title: Assessing patient-reported peripheral neuropathy: the reliability and validity of the European Organization for Research and Treatment of Cancer QLQ-CIPN20 Questionnaire.
abstract: OBJECTIVE
  This clinimetric analysis was conducted to evaluate the reliability, validity, and responsiveness to changeover time of the QLQ-CIPN20 when used to quantify patient-reported chemotherapy-induced peripheral neuropathy (CIPN).
  
  
  METHODS
  Participants recruited to four cooperative group trials were pooled to create two groups (n = 376, 575): those who did versus did not receive neurotoxic chemotherapy. QLQ-CIPN20 internal consistency reliability was assessed using Cronbach's alpha coefficients. Instrument validity was assessed using factor analysis, by evaluating score correlations with other CIPN and pain measures, and by comparing scores between contrasting groups. Cohen's d was used to assess responsiveness to change.
  
  
  RESULTS
  Alpha coefficients for the sensory, motor, and autonomic scales were 0.88, 0.88, and 0.78, respectively. However, autonomic scale and hearing loss items exhibited low item-item correlations (r ≤ 0.30) and thus were deleted. Moderate correlations were found between QLQ-CIPN20 and Brief Pain Inventory pain severity items (r 0.30-0.57, p ≤ .0001). Correlation between the QLQ-CIPN20 sensory and toxicity grading scale scores was low (r = .20; p ≤ .01). Mean scores were higher (worse) (p ≤ 0.0001) in individuals who did versus did not receive neurotoxic chemotherapy. The sensory and motor scales exhibited moderate-high responsiveness to change (Cohen's d = 0.82 and 0.48, respectively). Factor analysis indicated that the 16-item version formed distinct factors for lower and upper extremity CIPN, delineating typical distal to proximal CIPN progression.
  
  
  CONCLUSIONS
  Results provide support for QLQ-CIPN20 sensory and motor scale reliability and validity. The more parsimonious and clinically relevant 16-item version merits further consideration.
authors.affiliation: University of Michigan School of Nursing, 400 North Ingalls, Room 2151, Ann Arbor, MI, 48109-5482, USA, Ellenls@umich.edu.
authors.forename: Ellen M
authors.initials: EM
authors.lastname: Lavoie Smith
authors.forename: Debra L
authors.initials: DL
authors.lastname: Barton
authors.forename: Rui
authors.initials: R
authors.lastname: Qin
authors.forename: Preston D
authors.initials: PD
authors.lastname: Steen
authors.forename: Neil K
authors.initials: NK
authors.lastname: Aaronson
authors.forename: Charles L
authors.initials: CL
authors.lastname: Loprinzi
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D010146:Pain / Q000209:etiology; D063868:Patient Outcome Assessment; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced* / Q000175:diagnosis; D011788:Quality of Life; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D012959:Socioeconomic Factors; D011795:Surveys and Questionnaires / Q000592:standards*
chemical_list: D000970:Antineoplastic Agents
references.citation: Nurs Res. 2007 Sep-Oct;56(5):323-31
references.pmid: 17846553
references.citation: J Pain Symptom Manage. 2011 Dec;42(6):822-38
references.pmid: 21820851
references.citation: J BUON. 2010 Jul-Sep;15(3):435-46
references.pmid: 20941808
references.citation: J Peripher Nerv Syst. 2010 Dec;15(4):314-25
references.pmid: 21199103
references.citation: Qual Life Res. 2006 Feb;15(1):131-41
references.pmid: 16411037
references.citation: J Clin Oncol. 2011 Apr 10;29(11):1472-8
references.pmid: 21383290
references.citation: J Spec Pediatr Nurs. 2011 Jan;16(1):75-9
references.pmid: 21294838
references.citation: Ann Acad Med Singap. 1994 Mar;23(2):129-38
references.pmid: 8080219
references.citation: J Natl Compr Canc Netw. 2009 Sep;7 Suppl 5:S1-S26; quiz S27-8
references.pmid: 19755042
references.citation: Support Care Cancer. 2011 Jun;19(6):833-41
references.pmid: 20496177
references.citation: Res Nurs Health. 1991 Apr;14(2):165-8
references.pmid: 2047538
references.citation: Psychol Methods. 2004 Dec;9(4):466-91
references.pmid: 15598100
references.citation: Cancer. 2012 Oct 15;118(20):5171-8
references.pmid: 22415454
references.citation: J Am Acad Nurse Pract. 2004 Aug;16(8):353-9
references.pmid: 15455708
references.citation: Crit Rev Oncol Hematol. 2012 Apr;82(1):51-77
references.pmid: 21908200
references.citation: J Biopharm Stat. 2004 Feb;14(1):155-76
references.pmid: 15027506
references.citation: Eur J Cancer. 2005 May;41(8):1135-9
references.pmid: 15911236
references.citation: Semin Oncol Nurs. 2009 May;25(2 Suppl 1):S8-19
references.pmid: 19447319
references.citation: J Natl Cancer Inst. 2009 Dec 2;101(23):1624-32
references.pmid: 19920223
references.citation: Semin Oncol. 2006 Feb;33(1):15-49
references.pmid: 16473643
references.citation: Eur J Cancer. 2010 Feb;46(3):479-94
references.pmid: 20045310