Improving outcomes for care partners of persons with traumatic brain injury: Protocol for a randomized control trial of a just-in-time-adaptive self-management intervention

Noelle E Carlozzi, Angelle M Sander, Sung Won Choi, Zhenke Wu, Jennifer A Miner, Angela K Lyden, Christopher Graves, Srijan Sen, Noelle E Carlozzi, Angelle M Sander, Sung Won Choi, Zhenke Wu, Jennifer A Miner, Angela K Lyden, Christopher Graves, Srijan Sen

Abstract

Informal family care partners of persons with traumatic brain injury (TBI) often experience intense stress resulting from their caregiver role. As such, there is a need for low burden, and easy to engage in interventions to improve health-related quality of life (HRQOL) for these care partners. This study is designed to evaluate the effectiveness of a personalized just-in-time adaptive intervention (JITAI) aimed at improving the HRQOL of care partners. Participants are randomized either to a control group, where they wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback), or the JITAI group, where they wear the Fitbit®, provide daily reports of HRQOL and receive personalized self-management pushes for 6 months. 240 participants will be enrolled (n = 120 control group; n = 120 JITAI group). Outcomes are collected at baseline, 1-, 2-, 3-, 4-, 5- & 6-months, as well as 3- and 6-months post intervention. We hypothesize that the care partners who receive the intervention (JITAI group) will show improvements in caregiver strain (primary outcome) and mental health (depression and anxiety) after the 6-month (180 day) home monitoring period. Participant recruitment for this study started in November 2020. Data collection efforts should be completed by spring 2025; results are expected by winter 2025. At the conclusion of this randomized control trial, we will be able to identify care partners at greatest risk for negative physical and mental health outcomes, and will have demonstrated the efficacy of this JITAI intervention to improve HRQOL for these care partners. Trial registration: ClinicalTrial.gov NCT04570930; https://ichgcp.net/clinical-trials-registry/NCT04570930.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. Study schema.
Fig 1. Study schema.
Consort flow diagram.
Fig 2. CareQOL app.
Fig 2. CareQOL app.
Screen shots of the different elements of the CareQOL App.

References

    1. Rothing M, Malterud K, Frich JC. Caregiver roles in families affected by Huntington’s disease: a qualitative interview study. Scand J Caring Sci. 2013. doi: 10.1111/scs.12098
    1. Verhaeghe S, Defloor T, Grypdonck M. Stress and coping among families of patients with traumatic brain injury: a review of the literature. J Clin Nurs. 2005;14(8):1004–12. doi: 10.1111/j.1365-2702.2005.01126.x
    1. Carlozzi NE, Kratz AL, Sander AM, Chiaravalloti ND, Brickell TA, Lange RT, et al.. Health-related quality of life in caregivers of individuals with traumatic brain injury: development of a conceptual model. Arch Phys Med Rehabil. 2015;96(1):105–13. doi: 10.1016/j.apmr.2014.08.021
    1. Carlozzi NE, Brickell TA, French LM, Sander A, Kratz AL, Tulsky DS, et al.. Caring for our wounded warriors: A qualitative examination of health-related quality of life in caregivers of individuals with military-related traumatic brain injury. J Rehabil Res Dev. 2016;53(6):669–80. doi: 10.1682/JRRD.2015.07.0136
    1. Hart T, Vaccaro M, Collier G, Chervoneva I, Fann JR. Promoting mental health in traumatic brain injury using single-session behavioral activation and SMS messaging: A randomized control trial. Neuropsychological Rehabilitation. In Press.
