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DEVELOPING AND WRITING YOUR TRIOLOGICAL THESIS

DEVELOPING AND WRITING YOUR TRIOLOGICAL THESIS. Maureen Hannley, PhD. THE ROAD TO TRIO. Board-certified otolaryngologist In practice > 3 years Published > 2 papers & attended 3 national meetings Be proposed by 2 active members & approved by Council Write a thesis for review & approval.

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DEVELOPING AND WRITING YOUR TRIOLOGICAL THESIS

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  1. DEVELOPING AND WRITING YOUR TRIOLOGICAL THESIS Maureen Hannley, PhD

  2. THE ROAD TO TRIO • Board-certified otolaryngologist • In practice > 3 years • Published > 2 papers & attended 3 national meetings • Be proposed by 2 active members & approved by Council Write a thesis for review & approval

  3. THE MYTHOLOGY OF THE TRIOLOGICAL THESIS(or more Urban Legends Debunked)

  4. COMMON MYTHS Must be a production equivalent to a doctoral dissertation Cannot have been used for any other purpose Cannot have multiple authors

  5. SUCCESSFUL THESESTopic Areas2001 – 2014 (n = 333)

  6. SUCCESSFUL THESESProject Approach2009 – 2014 (n = 154) 7 4.5% 11 7.1% 31 20.1% 74 (48.05%) 31 20.1%

  7. STEPS TO BUILDING A THESIS • Preliminary steps • Read guidelines • Clear with proposers • Submit application to Trio • Develop the thesis plan • Topic • Idea • Necessary components • Submit IRB, IACUC application • Conduct the thesis project • Analyze the data • Write the paper

  8. THE MOST IMPORTANT RULE • Read the guidelines for thesis format and submission • Read them again • Follow them to the letter

  9. 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”

  10. FOUR TESTS OF THESIS TOPIC • Is it new? • Is it true? • So what? • Who cares? Fontanarosa, 2008

  11. INTERESTS, TOPICS, QUESTIONS, & PROBLEMS • Find an interest in a broad subject area • “What am I interested/expert in?” • Pediatric otolaryngology with impaired children • Narrow the interest to a plausible topic • “What are unsolved gaps or inconsistencies in this area?” • Candidacy of neurologically impaired children for tonsillectomy • Develop questions within the topic • “What do I want to know?” • Any difference between normal & impaired children in complications, recovery rate, outcomes? • Develop a rationale for the project • “Why is it important to know this?” • Demonstrate candidacy, secondary benefits

  12. Practical Problem motivates helps to solve ? Research Answer Research Question finds defines Research Problem Booth, Columb, & Williams, 1995

  13. SIX STEPS TO DEVELOP A COMPELLING NOVEL IDEA • Identify the niche area • Collect and critically analyze background information related to the problem • Develop a preliminary idea (don’t force it) • Assess the idea’s potential for success and modify it, if necessary • Seek constructive criticism from colleagues • Refine the idea to maximize its potential for impact on your field

  14. SOME INVESTIGATIONAL CATEGORIES • Descriptions of problems required for planning interventions • “Transtympanic vs. sustained release administration of gentamicin: Kinetics, morphology, and function” • “Survival and prognostic factors unique to surgically treated p16+ oropharyngeal cancer “ • Information required to evaluate ongoing interventions, assess progress • “Long-term follow-up for children treated with surgical intervention for chronic sinusitis • “Coblation tonsillectomy in children: the incidence of bleeding “ • Information required to define problems… • “Direct evidence of bacterial biofilms in otitis media” • Analyze possible causes… • “Inflammatory mediators drive metastasis and drug resistance in head & neck squamous cell carcinoma” • or offer solutions • “Potential for promoting recurrent laryngeal nerve regeneration by remote delivery of viral gene therapy” • “Facial determinants of female gender and feminizing forehead cranioplasty”

  15. ASKING THE RIGHT QUESTION • Ask a question with clinical relevance, not just clinicalapplication • Ask a question that interests you and will sustain your interest • Ask the question in such a way that either a positive or negative answer will be interesting • Be specific • Make sure you have time, resources • Subjects • Database/access, technical assistance • Collaborators if appropriate • Expertise!

  16. YOUR NEW BEST FRIEND • Consult a statistician UP FRONT! • Question design statistical treatment • Sample size estimations • Bias issues • Involve sponsor/mentor in planning process • Careful, comprehensive literature review

  17. THE CLINICAL 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, identify elements

  18. PICO • P = Population, Patient or Problem • I = Intervention • C = Control or Comparison • O = Outcome

  19. 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?” Patients Intervention Comparison Outcome

  20. REFINE YOUR RESEARCH QUESTION • Define the population or material 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.

  21. WRITE THE HYPOTHESIS • Write what you expect to findfrom your study. • State your hypothesis in a clear, concise sentence. • Should be directional and quantifiable • Should be simple, specific, andstated in advance

  22. TYPES OF HYPOTHESES • Null hypothesis (H0) • “There is no difference in symptom resolution or disease-specific QOL in children with recurrent acute sinusitis treated with ESS and those treated medically.” • Infers lack of bias in formulating question • Formal basis for testing statistical significance • Alternative hypothesis • “Children with recurrent acute sinusitis treated with ESS will have significantly better* symptom resolution and better disease-specific QOL than those treated medically.” *Definable amount that is clinically significant

  23. NOTE (NB) • An objective is NOT synonymous with an hypothesis. • Objective: what you want to accomplish with your project; where you are going • One step along continuum of progress toward a long-term goal • Hypothesis: best guess as to how the project will turn out, given the way you do it (subjects, methods, analysis) • Both MUST be stated.

