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
- Overview
- Content Validity
- Reliability
- Validity
- Ability to Detect Change
- Responder Thresholds
- Reference(s) of development / validation
- Other references
- Inclusion of the COA in product labelling
- Inclusion of the COA in product labelling (agency, drug, drug approval date, COA results) from PROLABELS search
- Existence of Scoring / Interpretation / User Manual
- Original language and translations
- References of translations
- Authors and contact information
- Condition of use: copyright
- Website
- Review copy
Overview
Instrument Name: Patient-Reported Outcomes Information System Bank v1.0 Sleep Disturbance
Abbreviation: PROMIS Bank v1.0 SD
Points for Consideration:
None
Description of Tool:
The Bank v1.0 - Sleep Disturbance is a 27-item PRO developed to assess sleep disturbance in adults. Respondents are asked to rate the items on a 5-level scale "Never", "Rarely", "Sometimes", "Often" to "Always". Higher scores indicate greater sleep disturbance.
Other Related Tools (if applicable):
PROMIS Bank v1.0 – Sleep Disturbance (screen-to-CAT)
PROMIS Short Form v1.0 – Sleep Disturbance 8a
PROMIS Short Form v1.0 – Sleep Disturbance 8b
PROMIS Short Form v1.0 – Sleep Disturbance 6a
PROMIS Short Form v1.0 – Sleep Disturbance-OA-Knee 6a
PROMIS Short Form v1.0 – Sleep Disturbance 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 disturbance
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 27
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 disturbance
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: None identified
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=0.70
- 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 disturbance than self-reported no sleep disorder groups (p<0.001)
Participants with untreated sleep disorder had significantly higher mean scores for sleep disturbance 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
Inclusion of the COA in product labelling (agency, drug, drug approval date, COA results) from PROLABELS search
None identified
Existence of Scoring / Interpretation / User Manual
Yes
Original language and translations
Original language: English
Translations found on Health measures website:
Danish
Italian
Hungarian
Portuguese (Brazil)
Korean
Spanish
Dutch
Dutch-Flemish
French
German
Hebrew
Latvian
Portuguese (Portugal)
Traditional Chinese
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
Condition of use: copyright
© 2008-2022 PROMIS Health Organization (PHO) This material can be reproduced without permission by clinicians for use with their own patients. Any other use, including electronic use, requires written permission of the PHO.
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
Website
https://www.healthmeasures.net/
Review copy
https://www.healthmeasures.net/