Patient-Reported Outcomes Measurement Information System - Pediatric Bank - Mobility

Instrument Name: Patient-Reported Outcomes Measurement Information System - Pediatric Bank - Mobility

Abbreviation: PROMIS Pediatric Bank v2.0 - Mobility

Points for Consideration:

Low level of publications. Does not always work well in patients with lower levels of mobility.

Description of Tool:

The PROMIS Pediatric Mobility scale is a PRO containing 44 items designed to assess activities of physical mobility such as getting out of bed or chair to activities such as running.

Minimum Qualification Required by COA Administrator: No degree requirement

Year: 2012

Objective of Development:

To assess activities of physical mobility such as getting out of bed or a chair to activities such as running

Population of Development: Age range (therapeutic indication):

8-17 years (All)

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

Neoplasms; Respiratory Tract Diseases; Pathological Conditions, Signs and Symptoms; Musculoskeletal Diseases; Male Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Hemic and Lymphatic Diseases; Nervous system diseases

COA type: PRO

Number of Items 24 items

Mode of Administration: Self-administered

Data Collection Mode: Paper and pen

Time for Completion: Not reported

Response Scales: 5-point verbal rating scale ranging from 1

Summary of Scoring:

Available Scores:
Global Score based on T-score conversion

Weighting:
No

Score Interpretation:
Higher score = Higher mobility

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: Yes

Evidence of a Saturation Grid: None identified

Evidence for Selection of Data Collection Method: None identified

Recall/Observation Period: In the past 7 days

Evidence for Selection of Reponse Options: Yes

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: None identified

Internal consistency (Cronbach's alpha): None Identified

Evidence of internal consistency:

Test-retest Reliability (ICC):

None identified

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

Not applicable

Evidence of test-retest or inter-rater reliability: No

Concurrent validity (convergent, divergent):

None identified

Known-group validity:

DeWalt DA (2015)

Known-groups validity

Measure/Groups of patients: Difference in Mobility scores between groups of children classified in groups according to their asthma control: good asthma control (n= 78) and poor asthma control (n= 59)
A combination of short and long versions were administered. None identified to distinguish between the results was given. The version number used was also Not mentioned.
A priori hypotheses: PROMIS measure would be sensitive to differences in health status
Were hypotheses confirmed: Yes
Results: t-test
Mobility scores were significantly higher 50(±8) in the good asthma control group than in the poor asthma control group 43(±7), t-test= 5.50; p<0.001
Population/Disease: Patients with asthma; n= 137 (mean age 12.04)

Measure/Groups of patients: Difference in Mobility scores between groups of children with cancer in active treatment (n= 93) or had completed cancer treatment, a survivorship group (n= 107)
A combination of short and long versions were administered. None identified to distinguish between the results was given. The version number used was also Not mentioned.
A priori hypotheses: PROMIS measure would be sensitive to differences in health status
Were hypotheses confirmed: Yes
Results: t-test
Mobility scores were significantly higher 51(±9) in the survivorship group than in the active treatment group 42(±9), t-test= 6.45; p<0.001
Population/Disease: Patients with cancer treatment; n= 200 (mean age 12.87)

Measure/Groups of patients: Difference in Mobility scores between groups of children with sickle cell disease classified in two groups: those who had received home treatment for pain in the past week (n= 72) and those who had Not (n= 162).
A combination of short and long versions were administered. None identified to distinguish between the results was given. The version number used was also Not mentioned.
A priori hypotheses: PROMIS measure would be sensitive to differences in health status
Were hypotheses confirmed: Yes
Results: t-test
Mobility scores were significantly higher 52(±7) in the No home treatment for pain in the past week group than in home treatment for pain in past week group 47(±10), t-test= 3.62; p<0.01
Population/Disease: Patients with sickle cell disease; n= 234 (mean age 12.49)

Measure/Groups of patients: Difference in Mobility scores between groups of children with obesity classified into two groups: BMI percentile < 99th (n= 69) and BMI percentile ≥ 99th (n= 67)
A combination of short and long versions were administered. None identified to distinguish between the results was given. The version number used was also Not mentioned.
A priori hypotheses: PROMIS measure would be sensitive to differences in health status
Were hypotheses confirmed: Yes
Results: t-test
Mobility scores were significantly higher 52(±6) in the BMI percentile < 99th group than BMI percentile ≥ 99th group 48(±8), t-test= 3.12; p<0.01
Population/Disease: Patients with sickle cell disease; n= 234 (mean age 11.90)

Measure/Groups of patients: Difference in Mobility scores between groups of children with pediatric kidney disease classified according to the glomerular filtration rate (eGFR) : CKD Stage 1 and 2 (eGFR ≥ 60; n= 169), CKD Stage 3 and 4 (eGFR 16-59; n= 80); CKD Stage 5 (eGFR ≤ 15; n= 26).
A combination of short and long versions were administered. None identified to distinguish between the results was given. The version number used was also Not mentioned.
A priori hypotheses: PROMIS measure would be sensitive to differences in health status
Were hypotheses confirmed: Yes
Results: ANOVA with Tukey post-hoc
Mobility scores were significantly higher 53(±8) in the CKD Stage 1 and 2 (eGFR ≥ 60) group than in CKD Stage 5 (eGFR ≤ 15) 46(±8), F= 6.69; p<0.05
Mobility scores were significantly higher 52(±8) in the CKD Stage 3 and 4 (eGFR 16-59)) group than in CKD Stage 5 (eGFR ≤ 15) 46(±8), F= 6.69; p<0.05
Population/Disease: Patients with chronic kidney disease ; n= 275 (mean age 13.40)

