Writing a Research ProtocolWriting a Research Protocol

Michael Aronica MDMichael Aronica MD

Program DirectorProgram Director

Internal Medicine-PediatricsInternal Medicine-Pediatrics

AssumptionsAssumptions

You already have a research question or You already have a research question or problemproblem

Have already searched, read and critically Have already searched, read and critically appraised the literatureappraised the literature

Research Protocol OutlineResearch Protocol Outline

TitleTitle Purpose Purpose Introduction Introduction HypothesisHypothesis Setting(s)Setting(s) SubjectsSubjects External ValidityExternal Validity DesignDesign

Dependent VariableDependent Variable Independent VariablesIndependent Variables Operational Operational

HypothesisHypothesis Data CollectionData Collection Sample SizeSample Size Data AnalysisData Analysis Time TableTime Table BudgetBudget

PICOPICO

PPatientsatients IInterventionntervention CComparisonomparison OOutcome(s)utcome(s)

TitleTitle

AccurateAccurate RelevantRelevant SuccinctSuccinct Use your PICO framing to make specificUse your PICO framing to make specific

PurposePurpose

A general statement of the purpose of the researchA general statement of the purpose of the research A series of specific aimsA series of specific aims

– To describe….To describe….

– To compare…To compare…

– To determine to effect of…To determine to effect of…

Introduction Introduction

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

3 paragraphs3 paragraphs– Why is topic important?Why is topic important?

» Why should I care; hookWhy should I care; hook

– What are the gaps in the literature?What are the gaps in the literature?» Transition: the gap you will addressTransition: the gap you will address

– What is your study purpose?What is your study purpose?» Can include hypotheses or questionsCan include hypotheses or questions

HypothesisHypothesis

Rephrase the purpose of the study in terms of the existing Rephrase the purpose of the study in terms of the existing information and the importance of the question. information and the importance of the question. – Specific “If-Then statement.Specific “If-Then statement.

A statement about the relationship between two variables A statement about the relationship between two variables that is designed to answer a research question. Identify the that is designed to answer a research question. Identify the direction of the relationship using terms such as greater than, direction of the relationship using terms such as greater than, less than, positively, or negatively. less than, positively, or negatively. – The strength of a person’s spiritual convictions is positively related to The strength of a person’s spiritual convictions is positively related to

their healththeir health The second feature of a research hypothesis is that it must be The second feature of a research hypothesis is that it must be

testable. Essentially, hypotheses testing the relationship testable. Essentially, hypotheses testing the relationship between variables requires observation, measurement, and between variables requires observation, measurement, and analysis. analysis. – Valid indicators would be needed for measuring spiritual convictions Valid indicators would be needed for measuring spiritual convictions

and health. and health.

Outline for a Research ProtocolOutline for a Research Protocol

SettingsSettings– Where will the research be done?Where will the research be done?

SubjectsSubjects– Who will be in the study? Who will be in the study?

– Inclusion Criteria: characteristics of potential subjects Inclusion Criteria: characteristics of potential subjects that contribute to the success of a study.that contribute to the success of a study.

– Exclusion Criteria: characteristics of potential subjects Exclusion Criteria: characteristics of potential subjects that may confuse, confound or invalidate results. By that may confuse, confound or invalidate results. By eliminating these subjects, the researcher can control eliminating these subjects, the researcher can control some of the variability.some of the variability.

External ValidityExternal Validity

To whom will your findings be generalizable?To whom will your findings be generalizable? The degree to which your sample’s findings will The degree to which your sample’s findings will

hold true to which population.hold true to which population.

DesignDesign

Study design you have chosen to useStudy design you have chosen to use– ExperimentalExperimental

– CohortCohort

– Cross-sectionalCross-sectional

– Case-control study Case-control study

– Include some discussion to showInclude some discussion to show that this is the that this is the preferred design for your purpose.preferred design for your purpose.

