DEVELOPING AND WRITING YOUR TRIOLOGICAL THESIS

1
DEVELOPING AND WRITING YOUR TRIOLOGICAL THESIS

• Maureen Hannley, PhD

2
SUCCESSFUL THESES2001 2006 (n 126)
3
SOME EXCELLENT REFERENCES

• Troidl, H et al., Surgical Research Basic
  Principles and Clinical Practice (3rd Ed.). New
  York Springer, 1998
• Booth, W, Colomb, G, Williams, J, The Craft of
  Research. Chicago The University of Chicago
  Press, 1995
• Belsher, J, Jacobsen, J, From Idea to Funded
  Project. Phoenix Oryx Press, 1992
• Spilker, B., Guide to Clinical Trials. New York
  Raven Press, 1991
• Norman, G, Streiner, D, PDQ Statistics (2d Ed.).
  St. Louis B.C. Decker, Inc., 1999
• Hulley S, Cummings S, et al, Designing Clinical
  Research (3rd Ed.), Philadelphia Lippincott
  Williams Wilkins, 2006.

4
MOTIVATIONS FOR DOING RESEARCH
5
Improve health through better medical practice
Influence others behavior or viewpoint
4
Change the body of knowledge
3
Gain personal satisfaction
2
Improve curriculum vitae
1
Kramer, 1995
5
(No Transcript)
6
BUILDING A THESIS
the-sis. A proposition stated or put forward
for consideration, especially one to be proved
or maintained against objections. Random
House College Dictionary
7
Practical Problem
motivates
helps to solve
?
Research Answer
Research Question
finds
defines
Research Problem
Booth, Columb, Williams, 1995
8
Clinical Problem
Research Question
Design
Method
Observation
Experiment
Consultation
Laboratory
Case Reports
Qualitative Research
Clinical
Series
Surveys
Troidl et al., 1998
9
INTERESTS, TOPICS, QUESTIONS, PROBLEMS

• Find an interest in a broad subject area
• What am I interested/expert in?
• Narrow the interest to a plausible topic
• What are unsolved gaps or inconsistencies in
  this area?
• Develop questions within the topic
• What do I want to know?
• Develop a rationale for the project
• Why is it important to know this?

10
DEVELOP AN IDEA

• Read the most authoritative sources until you
  come to a point where the sources disagree. This
  is where unsolved questions may reside.
• Talk with the leading figures in the area.
  Attend their lectures and be alert to problems
  they identify.
• Seek out and read strategic research plans of
  medical and research organizations.
• Contemplate your own experience. What are the
  problems or questions that frustrate you? Have
  you found a solution you think will benefit your
  peers and patients?

Naumann in Belcher Jacobsen, 1992
11
INVESTIGATIONAL CATEGORIES

• Descriptions of problems required for planning
  interventions
• Transtympanic vs. Sustained Release
  Administration of Gentamicin Kinetics,
  Morphology, and Function
• Carcinoma of the Oropharynx Factors Affecting
  Outcomes
• Improving Surgical Wound Healing with Basic
  Fibroblast Growth Factor After Radiation
• A Standardized Regimen of Antibiotics Prevents
  Infectious Complications in Skull Base Surgery
• Clinical and Symptom Criteria for the Active
  Diagnosis of Chronic Rhinosinusitis

12
INVESTIGATIONAL CATEGORIES

• Information required to evaluate ongoing
  interventions, assess progress
• The Long-term Effect of Adenotonsillectomy on
  Quality of Life in Pediatric Patients
• Therapeutic Selective Neck Dissection 25 Year
  Review
• Long-term Follow-up for Children Treated with
  Surgical Intervention for Chronic Sinusitis
• Intratympanic Dexamethasone for Sudden
  Sensorineural Hearing Loss Following Failure of
  Systemic Therapy
• Therapeutic Efficacy of the Epley Canalith
  Repositioning Maneuver
• Endoscopic Percutaneous Dilational Tracheotomy A
  Prospective Evaluation of 500 Consecutive Cases

13
INVESTIGATIONAL CATEGORIES

• Information required to define problems
• Direct Evidence of Bacterial Biofilms in Otitis
  Media
• Herpes Simplex Virus and Menieres Disease
• Analyze possible causes
• Direct Nasopharyngeal Reflux of Gastric Acid is
  a Contributing Factor in Refractory Chronic
  Rhinosinusitis
• The Role of Nitric Oxide in the Development of
  Distant Metastases from Squamous Cell Carcinoma
• or offer solutions
• Regular Tracheostomy Tube Changes to Prevent
  Formulation of Granulation Tissue

14
SELECT A TOPIC

• Relevance
• Avoidance of duplication originality
• Feasibility
• Ethical acceptability
• Applicability of possible results and
  recommendations
• Urgency of data needed
• The Big So-What

