Biostatistics and Research Design Center | Overview
Mission
The mission of the BARD Center is to promote excellence in the design and analysis of research studies at Boston Children’s Hospital. The ICCTR BARD Center provides biostatistical and methodological expertise, as well as scientific leadership through collaborative relationships with Boston Children’s investigators. The Center also provides educational offerings in a variety of areas. In the following sections of this site, we provide information on the BARD center services, external database resources, education, frequently asked questions as well as staff profiles.
Our group includes PhD and masters-level staff with experience in the design and analysis of a wide range of research studies, including basic research studies, observational and randomized studies, and survey research, qualitative evaluations, and high dimensional functional neuroimaging studies.
BARD services include:
- Full biostatistical project support, tailored to your study and resources
- Long-term collaborations with our faculty researchers
- Study design and grant preparation
- Short term consultations with our staff
For further information, please contact:
Dr. Edie Weller, Center Director
Dr. Michael Monuteaux, Center Assistant Director
BARD Center Services
The Biostatistics and Research Design (BARD) Center faculty and staff can collaborate with investigators on:
Protocol development/Grant preparation
We can ensure that the study objectives, specific aims, and endpoints are well defined, measurable and feasible and advise on appropriate design and methods. Members can write sections related to research aims, data collection and data management methods, registration and randomization, sample size and power, statistical analysis methods and interim monitoring.
Study Design and Planning
We provide advice on the most efficient, valid, and feasible study design (eg., cohort, case control, prospective, retrospective, cross sectional, randomized clinical trial, etc.) as well as advice on:
- Appropriate selection of the sample from the target population
- Choice of Control Group(s)
- Strategies for Recruitment and Retention
- Data Collection Methods
- Database Design
In addition, we provide guidance on design issues that are unique to the following methodologies:
- Qualitative Studies (use of focus groups, semi-structured or cognitive interviews)
- Survey Research, including instrument creation/validation and sampling and data collection methods (e.g., in-person or telephone interviews, mail surveys, web surveys)
Randomization
We generate randomization schemes and assignments for single- and double-blind studies. Members work in conjunction with the Research Pharmacy for the implementation of investigator-initiated randomized trials.
Data analysis
We analyze study data, provide interpretation of statistical analysis results, including interpretation of previously published results as well as results of ongoing analyses. This includes guidance on and development of:
- Statistical graphics and tabular displays of data
- Interim or final data analyses
- Data and safety monitoring board reports
In addition, we provide support for analysis issues that are unique to:
- Qualitative studies (advice on how to analyze qualitative data including transcribing and coding of focus groups and interviews)
- Survey research (data analysis from complex survey design, including the use of post-survey adjustments and post-stratification weights)
Manuscript preparation
We can contribute to the writing of manuscripts for submission to peer-reviewed scientific journals and prepare abstracts and presentations for scientific meetings.
WebPortal Program
The Web-Portal Program was developed by Research Computing (RC) and the Biostatistics and Research Design (BARD) Center to support multi-center studies. This program has two components- an external facing website and web-based file management system. The external facing website using a Wix-based framework. It can be used to advertise a study and to interface with a password-protected file management system. The web-based file management system with user authentication provides an effective way to manage multi-center studies. It provides a platform to communicate and distribute necessary information to sties. We provide a recommended set of trial folders that users can modify to support their specific needs.
Please complete the web portal form if you are interested in more information about this service. If you have any issues with the form, you can contact ICCTR@childrens.harvard.edu.
External Databases
The external database resource was developed by the Biostatistics and Research Design (BARD) Center with the goal of informing BCH investigators about external data resources available to conduct their research. It provides valuable information about the data included in each database or repository, and how to access and the cost of access. This resource includes information on databases such as the Ambulatory Health Care Data National Health Interview Study, Healthcare Cost & Utilization Project, Youth Risk Behavior Surveillance System, and the WHO Mortality Database.
BCH employees can go to the BCH internal website to view the external database resource information. Further detailed information on each resource is provided after the overview table. This includes information on the respondents (age and classification), data type (diagnoses, administrative, billing, survey), years that the data are collected, the purpose and scope and potential challenges/limitations as well as information on database/repository redesign.