Dependent VariableDependent Variable

Usually the health outcome(s) that you are Usually the health outcome(s) that you are studyingstudying

What type of variableWhat type of variable– ContinuousContinuous

– Catagorical/dichotomousCatagorical/dichotomous

Independent VariablesIndependent Variables

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

Potential confoundersPotential confounders

– AgeAge

– GenderGender

– RaceRace

– SESSES

– Severity of IllnessSeverity of Illness

Determined by literature search or expertsDetermined by literature search or experts

Operational HypothesisOperational Hypothesis

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

Usually a statistical hypothesisUsually a statistical hypothesis– Eg. The mean bone density loss is greater in Eg. The mean bone density loss is greater in

adolescents on Depo-Provera that those on adolescents on Depo-Provera that those on BCP’sBCP’s

– ‘‘Mean loss’ operationalizes decreased bone Mean loss’ operationalizes decreased bone densitydensity

Different from the null hypothesisDifferent from the null hypothesis

Data CollectionData Collection

How and by whom? How and by whom? Prepare detailed protocol so that every step Prepare detailed protocol so that every step

can be easily replicated by someone else. can be easily replicated by someone else. – Physiological or Biological MeasurementPhysiological or Biological Measurement– Observational MethodsObservational Methods– Interviews and QuestionnairesInterviews and Questionnaires

» scripts for structured interviewsscripts for structured interviews» formally constructed questionnairesformally constructed questionnaires

– Records or available dataRecords or available data

Data CollectionData Collection

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

For Quantitative studies:For Quantitative studies:– the measures should be objectivethe measures should be objective– approach should be systematicapproach should be systematic

» same questions or data in the same ordersame questions or data in the same order Two properties of instruments are importantTwo properties of instruments are important

– Validity: Validity: how well do the data reflect reality?how well do the data reflect reality?– Reliability: Reliability: how well do results compare if the instrument how well do results compare if the instrument

is applied more than once?is applied more than once?

Sample SizeSample 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. Alpha: the probability of a Type I error.

» Usually set at .05Usually set at .05» Alpha errors are like false alarms: you think you’re on to something, Alpha errors are like false alarms: you think you’re on to something,

but you’re really not. your result is a false positivebut you’re really not. your result is a false positive

– Beta: the probability of a Type II error. Beta: the probability of a Type II error. » Usually set at .2Usually set at .2» Beta errors are false negatives; there really is an effect in the real Beta errors are false negatives; there really is an effect in the real

world, but the study missed it. world, but the study missed it.

Also need to know the baseline characteristic of your Also need to know the baseline characteristic of your sample (eg prevalence) and the clinically significant sample (eg prevalence) and the clinically significant change you are trying to measurechange you are trying to measure

Online power calculatorsOnline power calculators

Data AnalysisData Analysis

Outline a strategy for analysisOutline 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-parametricParametric vs non-parametric

– Continuous outcomes vs dichotomous outcomesContinuous outcomes vs dichotomous outcomes

– Continuous variables va categorical variablesContinuous variables va categorical variables

Your strategy should indicate how you will test each Your strategy should indicate how you will test each operational hypothesis. operational hypothesis.

Discuss confounding and any other means for controlling Discuss confounding and any other means for controlling bias.bias.– StratifyingStratifying

– RegressionRegression

Time TableTime Table

Plan for accomplishing each step of the Plan for accomplishing each step of the studystudy

Help to organize the structure of a research Help to organize the structure of a research programprogram

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

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

Present in table formatPresent in table format

Time TableTime Table

Task O N D J F M A M J J A SRecruitment of Participants

Demographic Data, Consents

Revision of Surveillance Protocols

Programming Zoomerang Protocols

Surveillance Protocol #1

Surveillance Protocol #2

Obtain WISCP participation data

Combined Data Analysis

Organize Post-hoc Surveillance Meeting

Meeting to Discuss Surveillance

Writing Final Report

BudgetBudget

Not necessary for IRB submissionsNot necessary for IRB submissions Will be needed for institutional or other grantsWill be needed for institutional or other grants Know what the award is for and what are the Know what the award is for and what are the

constraints. constraints.