P NATALE1,2, R PERRONE3, A TONG1, T HARRIS4 E HANNAN1, A JU1, E BURNETTE5, N CASTELEIJN6, A CHAPMAN7, S EASTTY5, R GANSEVOORT6, M HORIE8, S HORIE9, B KNEBELMANN10, R LEE11, R MUSTAFA12, R SANDFORD13, A BAUMGART1, J CRAIG14, G RANGAN15, B SAUTENET16, A VIECELLI17, N AMIR1, N EVANGELIDIS1, C GUHA1, C LOGEMAN1, K MANERA1, A MATUS GONZALEZ1, M HOWELL1, G STRIPPOLI1,2, Y CHO17
1University Of Sydney, , Australia, 2University of Bari, , Italy, 3Tufts University School of Medicine, , United States, 4Polycystic Kidney Disease International, , United Kingdom, 5United Kingdom, , United Kingdom, 6University Medical Centre Groningen, , The Netherlands, 7University of Chicago, , United States, 8Mayo Clinic, , United States, 9Juntendo University, , Japan, 10Université de Paris APHP, , France, 11Australia, , Australia, 12University of Kansas, , United States, 13University of Cambridge, , United Kingdom, 14Flinders University, , Australia, 15Westmead Institute for Medical Research, , Australia, 16Université de Nantes, , France, 17University of Queensland, , Australia
Aim: An on online international workshop was conducted to discuss the identification or development of a core outcome measure for pain
Background: Pain is the highest prioritized patient-reported outcome in people with autosomal dominant polycystic kidney disease (ADPKD) but remains infrequently and inconsistently measured across trials.
Methods: We convened an international Standardized Outcomes in Nephrology – Polycystic Kidney Disease (SONG-PKD) consensus workshop involving 21 patients/caregivers and 40 health professionals (clinicians, nurses, researchers, policy makers, and industry representatives) from 18 countries
Results: 118 studies, we identified 26 measures: 12 (46%) measures were developed for a non-ADPKD population, 1 (4%) for chronic kidney disease, 2 (8%) for polycystic liver disease and 11 (42%) specifically for ADPKD. Ten anatomical sites were included, with the lower back the most common (10 measures [39%]), four measurement dimensions (intensity (23 [88%]), frequency (3 [12%]), temporality (2 [8%]), and sensory (21 [81%]), two pain types, nociceptive including visceral (15 [58%]) and somatic (5 [20%]), and neuropathic (2 [8%]), and twelve impact dimensions, where the most frequent was work (5 [31%]). The validation data for the measures were variable and only the ADPKD Impact Scale reported all psychometric domains.
Four themes were identified highlighting core issues related to measurement of pain in ADPKD: distressing and disrupting life participation, variability and ambiguity in defining pain, stigma, frustration and adaptation to pain, and ensuring validity and feasibility of pain measures.
Conclusions: Currently existing measures were found to be insufficient in capturing pain as a core outcome and need for a new validated measure was identified. A core outcome measure that is simple, succinct, and addresses the impact of pain on life participation may help to improve the measurement of pain in all trials to guide decision-making in people with ADPKD.
Patrizia Natale, Research Associate, has completed an MSc in Clinical Epidemiology at the University of Sydney, and a bachelor’s degree in Pharmacy. Patrizia is a researcher at the Centre of Kidney Research at the University of Sydney, and she has experience in Cochrane Systematic Reviews in patients with all stages of CKD (including patients undergoing dialysis and kidney transplant recipients), and in the design and conduct of randomized controlled trials and long-term cohort studies. She has completed the PhD in nephrology and kidney transplantation at the University of Bari, Italy.