Critical Analysis of Medical Studies - Respiratory Medicine

Introduction/Background

Before diving deep into this analysis, it is crucial to understand albuterol's meaning on one side and nebulized magnesium on the other side. Albuterol, which is sometimes referred to as salbutamol, is a medication used in the treatment or prevention of breath shortness and wheezing problems such as COPD (chronic obstructive pulmonary disease) and asthma, among many other diseases (Schuh et al., 2020). Albuterol can also be used in the prevention of asthma caused by exercise. According to Israel (2000), albuterol belongs to a group of medications collectively referred to as bronchodilators. Albuterol works in the trachea by opening up air passages and getting the muscles relaxed. Therefore, it is important to point out that controlling symptoms associated with breathing difficulties generally reduces the time lost from school or work (Schuh et al., 2020). Concerning how albuterol is used, it is crucial for the patient or someone taking care of the patient to read through the Patient Information Leaflet that is always given by the pharmacist before a patient can begin using this medication as well as in times the patient seeks a refill of the dose (Israel et al., 2000).

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On the other hand, nebulized magnesium is an alternative bronchodilator treatment for asthma, especially for patients who appear resistant to a standard remedy. Magnesium Sulphate (MgSO4) has so far been examined in both nebulized and intravenous forms, and the nebulized option has been confirmed to have the potential advantage of faster action and has limited side effects (Schuh et al., 2020). When the two forms are compared, nebulized magnesium is disadvantageous because it results in a reduction of drugs delivered. On the other hand, it increases a patient's respiratory efforts to improve the drug's effectiveness (Mangat et al., 1998).

Therefore, a respiratory examination in children and adolescents should be commenced with a general assessment of their breathing work. Fundamentally, children or adolescents in distress typically use accessory muscles to generate higher negative pleural pressures to overcome airway obstruction (McCaig et al., 002). For instance, a child or an adolescent's moderate respiratory distress involves shortness of breath and tachypnea, which can gradually turn to nasal flaring and subcostal reactions. In this sense, some researchers argue that a combination of albuterol and nebulized magnesium can work best compared to albuterol alone. This analysis seeks to determine the possibility of this viewpoint.

Critical Analysis

To find an appropriate answer to the clinical question, "In children and adolescents with residual moderate/severe respiratory distress after standard initial treatment, is albuterol plus nebulized magnesium more effective than albuterol alone in reducing the need for hospitalization?" This paper presents a detailed critical analysis using the MAARIE framework on Schuh et al.'s 2020 article titled "Effect of Nebulized Magnesium vs. Placebo Added to Albuterol on Hospitalization among Children with Refractory Acute Asthma Treated in the Emergency Department" (Schuh et al., 2020).

Methodology

The study under analysis got approval from the JAMA Institutional Review Board and was conducted by multiple authors in the setting of JAMA Medical Center, and was conducted by numerous researchers, namely Suzanne Schuh, James Sweeney, Rumantir, M., Coates, A. L., Willan, A. R., Stephens, D., and Amy C Plint.

Evaluation for conflict of interest: Having gone through the study, I feel that conflict of interest comes into play for several reasons. First, not all the authors submitted their conflict of interest disclosures. Some of the researchers reportedly received personal fees and grants from different organizations. Moreover, the funding for their study was offered by PCORI (Patient-Centered Outcomes Research Institution) in which not all the researchers submitted their disclosures of conflict of interest (COI). In his conflict of interest disclosure, Dr. Schuh reported that he received grants from CIHR (Canadian Institute for Health Research), PSIF (Physicians’ Services Incorporated Foundation), TRF (Thrasher Research Fund), as well as from Hospital for sick adolescents and children (Schuh et al., 2020). The researcher also reported that he got non-financial aid from La Diffusion Technique Francaise while in the process of this research (Schuh et al., 2020). Dr Sweeney on the other hand, reported in his conflict of interest disclosure that he received grants from the Hospital for Sick Children while conducting the study.

Dr Finkelstein also confirmed that he received grants from CIHR during the research process. Dr Zemek affirmed that he held competitively funded study donations from Ontario Neurotrauma Foundation, CIHR, CHEO Foundation, Physicians’ Services Incorporated Foundation, National Football League, Ontario SPOR Support Unit, Ontario Brain Institute, and other grants from the Clinical Research Chair in Pediatric Concussion from the University of Ottawa (Schuh et al., 2020). Dr. Gravel also reported that he received donations from CIHR during the research process. Dr. Ducharme pointed out that he received unobstructed research donations from Novartis, GlaxoSmithKline, Teva, AstraZeneca, and Trudell Medical; donations from CIHR, Thorasys, Covis, and GlaxoSmithKline; and personal fees from Teva, Covis, and Thorasys outside the submitted work (Schuh et al., 2020).

