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Critical Appraisal of Articles

Introduction

In the field of healthcare, in the recent times, there has been the inclusion of evidence-based practise which has evolved to such an extent that it has now become an expectation (Melnyk et al., 2018). All the healthcare professionals including nurses are expected to follow the practice of evidence-based into their care delivery. This is expected from the healthcare systems such that is ingrained in the national standards for the registered nurses as well as the code of ethics as provided by the Nurses and Midwifery Board of Australia (Grove & Gray, 2018). For the current assignment of critical appraisal for the evidence-based practice, the topic of interest that has been selected is asthma and the mode of drug delivery in pediatric patients in an emergency as well as critical care unit. Asthma is a chronic condition in which there is a chronic inflammation which is seen in the respiratory system of a person (Hufnagl et al., 2017).

It results in characteristic wheezing and causes difficulty in breathing. The cause of the same can be due to the presence of dust, pollen, smoke or other kinds of noxious substance (Jartti&Gern 2017; Pizaña&López, 2018). An acute exacerbation can be fatal and can lead to death and it is managed by administration of salbutamol which can be done by the use of nebulizer or spacer (Padem&Saltoun 2019). The evidence-based practise consists of three aspects and they are best available external evidence, the clinical expertise of the healthcare professional and the preference of the patient (Sonğur et al., 2018). The present assignment aims to provide a critical appraisal for two articles where the comparison have been made between the two modes mentioned-above and give the evidence-base for the effective mode of medication.

Article 1:

Iramain, R., Castro‐Rodriguez, J. A., Jara, A., Cardozo, L., Bogado, N., Morinigo, R., & De Jesús, R. (2019). Salbutamol and ipratropium by inhaler is superior to a nebulizer in children with severe acute asthma exacerbation: Randomized clinical trial. Pediatric Pulmonology, 54(4), 372-377.

Authorship

The primary author Iramain, R. is a faculty in the department of pediatrics in the emergency department of the clinical hospital in the national university of Asunción, Paraguay. There were a total of seven authors which included the primary author in the research and compilation of the present article which has been published (Iramain et al., 2019). All the authors work in the department of pediatrics and have worked previously on other articles related to the wellbeing of pediatric patients. The authors followed all the components for the formation of the article. The authors did not take a control group as it would be against the treatment protocol and unethical to withhold the treatment of beta-2 antagonist from asthmatics (Iramain et al., 2019). The protocol was reviewed and approved by the ethical committee of the clinical hospital. The authors have declared that there was no external funding that was taken for the study and the authors have declared that there was no conflict of interest concerning this article (Iramain et al., 2019).

Research question, aims or objectives or hypotheses

There are different schools of thought that govern the use of inhalers with spacer or nebulization in case of acute exacerbation of asthma (Fonceca et al., 2019). This is the major cause of maximum hospitalizations in children with asthma and timely and appropriate management is required to reduce the associated mortality and morbidity. The previous research has reflected that when salbutamol is administered with the help of inhaler as a metered-dose in case of moderate to severe asthmatic condition, it results in lesser hospitalizations, more clinical improvement and lesser adverse effects (GINA, 2017; Pollock et al., 2017). This article was conducted with an aim to compare the effectiveness of salbutamol with ipratropium bromide using spacer vs. its administration by nebulizer in patients with acute exacerbation of asthma (Iramain et al., 2019). This randomized controlled trial was conducted as there was no previous documentation of the study conducted in this particular subgroup with severe acute exacerbation. The authors hypothesized that use meter doses inhaler for the administration of salbutamol and ipratropium bromide with valved holding chamber would be more successful and have lesser adverse effects in comparison to the drugs delivered by nebulizer (Iramain et al., 2019).

Research Design

The present study was a randomized controlled trial which was conducted in the emergency departments of clinical hospital in the national university of Asunción, Paraguay. The children aged between the ages of two to eighteen years who were diagnosed with acute exacerbation of asthma were recruited for the study (Iramain et al., 2019). The study was conducted from a period of 2013 to 2017 and 103 children who satisfied the inclusion criteria were enrolled in the study (Iramain et al., 2019). The researchers randomly allocated the children into experimental groups and the nurses in the emergency department recorded the baseline data. The random allocation was done by the use of the table of a random number which is a computer-generated sequence (Iramain et al., 2019).