15
(No Transcript)
16
THE RESEARCH QUESTION

• Begin by asking the question as a general
  statement
• In patients with recurrent acute sinusitis by
  accepted criteria, is ESS the best treatment
  option to improve symptoms and disease-specific
  QOL?
• Use PICO to help structure the question

17
PICO

• P Population, Patient, or Problem
• I Intervention
• C Control or Comparison
• O Outcome

18
THE RESEARCH QUESTION

• P (Pediatric, adult) patients with
  recurrent acute sinusitis
• I Endoscopic sinus surgery
• C Medical treatment
• O Symptoms and disease-specific QOL
• In (age) patients with recurrent acute sinusitis
  by accepted criteria does ESS compared to medical
  treatment improve symptoms and disease-specific
  QOL?

19
REFINE YOUR RESEARCH QUESTION

• Define the population to be studied
• Define the period of time for the study
• Select the variables to be measured
• Change non-specific variables into variables that
  can be measured

20
WRITE THE HYPOTHESIS

• Write what you expect to find from your study
• What are the general relationships implied by
  your hypothesis?
• Are there any specific alternative relationships
  or explanations that would serve as competing or
  rival hypothesis?
• State your hypothesis in a clear, concise
  sentence
• Should be simple, specific, and stated in advance

21
TYPES OF HYPOTHESES

• Null hypothesis (Ho)
• There is no difference in symptom resolution or
  disease-specific QOL in children with recurrent
  acute sinusitis treated with ESS and those
  treated medically.
• Formal basis for testing statistical significance
• Alternative hypothesis (H1)
• Children with recurrent acute sinusitis treated
  with ESS will have significantly better symptom
  resolution and better disease specific QOL than
  those treated medically

22
DETERMINE WHAT YOU ARE GOING TO MEASURE

• Variables that you are going to need to measure
• Be parsimonious if it wont add to your answer,
  dont do it
• Each additional variable complicates your
  statistics increases your sample size
  requirement
• Recognize the value of independent converging
  measures
• Reliability and validity of instruments

23
SELECT VARIABLES

• Numerical
• Age
• Number of documented recurrences
• Categorical
• Involved site
• Disease outcome
• Tissue type
• Operational
• Dependent
• Independent
• Confounding
• Background

24
THE DOOMED DESIGN
v. A.1.a
V. A.1
..
v.A.1.b
Variable A
v.A.2.a
..
V. A.2
v.A.2.b
v.B.1.a
V. B.1
..
Variable B
v.B.1.b
v.B.2.a
..
V. B.2
v.B.2.b
25
Clinical Problem
Research Question
Design
Method
Observation
Experiment
Consultation
Laboratory
Case Reports
Qualitative Research
Clinical
Series
Surveys
Troidl et al., 1998
26
ESSENTIAL PRELIMINARIES

• Consult a statistician
• Question design statistical
  treatment
• Sample size estimations
• Involve sponsor/mentor in planning process
• Careful, comprehensive literature review

27
Research Question
Study Plan
Intended sample
Target population All adults
Patients in the investigators clinic who consent
to the study
design
Intended variables
Phenomena of interest
Errors
PREDICTOR Reported extra- esophageal reflux
CAUSE Actual extra- esophageal reflux
Association
Cause-effect
infer
OUTCOME Diagnosis of dysphonia in medical records
EFFECT Actual voice disorder
TRUTH IN THE STUDY
TRUTH IN THE UNIVERSE
Hulley et al., 2001
28
SELECT A STUDY STRATEGY

• Basic vs. clinical
• Prospective vs. retrospective
• Efficacy vs. efficiency
• Duration of study
• Cross-sectional vs. longitudinal
• Medical vs. patient outcome

29
TYPES OF STUDIES
30
TYPES OF STUDIES
31
FORMULATE PROJECT OBJECTIVES, HYPOTHESES

• Formulation of objectives will help
• Focus the study, narrowing it to essentials
• Avoid collection of data not strictly necessary
  for solving defined problem
• Organize the study in clearly defined parts or
  phases

32
SELECT YOUR SAMPLE(S)

• Describe the characteristics of the subjects who
  will be eligible for participation in your study
• Describe the characteristics of the subjects who
  will be excluded from your study
• Describe the population (beyond your sample) to
  which you wish to generalize your conclusions
• Determine sample size necessary for desired
  statistical power

33
ELIMINATE OR CONTROL THE BIASES

• Effects of historical events
• Effects of maturation, gender, ethnicity
• Effects of repeated measurement
• Instrument decay
• Effects of statistical regression
• Subject selection
• Loss of subjects
• Investigator bias

