Patient-Reported Outcome Measures (PROMs) for Acute Stroke: Rationale, Methods and Future Directions

Reeves, Mathew J.; Lisabeth, Lynda D.; Williams, Linda S.; Katzan, Irene; Kapral, Moira K.; Deutsch, Anne; Prvu‐Bettger, Janet

doi:10.1161/strokeaha.117.018912

Cited by 105 publications

(120 citation statements)

References 38 publications

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“…47 Although we found no overall association between SDB just after stroke and QOL at 90 days, an association was suggested in MAs, consistent with the observed adverse effects of SDB on the other stroke outcomes in this ethnic group. Use of patient-reported outcomes, such as QOL, in stroke research is growing with the recognition that measuring patient-perceived health status is critical to improvement of patient outcomes and involvement of patients more directly in stroke care decisions.…”

Section: Discussionsupporting

confidence: 79%

“…Use of patient-reported outcomes, such as QOL, in stroke research is growing with the recognition that measuring patient-perceived health status is critical to improvement of patient outcomes and involvement of patients more directly in stroke care decisions. 47 Although we found no overall association between SDB just after stroke and QOL at 90 days, an association was suggested in MAs, consistent with the observed adverse effects of SDB on the other stroke outcomes in this ethnic group. Literature on the association of SDB and QOL in stroke patients is limited.…”

Section: Discussionsupporting

confidence: 79%

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Sleep‐disordered breathing and poststroke outcomes

Lisabeth

Sánchez

Lim

et al. 2019

Annals of Neurology

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Objective: To examine the association between sleep-disordered breathing and stroke outcomes, and determine the contribution of sleep-disordered breathing to outcome disparities in Mexican Americans. Methods: Ischemic stroke patients (n = 995), identified from the population-based Brain Attack Surveillance in Corpus Christi Project (2010Project ( -2015, were offered participation in a sleep-disordered breathing study including a home sleep apnea test (ApneaLink Plus). Sleep-disordered breathing (respiratory event index ≥10) was determined soon after stroke. Neurologic, functional, cognitive, and quality of life outcomes were assessed at 90 days poststroke. Regression models were used to assess associations between sleep-disordered breathing and outcomes, adjusted for sociodemographics, prestroke function and cognition, health-risk behaviors, stroke severity, and vascular risk factors. Results: Median age was 67 years (interquartile range [IQR] = 59-78); 62.1% were Mexican American. Median respiratory event index was 14 (IQR = 6-25); 62.8% had sleep-disordered breathing. Sleep-disordered breathing was associated with worse functional outcome (mean difference in activities of daily living/instrumental activities of daily living score = 0.15, 95% confidence interval [CI] = 0.01-0.28) and cognitive outcome (mean difference in modified Mini-Mental State Examination = −2.66, 95% CI = −4.85 to −0.47) but not neurologic or quality of life outcomes. Sleep-disordered breathing accounted for 9 to 10% of ethnic differences in functional and cognitive outcome and was associated with cognitive outcome more strongly for Mexican Americans (β = −3.97, 95% CI = −6.63 to −1.31) than non-Hispanic whites (β = −0.40, 95% CI = −4.18 to 3.39, p-interaction = 0.15). Interpretation: Sleep-disordered breathing is associated with worse functional and cognitive function at 90 days poststroke. These outcomes are reasonable endpoints for future trials of sleep-disordered breathing treatment in stroke. If effective, sleep-disordered breathing treatment may somewhat lessen ethnic stroke outcome disparities.

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Section: Discussionsupporting

confidence: 79%

Section: Discussionsupporting

confidence: 79%

Sleep‐disordered breathing and poststroke outcomes

Lisabeth

Sánchez

Lim

et al. 2019

Annals of Neurology

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“…So far, there is no agreement about which critical measures should be routinely captured (4,15,16). Instead of a single instrument, a standard set of patient-centred and patient-reported outcome measures after stroke have been suggested to quantify outcomes accurately with validated instruments (16,17).…”

mentioning

confidence: 99%

The World Health Organization Disability Assessment Schedule (WHODAS 2.0) and the WHO Minimal Generic Set of Domains of Functioning and Health versus Conventional Instruments in subacute stroke