  24. LINKAGE OF THREE KEY COMPONENTS • Long-Term Goal: Broadest (the Forest) • Projects your continuum of research • Overall Objective: Narrower • Step along the continuum • Must be achieved regardless of how the hypothesis tests • Central Hypothesis: Narrowest (the Tree) • Best bet, but could be invalid (alternative presented later, therefore)

  25. LINKAGE OF KEY COMPONENTS GAP OR NEED OBJECTIVE CENTRAL HYPOTHESIS SPECIFIC AIMS EXPECTED OUTCOMES (working hypotheses)

  26. DETERMINE WHAT YOU ARE GOING TO MEASURE • Variables that you are going to need to measure • Be parsimonious; if it won’t add to your answer, don’t do it • But…Recognize the value of independent converging measures • Each additional variable complicates your statistics & increases your sample size requirement • Reliability and validity of instruments; relevance to question/topic

  27. VARIABLES Types of Variables Dependent Independent Qualitative Quantitative (Reflux) (Proton pump inhibitor vs pepsin antagonist) Nominal Interval Confounding (Sex, gender) (36o 38o) (Gastric ulcer) Ratio Ordinal (BMI, vital capacity) (TNM stage) Norman & Streiner, 2003

  28. SELECT A STUDY STRATEGY • Basic vs. clinical • Prospective vs. retrospective • Efficacy vs. effectiveness • Duration of study • Cross-sectional vs. longitudinal • Medical vs. patient outcome

  29. QUALITY vs BIAS IN CLINICAL RESEARCH Case report* Small case series* Cross-sectional study Case-control study Cohort study Clinical trial Randomized clinical trial Blinded randomized clinical trial BIAS BEST EVIDENCE *Can be used to illustrate concepts

  30. 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 • Each objective should have a hypothesis • Formulation of hypotheses will provide a basis to test achievement of objectives

  31. SELECT YOUR SAMPLE(S) • State inclusion and exclusion criteria for study subjects (or material) • Describe the population (beyond your sample) to which you wish to generalize your conclusions • Determine sample size necessary for desired statistical power

  32. 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

  33. CONDUCTING THE THESIS PROJECT

  34. SCIENTIFIC INTEGRITY AND ETHICS • Ethics in scientific design and conduct • Ethical justifiability • Clinical equipoise • Informed, comprehending, voluntary consent • Confidentiality • Conscientious, ethical use of animals • Scientific adequacy • Conflict of interest Riis, in Troidl, et al., 1998

  35. EXEMPTIONS TO IRB REQUIREMENT • Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens • Must be fully de-identified • Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: • public benefit or service programs; • procedures for obtaining benefits or services under those programs; • possible changes in or alternatives to those programs or procedures; or • possible changes in methods or levels of payment for benefits or services under those programs.

  36. DESIGN AND METHODOLOGY Who? What? Where? When? How much? WHY?

  37. ANIMAL USE AND CARE • Projects using vertebrate animals must be reviewed by your home institution IACUC • Justify choice of species • Specify and justify analgesia, euthanasia methods

  38. DATA ANALYSIS • Descriptive (should always be included) • Numbers, demographics: n, age, gender, ethnicity • Central tendency: mean, median, mode • Variation: range, standard deviation, percentile • Inferential (depends on design, question) • Process of inferring features of population from observations of a sample • Likelihood that observed effect/differences could be due to chance: standard error of mean • Many inferential tests depending on research design and whether data are normally distributed (parametric) or not (non-parametric)

  39. “A difference to be a difference should make a difference.”Gertrude Stein

  40. 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

  41. APPROACH TO THESIS PREPARATION “Writing is easy. All you have to do is sit and stare at the blank sheet of paper until the drops of blood form on your forehead.” Gene Fowler

  42. THE ABCs OF SCIENTIFIC WRITING • Accuracy • Brevity • Clarity

  43. TRY THIS • Tell the storyof your project in your own words; technical language can come later • What you did • Why you did it • How you did it • What you found • What it means

  44. 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 THE BAIT AND THE PUNCHLINE Booth, Colomb, & Williams, 1995

  45. 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. • Avoid weak verbs (“to find out”, “to characterize”, “to describe”) that give the impression of a hypothesis – seeking project, a.k.a. a fishing expedition. “To report” never good thesis approach • Avoid non-specific descriptors (“worse”, “more satisfied”, “less severe” etc) unless there is an operational definition • Objectives should be demonstrably achievable through selected methodology and subjects. • State assumptions underlying your project. • AND STATE YOUR HYPOTHESIS!

  46. METHODS AND PROCEDURES • Reveal how carefully you conducted your research • Allow another researcher to replicate your study • Sections • Subjects or participants • Experimental design • Equipment or measures • Procedures • Subject selection • Measurement of dependent variables • References to support choice of procedures, especially if options available • Statistical analysis

  47. A USEFUL EXERCISE • Convert pooled data to charts (bar, pie, scatter, etc.) • Write 1-2 bullets/sentences about what chart tells you • Write 1-2 bullets/sentences about any alternative explanations for the display • This can serve as outline for Results and Discussion sections

  48. RESULTS • Report only results that bear on your question (not every analysis needs to be shown) • Consider possible contributing factors to data outcomes • A good Results section should tell a story • Analyses that support the integrity of the study (internal consistency, variance, etc) • Present analyses in logical sequence • Use tables & figures to relieve clutter of numbers • No results in Discussion; no discussion in Results

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