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Use article by Kravlikova et al 2009.
Question 1: total 40 marks
1.1 Research questions. 4 marks
Which method is the most efficiency in the treatment of nicotine smokers leading smoking cessation or stop depending on tobacco?
Which of the tobacco treatment method will show results within the shortest time possible?
1.2 Key characteristics of the study design 2 marks
The study was done using qualitative and quantitative methods. It was carried out using double-blind, multicenter placebo-controlled study. Key characteristics used include randomly selected group from the medical center and placebo-controlled study.
1.3 Population source 3 marks
The population was selected randomly from two medical centers including Kutná Hora and Prague. It targeted nicotine smokers who were willing to leave the habit by reducing or quit rate the rate of smoking. The recruitment was done through advertising in a local newspaper by the name ‘Metro’ and by use of local leaflets. The willing smokers were invited to participate in the clinical trial aimed at controlling their habit of smoking.
1.4 exclusion and inclusion criteria 2 marks
The selection criteria included those willing smokers who saw it necessary to cessation and reduction their smoking habits. The personal screening was also involved in the selection. Those who had to participate were required to have been smoked for at least 18 years. Smoked about 15 cigarettes daily and have done so for about 3years. Furthermore, his body contains ? 10 ppm.
Exclusion included those who were currently using NRT and nicotine-containing products including pipes, snuff, and cigars. Moreover, those who were currently under smoking reduction and smoking cessation were excluded. Participates, who were had alcohol or problems of other drugs, precluded. Pregnant/lactation, with unstable myocardial infarction or angina pectoris within three months were also excluded. Lastly, those intending to get pregnancy, medication, and psychiatric treatment were also excluded.
1.5 interventions 3 marks
The subjects had to reduce their smoking habits by reducing their smoking cigarettes with the treatments as first intervention. However, subjects were allowed to use gun or inhaler placebo or nicotine 4 mg. The available nicotine gum and nicotine inhaler were used as active medication investigation. Most of the population was allowed to start using free active medication for ethical reasons.
1.6 Identify the dependent variable or primary outcome 2 marks
A mean age of 46 years for cigarette consumers and had 25 cpd ranging from 13 to 70 and they had started smoking at the age of 18years. The primarily expired value for CO was 23 ppm. The study depended on those participants who had met inclusion criteria and had been screened. The participants had low cpd number, FTND score and CO level as a baseline in subjects.
1.7 Characteristics for generalization 8 marks
The population must be identical to enable generalization. In this research we used cigarette smokers and data was collected in two health centers to represent the entire population.
Sample size must be an exact representation of the populations example 314 smokers were used in the study.
The incident of must occurred in the probability of situation and more wide position but estimated from a particular angle. In this particular situation controlled placebo trial was used.
The data need to be gathered in probability sampling where each member stands an equal chance of being selected.
1.8 Characteristics to prove valid of data 8 marks
The sample size is an essential element as it should be large enough to be able to represent the entire population. The sample should be randomly selected in the two medical centers, Prague and Kutná Hora. Using the study design, it is clear that the sample was collected from the two health centers after advertising using in leaflets and local newspaper.
Age representation is also important in the study of all the generations should be represented. The time the representatives had been smoking is essential, and it should be included apparently for valid research. The numbers of both male and female should be reasonable in the study. The level of CO cpd number and FTND score in each participant should record precisely.
The method used should give room for generalization, meaning it gives the accurate picture of the situation. Predetermined standard should be established against which other data were measured against each other. The exclusion criteria should be followed when selecting the data to use.
1.9 Clinical and statistical and significance and magnitude 8 marks
Testing for null hypothesis needs to be tested to certain whether the question which had been formulated was answered for statistical significance. The statements such as the variation between the controlled and experimental group were .05 are used. Further significance study design must compare more than two variables. Criteria to reject and accept participants need to be established. The population size needs to be truly reflected in the sample size.
The magnitude of the both clinical and statistical date depends much on effects of sample size. ES is used to show the magnitude of the research.
2.1 Explain the randomization of the study 1 mark
Yes, the participants were randomly selected in two health centers. Before the selection of who will participate, it was announced using leaflets and the local newspaper to give everyone a fair chance.
2.2 Concealed of sequence of selection 1 mark
Yes, indeed allocation sequence was concealed. It is not clear how the 314 participants were allocated between the male and female apart from giving mere statistics such as 183 females and 131 males. How allocation of such numbers was selected remains unclear
2.3 Where were the group similar? 2 marks
At the baseline since the average was calculated to get 46 years. The consumption of cigarette at baseline was given for the entire group at 25 cpd. Other levels of cpd, CO level, and FTND were all determined at baseline.
2.4 Blinding of the participants 1 mark
Yes, they were blinded to the group. This was achieved by not dividing them during the procedure process.
2.5 Explain the reported outcomes measures helped in follow-up 3 marks
A mean age of 46 years for cigarette consumers and had 25 cpd ranging from 13 to 70 and they had started smoking at the age of 18years. The primarily expired value for CO was 23 ppm. The study depended on those participants who had met inclusion criteria and had been screened. The participants had low cpd number, FTND score and CO level as a baseline in subjects.
2.6 Reliability of outcome 1 mark
Yes. It shows an accurate generalization.
2.7 Did conclusion count for participants 2 marks
Yes. The follow-ups were done through compliance whereby the 314 smokers were divided into different categories,105 to Placebo and 209 Active NRT.
2.8 Explain how the treat analysis used and how drop-outs were handled 1 mark
Yes, the drop-out was dealt with through use of short-term and long-term follow-ups
2.9 How study used enough participants to avoid chance of run-out 3 marks
Yes, the study used 314 smokers though it had earlier targeted 325 participants. This means only 11 participants did not make it. Going by the number, participants are enough hence no play chance.
Question 3
3.1 Give Experimental Event Rate (EER) at 12 months.
2 marks
Results shown were 18.7% vs. 8.6%, (p = 0.019).
3.2 Control Event Rate (CER) at 12 months
2 marks
A reduction of 17.2% vs. 18.1%, took place after twelve months in CER.
3.3 Compare control group and intervention group in Relative Risk (RR) at 12 months
2 marks
After twelve there was reduction of up to 17.2% vs. 18.1%, respectively. The intervention group had more reduction in cigarette smoking.
3.4 Describe average relative risk
2 marks
This refers to the ratio of probability of occurring of an event in a group that had been exposed to probability of events taking place in comparison, group that is non-exposed.
3.5 Calculation Absolute Risk Difference
3 marks
18.1%-17.2%=0.9%
0.9(0.016) =+-0.0144
3.6 Number Needed to Treat
2 marks
It Estimates grades on the mRS due to treatment result of 3.1 and has 95% confidence interval which is 2.6-3.6)
3.7 Meaning of NNT
2 marks
It refers to the absolute risk reduction inverse or refers to is the patients’ average number, which needs to be treated so as to prevent one additional undesired outcome.
Article 2: Santos et al 2009 BMC
Question 4: total 30 marks
4.1 Primary research question 4 marks
Does late preterm birth affect growth outcome if accessed in children with between 12-24 months?
4.1 Justification of the author
2 marks
The author state that preterm birth rate is increasing worldwide and there is need to access the effect of such.
4.2 Sample details
2 marks
Yes representative was used with the study using 3285 live birth to represent the entire population.
4.3 Detail the participants
8mark
Cohort size, 3285 singleton live births, 371 of those was late preterm birth. The entire population of the country is 323,000 people. The recruitment was done using random sampling through visiting daily five maternity hospitals. Main character was preterm birth within the normal birth. The groups were divided into late preterm and term children and compared in term of weight-for length, length-for age and weight for age.
4.4 Explain the exposure and state whether it was accurate or not
2 marks
Exposure was done by daily visit to hospital and interviewing the mothers. The exposure was done accurately determined since methods familiar with the local communities were used such as questionnaires and pre-test.
4.5 Give outcome and explain whether it was accurate
2 marks
371(11.3%) births were identified as late preterm. In 12 months the prevalence was (8.7), underweight (3.4), and wasting (1.1%) against 2.9%, 1.0% and 0.3% of term children.
The outcome was measured accurately since each group was calculated alone considering standard error.
4.7 Table of 2X2
2 marks
Stunting
No Stunting
Total
late pre-term
yes
26 (7.2)
81 (2.9)
107(10.7)
late pre-term
No
2.35
2.30
4.65
4.95
10.4
15.35
4.8 The Relative Risk (RR) Calculation of stunting at 24 months.
3 marks
3.36-2.30=1.06(0.09) =0.0954
0.0954×100=0.954
4.9 Risk Difference Calculate and words’ briefly describe
3 marks
Risk observed in late preterm children – Term children
6.5%- 5.7% =0.8%
Risk difference – Refers to difference between the risks observed in the two groups
4.10 Results and cofounders
2 marks
Indeed some adjustments were on results done for confounder. The main factors were issues related to late preterm birth by getting mothers’ report, wasting at 24 and 12 months and low number of babies born late preterm.
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