166. https://doi.org/10.1186/s12931-016-0481-x

Polosa, R., Morjaria, J. B., Prosperini, U., Russo, C., Pennisi, A., Puleo, R., Caruso, M., & Caponnetto, P. (2018). Health effects in COPD smokers who switch to electronic cigarettes: a retrospective-prospective 3-year follow-up. International journal of chronic obstructive pulmonary disease, 13, 2533–2542. https://doi.org/10.2147/COPD.S161138

Steinberg, M. B., Zimmermann, M. H., Delnevo, C. D., Lewis, M. J., Shukla, P., Coups, E. J., & Foulds, J. (2014). E-cigarette versus nicotine inhaler: comparing the perceptions and experiences of inhaled nicotine devices. Journal of general internal medicine, 29(11), 1444–1450. https://doi.org/10.1007/s11606-014-2889-7

Adib-Hajbaghery, M., & Tahmouresi, M. (2018). Nurse–patient relationship based on the Imogene king’s theory of goal attainment. Nursing and Midwifery Studies, 7(3), 141.
Appendices

Appendix A: Evaluation Matrix Table

Study Citation and Level of Evidence	Purpose	Design	Sample	Measurement tool(s)/Instrument(s)	Statistical Analysis	Key Findings
Polosa, R., Morjaria, J. B., Prosperini, U., Russo, C., Pennisi, A., Puleo, R., Caruso, M., & Caponnetto, P. (2018). Health effects in COPD smokers who switch to electronic cigarettes: a retrospective-prospective 3-year follow-up. International journal of chronic obstructive pulmonary disease, 13, 2533–2542. Level III	To establish the effects of e-cigarettes on the health of COPD smokers.	Retrospective cohort	44(37 male and 7 female).	CAT scores (COPD Assessment Tool) 6MWD (6-minute walk distance)	T-test Wilcoxon-signed rank test	There was no change in pulmonary function but a marked improvement in the rates of COPD exacerbations, 6MWD, and CAT scores (p<0.01) in the intervention group.
Polosa, R., Morjaria, J. B., Caponnetto, P., Prosperini, U., Russo, C., Pennisi, A., & Bruno, C. M. (2016). Evidence for harm reduction in COPD smokers who switch to electronic cigarettes. Respiratory Research, 17(1), 166 Level III	To determine the strategies of reducing harm among COPD smokers who used e-cigarettes	Retrospective cohort design	48: 24(ECs)	CAT scores (COPD Assessment Tool) 6MWD (6-minute walk distance)	Student’s t-test Wilcoxon-signed rank tests	The researchers noted a marked reduction in the consumption of cigarettes among patients who used ECs. Patients in the intervention group also had decreased COPD exacerbations at 12 and 24 months follow-up (2.3-1.8-1.4) with some statistical improvement in EC users’ capability to engage in physical activity. No change was noted in the control group.
Lee, S. M., Tenney, R., Wallace, A. W., & Arjomandi, M. (2018). E-cigarettes versus nicotine patches for perioperative smoking cessation: a pilot randomized trial. PeerJ, 6, e5609 Level I	To determine the feasibility of e-cigarettes in comparison to nicotine patches.	Pilot randomized trial	30	Pico Smokerlyzer and Ezone Spirometer	Fisher exact test, Student t-test Wilcoxon –signed-rank test.	The researchers noted the same satisfaction rates and smoking cessation in both groups. However, FEV₁ was greater in the e-cigarette group by 592ml.

Appendix B: Questionnaire

Q1. Do you feel happy about the decision to quit smoking?

Often
Never
Very Often

Sometimes

Q2. What motivated you to Quit Smoking?

Ban on smoking at work and home due to rules and peoples wishes
The high cost of cigarettes
Unpleasant smell,
Health concern
Pregnancy and breastfeeding

Q3. How many times have you switched to smoking tobacco after enrolling for cessation?

Never
Once
Twice
More than twice

Q4. What were the reasons for relapse?

Stress
To re-experience pleasure for tobacco smoking
A smoking environment
Withdrawal symptoms

Q5. In the next four months, do you think that you will smoke tobacco?

Never
Not Sure
Once
Several times

Q6. What Smoking Cessation method do you use?

E-cigarettes
NRT
Other

Q7. If you had the chance to re-select a method for cessation, would you still choose your current method?

Never
Yes

Q8. What action were you trying to achieve when you first stopped smoking on your last quit attempt?

