title: QUAlity of Life Assessment in Spina bifida for Adults (QUALAS-A): development and international validation of a novel health-related quality of life instrument.
abstract: OBJECTIVE
  Health-related quality of life (HRQOL) is important in spina bifida (SB) management. No clinically useful, comprehensive instrument incorporating bladder/bowel domains exists. We aimed to develop and validate a self-reported QUAlity of Life Assessment in Spina bifida for Adults (QUALAS-A).
  
  
  METHODS
  We drafted the 53-question pilot instrument using a comprehensive item generation/refinement process. It was administered to an international convenience sample of adults with SB and controls recruited online via social media and in person at outpatient SB clinics (January 2013-September 2014). Final questions were determined by: clinical relevance, high factor loadings and domain psychometrics in an Internal Validation Sample randomly selected from United States participants (n = 250). External validity was evaluated in United States and International External Validation Samples (n = 165 and n = 117, respectively). Adults with SB completed the validated general WHOQOL-BREF and International Consultation on Incontinence Questionnaire (ICIQ).
  
  
  RESULTS
  Mean age of 532 participants was 32 years (32.7 % males, 85.0 % Caucasian), similar to 116 controls (p ≥ 0.08). There were 474 online and 58 clinical participants (61.1 % eligible). Face validity and content validity of the 3-domain, 15-question QUALAS-A were established by patients, families and experts. Internal consistency and test-retest reliability were high for all domains (Cronbach's alpha ≥ 0.70, ICC ≥ 0.77). Correlations between QUALAS-A and WHOQOL-BREF were low (r ≤ 0.60), except for high correlations with Health and Relationships domain (0.63 ≤ r ≤ 0.71). Bladder and Bowel domain had a high correlation with ICIQ (r = -0.70). QUALAS-A scores were lower among adults with SB than without (p < 0.0001). QUALAS-A had good statistical properties in both External Validation Samples (Cronbach's alpha 0.68-0.77).
  
  
  CONCLUSIONS
  QUALAS-A is a short, valid HRQOL tool for adults with SB.
authors: Division of Pediatric Urology, Riley Hospital for Children at IU Health, Indiana University School of Medicine, 705 Riley Hospital Dr. #4230, Indianapolis, IN, 46205, USA. szymanko@iupui.edu.
authors: Konrad M
authors: KM
authors: Szymanski
authors: Division of Pediatric Urology, Riley Hospital for Children at IU Health, Indiana University School of Medicine, 705 Riley Hospital Dr. #4230, Indianapolis, IN, 46205, USA. rmisseri@iupui.edu.
authors: Rosalia
authors: R
authors: Misseri
authors: Division of Pediatric Urology, Riley Hospital for Children at IU Health, Indiana University School of Medicine, 705 Riley Hospital Dr. #4230, Indianapolis, IN, 46205, USA. bwhittam@iupui.edu.
authors: Benjamin
authors: B
authors: Whittam
authors: Division of Pediatric Urology, Riley Hospital for Children at IU Health, Indiana University School of Medicine, 705 Riley Hospital Dr. #4230, Indianapolis, IN, 46205, USA. rapososm@gmail.com.
authors: Sonia-Maria
authors: SM
authors: Raposo
authors: Division of Pediatric Urology, Riley Hospital for Children at IU Health, Indiana University School of Medicine, 705 Riley Hospital Dr. #4230, Indianapolis, IN, 46205, USA. sjking@iupui.edu.
authors: Shelly J
authors: SJ
authors: King
authors: Division of Pediatric Urology, Riley Hospital for Children at IU Health, Indiana University School of Medicine, 705 Riley Hospital Dr. #4230, Indianapolis, IN, 46205, USA. mkaefer@iupui.edu.
authors: Martin
authors: M
authors: Kaefer
authors: Division of Pediatric Urology, Riley Hospital for Children at IU Health, Indiana University School of Medicine, 705 Riley Hospital Dr. #4230, Indianapolis, IN, 46205, USA. rrink@iupui.edu.
authors: Richard C
authors: RC
authors: Rink
authors: Division of Pediatric Urology, Riley Hospital for Children at IU Health, Indiana University School of Medicine, 705 Riley Hospital Dr. #4230, Indianapolis, IN, 46205, USA. mpcain@iupui.edu.
authors: Mark P
authors: MP
authors: Cain
mesh_terms: D000328:Adult; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011594:Psychometrics; D011788:Quality of Life; D015203:Reproducibility of Results; D018434:Sickness Impact Profile; D016135:Spinal Dysraphism / Q000175:diagnosis* / Q000523:psychology; D011795:Surveys and Questionnaires; D014549:Urinary Incontinence / Q000175:diagnosis* / Q000523:psychology
keywords: Adult; Fecal incontinence; Meningomyelocele; Quality of life; Spinal dysraphism; Urinary incontinence