Clinical Trials Journal Article – A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy by Hajek et al. (2019).
Question
This assignment is based on the CONSORT Statement. Please look over attached link on consort 2010 statement and consort 2010 explanation and elaboration before proceeding with assignment. Then read article on e cigs vs nicotine then work on clinical trial questions.


Solution
Clinical
Trials Journal Article – A Randomized Trial of E-Cigarettes versus
Nicotine-Replacement Therapy by Hajek et al. (2019).
Section/Topic |
Item # |
Checklist item |
Answer |
Introduction: |
|||
Background and objectives |
2b |
Specific objectives or
hypotheses |
According to the study, using
nicotine patches and gum to help smokers quit is more effective than using
electronic cigarettes. |
Methods: |
|||
Trial design |
3a |
Type of Trial |
The trial was dedicated to
randomization. A pseudorandom number generator in Stata was used to generate
sequences if a participant’s information was already entered into the study
database. |
Participants |
4a |
Eligibility criteria for
participants |
After getting trial
materials and being prescreened for eligibility, it was decided whether or
not a person would be eligible to participate in the study. All participants
signed an informed consent form, and baseline data were collected from the
participants before they participated in the study. They were invited to a
baseline session if they met all requirements. |
|
Study Population
|
186 participants |
|
4b |
Settings and locations
where the data were collected |
The United Kingdom’s
National Health Service (NHS). E-cigarette starting kits include a nicotine
e-liquid bottle containing 18 mg/ml and a recommendation to purchase more
e-liquids in flavors and concentrations to fit your tastes. Nicotine
replacement products are available for up to three months at an NHS stop
smoking clinic in the United Kingdom. |
|
Interventions |
5 |
Treatment group and
comparison group interventions
|
Throughout this period,
patients received at least four weeks of counseling. |
Outcomes |
6a |
Primary and secondary (if
any) outcome measures |
One of the study’s primary
outcomes was a year of abstinence, which was later confirmed biochemically. Participants’
reports of therapy use and respiratory symptoms were secondary findings.
Biochemical evidence of abstinence had to be provided by participants to
participate in the study. |
Randomization: |
|
|
|
Sequence
generation |
8b |
Type of randomisation |
Simple |
Masking |
11a |
If done, who was masked
after assignment to interventions and how |
Was not done |
Statistical methods |
12a |
Statistical methods used
to compare groups for primary and secondary outcomes |
Smoking status at each
time point was regressed onto the trial group to investigate the primary and
secondary abstinence outcomes, respectively. The stratification factor was
taken into account in the primary analysis via an adjustment for the trial
center. The baseline covariates for each model were determined using stepwise
regression in the sensitivity experiments, and the results were examined. According
to binary regressions, electronic cigarette use is much more dangerous than
nicotine replacement therapy using generalized linear models with binomial
distributions and logarithmic linkages. |
Results: |
|||
Recruitment |
14a |
Dates defining the periods
of recruitment and follow-up |
Follow-up blood carbon
monoxide testing was required of those who had quit or cut back on smoking by
at least half after 52 weeks of treatment. During the 26-week and 52-week
periods in the trial, participants were contacted by phone. When interviewers
inquired about product consumption, they were prepared to answer honestly
because they knew the many treatment options. A £20 reward was given to those
who traveled and made an effort to attend the 52-week validation visit. |
14b |
Why did the trial end, or
was it stopped
|
Use and evaluation of
trial products and assessments of withdrawal symptoms and side effects were
observed. |
|
Baseline data |
15 |
Are there any differences
between demographic and clinical
characteristics of the treatment group and the intervention group |
After 52 weeks, people in
the e-cigarette group were more likely to use their allocated product than
those in the nicotine-replacement group. |
Outcomes |
17a |
For each primary
outcome, the estimated effect size, and its precision (95% confidence
interval or p-value)
|
Only 51.2 percent of those
who used nicotine-replacement products (NRT) reported throat or mouth
discomfort, compared to 65.3 percent of those who used electronic cigarettes.
The e-cigarette group had significantly less coughing and phlegm production
over 52 weeks than the nicotine-replacement group. There was no significant
difference in the frequency of wheezing and shortness of breath between the
two groups. |
Discussion: |
|||
Limitations |
20 |
Trial limitations,
addressing sources of potential bias and imprecision |
Nothing could hide the
assignment of products. The participants who participated in the e-cigarette
study exerted a lower effort to quit smoking than those who participated in
the nicotine replacement study. |
Potential bias not
addressed |
|
Are there any sources of
bias that were not addressed by the authors (this is your interpretation) |
Insufficient follow-up of
trial participants could be another source of bias if the results of multiple
imputations were consistent. |
Interpretation |
22 |
Interpretation consistent
with results and do results support the hypotheses |
They were more successful
at stopping smoking when they paired their e-cigarette use with behavioral counseling. |



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