Contributions of change in clinical status parameters to Patient Global Impression of Change (PGIC) scores among persons with fibromyalgia treated with milnacipran
- 1 May 2010
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Pain
- Vol. 149 (2), 373-378
- https://doi.org/10.1016/j.pain.2010.02.043
Abstract
Clinical trials on the treatment of pain syndromes have adopted Patient Global Impression of Change (PGIC) as a primary outcome. However, little is known about how change in clinical status influences these ratings. The present study examined relationships between changes in pain, depressed mood, physical functioning, vitality, sleep disturbance, cognitive complaints, and PGIC ratings among 1260 participants with fibromyalgia (FM) who completed one of two trials examining the safety and efficacy of milnacipran. Many of the relationships between change in clinical status and PGIC ratings were stronger among persons who rated themselves as improved (responders) versus those reporting no change or a worsening of their condition (non-responders). Among non-responders, simultaneous regression analysis revealed that greater degrees of depressed mood and pain, and poorer physical function were significantly associated with worse PGIC ratings. Among responders, improvements in pain were significantly associated with better PGIC ratings, along with improvements in vitality, sleep, physical function, and cognitive complaints. These findings underscore the complexity of global ratings in FM patients, and suggest the association between clinical status and PGIC ratings varies as a function of perceived treatment response. Several domains were associated with PGIC ratings, highlighting the need to assess multiple outcomes in clinical trials of treatments for FM.Keywords
This publication has 29 references indexed in Scilit:
- Further validation of the Multidimensional Fatigue Inventory in a US adult population samplePopulation Health Metrics, 2009
- Milnacipran for the treatment of fibromyalgia in adults: A 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trialClinical Therapeutics, 2008
- Context Effects in Survey Ratings of Health, Symptoms, and SatisfactionMedical Care, 2008
- Precision of Health-Related Quality-of-Life Data Compared With Other Clinical MeasuresMayo Clinic Proceedings, 2007
- The PTPN22*C1858T functional polymorphism is associated with susceptibility to inflammatory polyarthritis but neither this nor other variants spanning the gene is associated with disease outcomeAnnals Of The Rheumatic Diseases, 2007
- SF-36 Health Survey UpdateSpine, 2000
- The multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigueJournal of Psychosomatic Research, 1995
- Development and validation of a multiple ability self-report questionnaireJournal of Clinical and Experimental Neuropsychology, 1994
- The american college of rheumatology 1990 criteria for the classification of fibromyalgiaArthritis & Rheumatism, 1990
- The Subjective Experience of Acute Pain An Assessment of the Utility of 10 IndicesThe Clinical Journal of Pain, 1989