1. Writing a Research Protocol Michael Aronica MD Program Director Internal Medicine-Pediatrics

2. Assumptions You already have a research question or problem You already have a research question or problem Have already searched, read and critically appraised the literature Have already searched, read and critically appraised the literature

3. Research Protocol Outline Title Title Purpose Purpose Introduction Introduction Hypothesis Hypothesis Setting(s) Setting(s) Subjects Subjects External Validity External Validity Design Design Dependent Variable Independent Variables Operational Hypothesis Data Collection Sample Size Data Analysis Time Table Budget

4. PICO Patients Patients Intervention Intervention Comparison Comparison Outcome(s) Outcome(s)

5. Title Accurate Accurate Relevant Relevant Succinct Succinct Use your PICO framing to make specific Use your PICO framing to make specific

6. Purpose A general statement of the purpose of the research A general statement of the purpose of the research A series of specific aims A series of specific aims –To describe…. –To compare… –To determine to effect of…

7. Introduction Briefly justify the study in terms of existing information and the importance of the question. Briefly justify the study in terms of existing information and the importance of the question. 3 paragraphs 3 paragraphs –Why is topic important? »Why should I care; hook –What are the gaps in the literature? »Transition: the gap you will address –What is your study purpose? »Can include hypotheses or questions

8. Hypothesis Rephrase the purpose of the study in terms of the existing information and the importance of the question. Rephrase the purpose of the study in terms of the existing information and the importance of the question. –Specific “If-Then statement. A statement about the relationship between two variables that is designed to answer a research question. Identify the direction of the relationship using terms such as greater than, less than, positively, or negatively. A statement about the relationship between two variables that is designed to answer a research question. Identify the direction of the relationship using terms such as greater than, less than, positively, or negatively. –The strength of a person’s spiritual convictions is positively related to their health The second feature of a research hypothesis is that it must be testable. Essentially, hypotheses testing the relationship between variables requires observation, measurement, and analysis. The second feature of a research hypothesis is that it must be testable. Essentially, hypotheses testing the relationship between variables requires observation, measurement, and analysis. –Valid indicators would be needed for measuring spiritual convictions and health.

9. Outline for a Research Protocol Settings Settings –Where will the research be done? Subjects Subjects –Who will be in the study? –Inclusion Criteria: characteristics of potential subjects that contribute to the success of a study. –Exclusion Criteria: characteristics of potential subjects that may confuse, confound or invalidate results. By eliminating these subjects, the researcher can control some of the variability.

10. External Validity To whom will your findings be generalizable? To whom will your findings be generalizable? The degree to which your sample’s findings will hold true to which population. The degree to which your sample’s findings will hold true to which population.

11. Design Study design you have chosen to use Study design you have chosen to use –Experimental –Cohort –Cross-sectional –Case-control study –Include some discussion to show that this is the preferred design for your purpose.

12. Dependent Variable Usually the health outcome(s) that you are studying Usually the health outcome(s) that you are studying What type of variable What type of variable –Continuous –Catagorical/dichotomous

13. Independent Variables Risk factors, casual factors, experimental treatment, and other relevant factors Risk factors, casual factors, experimental treatment, and other relevant factors Potential confounders Potential confounders –Age –Gender –Race –SES –Severity of Illness Determined by literature search or experts Determined by literature search or experts

14. Operational Hypothesis Rephrase the purpose of the study as a series of comparative questions Rephrase the purpose of the study as a series of comparative questions Usually a statistical hypothesis Usually a statistical hypothesis –Eg. The mean bone density loss is greater in adolescents on Depo-Provera that those on BCP’s –‘Mean loss’ operationalizes decreased bone density Different from the null hypothesis Different from the null hypothesis

15. Data Collection How and by whom? How and by whom? Prepare detailed protocol so that every step can be easily replicated by someone else. Prepare detailed protocol so that every step can be easily replicated by someone else. –Physiological or Biological Measurement –Observational Methods –Interviews and Questionnaires »scripts for structured interviews »formally constructed questionnaires –Records or available data

16. Data Collection Include sample questionnaires or other data collection forms (instruments) Include sample questionnaires or other data collection forms (instruments) For Quantitative studies: For Quantitative studies: –the measures should be objective –approach should be systematic »same questions or data in the same order Two properties of instruments are important Two properties of instruments are important –Validity: how well do the data reflect reality? –Reliability: how well do results compare if the instrument is applied more than once?

17. Sample Size Calculations and the assumptions on which they are made. Calculations and the assumptions on which they are made. –Alpha: the probability of a Type I error. »Usually set at.05 »Alpha errors are like false alarms: you think you’re on to something, but you’re really not. your result is a false positive –Beta: the probability of a Type II error. »Usually set at.2 »Beta errors are false negatives; there really is an effect in the real world, but the study missed it. Also need to know the baseline characteristic of your sample (eg prevalence) and the clinically significant change you are trying to measure Also need to know the baseline characteristic of your sample (eg prevalence) and the clinically significant change you are trying to measure Online power calculators Online power calculators

18. Data Analysis Outline a strategy for analysis Outline a strategy for analysis A detailed list of statistical procedures is not necessary. A detailed list of statistical procedures is not necessary. –Parametric vs non-parametric –Continuous outcomes vs dichotomous outcomes –Continuous variables va categorical variables Your strategy should indicate how you will test each operational hypothesis. Your strategy should indicate how you will test each operational hypothesis. Discuss confounding and any other means for controlling bias. Discuss confounding and any other means for controlling bias. –Stratifying –Regression

19. Time Table Plan for accomplishing each step of the study Plan for accomplishing each step of the study Help to organize the structure of a research program Help to organize the structure of a research program Can assist in keeping on schedule and avoiding “costly” delays Can assist in keeping on schedule and avoiding “costly” delays Are especially important in residency-based research due to deadlines Are especially important in residency-based research due to deadlines Present in table format Present in table format

20. Time Table

21. Budget Not necessary for IRB submissions Not necessary for IRB submissions Will be needed for institutional or other grants Will be needed for institutional or other grants Know what the award is for and what are the constraints. Know what the award is for and what are the constraints.