Pediatric Outcome Data Collection Instrument - Self-Report

COA At-a-Glance

Evidence of cognitive interviewing of draft instrument in target patient population

Evidence of internal consistency

Evidence of test-retest or inter-rater reliability

Evidence of concurrent validity

Evidence of known-groups validity

Evidence of ability to detect change over time

Evidence of responder thresholds

Inclusion of the COA in product labelling

Daily function
Fine motor function
Self-care

Overview

Instrument Name: Pediatric Outcome Data Collection Instrument - Self-Report

Abbreviation: PODCI - Self-Report

Description of Tool:

The Pediatric Outcome Data Collection Instrument - Self Report is a PRO which includes 83 items covering upper extremetiy function, physical function and sports, transfers and mobility, comfort, happy and satisfied, and expectations in children aged 11 to 18 years. Higher scores represent higher functioning, more positive quality of life, more positive attributes, less pain, higher level of comorbidities.

Minimum Qualification Required by COA Administrator: No degree requirement

Comment:

An ObsRO version of the PODCI also exists

Year: 1998

Objective of Development:

To assess changes following pediatric orthopedic interventions for a broad range of diagNoses

Population of Development: Age range (therapeutic indication):

11-18 years (Musculoskeletal Pain)

Pediatric Population(s) in which COA has been used:

PODCI: Nervous System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Musculoskeletal Diseases; Wounds and injuries; Skin and Connective Tissue Diseases; Neoplasms; Nutritional and Metabolic Diseases; Mental disorders; Pathological Conditions, Signs and Symptoms; Immune System Diseases

COA type:

Number of Items 83

Mode of Administration:

Data Collection Mode:

Time for Completion: 10 to 12 minutes

Response Scales: Varies by item: 3-, 4-, 5- or 6-point verbal rating scale assessing frequency (“often,” “sometimes,” or “rarely or never”) or severity (None,” “very mild,” “mild,” “moderate,” “severe,” or “very severe”)

Summary of Scoring:

Available Scores:
Global Score is a normed score ranging from 0 to 70
Scores by domains

Weighting: Yes

Score Interpretation: Higher score = Higher functioning, more positive quality of life, more positive attributes, less pain, higher level of comorbidities


Content Validity

Evidence of Literature Review: Yes

Evidence of Instrument Review: Yes

Evidence of Clinical or Expert Input: Yes

Evidence of concept elicitation in target patient population: None identified

Evidence of a Saturation Grid: None identified

Evidence for Selection of Data Collection Method: None identified

Recall/Observation Period:

Evidence for Selection of Reponse Options: None identified

Evidence of cognitive interviewing of draft instrument in target patient population: Yes

Evidence of Preliminary Scoring of Items and Domains: Yes

Evidence related to respondent and administrator burden: None identified

Evidence of a Conceptual Framework: None identified

Evidence of an item-tracking matrix: None identified

Evidence related to item selection: None identified

Evidence of re-testing the final version: Yes


Reliability

Internal consistency (Cronbach's alpha): Yes

Evidence of internal consistency:

Test-retest Reliability (ICC):

Daltroy LH (1998)
Pearson's correlation coefficients (p Not stated for all values):
Global function & comfort: 0.95
Upper extremity function: 0.96
Physical Function & sports: 0.87
Transfers & mobility: 0.97
Comfort (pain free): 0.89
Happy & satisfied: 0.87
Expectations: 0.76
- Population/Disease: Adolescents with orthopedic condition (age range 11-18 years); n=30
- Was a definition of stability applied to identify stable patients: No
- Time frame or interval between the two administrations: 1-2 days

Inter-rater/ inter-interviewer reliability (kappa):

Not applicable

Evidence of test-retest or inter-rater reliability: Yes


Validity

Concurrent validity (convergent, divergent):

None identified

Known-group validity:

Daltroy LH (1998)
1- Measure/Groups of patients: Physician rating of global function
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: Correlations were found between physician rating of global function and scores of all PODCI subscales (r ranging from -0.01 to 0.70; p Not stated for all values), as well as with the POSNA global function and comfort (r=0.68; p Not stated)

2- Measure/Groups of patients: Physician rating of pain limitations
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: Correlation was found between physician rating of pain limitation scores of all PODCI subscales (r ranging from -0.05 to 0.48; p Not stated for all values), as well as with the POSNA global function and comfort (r=0.38; p Not stated)

3- Measure/Groups of patients: Physician rating of severity of diagNosis
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: Correlation were found between physician rating of severity of diagNosis scores of all PODCI subscales (r ranging from -0.33 to 0.10; p Not stated for all values), as well as with the POSNA global function and comfort (r=-0.20; p Not stated)