34
TO ENHANCE CREDIBILITY

• Appropriate controls
• Appropriate operational definitions
• Appropriate measurement tools
• Appropriate design and analysis
• Balanced perspective
• Cite others work
• If there are 2 camps, make sure you cite both
  sides

35
Nothing improves the performance of an
innovation more than the lack of
controls. Bearman et al., 1974
36
CONDUCTING THE THESIS PROJECT
37
SCIENTIFIC INTEGRITY AND ETHICS

• Ethics in scientific design and conduct
• Ethical justifiability
• Clinical equipoise
• Informed, comprehending, voluntary consent
• Confidentiality
• Use of animals
• Scientific adequacy
• Conflict of interest

Riis, in Troidl, et al., 1998
38
MANAGE THE DATA

• Collect the data
• Maintain quality control over the data
• Enter the data to a database
• Store the data
• Analyze the data

39
WRITING THE THESIS
process, a uniform level of scientific rigor can
be attained to achieve three objectives 1)
provide support for the most meritorious research
in otolaryngology and head
40
The Most Important Rule

• Read the guidelines for thesis format and
  submission
• Read them again
• Follow them to the letter

41
THE ABCs OF SCIENTIFIC WRITING

• Accuracy
• Brevity
• Clarity

42
STATE OBJECTIVES

• Cover different aspects of problem and
  contributing factors in coherent way and logical
  sequence.
• Use specific action-oriented verbs (to verify
  to compare to establish etc.) that correspond
  with goals and methodology.
• Objectives should be demonstrably achievable
  through selected methodology and subjects.
• State assumptions underlying your project.

43
MAKING YOUR CASE
Warrant
Claim
Evidence
Qualifications
Booth, Colomb, Williams, 1995
44
Tonsillectomy increases the risk of breast
cancer in women
Warrant
Claim
Evidence
Qualifications
Booth, Colomb, Williams, 1995
45
80 of all women with breast cancer have had
tonsillectomy
Warrant
Claim
Evidence
Qualifications
Booth, Colomb, Williams, 1995
46
There should be more stringent indications for
tonsillectomy in females
Warrant
Claim
Evidence
Qualifications
Booth, Colomb, Williams, 1995
47
Wait a minute!
Warrant
Claim
Evidence
Qualifications Oversimplification Overgeneralizati
on Special cases Other accounts Limiting
conditions
Booth, Colomb, Williams, 1995
48
THE BEST DEFENSE..

• Your Answers
• I claim that
• I limit it to
• I offer as evidence
• I offer this principle
• I can rebut that. First.
• My claim stands as long as...
• Well, I have to admit that

• The Questions
• What is your point?
• What is your claims scope?
• What evidence do you have?
• What links evidence to claim?
• But what about.?
• But what if.?
• No problems at all?

49
THE BAIT AND THE PUNCHLINE

• Introduction
• Opening quotation or fact
• Context of past research
• Condition of ignorance
• Cost of that ignorance
• Gist of solution

• Conclusion
• Gist of solution
• Larger significance or application
• What is still not known
• Call for further research
• Closing quotation or fact

Booth, Colomb, Williams, 1995
50
ILLUSTRATIONS

• To illustrate this
• Process
• Logical relationships
• Object
• Parts of complex object
• Action, step in process
• Results

• Use this
• Flow chart, decision tree
• Diagram, matrix
• Photo, drawing
• Microscopic view, drawing
• Schematic, photo, diagram
• Photo, graph, matrix

51
SCIENTIFIC INTEGRITY

• Scientific dishonesty
• Fabrication of data
• Selective, undisclosed rejection of undesired
  results
• Erroneous use of statistical methods to achieve
  desired outcome
• Distorted interpretation of results or
  conclusions
• Plagiarism of results or writings of other
  authors
• Distorted representation of other researchers
  results
• Wrongful or inappropriate attribution of
  authorship
• Omission of recognition of original observations
  made by other scientists

Riis, in Troidl, et al., 1998
52
THE MYTHOLOGY OF TRIO THESES

• Its not a thesisits more like a
  dissertation.
• It has to be kept completely secret from
  beginning to end.
• Nobody else can participate in the project or be
  named as an author.
• I cant use my MPH thesis as a basis for my
  Triological Society thesis.

53
SOURCES OF FUNDING

• NIH
• Small grant (R03) program
• Exploratory grant (R21) programs
• AAO-HNSF
• Percy Memorial Research Award (experienced inv.)
• Health Services Research Grant
• Combined grants (PSEF, AHNS)
• CORE program
• Other
• www.grantsnet.com
• www.cos.com

54
CONTACT

• Maureen Hannley, PhD
• 414-805-8308
• auntiemo_at_aol.com
• mhannley_at_mcw.edu