    1. Bendixen RM, Fairman AD, Karavolis M, Sullivan C, Parmanto B. A User-Centered Approach: Understanding Client and Caregiver Needs and Preferences in the Development of mHealth Apps for Self-Management. JMIR Mhealth Uhealth. 2017;5(9):e141. doi: 10.2196/mhealth.7136
    1. Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003;26(1):1–7. doi: 10.1207/S15324796ABM2601_01
    1. Muenchberger H, Kendall E, Kennedy A, Charker J. Living with brain injury in the community: outcomes from a community-based self-management support (CB-SMS) programme in Australia. Brain Inj. 2011;25(1):23–34. doi: 10.3109/02699052.2010.531689
    1. Niemeier JP, Kreutzer JS, Marwitz JH, Sima AP. A Randomized Controlled Pilot Study of a Manualized Intervention for Caregivers of Patients With Traumatic Brain Injury in Inpatient Rehabilitation. Arch Phys Med Rehabil. 2018. doi: 10.1016/j.apmr.2018.07.422
    1. Hart T, Driver S, Sander A, Pappadis M, Dams-O’Connor K, Bocage C, et al.. Traumatic brain injury education for adult patients and families: a scoping review. Brain Inj. 2018;32(11):1295–306. doi: 10.1080/02699052.2018.1493226
    1. Powell JM, Fraser R, Brockway JA, Temkin N, Bell KR. A Telehealth Approach to Caregiver Self-Management Following Traumatic Brain Injury: A Randomized Controlled Trial. J Head Trauma Rehabil. 2016;31(3):180–90. doi: 10.1097/HTR.0000000000000167
    1. Dikmen S, Corrigan JD, Levin HS, Machamer J, Stiers W, Weisskopf MG. Cognitive outcome following traumatic brain injury. J Head Trauma Rehab. 2009;24(6):430–8. doi: 10.1097/HTR.0b013e3181c133e9
    1. Dikmen S, Machamer JE, Winn HR, Temkin NR. Neuropsychological Outcome at 1-Year Post Head-Injury. Neuropsychology. 1995;9(1):80–90.
    1. Dikmen S, Mclean A, Temkin N. Neuropsychological and Psychosocial Consequences of Minor Head-Injury. J Neurol Neurosur Ps. 1986;49(11):1227–32. doi: 10.1136/jnnp.49.11.1227
    1. Dikmen S, Reitan RM, Temkin NR. Neuropsychological recovery in head injury. Arch Neurol-Chicago. 1983;40(6):333–8. doi: 10.1001/archneur.1983.04050060033004
    1. Burns AS, Marino RJ, Flanders AE, Flett H. Clinical diagnosis and prognosis following spinal cord injury. Handb Clin Neurol. 2012;109:47–62. doi: 10.1016/B978-0-444-52137-8.00003-6
    1. Ditunno JF Jr., Stover SL, Freed MM, Ahn JH. Motor recovery of the upper extremities in traumatic quadriplegia: a multicenter study. Arch Phys Med Rehabil. 1992;73(5):431–6.
    1. Waters RL, Yakura JS, Adkins RH, Sie I. Recovery following complete paraplegia. Arch Phys Med Rehabil. 1992;73(9):784–9.
    1. Waters RL, Adkins RH, Yakura JS, Sie I. Motor and sensory recovery following complete tetraplegia. Arch Phys Med Rehabil. 1993;74(3):242–7.
    1. Waters RL, Adkins RH, Yakura JS, Sie I. Motor and sensory recovery following incomplete paraplegia. Arch Phys Med Rehabil. 1994;75(1):67–72.
    1. Waters RL, Adkins R, Yakura J, Sie I. Donal Munro Lecture: Functional and neurologic recovery following acute SCI. J Spinal Cord Med. 1998;21(3):195–9. doi: 10.1080/10790268.1998.11719526
    1. Jorgensen HS, Nakayama H, Raaschou HO, Vive-Larsen J, Stoier M, Olsen TS. Outcome and time course of recovery in stroke. Part II: Time course of recovery. The Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995;76(5):406–12. doi: 10.1016/s0003-9993(95)80568-0
    1. Jorgensen HS, Nakayama H, Raaschou HO, Vive-Larsen J, Stoier M, Olsen TS. Outcome and time course of recovery in stroke. Part I: Outcome. The Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995;76(5):399–405. doi: 10.1016/s0003-9993(95)80567-2
    1. Corrigan JD, Cuthbert JP, Whiteneck GG, Dijkers MP, Coronado V, Heinemann AW, et al.. Representativeness of the Traumatic Brain Injury Model Systems National Database. J Head Trauma Rehab. 2012;27(6):391–403.
