Quality of life and quality-adjusted life years after stroke in Sierra Leone.

BACKGROUND: Stroke is a leading cause of mortality and negatively affects health-related quality of life (HRQoL). HRQoL after stroke is understudied in Africa and there are no reports of quality-adjusted life years after stroke (QALYs) in African countries. We determined the impact of stroke on HRQoL after stroke in Sierra Leone. We calculated QALYs at 1 year post-stroke and determined sociodemographic and clinical variables associated with HRQoL and QALYs in this population. METHODS: A prospective stroke register was established at the two-principal adult tertiary government hospitals in Freetown, Sierra Leone. Participants were followed up at 7, 90 days, and 1 year post-stroke to capture all-cause mortality and EQ-5D-3L data. QALYs were calculated at the patient level using EQ-5D-3L utility values and survival data from the register, following the area under the curve method. Utilities were based on the UK and Zimbabwe (as a sensitivity analysis) EQ-5D value sets, as there is no Sierra Leonean or West African value set. Explanatory models were developed based on previous literature to assess variables associated with HRQoL and QALYs at 1 year after stroke. To address missing values, Multiple Imputation by Chained Equations (MICE), with linear and logistic regression models for continuous and binary variables, respectively, were used. RESULTS: EQ-5D-3L data were available for 373/460 (81.1%), 360/367 (98.1%), and 299/308 (97.1%) participants at 7, 90 days, and 1 year after stroke. For stroke survivors, median EQ-5D-3L utility increased from 0.20 (95% CI: -0.16 to 0.59) at 7 days post-stroke to 0.76 (0.47 to 1.0) at 90 days and remained stable at 1 year 0.76 (0.49 to 1.0). Mean QALYs at 1 year after stroke were 0.28 (SD: 0.35) and closely associated with stroke severity. Older age, lower educational attainment, patients with subarachnoid hemorrhage and undetermined stroke types all had lower QALYs and lower HRQoL, while being the primary breadwinner was associated with higher HRQoL. Sensitivity analysis with the Zimbabwe value set did not significantly change regression results but did influence the absolute values with Zimbabwe utility values being higher, with fewer utility values less than 0. CONCLUSION: We generated QALYs after stroke for the first time in an African country. QALYs were significantly lower than studies from outside Africa, partially explained by the high mortality rate in our cohort. Further research is needed to develop appropriate value sets for West African countries and to examine QALYs lost due to stroke over longer time periods. DATA AVAILABILITY: The Stroke in Sierra Leone anonymized dataset is available on request to researchers, see data access section.

The feasibility, repeatability, validity and responsiveness of the EQ-5D-3L in Krio for patients with stroke in Sierra Leone.

