First, I need to thank my dissertation chair, Dr. David Reitman, for his commitment and support during this challenging research endeavor. Thank you for your time, insight, and belief in me as I worked through this multiphase project. I would also like to thank my committee members, Dr. Ryan Black and Dr. Barry Nierenberg, for their guidance. Dr. Black, your enthusiasm for measure development is contagious, and I sincerely appreciate all the time you spent with me trying out new programs and running syntax. Aside from my dissertation committee, I would like to thank my family for their unwavering support. Kelly-although we are many states away, I am grateful that we were able to work through the stages of our dissertations simultaneously and experience the challenge together. Last but not least, I want to thank my husband, Dr. Kevin McCaffrey, for his incredible patience, encouragement, love and support. iv TABLE OF CONTENTS LIST OF FIGURES .
BackgroundAlthough the quality of life (QoL) plays an important role in treatment decision making and clinical management of mycosis fungoides (MF) or Sézary syndrome (SS) subtypes of cutaneous T-cell lymphomas (MF/SS-CTCLs), an MF- or SS-specific measure of QoL does not exist.ObjectiveThe objective of this research was to develop and validate the first QoL instrument for MF/SS-CTCL using a patient-centered approach.MethodsA conceptual framework for the MF/SS-CTCL QoL was developed through a literature review and interviews with key opinion leaders. Concept elicitation with patients was utilized to refine the conceptual model and generate preliminary items. The items were then revised based on qualitative and quantitative feedback obtained through cognitive debriefing surveys and interviews with patients. Next, participants (N=126) completed the preliminary MF/SS-CTCL QoL and a comparator measure of health-related QoL (Skindex-29) through the PatientsLikeMe Open Research Exchange. The MF/SS-CTCL QoL was completed again 5 days later by 66 participants for the purposes of evaluating test-retest reliability. The MF/SS-CTCL QoL was finalized based on results from an empirical evaluation, which included both classical and modern test theory approaches. Specifically, this included evaluation of (1) the optimal item response theory measurement model; (2) item fit; (3) unidimensionality; (4) rating scale performance; (5) reliability; (6) test information (precision); (7) person-to-item map; (8) convergent and discriminant validity; and (9) presence of bias via differential item function.ResultsResults from the comprehensive psychometric evaluation utilizing a Rasch-Grouped Rating Scale model yielded a final 12-item instrument. The rating scale functioned as expected, and the instrument exhibited adequate person reliability (.87), good to excellent test-retest reliability (r=.89, P<.001), high levels of measurement precision, and good person-to-item targeting. The correlation between the MF/SS-CTCL QoL and the Skindex-29 (r=.852, P<.001) was significantly greater than the correlation between the MF/SS-CTCL QoL and syndrome stage (r=.260, P<.001), providing support for convergent and discriminant validity. Items did not show significant bias based on gender, age, or race. Rasch scores were converted to scaled scores with qualitative descriptive categories for ease of interpretation.ConclusionsEmpirical evaluation demonstrated strong evidence of excellent psychometric properties. Utilizing a patient-centered measure development approach ensures that this QoL instrument captures the information that is most meaningful and clinically relevant to patients.
These results provide strong preliminary support for the SOAPP-8 as a brief screening tool of aberrant opioid-related behavior in chronic pain patients.
The purpose of this study was to develop and validate a computer adaptive testing (CAT) version of the Addiction Severity Index-Multimedia Version (ASI-MV®), the Addiction Severity CAT. This goal was accomplished in four steps. First, new candidate items for Addiction Severity CAT domains were evaluated after brainstorming sessions with experts in substance abuse treatment. Next, this new item bank was psychometrically evaluated on a large non-clinical (n =4419) and substance abuse treatment sample (n =845). Based on these results, final items were selected and calibrated for the creation of the Addiction Severity CAT algorithms. Once the algorithms were developed for the entire assessment, a fully functioning prototype of an Addiction Severity CAT was created. CAT simulations were conducted and optimal termination criteria were selected for the Addiction Severity CAT algorithms. Finally, construct validity of the CAT algorithms was evaluated by examining convergent/discriminant validity and sensitivity to change. The Addiction Severity CAT was determined to be valid, sensitive to change, and reliable. Further, the Addiction Severity CAT’s time of administration was found to be significantly less than the average time of administration for the ASI-MV composite scores. This study represents the initial validation of an IRT-based Addiction Severity CAT, and further exploration of the Addiction Severity CAT is needed.
This comprehensive qualitative and quantitative investigation is an important first step in developing patient-reported outcome performance measures that capture the aspects of health care that are most important and relevant for patients. Limitations and future directions are discussed.
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