PATIENT-REPORTED MEASURES OF VASO OCCLUSIVE CRISIS OUTCOMES - GRADING THE LITERATURE
Author(s)
Rajpura JR1, Thomas J1, Shafer F2, Sivamurthy K2, Vendetti NJ3
1Purdue University, West Lafayette, IN, USA, 2Pfizer, Inc., Collegeville, PA, USA, 3Pfizer Inc., Collegeville, PA, USA
OBJECTIVES: Patient-reported measures of Vaso Occlusive Crisis (VOC) outcomes reported in literature were identified and quality of evidence for each type of measure was assessed. METHODS: PubMed, COCHRANE and CINAHL databases (1966 through August 2012) and reference lists of identified articles were searched for any patient-reported measures employed to assess VOC outcomes. Identified measures were categorized as: measures assessing pain, and measures assessing quality of life (QoL) due to VOC. Studies were assessed for quality of evidence based on risk of bias (coded ‘1’ for randomized controlled study without any serious limitations, else ‘0’), consistency (coded ‘1’ for demonstrated clinical and methodological homogeneity, else ‘0’), directness (coded ‘1’ for use of non-surrogate endpoint, else ‘0’) and precision (coded ‘1’ if total number of cases across all studies of measure was greater than 400, else ‘0’). Overall quality of evidence was calculated by summation of each domain score, where ‘4’ meant ‘high,’ ‘3,’ ‘moderate,’ ‘2,’ ‘low’ and scores less than or equal to ‘1’ denoted ‘very low’ quality of evidence. RESULTS: A total of 1,620 potentially relevant studies were identified and reviewed. Of those, 63 studies passed inclusion criteria and were retained for analyses. Twenty-three unique patient-reported measures of VOC outcomes were identified and categorized. Fifty-seven studies employed pain based measures and 12 studies employed QoL based measures. While, overall mean quality of evidence score was 2.17, mean quality of evidence score for pain based measures was 2.35 and for QoL based measures was 1.42. The most commonly employed pain based measures were Visual Analog Scales (VAS), (28 studies), whereas, the most commonly employed QoL based measure was school/work attendance, (4 studies). CONCLUSIONS: A variety of patient-reported measures of VOC outcomes were identified and categorized. VAS, and face based scales had higher quality of evidence compared to measure of school/work attendance.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PSY46
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Rare and Orphan Diseases