    1. Dimidjian S, Barrera M Jr., Martell C, Munoz RF, Lewinsohn PM. The origins and current status of behavioral activation treatments for depression. Annu Rev Clin Psychol. 2011;7:1–38. doi: 10.1146/annurev-clinpsy-032210-104535
    1. Dimidjian S, Hollon SD, Dobson KS, Schmaling KB, Kohlenberg RJ, Addis ME, et al.. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. J Consult Clin Psychol. 2006;74(4):658–70. doi: 10.1037/0022-006X.74.4.658
    1. Jacobson NS, Dobson KS, Truax PA, Addis ME, Koerner K, Gollan JK, et al.. A component analysis of cognitive-behavioral treatment for depression. J Consult Clin Psychol. 1996;64(2):295–304. doi: 10.1037//0022-006x.64.2.295
    1. Mazzucchelli T, Kane RA, Rees C. Behavioral Activation Treatments for Depression in Adults: A Meta-analysis and Review. Clinical Psychology: Science and Practice. 2009;16(4):383–411.
    1. Gawrysiak M, Nicholas C, Hopko DR. Behavioral Activation for Moderately Depressed University Students: Randomized Controlled Trial. J Couns Psychol. 2009;56(3):468–75.
    1. Hopko DR, Lejuez CW, Hopko SD. Behavioral Activation as an Intervention for Coexistent Depressive and Anxiety Symptoms Clinical Case Studies. 2004;3(1):37–48.
    1. NeCamp T, Sen S, Frank E, Walton MA, Ionides EL, Fang Y, et al.. Assessing Real-Time Moderation for Developing Adaptive Mobile Health Interventions for Medical Interns: Micro-Randomized Trial. Journal of medical Internet research. 2020;22(3):e15033. doi: 10.2196/15033
    1. Sen S, Kranzler HR, Krystal JH, Speller H, Chan G, Gelernter J, et al.. A prospective cohort study investigating factors associated with depression during medical internship. Arch Gen Psychiatry. 2010;67(6):557–65. doi: 10.1001/archgenpsychiatry.2010.41
    1. Carlozzi NE, Lange RT, French LM, Sander AM, Ianni PA, Tulsky DS, et al.. Understanding Health-Related Quality of Life in Caregivers of Civilians and Service Members/Veterans With TBI: Reliability and Validity Data for the TBI-CareQOL Measurement System. Arch Phys Med Rehabil. 2018. doi: 10.1016/j.apmr.2018.05.034
    1. Carlozzi NE, Kallen MA, Hanks R, Hahn EA, Brickell T, Lange R, et al.. The TBI-CareQOL Measurement System: Development and preliminary validation of health-related quality of life measures for caregivers of civilians and service members/veterans with traumatic brain injury. Archives of Physical Medicine & Rehabilitation. In Press. doi: 10.1016/j.apmr.2018.08.175
    1. Carlozzi NE, Kallen MA, Ianni PA, Hahn EA, French LM, Lange RT, et al.. The Development of a New Computer-Adaptive Test to Evaluate Strain in Caregivers of Individuals With TBI: TBI-CareQOL Caregiver Strain. Arch Phys Med Rehabil. 2018. doi: 10.1016/j.apmr.2018.05.033
    1. Carlozzi NE, Kallen MA, Sander AM, Brickell TA, Lange RT, French LM, et al.. The development of a new computer adaptive test to evaluate anxiety in caregivers of individuals with traumatic brain injury: TBI-CareQOL Caregiver-Specific Anxiety. Arch Phys Med Rehabil. 2018. doi: 10.1016/j.apmr.2018.05.027
    1. Fitzmaurice GM, Laird NM, Ware JH. Applied longitudinal analysis. Boston, MA: John Wiley & Sons; 2012.
    1. Holmen H, Torbjornsen A, Wahl AK, Jenum AK, Smastuen MC, Arsand E, et al.. A Mobile Health Intervention for Self-Management and Lifestyle Change for Persons With Type 2 Diabetes, Part 2: One-Year Results From the Norwegian Randomized Controlled Trial RENEWING HEALTH. JMIR Mhealth Uhealth. 2014;2(4):e57. doi: 10.2196/mhealth.3882
    1. Whitehead L, Seaton P. The Effectiveness of Self-Management Mobile Phone and Tablet Apps in Long-term Condition Management: A Systematic Review. Journal of medical Internet research. 2016;18(5):e97. doi: 10.2196/jmir.4883
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010;1(2):100–7. doi: 10.4103/0976-500X.72352
    1. Hoyer PO, Janzing D, Mooij JM, Peters J, Schölkopf B. Nonlinear causal discovery with additive noise models. Advances in neural information processing systems 2009.