- Population/Disease: Adolescents with orthopedic condition (age range 11-18 years); n=232

4- Measure/Groups of patients: Linear association with severity grade
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: Significant linear associations were found between severity grade and the score of the PODCI global function and comfort scale and the scores of all of its subscales, except the Comfort subscale (t test (1, 403 df): values ranging from 5.6 to 8.9; p Not stated for all values)
- Population/Disease: Adolescents with orthopedic condition and parents of children with orthopedic condition (age range 2-18 years); n=373

KNown-groups validity
1- Measure/Groups of patients: Two groups (subjects with lower extremity involvement: n=279; subjects without lower extremity involvement: n=94)
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: Significant differences were found between the two groups in the score of the PODCI global function and comfort scale and the scores of all of its subscales (t test: values ranging from 0.7 to 7.1; p Not stated for all values)

2- Measure/Groups of patients: Two groups (subjects with upper extremity involvement: n=136; subjects without upper extremity involvement: n=237)
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: Significant differences were found between the two groups in the score of the PODCI global function and comfort scale and the scores of all of its subscales (t test: values ranging from 0.1 to 7.2; p Not stated for all values)
- Population/Disease: Adolescents with orthopedic condition and parents of children with orthopedic condition (age range 2-18 years); n=373

Murali (2020)
KNown-groups validity
1- Measure/Groups of patients:
- Adolescents with OI Type I (mild form) (n= 82)
- Adolescents with OI Type III (severe form) (n= 37)
- Adolescents with OI Type IV (moderately severe form) (n= 53)
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: ANOVA; p< 0.05 for all results - In both, the self-reported version and the the adult-reported version, the mean standardized scores for the Upper Extremity and Physical Function, Transfer and Basic Mobility, and Sports and Physical Functioning scales were significantly lower in individuals with OI type III compared with OI types I and IV - In both, the self-reported version and the the adult-reported version, the mean scores were lower in OI type IV compared with OI type I in the Sports and Physical Functioning Core Scale - Population/Disease: Adolescents and parents of adolescents with Osteogenesis Imperfecta (OI) (age range 11 years–18 years 11 months); n= 172 2-Measure/Groups of patients: Brief Assessment of Motor Function (BAMF) - A priori hypotheses: Not stated - Were hypotheses confirmed: Not applicable - Results: Pearson's correlation coefficient. There was significant correlation between the PODCI Transfer and Basic Mobility and BAMF Lower Extremity (r ranging from 0.68 to 0.74; p< 0.001) - Population/Disease: Adolescents with Osteogenesis Imperfecta (OI) (age range 11 years–18 years 11 months); n Not stated Henricson (2014)[PODCI version Not specified] KNown-groups validity - Measure/Groups of patients: Children with Duchenne muscular dystrophy (DMD) stratified according to functional milestone groups (n per group Not stated) - A priori hypotheses: Not stated - Were hypotheses confirmed: Not applicable - Results: Method and exact data Not stated. All PODCI scales differed according to milestone group membership (p< 0.01–0.0000) - Population/Disease: Children with DMD (age range 3 to 18 years); n= 264

Evidence of Translatability Assessment: None identified

Evidence related to missing data: None identified

Evidence for Selection of Recall Period: None identified

Evidence of Administration Instructions and Training Provided: None identified

Evidence of concurrent validity: None identified

Evidence of known-groups validity: Yes

Evidence of ability to detect change over time: Yes


Ability to Detect Change

Ability to detect change (Responsiveness):

Daltroy LH (1998)
1- Methods:
- Population/Disease: Adolescents with orthopedic condition (age range 11-18 years); n=120
- Time horizon: 6 months
- Statistics used: Pearson correlation coefficient
Results:
- Correlations were found between adolescent change scores and adolescent transition scores (better versus worse) for the Upper extremity function, Physical sports and activities, Transfers and mobility, Comfort (pain free), and Happiness and satisfactions POSNA scales (r ranging from 0.01 to 0.46; p Not stated), and for the POSNA global function and comfort scale (r=0.35; p Not stated)
-Correlations were found between adolescent change scores and physician transition scores (better versus worse) for the Upper extremity function, Physical sports and activities, Transfers and mobility, Comfort (pain free), and Happiness and satisfactions POSNA scales (r ranging from -0.08 to 0.45; p Not stated), and for the POSNA global function and comfort scale (r=0.45 ; p Not stated)

