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This lecture focuses on the essential steps in developing a research project with a well-formulated question and hypotheses. It discusses proper literature citations, writing clear hypotheses, and grading clinical outcomes through practical examples, like the "Refresh Contacts" study. The presentation emphasizes the importance of originality, ethical considerations, and relevance in research. Learn how to effectively reference literature in the increasingly digital age and utilize the FINER criteria to evaluate the feasibility and importance of your research question.
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6350 Lecture 3: Developing a Project with Hypotheses • Key Concepts: How a question is developedProper Literature Citations (test)Hypothesis Writing (test)Clinical Grading (e.g., staining; test) Writing Questions and Hypotheses
Thought for the Day “To him/her whose elastic and vigorous thought keeps pace with the sun, the day is a perpetual morning” Henry David Thoreau
Student Research and the Research Question The Most Important Aspect of Research (according to JP) You want people to say: “What a neat idea!”when you describe your project
It’s Tough to Ask a Good Question! Writing Questions and Hypotheses
Dr. Paugh’s Example – The “Refresh Contacts” Study • Solution toxicities observed clinically with multi-purpose solutions (MPSs) • Carboxymethylcellulose (CMC): • Ubiquitous wood fiber; viscosifying agent in artificial tears and CL lubricants The Question: Can a pre-application drop of CMC reduce solution toxicity? Writing Questions and Hypotheses
Grade 3.5 SPK “worst sector” on a 0-4 Scale; Grade 14.5 on a 0 – 20 Total Scale Writing Questions and Hypotheses
Dr. Paugh’s Example What does the literature say? • Solution reactions exist: • especially silicone-hydrogels & MPSs • Evidence that CMC can neutralize MPS actives (i.e., PHMB) • Vehige et al., Eye and CL, 2003: chemical availability of PHMB less in water and MPS when CMC present • Also, bacterial survival rates greater when CMC added binding Writing Questions and Hypotheses
How Do We Reference the Literature? (especially in this increasingly electronic age?)
Literature Citations • Uniform Requirements for Manuscripts Submitted to Biomedical Journals • Used by many medical journals, including OVS, IOVS, etc. • International Committee of Medical Journal Editors (ICMJE); general medical journal editors who meet annually to develop uniform standards) • Consider reference software such as EndNote Writing Questions and Hypotheses
Citing Electronic Material: ICMJE* How To: SCCO Library: • Go to intranet, SCCO Library • Click on “How To” • Click on “ICMJE” • Go to specific chapter you need *Patrias K. Citing medicine: the NLM style guide for authors, editors, and publishers [Internet]. 2nd ed. Wendling DL, technical editor. Bethesda (MD): National Library of Medicine (US); 2007 [updated 2009 Oct 21; cited Year Month Day]. Available from: http://www.nlm.nih.gov/citingmedicine Writing Questions and Hypotheses
Citation-Journal (paper): • Use Index Medicus abbreviations for the journal (e.g., Optom Vis Sci) • List the first six authors followed by “et al.” • Example: • Halpern SD, Ubel PA, Caplan AL. Solid-organ transplantation in HIV-infected patients. N Engl J Med. 2002;347:284-7. Writing Questions and Hypotheses
Citation-Book (paper): • Personal Author: • Murray PR, Rosenthal KS, Kobayashi GS, Pfaller MA. Medical microbiology. 4th ed. St. Louis:Mosby;2002. + page numbers!!! Writing Questions and Hypotheses
Citation-CD-ROM(“electronic material”) e.g.: Anderson SC, Poulsen KB. Anderson’s electronic atlas of hematology [CD-ROM]. Philadelphia: Lippincott and Williams and Wilkins; 2002. e.g.: Writing Questions and Hypotheses
Citation-Internet Journal Article: e.g.: Writing Questions and Hypotheses
Citation-Homepage/Web Site • Cancer-Pain.org [homepage on internet]. New York: Association of Cancer Online Resources, Inc.; c2000-01 [updated 2002 May 16; cited 2002 Jul 9]. Available from http://www.cancer-pain.org/. Writing Questions and Hypotheses
Citation-SCCO Student Research Paper • Williams R. Strabismus and its therapies [student research paper]. Fullerton (CA): Southern California College of Optometry; 1980. • Note: could have a second author and faculty advisoras well Writing Questions and Hypotheses
FINER TEST (for student research) • F – feasible (adequate subjects, affordable?) • I – interesting (to investigator & profession) • N – novel (confirms or refutes prior work) • E - ethical • R – relevant? (to knowledge, clinical care?) (i.e., the So What? Test) Writing Questions and Hypotheses
Dr. Paugh’s Example (Refresh Contacts) • Poll Contact Lens Staff-What do you think? • So What? • Clinical care: • may corroborate in vitro findings • may develop a simple and cost effective solution to a given problem • Pre-application drop lubricates the lens-eye system-a benefit! • Feasibility! Writing Questions and Hypotheses