In a randomized controlled trial, use of random number table for the randomization is good as it can be applicable to all situations and the explicit list of parent sample is not required for the sampling (Jiang et al., 2017). Masking is also an important part of the randomized controlled trial as it would not reveal the allocation of the participants into the experimental group so that there is no influence on the intervention and results (Kim et al., 2018). After randomization, the allocation concealment was done by placing the allocation result into a sealed envelope. As it was unethical, the authors did not take a control group as it would mean to deny the patients treatment (Iramain et al., 2019).

Data collection

The authors have not explicitly mentioned the process of data collection and the baseline data for demographic details were collected by the nurses in the emergency department. The study participants were recruited in a consecutive manner from the children who fulfilled the criteria in the emergency department of the hospital (Iramain et al., 2019). As the authors have not provided any sampling method and it is seen that the study was conducted in a single setting in the hospital. The sampling method is a non-probability sampling that is convenience sampling. The children in the nebulizer group were given 0.5% salbutamol in normal saline solution every 7 minutes for two hours followed by every thirty minutes for two more hours (Iramain et al., 2019).

The children in metered-dose inhaler were administered two puffs of salbutamol every ten minutes for two hours followed by every thirty minutes for two more hours. The oxygen saturation was maintained by the administration of oxygen with a flow rate of 35-40% and 3L oxygen. Ipratropium bromide was administered to children in both the groups in between the administration of salbutamol such that all the children received both the drugs (Iramain et al., 2019). The nurses collected the data for oxygen saturation by the use of GE healthcare Dash 2500 monitor at the baseline, 30, 60, 90, 120 and 240 minutes. Oxygen saturation was the secondary outcome while the primary outcomes were respiratory rate, presence of wheeze and use of accessory muscles (Iramain et al., 2019). The adverse effect that was assessed as a part of the administration of the drugs which was in the objectives of the study and that was tachycardia.

If any of the study participants developed tachycardia it was noted as they had developed an adverse effect for the drug. Till this time, the researchers were kept blinded of the allocation of treatment (Iramain et al., 2019).

Data analysis

The authors have mentioned that they have used Epi-Info software for all the statistical analysis with the power of the study was taken as 90% and the level of significance was taken with p-value 0.05 (Iramain et al., 2019). The difference between the groups was evaluated with the chi-square test, continuous variables depending on the normalcy of distribution student t-test or Mann-Whitney test was conducted. For the pulmonary score, ≤ 6 survival analysis was conducted by Mantel-cox log-rank test (Iramain et al., 2019).

Discussion

The present study had a few limitations which the authors have explicitly mentioned the limitations. Firstly, the lung function test was not evaluated though objectively oxygen saturation and pulmonary scores were calculated (Iramain et al., 2019). Secondly, the follow-up of the patients after the discharge from the emergency department was not done. The authors have provided an argument that at 4th hours the pulmonary score was low and saturation was high which made the chance of relapse least (Iramain et al., 2019). Thirdly, age of onset of asthma and data for previous hospitalizations due to acute exacerbations was taken into account. Lastly, the only adverse effect that was accounted for was tachycardia but there are other adverse effects of the administration of salbutamol and ipratropium bromide was not evaluated for like vomiting and tremors (Iramain et al., 2019). The authors concluded that metered-dose inhaler with the administration of oxygen via cannula was more effective than a nebulizer. As this was the first study which was conducted in this particular subset of the population the authors recommend that more studies are required so that new findings can be corroborated (Iramain et al., 2019).

Article 2:

Roncada, C., Andrade, J., Bischoff, L. C., &Pitrez, P. M. (2018). Comparison of two inhalational techniques for bronchodilator administration in children and adolescents with acute asthma crisis: As meta-analysis. RevistaPaulista de Pediatria, 36(3), 364-371.

Authorship

The primary author Roncada, C. is a faculty in the department of pediatrics in aCentro Universitário da Serra Gaúcha, Caxias do Sul, RS, Brazil. There were a total of four authors which included the primary author in the research and compilation of the present article which has been published (Roncada et al., 2018). All the authors work in the department of pediatrics and have worked previously on other articles related to the wellbeing of pediatric patients. The authors followed all the components for the formation of the article (Roncada et al., 2018). The authors have not mentioned whether the protocol was reviewed and approved by the ethical board of the institute. However, as this was a systematic review, the researchers made sure that the study was registered on the website for the centre of reviews and dissemination (PROSPERO) (Roncada et al., 2018). As the present study conducted was a meta-analysis which is not primary research as previously published research material is used for the meta-analysis, the ethical approval can be rendered void. The authors have declared that there was no external funding that was taken for the study and the authors have declared that there was no conflict of interest with respect to this article (Roncada et al., 2018).

