HMRI

CReDITSS

Clinical Research Design, Information Technology and Statistical Support

>> CReDITSS Staff Profiles

 

SERVICES

We aim to provide comprehensive epidemiological and statistical support to biomedical researchers.


Grant applications

We encourage researchers to contact us at the initial stage of grant applications for help with:

  • Study design
  • Choice of instruments
  • IT needs, e.g. web-based randomisation and data capture, web-based educational tools etc
  • Statistical analysis plans
  • Sample size calculation


PhD project planning

We encourage students to get advice on design and analysis at the planning stage of their project. Students are generally expected to run their own analyses, but CReDITSS provides a package for guidance and advice (see fee structure below).


Data Analysis

We also provide data analysis services under a flexible model.  We can provide advice and guidance if staff and researchers want to perform the analysis themselves with the oversight of a statistician, or we can perform the analysis ourselves according to a statistical analysis plan (derived in consultation with the researchers) and provide a full report.  This also includes helping with the drafting of the manuscript and responding to reviewers.


Data Storage and Integrity 

In the event that we perform the analysis we also provide a repository of data in case of future queries, i.e. the original dataset, cleaned dataset, syntax and command files, are all saved in case any questions of data integrity or version control are raised in the future.  All files are on a password protected server in HMRI with regular backup.


Randomisation 

Our IT unit provides a web-based randomisation service with the option of web-based data entry that can be customised to suit the needs of each project.  This can handle varying block sizes, stratification, and minimisation.  (See IT section)

 

AREAS OF ACTIVITY

The last few years has seen many methodological innovations in epidemiological and statistical methods. The CReDITSS Unit offers help in the following areas:

Directed acyclic graphs to help identify sources of confounding; this includes both cross-sectional designs and longitudinal designs with time varying confounders.

Various statistical techniques:

  • t-tests /chi square tests/ANOVA (or non parametric equivalent)
  • linear regression
  • logistic regression/ discriminant analysis
  • Poisson/negative binomial regression
  • survival analysis
  • exploratory factor analysis
  • dependent/correlated data such as longitudinal or clustered (modelled with mixed models or GEEs)
  • meta-analysis/regression
  • competing risk survival analysis
  • predictive modelling with internal validation
  • structural equation modelling
  • latent class analysis/regression
  • linked data
  • Bayesian analysis
  • Mediation analysis, calculating direct and indirect effects, using marginal structural models

treatment of missing data, e.g. multiple imputation, pattern mixture models

Genome-wide association studies, including imputation to HapMap and 1000 Genomes, and principal components analysis for control of population stratification


WHO WE CAN HELP

The support services are accessible to all researchers, registrars, and Staff of the University of Newcastle, Hunter New England Local Health District, and HMRI.  In all these cases, an initial consultation of 1 hour is free.  In addition, support for grant applications is also provided free on the understanding that a budget for statistical analysis will be included in the grant, and if successful, the work will be brought to the unit.  Further work is charged at rates described below.

The unit will also undertake epidemiological and statistical support for biomedical researchers external to the University of Newcastle, the Hunter New England Local Health District, or HMRI, although this is at a different fee structure.

 

FEE STRUCTURE AND WHY WE HAVE TO CHARGE

The unit does not receive any infrastructure funding from the University of Newcastle or the Hunter New England Local Health District.  It is run by HMRI as a not-for-profit service to the research community.  Fees entirely cover the salaries of the statisticians working in the unit.

Internal clients

  • PhD student advice: A package is available that includes 2 hours of a senior statistician for design/analysis advice, and 6 hours of statistician time for practical advice (e.g. commands, syntax help etc) for $500. This has been approved by the University to be paid from annual RTS allowance
  • statistical analysis for ad hoc projects: $105/hour

For those with multiple projects and multiple statistical analyses, it is also possible to buy ongoing statistical support for the year:

  • one day/week of statistician time: $90/hour
  • two days/week of statistician time: $70/hour

External Clients

  • Statistical analysis for ad hoc projects: $150/hour
  • Ongoing statistical support at one or 2 days/week will need to be negotiated with the unit


HOW WE WORK AND HOW TO BOOK AN APPOINTMENT

Making an appointment

The unit’s business manager, Michelle Gillam, is the first point of contact. She will book a time for the initial consultation.  She can be reached at: michelle.gillam@hmri.com.au or +61 2 4042 0500.

Initial consultation

  • It is a good idea to come prepared with a clear idea of your aims, hypotheses, primary outcomes, and budget.
  • The researchers meet with the senior epidemiologist, or one of the senior statisticians, or both, to discuss the project, the main research questions and to put together the outline of the statistical analysis plan.
  • Based on that plan, a written quote is put together with the main analyses discussed and an estimate of the amount of time anticipated to deliver each analysis.
  • This quote is sent to the researcher for verification and if confirmed, the project is assigned to a statistician in the unit.
  • Depending on the workload of the unit there may be varying timelines for the delivery of the results and this will be discussed with the researchers.

Results

  • Statistical analyses are written up in a report that includes the methods, the results, and an interpretation. We will routinely meet with researchers to take them through the results face-to-face and answer any questions.
  • There is some leeway to modify and clarify various analyses but new directions and new analyses will need to be costed and quoted separately.

Publication

The quote includes time to provide feedback on the manuscript, assist in writing up the statistical methods, results and discussion, and respond to reviewers.

Authorship

We subscribe to the authorship guide suggested by the International Committee of Medical Journal Editors (ICMJE). The ICMJE recommends that authorship be based on the following 4 criteria:

  • Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
  • Drafting the work or revising it critically for important intellectual content; AND
  • Final approval of the version to be published; AND
  • Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Where these criteria are met we expect that unit staff will be included as authors on any publications resulting from their analyses and input

 

STATISTICAL PACKAGES USED

Statistical software used in the unit includes: Stata, SAS, JMP, R, and WinBUGS.

The unit does not routinely use SPSS and GraphPad so support for these packages is limited.

 

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