2- Methods:
- Population/Disease: Adolescents with orthopedic condition and global baseline composite score <80; n=49 (age range 11-18 years) - Time horizon: 6 months - Group definition: The authors selected the subset of patients who scored <80 on the composite score described as the average of the physician global functional assessment, the POSNA global assessment and the Child Health Questionnaire (CHQ) - Statistics used: t-test Results: t statistics for change from baseline to follow-up ranged from 1.0 to 3.6 (p Not stated) for the Upper extremity function, Physical sports and activities, Transfers and mobility, Comfort (pain free), and Happiness and satisfactions POSNA scales, and was of 3.0 for the POSNA global function and comfort scale 3- Methods: - Population/Disease: Adolescents with orthopedic condition and parents of children with orthopedic condition (age range 2-18 years); n=204 - Time horizon: 6 months - Group definition: Severity of baseline diagNosis (None, Mild, Moderate, Severe) - Statistics used: t-test Results: - None (n=33): t statistics for sensitivity of change from baseline to follow-up ranged from -3.3 to -0.1 (p Not stated) for the Upper extremity function, Physical sports and activities, Transfers and mobility, and Comfort (pain free) POSNA scales, and was of -2.7 for the POSNA global function and comfort scale - Mild (n=66): t statistics for sensitivity of change from baseline to follow-up ranged from -2.1 to 3.7 (p Not stated) for the Upper extremity function, Physical sports and activities, Transfers and mobility, and Comfort (pain free) POSNA scales, and was of -0.2 for the POSNA global function and comfort scale - Moderate (n=60): t statistics for sensitivity of change from baseline to follow-up ranged from -0.7 to -2.6 (p Not stated) for the Upper extremity function, Physical sports and activities, Transfers and mobility, and Comfort (pain free) POSNA scales, and was of 0.6 for the POSNA global function and comfort scale - Severe (n=33): t statistics for sensitivity of change from baseline to follow-up ranged from 0.7 to 6.4 (p Not stated) for the Upper extremity function, Physical sports and activities, Transfers and mobility, and Comfort (pain free) POSNA scales, and was of 5.5 for the POSNA global function and comfort scale Henricson (2014)[PODCI version Not specified] Methods: - Population/Disease: Children with Duchenne muscular dystrophy (DMD) (age range 3 to 18 years); n= 264 - Time horizon: 1 year - Group definition: Children who did Not lose a functional milestone versus those who did - Statistics used: Not stated Results: Exact data Not stated - PODCI Upper Extremity Function, Transfers and Basic Mobility, Sports and Recreation and the Global Scores differed significantly between functional milestone groups (p< 0,0025–0.0002) - Upper Extremity Function, Sports and Recreation and the Global Scores of the PODCI showed clinically-meaningful change in those who experienced the loss of a critical functional milestone (MCID was defined as meeting or exceeding change of 1/3 Standard Deviation of the measure for the whole group or among individuals who showed a change in milestone scale score indicating loss of a key functional ability) White (2010)[both PODCI versions, combined results] - Population/Disease: Patients diagNosed with Hunter disease (MPS II) (age range 4-16 years) who received enzyme replacement therapy (ERT); n= 5 - Time horizon: Minimum of 1 year of ERT - Statistics used: One tailed Wilcoxon signed rank test; exact data Not stated - Results: - There was significant improvement in PODCI Transfer/Basic mobility scores (p= 0.04), Sports and Physical functioning scores (p= 0.03) and Global functioning scores (p= 0.03)


Responder Thresholds

Evidence of responder thresholds: None identified


Reference(s) of development / validation

Daltroy LH, Liang MH, Fossel AH, Goldberg MJ. The POSNA pediatric musculoskeletal functional health questionnaire: report on reliability, validity, and sensitivity to change. Pediatric Outcomes Instrument Development Group. Pediatric Orthopaedic Society of North America. J Pediatr Orthop. 1998 Sep-Oct;18(5):561-71
PubMed abstract: https://pubmed.ncbi.nlm.nih.gov/9746401/


Other references

Barnes D, Linton JL, Sullivan E, et al. Pediatric outcomes data collection instrument scores in ambulatory children with cerebral palsy: an analysis by age groups and severity level. J Pediatr Orthop. 2008;28(1):97-102. doi:10.1097/bpo.0b013e31815a60e6White, Klane K, Hale, Susan, and Goldberg, Michael J. ‘Musculoskeletal Health in Hunter Disease (MPS II): ERT Improves Functional Outcomes’. 1 Jan. 2010 : 101 – 107. (Full Text Article: https://content.iospress.com/articles/journal-of-pediatric-rehabilitation-medicine/prm00112)

Murali, C.N., Cuthbertson, D., Slater, B. et al. Pediatric Outcomes Data Collection Instrument is a Useful Patient-Reported Outcome Measure for Physical Function in Children with Osteogenesis Imperfecta. Genet Med 22, 581–589 (2020). (Full Text Article: https://www.nature.com/articles/s41436-019-0688-6)