    1. Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD, et al.. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309(8):814–22. doi: 10.1001/jama.2013.879
    1. Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol. 2010;115(5):1063–70. doi: 10.1097/AOG.0b013e3181d9d421
    1. Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, et al.. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2016:1–17.
    1. Nahum-Shani I, Hekler EB, Spruijt-Metz D. Building health behavior models to guide the development of just-in-time adaptive interventions: A pragmatic framework. Health Psychology. 2015;34(S):1209. doi: 10.1037/hea0000306
    1. Thomas JG, Bond DS. Behavioral response to a just-in-time adaptive intervention (JITAI) to reduce sedentary behavior in obese adults: Implications for JITAI optimization. Health Psychology. 2015;34(S):1261. doi: 10.1037/hea0000304
    1. King AC, Hekler EB, Grieco LA, Winter SJ, Sheats JL, Buman MP, et al.. Harnessing different motivational frames via mobile phones to promote daily physical activity and reduce sedentary behavior in aging adults. 2013.
    1. Gustafson DH, McTavish FM, Chih M-Y, Atwood AK, Johnson RA, Boyle MG, et al.. A smartphone application to support recovery from alcoholism: a randomized clinical trial. JAMA psychiatry. 2014;71(5):566–72. doi: 10.1001/jamapsychiatry.2013.4642
    1. Witkiewitz K, Desai SA, Bowen S, Leigh BC, Kirouac M, Larimer ME. Development and evaluation of a mobile intervention for heavy drinking and smoking among college students. Psychology of Addictive Behaviors. 2014;28(3):639. doi: 10.1037/a0034747
    1. Ben-Zeev D, Brenner CJ, Begale M, Duffecy J, Mohr DC, Mueser KT. Feasibility, acceptability, and preliminary efficacy of a smartphone intervention for schizophrenia. Schizophrenia bulletin. 2014:sbu033.
    1. Riley W, Obermayer J, Jean-Mary J. Internet and mobile phone text messaging intervention for college smokers. Journal of American College Health. 2008;57(2):245–8. doi: 10.3200/JACH.57.2.245-248
    1. Free C, Knight R, Robertson S, Whittaker R, Edwards P, Zhou W, et al.. Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial. The Lancet. 2011;378(9785):49–55. doi: 10.1016/S0140-6736(11)60701-0
    1. Lawton MP, Kleban MH, Moss M, Rovine M, Glicksman A. Measuring caregiving appraisal. Journal of gerontology. 1989;44(3):P61–71. doi: 10.1093/geronj/44.3.p61
    1. Struchen MA, Atchison TB, Roebuck TM, Caroselli JS, Sander AM. A multidimensional measure of caregiving appraisal: validation of the Caregiver Appraisal Scale in traumatic brain injury. J Head Trauma Rehabil. 2002;17(2):132–54. doi: 10.1097/00001199-200204000-00005
    1. Carlozzi NE, Lange R, French L, Sander AM, Ianni P, Tulsky DS, et al.. Reliability and validity data for the TBI-CareQOL measurement system: Data from caregivers of civilian- and military-related traumatic brain injury. Under Review.
