Pediatric Outcome Data Collection Instrument - Parent

Instrument Name: Pediatric Outcome Data Collection Instrument - Parent

Abbreviation: PODCI-Parent

Points for Consideration:

Well used in NMD

Description of Tool:

The Pediatric Outcome Data Collection Instrument - Parent is an ObsRO which includes 86 items covering upper extremetiy function, physical function and sports, transfers and mobility, comfort, happy and satisfied, and expectations in children aged 2 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:

A self-report version of the PODCI also exists; the parent version actually has 2 sub-versions, one for parents of children ages 2-10 and one for parents of children ages 11-18. Scores for the 2 subversions are treated as equivalent and analyzed collectively.

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):

2-18 years (Cerebral Palsy, 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 86

Mode of Administration:

Data Collection Mode:

Time for Completion: 15 to 18 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

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: Yes

Evidence of re-testing the final version: Yes

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: 0.97
Upper extremity function: 0.94
Physical function & sports: 0.93
Transfers & mobility: 0.96
Comfort (pain free): 0.83
Happy & satisfied: 0.71
Expectations: 0.83
- Population/Disease: Parents of children and adolescents (age range 2-18 years) with orthopedic condition; n=70
- 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

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 0.12 to 0.75; p Not stated for all values), as well as with the POSNA global function and comfort (r=0.76; 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 limitations scores of all PODCI subscales (r ranging from -0.12 to 0.48; p Not stated for all values), as well as with the POSNA global function and comfort (r=0.13; 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 -0.46 to -0.04; p Not stated for all values), as well as with the POSNA global function and comfort (r=-0.41; p Not stated)
- Population/Disease: Parents of children and adolescents with orthopedic condition (age range 2-18 years); n=470

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: Parents of children and adolescents 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: Parents of children and adolescents with orthopedic condition (age range 2-18 years); n=373

Murali (2020)
KNown-groups validity
1- Measure/Groups of patients:
- Children with OI Type I (mild form) (n= 121)
- Children with OI Type III (severe form) (n= 58)
- Children with OI Type IV (moderately severe form) (n= 66)
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: ANOVA and Tukey’s studentized range test; p< 0.05 for all results - 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 - The mean scores were lower in OI type IV compared with OI type I in the Upper Extremity and Physical Function Core Scale for the early school age group (6-8 years) and in the Sports and Physical Functioning Core Scale in the preschool age group (2-5 years) - For the Pain/Comfort Core Scale, individuals with OI type III older than 6 years had significantly lower scores than individuals with OI type I Clinical validity 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; p< 0.001 for all results - There was significant correlation between the PODCI Upper Extremity and Physical Function and BAMF Fine Motor (r ranging from 0.45 to 0.57) and between the PODCI Transfer and Basic Mobility and BAMF Lower Extremity (r ranging from 0.63 to 0.83) - Population/Disease: Parents of children with Osteogenesis Imperfecta (OI) (age range 2 years–10 years 11 months); n= 245 Murali (2020)[Adolescent self-reported and parent-reported version] KNown-groups validity - 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 Thacher (2019) KNown-groups validity - Measure/Groups of patients: - Children with greater rachitic disease (Rickets Severity Score (RSS) ≥ 1.5); n= 34 - Children with lesser rachitic disease (RSS < 1.5); n= 18 - A priori hypotheses: Not stated - Were hypotheses confirmed: Not applicable - Results: Two-samplet-test - The mean Sports/physical functioning scale score was significantly lower in children with greater rachtic disease (29.6, Standard Deviation (SD) 17.0) than in children with lesser rachitic disease (40.9, SD 16.2); p= 0.0275 - The mean Pain/comfort scale score was significantly lower in children with greater rachtic disease (29.9, SD 14.6) than in children with lesser rachitic disease (45.3, SD 13.4); p= 0.0006 - Population/Disease: Parents of children with X-linked hypophosphatemia (age range 5 to 12 years; mean age 8.5+1.9); n= 52 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 Henricson (2013) KNown-groups validity 1- Measure/Groups of patients: Boys with Duchenne muscular dystrophy (DMD) (n= 24) vs typcially developed boys (n= 36) - A priori hypotheses: Not stated - Were hypotheses confirmed: Not applicable - Results: Standard between-group mean comparison tests; p= 0.0001 for all results - The mean PODCI Global score was significantly lower in the DMD group (73.8, SD 11.5) than in the typcially-developed group (97.9, SD 3.0) - The mean PODCI Transfer/Basic Mobility score was significantly lower in the DMD group (79.5, SD 13.5) than in the typcially-developed group (100.3, SD 1.6) - The mean PODCI Sports and Physical function score was significantly lower in the DMD group (55.0, SD 21.2) than in the typcially-developed group (95.8, SD 5.8) - Population/Disease: Parents of boys with DMD (age range 4-12 years, mean age 7.9 (SD 2.3)); n= 24 and parents of typcially-developed boys (age range 4-12 years, mean age 8.7 (SD 2.6)); n= 36 Clinical validity 2- Measure/Groups of patients: 6-minute walking distance (6MWD) test; 10-m run/walk velocity - A priori hypotheses: Not stated - Were hypotheses confirmed: Not applicable - Results: Person's correlation coefficient; p No stated for all results - There were signficant correlations between the 6MWD and the PODCI Global score (r= 0.68), the PODCI Transfer/Basic Mobility score (r= 0.79) and the PODCI Sports and Physical Function score (r= 0.68) - There were signficant correlations between the 10-m run/walk velocity and the PODCI Global score (r= 0.62), the PODCI Transfer/Basic Mobility score (r= 0.76) and the PODCI Sports and Physical Function score (r= 0.58) - Population/Disease: Boys with DMD (age range 4-12 years, mean age 7.9 (SD 2.3)); n= 24

