Part 1: (Initially undertaken on your own).

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Part 1: (Initially undertaken on your own)
Show the structured PICO question of the study
P- Young adults (18-25-year-old) who are a daily smoker and
try to get rid of smoking
I Text message-based smoking cessation intervention
program(SMS USA)
C- Smoking quitter control group (Researchers focused on
improving sleep and fitness habits together with the help of
messages for influencing to quit smoking )
O- improvement in smoking cessation rate with two
outcomes, such as primary and secondary outcomes:
Primary outcome: Continuous abstinence from smoking for
three months
Secondary outcome: reducing the habit of smoking to five or
fewer cigarettes from the quit day at four weeks post quit
program confirmed by the significant other groups. In these 4
weeks, 7 days of point prevalence abstinence would be
observed.

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COMPONENT RATINGS
A) SELECTION BIAS
(Q1) Are the individuals selected to participate in the study likely
to be representative of the target population?
1. Very likely
2. Somewhat likely
3.Not likely
4. Can’t tell
Provide your explanation:
Ans. Very likely
The research population has focused on a specific set of participants aged 18 to 25 years. The
research consists of elements related to community, age, race, medical record and laboratory reports.
The study involves criteria matched target population with a whole set of people. The research is not
selection biased as the target population has been mentioned. Selection bias is an error, which is
dependent on a specific type of data and can distort the entire research analysis. If the research has
selection biasness, the baseline characters are considered first in the research objective (Certo et al.,
2016, p.7).
This study is a pilot study and conducted in the preliminary level or smaller scale. Researchers favour
short studies as these types of studies are used to simplify the assessment of data and calculations
related to researches (Zahn et al. , 2019, p.85).
The participants were selected through an online advertisement, and 1916 participants were found
with the associated eligibility. 211 among them were eligible for the criteria. 101 participants were
randomly allocated in the group of intervention by computerised method, and the 63 participants were
placed in the control group. However, 47 candidates did not complete the registration process and quit.
The small sample size is easy to handle and manipulated, but it is also a limitation for the researcher.
Small sample size sometimes does not give the desired or very prominent outcomes, which happens to
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the study (Ybarra et al. , 2013, p. 1389).
The study involves random sampling method. The positive side of this sampling method is to reduce
biasness in the sample collection; as a result, each sample has an equal opportunity of distribution and
probability for participating in the research. There are numerous sorts of random sampling can be found
in scientific researches such as simple random sampling, unrestricted random sampling, systematic
random sampling, stratified random sampling, cluster random sampling, and multistage random
sampling. However, the researchers of the study did not mention any specific sampling process.
Researchers also assured about the minimal bias based on the baseline characteristics (Ybarra et al. ,
2013, p.1393). Assessment of eight of the final participants was conducted manually.
(Q2) What percentage of selected individuals agreed to participate?
1. 80 - 100% agreement
2. 60 – 79% agreement
3. less than 60% agreement
4. Not applicable
5. Can’t tell
Provide your explanation:
After collecting the participants from the advertisements, researchers find 1916 people. Then
eligibilities were assessed, and total of 585 people are selected. Among them 284 young people, only 90
refused to complete the registration method. There were 211 participants selected by random sampling.
101 persons were allotted in the intervention group, and 63 were located in the control group. The
allocation was proposed by computerised adaptive randomisation program. 47 participants were
prematurely terminated after randomisation as they did not complete the enrolment process. The data
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shows less than 60% of initial participants are involved til the end.
RATE THIS SECTION STRONG MODERATE WEAK
See dictionary 1 2 3
Provide your explanation:
Ans. 3 (weak)
The segment can be rated as weak. The reason for measuring the part as moderate as 100% of the
participants was not to participate, and there are some other parameters such as sex and age of the
participants. Among 1916 person, only 211 were eligible for the further participation of candidates in
the study. There are two groups, such as intervention and the control group. 47 participants were finally
excluded, and only164 participants were involved in the survey (Ybarra et al. , 2013, p.1388). It can be
said that the selection bias is poor in the research, as two criteria do not match. The representation of the
sample of the selected population in the study is inadequate.
The randomised control trial has faced many challenges in collecting the data and recruiting the
participants in a particular study. The problems regarding the data collection are responsible for
significant statistical outcomes. The absence of the participants is another problem faced by the
researchers. The process of data collection can be costly for the study and time consuming also.

