Biostat 699: Biostatistical Investigations, Winter 2023

Tuesday/Thursday 1-3pm

Instructor Information:

Phil Boonstra Jean Morrison Bhramar Jeremy Taylor

Mukherjee

Email philb@umich.edu jvmorr@umich.edu bhramar@umich.edu jmgt@umich.edu

Office SPH I 4632 SPH II M4148 SPH II M4208 SPH II M4507

(Tower)

Office TBD TBD TBD TBD

Hours

Course Objectives:
The overall objective of this course is to help the student integrate and apply
biostatistical concepts and techniques presented in Master's level courses. The
student will learn to identify the scientific objectives of a study and to develop a
statistical strategy appropriate for those objectives. The student will learn to plan
strategies for statistical design and analysis and to implement these strategies. The
student will integrate biostatistical approaches during the analysis of multi-faceted
projects. The student will learn to be aware of problems that arise in study design,
power and sample size determination and data collection. The student will learn to
communicate through presentation of oral and written reports, and through student
and faculty critiques of these reports at both the intermediate and final stages of
projects.

Organization of Class:
See the Canvas for the current course schedule.
The 4 in-class hours per week will be divided among:
1. Presentation and initial discussion of projects (led by faculty or visiting
presenters).
2. Presentation of intermediate and final results of projects (led by students).
3. Discussion of problems that arise in the design and analysis of biostatistical
investigations (led by faculty).
4. Discussion of topics in statistical methodology (led by faculty).
Students will be expected to:
1. Present intermediate and final written and oral reports of analyses.
2. Actively participate in classroom discussions of projects and articles,
 Biostat 699: Biostatistical Investigations, Winter 2023

Projects:

There will be four projects throughout the semester. Projects 1,2, and 4 will will
involve analysis of data collected as part of studies or experiments, while project 3
is focused on study design. Note that due to time constraints, successive projects
will overlap with each other. There will be some variation in the structure and
timeline for each project, but most of the projects will span 6-9 class periods.
Projects will have the following structures:
Projects 1, 2 and 4:
(a) A scientific investigator with little or no formal statistical training will attend
class and introduce the scientific objectives for the project. During this presentation
and later class periods, students are expected to ask questions in order to develop
a relevant statistical approach for the project and to collaborate with the scientist in
the definition and formalization of the statistical objectives of the project. The
scientific investigator will be available for questions at the initial presentation; the
instructors will act as the scientific investigator in subsequent class periods.
(b) (Projects 2 and 4 only) About 3-4 class periods later, half of the students will
give an 13 minute interim presentation covering the preliminary stages of their
investigation with slides formally created using any software. Interim presentations
will be given over two days. However, slides should be uploaded to canvas before
the first presentation class session begins. This interim presentation will include a
description of the problem, objectives, hypotheses, models (equations), proposed
tables and diagnostics, an interim report of analyses already performed, and any
identification of questions that may have been raised by the analysis. All students
are expected to be attentive during presentations and participate by asking
questions or engaging in discussion. Note: Each student will give an interim
presentation for project 2 OR project 4 (not both).
(c) (Projects 2 and 4 only) On the last day of the project, students who did not
give an interim presentation will give a 7 minute final presentation with slides
created using any software. Slides should be uploaded to canvas before the
presentation class session begins. The final presentation should include a summary
of objectives, hypotheses, models, and results. Due to time constraints, final
presentations can omit the background of the project.
(d) All students, regardless of type of oral presentation (interim or final), will hand in
a final written report for each project. Late reports will not be allowed except in
special circumstances and with prior approval of the instructors.
(e) Presentations and reports should all be created individually.
Project 3 (study design):
 Biostat 699: Biostatistical Investigations, Winter 2023

(a) At the beginning of the project, an instructor will present the objective of the
project. The instructor may "play the role" of an investigator.
(b) Project 3 will be completed in pairs.
(c) There is no written report for project 3. Students will answer structured
questions with supporting figures/tables to be handed in on the first day of final
presentations.
(d) During the last two class periods of project 3, all pairs of students will give a 13
minute final presentation. This presentation should cover the objective of the
project, the approach taken, and results. Final presentations will be given over two
course periods. Slides should be uploaded to canvas before the first presentation
class session begins.