Study design: Concerning the study design adopted by these researchers in this study, it is crystal clear that the Patient-Centered Outcomes Research Institution had no role to play, any decision to forward for publication purposes, and any conduct at all. It is hard to believe that a conflict of interest was unlikely in this study after a thorough examination of the processes involved.

Study hypothesis: According to Schuh et al., 2020), this study was premised on a hypothesis that "a combination of albuterol and nebulized magnesium is more effective than albuterol alone in reducing the need for hospitalization for children and adolescents with residual moderate/severe respiratory distress."

Population and Sample size: The researchers used a sample size of 284 patients comprising mainly of children between 2 to 17 years of age in the initial two-center trial that they launched, and this was meant or the purposes of detecting the minimally significant difference in the 15% points purposely to limit the rate of hospitalization from 30 percent to 15 percent with a power of 80 percent. In this phase of the research, the rate of the primary outcome had an overall speed of the event of 50 percent; therefore, the researchers would have been underpowered to evaluate their preliminary result. The researchers considered this phase of the study as a pilot phase, which was explicitly meant to inform the actual sample size calculations, which was essentially targeted at a difference of 10% between the significant outcome groups.

Since the study remained blinded, and no proper analysis was done, the resultant significant threshold also remained unaltered. The newly targeted difference of 10% points was primarily based on the national survey on pediatric emergency medicine physicians (data still unpublished) and the pieces of evidence that the difference had hitherto led to pertinent changes within the national guidelines. Using type-I, an 80% power and two-sided error of 0.005 was established with a target sample size of 816 respondents.

The specific population investigated was limited to children between the ages of 2-17 with acute refractory asthma. The inclusion criteria used in this study included children and adolescent patients undergoing acute asthma treatment for the past 24 hours. The criteria also included children and adolescents who had prior episodes of severe wheeze treated with an inhaled systematic corticosteroid or a bronchodilator and had tenaciously retainable to severe asthma after completing a one-hour first period of asthma treatment. The purpose of systematic corticosteroid in this regard was to specifically design to maximize routine management, which comprised of an oral corticosteroid (i.e., 1-2 mg/kg/dose, dexamethasone, maximum, 20 mg; or prednisolone, .3-0.6 mg/kg/dose, and ipratropium bromide treatments through a nebulizer or metered-dose inhaler (ipratropium bromide; albuterol, 5 mg/treatment; 500 μg/treatment).

The study also used exclusion criteria by excluding children and adolescents who require instant management of the airway; children and adolescents who had earlier received IV magnesium before their enrolment; children and adolescents who are experiencing comorbidities (i.e., neurologic, kidney, cardiovascular, chronic lung, or other systemic disorders; and most importantly, children and adolescents with known sensitivity and high reaction to magnesium. The exclusion criteria were also applied to the families who had an inadequate command of either French or English languages, those who were enrolled previously, and those who had no email or phone contact, making it difficult to reach them.

Assignment

The exact method that the authors used to do the randomization of respondents into treatment groups was 1:1 stratified. A computer-generated algorithm was to perform the blocked randomization task within the strata with block sizes that are also randomly chosen. The researchers maintained an equal number of respondents under each group/category. Each treatment method (a combination of nebulized magnesium and albuterol or albuterol alone) was also maintained in equal proportions and under the same conditions. While examining the study, I was able to see the difference in the effectiveness of the two drug administration methods mentioned above and that albuterol alone was more effective than a combination of nebulized magnesium and albuterol. It was easier to detect that there is still a continuous hospitalization of children and adolescents diagnosed with acute asthma. The next biggest difference between the two groups of asthma treatment was using a placebo and albuterol in treatment. The control group was maintained at 25 respondents.

Therefore, I believe that using either a combination of albuterol and nebulized magnesium, a combination of placebo and albuterol, and the use of albuterol alone could affect the results, even if the effect were too small to be noticed. It would leave me in awe of the large number of respondents using nebulized magnesium because their disease condition worsened, especially at the start of the research. It gladdened my heart to see that albuterol's continuous use alone considerably reduced the number of children and adolescents being hospitalized for asthma. The only question that comes to my mind is what can happen if the number of respondents representing those who received a combination of albuterol and nebulized magnesium could be reduced or increased. Essentially, there are two confusing variables that the researchers ought not to have considered in the foundation of their research the diagnosis of asthma due to airborne allergens and asthma due to COPD Overlap.

Even though both of the treatment methods above are hardly obtainable, so are the variables that can be added to the list of their foundational characteristics. Children or adolescents with COPD overlap may show different symptoms, disease progression, and treatment response.