Patient-Reported Outcomes Information System Bank v1.0 Sleep-Related Impairment

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

Sleep
Sleep impact

Overview

Instrument Name: Patient-Reported Outcomes Information System Bank v1.0 Sleep-Related Impairment

Abbreviation: PROMIS Bank v1.0 - SRI

Points for Consideration:

None

Description of Tool:

The Bank v1.0 - Sleep-Related Impairment is a 16-item PRO developed to assess sleep related impairment in adults. Respondents are asked to rate the items on a 5-level scale rangng from "Never", "Rarely", "Sometimes", "Often", to "Always". Higher scores indicate greater sleep-related impairment.

Other Related Tools (if applicable):

PROMIS Short Form v1.0 – SleepRelated Impairment 8a
PROMIS Short Form v1.0 – SleepRelated Impairment 4a
Differences between PROMIS measures can be found here: https://www.healthmeasures.net/images/PROMIS/Differences_Between_PROMIS_Measures/PROMIS_Sleep_Measure_Differences_05Dec2023.pdf

Minimum Qualification Required by COA Administrator: No degree requirement

Comment:

None

Year: 2010

Objective of Development:

To assess sleep-related impairment

Population of Development: Age range (therapeutic indication):

Age range: 23-80 years (Sleep disorder; Psychiatric; Normal sleepers)

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

None identified

COA type: PRO

Number of Items 16

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 to 5: 1="Never", 2="Rarely", 3="Sometimes", 4="Often", 5="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.

Weighting: No

Score Interpretation: Higher score=Greater sleep-related impairment


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: Yes

Evidence of a Saturation Grid: None identified

Evidence for Selection of Data Collection Method: None identified

Recall/Observation Period: Past 7-days

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: None identified

Evidence related to respondent and administrator burden: None identified

Evidence of a Conceptual Framework: Yes

Evidence of an item-tracking matrix: Yes

Evidence related to item selection: Yes

Evidence of re-testing the final version: Yes


Reliability

Internal consistency (Cronbach's alpha): None identified

Evidence of internal consistency: None identified

Test-retest Reliability (ICC):

None identified

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

None identified

Evidence of test-retest or inter-rater reliability: None identified


Validity

Concurrent validity (convergent, divergent):

Buysse DJ (2010)
- Correlation coefficient used: Product-moment correlation coefficient
- Measures: Pittsburgh Sleep Quality Index (PSQI)
- Results: r=0.85
- Population/Disease: Adults (aged 23-80 years) from the community with (n=734) and without self-reported sleep disorder (n=1259), and with clinically diagnosed sleep disorder (n=259)

Known-group validity:

Buysse DJ (2010)
- Measure/Groups of patients: Self-reported insomnia (n=258), sleep apnea (n=505), restless legs syndrome (n=132) vs no sleep disorder (n=1342); Untreated vs treated clinical sleep disorder
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results:
Participants with self-reported sleep disorder had significantly higher mean scores for sleep-related impairment than self-reported no sleep disorder groups (p<0.001) Participants with untreated sleep disorder had significantly higher mean scores for sleep-related impairment than those who received treatment (p<0.001) - Population/Disease: Adults (aged 23-80 years) from the community with (n=734) and without self-reported sleep disorder (n=1259), and with clinically diagnosed sleep disorder (n=259)

Evidence of Translatability Assessment: Yes

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: Yes

Evidence of known-groups validity: Yes

Evidence of ability to detect change over time: None identified


Ability to Detect Change

Ability to detect change (Responsiveness):

None identified


Responder Thresholds

Responder Thresholds:

None identified

Evidence of responder thresholds: None identified


Reference(s) of development / validation

Buysse, D. J., Yu, L., Moul, D. E., Germain, A., Stover, A., Dodds, N. E., Johnston, K. L., Shablesky-Cade, M. A., & Pilkonis, P. A. (2010). Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep, 33(6), 781–792. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/20550019/


Other references

Differences between PROMIS measures: https://www.healthmeasures.net/images/PROMIS/Differences_Between_PROMIS_Measures/PROMIS_Sleep_Measure_Differences_05Dec2023.pdf

Scoring instructions: https://www.healthmeasures.net/administrator/components/com_instruments/uploads/PROMIS%20Sleep%20Scoring%20Manual_05Dec2023.pdf

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


Inclusion of the COA in product labelling

None identified


Existence of Scoring / Interpretation / User Manual

Yes


Original language and translations

Original language: English

Translations found on Health measures website:
Spanish
Dutch
Dutch-Flemish
French
Hebrew
Traditional Chinese
Portuguese
Simplified Chinese (Mandarin)
Arabic
Translations may be requested by contacting: translations@healthmeasures.net.


References of translations

Dutch-Flemish
Terwee, C. B., Roorda, L. D., de Vet, H. C., Dekker, J., Westhovens, R., van Leeuwen, J., Cella, D., Correia, H., Arnold, B., Perez, B., & Boers, M. (2014). Dutch-Flemish translation of 17 item banks from the patient-reported outcomes measurement information system (PROMIS). Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 23(6), 1733–1741. https://doi.org/10.1007/s11136-013-0611-6


Authors and contact information

Authors: Daniel J. Buysse, MD, Lan Yu, PhD, Douglas E. Moul, MD, MPH, Anne Germain, PhD, Angela Stover, MA, Nathan E. Dodds, BS, Kelly L. Johnston, MPH, Melissa A. Shablesky-Cade, Paul A. Pilkonis, PhD

Contact:
Dr. Buysse,
3811 O’Hara ST, Pittsburgh,
PA 15213; Tel: (412) 246-6413; Fax: (412) 246-5300;
E-mail address: buyssedj@upmc.edu


Website

https://www.healthmeasures.net/


Review copy

https://www.healthmeasures.net/