Validity of the PROMIS-10 Global Health assessed by telephone and on paper in minor stroke and transient ischaemic attack in the Netherlands

Lam, Ka-Hoo; Kwa, Vincent I H

doi:10.1136/bmjopen-2017-019919

Cited by 32 publications

(45 citation statements)

References 26 publications

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“…In addition, the means for the GH domain scores at baseline in the rilonacept clinical trial provides evidence of the impact RP has on patients' HRQoL, as they are lower compared to population norm scores. These ndings are consistent with other clinical studies reporting lower PROMIS GH questionnaire scores and associated impacts in physical, mental, and social domains in cardiac and vascular populations [15][16][17].…”

Section: Discussionsupporting

confidence: 92%

Health-related Quality of Life in Patients With Recurrent Pericarditis: Results From a Phase 2 Study of Rilonacept

Lin

Klein

Cella³

et al. 2021

Preprint

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Background: Impact of recurrent pericarditis (RP) on patient health-related quality of life (HRQoL) was evaluated through qualitative patient interviews and as an exploratory endpoint in a Phase 2 trial evaluating the efficacy and safety of rilonacept (IL-1α/IL-1β blocker) to treat RP.Methods: Qualitative interviews were conducted with ten adults with RP to understand symptoms and HRQoL impacts, and the 10-item Patient-Reported Outcomes Measurement Information System Global Health (PROMIS Global) v1.2 was evaluated to determine questionnaire coverage of patient experience. The Phase 2 trial enrolled participants with active symptomatic RP (A-RP, n=16) and corticosteroid-dependent participants with no active recurrence at baseline (CSD-RP, n=9). All participants received rilonacept weekly for 6 weeks during a base treatment period (TP) plus an optional 18-week extension period (EP). Concomitant medications, including corticosteroids (CS), were tapered, if possible, during EP. HRQoL was assessed using the PROMIS Global, and patient-reported pain and blood levels of c-reactive protein (CRP) were also collected at Baseline and follow-up periods. Results: Information from qualitative interviews demonstrated that PROMIS GH concepts are relevant to adults with RP. From the Phase 2 trial, both participant groups showed impacted HRQoL at Baseline [mean PROMIS Global Physical Health (GPH) and Global Mental Health (GMH), were lower than population norm average]. In A-RP, GPH/MPH improved by end of base TP and were sustained through EP (similar trends were observed for pain and CRP). Similarly, in CSD-RP, GPH/MPH improved by end of TP and further improved at EP, during CS tapering or discontinuation, without disease recurrence (low pain scores and CRP levels continued during the TP and EP). Conclusion: This is the first study demonstrating impaired HRQoL in RP. Rilonacept treatment was associated with HRQoL improvements using PROMIS GH scores. Maintained/improved HRQoL during tapering/withdrawal of CS without recurrence suggests that rilonacept may provide an alternative to corticosteroids. Trial Registration: ClinicalTrials.Gov; NCT03980522; 5 June 2019, retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT03980522

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Section: Discussionsupporting

confidence: 92%

Health-related Quality of Life in Patients With Recurrent Pericarditis: Results From a Phase 2 Study of Rilonacept

Lin

Klein

Cella³

et al. 2021

Preprint

View full text Add to dashboard Cite

show abstract

“…In addition, the means for the PROMIS GH domain scores at baseline in the rilonacept clinical trial provide evidence of the impact RP has on patients' HRQoL, as they are lower compared to population norm scores. These findings are consistent with other clinical studies reporting lower PROMIS GH questionnaire scores and associated impacts in physical, mental, and social domains in cardiac and vascular populations [23][24][25]. The increase in both the GPH and GMH scores over the course of the study for both the A-RP and CSD-RP, in conjunction with improvements and/ or stable pericardial pain scores and CRP levels, shows that HRQoL scores may also be responsive to treatment as the patient's condition improves, particularly when on a treatment that addresses IL-1 driven pericardial inflammation.…”

Section: Impact On Intimacysupporting

confidence: 92%

Health-related quality of life in patients with recurrent pericarditis: results from a phase 2 study of rilonacept

