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Assignment 1 – 2018 – Questions

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Please include a word count at the beginning of your document.  The maximum length is 1000 words, so you will need to give brief answers.

The questions on this assignment relate to this articles (available on LMS):

Relton C, Strong M, Thomas KJ, Whelan B, Walters SJ, Burrows J, et al. Effect of Financial Incentives on Breastfeeding: A Cluster Randomized Clinical Trial. JAMA Pediatr 2018;172(2):e174523.

Question 1. What was the primary research question asked in this paper? (2.5 marks)

Question 2. What is the unit of analysis for the primary outcome, and how many units of analyses were included?  (1.5 marks)

Question 3. What was the primary outcome of this study, and how was it measured?  (2 marks)

Question 4. On page 3/7 (underthe subheading “statistical analysis”) the authors make the following statement in regards to individual level mother-infant feeding status outcome data collected using a questionnaire “… it became clear that this method would lead to poor estimates due to respondent bias”?What do the authors mean by this statement, and in what direction was this bias likely to have influenced the study results? (3 marks)

Question 5. Do you think that misclassification of the primary outcome may have occurred?  Give reasons for your response and outline what (if any) consequences this could have had on the final result of the study? (3 marks)

Question 6. What was the rate of loss to follow-up for the primary outcome?  What, if any, effect would loss have had on the final study outcomes. (2 marks)

Question 7. What proportion of the children in the intervention group actually received any vouchers as part of the intervention?  What impact could this have had on the primary outcomes from this study? (3 marks)

Question 8. Interpret the key results presented in table 3 in less than 50 words. (3 marks)

Question 9. Isthere a difference in the baseline breast feeding prevalencebetween the intervention and control groups listed in table 1 that could have affected the findings? If so, have the authors addressed your concerns in the analyses presented? (4 marks)

Question 10. What justification did the authors provide for undertaking this study as a cluster design? Do you think that a cluster randomised design was necessary in the context of this study?  Provide a justification for your answer.  (4 marks)

Question 11. You consider re-designing the study, using a) the same cluster design, but using individual participant outcomes, and b) using individually randomised study design.  Calculate the number of participants required, assuming a power of .8, a two-sided alpha of 0.05, the same effect (4% absolute difference), and a baseline prevalence of 31.7% in the control groups.  For the cluster trial, assume that 100 clusters (wards) are available and the ICC is 0.024, as reported in the paper.  When calculating these numbers, please use either Stata 14.1 or Stata 15’s  “clustersampsi” command.  Include the commands you use in your response.  Complete the following table to show your results.  (5 marks)

Design Clusters Participants per group Total participants
As published 92 5398 + 4612 10,010
Cluster design (individual patient)      
Individual design      

Question 12. Do you think the results from this trial are generalisable to Australia?  Why or why not?  In formulating your answer, consider the information found here – http://www.abs.gov.au/ausstats/abs@.nsf/Lookup/6664B939E49FD9C1CA257B39000F2E4B  (2 marks)

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Assignment 1 – 2018 – Questions

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Assignment 1 – 2018 – Questions

Question 1

The primary question in this study was: does offering financial incentives for breastfeeding increase breastfeeding at 6 – 8 weeks post-partum in areas with low (<40%) breastfeeding prevalence?

Question 2

The unit of analysis for the primary outcome was the electoral ward area while the prevalence of breastfeeding was treated as the continuous outcome. Four units of analysis were included.

Question 3

            The primary outcome of this study was the intervention effect on breastfeeding prevalence based on controlled baseline. The primary outcome was measured by a weighted multiple linear regression model where the weights for the outcomes were calculated using Donner and Klar method. The result of this analysis was based on a correlation between interclass coefficients which were estimated using Fleiss and Cuzick method. This method of analysis was intentional as it treated the electoral ward area at cluster level. When calculating for the primary data, the breast feeding prevalence at the electoral ward area level were analysed on a case basis where the number of infants with documented history of breastfeeding status was used as the denominator. Infant without breastfeeding outcome data were excluded in the analysis.

