Reference no: EM133051328

MD7123 Clinical Research Methods and Biostatistics - University of Chester

Assessment - Data analysis report

Analysis and interpretation of clinical data

The aim of this session is to introduce the data for analysis and discuss how they might be interpreted and analysed. This session will also cover how to plot overall-survival Kaplan Meier curves and ROC/AUC analysis.

Learning outcome 1: Select and justify appropriate statistical tests for particular types of data and research designs.
Learning outcome 2: Interpret and report statistical analyses output in and appropriate scientific manner.

Aim of assessment
The aim of this assignment is to interpret clinical data and draw inferences and conclusions. The assessment aims to develop your statistical analysis and interpretation skills.

Your report should include (for each section) - 500 words equivalent

a) Produce at least one graph that appropriately displays the data. The graph should be the most appropriate for the data you are analysing. It could be a histogram, box plot, bar chart, scatter plot etc.

b) Identify an appropriate statistical test and explain why it has been chosen (with supporting references)

c) Present the results and statistical analysis and briefly evaluate the outcome in a concluding paragraph(s). Any supplementary information can be placed in clearly labelled Appendices.

References
References: Reference List as APA 7 (in alphabetical order according to the first letter of the surname of the first author)

Part 1

Project: Clinical validation of serum IL-8 in colorectal cancer patients and efficacy of CETUX adjuvant treatment (Kanakis & Jones, 2021).

Colorectal cancer (CRC) is the third most common cancer and mainly affects the gastrointestinal track with smoking as a risk factor. The clinical diagnosis of this type of malignancy relies on colonoscopy but often imaging techniques, such as CT and MRI, can be applied. Carcinoembryonic Antigen (CEA) has been used as a serum tumour marker for the diagnosis of CRC, showing a sensitivity of 17.4 % to 100 % and specificity ranging from 66.1 % to 98.4 % (Sørensen et al., 2016) which underlies that in some cases it is not a reliable diagnostic biomarker. In the recent years, there is an effort of developing interleukin 8 (IL-8) as a valuable serum biomarker for the early detection of CRC (Lee et al., 2012).

Construct one summative table to describe the data (mean ± SE), identify any significant differences between controls and patients and describe any significant correlations between these biomarkers.

Part 2

The main effect of statins is lowering LDL-C levels, by as much as 60% (Kanaki, 2012), and currently there are eight different classes of drugs available (Xu et al, 2021). Statins lower LDL levels by inhibiting HMG-CoA reductase activity leading to decreases in hepatic cholesterol content resulting in an up-regulation of hepatic LDL receptors, which increases the clearance of LDL. A recent study by Kibble, Richardson, Parsons & Jones (2019) investigated the effect of Atorvastatin or Lovastatin on LDL-C and ambulatory blood pressure in patients with mild hypertension and hypercholesterolemia in a double blind, randomised, placebo-controlled study. Demographic and biochemical characteristics, as well as mean 24-h SBP and DBP levels at baseline for the Atorvastatin (20mg), Lovastatin (20mg) and Placebo groups are presented in Table 1. No significant differences were observed between groups at baseline evaluation. Follow up measurements were then taken at 26 weeks.

Part 3

Smoking is one of the major lifestyle factors influencing the health of human beings. Life-long cigarette smokers have a higher prevalence of common diseases such as atherosclerosis, COPD, and lung cancer with significant systemic impacts (Ryder, Saghizadeh, Ding, Nguyen & Soskolne, 2002). In addition, exposure to cigarette smoke has an adverse effect on the treatment outcomes of a variety of surgical and nonsurgical periodontal therapies. A low-grade systemic inflammatory response is evident in smokers as confirmed by numerous population-based studies: elevated levels of C-reactive protein (CRP), fibrinogen, and interleukin 1b, interleukin-6, as well as increased counts of WBC have been reported (Yanbaeva, Dentener, Creutzberg, Wesseing & Wouters, 2007).

A recent study by Jones, Beer, Green, Green & Barnett (2021) have produced an assay called the New Wonderful Biomarker (NWB) which they claim is more sensitive and specific for the detection of early-stage lung cancer than two other existing biomarkers (Carcino Emryonic Antigen (CEA) and Retinol-Binding Protein (RBP)). The authors claim that their new biomarker can detect lung cancer up to 4 months earlier, and therefore be vital for early treatment and possible more beneficial outcomes.

The criteria for cancer diagnosis using the NWB method is ≥ 459.43 pg/ml Conduct the analysis, interpret, and report your findings.

Part 4

Cardiovascular disease is the leading cause of death globally, which could be reduced with appropriate treatment (Ho, Bryson & Rumsfeld, 2009 and Baroletti & Dell'Orfano, 2010). Medication non-adherence in cardiovascular medicine is a significant preventable cause of substantial morbidity and mortality, which can translate to improved clinical outcomes, and could lead to significant reductions in healthcare costs (Simon, Kini, Levy & Ho, 2021)

A retrospective cohort study (Turner and Zatrak (2022) followed 300 patients' cardiovascular disease, for 15 years. They divided the participants into three identically sized groups, divided by medication adherence, Poor, Moderate and Good.
Conduct the analysis, interpret, and report your findings.

Attachment:- Clinical Research Methods and Biostatistics.rar