Report Structure

Written reports are limited to a maximum of six pages of text double spaced in 11
point font (excluding tables, figures, and supporting output). The written report
should use language appropriate for a medical journal (e.g. NEJM) and should
include the following:
• Title, date, and student identifier (The name of the professor whose
classroom you were in and the last 4 digits of student id). Do not put
your name on the title page or use your name in the filename.
• Abstract or executive summary (half page): A summary of the main findings.
Abstracts should stand alone, meaning that a reader should be able to
understand, at a very high level, the problem, the approach, and the main
findings that are subsequently described in the manuscript.
• Introduction: A short description of the problem. Students are discouraged
from providing extensive literature reviews and can generally depend upon
the scientific background provided by the investigator (1-2 paragraphs)
• Statistical Methods: This description can include technical language and
equations, but they should be provided in the context of the problem and
with appropriate interpretation for non-technical readers. It may be
appropriate to intersperse the methods with the results section if there are
several distinct parts to the analysis. You do not need to include print outs of
your code.
• Results: May include any of the following: summary statistics of the data,
description and interpretation of the fitted models and parameters estimated,
the values of estimates, hypotheses tested, relevant inferences (e.g.
probabilistic inferences such as confidence intervals, p-values), and tabular
and graphical representation of the results. Appendices should include
analysis results documenting the details of your analyses, such as evaluating
 Biostat 699: Biostatistical Investigations, Winter 2023

the validity of the assumptions or models used in the analysis, even if these
details are not included in the written report. Tables and figures that are of
major relevance to the main aims of the project should be placed in the main
text. Tables and figures that are not directly linked to the main goals of the
project should be placed in the Appendix. References in the main report to
tables, graphs, and computer output in the Appendix should identify the
relevant pages. Tables and graphs should be self-contained and should be
clearly labeled and numbered but need not be of presentation quality.
• Conclusions and Discussion (1 to 3 paragraphs): Descriptions of the
scientific conclusions that can be drawn from the analysis results;
unanswered questions needing additional study may be included. This section
should directly relate the performed analyses to the scientific question
addressed. Try to make this more than just a listing of alternative methods
you could have done but didn’t have the time to finish.
For project 1, students will complete a guided report in the form of typed answers to
a series of short answer questions corresponding to each element of the report. For
projects 2 and 4, students will hand in a more traditional report (but can and are
encouraged to look back at the guided questions for direction).
Grading rubric for written reports: Each report will be graded by two instructors
who each assign a score out of 50 according to the rubric below. The final score is
the sum of the two instructor scores and is out of 100.

Criterion Name Criterion Expectations Possible

Points

Abstract / Does the abstract concisely describe the study 5

Introduction question, design, and findings?
Does the introduction provide a clear
explanation and understanding of the problem
and scientific hypotheses?

Statistical Are the statistical methods and models clearly 25

methods explained and appropriately applied?
(application
Are the statistical analyses focused?
and
interpretation) Are the results interpreted correctly, clearly
explained, and presented in context of the
research setting?

Presentation of Is there an appropriate number of figures and 5

results tables in the main text, and are they the “right”
ones?
 Biostat 699: Biostatistical Investigations, Winter 2023

Are the figures and tables easy to read and

understand?

Conclusion Is there a discussion of the realistic limitations of 5

study design and analysis?
Is there discussion of how the findings fit in to
the scientific context?

Organization Is the report structured in a logical fashion? Is 5

each paragraph a logical sequence of sentences,
and each section should be a logical sequence of
paragraphs?
Are the tables and figures placed closed to their
first reference in the manuscript?

Style and Is the writing style appropriate to the audience? 5

Clarity
Are the spelling and grammar correct?

Total 50

Training in human subject research:

All students are required to take the UM PEERRS online training available at
http://my.research.umich.edu/peerrs/#requirements
All students should obtain certification in the following two modules:
• Responsible Conduct of Research & Scholarship Training (RCRS)
• Human Subjects Research Protections
All students are required to complete these modules by January 17, 2023.
Students will not receive a final grade in the course until the modules are
completed. Failure to comply with the due date may also impact the final grade

Final grade:

The final grade will be determined by the quality of the oral and written reports.
Both technical content and the presentation of that content are important (e.g.
organization and clarity of language).
The following will be considered in the final evaluation:
1. Project 1 final (guided) report: 15%
2. Project 2 final report: 23%
3. Project 3 final presentation 8%
 Biostat 699: Biostatistical Investigations, Winter 2023

4. Project 3 question answers: 15%

5. Project 4 final report: 23%
6. Interim presentation (project 2 or 4): 8%
7. Final presentation (project 2 or 4): 8%

Participation:

There are no formal points attached to class participation. However, students are
strongly encouraged to take an active role in class discussions. The following are
possible avenues for participation:
a) Asking or answering questions about projects or lecture topics during in-class
discussion
b) E-mailing a question to a professor to be answered publicly in class (questions
can be read anonymously if desired).
c) Posting questions or answers on class discussion boards.

