Sample Size and Sampling Techniques for Objective Research 1


study the impact of chronic diseases on the QoL of patients [99]. In the United States, QoL has become a new theme of Healthy People 2020, physicians and public health experts use QoL to measure the impact of chronic diseases, treatments, and the short-term and long-term damage caused by chronic diseases [110]. The effects affect not only the patient but also the community.

Studies on the QoL of people with asthma have shown that there is a relationship between the presence of asthma symptoms and QoL. The QoL score is significantly reduced if the patient has any asthma symptoms [80;90] even if the symptoms appeared before the time of the interview [90]. According to Alvim, the QoL of children with asthma will increase by 1.14 points if the child has no symptoms during the day, and increase by 0.82 points if the child has not been hospitalized for asthma in the past 12 months [27]. Siroux also demonstrated that the QoL and the level of asthma control are related to each other: the average QoL score of patients decreases by 0.5 points corresponding to each decrease in asthma control from good to uncontrolled (the QoL score of controlled patients is 6.4; partially controlled is 5.9 and uncontrolled is 5.4 with p<0.0001) [104]. During the treatment monitoring process for asthma patients, Chen also commented: poor asthma control can be considered a predictive indicator for patients having low QOL even after asthma has been treated [46].

In Vietnam, a study on the QOL of children with asthma at Bach Mai and Xanh Pon hospitals using a 23-question interview form had a Cronbach's alpha reliability coefficient of 0.94. The results showed that the QOL of children with asthma decreased to 4.61 ± 1.25; children with asthma symptoms and having to use rescue medication had lower QOL than children without symptoms; children who had not received asthma prophylaxis also had lower QOL than children who had received asthma prophylaxis.


[6], Doan Thi Thanh Binh believes that the severity of asthma reduces children's quality of life [1].

According to many experts, health education has an impact on the QoL of asthma patients. Cicutto found that health education for children with asthma helped improve their QoL [49], however, according to Boyd's assessment, the impact of health education on the QoL of patients is not clear and further research in this area is needed to clarify [36].

Thus, health education has proven to be an effective intervention in asthma prevention, so experts in the field of respiratory and bronchial asthma need to widely disseminate knowledge about asthma to the community [47].

In our country, author Pham Le Tuan, when studying the rate of asthma in Hanoi students, also said that it is necessary to implement a bronchial asthma program in schools, and to strengthen training and practice on bronchial asthma for school health workers [23].


Chapter 2. RESEARCH OBJECTS AND METHODS

2.1 Research subjects and locations

2.1.1 Research subjects

- Subjects for research objective 1 - describing the epidemiological characteristics of asthma: 13-14 year old children studying in grades 7-8 of secondary schools in Thanh Xuan and Long Bien districts at the time of the study.

- Subjects for research objective 2 - evaluating intervention effectiveness: children with asthma in Thanh Xuan and Long Bien districts participated in the study investigating epidemiological characteristics.

- Inclusion criteria: children selected for the intervention study were children with asthma identified according to ISAAC criteria, that is, children who had been diagnosed with asthma by a doctor.

- Exclusion criteria

+ Children do not agree to participate in the study.

+ Children transferred schools out of the study area during the intervention period from September 2012 to September 2013.

2.1.2 Research location

The study intentionally selected Thanh Xuan and Long Bien districts of Hanoi city due to differences in geographical location and level of urbanization.

- Thanh Xuan District, Hanoi is a district located in the southwest of Hanoi's inner city. The district has an area of ​​9.11 km 2 , the population in 2003 was 185,000 people, the population density here is 18,990 people / km 2 . Part of Trung Hoa Nhan Chinh urban area in the district is being built as a new center of Hanoi. Thanh Xuan apartment building area consists of 5-storey buildings that are now seriously degraded. National Highway 6 starts from Nga Tu So to the Northwestern provinces passing through the district. Nguyen Trai Street has many universities and factories such as Thang Long rubber, soap and tobacco factory, so the amount of pollution is very high.


The number of vehicles and traffic participants is very large, causing frequent traffic jams. The section of Ring Road 3 running through the district and 2 elevated roads to Noi Bai and Nhon are also under construction. Therefore, the entire central area of ​​Thanh Xuan district has become a large construction site with very few trees but a lot of dust and traffic fumes. The whole district has 11 wards and 11 secondary schools.

- Long Bien District is located in the Northeast of Hanoi, running along the northern bank of the Red River. The area of ​​the district is 60.38 km 2 , the population in 2003 was 170,000 people including 14 wards, the residents live mainly by farming, growing vegetables and crops. The district has 14 wards and 16 secondary schools.

2.2 Research methods

2.2.1 Research design

- Research design for objective 1: cross-sectional study

- Research design for objective 2: community intervention study with control and longitudinal follow-up.

2.2.2 Sample size and sampling technique

2.2.2.1 Sample size and sampling techniques for objective research 1

- Sample size: Apply the formula to calculate sample size to estimate 1 proportion in the population [ 20]


In there


2

n z

1 / 2

p (1 p )

p 2

P is the rate of diagnosed asthma in 13-14 year old children from previous study results = 2.6% [7]

The statistical significance level α was chosen to be 0.05.

z corresponds to α=0.05, result from table z = 1.96 ε is the relative error value, chosen = 0.22


Substitute into the formula


Rounded to 3000 children.


n 1.96 2


0.026 x 0.974

0.026 x 0.22 2


2973.4

Thus, in each district, it is necessary to interview at least 3,000 children aged 13-14 to determine the number of children with asthma.

- Sampling method: Applying the purposive sampling process combined with simple random. Following the sampling process according to the ISAAC survey guidelines, at each survey location, the sample unit is determined to be the schools.

Step 1: Intentionally select 2 research locations: Thanh Xuan district and Long Bien district. Through initial survey, Thanh Xuan district has 11 secondary schools and Long Bien district has 16 secondary schools.

Step 2: Randomly select schools by:

+ Create a sample framework for each district. Make a list of 16 secondary schools in Long Bien District and 11 secondary schools in Thanh Xuan District in alphabetical order of school names along with the total number of 13-14 year old students at each school.

+ Randomly select a number of secondary schools: in each district, draw lots with the school name written on them and draw lots for each secondary school in turn until there are at least 3,000 children aged 13-14, then stop.

Step 3: Take out all 13-14 year old students in the selected schools to include in the study.

In fact, 8 schools were selected in each district.

2.2.2.2 Sample size and sampling techniques for objective research 2

- Sample size: The study has 4 output indicators: asthma status including disease symptoms, asthma control score; school absenteeism due to asthma; knowledge about asthma and children's quality of life. Because there has been no previous research


Because there was no information about children's knowledge about asthma, this study chose 3 outcome indicators: school absenteeism due to asthma, asthma control score and children's quality of life to calculate the sample size for the intervention study.

+ With the output being the rate of absenteeism due to asthma, the sample size calculation formula was applied to measure the difference in the rate of children absenteeism due to asthma between the two study groups [13] [107]

n z 2

p 1 (1

p 1 ) p 2 (1

p 2 )


2

In there

,

( p 1 p 2 )


n

: Sample size of each intervention and control group

p 1

: The rate of children who have to miss school because of asthma is estimated from previous studies to be 38.5%

[15].

p 2

: Is the rate of children who have to miss school because of asthma expected to be achieved after the study,

estimated at 18.5%

α

: Is the probability of type I error = 0.05 corresponding to 95% confidence level

β

: Is the probability of type II error taken = 0.2 corresponding to a sample power of 80%, then

Look up the z table 2 α,β = 7.9

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Sample Size and Sampling Techniques for Objective Research 1

Substitute into the formula


n 7.9

0.385 x 0.615 0.185 x 0.815 77

0.385 0.185 2

Because the study period was 12 months, some children might drop out for many reasons, so the study added 10% of children, so the sample size for each group was 85 children.

+ With the output being the quality of life score, the sample size calculation formula was applied to measure the difference in average quality of life score between the two study groups [20] [107].


2

2 2 ( z z ) 2


In there

n

( 1

2 )


n

: Sample size of each intervention and control group

δ

: Is the common variance of the found mean (assuming the same

for all patients in the 2 groups) estimated from a previous study was 1.25 [6].

α

: Is the probability of type I error = 0.05 corresponding to 95% confidence level,

then the value of z 1-α/2 look up in the table z = 1.96

β

: Is the probability of type II error taken = 0.2 corresponding to a sample power of 80%, when

then look up the table z β = 0.84

μ 1

: Average found in control group patients

μ 2

: Average found in intervention group patients

With the desire to detect a difference in the average CLCS score between the two groups of 0.5 points, the study chose μ 1 - μ 2 = 0.5.

Substitute into the formula


2 x 1.25 2 (1.96 0.84) 2

n 0.5 2

98


Because the follow-up period of the study was 12 months, it was expected that some children would drop out for various reasons, so an additional 10% of the subjects were needed to participate in the study, so at least 108 children were needed in each group.

+ With the output being the asthma control score, the sample size calculation formula was applied to measure the difference in the mean asthma control score of children [20] [107].

2 2 ( z z ) 2

2

n

( 1

2 )


In there


n

: Sample size of each intervention and control group

δ

: Is the common variance of the found mean (assumed to be the same for

for all patients in both groups) estimated from the previous study was 3.2.

α

: Is the probability of type I error = 0.05 corresponding to 95% confidence level,

then the value of z 1-α/2 look up in the table z = 1.96

β

: Is the probability of type II error taken = 0.2 corresponding to a sample power of 80%, then

z table β = 0.84

μ 1

: Average found in control group patients

μ 2

: Average found in intervention group patients

With the desire to detect the difference in average asthma control test scores between the two groups of 1.4 points, the study chose μ 1 – μ 2 = 1.4. Instead of the formula

2 x 3.2 2 (1.96 0.84) 2

n 1.4 2

82


Because the follow-up period of the study was 12 months, it was expected that some children would drop out for various reasons, so an additional 10% of the subjects were needed to participate in the study, so at least 91 children were needed in each group.

Combining the sample size calculation results, each group required 108 children to participate in the intervention study.

- Sample selection : Apply purposive sampling process.

+ Selecting subjects for intervention research: In fact, the results obtained from the descriptive survey in 8 secondary schools in Thanh Xuan district showed that 134 children were diagnosed with asthma and in 8 secondary schools in Long Bien district, 126 children were diagnosed with asthma. At the end of September 2012, 1 child with asthma in Thanh Xuan district transferred schools, so to ensure that at least 108 children in each group participated in the intervention research, the study chose to include all 133 children in Thanh Xuan district.

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