Randomized Controlled Trial Pediatrics Assignment Sample

• Subject Name : Nursing

Office-Based Educational Handout for Influenza Vaccination

Summary of Randomized Controlled Trial Pediatrics

Critical appraisal is a methodology that is utilized to evaluate the quality of the article under the set parameters to identify the relevancy of each section of the article (Umesh et al., 2016). The paper will critically appraise the study presented by Scott, Opel, Reifler, Rikin, Pethe, Barrett, & Stockwell, (2019) to understand the quality of the work. The article presented by Scott et al. (2019) has conducted the randomized controlled to analyse the impact of the parental educational intervention concerning the child vaccine for influenza. The participants were parent-child dyads that were addressed in the waiting room before the visit to clinical care. The two experimental groups addressed with the session corresponding to their national or local data group. The primary outcome of the study was child influenza vaccine receipt concerning the day of visit to the clinic and till the end of the season. The study will utilize the JBI's critical appraisal tools to evaluate the study presented by Scott et al. (2019) by following the checklist for the randomized controlled trials (The University of Adelaide, 2020).

Critical Appraisal

Parents from the visiting room were asked to complete a baseline after their consent and after which they are randomly allocated according to sequential number to 1 of the three groups. This indicates that there are no chances of bias results as the parents are randomly allocated to the controlled and experimental group (Lim, & In, 2019). The stratification variable that has been utilized for the study is the primary language of the patient to improve their understanding. The control group only attended the baseline survey and both the experimental group attended the educational intervention before visiting the paediatric provider. The allocation concealment process were taken into the account as the division of the participant into the three groups was done by using the opaque and sealed envelope. These envelopes are prepared by using the permuted block randomization that help to randomly allocate the group in the treatment group by maintaining the balance. Sequentially numbered, opaque, sealed envelope (SNOSE) technique is useful to reduce the chances of baseness and it is a technique for the allocation of concealment (Sil et al., 2020).

The study had set many different parameters for the characteristics of the participants that are to be included in the study. The parent-child dyads were eligible if their primary language in English or Spanish, the child is older than 6 years and there is no contraindication to the influenza vaccine. The dyads that were not eligible for the study includes received influenza vaccine earlier and not present there for the visit. The study has also utilized the 5-question short scale version and Parent Attitudes about Childhood Vaccines Survey Tool [PACV-5] to evaluate the vaccine hesitancy. Blinding was performed as the entire participant are not aware of which group they belong to that decrease risk of bias results. Both the experimental group under the educational interventions are been provided with a single-page handout that they have to read in the waiting room. Blinding of the trials is important to reduce the chances of deliberate interpretation of the interventions that can increase the bias results (Wartolowska, 2017).

The blinding of the delivering team was also conducted in the study to reduce the chances of bias behaviour toward the experimental or controlled group. The providers in the study were unaware of the parents' participation in the study and the intervention was conducted with the parent in the waiting room. The double blinding is important to reduce the chances bias result from both the end that includes participant and delivering team to improve the accuracy of the result (David & Khandhar, 2020). The study has utilized two assessments for identifying the results but there is no information concerning the blinding of the assessors.

The experimental were treated similarly and the controlled group is treated slightly differently to understand the impact of the educational intervention over the parents of the children. In the study, the baseline survey was used to analyse the demographic characteristics, information about the child, parental knowledge, intent to the vaccine and their belief for all the three groups. After which the two experimental groups went for the educational intervention and the controlled group directly went to the visit. Similar attention to all the groups is important to help to accurately identify the impact of the intervention over the participants to discuss the results (Deaton & Cartwright, 2018).

The study has discussed the data related to the loss of follow up at overall and at individual intervention level. The study was started with the approach of 1071 dyads about which 501 were eligible for the study concerning the specific parameters of the interventions. The participants for the study are 402 because the participants that are eligible but unenrolled include 88% of the non-interested participant and 12% do not want their child record to be reviewed. At individual intervention scale local interventions face lost to follow-up of three participants, national-level lost follow-up of four participant and usual care lost follow-up of one participant. The accurate information concerning the post interventions is necessary to accurately identify the result concerning the participants (Herbert et al., 2018).

The study has analysed the participation concerning the IIT method and all the results from the participants are analysed concerning the intent to vaccine the children. The educational interventions are framed to improve the understanding and wish for vaccination of the children. Intent to treat is considered to be the gold standard method that compares the outcome concerning the randomized group it decreases the chances of bias results (McCoy, 2017). The outcomes are measured by taking the entire factor similar for all the three groups to improve the analysis of the results that are important to identify the impact of the educational intervention over the participant. The primary and secondary analysis is conducted by considering two aspects that include understanding the association of intervention with different groups and vaccine receipt. The second aspect is the association between parental intent to vaccinate, vaccine hesitancy and knowledge with child vaccine. The difference in the outcome measurement concerning the different group can increase complication there is need to measure the outcome in the same way. The primary analyses were conducted by utilizing the multivariable logistic regression that analysed the association of the educational intervention with the child influenza vaccine receipt. The secondary analysis was conducted by utilizing the SAS statistical software to improve the accuracy of the results. (Law et al., 2015).

