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Introduction


The primary aim of the Biostatistics Unit is to provide comprehensive, flexible and timely statistical support tailored to the ongoing needs of researchers at the Centre for Evaluation of Medicines (CEM), at St. Joseph's Healthcare Hamilton, and at the Faculty of Health Sciences at McMaster University.

The Biostatistics Unit aims to provide continuous help with routine and state-of-the-art statistical methods at various stages of the research process: planning, implementation, analysis and reporting. 







Research Priorities


    The specific aims of the Unit include:
  1. Provision of statistical consulting services to researchers at the Centre for Evaluation of Medicines, St. Joseph's Healthcare, and the Faculty of Health Sciences at McMaster University, including:
         ♦  Help with study planning
         ♦  Guidance with data collection methods
         ♦  Assistance with data analysis and interpretation of results, and
         ♦  Help with report writing and manuscript preparation

    2. Assistance to promote appropriate practice and application of statistical methods in healthcare research

    3. Provision of statistical support to researchers through collaboration on preparation of grant proposals and guidance on research plans and   
      methodologies

  4. Assistance to enhance proper and ethical application of statistical techniques through participation in reviews of Research Ethics Board  
      submissions

    5. Increasing the awareness of the utility of statistical methods in both healthcare research and teaching



Research Goals


   ♦ To support the research goals and objectives of CEM and HEI (formerly CE&B) through collaborative participation in research projects 
           taking place at CEM and HEI (formerly CE&B)

      ♦  To support the research goals of St. Joseph's Healthcare through collaborative efforts at St. Joseph's Healthcare Hamilton as well as
          projects taking place in other research hospitals that make up the Hamilton Health Sciences

     ♦   To support the research activities at St. Joseph's Healthcare through collaborative efforts in projects taking place at St. Joseph's 
          Healthcare Hamilton or by providing statistical support/advice as may be required or requested by various researchers within St. Joseph's 
          Healthcare Hamilton

     ♦  To continue to participate in the activities of the Research Ethics Board of St. Joseph's Healthcare Hamilton. We are currently working on
         a research proposal to investigate, through documentation, various statistical issues that arise in REB submissions. The goal is to identify
         common problems and then establish an education program to help investigators avoid these problems

     ♦  To continue contribute clinical trial or statistical methodology development through independent  research

  ♦ To present research findings at professional meetings and at CEM and HEI (formerly CE&B) rounds

     ♦  To continue to foster connections with researchers from other institutions nationally and internationally



Education


Education forms an integral part of our mandate as a unit within an academic institution. Dr. Thabane is a member of the Department of Health Research Methods, Evidence and Impact (Formerly the Department of Clinical Epidemiology and Biostatistics), which is the parent department for the Faculty at the Centre for Evaluation of Medicines.
Specific education goals of the Unit include:
  1. Supporting the HRM Program through participation in teaching or supervision of graduate students
  2. Supporting the BHSc undergraduate program as instructors
  3. Offering short courses and workshops to researchers:
         ♦  Bayesian methods
         ♦  meta-analysis methods
         ♦  writing workshops
         ♦  statistical consulting
         ♦  multivariate statistical methods 



Services


The Biostatistics Unit provides a wide spectrum of services:




Research design to ensure the integrity of the research
protocol, including:



            ♦  guidance on preparation of grant proposals
            ♦  identification of the most efficient design and planning of research studies
            ♦  assistance with devising effective sampling strategies
            ♦  help with sample size determination and power calculations, and
            ♦  hypothesis development 




Internet-based randomization service through REDCap:



            ♦  Service available 24 hours a day, 7 days a week
            ♦  Methods of randomization available: 
            ♦  Unrestricted: simple randomization 
            ♦  Restricted: block randomization 
            ♦  Stratified randomization
            ♦  Examination of the distributional properties of the sequence prior to first allocation
            ♦  Full documentation provided 


  
Case Report Form (CRF) design and development:



           ♦  provide assistance designing the CRF
           ♦  develop and thoroughly test the CRF prior to use
           ♦  data base designed to accommodate data collected on the CRF 




Data management services:



            Data Entry

             ♦  completed forms are faxed to a secure computer at the Biostatistics Unit for data entry 
             ♦  faxed data forms can be received 24 hours a day, 7 days a week
             ♦  data entry usually takes place the next  business day
             ♦  data are entered while the original CRF remains at the clinical site (no postage costs, no CRFs get lost in transport, CRFs 
                 remain in a secure  location, photocopying of CRF is not necessary)

   Data Cleaning

          ♦  query resolution takes place while study is ongoing
          ♦  clean database ensured shortly after study completion
          ♦  periodic data management update reports are provided to investigator 


 
Data analysis using standard statistical techniques and powerful
state-of-the-art methods, including:



          ♦  advice on what software to use
          ♦  tabular and graphical representation of data
          ♦  analysis using routine and advanced statistical procedures
          ♦  examination of model assumptions through diagnostic tests 




Interpretation of results: interpretation of statistical analyses
to enhance communication of the results in a clear, meaningful way, including:



          ♦  clear descriptions of methods used to analyze the data
          ♦  detailed reporting of the analysis results
          ♦  assistance with report writing for granting agencies
          ♦  assistance with manuscript preparation 



Short courses and workshops: customized short courses and
workshops on various statistical topics, including:



           ♦  Bayesian methods
           ♦  meta-analysis methods
           ♦  writing workshops
           ♦  statistical consulting
           ♦  multivariate statistical methods