Research Assignment1 Jisha Sara Abraham

Table of Contents

Critical Appraisal Skills Programme Checklist (2018)CITATION:Kepreotes, E., Whitehead, B., Attia, J., Oldmeadow, C., Collison, A., Searles, A., & Mattes, J. (2017). High-flow warm humidified oxygen versus standard low-flow nasal cannula oxygen for moderate bronchiolitis (HFWHO RCT): an open, phase 4, randomised controlled trial. The Lancet, 389(10072), 930–939. Retrieved from A: Are the results of the trial valid?×Did the trial address a clearly Yes focused issue? Can’t Tell No The trial has addressed a clearly focused issue because the researchers considered the local population, intervention given, compared two respiratory strategies, andalso considered the outcomes. High-flow warm humidified oxygen (HFWHO) isbeing used increasingly as an alternative to standard therapy, but evidence regarding its efficacy and safety regarding paediatric setting is lacking. The trialaimed to examine whether HFWHO provided enhanced respiratory support, therebyshortening time to weaning off oxygen.× Was the assignment of patients Yes to treatments randomised Can’t Tell NoThe assignment of patients to treatment was randomised. The researchersrandomly assigned 202 children under 2 years of age by two groups of 101 in eachgroup. They allocated the patients using a block size of four and stratification forgestational age. Allocation concealment is possible with all types of trial includingunblinded trials, Hence its possible in this study as it as an unblinded trial. × Were all the patients who entered Yes the trial properly accounted for at its conclusion? Can’t tell NoThe study began with the total sample size of 202 infants randomised into twogroups. Initially, 6 children were excluded, 4 from standard therapy and 2 from HFWHO due to treatment failure. 1 infant censored initially for the primary analysis transferred to other hospital due to a shortage of bed. The study concluded after three years and follow up data were available for a total of 186 children after 16 exclusions (seven in standard therapy, nine in HFWHO. This is less than a 20% drop-out rate and therefore is acceptable. Intention to treat was used for the strategic analysis of RCT that compares treatment in the groups to which they were originally randomly assigned (Gupta, 2011).Bottom of FormIs it worth continuing? ×Were patients, health workers Yesand study personnel blind to treatment? Can’t tell No The patients, health workers and study personnel were unblinded towards treatmentto the assigned group. Informed consent was obtained from all parents of infantsand it is a process of participants is informed about all aspects of the trial (Lokesh et al., 2013). The researchers compared two different respiratory managementstrategies, HFWHO and standard oxygen therapy, a blinded trial was not possible due to obvious visual difference between the two modes of oxygen delivery. ×Were the groups, similar at the start of the trial? Yes Can’t Tell No The selection of the group was children under 24 months from a different background. However, the gestational age and developmental stage in children inboth groups were different. The distribution of male and female in both groups show standard deviation of 74% of males and 26% of females for standard therapy whereas 62% in male and 38% of female with HFWHO. ×Aside from the experimentalYes Intervention, were the group treated equally? Can’t Tell No The group were treated equally except for the experimental intervention. The researchers followed well-defined protocol for conducting weaning of oxygen therapy for the management of bronchiolitis specifically in both groups. Same amount of time and attention given to both groups. The investigators followed the independent variable in participants in each group. Section B: What are the results?How large was the treatment effect? The result of the study did not show a difference in weaning time between standard therapy and HFWHO. The investigators were unable to calculate the secondary outcome of time to treatment failure as it was never reached by 50% of the population, and so, they substituted 24-hour survival without treatment failure. By these measures, HFWHO was greater than standard therapy, 90% versus 60% of patients were free of treatment failure, with a 95% confidence interval (CI). For accuracy of the results, probability (P) value <.05 and 95 % CI can be regarded as statistically significant that early usage of HFWHO prevents further deterioration.How precise was the estimate of the treatment effect? Quantitative approach used in this study to identify the problem and understands its prevalence’s (Ingham-Broomfield, 2014). Comparison of the intervention and control groups using the probability (P) value has been presented (Bland & Altman, 2011). The main finding was that HFWHO in reducing the need for ICUadmission, additional resources, due to 19 fewer treatment failures than with standard therapy. For accuracy of the results, P value <.05 and 95 % CI can be regarded as statistically significant that early usage of HFWHO prevents further deterioration. The results can be quite precise. Section C: Will the results help locally? ×Can the results be applied to Yes the local population, or in your context? Can’t tell No The study didn’t attain the aim and there is still need of other researches on the management of moderate bronchiolitis in infants. Also, trial evidence of safety andeffectiveness of the use of high flow FiO2 was lacking. Moreover, the small samplesize in a single facility limited the generalizability of the study. Hence, it cannot be applied to the local population and further large study would be appreciated. × Were all clinically important outcomes considered?YesCan’t tellNoThe researchers observed that HFWHO used at 1L/kg/min in babies with moderatebronchiolitis is a safe, effective therapy and reverses the clinical deterioration in some babies, reducing transfers to ICU. Moreover, parents of the babies rated thatHFWHO as being more comfortable and supportive during feeding than standardoxygen therapy, while there was no difference in sleep quality. × Are the benefits worth the Yes harms and costs?Can’t Tell NoThe trial looked at the adverse effects of both Standard and HFWHO interventions and the conclusion was that both