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

ABSTRACT: 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?

SUBMITTER: Hewitt J

PROVIDER: S-EPMC6604353 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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

Hewitt Jonathan J Pennington Anna A Smith Alexander A Gething Stephanie S Price Michelle M White James J Dewar Richard R Carter Ben B

BMC medicine 20190702 1

<h4>Background</h4>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.<h4>Methods</h4>In a blinded, UK-wide, mul ...[more]

PMID: 31262317

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Project description:IntroductionA decade after stroke, young stroke survivors continue to suffer from cognitive impairment. However, it is not known whether this long-term cognitive outcome is caused in part by further cognitive decline or solely by incomplete recovery from the acute effects of ischemic stroke. We studied changes in three cognitive domains over a 9-year follow-up period after first-ever and only ischemic stroke.Patients and methodsIn this prospective, two-center cohort study, we recruited consecutive 18-65 year-old patients with acute stroke between 2007 and 2009, along with demographically matched stroke-free controls. We performed comprehensive neuropsychological assessments at 3 months, 2, and 9 years after stroke, and we also performed neurological examinations at the time of inclusion and at the 9-year follow-up. We assessed the associations among stroke, follow-up time and long-term cognitive outcomes using repeated-measures analysis of variance.ResultsThe subjects comprised 85 patients who had had their first-ever and only ischemic stroke (mean age 53 years at inclusion), along with 31 stroke-free demographic controls. We compared the cognitive changes in patients to those in controls over a 9-year follow-up. After initial recovery between 3 months and 2 years after stroke, patients showed a decline in memory between 2 and 9 years after stroke compared to controls within the same time interval (immediate recall p < 0.001; delayed recall p < 0.001; list learning p < 0.001). Other than memory, we found no difference in cognitive changes between poststroke patients and controls.DiscussionOur main finding was memory decline over a decade in young first-ever stroke patients with no further stroke or neurodegenerative disease. Our study extends the previous results of further memory decline in elderly stroke survivors to young stroke survivors.ConclusionYoung stroke survivors might be at risk of memory decline over the decade following the stroke.

Project description:BackgroundStroke is a major cause of disability in older adults, but the evidence around post-acute treatment is limited and heterogeneous. We aimed to identify profiles of older adult stroke survivors admitted to intermediate care geriatric rehabilitation units.MethodsWe performed a cohort study, enrolling stroke survivors aged 65 years or older, admitted to 9 intermediate care units in Catalonia-Spain. To identify potential profiles, we included age, caregiver presence, comorbidity, pre-stroke and post-stroke disability, cognitive impairment and stroke severity in a cluster analysis. We also proposed a practical decision tree for patient's classification in clinical practice. We analyzed differences between profiles in functional improvement (Barthel index), relative functional gain (Montebello index), length of hospital stay (LOS), rehabilitation efficiency (functional improvement by LOS), and new institutionalization using multivariable regression models (for continuous and dichotomous outcomes).ResultsAmong 384 patients (79.1±7.9 years, 50.8% women), we identified 3 complexity profiles: a) Lower Complexity with Caregiver (LCC), b) Moderate Complexity without Caregiver (MCN), and c) Higher Complexity with Caregiver (HCC). The decision tree showed high agreement with cluster analysis (96.6%). Using either linear (continuous outcomes) or logistic regression, both LCC and MCN, compared to HCC, showed statistically significant higher chances of functional improvement (OR = 4.68, 95%CI = 2.54-8.63 and OR = 3.0, 95%CI = 1.52-5.87, respectively, for Barthel index improvement ?20), relative functional gain (OR = 4.41, 95%CI = 1.81-10.75 and OR = 3.45, 95%CI = 1.31-9.04, respectively, for top Vs lower tertiles), and rehabilitation efficiency (OR = 7.88, 95%CI = 3.65-17.03 and OR = 3.87, 95%CI = 1.69-8.89, respectively, for top Vs lower tertiles). In relation to LOS, MCN cluster had lower chance of shorter LOS than LCC (OR = 0.41, 95%CI = 0.23-0.75) and HCC (OR = 0.37, 95%CI = 0.19-0.73), for LOS lower Vs higher tertiles.ConclusionOur data suggest that post-stroke rehabilitation profiles could be identified using routine assessment tools and showed differential recovery. If confirmed, these findings might help to develop tailored interventions to optimize recovery of older stroke patients.