Measure/Groups of patients: Difference in Mobility scores between groups of children with active nephrotic syndrome (n= 53) or inactive nephrotic syndrome (n= 96)
A combination of short and long versions were administered. None identified to distinguish between the results was given. The version number used was also Not mentioned.
A priori hypotheses: PROMIS measure would be sensitive to differences in health status
Were hypotheses confirmed: Yes
Results: t-test
Mobility scores were significantly higher 54(±7) in the inactive nephrotic syndrome group than in the active nephrotic syndrome group 49(±10), t-test= 3.25; p<0.01
Population/Disease: Patients with or without nephrotic syndrome; n= 149 (mean age 13.40)

Measure/Groups of patients: Difference in Mobility scores between groups of children with different rheumatic disease (juvenile dermatomyositis, juvenile idiopathic arthritis, systemic lupus erythematosus) classified by the number of school days missed: 3 or more (n= 137) or 0 to 2 (n= 169)
A combination of short and long versions were administered. None identified to distinguish between the results was given. The version number used was also Not mentioned.
A priori hypotheses: PROMIS measure would be sensitive to differences in health status
Were hypotheses confirmed: Yes
Results: t-test
Mobility scores were significantly higher 51(±9) in the 0 to 2 school days missed group than in the more than 3 school days missed group 48(±11), t-test= 2.56; p<0.05
Population/Disease: Patients with rheumatic disease; n= 306 (mean age 12.83)

Measure/Groups of patients: Difference in Mobility scores between groups of children which had been hospitalized one or more times in the past 6 months (n= 284) or Not (n= 759)
A combination of short and long versions were administered. None identified to distinguish between the results was given. The version number used was also Not mentioned.
A priori hypotheses: PROMIS scores would be higher in the group of children without hospitalization during the past 6 months
Were hypotheses confirmed: Yes
Results: t-test
Mobility scores were significantly higher 51(±9) in the Non-hospitalized group than in the group of children with one or more hospitalizations during the past 6 months 46(±10), t-test= 7.53; p<0.001
Population/Disease: Patients with or without one or more hospitalization during the past 6 months; n= 1043 (age range 8-17, mean age Not stated)

Dampier C (2016)
KNown-groups validity
1- Measure/Groups of patients: Patients with current hip or joint issues (n= 40) vs patients without current hip or joint issues (n= 194)
- Results: T-test; Linear Regression Modeling; all results p< 0.01
- Mobility scores were significanty higher in patients without current hip or joint issues (51.9, SD 7.6) than in patients with current hip or joint issues (43.8, SD 9.2)
- There were significant relationships between Mobility scores and current hip or joint issues (Regression coefficient: -6.2, Standard Error (SE): 1.7)
- Population/Disease: Children and adolescents diagNosed with Sickle Cell Disease (mean age 12.5, SD 2.8); n= 234

2- Measure/Groups of patients: Patients who experienced pain at home in the past 7 days (n= 72) vs patients who did Not experience pain at home in the past 7 days (n= 162)
- Results: T-test; Linear Regression Modeling; all results p< 0.01
- Mobility scores were significanty higher in patients who did Not experience pain (52.4, SD 6.8) than in patients who experienced pain (46.9, SD 9.8)
- There were significant relationships between Mobility scores and pain in the past 7 days (Regression coefficient: -4.4, SE: 1.3)
- Population/Disease: Children and adolescents diagNosed with Sickle Cell Disease (mean age 12.5, SD 2.8); n= 234

3- Measure/Groups of patients: Number of pain episodes managed at home, number of emergency deparmtment (ED) visits for pain, and number of hospitalizations in the past 6 months
- Results: Linear Regression Modeling. There were significant relationships between Mobility scores and number of pain episodes managed at home (Regression coefficient: -0.2, Standard Error (SE): 0.1; p< 0.01), number of ED visits (Regression coefficient: -1.0, SE: 0.3; p< 0.01) and number of hospitalizations (Regression coefficient: -0.8, SE: 0.3; p< 0.05)
- Population/Disease: Children and adolescents diagnosed with Sickle Cell Disease (mean age 12.5, SD 2.8); n= 153

Evidence of Translatability Assessment: None identified

Evidence related to missing data: None identified

Evidence for Selection of Recall Period: Yes

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):

Reeve BB (2018)
- Population/Disease: Children 8–17 years with cancer (n= 96), Nephrotic Syndomre (n= 127) and Sickle Cell Disease (n= 121)
- Time horizon: Assessment points based on disease events (T2)
- Statistics used: Linear Mixed Models
Results: Mean scores worsened from T1 (baseline) to T2 (event) (p < 0.05) as expected, and significantly improved from T2 to T3 (b= 3.7; p< 0.001) and from T2 to T4 (p < 0.05).
- Magnitude of change: The MID of 3 points was exceeded going from T2 to T3 and from T2 to T4.

