title: Psychometric evaluation of two scales assessing functional status and peripheral neuropathy associated with chemotherapy for ovarian cancer: a gynecologic oncology group study.
abstract: OBJECTIVE
  To evaluate the psychometric properties of two adapted scales, one for functional status and one for peripheral neuropathy secondary to neurotoxic chemotherapy.
  
  
  METHODS
  Repeated measures methodologic design conducted within a Gynecologic Oncology Group (GOG) phase III clinical trial that randomly assigned patients with advanced epithelial ovarian cancer to cisplatin and cyclophosphamide or cisplatin and paclitaxel.
  
  
  METHODS
  8 GOG institutions participating in the GOG clinical trial.
  
  
  METHODS
  88 evaluable outpatients enrolled in the GOG clinical trial. Sample size at time 1 (T1) was 88 patients and at time 2 (T2) was 67 patients.
  
  
  METHODS
  All scales were administered at T1 (prior to initiation of chemotherapy) and T2 (after six cycles of chemotherapy but prior to second-look laparotomy). Internal consistency reliability, criterion validity, and construct validity were evaluated, and clinical application was explored.
  
  
  METHODS
  Self-reported peripheral neuropathy and functional status (comprised of physical function and role function subscales), the GOG performance status scale, and the GOG toxicity criteria.
  
  
  RESULTS
  Reliability coefficients at T1 were physical function = 0.83, role function = 0.96, and peripheral neuropathy = 0.91; at T2, they were physical function = 0.83, role function = 0.92, and peripheral neuropathy = 0.89. At T1, physical function and role function correlated positively with performance status. Peripheral neuropathy correlated positively with GOG toxicity criteria used at T2. Principal component factor analysis suggested that the functional status scale had a two-factor structure with factors representing general and specific mobility and that the peripheral neuropathy scale also had a two-factor structure with factors representing foot and hand neuropathy.
  
  
  CONCLUSIONS
  The physical function, role function, and peripheral neuropathy scales have internal consistency, reliability, criterion validity, and construct validity. However, revision of the scales should address modification of specific questions and consider increasing the Likert scale from a four-point to a five- or seven-point scale to enhance clinical sensitivity and application.
  
  
  CONCLUSIONS
  With minor modifications, these scales should be useful in assessing physical function, role function, and peripheral neuropathy in patients who receive agents that may cause peripheral neuropathy.
authors.affiliation: Sloan-Kettering Cancer Center, New York, NY, USA. almadrol@mskcc.org
authors.forename: Lois
authors.initials: L
authors.lastname: Almadrones
authors.forename: Debroah B
authors.initials: DB
authors.lastname: McGuire
authors.forename: Janet Ruth
authors.initials: JR
authors.lastname: Walczak
authors.forename: Colleen M
authors.initials: CM
authors.lastname: Florio
authors.forename: Chunqiao
authors.initials: C
authors.lastname: Tian
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects*; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced* / Q000145:classification / Q000175:diagnosis*; D011594:Psychometrics / Q000295:instrumentation*; D015203:Reproducibility of Results
chemical_list: D003520:Cyclophosphamide; D017239:Paclitaxel; D002945:Cisplatin