Writing a research protocol
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Writing a Research Protocol. Michael Aronica MD Program Director Internal Medicine-Pediatrics. Assumptions. You already have a research question or problem Have already searched, read and critically appraised the literature. Title Purpose Introduction Hypothesis Setting(s)

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Writing a Research Protocol

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Writing a Research Protocol

Michael Aronica MD

Program Director

Internal Medicine-Pediatrics


  • You already have a research question or problem

  • Have already searched, read and critically appraised the literature







External Validity


Dependent Variable

Independent Variables

Operational Hypothesis

Data Collection

Sample Size

Data Analysis

Time Table


Research Protocol Outline


  • Patients

  • Intervention

  • Comparison

  • Outcome(s)


  • Accurate

  • Relevant

  • Succinct

  • Use your PICO framing to make specific


  • A general statement of the purpose of the research

  • A series of specific aims

    • To describe….

    • To compare…

    • To determine to effect of…


  • Briefly justify the study in terms of existing information and the importance of the question.

  • 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


  • 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.

    • 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.

    • Valid indicators would be needed for measuring spiritual convictions and health.

Outline for a Research Protocol

  • Settings

    • Where will the research be done?

  • 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.

External Validity

  • To whom will your findings be generalizable?

  • The degree to which your sample’s findings will hold true to which population.


  • Study design you have chosen to use

    • Experimental

    • Cohort

    • Cross-sectional

    • Case-control study

    • Include some discussion to showthat this is the preferred design for your purpose.

Dependent Variable

  • Usually the health outcome(s) that you are studying

  • What type of variable

    • Continuous

    • Catagorical/dichotomous

Independent Variables

  • Risk factors, casual factors, experimental treatment, and other relevant factors

  • Potential confounders

    • Age

    • Gender

    • Race

    • SES

    • Severity of Illness

  • Determined by literature search or experts

Operational Hypothesis

  • Rephrase the purpose of the study as a series of comparative questions

  • 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

Data Collection

  • How and by whom?

  • 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

Data Collection

  • Include sample questionnaires or other data collection forms (instruments)

  • 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

    • Validity: how well do the data reflect reality?

    • Reliability: how well do results compare if the instrument is applied more than once?

Sample Size

  • 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

  • Online power calculators

Data Analysis

  • Outline a strategy for analysis

  • 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.

  • Discuss confounding and any other means for controlling bias.

    • Stratifying

    • Regression

Time Table

  • Plan for accomplishing each step of the study

  • Help to organize the structure of a research program

  • Can assist in keeping on schedule and avoiding “costly” delays

  • Are especially important in residency-based research due to deadlines

  • Present in table format

Time Table


  • Not necessary for IRB submissions

  • Will be needed for institutional or other grants

  • Know what the award is for and what are the constraints.

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