The Use of Patient Reported Outcome Measures (PROMs) 6 Months Post-Stroke and Their Association with the National Institute of Health Stroke Scale (NIHSS) on Admission to Hospital.

Patient Reported Outcome Measures (PROMs) assess clinical outcomes from the perspective of the patient. The stroke community recommended fifteen questions for use in stroke survivors, based on the established PROMIS10 with five additional stroke-specific questions. This study aimed to determine its association with the National Institute of Health Stroke Scale (NIHSS) on admission. PROM responses were taken from an existing randomised control trial and, using secondary analysis, the total score was calculated out of 100. The association between PROMs and NIHSS was estimated. Using a multivariable regression, an adjusted mean difference (aMD) in PROM total score for the baseline clinical characteristics was calculated. 343 participants (16.3%) completed the PROM; mean age 71.7 (30-94) years; 133 women (38.8%). There was a strong association between increasing NIHSS Scores on admission to hospital and worsening PROM scores at 6 months (p = 0.002). There was consistency between the NIHSS and modified Rankin score with the stroke-specific domain and total PROM scores. When adjusted, women had lower (worse) total PROM scores, with aMD = -3.85 (95% CI -6.30--1.41; p = 0.002) and so did haemorrhagic strokes, with a reduction of 3.88 (95% CI -0.61-7.37; p = 0.097). This study contributes to the evaluation process of this stroke-specific PROM and emphasises that stroke severity on admission correlates with poorer patient outcomes 6 months following a stroke, especially in women and those suffering haemorrhagic stroke.

A multi-centre, UK-based, non-inferiority randomised controlled trial of 4 follow-up assessment methods in stroke survivors.

BACKGROUND: Recovery following a stroke is a long and ongoing process. Post-stroke follow-up after leaving the hospital is recommended. Methods for follow-up patients include face-to-face, via the telephone, post or online (internet). However, there is a debate which method is preferred by patients. This study aimed to determine whether telephone interview, online questionnaire and postal questionnaire were as acceptable as face-to-face follow-up. METHODS: In a blinded, UK-wide, multi-centre, Zelen's designed, 4-arm (postal, online, telephone, compared to face-to-face), pragmatic non-inferiority randomised controlled trial of the mode of administration, stroke survivors were randomised to postal, online, telephone and face-to-face assessment, in an equal ratio (1:1:1:1). The primary outcome was the proportion of participants that responded to the three allocation groups, compared to the face-to-face group. Subgroup analyses for age, aphasia and type and severity of stroke were carried out. A non-inferiority margin of 0.025 was used, and Holm-Bonferroni multiplicity adjustment was made. RESULTS: Of the 2074 eligible patients randomised, 55% were male (1142/2074), with an average age of 73.0 years old (SD = 13.2). Of those randomised, 22% (116/525), 9% (47/515) and 20% (101/513) responded in postal, online and telephone, respectively, compared to 17% (89/521) in the face-to-face group. The reduction in the online response rate compared to face-to-face was found to be both inferior and not non-inferior and estimated as an 8% reduction (95% CI 3.9 to 12.0%; p < 0.001). The association with lower online completion was present regardless of age, stroke type (haemorrhage or infarct) and stroke severity. In haemorrhagic stroke, the reduction in response online, compared to face-to-face, was 21% (95% CI 10 to 32%; p value = 0.002). A secondary analysis found non-aphasic stroke survivors preferred postal completion adjusted odds ratio of 1.43 (95% CI 1.04 to 1.95; p = 0.026). CONCLUSIONS: The study found that fewer stroke survivors completed follow-up assessment using an online method, compared to face-to-face. This finding was present in all age groups. Caution should be employed when considering online follow-up methods in stroke survivors, particularly in those who have experienced a cerebrovascular haemorrhage. TRIALS REGISTRATION: ClinicalTrials.gov, NCT03177161 . Registered on 6 June 2017.

Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol.

BACKGROUND: UK-wide national clinical guidelines promote routine 6-month post-stroke follow-up assessment. However, as part of this 6-month assessment little information is gathered from the patient's perspective. The means of collecting this patient-centred information might be served best by a patient-reported outcome measure (PROM) at the 6-month assessment time point. Currently, four different methods of 6-month follow-up assessment occur; the most common being face-to-face interview followed by telephone interview, postal questionnaire and online questionnaire. Therefore, this study will investigate if the acceptability of telephone, online or postal administration of a PROM at the 6-month post-stoke time point is not inferior to face-to-face administration. METHODS/DESIGN: A UK multicentre, blinded (analyst and researcher), pragmatic, non-inferiority study, with 80% power using a 2.5% non-inferiority margin was designed to compare the acceptability of three modes of administration (telephone interview, postal questionnaire and online questionnaire) compared with face-to-face interview administration of a PROM. We plan to approach and randomise a minimum of 808 potentially eligible participants, 202 participants per group. DISCUSSION: The aim of this ongoing research is to understand if there is a difference between face-to-face administration and the other three methods of administering a PROM as a patient-centred supplement to the 6-month review for stroke survivors. In utilising a pragmatic design, it is believed that this study will offer UK wide generalisable results, of the acceptability of the methods under investigation, to inform clinicians and commissioners of stroke services. TRIALS REGISTRATION: ClinicalTrials.gov: NCT03177161 . Registered on 6 June 2017.

An International Standard Set of Patient-Centered Outcome Measures After Stroke.

BACKGROUND AND PURPOSE: Value-based health care aims to bring together patients and health systems to maximize the ratio of quality over cost. To enable assessment of healthcare value in stroke management, an international standard set of patient-centered stroke outcome measures was defined for use in a variety of healthcare settings. METHODS: A modified Delphi process was implemented with an international expert panel representing patients, advocates, and clinical specialists in stroke outcomes, stroke registers, global health, epidemiology, and rehabilitation to reach consensus on the preferred outcome measures, included populations, and baseline risk adjustment variables. RESULTS: Patients presenting to a hospital with ischemic stroke or intracerebral hemorrhage were selected as the target population for these recommendations, with the inclusion of transient ischemic attacks optional. Outcome categories recommended for assessment were survival and disease control, acute complications, and patient-reported outcomes. Patient-reported outcomes proposed for assessment at 90 days were pain, mood, feeding, selfcare, mobility, communication, cognitive functioning, social participation, ability to return to usual activities, and health-related quality of life, with mobility, feeding, selfcare, and communication also collected at discharge. One instrument was able to collect most patient-reported subdomains (9/16, 56%). Minimum data collection for risk adjustment included patient demographics, premorbid functioning, stroke type and severity, vascular and systemic risk factors, and specific treatment/care-related factors. CONCLUSIONS: A consensus stroke measure Standard Set was developed as a simple, pragmatic method to increase the value of stroke care. The set should be validated in practice when used for monitoring and comparisons across different care settings.