Research Design and MethodsBetsy MyersHospital for Special Surgery

Took about 25 minutes

Research PlanPortrayWhat you intend to doSpecific AimsWhy it is importantBackground and Significance

Research PlanWhat has been done so farPreliminary StudiesHow you are going to do itResearch Design and Methods

Getting StartedRead instructions on how to prepare Research Design and Methods section

InstructionsDescribe the research design conceptual or clinical framework, procedures, and analyses to be used to accomplish the specific aims of the project.http://grants1.nih.gov/grants/funding/phs398/phs398.docInstructions for PHS 398 Rev. 09/2004

Instructionsinclude how the data will be collected, analyzed, and interpreted as well as the data-sharing plan as appropriate.http://grants1.nih.gov/grants/funding/phs398/phs398.docInstructions for PHS 398 Rev. 09/2004

InstructionsDescribe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, or technologies for the proposed studies.http://grants1.nih.gov/grants/funding/phs398/phs398.docInstructions for PHS 398 Rev. 09/2004

InstructionsDiscuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims.provide a tentative sequence or timetable for the project.http://grants1.nih.gov/grants/funding/phs398/phs398.docInstructions for PHS 398 Rev. 09/2004

Main Points That You Must Get AcrossResearch design, if carried out successfully, will accomplish Specific AimsMethods are feasible and well developedApproach is original

Main Points That You Must Get AcrossData will be analyzed correctlyEnough subjects/specimens will be tested to lead to conclusive resultsLimitations are of minor concern onlyStudy can be accomplished in requested time

OrganizationNo one organization fits all proposalsTry to organize in logical sequence of Specific Aims and corresponding experiments

OutlineStart with an outlineD. RESEARCH DESIGN AND METHODS D1. OverviewFlowchartBrief description D2. Aim 1RationaleDesign

AudienceWrite for reviewers and funding agency staff

AudienceReviewers are informed readers but not necessarily experts in your specific area Funding agency (NIH) personnel want to know health impact Keep in mind that you need to be very clear and you need to emphasize health significance throughout

OrganizationConsider giving overview at start of entire sectionDescribe overall approach that will be used to achieve aimsConsider using flowchart or table

Example of Chart

microPET/CTExperimentalCol2.3tk+/+EGR-1-/-ControlCol2.3tk+/+EGR-1+/+Col2.3tk+/+EGR-1-/-Ex-vivo analysisQCT, HMM, QAR, IHCAim 2Aim 3Part 1Part 2Aim 1Mayer-KuckukX

For Each Specific AimReiteration of Research QuestionRationaleDesign, ApproachMethodsAnticipated Results, InterpretationDifficulties, Limitations, Alternative approaches

Or could include section onDetailed Methodscommon to more thanone Specific Aimafter description of Aims

RationaleDirectly and succinctly reiterate why you are doing this Specific Aim

Design/ApproachBriefly describeDesign of studyChoice of specimensChoice of interventions/independent factors and outcome assessments

MeasurementsDescribe techniques and equipment for measuring all variablesUse illustrationsDemonstrate that measurements will be accurate, precise, sensitive, specific

Novel MethodsEmphasize what is new about your methodsPoint out advantages to using your proposed techniques over other approaches

Data AnalysisDescribe approach for data analysis in detail

Raw DataConclusions & InterpretationAnalysis should notbe Black Box

Data AnalysisIf using analytic statistics, specifyStatistical parameters and testsAssumptions of testsAlpha level

Alpha = probability of falsely rejecting null hypothesisReference if statistical approach is not well known

Power AnalysisRemember that you need to determineHow many specimens are needed to have a certain probability of detecting an effect?

Keep in Mind...Goal is to demonstrate that enough data will be collected to support analysisStraightforward procedureBut is ballpark approach

Number of Specimens in Research PlanState assumptions and methods used for power analysisSpecify primary outcome variableSpecify factor(s) or independent variable(s) of interest

Number of Specimens in Research PlanState proposed statistical test or interval estimation

Examples:Analysis of varianceLinear regressionNote that each test has specific formula for power/number of specimens

Number of Specimens in Research PlanGive alpha levelAlpha = probability of falsely rejecting null hypothesisGive beta level or powerBeta = probability of falsely accepting null hypothesisDescribe effect size

Effect Sizeto answer the question What are my chances of finding it?, the researcher needs to have some idea of how big it is

J CohenStatistical Power Analysis for the Behavioral Sciences

Effect SizeRatio of expected difference to measure of variabilityBased onPublished workPreliminary studiesEducated guess

Use an effect size of scientific or clinical importance

Number of SpecimensCalculate numberHand calculationComputer programs, e.g., nQuery, PASSIf using educated guess for effect size, determine number for several effect sizesAdjust for loss of laboratory animals if applicable

Expected Results and InterpretationRemember to discuss expected results and interpretation of analysisCollection ofinformationInterpretation ofresults to answer...Researchquestion Study design Analysis of findingsClose theloop

Theory = intellectual construct used to explain findingsHypothesis = derived predictions of theories

Studies often generate more questions than answers

LimitationsInclude segment on potential difficulties & limitations at one of following locationsUnder each Specific AimEnd of entire Research Design and Methods section As they occur in methodsUse limitations to point to future studies

TimetableInclude timeline or timetable at end of Research Design and MethodsGive enough detail for evaluationMake certain it is reasonable

YEAR 1

YEAR 2

YEAR 3

Aim 1

Part A

Part B

Aim 2

Part A

Part B

EndingClose Research Design and Methods with overall statement about significance of studies Be enthusiastic

Tips on Clarity and StyleMake appearance conducive to easy reading on paper and on screenNeatWhite space11-12 point font

Tips on Clarity and StyleProofread Make figures, tables, and legends legible

LengthStick to page length recommendationsRO1:

Research Plan must be Research Design/Methods:13-15

Informative WritingTarget readers understandingInform the readerExplain what is difficult to understandSay only what needs to be said

AvoidOverly ambitious research plansContingent Specific AimsComplex, emerging techniques without establishing familiarity or including expertToo little detail on data analysisUnder-powered studies

Summary: Successful Research Design and MethodsBright ideaWell developed and clearly described methodsAppropriate data analysisLarge enough sample sizePlenty of time to do the workOnly minor limitationsClear pathway to strong conclusions

Took about 25 minutes

Theory = intellectual construct used to explain findingsHypothesis = derived predictions of theories

Studies often generate more questions than answers