A Validation Study of PROMIS Sleep Disturbance (PROMIS-SD) and Sleep Related Impairment (PROMIS-SRI) Item Banks in Individuals with Idiopathic Parkinson’s Disease and Matched Controls

Jones, Jolynn; Nielson, Spencer; Trout, Jonathan; Swenson, Mckaella; Reiley, Joseph; Tanner, Jared J.; Bowers, Dawn; Kay, Daniel B.

doi:10.3233/jpd-202429

Cited by 8 publications

(5 citation statements)

References 30 publications

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“…The CAARS-S:S served as a patient reported outcome of symptoms associated with inattention and executive dysfunction ( 43 , 44 ). Additionally, the Patient-Reported Outcomes Measurement Information System (PROMIS) was used to evaluate sleep related impairment (PROMIS-Sleep Related Impairment), applied cognitive abilities (PROMIS-Applied Cognition) and fatigue (PROMIS-Fatigue) ( 45 ). Self-reported questionnaires and outcome measures were collected at screening and visit 9.…”

Section: Methodsmentioning

confidence: 99%

Multi-session transcutaneous auricular vagus nerve stimulation for Parkinson's disease: evaluating feasibility, safety, and preliminary efficacy

Lench,

Turner,

McLeod

et al. 2023

Front. Neurol.

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BackgroundIn pre-clinical animal models of Parkinson's disease (PD), vagus nerve stimulation (VNS) can rescue motor deficits and protect susceptible neuronal populations. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a non-invasive alternative to traditional invasive cervical VNS. This is the first report summarizing the safety, feasibility, and preliminary efficacy of repeated sessions of taVNS in participants with PD.ObjectivesTo evaluate the feasibility, safety, and possible efficacy of taVNS for motor and non-motor symptoms in mild to moderate PD.MethodsThis is a double-blind, sham controlled RCT (NCT04157621) of taVNS in 30 subjects with mild to moderate PD without cognitive impairment. Participants received 10, 1-h taVNS sessions (25 Hz, 200% of sensory threshold, 500 μs pulse width, 60 s on and 30 s off) over a 2-week period. Primary outcome measures were feasibility and safety of the intervention; secondary outcomes included the MDS-UPDRS, cognitive function and self-reported symptom improvement.ResultstaVNS treatment was feasible, however, daily in-office visits were reported as being burdensome for participants. While five participants in the taVNS group and three in the sham group self-reported one or more minor adverse events, no major adverse events occurred. There were no group differences on blood pressure and heart rate throughout the intervention. There were no group differences in MDS-UPDRS scores or self-reported measures. Although global cognitive scores remained stable across groups, there was a reduction in verbal fluency within the taVNS group.ConclusionstaVNS was safe, and well-tolerated in PD participants. Future studies of taVNS for PD should explore at-home stimulation devices and optimize stimulation parameters to reduce variability and maximize engagement of neural targets.

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Section: Methodsmentioning

confidence: 99%

Multi-session transcutaneous auricular vagus nerve stimulation for Parkinson's disease: evaluating feasibility, safety, and preliminary efficacy

Lench,

Turner,

McLeod

et al. 2023

Front. Neurol.

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“…Internal consistency has previously been very high (Cronbach α >.94). [15] Hypersomnolence will be assessed with the 8-item Epworth Sleepiness Scale. [16] Score ranges from 0 to 24 (internal consistency Cronbach α=.82).…”

Section: Other Measuresmentioning

confidence: 99%

Testing a Consumer Wearables Program to Promote the Use of Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: Protocol for a Pilot Randomized Controlled Trial (Preprint)

Mak,

Ash,

Liang

et al. 2024

Preprint

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BACKGROUND Although positive airway pressure (PAP) therapy is considered first-line treatment for obstructive sleep apnea (OSA), non-adherence is common. Numerous factors influence PAP use, including a belief that the therapy is important and effective. In theory, providing information to patients about their blood oxygen levels during sleep, which may be low when PAP is not used, juxtaposed to information about their PAP use may influence a patient’s beliefs about therapy and increase PAP use. With the advent of wearable devices’ blood oxygen saturation monitoring capability (and the existing routine availability of PAP use data transmitted via modem to clinical dashboards), there is an opportunity to provide this combination of information to patients. OBJECTIVE The Chronic care management with wearable devices in patients prescribed Positive Airway Pressure therapy (mPAP) study is a pilot randomized waitlist-controlled trial testing the feasibility, acceptability, and preliminary efficacy of a program that augments current PAP therapy data with consumer-grade wearable device to promote self-management of PAP therapy for OSA. METHODS Single-blinded randomized controlled trial. We will randomize 50 individuals with a history of OSA who receive care from a Department of Veterans Affairs medical center in the Los Angeles area and are nonadherent to prescribed PAP therapy to Immediate intervention or Waitlist control. During a 28-day intervention, the participants will wear a study-provided consumer wearable device and complete a weekly survey about their OSA symptoms. A report that summarizes consumer wearable-provided oxygen saturation values, PAP use derived from modem data, and patient-reported OSA symptoms will be prepared weekly and shared with the patient. Immediate intervention group will begin intervention immediately after randomization (T1). Assessments will occur at week 5 (T3; one-week post-treatment for Immediate intervention group and repeat baseline for Waitlist control group) and week 11 (T5; follow-up for Immediate intervention group and one-week post-treatment for Waitlist control group). The primary outcome will be the change in 7-day PAP adherence (average minutes/night) from T1 to T3. The primary analysis will be a comparison of the primary outcome between the Immediate intervention and the Waitlist control groups (intention-to-treat design), using a two-sample t-test on change scores (unadjusted). RESULTS Recruitment began in October 2023. Data analysis is expected to begin in September 2024 when all follow-ups are complete, and a manuscript summarizing trial results will be submitted following completion of data analysis. CONCLUSIONS Findings from the study may provide additional insights on how patients with OSA might use patient-generated health data collected by consumer wearables to inform self-management of OSA, and possibly increase their use of PAP therapy. CLINICALTRIAL ClinicalTrials.gov NCT06039865

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“…More information and available language versions can be found on the ePROVIDE website ( https://eprovide.mapi-trust.org/instruments/pittsburgh-sleep-quality-index ). The PROMIS Sleep Disturbance and Sleep-Related Impairment item banks and derivative short forms and CAT were found to be unidimensional and have been validated in several general and clinical populations [ 141 – 144 ]. Evidence for construct validity, test–retest reliability and responsiveness of the PROMIS Sleep Disturbance CAT was found in Dutch people with diabetes (F. Rutters, unpublished results).…”

Section: Best Proms For Use In People With Diabetesmentioning

confidence: 99%

Patient-reported outcomes for people with diabetes: what and how to measure? A narrative review

Terwee

Elders

Blom³

et al. 2023

Diabetologia

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Patient-reported outcomes (PROs) are valuable for shared decision making and research. Patient-reported outcome measures (PROMs) are questionnaires used to measure PROs, such as health-related quality of life (HRQL). Although core outcome sets for trials and clinical practice have been developed separately, they, as well as other initiatives, recommend different PROs and PROMs. In research and clinical practice, different PROMs are used (some generic, some disease-specific), which measure many different things. This is a threat to the validity of research and clinical findings in the field of diabetes. In this narrative review, we aim to provide recommendations for the selection of relevant PROs and psychometrically sound PROMs for people with diabetes for use in clinical practice and research. Based on a general conceptual framework of PROs, we suggest that relevant PROs to measure in people with diabetes are: disease-specific symptoms (e.g. worries about hypoglycaemia and diabetes distress), general symptoms (e.g. fatigue and depression), functional status, general health perceptions and overall quality of life. Generic PROMs such as the 36-Item Short Form Health Survey (SF-36), WHO Disability Assessment Schedule (WHODAS 2.0), or Patient-Reported Outcomes Measurement Information System (PROMIS) measures could be considered to measure commonly relevant PROs, supplemented with disease-specific PROMs where needed. However, none of the existing diabetes-specific PROM scales has been sufficiently validated, although the Diabetes Symptom Self-Care Inventory (DSSCI) for measuring diabetes-specific symptoms and the Diabetes Distress Scale (DDS) and Problem Areas in Diabetes (PAID) for measuring distress showed sufficient content validity. Standardisation and use of relevant PROs and psychometrically sound PROMs can help inform people with diabetes about the expected course of disease and treatment, for shared decision making, to monitor outcomes and to improve healthcare. We recommend further validation studies of diabetes-specific PROMs that have sufficient content validity for measuring disease-specific symptoms and consider generic item banks developed based on item response theory for measuring commonly relevant PROs. Graphical Abstract

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A Validation Study of PROMIS Sleep Disturbance (PROMIS-SD) and Sleep Related Impairment (PROMIS-SRI) Item Banks in Individuals with Idiopathic Parkinson’s Disease and Matched Controls

Cited by 8 publications

References 30 publications

Multi-session transcutaneous auricular vagus nerve stimulation for Parkinson's disease: evaluating feasibility, safety, and preliminary efficacy

Multi-session transcutaneous auricular vagus nerve stimulation for Parkinson's disease: evaluating feasibility, safety, and preliminary efficacy

Testing a Consumer Wearables Program to Promote the Use of Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: Protocol for a Pilot Randomized Controlled Trial (Preprint)

Patient-reported outcomes for people with diabetes: what and how to measure? A narrative review

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