OBJECTIVES: To assess the feasibility, repeatability, validity and responsiveness of the EQ-5D-3L in Krio for patients with stroke in Sierra Leone, the first psychometric assessment of the EQ-5D-3L to be conducted in patients with stroke in Sub Saharan Africa. METHODS: A prospective stroke register at two tertiary government hospitals recruited all patients with the WHO definition of stroke and followed patients up at seven days, 90 days and one year post stroke. The newly translated EQ-5D-3L, Barthel Index (BI), modified Rankin Scale (mRS) and National Institute of Health Stroke Scale (NIHSS), a measure of stroke severity, were collected by trained researchers, face to face during admission and via phone at follow up. Feasibility was assessed by completion rate and proportion of floor/ceiling effects. Internal consistency was assessed by inter item correlations (IIC) and Cronbach's alpha. Repeatability of the EQ-5D-3L was examined using test-retest, EQ-5D-3L utility scores at 90 days were compared to EQ-5D-3L utility scores at one year in the same individuals, whose Barthel Index had remained within the minimally clinical important difference. Known group validity was assessed by stroke severity. Convergent validity was assessed against the BI, using Spearman's rho. Responsiveness was assessed in patients whose BI improved or deteriorated from seven to 90 days. Sensitivity analyses were conducted using the UK and Zimbabwe value sets, to evaluate the effect of value set, in a subgroup of patients with no formal education to evaluate the influence of patient educational attainment, and using the mRS instead of the BI to evaluate the influence of utilising an alternative functional scale. RESULTS: The EQ-5D-3L was completed in 373/460 (81.1%), 360/367 (98.1%) and 299/308 (97.1%) eligible patients at seven days, 90 days and one year post stroke. Missing item data was low overall, but was highest in the anxiety/depression dimension 1.3% (5/373). Alpha was 0.81, 0.88 and 0.86 at seven days, 90 days and one year post stroke and IIC were within pre-specified ranges. Repeatability of the EQ-5D-3L was moderate to poor, weighted Kappa 0.23-0.49. EQ-5D-3L utility was significantly associated with stroke severity at all timepoints. Convergent validity with BI was strong overall and for shared subscales. EQ-5D-3L was moderately responsive to both improvement Cohen's D 0.55 (95% CI:0.15-0.94) and deterioration 0.92 (95% CI:0.29-1.55). Completion rates were similar in patients with no formal education 148/185 (80.0%) vs those with any formal education 225/275 (81.8%), and known group validity for stroke severity in patients with no formal education was strong. Using the Zimbabwe value set instead of the UK value set, and using the mRS instead of the BI did not change the direction or significance of results. CONCLUSIONS: The EQ-5D-3L for stroke in Sierra Leone was feasible, and responsive including in patients with no formal education. However, repeatability was moderate to poor, which may be due to the study design, but should add a degree of caution in the analysis of repeated measures of EQ-5D-3L over time in this population. Known group validity and convergent validity with BI and mRS were strong. Further research should assess the EQ-5D in the general population, examine test-retest reliability over a shorter time period and assess the acceptability and validity of the anxiety/depression dimension against other validated mental health instruments. Development of an EQ-5D value set for West Africa should be a research priority.

Participants' experiences and acceptability of a home-based walking exercise behaviour-change intervention (MOtivating Structure walking Activity in people with Intermittent Claudication (MOSAIC)).

OBJECTIVES: This study explored the experiences and acceptability of a novel, home-based, walking exercise behaviour-change intervention (MOtivating Structured walking Activity in people with Intermittent Claudication (MOSAIC)) in adults with Peripheral Arterial Disease (PAD). DESIGN AND SETTING: Individual semi-structured audio-recorded interviews were conducted with adults with Peripheral Arterial Disease who had completed the MOSAIC intervention as part of a randomised clinical trial. Data were analysed using inductive reflexive thematic analysis and interpreted using the seven-construct theoretical framework of acceptability of healthcare interventions (TFA). PARTICIPANTS: Twenty participants (mean age (range) 67(54-80) years, 70% male, 55% White British) were interviewed. RESULTS: One central theme was identified: Acceptability of walking exercise as a treatment. This theme was explained by four linked themes: Exploring walking exercise with a knowledgeable professional, Building confidence with each step, Towards self-management-learning strategies to continue walking and The impact of walking exercise. These themes were interpreted using six of the seven TFA constructs: affective attitude, burden, perceived effectiveness, intervention coherence, opportunity costs, and self-efficacy. CONCLUSIONS: Participants perceived MOSAIC as an effective, acceptable, and low burden intervention. Physiotherapists were regarded as knowledgeable and supportive professionals who helped participants understand PAD and walking exercise as a treatment. Participants developed confidence to self-manage their condition and their symptoms. As participants confidence and walking capacity improved, they expanded their activities and gained a more positive outlook on their future. MOSAIC is an acceptable intervention that may facilitate adoption of and access to exercise for people with PAD.

Factors guiding therapist decision making in the rehabilitation of physical function after severely disabling stroke - an ethnographic study.

