Preparing for your Research Project Christopher Kabir, MS PCOR Coordinator Department of Research July 21, 2016

Overview Focus on practical tips to think about before conducting your project: Generating research questions Hypothesis Testing Data Collection Analysis Consideration Presentation of Results

Garbage in, garbage out

Garbage in, garbage out Solution: Planning takes time and your proposal and IRB application should be viewed as helpful tools to promote good science. The more you rush, the more likely your project will fall short of meeting your goals

Getting Started where are the knowledge gaps?” Research is an iterative process… be patient and use a realistic study timeline based on your schedule and needs! Literature reviews will almost always be your starting point to any research project. “What’s been done and where are the knowledge gaps?”

Literature Review Take Away This is the most overlooked step There is much more to a study publication than the main results Look for methodologies, the sample population, and limitations If you see a trend between the studies, this is a sign that you should do a more in-depth lit review (consider a spreadsheet) A literature review can also be a study and publishable article! If you see a blatant lack of studies on the subject, this is a sign that this research area is novel

Hypothesis Testing There is a lot of emphasis around hypotheses, because this is the fulcrum of the modern scientific method. Check your hypothesis quality Compare it to other similar studies Ask the experts, your colleagues Outside the box: Search google, technical papers, clinicaltrials.gov, professional/ advocacy associations, conference abstracts!

Hypothesis Testing P What’s the population (exclusion/ inclusion It’s a thoughtful, evidence-based statement (not a question) P What’s the population (exclusion/ inclusion criteria)? I Is there a treatment or intervention that is of interest to study in relation to outcomes? C What groups are being compared? O What is the outcome measurement? Does anyone know what PICO is an acronym for?

Hypothesis Testing Use visual diagrams, equations, or table shells to look at your project from different angles -include the largest possible model to be considered and narrow down your questions -check your hypothesis for alignment with your research goal -define your outcomes, predictors, and confounders specifically and use references if possible

Hypothesis Testing Assessing its strength Is it novel, supported by research but not uniformly confirmed? Will results change current knowledge/ assumptions or medical practice? Is it feasible to conduct ethically and regarding resources and time dedication? Is it logical biologically? Does anyone know what PICO is an acronym for?

Hypothesis Testing Simplicity is necessary To assess the association/ effect of [independent variable] with/on [dependent variable] in [patient population] at [time frame] Does anyone know what PICO is an acronym for?

Sample size Magnitude of effect- what is the difference in outcome that indicates these two groups are truly different? How many patients are needed to enroll that will lead to a robust sample and confidence in findings? What is the statistical difference that will indicate clinical difference? Look for expert opinion, evidence from a literature review, or other data for an estimate Does anyone know what PICO is an acronym for?

Data Collection All variables need to be pre-defined in a data dictionary Collection begins after IRB approval Variable # var_name (no more than 9 characters, no punctuation) Variable definition (units of measurement) Coded values 1 ID Study subject ID 2 sex 0="male; 1="female" 3 race 0="white"; 1="black; 2="asian" 4 ethnicity 0="non-hispanic"; 1="hispanic" 5 dia_base baseline diastolic blood pressure 6 sys_base baseline systolic blood pressure 7 dia_final 6-month diastolic blood pressure 8 sys_final 6-month systolic blood pressure 9 age in years (continuous)

Data Collection Once collection starts, the biggest mistake made is not addressing the errors quickly and adequately! Collect original data points whenever possible Use coded values to reduce errors and increase efficiency

Analysis Descriptives Table 1: Patient Characteristics Necessary for every project, small or big Continuous variables are described as Mean/ Standard Deviation (normal distribution) Categorical variables (e.g., yes/no, race, gender) Number/ Percent Table 1: Patient Characteristics (N= ) Demographics   Age M (SD) Male Male number (%) Race White number (%) Black Asian Clinical Characteristics Vitamin D Deficient (<xx) Insufficient (xx-xx) Normal (>xx)

Analysis Inferential Chi-square test for independence Used to test differences of proportions between two groups Proportions are used for categorical variables, in which the numeric value has no significance (race, sex) 2x2 table Disease No Disease Exposure/risk #(%) No exposure/ risk

Analysis Inferential Student’s t-test Used to test differences of means between two groups Means are used for continuous variables, in which the numeric value has significance (age, test result, temperature) 2x2 table Disease No Disease Exposure/risk M(SD) No exposure/ risk

Analysis Take Away The best studies actually use a simple t-test Why? research uses a strong study design results are clearly interpretable

Planning checklist Start with the research outline, not the IRB application Develop your research objective Conduct your literature review Fine tune your hypothesis Establish your team and roles Write your protocol Submit application to Protocol Review Committee Submit application to IRB (use most recent versions available online)

Resources AHC Library http://aoapps.advocatehealth.com/libraryonline/Pages/Library-Network-Home.aspx Get an NCBI account to organize and store your references Compare literature in charts (PICO)

Resources Department of Research http://www.advocatehealth.com/research-support Methodology guidance Resource needs REDCap, Qualtrics Statistical support Sample size estimation Analysis plan Variable list

Resources AHC IRB Use new forms for each new project as forms update frequently: http://www.advocatehealth.com/forms2 FORMS NEEDED HRP-211 HRP-226 HRP-503 HRP-502 (consent form) IRB Fee Waiver Data Collection Tool Learn about the process http://www.advocatehealth.com/documents/IRB/Research_Study_Launch_Sequence_01-07-16.pdf Learn about the office http://www.advocatehealth.com/irb

If you have questions or need assistance please contact me. Thank you! If you have questions or need assistance please contact me. Christopher.kabir@advocatehealth.com