SPH Policy Statement on Academic Integrity:

The faculty of the School of Public Health believes that the conduct of a student
registered or taking courses in the School should be consistent with that of a
professional person. Students should show courtesy, honesty, and respect toward
faculty members, guest lecturers, administrative support staff, and fellow students.
Similarly, students should expect faculty to treat them fairly, showing respect for
their ideas and opinions and striving to help them achieve maximum benefits from
their experience in the School. Student academic misconduct refers to behavior that
may include plagiarism, cheating, fabrication, falsification of records or official
documents, intentional misuse of equipment or materials (including library
materials), and aiding and abetting the perpetration of such acts. The preparation
of reports, papers, and examinations, assigned on an individual basis, must
represent each student's own effort. Reference sources should be indicated clearly.
The use of assistance from other students or aids of any kind during a written
examination, except when the use of aids such as electronic devices, books or notes
has been approved by an instructor, is a violation of the standard of academic
conduct.
 Biostat 699: Biostatistical Investigations, Winter 2023

Student Well-Being:

SPH faculty and staff believe it is important to support the physical and emotional
well-being of our students. If you have a physical or mental health issue that is
affecting your performance or participation in any course, and/or if you need help
connecting with University services, please contact the instructor or the Office of
Academic Affairs.

Please visit https://sph.umich.edu/community/student-experience/health-well-

being.html for information on wellness resources available to you.

Student Accommodations:

Students should speak with their instructors before or during the first week of
classes regarding any special needs. Students can also visit the Office of Academic
Affairs for assistance in coordinating communications around accommodations.

Students seeking academic accommodations should register with Services for

Students with Disabilities (SSD). SSD arranges reasonable and appropriate
academic accommodations for students with disabilities. Please visit
https://ssd.umich.edu/students for more information on student accommodations.

Students who expect to miss classes, examinations, or other assignments as a

consequence of their religious observance shall be provided with a reasonable
alternative opportunity to complete such academic responsibilities. It is the
obligation of students to provide faculty with reasonable notice of the dates of
religious holidays on which they will be absent. Please
visit http://www.provost.umich.edu/calendar/religious_holiday_guidance.html for the
complete University policy.

Diversity, Equity, and Inclusion (DEI):

At SPH, our mission to promote population health worldwide is inseparable from our
aim to develop more effective and socially just systems for creating and
disseminating knowledge. As part of this, we recognize the historical and
contemporary expressions of social discrimination globally, and seek to promote
and extend opportunities for members of all groups experience such
marginalization. We commit to developing the institutional mechanisms and norms
necessary to promote the values of diversity, equity, and inclusion, both inside and
 Biostat 699: Biostatistical Investigations, Winter 2023

outside our classrooms. To this end, SPH upholds the expectations that all courses
will (1) be inclusive, (2) promote honest & respectful discussions, (3) follow
multicultural ground rules and (4) abide by UM policies and procedures.

• Inclusive courses, are those in which teachers and learners co-create and
co-sustain environments that support and encourage all members to
participate equitably. See
http://crlt.umich.edu/multicultural-teaching/inclusive-teaching-strategies for
more resources.
• Honest & respectful (rather than safe) discussions promote diversity and
social justice learning by acknowledging dynamics of oppression and privilege
both inside and outside the classroom.
• Multicultural ground rules acknowledge diverse experiences in the
classroom and offer strategies for holding one another appropriately
accountable. See examples from the UM Program on Intergroup Relations and
others at http://www.ncdd.org/.
• UM policies and procedures can be found at http://diversity.umich.edu
with additional resources and instructions for reporting discrimination at
https://sph.umich.edu/diversity-equity-inclusion/resources.html.