Lerman JA, Sullivan E, Barnes DA, Haynes RJ. The Pediatric Outcomes Data Collection Instrument (PODCI) and functional assessment of patients with unilateral upper extremity deficiencies. J Pediatr Orthop. 2005 May-Jun;25(3):405-7. doi: 10.1097/01.bpo.0000149866.80894.70. PMID: 15832164. (Full text article: https://pubmed.ncbi.nlm.nih.gov/15832164/)

Lerman JA, Sullivan E, Barnes DA, Haynes RJ. The Pediatric Outcomes Data Collection Instrument (PODCI) and functional assessment of patients with unilateral upper extremity deficiencies. J Pediatr Orthop. 2005 May-Jun;25(3):405-7. doi: 10.1097/01.bpo.0000149866.80894.70. PMID: 15832164. (Full text article: https://pubmed.ncbi.nlm.nih.gov/15832164/)

Lerman, Joel A. MD; Sullivan, Elroy PhD; Haynes, Richard J. MD The Pediatric Outcomes Data Collection Instrument (PODCI) and Functional Assessment in Patients With Adolescent or Juvenile Idiopathic Scoliosis and Congenital Scoliosis or Kyphosis, Spine: September 15, 2002 - Volume 27 - Issue 18 - p 2052-2057 (Full text article: https://pubmed.ncbi.nlm.nih.gov/12634568/)

O'Brien A, Bompadre V, Hale S, White KK. Musculoskeletal function in patients with mucopolysaccharidosis using the pediatric outcomes data collection instrument. J Pediatr Orthop. 2014 Sep;34(6):650-4. doi: 10.1097/BPO.0000000000000168. PMID: 24598580. (Full text article: https://pubmed.ncbi.nlm.nih.gov/24598580/)

Gates, Philip E. MD; Campbell, Susan R. PhD Effects of Age, Sex, and Comorbidities on the Pediatric Outcomes Data Collection Instrument (PODCI) in the General Population, Journal of Pediatric Orthopaedics: March 2015 - Volume 35 - Issue 2 - p 203-209
doi: 10.1097/BPO.0000000000000233 (Full text article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4323549/)


Inclusion of the COA in product labelling

None identified


Existence of Scoring / Interpretation / User Manual


Original language and translations

Original language:
English for the USA

Translations:
Dutch for the Netherlands
Korean for Korea
Portuguese for Brazil
Spanish
Turkish for Turkey


References of translations

Brazilian:
do Monte FA, Ferreira MN, Petribu KC, Almeida NC, Gomes JB, MariaNo MH, Mesquita ZB, Simões DM, Rodrigues AF, Souza MA. Validation of the Brazilian version of the Pediatric Outcomes Data Collection Instrument: a cross-sectional evaluation in children and adolescents with juvenile idiopathic arthritis. BMC Pediatr. 2013 Oct 30;13:177
Dutch:
van der Holst M, Vlieland TP, van de Sande MA, van Egmond-van Dam JC, Vermeulen HM, Nelissen RG. Translation and adaptation of the Pediatric Outcome Data Collecting Instrument (PODCI) into the Dutch language and preliminary validation in children with Neonatal Brachial Plexus Palsy. J Pediatr Rehabil Med. 2015;8(3):219-2
Korean:
Kwon DG, Chung CY, Lee KM, Lee DJ, Lee SC, Choi IH, Cho TJ, Yoo WJ, Park MS. Transcultural adaptation and validation of the Korean version of the Pediatric Outcomes Data Collection Instrument (PODCI) in children and adolescents. J Pediatr Orthop. 2011 Jan-Feb;31(1):102-6
Spanish:
Wren TA, Sheng M, Bowen RE, Scaduto AA, Kay RM, Otsuka NY, Hara R, Chan LS. Concurrent and discriminant validity of Spanish language instruments for measuring functional health status. J Pediatr Orthop. 2008 Mar;28(2):199-212
Turkish:
Merder-Coskun D, Kenis-Coskun O, Celenlioğlu AE, Akman M, Karadag-Saygi E, Uzuner A. Reliability of cross-cultural adapted Turkish version of the Pediatric Outcomes Data Collection Instrument (PODCI). J Pediatr Rehabil Med. 2016 May 31;9(2):101-5


Authors and contact information

Contact:
AAOS (American Academy of Orthopaedic Surgeons) Customer Service
USA
E-mail: customerservice@aaos.org


Website

https://www5.aaos.org/uploadedFiles/PreProduction/Quality/About_Quality/outcomes/Adolescent_Self.pdf


Review copy

https://www5.aaos.org/uploadedFiles/PreProduction/Quality/About_Quality/outcomes/Adolescent_Self.pdf