A Randomized Clinical Trial Of The Efficacy Of Extended Smoking Cessation Treatment For Adolescent Smokers

Methodology

Discuss about the Critical Appraisal for Nicotine & Tobacco Research.

Bailey, S. R., Hagen, S. A., Jeffery, C. J., Harrison, C. T., Ammerman, S., Bryson, S. W., … & Killen, J. D. (2013). A randomized clinical trial of the efficacy of extended smoking cessation treatment for adolescent smokers. nicotine & tobacco research, 15(10), 1655-1662.

1. a) The title of the article “A randomized clinical trial of the efficacy of extended smoking cessation treatment for adolescent smokers” is an appropriate title. This is due to the way the researchers structure the research process. The target population of adolescents, randomization of the trial group and the extension period of treatment are all aspects that have well been applied. The article studies the impact of extended smoking cessation treatment to school going adolescent smokers.
2. b) The reason for the study given by the authors is that there are a relatively small number of studies, well designed done on teen smoking cessations. It fills the gap on the study of the effect of smoking cessation to school going teen smokers. The study is also properly designed to fit the requirements.
3. a) Selection bias results where there is an issue with the selection of participants. That is where the researchers select the participants without considering a clear inclusion and exclusion criteria.
4. i) Sampling involved all the students in 3 years of study in 10 participating schools according to their smoking habits. All students who used to smoke more than 10 cigarettes a day were eligible for the research. The all-inclusive strategy eliminates any instance of selection bias.
5. ii) The sample represents the population quite well since it includes all adolescent smokers in the institutions participating. out of the 612 eligible students, 141 of them participated in the research process. This is a more than 20% representation which gives satisfactory results. The outcome can thus be generalized to the population.

The sample size of 141 smoking students is satisfactory. It is greater than 30 and thus significant to represent the population at large. The research outcome will thus be reliable and applicable to the entire population.

1. b) Allocation bias occurs when there is a significant difference between the participants in the treatment groups.
2. i) The risk of bias in the selection of participants was eliminated by giving all the smoking students a chance to decide whether to participate in the process. The open-label treatment was designed for all smoking students in the schools a chance to decide on whether they would join the research. The students were randomly allocated to the intervention or control group randomly via a computerized mode. This eliminates allocation bias since the researchers had no control on the members of the different groups.
3. ii) It is necessary to have the control group and the intervention group similar in order to avoid changes that may arise from any diversion in characteristics. This simply implies that the two groups experience exactly the same problem. Similar intervention and control groups validate the resulting difference in the outcome.

 At baseline, the two groups were similar in characteristics. This is because of the participants on the bias of similar inclusive criteria. The number of members to be in either the control or intervention group was randomly done via computer. Thus the researchers eliminate any chance of bias in the allocation and also ensure that the numbers are the same in both groups. Similar characteristics and quantity qualifies the difference in the outcome. It guarantees that the resultant difference is just due to the intervention and not the participants.

1. Drop-outs in research may interfere with the final results of the process
2. i) In any given research process, it is necessary to record drop-out rates. This ensures that the purported loss of data that the participants fail to give is accounted for in the deduction of results. Difference in drop-outs in the different groups may alter the outcome of the research.
3. ii) In the research above, among the participants who satisfied the inclusion criteria only 1 in every group dropped with the reason that the both cohabited with a participant in their group. This has no significant effect on the findings of the study since they are well represented by their roommate. The drop-outs have no effect on the diversity between the groups since each is well represented.

The intervention included additional group sessions for a 14 weeks period with plans to cope up with urging situations, prevent relapse and as phone interventions. The description is clear and can be used as a guide for future research on the same topic. Employing the intervention as indicated is possible in future research.

1. b) The research takes into consideration all the eligible students in the school institutions. The screening process on the inclusive criteria was well established. Allocation to the two groups was randomly done via computer. The participants were also blinded on the group allocation till the end of the open-label treatment period. The proper planning on the selection and allocation processes eliminates any possibilities of bias in the process.
2. c) Performance bias happens when either the control or intervention gets more attention than the other. This affects the internal validity of the research results. The blinding of the participants to allocation can cause biases in treating the different groups during the open-label treatment. The researchers checked the progress of the participants in both groups on a monthly basis. The treatment site between the groups is the same since they all were assessed on phone calls and thus the setting is constant. The examiners were all graduates and thus tend to give a similar quality of treatment to the participants. The qualifications indicate that there is no significant risk of bias in intervention.
3. d) In the research, 21%of the students determined to be eligible for the study passed the inclusion criteria. The results of the research are thus valid and can be generalized to the whole population. The application of extended smoking cessation treatment in teens will thus help fight the problem in the society.
4. There was need to seek the consent of the students before they could be included in the process. Those below 18 years of age signed an assent form while the others above 18 years signed a consent form. The ones under 18 years of age and passed the eligibility test a telephone screening to get the individuals health record from the parent or guardian. For year 1 students, either oral or written consent forms were signed while year 2 and 3 students were required to sign a written consent form. Ethical concerns of the research process were well taken care of. There are no records of issues with conflict of interest in the research.

Part B

1. The study finds that recommendations given in recent studies that school-based intervention for longer durations that include psychosocial component tends to increase adolescents smoking cessation rates. This is a result of the conducive and encouraging environment that is possible and applicable in the school setting. The attention given to the students also alters the results in the process.
2.   The main strength of the research is in the choice of research trainers and therapists. Their expertise in the field indicates a higher level of efficiency in the performance. These eliminate instances of negative outcomes that may result from in competencies. The setting of the research within the schools is also an aspect of the strength of the research. The weakness of the research is on the follow-up process. Phone calls are not efficient ways to get the necessary progress. It would be better if interviews and questionnaires are involved in the process. This would increase the assurance of clear results that portray the result on the firsthand basis.
3.   According to Kalb et al (2015), nursing education requires that there is proper administration, collegial support and a sustained institution in order to attain the expected goals. This is in line with the result of the study that a proper approach to the problem will increase the smoking cessation rates. Proper planning of the research to keep track of the improvement of the participants’ ways of coping with the problem is essential. Following the improvements of the participants keenly validates the outcome. It develops a sense of reliability of the outcome on every participant.

The study also suggests that increased exposure/ intervention period definitely results in improved cessation rates. Brandon et al (2016) state that an increase in duration and intensity of intervention above 6 months improves abstinence rate. This, therefore, indicates that increase in exposure time will improve the rate of cessation in smoking adolescents. There is need that further research in longer periods of exposure to the intervention is applied.

In conclusion, the extended smoking cessation strategy is effective in assisting teens to counter the problem. The community should apply the method in the institutions of learning. There is need to do a study for a period longer than six months. This will further emphasize on the results.

Brandon, T. H., Simmons, V. N., Sutton, S. K., Unrod, M., Harrell, P. T., Meade, C. D., … & Meltzer, L. R. (2016). Extended self-help for smoking cessation: a randomized controlled trial. American journal of preventive medicine, 51(1), 54-62.

Kalb, K. A., O’Conner-Von, S. K., Brockway, C., Rierson, C. L., & Sendelbach, S. (2015). Evidence-based teaching practice in nursing education: Faculty perspectives and practices. Nursing education perspectives, 36(4), 212-219.