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Health Technol Assess ; 26(31): 1-88, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1963373


BACKGROUND: Urinary incontinence affects around half of stroke survivors in the acute phase, and it often presents as a new problem after stroke or, if pre-existing, worsens significantly, adding to the disability and helplessness caused by neurological deficits. New management programmes after stroke are needed to address urinary incontinence early and effectively. OBJECTIVE: The Identifying Continence OptioNs after Stroke (ICONS)-II trial aimed to evaluate the clinical effectiveness and cost-effectiveness of a systematic voiding programme for urinary incontinence after stroke in hospital. DESIGN: This was a pragmatic, multicentre, individual-patient-randomised (1 : 1), parallel-group trial with an internal pilot. SETTING: Eighteen NHS stroke services with stroke units took part. PARTICIPANTS: Participants were adult men and women with acute stroke and urinary incontinence, including those with cognitive impairment. INTERVENTION: Participants were randomised to the intervention, a systematic voiding programme, or to usual care. The systematic voiding programme comprised assessment, behavioural interventions (bladder training or prompted voiding) and review. The assessment included evaluation of the need for and possible removal of an indwelling urinary catheter. The intervention began within 24 hours of recruitment and continued until discharge from the stroke unit. MAIN OUTCOME MEASURES: The primary outcome measure was severity of urinary incontinence (measured using the International Consultation on Incontinence Questionnaire) at 3 months post randomisation. Secondary outcome measures were taken at 3 and 6 months after randomisation and on discharge from the stroke unit. They included severity of urinary incontinence (at discharge and at 6 months), urinary symptoms, number of urinary tract infections, number of days indwelling urinary catheter was in situ, functional independence, quality of life, falls, mortality rate and costs. The trial statistician remained blinded until clinical effectiveness analysis was complete. RESULTS: The planned sample size was 1024 participants, with 512 allocated to each of the intervention and the usual-care groups. The internal pilot did not meet the target for recruitment and was extended to March 2020, with changes made to address low recruitment. The trial was paused in March 2020 because of COVID-19, and was later stopped, at which point 157 participants had been randomised (intervention, n = 79; usual care, n = 78). There were major issues with attrition, with 45% of the primary outcome data missing: 56% of the intervention group data and 35% of the usual-care group data. In terms of the primary outcome, patients allocated to the intervention group had a lower score for severity of urinary incontinence (higher scores indicate greater severity in urinary incontinence) than those allocated to the usual-care group, with means (standard deviations) of 8.1 (7.4) and 9.1 (7.8), respectively. LIMITATIONS: The trial was unable to recruit sufficient participants and had very high attrition, which resulted in seriously underpowered results. CONCLUSIONS: The internal pilot did not meet its target for recruitment and, despite recruitment subsequently being more promising, it was concluded that the trial was not feasible owing to the combined problems of poor recruitment, poor retention and COVID-19. The intervention group had a slightly lower score for severity of urinary incontinence at 3 months post randomisation, but this result should be interpreted with caution. FUTURE WORK: Further studies to assess the effectiveness of an intervention starting in or continuing into the community are required. TRIAL REGISTRATION: This trial is registered as ISRCTN14005026. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 31. See the NIHR Journals Library website for further project information.

Urinary incontinence affects around half of stroke survivors. It causes embarrassment and distress, affecting patients' ability to take part in rehabilitation. It also has a major impact on families and may determine whether or not patients are able to return home. Finding the underlying cause and addressing it can prevent, cure or reduce problems. Doing this in a systematic way for everyone with incontinence problems as early as possible after the stroke, while they are still in hospital, may work best. We also wanted to avoid using catheters in the bladder to drain the urine away, as these are often unnecessary and can cause urinary tract infections. This study aimed to test whether or not continence problems and the use of urinary catheters could be reduced if everyone with incontinence was fully assessed and given the right management and support early after hospital admission. We also wanted to find out if the benefits outweighed the costs. We planned to involve 1024 men and women with incontinence from 18 stroke units in the study, with 512 people receiving the intervention and 512 receiving usual care. However, the trial was paused because of COVID-19, at which time only 157 participants had been recruited. When we were thinking about restarting the study and looked at its progress, we found that not enough people had agreed to take part and, of those who had agreed, many had not returned their outcome questionnaires. This indicated that the trial was not feasible and should not restart. We could not make any firm conclusions about whether or not the intervention worked, as not enough people were involved. We found that stays in hospital after stroke are shorter than they were in the past. This suggests that future studies investigating ways of treating incontinence should consider interventions with management and support for incontinence that continue after patients leave the hospital.

