Use of patient-reported global assessment measures in clinical trials of chronic pain treatments: ACTTION systematic review and considerations.

Autor:	Langford DJ; Department of Anesthesiology, Critical Care and Pain Management, Pain Prevention Research Center at Hospital for Special Surgery, New York, NY, United States.; Department of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, NY, United States.; Department of Anesthesiology, Weill Cornell Medicine, New York, NY, United States., Mark RP; Department of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, NY, United States., France FO; Department of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, NY, United States., Nishtar M; Department of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, NY, United States., Park M; Department of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, NY, United States., Sharma S; Department of Neurosurgery, Neuro Pain Management Center, University of Rochester, Rochester, NY, United States., Shklyar IC; Department of Anesthesiology, Critical Care and Pain Management, Pain Prevention Research Center at Hospital for Special Surgery, New York, NY, United States.; College of Liberal Arts, The University of Texas at Austin, Austin, TX, United States., Schnitzer TJ; Department of Physical Medicine and Rehabilitation, Northwestern University, Chicago, IL, United States., Conaghan PG; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom., Amtmann D; Department or Rehabilitation Medicine, University of Washington, Seattle, WA, United States., Reeve BB; Department of Population Health Sciences, Center for Health Measurement, Duke University School of Medicine, Durham, NC, United States., Turk DC; Department of Anesthesiology, Weill Cornell Medicine, New York, NY, United States., Dworkin RH; Department of Anesthesiology, Critical Care and Pain Management, Pain Prevention Research Center at Hospital for Special Surgery, New York, NY, United States.; Department of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, NY, United States., Gewandter JS; Department of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, NY, United States.
Jazyk:	angličtina
Zdroj:	Pain [Pain] 2024 Nov 01; Vol. 165 (11), pp. 2445-2454. Date of Electronic Publication: 2024 May 14.
DOI:	10.1097/j.pain.0000000000003270
Abstrakt:	Abstract: Establishing clinically meaningful changes in pain experiences remains important for clinical trials of chronic pain treatments. Regulatory guidance and pain measurement initiatives have recommended including patient-reported global assessment measures (eg, Patient-Global Impression of Change [PGIC]) to aid interpretation of within-patient differences in domain-specific clinical trial outcomes (eg, pain intensity). The objectives of this systematic review were to determine the frequency of global assessment measures inclusion, types of measures, domains assessed, number and types of response options, and how measures were analyzed. Of 4172 abstracts screened across 6 pain specialty journals, we reviewed 96 clinical trials of chronic pain treatments. Fifty-two (54.2%) studies included a global assessment measure. The PGIC was most common (n = 28; 53.8%), with relatively infrequent use of other measures. The majority of studies that used a global assessment measure (n = 31; 59.6%) assessed change or improvement in an unspecified domain. Others assessed overall condition severity (n = 9; 17.3%), satisfaction (n = 8; 15.4%), or overall health status/recovery (n = 5; 9.6%). The number, range, and type of response options were variable and frequently not reported. Response options and reference periods even differed within the PGIC. Global assessment measures were most commonly analyzed as continuous variables (n = 24; 46.2%) or as dichotomous variables with positive categories combined to calculate the proportion of participants with a positive response to treatment (n = 18; 34.6%). This review highlights the substantial work necessary to clarify measurement and use of patient global assessment in chronic pain trials and provides short- and long-term considerations for measure selection, reporting and analysis, and measure development. (Copyright © 2024 International Association for the Study of Pain.)
Databáze:	MEDLINE
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