The Feasibility and Validity of PROMIS: A Novel Measure of Quality of Life among Children with Cleft Lip and Palate.
BACKGROUND
Health-related quality of life is inconsistently captured among children with cleft lip and palate. The Patient-Reported Outcomes Measurement Information System (PROMIS) captures health-related quality of life, with the added benefit of comparability across clinical conditions. In this study, the authors define the validity and feasibility of PROMIS among children with clefts.


METHODS
Children with cleft lip and palate who were at least 5 years old and able to complete instruments independently were eligible for inclusion (n = 93). Children completed PROMIS anxiety, depression, and peer relationship item banks as short forms or computerized adaptive tests. Participants also completed the Pediatric Quality of Life Inventory. Construct validity was measured by Spearman correlations between PROMIS and the Pediatric Quality of Life Inventory controlling for race, sex, age, and income. Feasibility was measured using instrument completion time, reading level, and floor/ceiling effects.


RESULTS
PROMIS computerized adaptive tests (peer relationship, r = 0.49; depression, r = -0.56; and anxiety, r = -0.36) and short forms (peer relationship, r = 0.65; depression, r = -0.54; and anxiety, r = -0.56) demonstrated moderate correlation with the Pediatric Quality of Life Inventory. Computerized adaptive tests had fewer floor (0 percent versus 0 percent) and ceiling (8.6 to 19.3 percent versus 21.8 to 41.9 percent) effects than short forms, and demonstrated better readability. Computerized adaptive tests required more time than short forms (peer relationship, 0.84 ± 0.67 versus 1.3 ± 0.92; depression, 0.52 ± 0.38 versus 1.1 ± 0.73; and anxiety, 0.53 ± 0.23 versus 1.1 ± 0.62; p = 0.001), as each computerized adaptive test included on average four more questions.


CONCLUSIONS
PROMIS correlates well with the Pediatric Quality of Life Inventory and demonstrates similar accuracy, with better readability and efficiency. Use of PROMIS will improve our ability to compare children with cleft lip and palate to diverse populations and clinical conditions.


METHODS
Diagnostic, II.
Ann Arbor, Mich.|From the Section of Plastic and Reconstructive Surgery, Department of Surgery, University of Michigan Health Systems, and the Department of Physical Medicine and Rehabilitation, University of Michigan Health Systems.
Kavitha
K
Ranganathan
Ann Arbor, Mich.|From the Section of Plastic and Reconstructive Surgery, Department of Surgery, University of Michigan Health Systems, and the Department of Physical Medicine and Rehabilitation, University of Michigan Health Systems.
Danielle
D
Shapiro
Ann Arbor, Mich.|From the Section of Plastic and Reconstructive Surgery, Department of Surgery, University of Michigan Health Systems, and the Department of Physical Medicine and Rehabilitation, University of Michigan Health Systems.
Noelle E
NE
Carlozzi
Ann Arbor, Mich.|From the Section of Plastic and Reconstructive Surgery, Department of Surgery, University of Michigan Health Systems, and the Department of Physical Medicine and Rehabilitation, University of Michigan Health Systems.
Michaella
M
Baker
Ann Arbor, Mich.|From the Section of Plastic and Reconstructive Surgery, Department of Surgery, University of Michigan Health Systems, and the Department of Physical Medicine and Rehabilitation, University of Michigan Health Systems.
Christian J
CJ
Vercler
Ann Arbor, Mich.|From the Section of Plastic and Reconstructive Surgery, Department of Surgery, University of Michigan Health Systems, and the Department of Physical Medicine and Rehabilitation, University of Michigan Health Systems.
Steven J
SJ
Kasten
Ann Arbor, Mich.|From the Section of Plastic and Reconstructive Surgery, Department of Surgery, University of Michigan Health Systems, and the Department of Physical Medicine and Rehabilitation, University of Michigan Health Systems.
Seth A
SA
Warschausky
Ann Arbor, Mich.|From the Section of Plastic and Reconstructive Surgery, Department of Surgery, University of Michigan Health Systems, and the Department of Physical Medicine and Rehabilitation, University of Michigan Health Systems.