Stroke , Urinary Incontinence , Adult , COVID-19 , Cost-Benefit Analysis , Female , Humans , Male , Program Evaluation , Quality of Life , Stroke/complications , Surveys and Questionnaires , Urinary Incontinence/etiology , Urinary Incontinence/therapy
BMJ Open ; 11(1): e045889, 2021 01 17.
Article in English | MEDLINE | ID: covidwho-1832434


BACKGROUND: The COVID-19 pandemic has had a major impact on delivery of social support services. This might be expected to particularly affect older adults and people living with dementia (PLWD), and to reduce their well-being. AIMS: To explore how social support service use by older adults, carers and PLWD, and their mental well-being changed over the first 3 months since the pandemic outbreak. METHODS: Unpaid dementia carers, PLWD and older adults took part in a longitudinal online or telephone survey collected between April and May 2020, and at two subsequent timepoints 6 and 12 weeks after baseline. Participants were asked about their social support service usage in a typical week prior to the pandemic (at baseline), and in the past week at each of the three timepoints. They also completed measures of levels of depression, anxiety and mental well-being. RESULTS: 377 participants had complete data at all three timepoints. Social support service usage dropped shortly after lockdown measures were imposed at timepoint 1 (T1), to then increase again by T3. The access to paid care was least affected by COVID-19. Cases of anxiety dropped significantly across the study period, while cases of depression rose. Well-being increased significantly for older adults and PLWD from T1 to T3. CONCLUSIONS: Access to social support services has been significantly affected by the pandemic, which is starting to recover slowly. With mental well-being differently affected across groups, support needs to be put in place to maintain better well-being across those vulnerable groups during the ongoing pandemic.

COVID-19/psychology , Caregivers/psychology , Dementia/psychology , Health Facility Closure , Social Work , Adult , Aged , Aged, 80 and over , Anxiety/epidemiology , COVID-19/prevention & control , Depression/epidemiology , Female , Humans , Longitudinal Studies , Male , Mental Health , Middle Aged , Social Support , United Kingdom/epidemiology , Young Adult
EuropePMC; 2022.
Preprint in English | EuropePMC | ID: ppcovidwho-333110