Dr. Paugh’s Example • Is there a difference between pre-instillation of a CMC vs. a non-CMC lubricant? • i.e., subjective? • Dryness, comfort etc. • i.e., objective? • Staining (overall and cumulative) • Bulbar injection • Limbal redness Writing Questions and Hypotheses
REFINING AND DEFINING:IMPORTANT!!!!!!!!! • Keep it small • Define the population rigorously • Focus on one thing - one relationship • Define the end-point in terms of primary outcome variable(s) and secondary outcome variable(s) • What exactly are you going to measure? Writing Questions and Hypotheses
Dr. Paugh’s example Population • Experienced soft lens wearers • NB: ideal would be identified solution responders • In reality, ANY soft lens wearers • > age 18 (expedited IRB review) • No torics • Fit with lens material that is likely to demonstrate the problem- Ethics??? Writing Questions and Hypotheses
Dr. Paugh’s example, cont’d Methods: • Fit all subjects with one lens material • All subjects disinfect with ReNu • During one 4-week period, use ReNu lubricant as pre-application drop • During 2nd 4-week period, use CMC lubricant as pre-application drop • Responses: subjective & biomicroscopy Writing Questions and Hypotheses
Variables – Definitions (textbook) • Independent variable or Predictor variable • The variable that is held constant; HOWEVER, the investigator controls it • A factor that is suspected to influence the outcome of an analytic study (e.g., a CL lubricant, or drug treatment, etc.) • Dependent variable or Outcome variable • Primary • Secondary • The response of interest (e.g., the development of staining, cure of disease etc.) Writing Questions and Hypotheses
Dr. Paugh’s Example • What is the independent / predictor variable? • e.g., disinfecting solution? • Lens material? • Length of wear? • Lubricant? • What is the dependent / outcome variable? • e.g., comfort? staining? refractive error? Writing Questions and Hypotheses
Research Questions: Summary • “Ask a Good Question!!!” • How? Discover an unanswered need: • Why does this happen clinically? What is known about this?, etc. Literature review; speak with experts Writing Questions and Hypotheses
Dr. Paugh’s Questions-Personal • How long does an ophthalmic solution last on the ocular surface? • Can a novel, more convenient method be developed to measure epithelial barrier function? • What are the factors that influence tear exchange beneath contact lenses? • Does ed peri-ocular humidity improve non-invasive tear parameters? • What is the in situ aqueous tear viscosity? Writing Questions and Hypotheses
Dr. Paugh’s Questions-Student • How much plus can be added to a rigid CL prior to optical distortion? • What is the prevalence of MGD? • Do warm compresses for MGD really provide benefit? • Do neophyte, latent hyperopes accept more plus with rigid contact lenses? Writing Questions and Hypotheses
List in Your Hands!!! Faculty to Contact: • Drs. Sendrowski, Comer, Tong: Ocular Disease • Drs. Barnhardt, Cotter, Borsting, Chu: • Pediatrics, VT, dyslexia, strabismus • Drs Jim Bailey, Stark • Accommodation, VT, Visual Optics • Drs. Edrington, Marsden, Lam et al. • Contact lenses, tear film, keratoconus • Dr. Ridder: Contrast threshold, ERG, aberrations • Dr. Paugh: Tears, CLs, dry eye Writing Questions and Hypotheses
GENERATING HYPOTHESES • Specify the end-point carefully: • e.g., IOP, TBUT, BI to break, etc. • What are you measuring exactly? • Is it best expressed as a mean? • e.g., average score, average difference, average visual acuity, average IOP • Is it best expressed as a proportion? • e.g., percentages, proportion with and without (a condition), categories (disease, no disease) Writing Questions and Hypotheses
HYPOTHESES: General • Null is always “no difference” • Alternative can be one-tailed or two-tailed • What is of interest to you? • What makes sense clinically? Writing Questions and Hypotheses
NULL HYPOTHESIS • There is no difference between... • ...Is not associated with... • ...Is not different... • Symbols: mu for means pi for proportions • Use equal sign = • E.g.: • Ho: 1 = 2 • Ho: 1 = 2 Writing Questions and Hypotheses
ALTERNATIVE HYPOTHESIS • One-tailed or two-tailed? • Not equal, greater than, less than • Symbols: (mu) for means (pi) for proportions • Use appropriate mathematical symbol for one-tailed or two-tailed ≠; >; < Writing Questions and Hypotheses
Dr. Paugh’s CMC Example • What exactly did we measure as the principal outcome measure? • Is this expressed as a proportion or a mean? Writing Questions and Hypotheses
Dr. Paugh’s Example • Should the alternative hypothesis be one-tailed or two-tailed? • Could SCL wearers have more or less staining when using lubricants? • Two-tailed makes it more difficult to demonstrate significance, but, more robust statistically use 2-tailed approach if possible Writing Questions and Hypotheses
Examples: Writing Hypotheses • Null (no difference) Hypothesis: • E.g., There is no difference in the residence time, in minutes, between product 1 and product 2 • Ho: 1 = 2 • Alternative Hypothesis: • There is a difference in residence time, in minutes, between product 1 and product 2 • HA: 1 ≠ 2 • Two-tailed most robust (because covers all possible outcomes) Writing Questions and Hypotheses