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 (Responsiveness):

Daltroy LH (1998)
1- Methods:
- Population/Disease: Parents of children and adolescents with orthopedic condition and global baseline composite score <80; n=113 (age range 2-18 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 3.1 to 8.6 (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 8.8 for the POSNA global function and comfort scale 2- Methods: - Population/Disease: Parents of children or adolescents with orthopedic condition; n=204 (age range 2-18 years) - 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) Henricson (2013) - Population/Disease: Boys with DMD (age range 4-12 years, mean age 7.9 (SD 2.3)); n= 13 - Time horizon: 1 year - Measure: 6-minute walking distance (6MWD) test - Statistics used: Person's correlation coefficient; p Not stated for all results - Results: - There was high correlation between the 1 year mean change in 6MWD score (-53.67, SE 25.96) and 1 year mean change in PODCI Global score (-5.05, SE 2.24); r= 0.76 - There was high correlation between the 1 year mean change in 6MWD score (-53.67, SE 25.96) and 1 year mean change in PODCI Transfer/Basic Mobility score (-9.95, SE 3.94); r= 0.93 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) Tomazos (2016) - Population/Disease: Children with Hypophosphatasia (HPP) (age range 5-12 years); 127 data points - Time horizon: Not stated - Measure: 6-minute walking distance (6MWD) test - Statistics used: Person's correlation coefficient; p< 0.001 for all results - Results: There was significant correlation between changes in the 6MWD and changes in the PODCI subscales, including Global function (r= 0.76) Transfer/Basic Mobility (r=0.69), and Sports/Physical Functioning (r=0.78) Whyte (2016) - Population/Disease: Children with Hypophosphatasia (HPP) (age range 5-12 years); 84 data points - Time horizon: Not stated - Measure: Radiographic Global Impression of Change (RGI-C) - Statistics used: Person's correlation coefficient - Results: There was significant correlation between changes from baseline in the RGI-C and changes from baseline in the PODCI (r= 0.595; p< 0.0001)

Evidence of responder thresholds: None identified

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/

Allen DD, Gorton GE, Oeffinger DJ, Tylkowski C, Tucker CA, Haley SM. Analysis of the pediatric outcomes data collection instrument in ambulatory children with cerebral palsy using confirmatory factor analysis and item response theory methods. J Pediatr Orthop. 2008 Mar;28(2):192-8.
Full Text Article https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2680679/

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)

T.O. Carpenter, M.P. Whyte, E.A. Imel, A.M. Boot, W. Hogler, A. Linglart, et al.,Burosumab therapy in children with X-linked hypophosphatemia, N. Engl. J. Med.378 (21) (2018) 1987–1998 (Full Text Article: https://www.nejm.org/doi/10.1056/NEJMoa1714641)

Thacher TD, Pettifor JM, Tebben PJ, Creo AL, Skrinar A, Mao M, Chen CY, Chang T, San Martin J, Carpenter TO. Rickets severity predicts clinical outcomes in children with X-linked hypophosphatemia: Utility of the radiographic Rickets Severity Score. Bone. 2019 May;122:76-81. (Full Text Article: https://www.sciencedirect.com/science/article/pii/S875632821930050X?via%3Dihub)

White, 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)
Whyte MP, Fujita KP, Moseley S, Thompson DD, McAlister WH. Validation of a Novel Scoring System for Changes in Skeletal Manifestations of Hypophosphatasia in Newborns, Infants, and Children: The Radiographic Global Impression of Change Scale. J Bone Miner Res. 2018 May;33(5):868-874. (Full Text Article: https://asbmr.onlinelibrary.wiley.com/doi/full/10.1002/jbmr.3377)

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/)

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

None identified

Original language:
English for the USA

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

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

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