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B) STUDY DESIGN
Indicate the study design
1. Randomised controlled trial
2. Controlled clinical trial
3. Cohort analytic (two-group pre + post)
4. Case-control
5. Cohort (one group pre + post (before and after))
6. Interrupted time series
7. Other, please specify:
8. Can’t tell
Was the study described as randomised? If NO, go to Component C.
Yes
Author used randomised control method and he applied some words such as randomly
assigned and randomization process.
If Yes, was the method of randomisation described? (See dictionary)
Yes
The author describes an allocation sequence 2:1.
If Yes, was the method appropriate? (See dictionary)
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Yes
Provide your explanation:
The research is based on the Randomized Control Trial. This trial is associated with the two arms
randomised control trial with adaptive randomisation. The adaptive randomisation is related to both
intervention groups and control groups. The groups are selected in terms of the participants’ gender and
their smoking rates (heavy or light) (Ybarra et al. , 2013, p.1394).
The randomised control trial is mostly used to avoid the biasness in the data collection from the
participants. The cause-effect relationship has been recognized between the intervention group and
resulted in the outcome of the research (Navas-Carretero & Martinez, 2015, p. S55). Avoidance of
biasness is the most effective result, which makes the researchers choose the RCT analysis. The
biasness can be avoided in the intervention and the control group (MacLeod & Clarke, 2015, p. 68). The
sequence generation is the rule of intervention allocated to specify according to several random
processes (de Jong et al., 2016, p.660).
The computer-based adaptive randomisation process did allocation of the participants for minimising
the possibilities of imbalance in the study groups regarding smoking and the gender of the smokers.
Initially, 101 participants were selected in the intervention groups, and the 63 participants are selected
in the control group. The randomisation is the specific scheme in which the probability of treatment or
the clinical assignments can change according to the clinical manifestation (Cattaneo, Frandsen &
Titiunik, 2015, p.15). The advantages regarding the covariant with the influential factors of the
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covariant for the control trial.
RATE THIS SECTION STRONG MODERATE WEAK
See dictionary 1 2 3
Rate of the section is strong. Every method was mentioned clearly, but the interventions cannot be
predicted. The control trial methods have some spontaneous result, which cannot intervene by the
investigator. The authors stated that they used a computerised adaptive
randomisation program; difficulties emerged with the randomisation program, so
the authors manually assign the last eight participants to balance allocations. The
adaptive randomisation control process includes sequential concealments. The
allocation concealment defines as the process, which consists of the study groups
to protect the data from biasness (Clark, Fairhurst & Torgerson,2016, p.3). The study is
based on the computer-based program in randomising the participants. The study
will analyse the participants with randomised control trial, which helped the
participants in an objective, systematic and highly controlled manner. The author
has chosen the adaptive randomisation method in the randomised control trial.
C) CONFOUNDERS
(Q1) Were there important differences between groups prior to the intervention?
1.Yes
2. No
3. Can’t tell

