PROMIS Pediatric Bank v2.0- Pain interference

Instrument Name: PROMIS Pediatric Bank v2.0- Pain interference

Abbreviation: None

Points for Consideration:

The GenPop (general population) v3.0 Pediatric replaced the v2.0 measures based on a sample from the general pediatric population to make a PROMIS score easier as it is referencing just the general population. No items were revised between the v2.0 and GenPop v3.0 Pain Interference measures.

Description of Tool:

The PROMIS Pain Interference domain is a 20-item PRO developed to measure the consequences of pain on relevant aspects of one's life, including the extent to which pain hinders engagement with social, cognitive, emotional, physical and recreational activities in children aged 8-17 years. Patients are asked to rate their pain interference on a 5-level scale "Never", "Almost Never", "Sometimes", "Often", "Almost Always". Higher scores represent greater pain interference.

Other Related Tools (if applicable):

PROMIS Pediatric Bank GenPop v3.0 - Pain Interference.
A short form also exists: PROMIS Pediatric Short Form v2.0 - Pain Interference 8a
Parent proxy versions also exist: PROMIS Parent Proxy Bank v2.0 - Pain Interference and the PROMIS Parent Proxy Short Form v2.0 - Pain Interference 8a
An adult item bank and short forms also exist: PROMIS Bank v1.1 - Pain Interference, PROMIS Short Form v1.1 - Pain Interference 4a, PROMIS Short Form v1.1 - Pain Interference 6a, PROMIS Short Form v1.1 - Pain Interference 6b and the PROMIS Short Form v1.1 - Pain Interference 8a

Minimum Qualification Required by COA Administrator: No degree requirement

Comment:

Assesses consequences of pain on social, cognitive, emotional, physical and recreational activities

Year: 2010

Objective of Development:

To assess the negative effects of pain on functioning experienced by the vast majority of pediatrics who have pain

Population of Development: Age range (therapeutic indication):

Age range: 8-17 years (non disease specific)

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

General population sample of children; Asthma; ADD/ADHD/Arthritis; Gastrointestinal Disorders; Mental disorders; Immune disorders; Chron's disease; Chronic kidney disease; Cancer; Sickle Cell Disease; Type 1 diabetes

COA type: PRO

Number of Items 20

Mode of Administration: Self-administered

Data Collection Mode: Paper and pen or digital administration

Time for Completion: No information

Response Scales: 5-point Likert scale ranging from 1="Never", 2="Almost never", 3="Sometimes", 4="Often", 5="Almost always"

Summary of Scoring:

Available scores: The PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
Raw Summed Score (8-40)
T-Score (34-78)- a score of 40 is one SD lower than the mean of the reference population; a score of 60 is one SD higher than the mean of the reference population
Standard error (SE) on T-score metric (3.0-3.6)

Weighting: No.

Score Interpretation: Higher PROMIS T-score represents more of the concept being measured i.e., higher score=greater pain interference.

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: Yes

Recall/Observation Period: 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: Yes

Internal consistency (Cronbach's alpha): Yes

Evidence of internal consistency: Varni JW (2010) - Method: Calculating an Item Response Theory (IRT) simulation-based reliability for the scores: a posteriori (SFuEAP) estimates and short form summed score expected a posteriori (SFxEAP) estimates - Results: SFuEAP: 0.88 SFxEAP: 0.87 - Population/disease: children between ages 8 and 17 from general pediatrics and subspecialty clinics; n=54

Test-retest Reliability (ICC):

Varni JW (2010)
Test-retest reliability
Correlation Coefficient used: not stated. Correlations for the short form scores were 0.62 and 0.66, and the correlation for the CAT scores was 0.65
Was a definition of stability applied to identify stable patients: No
Time frame between the two administrations: 2 weeks
Population/disease: Children between ages 8 and 17 from general pediatrics and subspecialty clinics; n=54

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

None identified

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

Concurrent validity (convergent, divergent):

None identified

Known-group validity:

Dampier C (2016)
- Measure/Groups of patients: 12-17 vs 8-11 years; male vs female; SC/SB+ thalassemia vs SS/SB0 thalassemia (genotype); hip pain vs no hip pain (parent report); pain in past 7 days vs no pain in past 7 days; home vs emergency department managed pain)
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results
Age: Adolescents (aged 12-17) years reported significantly higher pain interference scores than younger children (aged 8-11 years) (p<0.01) Gender: Females reported significantly higher pain interference scores than males (p<0.05) Genotype: No significant differences Hip pain: Significantly higher pain interference scores were reported by participants with hip or joint problems (p<0.05) Pain in past 7 days: Significantly higher pain interference scores were reported by participants who experienced pain in past 7 days than no pain (p<0.01) Pain management: The number of pain episodes managed at home, emergency department visits and hospitilizations for pain in the past 6 months were significantly and positively associated with increase in pain interference scores (p<0.05) - Population/Disease: Participants (mean age 12.5 +/- 2.8 years, 49.8% female) with sickle cell disease; n=235

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: Yes

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):

