James J. Irrgang, PhD, PT, ATC
The Department of Orthopaedic Surgery works with University of Pittsburgh Medical Center on a number of clinical research projects.
The mission for clinical research within the Department of Orthopaedic Surgery is to support and conduct research involving patients that shapes the future of evidence-based orthopaedic practice. This includes support of clinically relevant research involving patients to answer questions related to the usefulness of examination procedures and diagnostic tests, the effectiveness, efficacy and safety of surgery and other therapeutic interventions and the power of prognostic indicators.
Goals and Objectives
- Establish an infrastructure to support clinical research
- Seek industry, foundation and federal funding to support clinical research
- Collaborate with basic scientists to enhance translational research
- Provide advice and support related to research design and data analysis
- Educate and mentor fellows, residents and students
- Perform scientific and risk management review
- Ensure compliance with all regulations governing clinical research
An important priority within the Department of Orthopaedic Surgery is the development of an infrastructure to support clinical research. This includes establishment of a research registry, development of a computerized clinical data repository and personnel to support clinical research activities.
Computerized Clinical Data Repository
To capitalize on the large clinical practice within the Department of Orthopaedic Surgery, the department is committed to development of a computerized clinical data repository. This system allows for collection of clinical outcomes data as part of routine clinical practice. The computerized clinical data repository includes patient-reported data as well as data from the clinical examination and surgery. Patient-reported data includes a variety of validated questionnaires to determine how the patient’s condition affects his/her symptoms, activity, and participation in life situations. Additionally questions are administered to determine the patient’s chief complaint, history of current injury and past medical history, all of which may influence the clinical outcome. The patient-reported data is immediately summarized and available to the surgeon for use during the clinical encounter.
To facilitate collection of patient-reported data, the Department of Orthopaedic Surgery is in the process of implementing an Internet based patient-intake data collection system that was developed by Magee Women’s Hospital. This system allows patients to provide information concerning their condition using a touch screen laptop computer that is wirelessly connected to a local server or by logging into a secure Web site from home or work. A computerized collection of patient-reported information while the patient is in the clinic takes advantage of unutilized patient time, helps to increase operational efficiency, and provides the physician and patient with an instantaneous summary of the patient’s status. To enhance follow-up, patients will be able to log on to a secure Web site to provide updated information concerning their condition.
In addition to patient-reported data, the computerized clinical data repository includes information from the clinical examination, such as range of motion and laxity, as well as surgical findings and procedures. Clinical data, including findings from the physical examination as well as surgical findings and procedures, are input directly into the system using computers located in the examination room and surgical suite.
Data will be entered into the computerized clinical data repository longitudinally over the episode of care including before surgery and during the course of recovery. Annual or biannual data will be collected to provide long-term follow-up for select diagnoses and/or surgical procedures. Condition-time- and/or protocol-specific algorithms will be used to determine the data that need to be collected and/or updated at any given encounter. The system is also be able to accommodate algorithms to administer unique questions based upon responses to prior questions. As a result of this, the data collection process will be tailored to the unique responses from the patient or clinician, which improves efficiency of data capture. These algorithms will be easily adjustable to tailor the data collection process to unique clinical populations within the Department. In the future, the clinical data repository will be integrated with the UPMC electronic medical record.
The computerized clinical data repository will be designed to meet all HIPAA regulations. As such, each patient will be assigned a unique identification number that allows linking of data from multiple encounters and all data will be encrypted when transmitted over the Internet. To permit use of clinical data for research purposes, patients will be enrolled in an IRB approved research registry. Enrollment of patients into the research registry will permit use of the patients’ clinical data for research purposes and will permit researchers to contact and invite patients to participate in future clinical research based upon knowledge of the patients’ protected health information.
Development and implementation of the computerized clinical data repository will provide a rich data source for future clinical research. This research may address questions related to accuracy of physical examination or diagnostic procedures, outcomes of specific surgical interventions, or prognostic factors that influence clinical outcome. The data will also be used to generate hypotheses for future research studies, to provide preliminary work for funding applications and to provide clinical research training opportunities for junior faculty, fellows, residents and students. To be compliant with all federal and institutional regulations, all research involving use of data from the clinical outcomes data collection system will require prior approval from the University of Pittsburgh Internal Review Board.