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The following are examples of confounders:
1. Race
2. Sex
3. Marital status/family
4. Age
5. SES (income or class)
6. Education
7. Health status
8. Pre-intervention score on outcome measure
Provide your explanation:
Ans. Yes
Confounding factors are one of the essential aspects of epidemiological studies. Confounding factors
are often acting as the distortion factor for the researches. The dissimilarities between groups before the
intervention were determined (Ybarra et al. , 2013, p.1394). There are some cofounders associated to
the study such as income class, pre-intervention measures, but the cofounder related to the higher
studies are not emphasised. Education is an important factor in quitting smoking. It can be observed that
a true collection of the participants were carried out. The factors associated with the confounders are
determining areas of research analysis. The confounder factors can be detected, but biasness and
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ambiguity arise due to wrong identification of non- confounding factors. There are specific ways to
solve the issues related to confounding factors in various stages of the analysis, such as at the stage of
study design and the stage of the investigation. During the study design, methods can be considered as
matching in case-control and randomisation (Frieden, 2017, p.467). The methods, which are, can be
detected the presence of the confounding factors such as stratification, standardisation and multivariate
analysis (Amouzegar, 2016 p. 667).
Biological sex or gender and smoking level are the primary potential confounders of the research.
However, sex, smoking intensity, education and race were selected as the effect modifier in statistical
analysis. Minimalizing the effect of possible imbalance among the intervention and control group with
gender and smoking intensity of participants (Vahlberg et al.,2017, p. 1616). The treatment group, with
the comparison of the control group, has the ratio of 2:1 has to be maintained. The treatment arm is
higher than the control arm of the research. The ratio is responsible for more appropriate information
regarding intervention related outcomes. Despite employment status, the baseline data can be
statistically similar between the two groups of the research analysis (Novak et al.,2017, p.127).
(Q2) If yes, indicate the percentage of relevant confounders that were controlled (either
in the design (e.g. stratification, matching) or analysis)?
1. 80 – 100% (most)
2. 60 – 79% (some)
3. Less than 60% (few or none)
4. Can’t Tell
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RATE THIS
SECTION
STRONG MODERAT
E
WEAK
See dictionary 1 2 3
Provide your explanation:
Ans. Can’t tell
In this study percentage of the relevance of the confounders cannot be determined as the authors of the
study could not mention which confounder detecting method has been used in the research. They
mentioned the ratio between the intervention and control arm, which is 2:1. The potential confounders
for the study are biological sex, the intensity of smoking. The effect of modifiers are educational level
and race.
D) BLINDING
(Q1) Was (were) the outcome assessor(s) aware of the intervention or exposure status of
participants?
1. Yes
2. No

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3. Can’t tell
Provide your explanation:
Yes, the evaluators were also aware of the expected intervention as the research was randomised,
and text message outcome was clear. The professionals appointed for investigation were aware of the
expected outcome, and interpretation of the messages was various for different people. There are
different people, especially the research outcome assessors are considered as the blinders. The
investigators are also blinded in the researches when the researchers and investigator are different. The
scarcity of blinding method helps to assess the accuracy of the research, however the particular risks of
biasness with more precise outcomes. There are both subjective and objective deliberating blinding in
the research analyses. In this experiment, the blinding was not applied to the participants. Blinding is
one of the techniques applied to avoid biasness during the data collection or during observation of
outcomes. Blinding sometimes termed as masking in RCT. Three types of bias can be found in
researches such as confounding bias, selection bias and information bias. No particular reference of
blinding can be found in this research. Here, researchers have given equal chances in RCT as the
participants were allocated into two arms, such as the intervention group and control group.
(Q2) Were the study participants aware of the research question?
1. Yes
2. No
3. Can’t tell
Provide your explanation:
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No. They were not aware of the questions as these are computer-based questions. The ITT analysis was
randomised. The process of masking was done to the participants. It was essential to mask or unmask
participants for performing the randomised control trial in a deliberate manner. The dearth of blinding is
in the actual outcomes in the risk of biasness due to scarcity of blinding among the participants.
Outcome of the blinding in the participants is significant for the trial.
RATE THIS SECTION STRONG MODERATE WEAK
See dictionary 1 2 3
Provide your explanation:
Answer: 2. Moderate
The participants were included in process of blinding. The observations of blinding is also
related with the participants, outcome assessor, analysts, and investigator. The
blinding method is categorised by the number of participants associated with the
trial. The examples for blinding trials are an open-label trial, single-blinded trial,
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double-blinded trial, triple blinded trial, and quadruple blinded trial (Senior, 2015,
p.85). The experiments have some possibilities of facing challenges related to
ethical, methodological, technical considerations (McGirr et al.,2015, p.700). The trials
cannot be stated as single-blinded or double-blinded, although it cannot explicitly
be said which groups were taken under consideration for blinding methods. The
conditions associated with performing methods were not explained in the research
clearly.
The research shows that participants were blinded, but the investigator of
outcome was aware of the fact(Ybarra et al. , 2013, p.1391). Even the questions were
not revealed to the participants for the appropriate outcome and accurate
observation. So it can be said that the blinding method related to the research
were moderate.
E) DATA COLLECTION METHODS
(Q1) Were data collection tools shown to be valid?
1. Yes
2. No
3. Can’t tell
Provide your explanation:
The researchers used some data collecting tool for analyse the outcome of the study. Data collected by

