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Unit of study_

BSTA5005: Clinical Biostatistics

Semester 2, 2022 [Online] - Camperdown/Darlington, Sydney

The aim of this unit is to enable students to use correctly statistical methods of particular relevance to evidence-based health care and to advise clinicians on the application of these methods and interpretation of the results. Content: Clinical trials (equivalence trials, cross-over trials); Clinical agreement (Bland-Altman methods, kappa statistics, intraclass correlation); Statistical process control (special and common causes of variation; quality control charts); Diagnostic tests (sensitivity, specificity, ROC curves); Meta-analysis (systematic reviews, assessing heterogeneity, publication bias, estimating effects from randomised controlled trials, diagnostic tests and observational studies).

Unit details and rules

Unit code BSTA5005
Academic unit Public Health
Credit points 6
Prohibitions
? 
None
Prerequisites
? 
(PUBH5010 or BSTA5011 or CEPI5100 ) and BSTA5002
Corequisites
? 
BSTA5006 and (BSTA5210 or BSTA5007)
Assumed knowledge
? 

None

Available to study abroad and exchange students

No

Teaching staff

Coordinator Erin Cvejic, erin.cvejic@sydney.edu.au
Type Description Weight Due Length
Assignment Assignment 1
This assessment covers Modules 1 and 2.
30% -
Due date: 29 Aug 2022 at 23:59
6-8 pages
Outcomes assessed: LO1 LO2 LO8 LO9
Assignment Assignment 2
This assessment covers Module 3.
35% -
Due date: 26 Sep 2022 at 23:59
6-8 pages
Outcomes assessed: LO3 LO4 LO8 LO9
Assignment Assignment 3
This assessment covers Module 4.
35% -
Due date: 07 Nov 2022 at 23:59
6-8 pages.
Outcomes assessed: LO5 LO6 LO7 LO8 LO9

Assessment summary

  • Assignment 1 covers Module 1 and Module 2 content (approximately half of the assessment covering each module)
  • Assignment 2 covers Modules 3 content
  • Assignment 3 covers Module 4 content
  • All assessments must be submitted to pass the course.

Detailed information for each assessment can be found on Canvas. 

Assessment criteria

Grade

Mark Range

Description

AF

Absent fail

Range from 0 to 49

To be awarded to students who fail to demonstrate the learning outcomes for the unit at an acceptable standard through failure to submit or attend compulsory assessment tasks or to attend classes to the required level. 

FA

Fail

Range from 0 to less than 50

To be awarded to students who, in their performance in assessment tasks, fail to demonstrate the learning outcomes for the unit at an acceptable standard established by the faculty. 

PS

Pass

Range from 50 to less than 65

To be awarded to students who, in their performance in assessment tasks, demonstrate the learning outcomes for the unit at an acceptable standard.

CR

Credit

Range from 65 to less than 75

To be awarded to students who, in their performance in assessment tasks, demonstrate the learning outcomes for the unit at a good standard.

D

Distinction

Range from 75 to less than 85

To be awarded to students who, in their performance in assessment tasks, demonstrate the learning outcomes for the unit at a very high standard.

HD

High distinction

Range from 85 to 100 inclusive

To be awarded to students who, in their performance in assessment tasks, demonstrate the learning outcomes for the unit at an exceptional standard.

For more information see guide to grades.

Late submission

In accordance with University policy, these penalties apply when written work is submitted after 11:59pm on the due date:

  • Deduction of 5% of the maximum mark for each calendar day after the due date.
  • After ten calendar days late, a mark of zero will be awarded.

This unit has an exception to the standard University policy or supplementary information has been provided by the unit coordinator. This information is displayed below:

Standard BCA policy for late penalties for submitted work is a 5% deduction from the earned mark for each day the assessment is late, up to a maximum of 50%.

Academic integrity

The Current Student website  provides information on academic integrity and the resources available to all students. The University expects students and staff to act ethically and honestly and will treat all allegations of academic integrity breaches seriously.  

We use similarity detection software to detect potential instances of plagiarism or other forms of academic integrity breach. If such matches indicate evidence of plagiarism or other forms of academic integrity breaches, your teacher is required to report your work for further investigation.

You may only use artificial intelligence and writing assistance tools in assessment tasks if you are permitted to by your unit coordinator, and if you do use them, you must also acknowledge this in your work, either in a footnote or an acknowledgement section.

Studiosity is permitted for postgraduate units unless otherwise indicated by the unit coordinator. The use of this service must be acknowledged in your submission.

Simple extensions

If you encounter a problem submitting your work on time, you may be able to apply for an extension of five calendar days through a simple extension.  The application process will be different depending on the type of assessment and extensions cannot be granted for some assessment types like exams.

Special consideration

If exceptional circumstances mean you can’t complete an assessment, you need consideration for a longer period of time, or if you have essential commitments which impact your performance in an assessment, you may be eligible for special consideration or special arrangements.

