RCT Paper Analysis Assignment Sample

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• Subject Name : Nursing

Office-Based Educational Handout for Influenza Vaccination

Aim of the research

The research aimed at assessing the impact of parent educational intervention on influenza disease on child vaccine receipt.

PICO question

Population	Parents of children >= 6 months
Intervention	Educational handouts about influenza
Comparison	Child influenza vaccine receipt by the end of the season compared with child influenza vaccine receipt on the day of a clinical visit.
Outcome	Get children vaccinated for influenza disease.

JBI Critical Appraisal Tool for RCT Validation of Study

From the JBI critical analysis tool of randomized control trial, various aspects of the study are evaluated (Scott, Opel & Reifler et al., 2019). It includes randomization of study participants, treatment allocation, blinding of treatment groups, outcomes assessment, intervention is done, reliability, statistical analysis, and the study design (Scott et al., 2019). All were found to be appropriate in the study because the overall appraisal concludes that important information needed to do analysis was included in the project. Vaccine effectiveness will be promoted by future interventions to have an useful impact on child vaccine coverage (Scott et al., 2019).

Randomization of Study Participants

There were differences between the study participants that included a comparison group constituting a threat to study explored and internal validity (Al-Lamee, Thompson & Dehbi et al., 2018). The participants were allocated using a true randomization assignment of participants, it means that the procedure used allocates the participants to groups based on chance and not influenced by known characteristics of the participants (Scott et al., 2019). The enrollment of participants included 570 participants out of which 493 received the influenza vaccine;35 were a child not with parent or guardian; 16 already showed provider; 9 were in clinic for vaccine only visit; 8 were illiterate; 7 were having egg allergy; and 2 were unsure about whether their child received influenza vaccine yet or not.

Allocation of Concealment Similarity of Groups

The concealment of allocation to procedures prevented the allocation of participants from knowing before allocation which treatment or control was there in the next process (Scott et al., 2019). The concealment of allocation was appropriately used and this reduced risk that may purposefully intervene and deliberate the allocation of participants to the control group or treatment group and therefore prevented from distorting the implementation of allocation process before allocation which control or treatment in the allocation process. Here, in this article, the central randomization system was used by distributing an equal number of participants in each group (Scott et al., 2019).

Treatment Groups Same at The Baseline

After the consent and randomly assigned, the participant's number in total was 402 and divided in 1:1:1 which is 134 for local, national, and usual care each. The experimental design of this study evaluated the effect of an intervention for caregivers (Scott et al., 2019).

Blinding of Participants, Healthcare Professionals, and Study Investigation

Blinding of participants refers to the participation of family members of children who were involved in the study. Participants were not aware of the group was receiving a treatment of interest or if any control interventions were given to the participants. Medical records play a greater role in understanding relationships as they have a link between alignment of procedure and self-reporting parental talent. The assessment of influenza vaccine receipt through a child's medical record improves understanding of the relationship between self-reporting parental talent and alignment of the procedure (Scott et al., 2019).

Delivering Treatment Blind to Treatment Assignment

The participants were aware not aware about the study, so the control and comparison group were difficult to handle. All performed well in the research conducted for social welfare.

Outcomes Assessors Blind to Treatment Assignment

No, the outcome assessors were knowing about the research being done. However, in the article, an appropriate blinding concept was used to get the efficiency of interventions (Scott et al., 2019). This is also sometimes called masking so that the participants involved in the study do not react or respond differently based on the interventions and results.

Treatment Groups Treated Effectively

Both groups were given same type of treatment during complete study. In the study, vaccine hesitancy was analyzed, and the questionnaire was made using the health belief model. The assessment was done on a short scale version of five ratings using 15 questions of Parent Attitudes About Childhood Vaccines Survey Tool (PACV – 5) (Scott et al., 2019). This tool is also found to be useful in various demographics by knowing parental belief on influenza vaccine effectiveness, minimal concerns, parental beliefs that shot does not cause flu about side effects associated with child influenza vaccine receipt.

Time of Data Analysis and Intention-To-Treat Analysis

This randomized control trial study aimed to assess the impact of parent educational intervention on influenza disease on child vaccine receipt provided an educational handout to parents. It was found from the analysis that there was a strong association with the increase of child influenza vaccine receipt by the end of the influenza season (Scott et al., 2019). The pro-vaccine educational material was studied in the previous article, though the researcher did a primary assessment of prenatal vaccine hesitancy and intent to vaccinate. A different timeline of the study was used with a different mode of delivery. The focus of the study was on adolescents, adults, and pregnant women populations. Educational handouts were found to be very successful through this study (Jacka, O’Neil & Opie et al., 2017). Hence, this was the first successful study for vaccination of children. This was the first study found successful after the evaluation of the effect of an intervention with educational handouts in the clinic setting on child influenza vaccine receipt (Scott et al., 2019).