    1. Malec J. The Mayo-Portland Adaptability Inventory. The Center for Outcome Measurement in Brain Injury 2005 [.
    1. Malec JF, Kean J, Altman IM, Swick S. Mayo-Portland adaptability inventory: comparing psychometrics in cerebrovascular accident to traumatic brain injury. Archives of Physical Medicine & Rehabilitation. 2012;93(12):2271–5. doi: 10.1016/j.apmr.2012.06.013
    1. Malec JF, Kragness M, Evans RW, Finlay KL, Kent A, Lezak MD. Further psychometric evaluation and revision of the Mayo-Portland Adaptability Inventory in a national sample. J Head Trauma Rehabil. 2003;18(6):479–92. doi: 10.1097/00001199-200311000-00002
    1. Malec JF, Moessner AM, Kragness M, Lezak MD. Refining a measure of brain injury sequelae to predict postacute rehabilitation outcome: rating scale analysis of the Mayo-Portland Adaptability Inventory. J Head Trauma Rehabil. 2000;15(1):670–82. doi: 10.1097/00001199-200002000-00006
    1. Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015;28(6):489–98. doi: 10.1002/jts.22059
    1. Verhey R, Chibanda D, Gibson L, Brakarsh J, Seedat S. Validation of the posttraumatic stress disorder checklist—5 (PCL-5) in a primary care population with high HIV prevalence in Zimbabwe. BMC Psychiatry. 2018;18(1):109. doi: 10.1186/s12888-018-1688-9
    1. Ashbaugh AR, Houle-Johnson S, Herbert C, El-Hage W, Brunet A. Psychometric Validation of the English and French Versions of the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). PLoS One. 2016;11(10):e0161645. doi: 10.1371/journal.pone.0161645
    1. Walker WC, McDonald SD, Franke LM. Diagnostic accuracy of Posttraumatic Stress Disorder Checklist in blast-exposed military personnel. J Rehabil Res Dev. 2014;51(8):1203–16. doi: 10.1682/JRRD.2013.12.0271
    1. Demirchyan A, Goenjian AK, Khachadourian V. Factor Structure and Psychometric Properties of the Posttraumatic Stress Disorder (PTSD) Checklist and DSM-5 PTSD Symptom Set in a Long-Term Postearthquake Cohort in Armenia. Assessment. 2015;22(5):594–606. doi: 10.1177/1073191114555523
    1. Dickstein BD, Weathers FW, Angkaw AC, Nievergelt CM, Yurgil K, Nash WP, et al.. Diagnostic Utility of the Posttraumatic Stress Disorder (PTSD) Checklist for Identifying Full and Partial PTSD in Active-Duty Military. Assessment. 2015;22(3):289–97. doi: 10.1177/1073191114548683
    1. Karstoft KI, Andersen SB, Bertelsen M, Madsen T. Diagnostic accuracy of the posttraumatic stress disorder checklist-civilian version in a representative military sample. Psychol Assess. 2014;26(1):321–5. doi: 10.1037/a0034889
    1. Gardner PJ, Knittel-Keren D, Gomez M. The Posttraumatic Stress Disorder Checklist as a screening measure for posttraumatic stress disorder in rehabilitation after burn injuries. Arch Phys Med Rehabil. 2012;93(4):623–8. doi: 10.1016/j.apmr.2011.11.015
    1. Lima Ede P, Barreto SM, Assuncao AA. Factor structure, internal consistency and reliability of the Posttraumatic Stress Disorder Checklist (PCL): an exploratory study. Trends Psychiatry Psychother. 2012;34(4):215–22. doi: 10.1590/s2237-60892012000400007
    1. Terhakopian A, Sinaii N, Engel CC, Schnurr PP, Hoge CW. Estimating population prevalence of posttraumatic stress disorder: an example using the PTSD checklist. J Trauma Stress. 2008;21(3):290–300. doi: 10.1002/jts.20341
    1. Bliese PD, Wright KM, Adler AB, Cabrera O, Castro CA, Hoge CW. Validating the primary care posttraumatic stress disorder screen and the posttraumatic stress disorder checklist with soldiers returning from combat. J Consult Clin Psychol. 2008;76(2):272–81. doi: 10.1037/0022-006X.76.2.272
