LI Course
CE Hours: 3 contact hours

Partnership: None

Statement of Purpose and Institute Overview: The purpose of this institute is to present the mechanisms needed to design and implement a successful longitudinal health survey research study that uniquely combines health-related quality of life (HRQL) data with ongoing clinical data. Based on our experiences with our longitudinal HRQL cardiac surgery patients, we will address the challenges this type of study pose and ways to overcome them. HRQL data, in general, is captured at a few time points – ideally one before an intervention and then at some point(s) post intervention. Much of the HRQL literature is reported from studies that were not prospectively designed and is merely a retrospective analysis; even if prospectively designed it is often flawed. Frequently the data collection time points are loosely defined and the other data collected, to be used to make associations with the HRQL data, is lacking. We will outline the key elements in prospectively designing health survey studies that enable you to evaluate appropriate outcomes. The use of demographic and clinical data are important when discussing HRQL results as patient characteristics and subsequent clinical events may impact HRQL. The collection of clinical data longitudinally is ideal and very rare in HRQL studies. We will discuss the challenges in collecting repeated clinical information and provide some insight into this process and options to consider. One area of importance in longitudinal research is the management of the data. Techniques in managing repeated data elements and maintaining high data integrity will be addressed. Other topics such as the resources necessary and available to carry out a longitudinal study, the accessibility of the population to be studied, and the importance of maximizing the response rate to the surveys over time will be addressed. Maintaining a high response rate at the subsequent time points is vital to the success and reporting of the study results. Our institution began our present HRQL study in September 2005. To date, implementing our new design, we have enrolled over 600 patients who have undergone an open-heart cardiac procedure. Our overall response rate across all time points averages around 78%. We will also address the personnel and space requirements that are needed initially as well as the challenges faced with program growth. Presently, our research team includes: a medical director, a research administrator, a clinical research administrator, a database administrator, and a biostatistician. As our program grows, we are finding a need for more personnel.

Session Objectives: #1: Upon completion of this course, the participant will be able to list and discuss the essential elements involved in designing and implementing an intensive longitudinal study that combines clinical and health survey data. #2: Upon completion of this course, the participant will be able to discuss the challenges and limitations in data collection and management of a longitudinal study that combines clinical and health survey data. #3: Upon completion of this course, the participant will demonstrate an understanding of the processes necessary to develop and implement a survey based longitudinal study.

CE Credits: CME, Health Education (CHES), Nursing