The statistical analysis is appropriately utilized in the study to evaluate the different result obtained after the baseline and post-survey. The educational intervention impact is evaluated by the regression method to understand the intent of the parents concerning the vaccination of the child. The statistical analysis is important to correlate the results of the participants to reveals the outcome of the interventions (Wennmacker et al., 2018). The study has also discussed the strength and limitation of the study that is important to understand the gap in the study that can be addressed by the other study. Strength and limitation in the study are important to be discussed for the internal validation which helps the study to understand the areas which can have been not addressed in the study (Booth & Tannock, 2014).

Applying the Evidence

The study represents that there has been an increase in the prevalence of influenza that has directly increase complication for the children. The reluctance behaviour toward the vaccine is one of the major public health complications that need to be addressed to decrease the rate of influenza. The parental educational intervention is important to improve the understanding and knowledge concerning the importance of the vaccine.

The study has revealed that educational interventions hand-out is associated with the increased child influenza vaccine receipts by the end. The findings from the study can be utilized in the case scenario to improve the parent behaviour to promote the immunization in the child for influenza. The nurse can conduct the educational interventions to improve the parent’s intent concerning the immunization which is necessary to increasing influenza in children.

The study can be concluded by adding that the article presented by Scott et al. (2019) clearly stated that educational interventions can be utilized to improve the rate of immunization. The study has accurately followed the blinding and allocation of concealment that is important for the randomized controlled trials. The study has utilized the two experimental group to understand the impact of the educational intervention over the intent of the parents concerning the immunization. The findings reveal that national data is considered to be more impactful to improve the parent perspective concerning the rate of immunization in the children. The study findings can be utilized to address the scenario that needs to improve the parent perspective concerning the immunization of the child with influenza. The findings of the study have great application in the clinical practise as they can help to improve the parent’s perspective concerning the immunization that is important to reduce the influenza rate.

References for Randomized Controlled Trial Pediatrics

Booth, C. M. & Tannock, I. F. (2014). Randomised controlled trials and population-based observational research: partners in the evolution of medical evidence. British Journal of Cancer, 110(3), 551–555. DOI: 10.1038/bjc.2013.725

David, S. & Khandhar, P. B. (2020). Double-Blind Study. Treasure Island, United Kingdom: StatPearls Publishing.

Deaton, A. & Cartwright, N. (2018). Understanding and misunderstanding randomized controlled trials. Social Science & Medicine (1982), 210, 2–21. DOI: 10.1016/j.socscimed.2017.12.005

Herbert, R. D., Kasza, J., & Bø, K. (2018). Analysis of randomised trials with long-term follow-up. BMC Medical Research Methodology, 18(48), 1-9. DOI: 10.1186/s12874-018-0499-5 

Law, G. C., Apfelbacher, C., Posadzki, P. P., Kemp, S. & Tudor Car, L. (2018). Choice of outcomes and measurement instruments in randomised trials on eLearning in medical education: a systematic mapping review protocol. Systematic Reviews, 7(75), 1-5. DOI: 10.1186/s13643-018-0739-0 

Lim, C. Y., & In, J. (2019). Randomization in clinical studies. Korean Journal of Anesthesiology, 72(3), 221–232. DOI: 10.4097/kja.19049

McCoy C. E. (2017). Understanding the intention-to-treat principle in randomized controlled trials. The Western Journal of Emergency Medicine, 18(6), 1075–1078. DOI: 10.5811/westjem.2017.8.35985

Scott, V. P., Opel, D. J., Reifler, J., Rikin, S., Pethe, K., Barrett, A., & Stockwell, M. S. (2019). Office-based educational handout for influenza vaccination: a randomized controlled trial. Pediatrics, 14(2), 1-9. DOI: 10.1542/peds.2018-2580 

Sil, A, Kumar, P, Kumar, R, Das, N. K. (2020). Selection of control, randomization, blinding, and allocation concealment. Indian Dermatol Online J 10, 601-605. DOI: http://www.idoj.in/text.asp?2019/10/5/601/265631

Umesh, G., Karippacheril, J. G. & Magazine, R. (2016). Critical appraisal of published literature. Indian Journal of Anaesthesia, 60(9), 670–673. DOI: 10.4103/0019-5049.190624

Wartolowska, K., Beard, D. & Carr, A. (2017). Blinding in trials of interventional procedures is possible and worthwhile. F1000Research, 6, 1-16. DOI: 10.12688/f1000research.12528.2

Wennmacker, S. Z., van Dijk, A. H., Drenth, J. P. H., Donkervoort, S. C., Boerma, D., Westert, G. P. & de Reuver, P. R. (2018). Statistical analysis plan of a randomized controlled trial to compare a restrictive strategy to usual care for the effectiveness of cholecystectomy (SECURE trial). Trials, 19(604), 1-10. DOI: 10.1186/s13063-018-2989-5

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