Steven R
SR
Buchman
Ann Arbor, Mich.|From the Section of Plastic and Reconstructive Surgery, Department of Surgery, University of Michigan Health Systems, and the Department of Physical Medicine and Rehabilitation, University of Michigan Health Systems.
Jennifer F
JF
Waljee
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002971:Cleft Lip; D002972:Cleft Palate; D003430:Cross-Sectional Studies; D005240:Feasibility Studies; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D063868:Patient Outcome Assessment; D011446:Prospective Studies; D011788:Quality of Life; D015203:Reproducibility of Results; D055815:Young Adult
Demir T, Karacetin G, Baghaki S, Aydin Y. Psychiatric assessment of children with nonsyndromic cleft lip and palate. Gen Hosp Psychiatry 2011;33:594603.
Feragen KB, Borge AI. Peer harassment and satisfaction with appearance in children with and without a facial difference. Body Image 2010;7:97105.
Brand S, Blechschmidt A, Müller A, et al. Psychosocial functioning and sleep patterns in children and adolescents with cleft lip and palate (CLP) compared with healthy controls. Cleft Palate Craniofac J. 2009;46:124135.
Boes AD, Murko V, Wood JL, et al. Social function in boys with cleft lip and palate: Relationship to ventral frontal cortex morphology. Behav Brain Res. 2007;181:224231.
Broder H, Strauss RP. Self-concept of early primary school age children with visible or invisible defects. Cleft Palate J. 1989;26:114117; discussion 117.
Cheung LK, Loh JS, Ho SM. The early psychological adjustment of cleft patients after maxillary distraction osteogenesis and conventional orthognathic surgery: A preliminary study. J Oral Maxillofac Surg. 2006;64:17431750.
Black N. Patient reported outcome measures could help transform healthcare. BMJ 2013;346:f167.
Cella D, Yount S, Rothrock N, et al.; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): Progress of an NIH Roadmap cooperative group during its first two years. Med Care 2007;45(Suppl 1):S3S11.
Conway PH, Clancy C. Transformation of health care at the front line. JAMA 2009;301:763765.
Ranganathan K, Vercler CJ, Warschausky SA, MacEachern MP, Buchman SR, Waljee JF. Comparative effectiveness studies examining patient-reported outcomes among children with cleft lip and/or palate: A systematic review. Plast Reconstr Surg. 2015;135:198211.
Queiroz DM, Amorim MH, Zandonade E, Miotto MH. Quality of life of children and adolescents with cancer: Revision of studies literature that used the Pediatric Quality Of Life Inventory (in Portuguese). Invest Educ Enferm. 2015;33:343354.
Shapiro DN, Waljee J, Ranganathan K, Buchman S, Warschausky S. Gender and satisfaction with appearance in children with craniofacial anomalies. Plast Reconstr Surg. 2015;136:789e795e.
Fries JF, Bruce B, Cella D. The promise of PROMIS: Using item response theory to improve assessment of patient-reported outcomes. Clin Exp Rheumatol. 2005;23(Suppl 39):S53S57.
Waljee JF, Carlozzi N, Franzblau LE, Zhong L, Chung KC. Applying the patient-reported outcomes measurement information system to assess upper extremity function among children with congenital hand differences. Plast Reconstr Surg. 2015;136:200e207e.
Morgan JH, Kallen MA, Okike K, Lee OC, Vrahas MS. PROMIS physical function computer adaptive test compared with other upper extremity outcome measures in the evaluation of proximal humerus fractures in patients older than 60 years. J Orthop Trauma 2015;29:257263.
Tyser AR, Beckmann J, Franklin JD, et al. Evaluation of the PROMIS physical function computer adaptive test in the upper extremity. J Hand Surg Am. 2014;39:20472051.e4.
Varni JW, Magnus B, Stucky BD, et al. Psychometric properties of the PROMIS pediatric scales: Precision, stability, and comparison of different scoring and administration options. Qual Life Res. 2014;23:12331243.