Research question, aims or objectives or hypotheses

One of the most common chronic diseases that affect the children is that of asthma and in recent times the incidence has increased (GBD 2015 Chronic Respiratory Disease Collaborators, 2017). The signs and symptoms of the disease are related to the bronchial hyperresponsiveness and these are persistent and recurrent (Dharmage et al., 2019). There are various factors for the commencement of the disease as well as an acute exacerbation of asthma and they are exposed to dust, pets, mold, infection of the respiratory system and smoke (Ring et al., 2014). In the case of acute exacerbation, the guidelines recommend the use of short-acting bronchodilators which can help to ease the breathing. Historically, administration of the drug is done by nebulization and in the recent, there is an exploration of administration by inhalers with a spacer. However, it is used less due to less understanding of the technique (Pijnenburg&Szefler, 2015). The literature shows the difference in opinion on the effectiveness of the administration of the drug by the means of nebulization compared to the metered-dose inhaler with a spacer. The present study was conducted with an aim to compare the effectiveness of treatment for asthma in pediatric patients in the emergency department by the means of nebulizer and metered‑dose inhaler with spacer for the administration of beta-2 agonist (Roncada et al., 2018).

Research design

The present research was conducted consecutively firstly as systematic review followed by the meta-analysis. For the best possible evidence that is required for the conduction of systematic review is to include the highest level of evidence as per the pyramid of evidence hierarchy (Djulbegovic&Guyatt, 2017). Authors selected randomized controlled trials according to the inclusion and exclusion criteria. The articles after the removal of duplicates and outcome variables as per the analysis for the systematic review the meta-analysis was conducted (Roncada et al., 2018). As the research design was a systematic review and meta-analysis, the authors have not provided much information regarding research design. The authors have conducted the study as per the proper study design for both systematic reviews as well as meta-analysis (Roncada et al., 2018).

Data collection

The articles relevant to the topic were the data that was collected for the systematic review followed by meta-analysis. The eligibility criteria for the articles that were to be chosen include the articles selected by the researchers individually were automatically included; if only one researcher selected an article it was excluded; if an article was selected by two researchers was jointly reviewed and accepted if it met the criteria (Roncada et al., 2018). For the systematic review, the articles included were such that they included randomized controlled trials with or without the use of a placebo (Roncada et al., 2018). The articles which were included if they addressed the comparison of the efficacy between nebulization and metered dose inhaler-spacer for the treatmentof asthma in pediatric patients. The data was collected from databases like PubMed, Scientific Electronic Library Online(SciELO), and ScienceDirect (Roncada et al., 2018).

Search limiters were used for time and keywords to select the headings and abstract. Also, the authors used Boolean operator AND to refine the search but no filter was applied for language or audience. For the meta-analysis, for the comparison the data was collected from the articles that were selected the comparison of the use of the metered-dose inhaler with spacer and nebulizer; heart rate; respiratory rate; saturation of oxygen; clinical score (Roncada et al., 2018). The data collected for comparison was also pertaining to the symptoms like the presence of wheezing, cyanosis, retractions of the chest and transcutaneous saturation of oxygen and the points were allocated from a range of 0 to 15 points (Roncada et al., 2018).

Data analysis

After the articles were selected, all the selected articles were exported to the extensions of MEDLINE and RIS. Further, the data was imported to the elaboration of systematic reviews that is State of the Art through Systematic Review, StArt (Roncada et al., 2018). This software was used for the identification of duplicate articles as the articles were included as selected by all the three researchers independently. This also helped in the identification of included and excluded articles. The analysis of the articles was conducted by the researchers independently, reviewed and revised. After the conduction of systematic review, for the meta-analysis, the articles those were included in the systematic review after identification of outcome variables were imported to the software review manager (Roncada et al., 2018). Using the software, bivariate differential statistics was conducted for comparison of means was applied. The estimation of intergroup that is metered-dose inhaler-spacer and nebulizer and the outcome means was estimated with a 95% confidence interval (Roncada et al., 2018).