Special consideration applications will not be affected by a simple extension application.

Using AI responsibly

Co-created with students, AI in Education includes lots of helpful examples of how students use generative AI tools to support their learning. It explains how generative AI works, the different tools available and how to use them responsibly and productively.

WK Topic Learning activity Learning outcomes
Multiple weeks Module 1: Statistical Process Control Individual study (20 hr) LO1 LO2 LO8 LO9
Module 2: Clinical Agreement Individual study (20 hr) LO1 LO2 LO8 LO9
Module 3: Diagnostic Tests, Systematic Reviews and Meta-Analysis Individual study (40 hr) LO3 LO4 LO8 LO9
Module 4: Clinical Trials Individual study (40 hr) LO5 LO6 LO7 LO8 LO9

Study commitment

Typically, there is a minimum expectation of 1.5-2 hours of student effort per week per credit point for units of study offered over a full semester. For a 6 credit point unit, this equates to roughly 120-150 hours of student effort in total.

Learning outcomes are what students know, understand and are able to do on completion of a unit of study. They are aligned with the University's graduate qualities and are assessed as part of the curriculum.

At the completion of this unit, you should be able to:

  • LO1. Understand and apply Continuous Quality Improvement to medical studies and hospital data including detection of special and common causes of variation
  • LO2. Explain and apply appropriate measures of agreement and consistency for both raters and continuous measurements
  • LO3. Calculate measures of the performance of diagnostic tests and interpret these via ROC curves where appropriate
  • LO4. Describe systematic reviews and undertake meta-analyses of various types of studies
  • LO5. Understand advantages and disadvantages of cross-over designs in general and be able to analyse 2x2 designs
  • LO6. Explain the role of, and the relationships between, non-inferiority, efficacy and equivalence trials
  • LO7. Calculate and report sample sizes for non-inferiority and equivalence trials
  • LO8. Choose the appropriate graphical and/or statistical methods to answer clinical questions
  • LO9. Effectively communicate the results of, and ideas behind statistical analyses performed to clinicians and statisticians

Graduate qualities

The graduate qualities are the qualities and skills that all University of Sydney graduates must demonstrate on successful completion of an award course. As a future Sydney graduate, the set of qualities have been designed to equip you for the contemporary world.

GQ1 Depth of disciplinary expertise

Deep disciplinary expertise is the ability to integrate and rigorously apply knowledge, understanding and skills of a recognised discipline defined by scholarly activity, as well as familiarity with evolving practice of the discipline.

GQ2 Critical thinking and problem solving

Critical thinking and problem solving are the questioning of ideas, evidence and assumptions in order to propose and evaluate hypotheses or alternative arguments before formulating a conclusion or a solution to an identified problem.

GQ3 Oral and written communication

Effective communication, in both oral and written form, is the clear exchange of meaning in a manner that is appropriate to audience and context.

GQ4 Information and digital literacy

Information and digital literacy is the ability to locate, interpret, evaluate, manage, adapt, integrate, create and convey information using appropriate resources, tools and strategies.

GQ5 Inventiveness

Generating novel ideas and solutions.

GQ6 Cultural competence

Cultural Competence is the ability to actively, ethically, respectfully, and successfully engage across and between cultures. In the Australian context, this includes and celebrates Aboriginal and Torres Strait Islander cultures, knowledge systems, and a mature understanding of contemporary issues.

GQ7 Interdisciplinary effectiveness

Interdisciplinary effectiveness is the integration and synthesis of multiple viewpoints and practices, working effectively across disciplinary boundaries.

GQ8 Integrated professional, ethical, and personal identity

An integrated professional, ethical and personal identity is understanding the interaction between one’s personal and professional selves in an ethical context.

GQ9 Influence

Engaging others in a process, idea or vision.

Outcome map

Learning outcomes Graduate qualities
GQ1 GQ2 GQ3 GQ4 GQ5 GQ6 GQ7 GQ8 GQ9

This section outlines changes made to this unit following staff and student reviews.

This is the forth offering of the revised version of CLB. To accommodate the new Module 4 on Clinical Trials we have reduced and re-arranged the other modules. This has been achieved by removing concepts and methods that are less commonly used in biostatistical practice and eliminating many of the readings. Additionally, in response to student feedback, we have reduced the number of assignments from 4 to 3.

This unit is delivered externall as part of the Biostatistics Collaboration of Australia (BCA). 

Software requirements: For this course you will need access to software that can perform the various analyses required for the exercises and assignments. R or Stata is recommended, although students have successfully completed this course using SAS. Excel may also be quite useful for several modules.

Disclaimer

The University reserves the right to amend units of study or no longer offer certain units, including where there are low enrolment numbers.

To help you understand common terms that we use at the University, we offer an online glossary.