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the tools were responsible for understanding whether the secession program was successful or not.
Validity is the best accessible estimate to the fact of a given proposition, inference of conclusion. There
are two types of validity can be found, such as internal and external. A measurement technique or
instrument is considered valid if it measures what it aims to measure Researchers were aware of NIH’s
Behavioural Change Consortium, and they utilised the scale to analyse
participants’ responses for the research method. Another tool called the
Fagerstrom Test of Nicotine Dependence (FTND) scale was used for the
measurement of the level of tobacco dependence in the participant (Etter &
Eissenberg, 2015, p.72). The secondary outcome of this result was found prior to the
primary outcome. The self-reported survey was used as a tool for collecting primary data regarding the
quitting tendency of participants. The researchers for measuring physical characteristic and self-efficacy
used a four-item scale. Lawrance and Rubinson developed a special scale.
Multidimensional Scale of Perceived Social Support is used for measuring the
social support for participants (Guan et al.,2015, p. 227). Researchers used
Epidemiologic Studies Depression Scale for measuring the depression level of
participants. The outcomes or responses were collected from PHQ's four-point
Likert scale. There was no specific valid tool used in the research.
(Q2) Were data collection tools shown to be reliable?
1. Yes
2. No
3. Can’t tell
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Provide your explanation:
Dependency of data collection reliability is related to the number of repetition of the process for
specific research outcome . There are several types of reliabilities such as inter-observer, test-retest,
internal consistency, parallel forms reliabilities in the study. The reliability for research is dependent
upon several factors such as tool, observer, analyser and other related to the research. Cronbach’s α
is one of the most standard test engaged in governing internal consistency (Bonett
& Wright, 2015, p.12). This method can be used if the instruments with questions
have more than two responses. Reliability of Cronbach’s α is higher and
acceptable if the score is above 0.7 as the range of this attribute is in between 0-
1.
The researchers have shown that Cronbach’s α is higher than 0.7, which means
the reliability is in a higher range. Any other reliability factor did not mention in
the pare. The test was reliable as the instrumentation, and the Cronbach’s α was
higher (Ybarra et al. , 2013, p. 1390).
RATE THIS SECTION STRONG MODERATE WEAK
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See dictionary 1 2 3
Provide your explanation:
The section is moderate as this includes valid tools and reliable. However, the validity of the
instruments was explicitly analysed. The authors only presented the result of the
reliability test for psychosocial characteristics using Cronbach’s α. There is an
ambiguity for the validity of used tools in the researches. The researcher has
organised the observation with proper validity and reliability, but that has not seen
in the paper.
F) WITHDRAWALS AND DROP-OUTS
(Q1) Were withdrawals and drop-outs reported in terms of numbers and/or reasons per
group?
1. Yes
2. No
3. Can’t tell
4. Not Applicable (i.e. one time surveys or interviews)
Initially, there were 211 participants whereas during randomisation 164 eligible candidates
found and among the 101 were allocated in the intervention group. The 63 were allocated in the
control group, and 47 were excluded from the research due to incomplete enrolment. Attrition
has been found in the research. Attrition happened when some candidates left the group of

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(Q2) Indicate the percentage of participants completing the study. (If the percentage
differs by groups, record the lowest).
1. 80 -100%
2. 60 - 79%
3. less than 60%
4. Can’t tell
5. Not Applicable (i.e. Retrospective case-control)
211 participants were selected whereas during randomisation 164 eligible candidates found and
among the 101 were allocated in the intervention group. The 63 were allocated in the control group,
and 47 were excluded from the research due to incomplete enrolment. During the research 11
participants of the intervention group were misplaced or out of the track from the online surveys,
and 6 from the control group could not find from the control group. The percentage of eligible
people has been calculated below.
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RATE THIS SECTION STRONG MODERATE WEAK
See dictionary 1 2 3 Not Applicable
G) INTERVENTION INTEGRITY
(Q1) What percentage of participants received the allocated intervention or exposure of
interest?
1. 80 -100%
2. 60 - 79%
3. less than 60%
4. Can’t tell
Provide your explanation:
Eligible=164
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Answer: 1. 80 -100%
Intervention integrity/ fidelity is the interpretation of outcomes of any result with
ambiguity and self-efficacy. The dissemination of evidence-based practice and quality
improvement of studies can be assured by the intervention integrity. Empirical studies are an integral
part of the randomisation control trial with the apparent intervention of the obtained result. There are
two ways of the intervention integrity such as; competently or the competence and according to
protocol. The integrity or fidelity measurement is important to calculate, assess, the efficacy of given
treatment and service administration. It can be said that 80%-100% of the patients were received
allocated intervention of the research. The number of population 1331 and the 164 have come under the
intervention. The total eligible participants were 211; among them, 101 were selected for the
intervention group. However, 96 were finally got the response as 5 participants withdrew
themselves(Ybarra et al. , 2013, p.1392). The percentage of participants receive the
assigned intervention can be calculated as follows: 96/101 x 100% = 95 %.
(Q2) Was the consistency of the intervention measured?
1. Yes
2. No
3. Can’t tell

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Provide your explanation:
The intervention was nearly consistent for the study. Assessment of intervention fidelity was very
important for the assessment of the research. Adherence, quality of delivery, exposure,
program differentiation, and participant responsiveness are the five necessary
dimensions which are needed to measure for intervention integrity (Horner & Sugai,
2015, p.82). The interventions are seemed to be consistent as the researchers found
the improvement of sleep and physical condition. However, it has also been
finding that no significant differences were found by the researchers.
(Q3) Is it likely that subjects received an unintended intervention (contamination or co-
intervention) that may influence the results?
1. Yes
2. No
3. Can’t tell
Provide your explanation:
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Ans. Yes
Intervention and control group can obtain unintended intervention contamination. The intervention
group were received a 6-week cessation program, which aimed to quit smoking.
The participants received four messages each day except the first day and
fourteenth day. Two online message websites text buddy and text crave were
accessed by the participants (Ybarra et al., 2013, p.1389). The control group was
given similar text-messaging programs to treatment arm in terms of a number of
messages for six weeks. Nine messages were sent to both the groups in quit day.
However, the aims of this research were the improvement of sleep and physical
exercise habits. So the possibility of overlapping intervention cannot be denied.
The two groups were selected for the two different objectives. So it can be said
that the contamination of intervention can happen.
H) ANALYSES
(Q1) Indicate the unit of allocation (circle one)
community / a group of people / individual or patient
(Q2) Indicate the unit of analysis (circle one)
community / a group of people / individual or patient
Provide your explanation to Q1 & Q2:
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The research was conducted on the basis of the effect of secession program on smokers. The age group
of smokers was between 18 to 25 years (Ybarra et al., 2013, p.1388). Each individual
experienced the individual effect of the programs, and they would feel different outcomes for the
programs. Randomisation was performed for better experience and analysis of outcome on the
individuals. There were two major groups, which were involved in the secession program for two armed
control method. One of those was the control group, and the other one was the intervention group.
Randomisation was carried out for completing the method, although there was a survey which included
individual questions. Thus, it can be understood that the analysis for the research was dependent on the
individuals.
(Q3) Are the statistical methods appropriate for the study design? [Please attempt to
answer this question within your current knowledge of statistics. You may wish to state
the limitations of your knowledge]
1. Yes
2. No
3. Can’t tell
Provide your explanation:
Depending on my recent statistical acquaintance, I cannot explain which particular statistical analysis
was taken place, but it can be assumed that the chi-square test was executed. The statistical analysis

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related to the research must be appropriate for the accurate analysis of this research. The researchers
took a survey of every participant for individual data analysis. The logistic regression model was
employed to analyse the odds of smoking between two groups. ITT analysis and pre-protocol
analysis were taken place for better understanding of the condition of patients (Ybarra et al., 2013,
p.1391).
(Q4) Is the analysis performed by intervention allocation status (i.e. intention to treat)
rather than the actual intervention received?
1. Yes
2. No
3. Can’t tell
Provide your explanation:
Intention to treat analysis method was carried out in the research. According to the researchers, this
method is one of the best methods for reducing the biasness of result (Haussen et al.,2017, p.920). This
method can help to detect the biasness of intervention effect in randomised controlled trial.
The actual intervention analysis is also conducted by the researchers for
intervening the result in between the two groups, which are by the control group
and intervention group (Skúladóttir ,2016, p.40). The two arms of the intervention
group were distinguished through the selection method of randomisation. The
randomisation was actually a computer-based system. Through the system, in the
intervention group 101 participants were included, whereas 47 participants were
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excluded from the research as randomisation of the computer-based program was
not responded, and those participants did not attend ITT analysis.
GLOBAL RATING
COMPONENT RATINGS
Please transcribe the information from the grey boxes on pages 1-4 onto this page. See
dictionary on how to rate this section.
A SELECTION BIAS STRONG MODERATE WEAK Resulted
rating
1 2 3 Weak or 3
B STUDY DESIGN STRONG MODERATE WEAK
1 2 3 Strong or1
C CONFOUNDERS STRONG MODERATE WEAK
1 2 3 Weak or 3
D BLINDING STRONG MODERATE WEAK
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1 2 3 Moderate or 2
E DATA COLLECTION
METHOD
STRONG MODERATE WEAK
1 2 3 Strong or 1
F WITHDRAWALS AND
DROPOUTS
STRONG MODERATE WEAK
1 2 3 Strong or 1
CIISV.Jo81488
GLOBAL RATING FOR THIS PAPER (circle one):
1 STRONG (no WEAK ratings)
2 MODERATE (one WEAK rating)
3 WEAK (two or more WEAK ratings)
Part 2:
Discuss now your report with your partner working through each
item and the epidemiological principles. Complete the remainder
of these questions. You may change your initial responses from
the independent draft that was submitted prior to discussion.
With both reviewers discussing the ratings:

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Is there a discrepancy between the two reviewers with respect to the
component (A-F) ratings?
No
Yes
If yes, indicate the reason for the discrepancy
1. Oversight
2. Differences in interpretation of criteria
3. Differences in interpretation of study
Describe what happened when you exchanged your drafts, and
the describe the outcome of the discussion (you may describe
what you learned during the process):
After the drafts were exchanged, a piece of significant knowledge about
the prevalence of smoking among the people was gained. The
comparative assessment was done correctly after the initial
independent assessment. Participants supporting the intervention plan
were seen to have undergone the four weeks quit strategy.
If you were unable to complete the above comparison, please describe
the reason and state the risk of failing to undertake a comparative
assessment after initial independent assessment.
Final decision of both reviewers (circle one):
1 STRONG
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2 MODERATE
3 WEAK
Provide your explanation:
Moderate is selected in the decision-rating list since this paper has some
bias in it. This bias may have deviated the provided results. Confounding
effects such as age and sex has been a part of bias in this study.
Results:
How large was the effect of the intervention? Is the effect
clinically meaningful? (consider the outcomes measured, whether
the primary outcome is clearly specified, and the key results for
each outcome) You may also try to rework the analysis to make it
more understandable.
Provide your explanation:
The intervention concerning the cessation of smoking of five or less than
five cigarettes after the quit day has passed (post quit day). This
statement is clinically meaning full since after the participants were
selected by the online tool to divide them into an intervention and
control group. After the research study was performed, the primary
outcome was clearly specified. This outcome stated that the participants
were selected as 'quit' when they were found to decrease their smoking
rate to five or four cigarettes per day. This outcome was a result of
three-month continuous abstinence. The significant effects for each of
the outcome are also properly justified since there is a significant
difference among the number of participants actually in the 'quit'
category and the normal category. The secondary outcome is also
clearly stated in this study. Seven-day point prevalence tests were
performed to find out the number of people who underwent a post quit
plan.
Your overall conclusions about this study:
Considering both the trustworthiness of the study and the findings, make
a brief overall conclusion and describe what you think the implications
would be in practice.
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Provide your explanation:
This study has no major bias in it; however, it has a selection bias for
the age range. Age and sex were placed in the baseline of the bias list
for this study. Therefore, this study can be trusted for being relevant in
finding the actual number of people willing to quit smoking. The full-
powered sample will be used in future researches to conduct their
studies, which will include the understanding of the mechanisms
involved in a decrease in the rate of smoking for the participants.
Profiles should also be identified, which will help in the proper collection
of participant data. Therefore, it can be stated that although there are
few flaws in this research, this study can be considered relevant in
nature.

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References
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