Singh A (2020)
- Method: Responsiveness to change was assessed by comparing PROMIS scores at three timepoints (Time 0: acute care facility visit (emergency department ot hospitalization) for vaso-occlusive; Time 1: 7 to 10 days; Time 2: 1-3 months post treat and discharge) using linear mixed models, distribution-based methods and anchor-based methods.
- Results:
There was a significant change in PROMIS T scores for pain interference at 7-10 (-6.0; p<0.01; -10.3 to -1.8 95% CI) and 1-3 months (-11.1; p<0.01; -15.2 to -7.0 95% CI) compared with the scores at the time of the acute care visit (linear mixed models). At 7-10 days (n=30), there was a moderate effect size (0.54) and a large effect size was observed at 1-3 months (n=43; 0.87). The SEM estimates for pain interference was less than four. At the 7-to 10-day (time 1) assessment (n=30), 46.7% had greater than a 1 SEM improvement in score. At the 1-3 month (time 2) assessment (n=43), 65.1% had greater than a 1 SEM improvement in score (Distribution-based method) At the 7-10 day follow-up, there was no significant change for the pain interference scores among children who reported little to no improvment since the acute care visit. Among those who reported considerable improvement, there was a significant change (p value not reported) in pain interference scores (mean change= -6.7; -11.3 to -2.0 95% CI) at 7-10 days (n=34) and at 1-3 months (p value not reported; mean change=-13.5; -17.0 to -9.9 95% CI) (anchor based method) Population/Disease: Children (aged 8 years and older) with sickle cell disease; n=67

Responder Thresholds:

Health Measures website:
Improvement: 10 points (patients and clinicians)
Deterioration: 10 points (patients), 5 points (clinicians)

Evidence of responder thresholds: Yes

Walsh, T. R., Irwin, D. E., Meier, A., Varni, J. W., & DeWalt, D. A. (2008). The use of focus groups in the development of the PROMIS pediatrics item bank. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 17(5), 725–735. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/18427951/

Irwin, D. E., Varni, J. W., Yeatts, K., & DeWalt, D. A. (2009). Cognitive interviewing methodology in the development of a pediatric item bank: a patient reported outcomes measurement information system (PROMIS) study. Health and quality of life outcomes, 7, 3. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/19166601/

Varni, J. W., Stucky, B. D., Thissen, D., Dewitt, E. M., Irwin, D. E., Lai, J. S., Yeatts, K., & Dewalt, D. A. (2010). PROMIS Pediatric Pain Interference Scale: an item response theory analysis of the pediatric pain item bank. The journal of pain, 11(11), 1109–1119. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/20627819/

DeWalt, D. A., Rothrock, N., Yount, S., Stone, A. A., & PROMIS Cooperative Group (2007). Evaluation of item candidates: the PROMIS qualitative item review. Medical care, 45(5 Suppl 1), S12–S21. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/17443114/

Varni, J. W., Magnus, B., Stucky, B. D., Liu, Y., Quinn, H., Thissen, D., Gross, H. E., Huang, I. C., & DeWalt, D. A. (2014). Psychometric properties of the PROMIS ® pediatric scales: precision, stability, and comparison of different scoring and administration options. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 23(4), 1233–1243. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/24085345/

Dampier, C., Barry, V., Gross, H. E., Lui, Y., Thornburg, C. D., DeWalt, D. A., & Reeve, B. B. (2016). Initial Evaluation of the Pediatric PROMIS® Health Domains in Children and Adolescents With Sickle Cell Disease. Pediatric blood & cancer, 63(6), 1031–1037. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/26895143/

Singh, A., Dasgupta, M., Simpson, P. M., Brousseau, D. C., & Panepinto, J. A. (2020). Can PROMIS domains of pain and physical functioning detect changes in health over time for children with sickle cell disease?. Pediatric blood & cancer, 67(5), e28203. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/32026613/

Carle, A. C., Bevans, K. B., Tucker, C. A., & Forrest, C. B. (2021). Using nationally representative percentiles to interpret PROMIS pediatric measures. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 30(4), 997–1004.Full Text Article: https://pubmed.ncbi.nlm.nih.gov/33201388/

Scoring and implementation: https://www.healthmeasures.net/index.php

GenPop v3.0: https://www.healthmeasures.net/images/PROMIS/Differences_Between_PROMIS_Measures/PROMIS_Pain_Interference_Measure_Differences_05Dec2023.pdf

Translations avaliable: https://www.healthmeasures.net/explore-measurement-systems/promis/intro-to-promis/available-translations

None identified

None identified

Yes

Original language: English for the UK

Translations:
Flemish
Finnish
Swedish
Bulgarian
Greek
Hungarian
Dutch
Spanish
Translations may be requested by contacting: translations@healthmeasures.net.

None identified

Varni JW
Department of Pediatrics
College of Medicine
Department of Landscape Architecture and Urban Planning, College of Architecture
Texas A&M University
College Station
TX, USA

Contact: help@healthmeasures.net

© 2010-2016 PROMIS Health Organization and PROMIS Cooperative Group

Measures can be obtained here: https://www.healthmeasures.net/index.php?Itemid=992)
- Paper-based measures are available in PDF form.
- PROMIS measures are available for digital administration (Computer Adaptive Tests [CATs]. short forms and profiles)
- Electronic administration of the measures for other purposes or by commercial users require HealthMeasures Electronic Administration Permission (HEAP), which includes a permission letter and screenshot review. Single research studies by non-commercial users are exempt from the HEAP requirement.

HEAP fees (charged for the review and approval process):
- Paper administration of English or Spanish measure: free
- Non-commercial electronic administration of English or Spanish measure for research: free
- Non-commercial use of existing measures: $550 per measure for study duration or 3-year term.
- Commercial use of existing measures: $700 per measure for study duration or 3-year term.
- Non-commercial use of custom measures: $700 per measure for study duration or 3-year term.
- Commercial use of custom measures: $850 per measure for study duration or 3-year term.
- Commercial use of all non-English translated measures: by quote.

More information can be found here: https://www.healthmeasures.net/explore-measurement-systems/promis/obtain-administer-measures

https://www.healthmeasures.net/

https://www.healthmeasures.net/