Klassen AF, Tsangaris E, Forrest CR, et al. Quality of life of children treated for cleft lip and/or palate: A systematic review. J Plast Reconstr Aesthet Surg. 2012;65:547557.
Eckstein DA, Wu RL, Akinbiyi T, Silver L, Taub PJ. Measuring quality of life in cleft lip and palate patients: Currently available patient-reported outcomes measures. Plast Reconstr Surg. 2011;128:518e526e.
Thissen D, Liu Y, Magnus B, et al. Estimating minimally important difference (MID) in PROMIS pediatric measures using the scale-judgment method. Qual Life Res. 2016;25:1323.
DeWalt DA, Gross HE, Gipson DS, et al. PROMIS pediatric self-report scales distinguish subgroups of children within and across six common pediatric chronic health conditions. Qual Life Res. 2015;24:21952208.
Döring AC, Nota SP, Hageman MG, Ring DC. Measurement of upper extremity disability using the Patient-Reported Outcomes Measurement Information System. J Hand Surg Am. 2014;39:11601165.
Huang G, Fang CH, Agarwal N, Bhagat N, Eloy JA, Langer PD. Assessment of online patient education materials from major ophthalmologic associations. JAMA Ophthalmol. 2015;133:449454.
De Felippe N, Kar F. Readability of information related to the parenting of a child with a cleft. Interact J Med Res. 2015;4:e14.
Manary MP, Boulding W, Staelin R, Glickman SW. The patient experience and health outcomes. N Engl J Med. 2013;368:201203.
Marcusson A, Akerlind I, Paulin G. Quality of life in adults with repaired complete cleft lip and palate. Cleft Palate Craniofac J. 2001;38:379385.
Millard T, Richman LC. Different cleft conditions, facial appearance, and speech: Relationship to psychological variables. Cleft Palate Craniofac J. 2001;38:6875.
Oosterkamp BC, Dijkstra PU, Remmelink HJ, et al. Satisfaction with treatment outcome in bilateral cleft lip and palate patients. Int J Oral Maxillofac Surg. 2007;36:890895.
Shapiro DN, Waljee J, Ranganathan K, Buchman S, Warschausky S. Using the patient reported outcomes measurement information system to evaluate psychosocial functioning among children with craniofacial anomalies. Plast Reconstr Surg. 2015;135:16731679.
Kashikar-Zuck S, Carle A, Barnett K, et al. Longitudinal evaluation of Patient Reported Outcomes Measurement Information Systems (PROMIS) measures in pediatric chronic pain. Pain 2016;157:339347.
Bartlett SJ, Orbai AM, Duncan T, et al. Reliability and validity of selected PROMIS measures in people with rheumatoid arthritis. PLoS One 2015;10:e0138543.
Jacobson CJ Jr, Kashikar-Zuck S, Farrell J, et al. Qualitative evaluation of pediatric pain behavior, quality, and intensity item candidates and the PROMIS pain domain framework in children with chronic pain. J Pain 2015;16:12431255.
Kratz AL, Slavin MD, Mulcahey MJ, Jette AM, Tulsky DS, Haley SM. An examination of the PROMIS pediatric instruments to assess mobility in children with cerebral palsy. Qual Life Res. 2013;22:28652876.
Mulcahey MJ, Slavin MD, Ni P, et al. Computerized adaptive tests detect change following orthopaedic surgery in youth with cerebral palsy. J Bone Joint Surg Am. 2015;97:14821494.
Hung M, Hon SD, Cheng C, et al. Psychometric evaluation of the lower extremity computerized adaptive test, the modified Harris hip score, and the hip outcome score. Orthop J Sports Med. 2014;2:2325967114562191.
Hullmann SE, Ryan JL, Ramsey RR, Chaney JM, Mullins LL. Measures of general pediatric quality of life: Child Health Questionnaire (CHQ), DISABKIDS Chronic Generic Measure (DCGM), KINDL-R, Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales, and Quality of My Life Questionnaire (QoML). Arthritis Care Res (Hoboken) 2011;63(Suppl 11):S420S430.