Education
The Biostatistics and Research Design (BARD) Center offers educational opportunities for Boston Children's researchers on statistical design and analysis considerations for research studies. We also offer workshops on the use of statistical packages for data management and reporting. The objective of the BARD Educational Program is to impart a practical, conceptual understanding of the content we teach. Specifically, in each course we strive to achieve the following learning objectives:
- An understanding of the purpose/intent of the method
- An understanding of when/under what circumstances the method is applicable
- An ability to interpret the method’s results, in context
- An ability to critically evaluate the scientific literature where the method is used
- An ability to use the method with guidance from a biostatistician, when appropriate
Educational program offerings
The following table provides a description of the BARD Educational Offerings. BCH employees can register for a course or view our video educational library on the BCH internal website. We also encourage researchers to explore the Harvard Catalyst educational opportunities. Contact icctr-education@childrens.harvard.edu with any questions.
| Course Title | Course Description |
|---|---|
| General | |
| How to Work with a Biostatistician | Basic principles of working with a biostatistician. |
| Design Series | |
| Case Series and Case-Control Studies | Design and implementation of case series and case-control studies in the context of specific biomedical examples. |
| Clinical Trials | In this course, an introduction to clinical trials will be offered in 3 parts dedicated to discussing the statistical aspects of phase I, II and III trials. |
| Cross-Sectional and Cohort Studies | Practical overview of cross-sectional and cohort study designs using examples drawn from pediatric clinical research |
| Design Makes a Difference: Choosing the Right Design for Your Research Question | Concepts essential for writing a grant proposal/protocol; communicating results; and appraising others’ work. |
| Power and How to Get It: Sample Size and Detectable Effects | Justifying the design and sample size for grants/protocols; assessing power and communicating key issues. |
| Survey Research: Design, Implementation and Analysis | Design, implementation, and analysis of survey research in pediatrics. |
| Analysis Series | |
| Data Visualization and Basic Statistical Testing | Basic principles of biostatistics. Related course -Data Management and Reporting in SPSS. |
| Linear Regression | Concepts and examples of linear regression analysis. |
| Logistic Regression | Examples and interpretation of logistic regression analysis. |
| Longitudinal Analysis | Examples and interpretation of longitudinal analysis. |
| Survival Analysis | Survival analysis - what is it and why is it different? |
| Special Topics | |
| Data management and reporting in SPSS | Introduction to the statistical software package SPSS. Related course- Data Visualization and Basic Statistical Testing. |
| Economic Evaluation Methods | Principles of economic evaluations of health care interventions; measurement/ analysis of economic outcomes. |
| Inter-rater Reliability Studies | Analysis of studies with multiple raters to determine reliability. |
| Introduction to STATA | Introduction to the statistical software package STATA and how it can be used in clinical research |
| Qualitative Methods | Introduction to qualitative research for use in pediatrics research. |
| Statistical Considerations for Laboratory Researchers | Design and analysis issues relevant for pre-clinical research (for example, cell lines, in-vitro, in-vivo) |
| Survey Validation Methodology | Item development, instrument and scale construction and the psychometric properties of a survey instrument. |
| The Fuss About P Values | P-values and hypothesis testing, the go-to technique for statistical inference in all branches of science for nearly a century, have nonetheless been under constant attack ever since they were introduced. The controversy is as hot as ever today. This single-session course will review the issues, survey alternatives, and provide guidance for everyday practice. |
Frequently asked questions
Who can request help?
Any faculty or trainee at BCH is eligible to request our help. Clinical, preclinical, or translation research studies are all eligible.
When should I consult with a biostatistician?
As early in the planning stages of your study as possible!
How can I access services?
Use the following flow chart to determine how to access services or fill out an online support request.
How does 'funded support' work?
- "Funded support" is required if the investigator needs more help than a one-hour consult can provide.
- A BARD Center team member and Investigator determine the number of hours/effort needed.
- Budget and scope of work are created and approved by ICCTR and Investigator.
Please note:
- Rates vary according to expertise and experience.
- Funding is not required if the work is for an extramural grant application that budgets support for the BARD staff member (as co-investigator, or key personnel).
- Trainees (e.g. residents and fellows) with research scholarship requirements can receive 20 hours of support for a discounted rate if BARD Center Members have availability.
How to do I prepare for a consult with a BARD Center member?
- Have your study aims/hypotheses finalized.
- If possible, explore funding resources in case you require additional support beyond the consult.
- Consider whether the degree of collaboration you require with the BARD Center member may entail authorship on the resulting academic product.
How soon after I submit a request can I expect a response?
Someone from the BARD Center will contact you within 10 business days to discuss your request.