Proposal: Evaluating the impact of systemic corticosteroids in regard to outcomes related to morbidity and mortality.

Research Proposal

Background and Rationale

Asthma is a chronic respiratory condition that results from chronic airway inflammation and airway hyper-responsiveness. It is characterised by partially reversible airway obstruction with expiratory airflow restriction and intermittent acute exacerbations, with sudden and progressive increases in breathlessness from that experienced at baseline (Holgate et al., 2015). Asthma is recognised by the World Health Organisation as being a major global public health problem, with estimates that more than 235 million persons are affected, which is excluding figures from reported rates of under-diagnosis (World Health Organisation, 2018). The prevalence rate is documented to exceed 20% in most English-speaking countries and approximately 5% in low-income countries where there are minimal asthma related risk factors (Lai et al., 2009). Moreover, asthma is the commonest chronic disease in children, with one third experiencing significant functional disability and being responsible for more than 14 million missed days from school and education (Lipstein et al., 2009).

In its latest report, the Global Asthma Network (2018) reports that asthma contributes to high rates of morbidity and mortality, being the 16^th leading cause of years lived with disability and responsible for approximately 1000 deaths per day. This equates to 10.5 million life-years lost due to premature deaths, or an age-adjusted mortality rate of 148 per 100,000 persons. In the UK, asthma currently affects 5.4 million persons, including 1.1 million children and 4.3 million adults and has been consistently responsible for more than 1000 deaths per year over the past few decades (Mukherjee et al., 2016). Acute exacerbations of asthma are the primary pathophysiological event leading to mortality and more than 180 persons per day are admitted to UK hospitals experiencing potentially life threatening airflow restriction (Asthma UK, 2018). More international estimates suggest that asthma is responsible for 0.6% of all hospitalisations among most continents, but this varies by almost 10-fold between individual countries (Global Asthma Network, 2018). Asthma is also associated with considerable socioeconomic costs due to its prevalence; with a high demand for healthcare services and medicines and adversely impacting upon society, due to absence or disability, leading to losses in work productivity (Nunes et al., 2017). In a review of the economic burden related to asthma, the annual cost per person was found to vary between $150-3000, whilst annual costs exceeded $24 billion in Europe and £5 billion in the UK, with most of this cost being attributable to pharmacotherapy (Sadatsafavi et al., 2014).

Notably, a substantial proportion of asthma related hospital admissions and deaths are considered preventable with optimal management regimes and review, patient actions plans and stringent adherence to pharmacological agents (Torjesen, 2014). In a recent confidential enquiry into 195 asthma deaths that occurred in the UK over a 12-month period, the Royal College of Physicians suggested that two thirds of these deaths could have been prevented through better management. This is reported to have principally evolved through undertreatment of asthma, where there were failings in routine care, poor adherence to asthma guidelines and suboptimal prescribing practices (Levy, 2015). Notably, more than 50% of all asthma deaths were in patients categorised as having mild or moderate disease, which may have resulted in a degree of medical and individual level complacency, whilst greater attention is given to those with severe asthma who tend to experience greater disability and impaired quality of life (D'Amato et al., 2016; Levy et al., 2014).

Asthma exacerbations are a medical emergency that requires immediate intervention using a pharmacological sequence of drugs, in order to prevent the need for hospital admission or death (Fuhlbrigge et al., 2012). In order to prevent or reduce exacerbations, it is important that patients are prescribed the most appropriate pharmacotherapy and adhere to this in the long-term. Indeed, poor adherence to asthma medication is a major contributor to recurrent exacerbations and failure to achieve treatment goals (Global Initiative for Asthma, 2018). Upon observation of a patient admitted to the Emergency Department with an acute asthma exacerbation, it became evident that they had not been reviewed by their General Practitioner over the preceding six months, which had prevented them acquiring an up-to-date and optimised medication regime and had led to intermittency in adherence to their inhalers. Given that UK hospitals receive a substantial proportion of acute asthma cases, this represents an opportunity to explore and review the patients long-term asthma medication, of which, alterations could lead to more desirable outcomes. In addition, it is important that the factors affecting adherence are identified and addressed, such that the applied pharmacotherapy can translate into clinically meaningful effects. Therefore, the focus of this dissertation is to identify the most effective asthma medications through evaluating their evidence base and impact on outcomes, of which, can ultimately be used as part of a self-management strategy in the community to prevent from adverse sequalae. Moreover, as a fundamental and complementary aspect, the factors affecting adherence to these medications will be reviewed.

