Biostatistics & Data Services

Biostatistics & Data Services

Biostatistics & Data Services offers a full range of statistical consulting services for all phases of a research project including the planning of the initial study, the design of experiments and the consideration of sample size and power analysis. Statistical modeling, data analysis and statistical interpretation further help investigators efficiently gather the information needed to develop valid conclusions. This division is also equipped to offer services for acquiring, collecting and maintaining data for registries and select research projects.

Working with investigators from many different disciplines and different levels of experience, we have provided statistical consultation or have collaborated on projects in a number of areas that include the following:

• Adult Critical Care
• Basic science laboratories
• Cardiology
• Chaplaincy Service
• Charles Warren Fairbanks Center for Medical Ethics
• Medical quality
• Emergency department
• Gastroenterology
• Human Resources
• Neurophysiology
• Neurosurgery
• Nursing quality
• OBGYN (Methodist)
• Orthopedics
• Peds - Neonatology
• Pharmacy
• Radiation Oncology
• Transplant
• Urogynecology
• Urology

For further information, please contact Colin Terry (317.962.2045).

Statistical Consulting

There are many common challenges in designing and performing research experiments and questions surrounding statistical issues are usually plentiful. MRI offers statistical expertise to investigators at IU Health who are involved in a wide variety of projects.

From laboratory experiments to clinical trials, the use of statistics in medical research is ever present. Whether being used in a simple descriptive manner or to evaluate complicated mathematical models, statistics are often needed to help answer scientific questions. In general, most research studies consist of collecting data from a sample of the target population and making inferences about the population based on the findings in the sample. Although there are many specific uses for statistical theory in these research projects, statistics play two main roles in the experimental process:

Planning stage – The focus is on the design of the experiments, which is essential to produce any type of meaningful result. Many experiments or research projects take a turn for the worse before any data are even collected. A poor study design can doom a research project from the onset. Ensuring that necessary data are collected using proper methods is a key step in building a quality study. Too often data are collected without regard to the research question, only to find that the information gathered is insufficient for drawing meaningful conclusions. This insufficiency may be in the type of information collected or in the amount collected. Attention must be given to the amount of data needed in order to have a reasonable chance of detecting the hypothesized differences.

Data analysis – Appropriate model-building techniques, computation, and interpretation of results are of paramount importance when answering the research question. Once an experiment is completed and all information has been gathered, statistical analysis is often required. With the advancement of software packages, it is possible for almost anybody to perform statistical tests. Unfortunately, this also affords the opportunity for misuse and abuse of statistics. Understanding the underlying assumptions and statistical theory behind these models and tests is of great importance when making inferences based on the results. Many commonly used concepts, such as confidence intervals, power and P-values are often misunderstood, leading to misstated conclusions.

Collaboration or consultation with a statistician at all stages of the research process will be beneficial to the project and will aid in avoiding common pitfalls, helping the project to move along more efficiently. So, are you wondering which of your outcome variables might best capture the desired information? How your data should be analyzed? How many subjects will be needed for your study to have adequate power? What statistical information is needed for your IRB submission? These are just a few examples of issues that statistical consulting can help answer.

To discuss your project, please contact Colin Terry (317.962.2045).

Data Registry Management

The Research Data and Information Coordinator administers and coordinates several large data registries and research studies. Services encompass all aspects of projects, from submitting the protocol to the Institutional Review Board (IRB) to securing subject consent and collecting and processing all necessary study data. Current projects underway include the following:

1. Medtronic Product Surveillance Registry: IU Health Enterprise Clinical Research Operations participates in the Cardiac Rhythm Disorders arm as well as the Deep Brain Stimulation (DBS) arm (mainly for Parkinson’s Disease and Essential Tremor) of this standard of care registry. Any patient who receives a qualifying Medtronic device is eligible to be followed. Under the cardiac umbrella, these are patients with pacemakers, ICDs, and biventricular devices with implanted leads that bear a qualifying model number. Cardiac patients are eligible for participation for the first 30 days after their implantation procedure. However, DBS patients are given the opportunity to participate in the registry the morning of surgery. A short questionnaire will also be administered at this time. Follow-up questionnaires are worked into the follow-up appointments in clinic. There are no questionnaires for cardiac patients. The purpose of the registry is to continue with evaluating and reporting Medtronic product safety and effectiveness.
2. National Biological Sample and Data Repository for Pulmonary Arterial Hypertension: This NIH-sponsored registry is for patients who meet the criteria of World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH). To qualify for the registry, a patient’s right heart catheterization measurements need to be within a specific range. Qualifying patients are consented during pulmonology appointments, and those who choose to participate have their blood drawn and analyzed. This is an observational study with multiple objectives: 1) to characterize the demographics and clinical course of patients with WHO group 1 pulmonary arterial hypertension, 2) to evaluate the differences in patient outcomes within WHO group 1 subgroups, 3) to compare outcomes among patients who do and do not meet traditional criteria for establishing the diagnosis of PAH, and 4) to identify clinical predictors of the long- and short-term outcomes.
3. Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support): This project follows patients who receive FDA-approved ventricular assist devices (VADs). The intent of this national observational study is to raise the standard of care for heart failure patients by following their continued clinical treatment, quality of life measures, and neurocognitive testing results during their hospital stay and routine follow-up visits.

To discuss your data registry project, please contact Colin Terry (317.962.2045).