To assess how I would go
To take it one cigarette at a time
To attain a short-term goal
Not to smoke again

Purpose Statement

Theoretical/Conceptual Framework

Literature Review

Tobacco smoking causes high incidences of complications (Lee et al., 2018). It is for this reason that ECs are alternatively used as a cessation method. Therefore, they conducted a study whose purpose was to establish the acceptability and feasibility of ECs when compared to the nicotine patch. In randomized controlled research design, Lee et al. (2018) randomized 30 patients to an intervention (EC n=20) or a control group (nicotine patch n=10). The participants received brief counseling and referred to a smokers’ Helpline in California. The rates of cessation established through the amount of exhaled carbon monoxide were the primary outcome while the secondary outcome was lung function, smoking habits, product satisfaction, and adverse effects. The researchers found a similar rate of cessation in both groups but in the intervention group, FEV1- 592 ml and FEV1/FVC ratio- 40.1 % was more than in the reference group. Although the findings supported the long-term ECs use in cessation when compared to nicotine patches, Lee et al. (2018) did not mention whether the population sampled had COPD and there was inconsistency in behavior support that was given to participants in both groups. Research Proposal- E-cigarettes In COPD Smokers.

Research Question

Broad Research Question

What is the effectiveness of E-cigarettes for cessation in COPD smokers?

Specific Research Questions

What motivates COPD smokers to quit smoking?
What are the reasons for relapse in COPD smokers?
What smoking-cessation methods do COPD smokers prefer?

Independent variable	Conceptual Meaning/Operational Method
Mode of smoking cessation	Method to stop smoking tobacco
Motivations to quit smoking	Reasons to stop tobacco consumption.
Reasons for relapse	Going back to regular tobacco smoking
Dependent
Smoking cessation	Process of discontinuing tobacco smoking

Methods

Research Design

Sample

Target population-The study will only incorporate patients diagnosed with COPD who currently smoke or previously smoked within the last 6 months attending the respiratory clinic.

Accessible sample– COPD patients attending the respiratory clinic who use ECs for smoking cessation as the intervention group and those who use NRT as the control group.

Sampling Procedure, Inclusion and Exclusion Criteria

Ethical Considerations

Setting

Instrumentation

Reliability and Validity

Data Analysis

Summary

Background

Purpose Statement

Theoretical/Conceptual Framework

The protection motivation theory (PMT) by Rogers will provide a cognitive conceptual framework to investigate the motivations for cessation, reasons for cessation, and methods of cessation among COPD smokers. Initially, this theory explained the reasons people develop protection motivation and the influence of fear in the entire process. In its original model, fear was a vital factor that influenced the selection of behavior by a person while cognition played a major role in decision-making, which led to behavior change (Sabzmakan et al., 2018). This theory has undergone several revisions since it was first developed. Its current form has two major pathways namely; the coping and threat appraisal. The collaboration that exists between the two pathways is the determinants of the likelihood of whether or not a patient with COPD can cease smoking.

The threat appraisal pathway evaluates maladaptive behaviors using four constructs grouped into two perceived rewards (extrinsic and intrinsic rewards) and perceived threats (vulnerability and severity) (Sabzmakan et al., 2018). Coping appraisal evaluates a patient’s ability to manage and avoid threats sing three constructs grouped into two: perceived cost (response cost) and perceived efficacy (self-efficacy and response efficacy) (Sabzmakan et al., 2018). COPD smokers who perceive smoking to be detrimental with a greater threat can cope and develop non-smoking behavior is will hardly continue to smoke. In his study, the PMT will be used to predict a patient’s motivations to quit smoking, relapse reasons, and methods of quitting. Research Proposal- E-cigarettes In COPD Smokers.

Literature Review

Tobacco smoking causes high incidences of complications (Lee et al., 2018). It is for this reason that ECs are alternatively used as a cessation method. Therefore, they conducted a study whose purpose was to establish the acceptability and feasibility of ECs when compared to the nicotine patch. In randomized controlled research design, Lee et al. (2018) randomized 30 patients to an intervention (EC n=20) or a control group (nicotine patch n=10). The participants received brief counseling and referred to a smokers’ Helpline in California. The rates of cessation established through the amount of exhaled carbon monoxide were the primary outcome while the secondary outcome was lung function, smoking habits, product satisfaction, and adverse effects. The researchers found a similar rate of cessation in both groups but in the intervention group, FEV1- 592 ml and FEV1/FVC ratio- 40.1 % was more than in the reference group. Although the findings supported the long-term ECs use in cessation when compared to nicotine patches, Lee et al. (2018) did not mention whether the population sampled had COPD and there was inconsistency in behavior support that was given to participants in both groups. Research Proposal- E-cigarettes In COPD Smokers.

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