    1. Elhai JD, Gray MJ, Docherty AR, Kashdan TB, Kose S. Structural validity of the posttraumatic stress disorder checklist among college students with a trauma history. J Interpers Violence. 2007;22(11):1471–8. doi: 10.1177/0886260507305569
    1. DuHamel KN, Ostrof J, Ashman T, Winkel G, Mundy EA, Keane TM, et al.. Construct validity of the posttraumatic stress disorder checklist in cancer survivors: analyses based on two samples. Psychol Assess. 2004;16(3):255–66. doi: 10.1037/1040-3590.16.3.255
    1. Ventureyra VA, Yao SN, Cottraux J, Note I, De Mey-Guillard C. The validation of the Posttraumatic Stress Disorder Checklist Scale in posttraumatic stress disorder and nonclinical subjects. Psychother Psychosom. 2002;71(1):47–53. doi: 10.1159/000049343
    1. Boake C. Supervision rating scale: a measure of functional outcome from brain injury. Arch Phys Med Rehabil. 1996;77(8):765–72. doi: 10.1016/s0003-9993(96)90254-3
    1. Buysse DJ, Yu L, Moul DE, Germain A, Stover A, Dodds NE, et al.. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep. 2010;33(6):781–92. doi: 10.1093/sleep/33.6.781
    1. Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, et al.. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007;45(5 Suppl 1):S3–S11. doi: 10.1097/01.mlr.0000258615.42478.55
    1. Bartlett SJ, Orbai AM, Duncan T, DeLeon E, Ruffing V, Clegg-Smith K, et al.. Reliability and Validity of Selected PROMIS Measures in People with Rheumatoid Arthritis. PLoS One. 2015;10(9):e0138543. doi: 10.1371/journal.pone.0138543
    1. Quach CW, Langer MM, Chen RC, Thissen D, Usinger DS, Emerson MA, et al.. Reliability and validity of PROMIS measures administered by telephone interview in a longitudinal localized prostate cancer study. Qual Life Res. 2016;25(11):2811–23. doi: 10.1007/s11136-016-1325-3
    1. Kappelman MD, Long MD, Martin C, DeWalt DA, Kinneer PM, Chen W, et al.. Evaluation of the patient-reported outcomes measurement information system in a large cohort of patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2014;12(8):1315–23.e2. doi: 10.1016/j.cgh.2013.10.019
    1. Bajaj JS, Thacker LR, Wade JB, Sanyal AJ, Heuman DM, Sterling RK, et al.. PROMIS computerised adaptive tests are dynamic instruments to measure health-related quality of life in patients with cirrhosis. Aliment Pharmacol Ther. 2011;34(9):1123–32. doi: 10.1111/j.1365-2036.2011.04842.x
    1. Bode RK, Hahn EA, DeVellis R, Cella D. Measuring participation: the Patient-Reported Outcomes Measurement Information System experience. Arch Phys Med Rehabil. 2010;91(9 Suppl):S60–5. doi: 10.1016/j.apmr.2009.10.035
    1. Cook KF, Jensen SE, Schalet BD, Beaumont JL, Amtmann D, Czajkowski S, et al.. PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions. J Clin Epidemiol. 2016;73:89–102. doi: 10.1016/j.jclinepi.2015.08.038
    1. Cella D, Lai JS, Jensen SE, Christodoulou C, Junghaenel DU, Reeve BB, et al.. PROMIS Fatigue Item Bank had Clinical Validity across Diverse Chronic Conditions. J Clin Epidemiol. 2016;73:128–34. doi: 10.1016/j.jclinepi.2015.08.037
    1. Kratz AL, Schilling S, Goesling J, Williams DA. The PROMIS FatigueFM Profile: a self-report measure of fatigue for use in fibromyalgia. Qual Life Res. 2016;25(7):1803–13. doi: 10.1007/s11136-016-1230-9
    1. Cook KF, Bamer AM, Roddey TS, Kraft GH, Kim J, Amtmann D. A PROMIS fatigue short form for use by individuals who have multiple sclerosis. Qual Life Res. 2012;21(6):1021–30. doi: 10.1007/s11136-011-0011-8
    1. Tulsky DS, Kisala PA, Victorson D, Carlozzi N, Bushnik T, Sherer M, et al.. TBI-QOL: Development and Calibration of Item Banks to Measure Patient Reported Outcomes Following Traumatic Brain Injury. J Head Trauma Rehabil. 2015.