PURPOSE: Whilst strong evidence supports rehabilitation to improve outcomes post-stroke, there is limited evidence to guide rehabilitation in the most severely disabled group. In an era of evidence-based practice, the aim of the study was to understand what factors guide physiotherapists (PTs) and occupational therapists (OTs) to select particular interventions in the rehabilitation of physical function after severely disabling stroke. MATERIAL AND METHODS: An ethnographic study was undertaken over an 18-month period involving five London, UK stroke services. Seventy-nine primary participants (30 PTs, 22 OTs, and 27 stroke survivors) were recruited to the study. Over 400 h of observation, 52 semi-structured interviews were conducted. Study data were analysed through thematic analysis. RESULTS: Key factors guiding therapist decision making were clinical expertise, professional role, stroke survivors' clinical presentation, therapist perspectives about stroke recovery, and clinical guidelines. Research evidence, stroke survivors' treatment preferences, organisational type, and pathway design were less influential factors. Therapy practice did not always address the physical needs of severely disabled stroke survivors. CONCLUSIONS: Multiple factors guided therapist decision making after severely disabling stroke. Alternative ways of therapist working should be considered to address the physical needs of severely disabled stroke survivors more fully.Implications for rehabilitationMultiple factors guide therapist decision making after severely disabling stroke, some of which result in the use of interventions that do not fully address stroke survivors' clinical needs.Therapists should critically reflect upon their personal beliefs and attitudes about severely disabling stroke to reduce potential sources of bias on decision making.Therapists should consider the timing and intensity of therapy delivery as well as their treatment approach to optimise outcomes after severely disabling stroke.

Impact of depression on stroke outcomes among stroke survivors: Systematic review and meta-analysis.

BACKGROUND: Depression may negatively affect stroke outcomes and the progress of recovery. However, there is a lack of updated comprehensive evidence to inform clinical practice and directions of future studies. In this review, we report the multidimensional impact of depression on stroke outcomes. METHODS: Data sources. PubMed, PsycINFO, EMBASE, and Global Index Medicus were searched from the date of inception. Eligibility criteria. Prospective studies which investigated the impact of depression on stroke outcomes (cognition, returning to work, quality of life, functioning, and survival) were included. Data extraction. Two authors extracted data independently and solved the difference with a third reviewer using an extraction tool developed prior. The extraction tool included sample size, measurement, duration of follow-up, stroke outcomes, statistical analysis, and predictors outcomes. Risk of bias. We used Effective Public Health Practice Project (EPHPP) to assess the quality of the included studies. RESULTS: Eighty prospective studies were included in the review. These studies investigated the impact of depression on the ability to return to work (n = 4), quality of life (n = 12), cognitive impairment (n = 5), functioning (n = 43), and mortality (n = 24) where a study may report on more than one outcome. Though there were inconsistencies, the evidence reported that depression had negative consequences on returning to work, functioning, quality of life, and mortality rate. However, the impact on cognition was not conclusive. In the meta-analysis, depression was associated with premature mortality (HR: 1.61 (95% CI; 1.33, 1.96)), and worse functioning (OR: 1.64 (95% CI; 1.36, 1.99)). CONCLUSION: Depression affects many aspects of stroke outcomes including survival The evidence is not conclusive on cognition and there was a lack of evidence in low-income settings. The results showed the need for early diagnosis and intervention of depression after stroke. The protocol was pre-registered on the International Prospective Register of Systematic Review (PROSPERO) (CRD42021230579).

Physiotherapists' perspectives of barriers and facilitators to effective community provision after hip fracture: a qualitative study in England.

PURPOSE: to investigate physiotherapists' perspectives of effective community provision following hip fracture. METHODS: qualitative semi-structured interviews were conducted with 17 community physiotherapists across England. Thematic analysis drawing on the Theoretical Domains Framework identified barriers and facilitators to implementation of effective provision. Interviews were complemented by process mapping community provision in one London borough, to identify points of care where suggested interventions are in place and/or could be implemented. RESULTS: four themes were identified: ineffective coordination of care systems, ineffective patient stratification, insufficient staff recruitment and retention approaches and inhibitory fear avoidance behaviours. To enhance care coordination, participants suggested improving access to social services and occupational therapists, maximising multidisciplinary communication through online notation, extended physiotherapy roles, orthopaedic-specific roles and seven-day working. Participants advised the importance of stratifying patients on receipt of referrals, at assessment and into appropriately matched interventions. To mitigate insufficient staff recruitment and retention, participants proposed return-to-practice streams, apprenticeship schemes, university engagement, combined acute-community rotations and improving job description advertisements. To reduce effects of fear avoidance behaviour on rehabilitation, participants proposed the use of patient-specific goals, patient and carer education, staff education in psychological strategies or community psychologist access. Process mapping of one London borough identified points of care where suggested interventions to overcome barriers were in place and/or could be implemented. CONCLUSION: physiotherapists propose that effective provision of community physiotherapy following hip fracture could be improved by refining care coordination, utilising stratification techniques, employing enhanced recruitment and retainment strategies and addressing fear avoidance behaviours.

