Critical Appraisal of a Text Message-Based Smoking Cessation Program

This assignment presents a critical appraisal of a randomized controlled trial (RCT) evaluating a text message-based smoking cessation program (SMS USA) for young adults aged 18-25. The study, described by Ybarra et al. (2013), employed a PICO framework to assess the intervention's effectiveness in improving smoking cessation rates. The analysis involves a structured assessment using a quality assessment tool, examining components like selection bias, study design, confounding factors, and blinding. The assessment reveals the study's strengths and weaknesses, including aspects of the randomisation process, the handling of potential confounders like gender and smoking intensity, and the awareness of outcome assessors. The assignment highlights the challenges in data collection, participant recruitment and the limitations of the study. The study design is identified as a randomised control trial with adaptive randomisation, and the analysis provides a detailed evaluation of the study's methodological rigor and potential for bias. The study's findings and the critical appraisal contribute to a better understanding of the effectiveness of text messaging interventions for smoking cessation.

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.

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

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

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.

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)

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

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

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

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 

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

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:

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,