Department of Pediatrics Process for Requesting Statistical Services Due to the large demand for statistical services, requests are being prioritized as follows in order to ensure service provision contributes to measurable outcomes for the Department of Pediatrics: 1) Consultation and analyses related to grant preparation; 2) Analysis of data from funded research for preparation of manuscripts/abstracts; 3) Assistance with unfunded projects All requests require initial consultation with Dr. Thabane. Prior to meeting with him, please provide the information outlined in the following pages, based on the nature of service you require. If your request is neither related to grant nor manuscript preparation, please complete the information to the best of your ability given the stage of your project. Should the request involve data analysis, Dr. Thabane will assign an analyst and set the priority. As always, Faculty members must attend all consultations with their trainees. Questions? Lindsay Akrong Research Services Specialist x 75821 lakrong@mcmaster.ca Meetings made by prior appointment with Dr. Thabane will be held in room HSC 3A72 on Thursdays ONLY. Emmy Cheng will be available in 3A72 on Mondays. Department of Pediatrics Service Request Form Instructions 1. Complete Statistical Services Request Form. ALL fields must be complete for your request to be processed. 2. Consultation with Dr. Thabane: E-mail (no phone calls, please) your Request Form to Rosemary Oliveira (rolivei@mcmaster.ca and lakrong@mcmaster.ca). Rosemary will respond with your appointment date/time. 3. Bring a hard copy of this Request Form, with appointment date and time recorded, to your appointment. Faculty must attend appointment with trainees. Faculty Information Faculty Member Name: Division: If related to trainee research project: Name of Trainee: Trainee Program: Statistical Services Is your research funded Do you require service for or unfunded grant preparation REB preparation manuscript/abstract preparation Other (explain): Please check off the service(s) you require and complete as much of the information on the following pages as possible Study design consult Sample size calculation Data collection protocol Database set-up Data verification and data entry Data analysis by analyst Review REB application for statistics plan Instruction in use of statistical software Interpretation of results Compiling statistics section of grant applications or manuscripts for publication Generation of figures/tables (for presentations/manuscripts) Other (please explain): OFFICE USE ONLY Date Request Received: Date of Appointment: Service completed at this appointment Service ongoing Summary of services provided Signature of Statistician/Analyst: Date: Meetings made by prior appointment with Dr. Thabane will be held in room HSC 3A72 on Thursdays ONLY. Emmy Cheng will be available in 3A72 on Mondays. Department of Pediatrics A. Consultation and analyses for GRANT application TITLE of PROJECT: PI: FUNDING AGENCY: DATE for SUBMISSION: For the items below provide a written summary: 1. Rationale (brief – 1-2 paragraphs) 2. Objectives and Hypotheses 3. Study design including inclusion and exclusion criteria 4. Primary and secondary outcomes 5. Outcome measures 6. Base (control) rate for the primary outcome, mean, standard deviation, anticipated magnitude of effect B. Statistical analysis plan for MANUSCRIPT or ABSTRACT preparation TITLE of PROJECT: SENIOR AUTHOR: FUNDING SOURCE for study: INTENDED JOURNAL(S) or MEETING for ABSTRACT SUBMISSION: DATE for SUBMISSION (if applicable): Project Information For the items below provide a written summary: 1. Rationale (brief – 1-2 paragraphs) 2. Objectives and Hypothesis 3. Study design including inclusion and exclusion criteria 4. Description of group(s) studied with sample sizes 5. Primary and secondary outcomes 6. Variable measurements 7. Definition of groups for analysis – such as shown to the right Statistical Analysis Plan Total # subjects screened # excluded # who met inclusion criteria # who did not complete study # who completed part of study # who completed full protocol Provide as much information as you can for the following and create mock tables or figures to demonstrate how you plan to present the data in the paper/abstract /poster. The attached Tables are provided as examples. 1. Variable definition table (see Table 1 for example): Create a table that shows each of the measurements, whether they need to be calculated from the data set, and whether or not they are categorical (if so then how they are to be categorized) 2. Descriptive Statistics (see Table 2): Provide measures for which you wish to have descriptive statistics to describe study group characteristics and/or demographics and provide a sample tables. Indicate any sub-group analysis to be done. 3. Univariate and or multivariate regression analysis (see example Table 3): If you plan to do univariate regression analysis then provide the dependent variable(s) and a list of all variables to be tested. 3 of 5 Department of Pediatrics Table Examples Table 1: Variable Definition Table (Cat* = categorical variable) Marital Status Variable None Calculation Units Cat* Ethnicity None Cat* Drink of alcoholic beverage Cat* Past month, > 5 drinks/day Smoking None None Cat* Cat* Education Household income None None Yr Cat* Physical activity - How active during leisure time? Mainly sedentary = 0 Mild exercise = 1 Moderate exercise = 2 Strenuous exercise = 3 Cat* Height Weight Birth date Date of visit Age None None =(date of visit) – (birth date) Categories Currently married Not married Hispanic South Asian East/S-E Asian African Aboriginal European Other Don’t Know Never, or < 1 drink/mo Once a month Once a week Between 4 and 6 times a week Everyday Yes/No Currently Formerly Never $ 0-50,000 ≥50,000 0 1 2 3 m kg Yr 4 of 5 Department of Pediatrics Table 2: Demographic characteristics of subjects by treatment group (Values are median (IQR)) Group A N (%) Group B N (%) Group C N (%) Total\Sample N (%) Characteristics Age (yr) Ethnicity (% subjects) European Hispanic South Asian Aboriginal Other Not known Smoking history, n (%) Never smoked Former smoker Smoked in last year (or at least in part) Education (# yr) Household income <50,000 >50,000 Marital status (%) Married/cohabiting Single Table 3 – Univariate analysis for Variable X (*Adjusted for pre-study BMI) Variables Unadjusted β (95% CI) Pr > |t| Adjusted* β (95% CI) Pr>[t] Current age in pregnancy (yr) Education (yr in school) Ethnicity – European vs other Income >=$50K vs <$50K Total Physical Activity 2 vs 0 Total Physical Activity 3 vs 0 Total Physical Activity>=4 vs 0 Former Smoker vs Never Current smoker vs Never 5 of 5