Introduction As mortality rates from COVID-19 disease fall, the high prevalence of long-term sequelae (Long COVID) is becoming increasingly widespread, challenging healthcare systems globally. Traditional pathways of care for Long Term Conditions (LTCs) have tended to be managed by disease-specific specialties, an approach that has been ineffective in delivering care for patients with multi-morbidity. The multi-system nature of Long COVID and its impact on physical and psychological health demands a more effective model of holistic, integrated care. The evolution of integrated care systems (ICSs) in the UK presents an important opportunity to explore areas of mutual benefit to LTC, multi-morbidity and Long COVID care. There may be benefits in comparing and contrasting ICPs for Long COVID with ICPs for other LTCs. Methods and analysis This study aims to evaluate health services requirements for ICPs for Long COVID and their applicability to other LTCs including multi-morbidity and the overlap with medically not yet explained symptoms (MNYES). The study will follow a Delphi design and involve an expert panel of stakeholders including people with lived experience, as well as clinicians with expertise in Long COVID and other LTCs. Study processes will include expert panel and moderator panel meetings, surveys, and interviews. The Delphi process is part of the overall STIMULATE-ICP programme, aimed at improving integrated care for people with Long COVID. Ethics and dissemination Ethical approval for this Delphi study has been obtained (Research Governance Board of the University of York) as have approvals for the other STIMULATE-ICP studies. Study outcomes are likely to inform policy for ICPs across LTCs. Results will be disseminated through scientific publication, conference presentation and communications with patients and stakeholders involved in care of other LTCs and Long COVID. Registration Researchregistry: . Strengths and limitations of this study Gap There is no general model for providing ICPs to many LTCs, especially in case of multi-morbidity or MNYES. Solution We will develop policy recommendations for such ICPs based upon a Delphi process exploring the value and interchangeability of elements of ICPs for Long COVID. This will help patients and clinicians navigate access to, or provide ICPs for, LTCs. Strengths A key tenet is that people with lived experience of Long COVID or an LTC will be involved from inception in the design and conduct of the study. Weaknesses Possible under-representation of digitally hard to reach groups, although efforts will be made to ensure that data collection is widely inclusive, following the NIHR INCLUDE framework.

BMJ Open ; 12(3): e053111, 2022 03 15.
Article in English | MEDLINE | ID: covidwho-1745693


OBJECTIVES: This mixed-method process evaluation underpinned by normalisation process theory aims to measure fidelity to the intervention, understand the social and structural context in which the intervention is delivered and identify barriers and facilitators to intervention implementation. SETTING: RETurn to work After stroKE (RETAKE) is a multicentre individual patient randomised controlled trial to determine whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care is a clinically and cost-effective therapy to facilitate return to work after stroke, compared with usual care alone. This protocol paper describes the embedded process evaluation. PARTICIPANTS AND OUTCOME MEASURES: Intervention training for therapists will be observed and use of remote mentor support reviewed through documentary analysis. Fidelity will be assessed through participant questionnaires and analysis of therapy records, examining frequency, duration and content of ESSVR sessions. To understand the influence of social and structural contexts, the process evaluation will explore therapists' attitudes towards evidence-based practice, competency to deliver the intervention and evaluate potential sources of contamination. Longitudinal case studies incorporating non-participant observations will be conducted with a proportion of intervention and usual care participants. Semistructured interviews with stroke survivors, carers, occupational therapists, mentors, service managers and employers will explore their experiences as RETAKE participants. Analysis of qualitative data will draw on thematic and framework approaches. Quantitative data analysis will include regression models and descriptive statistics. Qualitative and quantitative data will be independently analysed by process evaluation and Clinical Trials Research Unit teams, respectively. Linked data, for example, fidelity and describing usual care will be synthesised by comparing and integrating quantitative descriptive data with the qualitative findings. ETHICS AND DISSEMINATION: Approval obtained through the East Midlands-Nottingham 2 Research Ethics Committee (Ref: 18/EM/0019) and the National Health ServiceResearch Authority. Dissemination via journal publications, stroke conferences, social media and meetings with national Stroke clinical leads. TRIAL REGISTRATION NUMBER: ISRCTN12464275.

Stroke Rehabilitation , Stroke , Caregivers , Humans , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Return to Work , Stroke/therapy , Surveys and Questionnaires , Survivors
Preprint in English | EuropePMC | ID: ppcovidwho-327724


Background: Pulse oximetry was widely used in hospitals and at home to monitor blood oxygen during the COVID-19 pandemic. There have been concerns regarding potential bias in pulse oximetry measurements for people with dark skin. We aimed to assess the effects of skin pigmentation on the accuracy of oxygen saturation measurement by pulse oximetry (SpO2) compared with the gold standard SaO2 measured by CO-oximetry. Methods We searched Ovid MEDLINE, Ovid Embase, and EBSCO CINAHL Plus (up to December 2021), as well as and World Health Organization International Clinical Trials Registry Platform (up to August 2021). We identified studies comparing SpO2 values in any population, in any care setting, using any type of pulse oximeter, with SaO2 by standard CO-oximetry;and measuring the impact of skin pigmentation or ethnicity on pulse oximetry accuracy. We performed meta-analyses for mean bias (the primary outcome in this review) and its standard deviations (SDs) across studies included for each subgroup of level of skin pigmentation and ethnicity. We calculated accuracy root-mean-square (Arms) and 95% limits of agreement based on pooled mean bias and pooled SDs for each subgroup. Results We included 32 studies (6505 participants);27/32 (84.38%) in hospitals and none in people's homes. Findings of 14/32 studies (43.75%) were judged, via QUADAS-2, at high overall risk of bias. Fifteen studies measured skin pigmentation and 22 referred only to ethnicity. Compared with standard SaO2 measurement, pulse oximetry probably overestimates oxygen saturation in people with dark skin (pooled mean bias 1.11%;95% confidence interval 0.29% to 1.93%) and people described as Black/African American (pooled mean bias 1.52%;0.95% to 2.09%) (moderate- and low-certainty evidence). These results suggest that, for people with dark skin, pulse oximetry may overestimate blood oxygen saturation by around 1% on average compared with SaO2. The bias of pulse oximetry measurements for people with other levels of skin pigmentation, or those from the White/Caucasian group is more uncertain. The data do not suggest overestimation in people from other ethnic groups such as those described as Asian, Hispanic, or mixed ethnicity (pooled mean bias 0.31%, 0.09% to 0.54%), but this evidence is low certainty. Whilst the extent of mean bias is small or negligible for all the subgroups of population evaluated, the associated imprecision is unacceptably large (with the pooled SDs > 1%). Nevertheless, when the extents of measurement bias and precision are considered jointly in Arms, pulse oximetry measurements for all the subgroups appear acceptably accurate (with Arms < 4%). Conclusions Low-certainty evidence suggests that pulse oximetry may overestimate oxygen saturation in people with dark skin and people whose ethnicity is reported as Black/African American, compared with SaO2, although the overestimation may be quite small in hospital settings. The clinical importance of any overestimation will depend on the particular clinical circumstance. Pulse oximetry measurements appear accurate but imprecise for all levels of skin pigmentation. The evidence relates to clinician-measured oximetry in health care environments and may not be reflected in home pulse oximetry where other factors may also influence accuracy.

Int J Geriatr Psychiatry ; 36(3): 393-402, 2021 03.
Article in English | MEDLINE | ID: covidwho-777452


OBJECTIVES: The aim of this national survey was to explore the impact of COVID-19 public health measures on access to social support services and the effects of closures of services on the mental well-being of older people and those affected by dementia. METHODS: A UK-wide online and telephone survey was conducted with older adults, people with dementia, and carers between April and May 2020. The survey captured demographic and postcode data, social support service usage before and after COVID-19 public health measures, current quality of life, depression, and anxiety. Multiple linear regression analysis was used to explore the relationship between social support service variations and anxiety and well-being. RESULTS: Five hundred and sixty-nine participants completed the survey (61 people with dementia, 285 unpaid carers, and 223 older adults). Paired samples t-tests and X2 -tests showed that the mean hour of weekly social support service usage and the number of people having accessed various services was significantly reduced post COVID-19. Multiple regression analyses showed that higher variations in social support service hours significantly predicted increased levels of anxiety in people with dementia and older adults, and lower levels of mental well-being in unpaid carers and older adults. CONCLUSIONS: Being unable to access social support services due to COVID contributed to worse quality of life and anxiety in those affected by dementia and older adults across the UK. Social support services need to be enabled to continue providing support in adapted formats, especially in light of continued public health restrictions for the foreseeable future.

COVID-19 , Dementia , Aged , Aged, 80 and over , Caregivers , Humans , Quality of Life , SARS-CoV-2 , Social Support , United Kingdom