Lin

Klein

Cella

et al. 2021

BMC Cardiovasc Disord

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Background Impact of recurrent pericarditis (RP) on patient health-related quality of life (HRQoL) was evaluated through qualitative patient interviews and as an exploratory endpoint in a Phase 2 trial evaluating the efficacy and safety of rilonacept (IL-1α/IL-1β cytokine trap) to treat RP. Methods Qualitative interviews were conducted with ten adults with RP to understand symptoms and HRQoL impacts, and the 10-item Patient-Reported Outcomes Measurement Information System Global Health (PROMIS GH) v1.2 was evaluated to determine questionnaire coverage of patient experience. The Phase 2 trial enrolled participants with active symptomatic RP (A-RP, n = 16) and corticosteroid-dependent participants with no active recurrence at baseline (CSD-RP, n = 9). All participants received rilonacept weekly during a 6-week base treatment period (TP) plus an optional 18-week extension period (EP). Tapering of concomitant medications, including corticosteroids (CS), was permitted during EP. HRQoL was assessed using the PROMIS GH, and patient-reported pain and blood levels of c-reactive protein (CRP) were collected at Baseline and follow-up periods. A secondary, descriptive analysis of the Phase 2 trial efficacy results was completed using HRQoL measures to characterize both the impact of RP and the treatment effect of rilonacept. Results Information from qualitative interviews demonstrated that PROMIS GH concepts are relevant to adults with RP. From the Phase 2 trial, both participant groups showed impacted HRQoL at Baseline (mean PROMIS Global Physical Health [GPH] and Global Mental Health [GMH], were lower than population norm average). In A-RP, GPH/MPH improved by end of base TP and were sustained through EP (similar trends were observed for pain and CRP). Similarly, in CSD-RP, GPH/MPH improved by end of TP and further improved during EP, during CS tapering or discontinuation, without disease recurrence (low pain scores and CRP levels continued during the TP and EP). Conclusion This is the first study demonstrating impaired HRQoL in RP. Rilonacept treatment was associated with HRQoL improvements using PROMIS GH scores. Maintained/improved HRQoL during tapering/withdrawal of CS without recurrence suggests that rilonacept may provide an alternative to CS. Trial registration: ClinicalTrials.Gov; NCT03980522; 5 June 2019, retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT03980522.

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“…The PROMIS 10 has been shown as a feasible instrument in stroke survivors [19][20][21][22][23][24] and exhibited the components of patient reported morbidity. Particularly when considering the high post-stroke prevalence of PROM morbidity immediately after stroke.…”

Section: Discussionmentioning

confidence: 99%

MORe PREcISE: A Multicenter Prospective Cohort of Patient Reported Outcome Measures in Stroke

Corrigan

Carter

Smith

et al. 2021

Preprint

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Background and Purpose: The use of patient reported outcomes measures (PROMs) may offer utility and provide outcome measures that are important for stroke survivors. This study used a stroke specific PROM, which contains Mental health (MH) and Physical Health (PH). The primary aim of this study was to assess the association between the MH and PH measures following a stroke and preexisting health conditions. Methods: A multicenter prospective cohort study at 19 hospital sites across England and Wales during 2019 was conducted. Prevalence of morbidity within PROMs was estimated with 95% confidence intervals (95% CI). The association between each PROM domain and demographic and health conditions were calculated using a multilevel multivariable linear model fitting the adjusted mean difference (aMD). Results: PROM morbidity was high post stroke; 93.2% of the participants reported combined post stroke PROM morbidity. The MH domain was associated with pre-existing: diabetes, previous stroke, age, and sex. The PH domain was found to be associated with gender (female) and previous stroke, Conclusions: Stroke survivors ubiquitously suffer morbidity. Risk factors associated with worsening MH and PH morbidity have implications in clinical management as they offer an opportunity to intervene, particularly to prevent long term mental health. PROMs provide useful outcome measure that matter to stroke survivors.

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Validity of the PROMIS-10 Global Health assessed by telephone and on paper in minor stroke and transient ischaemic attack in the Netherlands

Cited by 32 publications

References 26 publications

Health-related Quality of Life in Patients With Recurrent Pericarditis: Results From a Phase 2 Study of Rilonacept

Health-related Quality of Life in Patients With Recurrent Pericarditis: Results From a Phase 2 Study of Rilonacept

Health-related quality of life in patients with recurrent pericarditis: results from a phase 2 study of rilonacept

MORe PREcISE: A Multicenter Prospective Cohort of Patient Reported Outcome Measures in Stroke

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