Question 4

            Respondent bias refers to a tendency by the respondents in a study to give false and misleading information about the information being sought. Respondent bias are often prevalent where the participants are expected to offer self-reports about themselves, or in situations where structured interviews or survey designs are adopted. A wide range of factors can induce response bias, nevertheless, all area related to the fact that human beings respond to stimuli based on an integration of multiple source of information. In this case, the motivation for incentives may have affected the mothers to lie about the status of breastfeeding.

            Where respondents give false information about surveys, these responses have a major impact on the validity of the questionnaires and therefore the results of the study. In this case, the false information would have resulted in a conclusion offering financial incentives for breastfeeding increase breastfeeding in areas with low breastfeeding prevalence.

Question 5

I do not think misclassification of the primary outcome occurred. The researchers designed the study in a way that allowed precise acquisition of relevant data for appropriate answering of the question raised. The classifications in the primary outcomes captured all the aspect required to answer the research question. If misclassification of the primary outcome would have occurred, the final results would not be reliable and therefore leading to a wrong conclusion.

Question 6

            The rates for lost of follow up in the primary outcome were 7.9% for the intervention group, and 8.2% for the control group. The loss to follow up in this case was insignificant and did not have any impact on the final outcome of the study. However, if any major loss would have been experienced, the final result would be significantly skewed.

Question 7

Within the six-month period, a total of 2179 representing (40.4 %) of all the eligible infants claimed for vouchers in the intervention group. Claiming for voucher positively impact on the primary outcome because it suggested that the intervention (financial incentive) was influencing the decision to improve the level of breastfeeding in the intervention group as compared to the control group and baseline statistics.

Question 8

            There was a 6.2 % increase in breastfeeding after the intervention in the six-month period. The impact of the intervention efforts was more in quarter 3 and 4. In the nutshell, financial incentives incrementally result in increased rates of breastfeeding within the six-month period.

Question 9

            Based on the parameters compared as the baseline characteristics in the intervention and control group in table 1, there were no significant population differences that could have resulted to major impact on the final results. Furthermore, there was no significant differences in the number of infants due, the baseline breastfeeding prevalence, and deprivation scores. However, the total tally of births within the six month period in both the control and intervention group differs significantly. The intervention group had more births than the control group, meaning the rates of breastfeeding reports were higher in the intervention group than the control group. The researchers have not addressed this concern in the analysis provided yet the difference in tally could have affected the findings.

Question 10

            The author argues that a cluster design would assess an area level impact of financial incentives on breastfeeding. The cluster randomised design was necessary in the context of the study because of its ability to eliminate bias during the randomization process. The researcher selected an expert blinded to ward names to use computer generated random sequence allocation method to allocate the clusters as either intervention or control group.

Question 11

Clustersampsi 0.317 1, alpha(0.8) power(.05) ratio(0.04)

Estimated sample size for two-sample comparison of proportions

Test Ho: p1 = p2, where p1 is the proportion in population 1

                    and p2 is the proportion in population 2

Assumptions:

         alpha =   0.8000  (two-sided)

         power =   0.0500

            p1 =   0.3170

            p2 =   1.0000

         n2/n1 =   0.024

Estimated required sample sizes:

            n1 =       5867

            n2 =       5013

Design Clusters Participants per group Total participants
As published 92 5398 + 4612 10,010
Cluster design (individual patient) 100 5867+5013 10880
Individual design 86 4959+4398 9357

Question 12

            The results from this trial cannot be generalisable to Australia because of differences in contexts and test factors, however, it is apparent from the data on breastfeeding presented by the Australian Bureau of Statistics that there is urgent need for research to determine which factor can improve the prevalence of breast feeding in Australia.

References

Australian Bureau of Statistics, (2012). Australian health survey: Health service usage and health related actions, 2011-12. ABS. Retrieved from, http://www.abs.gov.au/ausstats/abs@.nsf/Lookup/6664B939E49FD9C1CA257B39000F2E4B

Relton, C., Strong, M., Thomas, K. J., Whelan, B., Walters, S. J., Burrows, J., et al., (2018). Effect of financial incentives on breastfeeding: a cluster randomized clinical trial. JAMA Pediatr, 172(2).

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