Proposed Methodology

In order to best evaluate the most efficacious asthma medications for self-management and identify the factors resulting in poor adherence, the most appropriate research methodology is secondary. This is because there is already a diverse range of evidence available within the literature base and conducting a primary study would unlikely yield any additional useful information that is not already available. Moreover, conducting a high quality primary research study, such as a randomised controlled trial, would take considerable planning and time, which is not feasible in the given time frame. The proposed secondary methodology would include a structured and systematic literature view, which is a widely used research modality that facilitates identification and evaluation of numerous heterogenous studies, such that the collective findings can be constructed into meaningful information (Gough et al., 2012). The review will principally rely upon quantitative as it is more objective and amenable to comparative analysis, than compared to qualitative data, which will be important to synthesising useful results and discussion points (Sousa et al., 2007). However, given that this research is attempting to identify and evaluate the factors affecting adherence to asthma medication, the incorporation of qualitative data may be required, in which case, the review will be compromised of mixed data. Given the literature review approach, this reflects non-experimental design, which is recognised as being useful in determining the most up-to-date information and recent trends, which can help to identify and/or address areas of uncertainty and in directing future research (Walker, 2005).

Furthermore, literature reviews utilise a broad range of processes that enable the research to remain focussed upon the area of interest. This involves the development of the research question and its aims and objectives and constructing a search strategy with a filtering process, to allow large numbers of studies to be reviewed and screened for eligibility (Garg, 2016). In addition, the literature review process can readily apply assessments of the quality of evidence, so that the collective findings are based on the most credible and trustworthy studies and not subject to error from bias or confounding, which supports the principles of best research practice (Meyer, 2017). The critical appraisal process will utilise a well-recognised framework for evaluating the quality of evidence, which is that of the Critical Skills Appraisal Program (2018).

In regard to methods of data analysis and presenting the findings, for the effectiveness of asthma medications for self-management, this will involve a descriptive strategy and where possible, the amalgamation of data, to formulate collective meanings and results. Of note, the merging of data and its subsequent analysis may not be possible if eligible studies are lacking homogeneity, however, if this is not the case, data will be re-analysed using the Microsoft Excel Statistics Package. Statistical tests for data analysis may include means, standard deviations, standard t-tests, paired t-tests and one-way ANOVA, which can provide a means for demonstrating differences between groups of data (Campbell et al., 2007). For the evaluation of factors causing poor medication adherence, a thematic analysis will be utilised to help structure and guide the results and discussion process. Indeed, the use of a thematic approach in research is considered a highly useful strategy to analysing heterogenous data outcomes, which is the expected outcome given the substantial amounts of literature in existence for the given research topic (Vaismoradi et al., 2013).

Timeline

In order to organise the research and ensure efficiency, a timeline (figure 1, below) has been created to help guide the author through the research process. Timelines are important in ensuring that the researchers time is appropriately managed and not underestimated, such that the flow of its processes are uniform and error-free, allowing for the production of high quality research within the allocated time frame (World Health Organisation, 2015).

Figure 1. Timeline of research processes, their time of initiation and expected duration of time for completion.

• Task 1: Research proposal
• Task 2: Review feedback
• Task 3: Literature review
• Task 4: Screen eligible studies
• Task 5: Critical appraisal
• Task 6: Extract and analyse outcome data
• Task 7: Construct themes and discussion
• Task 8: Review feedback for part submission
• Task 9: Complete remaining aspects of dissertation
• Task 10: Review completed draft

References

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