were safe. There were no serious adverse events. Adverse events were minimal with 2 occurring in each group. The cost analysis indicated that standard therapy was significantly more inexpensive than HFWHO. However, the trial showed that HFWHO significantly reduced ICU admission, additional support as 19 fewer treatment failures compared to standard therapy. The result of the experimental trial shows the HFWHO looks more dramatic than standard therapy. Hence, HFWHO could be a cost-effective option in some cases.The aim of this study clearly stated that “To examine whether HFWHO gives adequate respiratorysupport thereby shortening time to weaning off oxygen”. Bronchiolitis is the common respiratory tractinfection of children under 2 years and leads to hospital admission (Meissner, 2012). In quantitative research, the method is used to quantify the problem by means of numerical data (Dovetail, 2019).The author used various statistical analyses and considered historical data to estimate study size and introduced well-defined oxygen weaning procedure. Informed consent is the process where the patients or legal guardians be informed of all the aspects of the trial (Nijhawan et al.,2013). Written informed consent obtained from the infant’s parents or guardian prior to trial. The inclusion criteria were set based on physiological parameters such as heart rate, respiratory rate, SPO2 level, feeding ability.The study was a thorough, concise and followed the best methodology for conducting and analysing a randomised controlled trial. The trial has used stratified random sampling to reflect adequately the proportion of the population with a specific characteristic (ThoughtCo, 2019). The randomisationstrategy was excellent, randomising in blocks, for important for seasonal disease and stratifying the degrees of prematurity, a major severity risk factor ( Kang, Ragan & Park, 2008). Also, the researchers explained clearly why blinding was not possible with this intervention. The investigator’sstatistical plan was very clear and thoughtful (McHugh, Lake, 2011). The trial did not attain itsprimary outcome of weaning time off oxygen however, the median time to weaning oxygen reduced from a historical data of 38 hours to 24 hours for the standard therapy group. The null hypothesis in this trial would be rejected as it compared with two intervention (Zhong, 2009). The use of PRISMA flow chart (figure 2) for a literature review which explains the selection process in a quick glance would be appreciated (Stovold, Beecher, Foxlee & Noel-Storr,2014). The investigators found no differences between HFWHO and ST for time to weaning of oxygen but see some differences in event-free survival at 24 hours (90% for HFWHO versus 60% for ST). The researchers concluded from the findings of no differences in oxygen weaning time that the mode of oxygen delivery did not significantly alter the underlying disease process, but that HFWHO use might have prevented ICU admission in some children. However, the researchers were cautious not to oversell this finding in the abstract or in their discussion.The critical review process is effective in integrating clinical practice knowledge with research evidence (McGrath, 2005). The author reviewed some background literature. According to this study, HFWHO may be more effective than standard oxygen therapy in preventing care escalation in infants with bronchiolitis treated outside an intensive care unit. The potential benefit in exploring the issue has been discussed and the words that prove that early usage of HFWHO improved clinical outcome, reduced mortality. The author did mention the review in the study with daily visits and training with all healthcare workers. However, no evidence available about parent’s education. Evidences of follow-up was not available from all the participants after 30 days of discharge however, the researchers were obtained report from parents at the earliest after 30 days. As this was a single-centre study, this is certainly a concern that studies of this type won’t be generalisable to other institutions. On the other hand, bronchiolitis trials are notoriously difficult to manage in a multi-centre format, because the severity scoring criteria are necessarily a bit subjective and it’s difficult to maintain uniformity of scoring and clinical practice among multiple centres over the prolonged study period.References:Bland. J. M., & Altaman. D. G. (2011). Comparisons against baseline within randomised groups are often used and can be highly misleading. NCBI Journal, 12 (264),. doi: 10.1186/1745-6215-12-264Broomfield. R. (2014). A Nurses’ guide to Quantitative Research. Australian Journal of Advanced Nursing, 32(2),. Retrieved from (2019, March 08). The difference between qualitative and quantitative research [Blog Post] Retrieved from, K. S. (2011). Perspectives in clinical research: Intention-to-treat concept: A review. Indian society for clinical research,4(3),134-140. doi: 10.4103/2231-4040.116779Kang, Ragan,G.B. & Park.J. (2008). Issues in Outcomes Research: An Overview of Randomization Techniques for Clinical Trials. Journal of Athletic Training, 43 (2), 215- 221. doi: 10.4085/1062-6050-43.2.215Nijhawan. L. P., Janodia. M. D., Muddukrishna. B. S., Bhat. K. M., Bairy. K. M., Udupa. N., & Musmade. P. B. (2013). Informed consent: Issues and challenges, Journal of advanced Pharmaceutical Technology & Research, 4(3), 134-140. doi: 10.4103/2231-4040.116779McHugh, M. D., & Lake. E. T. (2010). Understanding Clinical Expertise: Nurse Education, Experience, and the Hospital Context. NCBI Journal,33(4), 276-287. doi: 10.1002/nur.20388McGrath. J . (2005). Critical Thinking and Evidence: Based Practice. Journal of professional Nursing, 21(6), 364-371., H. C. (2012). Principles and practices of paediatric infectious disease: Bronchiolitis. Science Direct, 33(2), 231-235. Stovold, E. Deirdre, B. Foxlee, R & Noel-Storr, A. (2014). Study flow diagrams in Cochrane systematic review updates: An adapted PRISMA flow diagram. NCBI Journal, 3(54), doi: 10.1186/2046-4053-3-54 ThoughtCo. (2019, March 01). Understanding Stratified Samples and How to Make Them [ Blog Post]. Retrieved from, (2009). How to Calculate Sample Size in Randomized Controlled Trial?. Journal of Thoracic Disease,1(1), 51-54. Retrieved from https://www.ncbi.nlm.