Discussion

The authors have reflected the limitations of the articles selected as well as for the study conducted. The main limitations of the articles that were selected were that there was no standardization for the evaluation of pulmonary function in the articles. The main markers for asthma that were variants used were FEV1, forced vital capacity (FVC) and Tiffeneau index,which evaluates the relationship between these variables (FEV1/FVC), as well as levels of exhaled nitric oxide (FeNo) (Roncada et al., 2018). The main limitation of the meta-analysis that was conducted is that it did not show that improvement in the function of lung in the markers when both the administration techniques were used. As the disease like asthma is heterogeneous so this limitation is acceptable as the outcomes are also variables (Roncada et al., 2018). The result of the present study showed that there was no difference when the drugs were administered via metered-dose inhaler with spacer or nebulizer. The authors did not give any recommendation for future studies.

Comparison

The topic of interest for the present assignment is asthma and the way the drugs can be administered to the pediatric patients who suffer from acute exacerbation of asthma. Acute exacerbation of asthma results in recurrent hospitalization and if not tackled properly can result in hypoxia and even death (Padem&Saltoun, 2019). The first article that is discussed is a randomized controlled trial and the results obtained by from the randomized controlled trial can be considered reliable and valid. The result of the randomized controlled trial reflected that metered-dose inhaler with spacer for the administration of salbutamol and ipratropium bromide compared to nebulization in the emergency department (Iramain et al., 2019).

When this was compared to the second article which was a meta-analysis it showed different results. The result of that study reflected that there was no difference in the efficacy when the administration of beta-2 agonist was done by metered-dose inhaler with spacer and nebulizer. The meta-analysis was conducted properly and the articles selected for the systematic review and meta-analysis were all randomized controlled trial (Roncada et al., 2018). This makes the results obtained from the meta-analysis more valid and the result can be accepted by the nurses in clinical practice. It can be recommended that as there was no difference in the way the drug is administered and going by the components of evidence-based practice the drug can be administered as per the clinical expertise and preferences of the patient. The guidelines for the nursing practice are to carry out the practice which is evidence-based and it has to be done as per what is comfortable to the patient more than the clinical expertise.

Conclusion

Asthma is one of the chronic conditions which are most commonly seen in childhood which is an inflammatory condition of the respiratory condition in which the patient is unable to breathe properly and there is a characteristic wheeze. Due to acute exacerbation of asthma, it can cause multiple hospitalizations and if not managed can result in the demise of the patient. Administration of salbutamol with or without ipratropium bromide is the first line of treatment for controlling acute exacerbation. There are various ways in which this can be administered but for the clinical practice, it is required that these ways are explored and evaluated in terms of effectiveness. This can be set for the evidence-based practice in clinical treatment. From the critical appraisal of the two selected articles, one of which was a randomized controlled trial and the other one was a meta-analysis the result of the latter can be accepted into the clinical practice. This is because of the hierarchy of evidence where meta-analysis is the highest level of evidence and is at the top of the pyramid. It can be recommended considering the components of evidence-based practice are that administration of the drug to be done as per what is comfortable to the patient more than the clinical expertise.

References

Dharmage, S. C., Perret, J., &Custovic, A. (2019).Epidemiology of asthma in children and adults. Frontiers in Pediatrics, 7, 246.https://doi.org/10.3389/fped.2019.00246.

Djulbegovic, B., &Guyatt, G. H. (2017). Progress in evidence-based medicine: A quarter century on. The Lancet, 390(10092), 415-423. https://doi.org/10.1016/S0140-6736(16)31592-6.

Fonceca, A. M., Ditcham, W. G. F., Everard, M. L., &Devadason, S. (2019). Drug administration by inhalation in children.In Kendig's Disorders of the Respiratory Tract in Children (pp. 257-271). Content Repository Only!.https://doi.org/10.1016/B978-0-323-44887-1.00016-X.

GBD 2015 Chronic Respiratory Disease Collaborators. (2017). Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990–2015: A systematic analysis for the Global Burden of Disease Study 2015. The Lancet.Respiratory Medicine, 5(9), 691.https://doi.org/10.1016/S2213-2600(17)30293-X.