Outcomes Measurement in Same Way for Treatment Groups

The sample size was found to be adequate as 1071 parent-child dyads were approaches, 501 were eligible, 402 were enrolled, and 400 were analyzed. The equal distribution of participants was done by evaluating the mean of study. The median child and parentage were 4.3 (interquartile range 1.5–9.5) and 33.0 (interquartile range 27.0–40.0) years, respectively. The major contribution of children was from Hispanic mothers, who have insurance and good health. Parents of Hispanic mothers were educated out of which some refused treatment and one third refused treatment for vaccination. Equal state of distribution was found in subgroups between usual care arms and national data intervention (Scott et al., 2019). The study was highly reliable and validated because in this efficient screening of patients was done in primary care settings, The Parent Attitudes About Childhood Vaccines Survey Tool [PACV-5] was used in the research and demographics in the study were found to be useful (Scott et al., 2019). The study design, tool, sampling, mathematical calculations, and interpretation of results were done in a validated manner. This was an effective study that posed correct results from analysis with future interventions to promote influenza vaccine effectiveness on child vaccine coverage (Scott et al., 2019).

Study Results

The results of the study gave a significant presentation that a targeted approach is the source of data to get an additional benefit to child vaccine receipt. The difference was calculated by linking the association of the number of children affected by influenza and deaths occurred (Scott et al., 2019). This has impacted a community at large extent by assessing the higher influenza vaccine coverage rate in the parent's local community. This has led to a desirable hypothesized impact on society and local data intervention revealed that many people of the community felt that they have bee affected by influenza, but they were not (Scott et al., 2019).

Outcome Measures

The outcome measure of the study presented that parents who received an intervention have a greater rating of child influenza vaccine receipt by the end of the season that the day of a clinical visit. To evaluate this, multivariate logistic regression analysis was used to assess the association between vaccination and intervention with the adjustment of variables (Scott et al., 2019).

Interpretation of Effect Size

The odds ratio was used to interpret the effect size with an intervention had greater odds of child influenza vaccine receipt by the end of the season but not on the day of their clinical visit. Educational intervention in the waiting room before a visit to pediatrician help in increasing child influenza vaccine receipt (Scott et al., 2019).

Statistical Significance

The statistical analysis was done for the intention to treat analysis as denoted as the primary analysis. For this study, per-protocol was conducted for the parents who did receive the influenza vaccine that season was excluded. Fisher’s exact test and frequency statistics were used to describe the characteristics of participants in each study arm based on the variable type (Scott et al., 2019). Multivariate regression analysis was used for primary analysis to assess the association of any educational intervention with child influenza vaccine receipt, adjusting for any baseline differences (P ≤ .10) among arms. In secondary regression analyses, the study was assessed on the association of intervention subgroups individually (local data intervention versus usual care and national data intervention versus usual care) with vaccine receipt, adjusting for baseline differences, and the association of parental intent to vaccinate, vaccine hesitancy, and influenza vaccine beliefs and/or knowledge with child vaccine receipt, adjusting for an arm. SAS statistical software was used to do statistical analysis (Scott et al., 2019).

Strength of Results

The strength of the study is that it includes a randomized control trial for the assessment of intention to vaccinate and baseline vaccine hesitancy to decrease confounding effects. From the study, it was found that pediatric providers were not aware of minimizing social desirability bias and study participation. The influenza vaccine receipt was assessed through a child’s medical record improvement for understanding the relationship between self-reporting and the intention to get vaccinated (Scott et al., 2019).

Possible Application of Scenario

The modes of information delivery should be chosen that include cost-effectiveness models such as video, paper handout, interactive social media, and text messaging so that there is an increase in child influenza vaccine receipt and feasibility of implementation (Scott et al., 2019).

Reference for RCT Paper Analysis

Al-Lamee, R., Thompson, D., Dehbi, H. M., Sen, S., Tang, K., Davies, J., ... & Nijjer, S. S. (2018). Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. The Lancet, 391(10115), 31-40. https://doi.org/10.1016/S0140-6736(17)32714-9

Jacka, F. N., O’Neil, A., Opie, R., Itsiopoulos, C., Cotton, S., Mohebbi, M., ... & Brazionis, L. (2017). A randomised controlled trial of dietary improvement for adults with major depression (the ‘SMILES’trial). BMC medicine, 15(1), 1-13. https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-017-0791-y?mod=article_inline

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, 144(2). https://doi.org/10.1542/peds.2018-2580

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