Tarvonen-Schröder

Hurme²,

Laimi³

2019

J Rehabil Med

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LAY ABSTRACTThis study compared short generic International Classification of Functioning, Disability and Health (ICF)based measures of functioning, the patient-and proxyreported 12-item World Health Organization Disability Assessment Schedule (WHODAS 2.0) and the 7-item WHO Minimal Generic Set of domains of functioning and health assessed by a neurologist, with traditionally used measures of stroke in the subacute phase. Although proxies rated 6 out of 12 separate WHODAS functions more impaired than did the patients, the scores of patient-and proxy-reported WHODAS 2.0 and the WHO Minimal Generic Set correlated well with each other and with older measures of stroke severity (National Institutes of Health Stroke Scale) and dependence (modified Rankin Scale and Functional Independence Measure). Both ICF-based tools, despite their brevity, were useful in finding disabilities for patient-and family-centred goal-setting and service-planning after subacute stroke rehabilitation. Objective: To compare short generic International Classification of Functioning, Disability and Health (ICF)-based measures of functioning with traditional measures of stroke severity and dependence in subacute stroke. Methods: In this cross-sectional study patients with stroke (n = 195) and their significant others completed the 12-item World Health Organization Disability Assessment Schedule (WHODAS 2.0) at discharge from rehabilitation. A neurologist assessed functioning with the 7-item World Health Organization (WHO) Minimal Generic Set of domains of functioning and health. These scores were compared with assessments of severity of stroke (National Institutes of Health Stroke Scale; NIHSS) and dependence (modified Rankin Scale; mRS; and Functional Independence Measure; FIM).Results: From mild to severe stroke, increasing disability was found in single items and sum scores of WHODAS and the WHO Minimal Generic Set. Although proxies rated 6 out of the 12 separate WHO-DAS functions more impaired than did the patients, correlations between the different measures (proxyand patient-WHODAS, the WHO Minimal Generic Set, mRS, NIHSS and FIM total and sub-scores) were strong to very strong, except for moderate correlations between patient-WHODAS, and NIHSS or FIM cognitive sub-score. Conclusion: Despite their brevity, both generic ICFbased tools were useful in finding disabilities for patient-and family-centred goal-setting and serviceplanning after subacute rehabilitation.

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“…One question is whether mRs is sensitive enough to identify clinical benefit of reduction in frequency of hematoma expansion with an intervention. mRs evaluates the domains of mobility, self-care, and independence but not cognitive or social functions [23]. New patient-reported outcome measures (PROMs) such as Patient-Reported Outcome Measurement Information System (PROMIS), Quality of Life in Neurological Disorders (NeuroQOL), and 10-item PROMIS Global Health (PROMIS-10) [23-25] may provide more sensitive assessment of clinical benefit on reduction in frequency of hematoma expansion in future clinical trials.…”

Section: Discussionmentioning

confidence: 99%

Intensive Blood Pressure Lowering in Patients with Moderate to Severe Grade Acute Cerebral Hemorrhage: Post Hoc Analysis of Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-2 Trial

et al. 2020

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Objective: To study the effect of intensive blood pressure reduction in patients with moderate to severe intracerebral hemorrhage (ICH) within the subjects recruited in Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 trial. Design: Randomized, multicenter, 2 group, open-label clinical trial. Setting: A total of 110 sites in the USA, Japan, China, Taiwan, South Korea, and Germany. Patients: A total of 1,000 patients underwent randomization from May 2011 till September 2015. Interventions: We analyzed the effect of intensive (goal 110-139 mm Hg) over standard (goal 140-179 mm Hg) systolic blood pressure (SBP) reduction using intravenous nicardipine within 4.5 h of symptom onset in moderate to severe grade subjects with ICH in a non-prespecified analysis. Moderate to severe grade was defined by Glasgow Coma Scale score <13 or baseline National Institutes of Health Stroke Scale score ≥10 or baseline intraparenchymal hemorrhage volume ≥30 mL or presence of intraventricular hemorrhage. The primary outcome was death or disability (score 4-6 on the modified Rankin scale) at 3 months after randomization ascertained by a blinded investigator. Measurements and Main Results: Of a total of 682 subjects who met the definition of moderate to severe grade (mean age 61.9 ± 13.1 years, 62.5% men) with a mean baseline SBP of 174.7 ± 24.8 mm Hg, the frequency of hematoma expansion was significantly lower among subjects randomized to intensive SBP reduction than among subjects randomized to standard SBP reduction (20.4 vs. 27.9%, relative risk [RR]: 0.7; 95% confidence interval [CI]: 0.55-0.96). The primary endpoint of death or disability was observed in 52.5% (170/324) of subjects receiving intensive SBP reduction and 48.9% (163/333) of subjects receiving standard SBP reduction (RR: 1.1; 95% CI: 0.9-1.2). Conclusions: Intensive SBP lowering reduced the frequency of hematoma expansion but did not reduce the rate of death or disability in patients with moderate to severe grade ICH.

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Patient-Reported Outcome Measures (PROMs) for Acute Stroke: Rationale, Methods and Future Directions

Cited by 105 publications

References 38 publications

Sleep‐disordered breathing and poststroke outcomes

Sleep‐disordered breathing and poststroke outcomes

The World Health Organization Disability Assessment Schedule (WHODAS 2.0) and the WHO Minimal Generic Set of Domains of Functioning and Health versus Conventional Instruments in subacute stroke

Intensive Blood Pressure Lowering in Patients with Moderate to Severe Grade Acute Cerebral Hemorrhage: Post Hoc Analysis of Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-2 Trial

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