GINA. (2017). Global initiative for asthma-global strategy for asthma management and prevention NHLBI/WHO workshop report.https://ginasthma.org/wp-content/uploads/2019/01/2012-GINA.pdf.

Grove, S. K., & Gray, J. R. (2018). Understanding Nursing Research E-Book: Building an Evidence-Based Practice. Elsevier Health Sciences.

Hufnagl, K., Hirt, R., &Robibaro, B. (2017).Out of breath: Asthma in humans and their animals.In Comparative Medicine (pp. 71-85).Springer, Cham.https://doi.org/10.1007/978-3-319-47007-8_5.

Iramain, R., Castro‐Rodriguez, J. A., Jara, A., Cardozo, L., Bogado, N., Morinigo, R., & De Jesús, R. (2019). Salbutamol and ipratropium by inhaler is superior to nebulizer in children with severe acute asthma exacerbation: Randomized clinical trial. Pediatric Pulmonology, 54(4), 372-377. https://doi.org/10.1002/ppul.24244.

Jartti, T., &Gern, J. E. (2017).Role of viral infections in the development and exacerbation of asthma in children. Journal of Allergy and Clinical Immunology, 140(4), 895-906. https://doi.org/10.1016/j.jaci.2017.08.003.

Jiang, H., Belkin, D., Savel’ev, S. E., Lin, S., Wang, Z., Li, Y., ...&Barnell, M. (2017). A novel true random number generator based on a stochastic diffusive memristor. Nature Communications, 8(1), 1-9. https://doi.org/10.1038/s41467-017-00869-x.

Kim, H. S., Lee, S., & Kim, J. H. (2018). Real-world evidence versus randomized controlled trial: Clinical research based on electronic medical records. Journal of Korean Medical Science, 33(34).https://doi.org/10.3346/jkms.2018.33.e213.

Melnyk, B. M., Gallagher‐Ford, L., Zellefrow, C., Tucker, S., Thomas, B., Sinnott, L. T., & Tan, A. (2018). The first US study on nurses’ evidence‐based practice competencies indicates major deficits that threaten healthcare quality, safety, and patient outcomes. Worldviews on Evidence‐Based Nursing, 15(1), 16-25. https://doi.org/10.1111/wvn.12269.

Padem, N., &Saltoun, C. (2019).Classification of asthma.In Allergy & Asthma Proceedings, 40(6), 385-388

Pijnenburg, M. W., &Szefler, S. (2015). Personalized medicine in children with asthma. Paediatric Respiratory Reviews, 16(2), 101-107. https://doi.org/10.1016/j.prrv.2014.10.003.

Pizaña, A. A., &López, J. G. H. (2018).Role of viral infections in the development and exacerbation of asthma in children. Alergia, Asma e InmunologíaPediátricas, 27(2), 49-59. https://www.medigraphic.com/cgi-bin/new/resumenI.cgi?IDREVISTA=35&IDARTICULO=80533&IDPUBLICACION=7763.

Pollock, M., Sinha, I. P., Hartling, L., Rowe, B. H., Schreiber, S., &Fernandes, R. M. (2017). Inhaled short‐acting bronchodilators for managing emergency childhood asthma: An overview of reviews. Allergy, 72(2), 183-200. https://doi.org/10.1111/all.13039.

Ring, J., Akdis, C., Lauener, R., Schäppi, G., Traidl‐Hoffmann, C., Akdis, M., ...&Bienenstock, J. (2014). Global allergy forum and second DAVOS declaration 2013 allergy: barriers to cure–challenges and actions to be taken. Allergy, 69(8), 978-982. https://doi.org/10.1111/all.12406.

Roncada, C., Andrade, J., Bischoff, L. C., &Pitrez, P. M. (2018). Comparison of two inhalational techniques for bronchodilator administration in children and adolescents with acute asthma crisis: As meta-analysis. RevistaPaulista de Pediatria, 36(3), 364-371. https://doi.org/10.1590/1984-0462/;2018;36;3;00002.

Sonğur, C., Özer, Ö.,Gün, Ç., & Top, M. (2018). Patient safety culture, evidence-based practice and performance in nursing. Systemic Practice and Action Research, 31(4), 359-374. https://doi.org/10.1007/s11213-017-9430-y.

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