Project description:BackgroundSCORE is the first randomised controlled trial (RCT) to examine shared oncologist and general practitioner (GP) follow-up for survivors of colorectal cancer (CRC). SCORE aimed to show that shared care (SC) was non-inferior to usual care (UC) on the EORTC QLQ-C30 Global Health Status/Quality of Life (GHQ-QoL) scale to 12 months.MethodsThe study recruited patients from five public hospitals in Melbourne, Australia between February 2017 and May 2021. Patients post curative intent treatment for stage I-III CRC underwent 1:1 randomisation to SC and UC. SC replaced two oncologist visits with GP visits and included a survivorship care plan and primary care management guidelines. Assessments were at baseline, 6 and 12 months. Difference between groups on GHQ-QoL to 12 months was estimated from a mixed model for repeated measures (MMRM), with a non-inferiority margin (NIM) of -10 points. Secondary endpoints included quality of life (QoL); patient perceptions of care; costs and clinical care processes (CEA tests, recurrences). Registration ACTRN12617000004369p.Findings150 consenting patients were randomised to SC (N = 74) or UC (N = 76); 11 GPs declined. The mean (SD) GHQ-QoL scores at 12 months were 72 (20.2) for SC versus 73 (17.2) for UC. The MMRM mean estimate of GHQ-QoL across the 6 month and 12 month follow-up was 69 for SC and 73 for UC, mean difference -4.0 (95% CI: -9.0 to 0.9). The lower limit of the 95% CI did not cross the NIM. There was no clear evidence of differences on other QoL, unmet needs or satisfaction scales. At 12 months, the majority preferred SC (40/63; 63%) in the SC group, with equal preference for SC (22/62; 35%) and specialist care (22/62; 35%) in UC group. CEA completion was higher in SC. Recurrences similar between arms. Patients in SC on average incurred USD314 less in health costs versus UC patients.InterpretationSC seems to be an appropriate and cost-effective model of follow-up for CRC survivors.FundingVictorian Cancer Agency and Cancer Australia.

Project description:ObjectiveTo assess whether decompression alone is non-inferior to decompression with instrumented fusion five years after primary surgery in patients with degenerative lumbar spondylolisthesis.DesignFive year follow-up of a randomised, multicentre, non-inferiority trial (Nordsten-DS).Setting16 public orthopaedic and neurosurgical clinics in Norway.ParticipantsPatients aged 18-80 years with symptomatic lumbar spinal stenosis and a spondylolisthesis of 3 mm or more at the stenotic level.InterventionsDecompression surgery alone and decompression with additional instrumented fusion (1:1).Main outcome measuresThe primary outcome was a 30% or more reduction in Oswestry disability index from baseline to five year follow-up. The predefined non-inferiority margin was a -15 percentage point difference in the proportion of patients who met the primary outcome. Secondary outcomes included the mean change in Oswestry disability index, Zurich claudication questionnaire, numeric rating scale for leg and back pain, and EuroQol Group 5-Dimension (EQ-5D-3L) questionnaire.ResultsFrom 12 February 2014 to 18 December 2017, 267 participants were randomly assigned to decompression alone (n=134) and decompression with instrumented fusion (n=133). Of these, 230 (88%) responded to the five year questionnaire: 121 in the decompression group and 109 in the fusion group. Mean age at baseline was 66.2 years (SD 7.6), and 69% were women. In the modified intention-to-treat analysis with multiple imputation of missing data, 84 (63%) of 133 people in the decompression alone group and 81 (63%) of 129 people in the fusion group had a at least a 30% reduction in Oswestry disability index, a difference of 0.4 percentage points. (95% confidence interval (CI) -11.2 to 11.9). The respective results of the per protocol analysis were 65 (65%) of 100 in the decompression alone group and 59 (66%) of 89 in the fusion group, a difference of -1.3 percentage points (95% CI -14.5 to 12.2). Both 95% CIs were higher than the predefined non-inferiority margin of -15%. The mean change in Oswestry disability index from baseline to five years was -17.8 in both groups (mean difference 0.02 (95% CI -3.8 to 3.9)). Results of the other secondary outcomes were in the same direction as the primary outcome. From two to five year follow-up, a new lumbar operation occurred in six (5%) of 123 people in the decompression group and 11 (10%) of 113 people in the fusion group, with a total from baseline to five years of 21 (16%) of 129 people and 23 (18%) of 125, respectively.ConclusionsIn participants with degenerative spondylolisthesis, decompression alone was non-inferior to decompression with instrumented fusion five years after primary surgery. Proportions of subsequent surgeries at the index level or an adjacent lumbar level were no different between the groups.Trial registrationClinicalTrials.gov NCT02051374.

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

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

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