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PROMIS-29
Availability
The instrument is freely available here: PROMIS website.
Classification
Supplemental – Highly Recommended: Stroke
Short Description of Instrument
The Patient Reported Outcomes Measurement Information System (PROMIS) Version 1.0 contains 12 calibrated item banks with Likert style items (e.g., anger, anxiety, depression, fatigue (Cella et al., 2010; Garcia et al., 2007), pain (Amtmann et al., 2010), physical function, satisfaction with social activities and roles, sleep/wake disturbance (Bruni et al., 1996, 1994; Spruyt & Gozal 2011), and global health (Cella et al., 2010; Hays et al., 2009)). It is part of the NIH goal to develop systems to support NIH-funded research supported by all of its institutes and centers. PROMIS measures cover physical, mental, and social health and can be used across chronic conditions.
 
The instrument is domain-focused (domains listed above) rather than specific to a particular disease; however, a disease-customized measurement approach can be utilized by choosing the PROMIS measures most relevant to the specific disease. See: PROMIS Domain Framework for pediatric and adult domains.
 
PROMIS-29 includes seven HRQOL domains (physical functioning, anxiety, depression, fatigue, sleep disturbance, social functioning, and pain), and the pain domain has two subdomains (interference and intensity). Each of the seven domains has four 5-level items (i.e., 16 decrements each). In addition to these items, pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain (10), adding 10 additional decrements.
 
Administration:  Fixed length scale
 
Time: Approximately 20 minutes
 
Ages: Adult (ages 18+)
 
Cost: No licensing or royalty fees for English and Spanish PROMIS measures used in individual research, clinical practice, educational assessment or other application. Translations in other languages have a distribution fee. Permission is required for commercial use or integration into proprietary technology; see PROMIS Terms and Conditions of Use for details.
 
Afrikaans, Arabic, Bosnian, Bulgarian, Croatian, Czech, Dutch, English, Finnish, French, Georgian, German, Greek, Gujarati, Hebrew, Hungarian, Italian, Kannada, Kazakh, Korean, Latvian, Lithuanian, Macedonian, Malay, Malayalam, Marathi, Norwegian, Odia/Orya, Polish, Portuguese, Punjabi, Romanian, Russian, Serbian, Simplified Chinese (Mandarin), Slovak, Spanish, Swedish, Tamil, Telugu, Thai, Traditional Chinese, Turkish, Ukranian, Urdu; see PROMIS Translations for details.
 
Advantages: Brief, yet reliable.
 
Comments/Special Instructions
N/A
Scoring and Psychometric Properties
Scoring: T scores for all scales. For the PROMIS – 29 Adult Profile 2.1 instrument, an Anxiety raw score of 10 converts to a T-score of 59.5 with a standard error (SE) of 2.6 (see scoring table for the 4a short form v2.1 in Appendix 1 of the PROMIS Scoring Manual). Thus, the 95% confidence interval around the observed score ranges from 54.4 to 64.6 (T-score + (1.96*SE) or 59.5 + (1.96* 2.6).
 
In all cases, a high score means more of domain. For example, higher scores on the fatigue measures indicate poorer health whereas higher scores on physical functioning measure indicate better health.
 
Standardization Population: For most domains, T-scores relate to the US General Population. See PROMIS Calibrations Testing for further details regarding sample for specific ages and domains.
 
Scoring Manuals is available at: PROMIS Global Scoring Manual.
 
Psychometric Properties: Substantial qualitative and quantitative evidence has been gathered that supports the validity of PROMIS measures. More information about validation is available at: PROMIS Validation
References
Allen J, Alpass FM, Stephens CV. The sensitivity of the MOS SF-12 and PROMIS® global summary scores to adverse health events in an older cohort. Qual Life Res. 2018;27(8):2207-2215.
 
Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 2010;150(1):173–182.
 
Barile JP, Reeve BB, Smith AW, Zack MM, Mitchell SA, Kobau R, Cella DF, Luncheon C, Thompson WW. Monitoring population health for Healthy People 2020: evaluation of the NIH PROMIS® Global Health, CDC Healthy Days, and satisfaction with life instruments. Qual Life Res. 2013;22(6):1201–1211.   
 
Blumenthal KJ, Chang Y, Ferris TG, Spirt JC, Vogeli C, Wagle N, Metlay JP. Using a Self-Reported Global Health Measure to Identify Patients at High Risk for Future Healthcare Utilization. J Gen Intern Med. 2017;32(8):877–882.   
 
Bruni O, Ottaviano S, Guidetti V, Romoli M, Innocenzi M, Cortesi F, Giannotti F. The Sleep Disturbance Scale for Children (SDSC) construction and validation of an instrument to evaluate sleep disturbances in childhood and adolescence. J Sleep Res. 1996;5(4):251–261.
 
Bruni O, Romoli M., Innocenzi M, Giannotti F, Cortesi F and Ottaviano S. Prevalenza dei disturbi del sonno in eth scolare. In: Di Perri R., Raffaele M., Silvestri R. and Smirne S. (Eds) 11 Sonno in ltaliu 1994. Poletto Ed., Milano, 1994 163–171.   
 
Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce BRM. The patient reported outcomes measurement information system (PROMIS): progress of an NIH roadmap cooperative group during its first two years. Med Care. 2007;45:S3–S11.   
 
Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. J Clin Epidemiol. 2010;63(11):1179–1194.   
 
Craig BM, Reeve BB, Brown PM, Cella D, Hays RD, Lipscomb J, Pickard AS, Revicki DA. US Valuation of Health Outcomes Measured Using the PROMIS-29. VALUE HEALTH. December 2017; 17(8): 846-853.   
 
Garcia SF, Cella D, Clauser SB, Flynn KE, Lad T, Lai JS, Reeve BB, Smith AW, Stone AA, Weinfurt K. Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative. J Clin Oncol. 2007;25(32):5106–5112.   
 
Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the PROMIS® measures of self-efficacy for managing chronic conditions. Qual Life Res. 2017;26(7):1915-1924.   
 
Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009;18(7):873–880.   
 
Hays RD, Revicki DA, Feeny D, Fayers P, Spritzer KL, Cella D. Using Linear Equating to Map PROMIS(®) Global Health Items and the PROMIS-29 V2.0 Profile Measure to the Health Utilities Index Mark 3. Pharmacoeconomics. 2016;34(10):1015-1022.   
 
Hays RD, Spritzer KL, Schalet BD, Cella D. PROMIS(®)-29 Profile Physical and Mental Health Summary Scores. Qual Life Res. 2018; 27(7): 1885-1891.    
 
Hinami K, Smith J, Deamant CD, DuBeshter K, Trick WE. When do patient-reported outcome measures inform readmission risk? J Hosp Med. 2015;10(5):294-300.   
 
Hinchcliff M, Beaumont, Thavarajah K, Varga J, Chung A, Podlusky S, Carns M, Chang RW, Cella D. Validity of two new patient-reported outcome measures in systemic sclerosis: Patient-Reported Outcomes Measurement Information System 29-Item Health Profile and Functional Assessment of Chronic Illness Therapy-Dyspnea short form. Arthritis Care Res. 2011;63(11):1620-1628.
 
Kobau R, Cui W, Zack MM. Adults with an epilepsy history fare significantly worse on positive mental and physical health than adults with other common chronic conditions-Estimates from the 2010 National Health Interview Survey and Patient Reported Outcome Measurement System (PROMIS) Global Health Scale. Epilepsy Behav. 2017;72:182-184.   
 
Revicki DA, Kawata AK, Harnam N, Chen WH, Hays RD, Cella D. Predicting EuroQol (EQ-5D) scores from the patient-reported outcomes measurement information system (PROMIS) global items and domain item banks in a United States sample. Qual Life Res. 2009;18(6):783-791.   
 
Spruyt K, Gozal D. Pediatric sleep questionnaires as diagnostic or epidemiological tools: a review of currently available instruments. Sleep Med Rev. 2011;15(1):19–32.   
 
Shulman LM, Velozo C, Romero S, Gruber-Baldini AL. Comparative study of PROMIS? self-efficacy for managing chronic conditions across chronic neurologic disorders. Qual Life Res. 2019 Mar 26. doi: 10.1007/s11136-019-02164-2. [Epub ahead of print]   
 
Thompson NR, Lapin BR, Katzan IL. Mapping PROMIS Global Health Items to EuroQol (EQ-5D) Utility Scores Using Linear and Equipercentile Equating. Pharmacoeconomics. 2017;35(11):1167-1176.   
 
Stroke Specific References:  
 
Katzan IL, Lapin B. PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) Scale in Stroke: A Validation Study. Stroke. 2018;49(1):147-154.   
 
Lam KH, Kwa VIH. Validity of the PROMIS-10 Global Health assessed by telephone and on paper in minor stroke and transient ischaemic attack in the Netherlands. BMJ Open. 2018;8(7):e019919.    
 
Lapin B, Thompson NR, Katzan IL. Letter by Lapin et al Regarding Article, "PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) Scale in Stroke: A Validation Study". Stroke. 2018;49(5):e214.   
 
Lapin BR, Thompson NR, Schuster A, Katzan IL. Patient versus proxy response on global health scales: no meaningful DIFference. Qual Life Res.  2019;28(6):1585-1594.   
 
Reeves MJ, Hughes AK, Woodward AT, Freddolino PP, Coursaris CK, Swierenga SJ, Schwamm LH, Fritz MC. Improving transitions in acute stroke patients discharged to home: the Michigan stroke transitions trial (MISTT) protocol. BMC Neurol. 2017;17(1):115.   
 
Salinas J, Sprinkhuizen SM, Ackerson T, Bernhardt J, Davie C, George MG, Gething S, Kelly AG, Lindsay P, Liu L, Martins SC, Morgan L, Norrving B, Ribbers GM, Silver FL, Smith EE, Williams LS, Schwamm LH. An International Standard Set of Patient-Centered Outcome Measures After Stroke. Stroke. 2016;47(1):180-186.