Reeve BB (2016)
- Population/Disease: Children 8–18 years with cancer (n= 90), Nephrotic Syndrome (n= 114) and Sickle Cell Disease (n= 88)
- Time horizon: Assessment points based on disease events (T2)
- Statistics used: Linear Mixed Models
Results: Relative to T2, mean scores were significantly improved at T1, T3 and T4 (p< 0.05)
- Magnitude of change: mean improvement of 2.55 to 6.40 points

Dampier C_Jaeger B (2016)
- Population/Disease: 21 children diagNosed with Sickle Cell Disease (mean age 12.5 (SD 3.1))
- Time horizon: Pain hospitalization (16.6 ± 19.1 months from baseline visit)
- Statistics used: Generalized Linear Model
Results: Mobility scores significantly decreased during pain hospitalization in comparison to scores from the initial clinic visits (p< 0.01)
- Magnitude of change: Mean difference –5.6 (Standard Error: 1.8)

Responder Thresholds:

Healthmeasures Website
- Population/Disease: Referent population (age Not stated)
- Method used: CID - Distribution
- Results: T score (50±10)

Thissen (2016)
- Population/Disease: Adolescents (n= 78, mean age 19.6 (1.5)), Parents (n= 85, mean age 42.9(7.9)) recruited at four clinical sites using PROMIS in pediatric populations with specific diseases (cancer, sickle cell disease, asthma, nephrotic syndrome) and clinicians (n=83, mean age 41.6(9.2))
- Methods used: CID Scale-judgment methods
- Results:
clinicians: 2 points
parents/adolescent: 3 points

Evidence of responder thresholds: Yes

Dampier C, Jaeger B, Gross HE, et al. Responsiveness of PROMIS® Pediatric Measures to Hospitalizations for Sickle Pain and Subsequent Recovery. Pediatr Blood Cancer. 2016;63(6):1038-1045. doi:10.1002/pbc.25931 (https://onlinelibrary.wiley.com/doi/full/10.1002/pbc.25931)

Dampier, C., Barry, V., Gross, H.E., Lui, Y., Thornburg, C.D., DeWalt, D.A. and Reeve, B.B. (2016), Initial Evaluation of the Pediatric PROMIS® Health Domains in Children and Adolescents With Sickle Cell Disease. Pediatr Blood Cancer, 63: 1031-1037 (https://onlinelibrary.wiley.com/doi/full/10.1002/pbc.25944)

DeWalt DA, Rothrock N, Yount S. Evaluation of item candidates: the PROMIS qualitative item review. Med Care. 2007 May;45(5 Suppl 1):S12-21. (Full Text Article) (https://pubmed.ncbi.nlm.nih.gov/17443114/)

DeWitt EM, Stucky BD, Thissen D. Construction of the eight-item patient-reported outcomes measurement information system pediatric physical function scales: built using item response theory. J Clin Epidemiol. 2011 Jul;64(7):794-804. (Full Text Article) (https://pubmed.ncbi.nlm.nih.gov/21292444/)

Irwin DE, Varni JW, Yeatts K. Cognitive interviewing methodology in the development of a pediatric item bank: a patient reported outcomes measurement information system (PROMIS) study. Health Qual Life Outcomes. 2009 Jan 23;7:3. (Full Text Article) (https://pubmed.ncbi.nlm.nih.gov/19166601/)

Irwin DE, Stucky BD, Thissen D. Sampling plan and patient characteristics of the PROMIS pediatrics large-scale survey. Qual Life Res. 2010 May;19(4):585-94. (Full Text Article) (https://pubmed.ncbi.nlm.nih.gov/20204706/)

Reeve, B.B., Edwards, L.J., Jaeger, B.C. et al. Assessing responsiveness over time of the PROMIS® pediatric symptom and function measures in cancer, nephrotic syndrome, and sickle cell disease. Qual Life Res 27, 249–257 (2018)

[Conference Abstract] Reeve B.B., Edwards L.J., Jaeger B.C., et al Assessing responsiveness over time of the PROMIS pediatric health-related quality of life measures in 3 chronic diseases. Qual. Life Res.. 2016;25(1 Supplement 1):47-48

Quinn, H., Thissen, D., Liu, Y. et al. Using item response theory to enrich and expand the PROMIS® pediatric self report banks. Health Qual Life Outcomes 12, 160 (2014) (https://hqlo.biomedcentral.com/articles/10.1186/s12955-014-0160-x)

Walsh TR, Irwin DE, Meier A. The use of focus groups in the development of the PROMIS pediatrics item bank. Qual Life Res. 2008 Jun;17(5):725-35. (Full Text Article) (https://pubmed.ncbi.nlm.nih.gov/18427951/)

None identified

None identified

Yes

Original Language: English for the USA

Translations:
Spanish for Spain
Chinese for China (Simplified)
German for Germany
Dutch for the Netherlands
Dutch-Flemish for the Netherlands and Flanders

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