    1. Purvis TE, Andreou E, Neuman BJ, Riley LH 3rd, Skolasky RL. Concurrent Validity and Responsiveness of PROMIS Health Domains Among Patients Presenting for Anterior Cervical Spine Surgery. Spine (Phila Pa 1976). 2017. doi: 10.1097/BRS.0000000000002347
    1. Carlozzi NE, Ianni PA, Tulsky DS, Brickell TA, Lange RT, French LM, et al.. Understanding Health-Related Quality of Life in Caregivers of Civilians and Service Members/Veterans With Traumatic Brain Injury: Establishing the Reliability and Validity of PROMIS Fatigue and Sleep Disturbance Item Banks. Arch Phys Med Rehabil. 2018. doi: 10.1016/j.apmr.2018.05.020
    1. Carlozzi NE, Hanks R, Lange RT, Brickell TA, Ianni PA, Miner JA, et al.. Understanding Health-related Quality of Life in Caregivers of Civilians and Service Members/Veterans With Traumatic Brain Injury: Establishing the Reliability and Validity of PROMIS Mental Health Measures. Arch Phys Med Rehabil. 2018. doi: 10.1016/j.apmr.2018.05.021
    1. Pilkonis PA, Yu L, Dodds NE, Johnston KL, Maihoefer CC, Lawrence SM. Validation of the depression item bank from the Patient-Reported Outcomes Measurement Information System (PROMIS) in a three-month observational study. J Psychiatr Res. 2014;56:112–9. doi: 10.1016/j.jpsychires.2014.05.010
    1. Salsman JM, Butt Z, Pilkonis PA, Cyranowski JM, Zill N, Hendrie HC, et al.. Emotion assessment using the NIH Toolbox. Neurology. 2013;80(11 Suppl 3):S76–86. doi: 10.1212/WNL.0b013e3182872e11
    1. Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the PROMIS(R) measures of self-efficacy for managing chronic conditions. Qual Life Res. 2017;26(7):1915–24. doi: 10.1007/s11136-017-1527-3
    1. Carlozzi NE, Goodnight S, Casaletto KB, Goldsmith A, Heaton RK, Wong AW, et al.. Validation of the NIH Toolbox in Individuals with Neurologic Disorders. Arch Clin Neuropsychol. 2017:1–19.
    1. Salsman JM, Victorson D, Choi SW, Peterman AH, Heinemann AW, Nowinski C, et al.. Development and validation of the positive affect and well-being scale for the neurology quality of life (Neuro-QOL) measurement system. Qual Life Res. 2013;22(9):2569–80. doi: 10.1007/s11136-013-0382-0
    1. Carlozzi NE, Ianni PA, Lange RT, Brickell TA, Kallen MA, Hahn EA, et al.. Understanding health-related quality of life of caregivers of civilians and service members/veterans with Traumatic Brain Injury: Establishing the reliability and validity of PROMIS social health measures. Arch Phys Med Rehabil. 2018. doi: 10.1016/j.apmr.2018.06.026
    1. Allen J, Alpass FM, Stephens CV. The sensitivity of the MOS SF-12 and PROMIS(R) global summary scores to adverse health events in an older cohort. Qual Life Res. 2018.
    1. Kasturi S, Szymonifka J, Burket JC, Berman JR, Kirou KA, Levine AB, et al.. Feasibility, Validity, and Reliability of the 10-item Patient Reported Outcomes Measurement Information System Global Health Short Form in Outpatients with Systemic Lupus Erythematosus. J Rheumatol. 2018;45(3):397–404. doi: 10.3899/jrheum.170590
    1. Katzan IL, Lapin B. PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) Scale in Stroke: A Validation Study. Stroke. 2018;49(1):147–54. doi: 10.1161/STROKEAHA.117.018766
    1. Lapin B, Thompson NR, Schuster A, Katzan IL. Clinical Utility of Patient-Reported Outcome Measurement Information System Domain Scales. Circ Cardiovasc Qual Outcomes. 2019;12(1):e004753. doi: 10.1161/CIRCOUTCOMES.118.004753
    1. Stoop N, Menendez ME, Mellema JJ, Ring D. The PROMIS Global Health Questionnaire Correlates With the QuickDASH in Patients With Upper Extremity Illness. Hand (N Y). 2018;13(1):118–21. doi: 10.1177/1558944717691127

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel