Biostatistics and Epidemiology Report

This biostatistics and epidemiology report details a comparative study between a newly developed anticoagulant, Drug X, and the established anticoagulant, Warfarin. The study aims to determine if there's a significant difference in their blood anticoagulation capabilities. The null hypothesis posits no significant difference, while the alternative hypothesis suggests a significant difference. The study employs a diagnostic and observational design, involving 35 patients with deep vein thrombosis at San Louis Hospital in Turkey. Patients are randomly assigned to treatment groups receiving varying doses of either Drug X or Warfarin, with a control group included. Blood samples are collected at regular intervals, and prothrombin time and partial thromboplastin time are measured using specific reagents and equipment. Data analysis, using SPSS version 22, focuses on mean plasma concentrations and standard deviations, presented via graphs and tables. The study acknowledges limitations, such as potential sample homogeneity. The report concludes with references to relevant literature on anticoagulants and statistical analysis techniques.

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Biostatistics and Epidemiology
Student’s Name
Date of Submission

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Introduction
The anticoagulants are very important in the prevention of blood clotting as well as the
diagnosis of various blood clotting disorders in patients. They also make it possible for the
hemostatic status of an individual to be accessed 1. However, the effectiveness of anticoagulants
varies greatly and hence the need to make a comparison between one anticoagulant against
another. This study therefore aims at making a comparison between a recently developed
anticoagulant against warfarin 2.
Aim
To make a comparison of newly discovered drug X against warfarin, both being
anticoagulants.
Hypothesis
Null hypothesis: there is no significant difference between drug X and warfarin in terms
of blood anticoagulation capabilities.
Alternate hypothesis: there is a significant difference between drug X and warfarin in
terms of blood anticoagulation capabilities.
Study limitations
The clinical samples from the study subject might be stable, and homogenous as
compared to those collected from other centers like emergency departments.
Methodology
In this study, an evaluation of the specificity and sensitivity of blood clotting drugs in
terms of prothrombin time and the partial thromboplastin time of drug X against warfarin. A
convenient sample of thirty-five patients will be randomly samples for use in this study. The
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inclusion criteria will be based on patients being of eighteen years and above, both men and
women. They will be required to fill an informed consent form of acceptance to participate.
Study design
This will be a diagnostic and observational study which will be carried at San Loius
hospital in Turkey. Initially, ethical clearance will be sought from the University ethical
committee. The study subjects will be drawn from those admitted in this hospital for the period
between September to November 2017 and suffering from deep vein thrombosis. Twenty of
them will be treated using daily doses of 5, 10, 15mL of warfarin while the other ten will be
treated using similar doses of drug X. another group of ten patients will be used as a control
group, having no known blood clotting problems in order to test the normal ranges of the tests to
be performed.
Sample collection and testing
The blood samples will be collected after every two hours of each drug administration per
group, as well as two hours before the next dose is given. The prothrombin time for the blood
samples will be done using the STA neoplastine reagent CI plus while the partial thromboplastin
time will be done using STA cephascreen and processing done of STA-R coagulation analyzer
equipment 3.
Confounding variables
While this research will be based on the two anticoagulant drugs, other variables such as
gender, age and other health conditions that might affect the variables in this research will not be
measured.
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Data analysis
The plasma concentrations will be expressed in terms of means and standard deviations.
The results will be presented in form of scatter graphs, tables and charts to determine the
differences in the anticoagulation properties of drug X against warfarin. Overall data will be
analyzed using the SPSS version 22 statistical software 4.
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References
1. Sankaranarayanan R, J Fox D. Are Some Anticoagulants More Equal Than
Others?-Evaluating the Role of Novel Oral Anticoagulants in AF Ablation. Current cardiology
reviews. 2016 Nov 1;12(4):330-5.
2. Ashburner JM, Go AS, Chang Y, Fang MC, Fredman L, Applebaum KM, Singer
DE. Influence of Competing Risks on Estimating the Expected Benefit of Warfarin in
Individuals with Atrial Fibrillation Not Currently Taking Anticoagulants: The Anticoagulation
and Risk Factors in Atrial Fibrillation Study. Journal of the American Geriatrics Society. 2017
Jan 1;65(1):35-41.
3. Colombini MP, Derogis PB, Aranda VF, Guerra JC, Hamerschlak N, Mangueira
CL. Comparison of different laboratory tests in the evaluation of hemorrhagic risk of patients
using rivaroxaban in the critical care setting: diagnostic accuracy study. Thrombosis Journal.
2017 Aug 15;15(1):21.
4. Asthana HS, Bhushan B. Statistics for social sciences (with SPSS applications).
PHI Learning Pvt. Ltd.; 2016 Jun 7.
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