Stroke Survivor's Satisfaction and Experience with Rehabilitation Services: A Qualitative Systematic Review.

Research in healthcare is increasingly focused on quality assurance and continuous quality improvement aiming to promote service quality. Satisfaction is a key endpoint in outcomes research and service benchmarking, along with "traditional" clinical outcomes. What controls stroke survivors' satisfaction differs among qualitative studies' conclusions, but there is general consensus on the importance of communication, improvement in activity, and engagement in goal setting. This review aims to collect and synthesise studies of the satisfaction of stroke survivors with rehabilitation services. A systematic search was conducted in seven electronic databases, including CINAHL, OVID, Pedro, Scopus Midline, Web of Science, and PubMed. The database search yielded 1339 studies, while one additional work was identified through hand searching. After removing duplicates, 74 studies were read in full, and after resultant exclusions, 12 qualitative studies were systematically reviewed, extracted, and appraised by two reviewers independently (HAS and RT) and the third reviewer (CS) was available for any disagreement. Five analytical themes were identified: Healthcare Professional-Patient Relationship (HCP), Delivery Service, Perceived Patient Autonomy (PPA), Expectations Shape Satisfaction, and Culture Influences Satisfaction. The studies of survivors' satisfaction, experiences, and their rehabilitative needs with the services they receive have provided different factors that influence their satisfaction during rehabilitation in different countries worldwide. However, the context in which the studies were conducted is quite limited, and more detailed studies are required for many underexplored contexts.

Stroke in Sierra Leone. the stroke risk factors for people with HIV: A prospective case-control study.

BACKGROUND: HIV infection rates are relatively low in Sierra Leone and in West Africa but the contribution of HIV to the risk factors for stroke and outcomes is unknown. In this study, we examined stroke types, presentation, risk factors and outcome in HIV stroke patients compared with controls. METHODS: We used data from the Stroke in Sierra Leone Study at 2 tertiary hospitals in Freetown, Sierra Leone. A case control design was used to compare stroke type, presentation, risk factors and outcome in sero-positive HIV patients with HIV negative stroke controls. Controls were matched for age and gender and a 1:4 ratio cases to controls was used to optimize power. Analysis was performed using the Pearson x2 for categorical variable, Paired-T test and Mann-Whitney U test for continuous variables. A p-value of less than 0.05 was taken as the level of statistical significance. RESULTS: Of 511 (51.8%) stroke patients tested for HIV, 36 (7.1%) were positive. Univariate unmatched analysis showed a stroke mean age of 49 years in HIV-positive versus 58 years in HIV-negative population (p = <0.001). In the case-control group, ischaemic stroke is the major type reported in both populations, HIV-negative population: 77 (53.5%) versus HIV-positive: 25 (69.4%) (p = 0.084). Hypertension is the most prevalent risk factor in both groups, HIV-positive: 23 (63.9%) versus HIV-negative: 409 (86.1%) (p = 0.001). Lower CD4+ count is associated in-hospital mortality (p = <0.001). CONCLUSION: These findings support the current call for timely management of stroke and HIV through integrated care.

Frequency, duration, and type of physiotherapy in the week after hip fracture surgery - analysis of implications for discharge home, readmission, survival, and recovery of mobility.

PURPOSE: To examine the association between physiotherapy access after hip fracture and discharge home, readmission, survival, and mobility recovery. METHODS: A 2017 Physiotherapy Hip Fracture Sprint Audit was linked to hospital records for 5383 patients. Logistic regression was used to estimate the association between physiotherapy access in the first postoperative week and discharge home, 30-day readmission post-discharge, 30-day survival and 120-days mobility recovery post-admission adjusted for age, sex, American Society of Anesthesiology grade, Hospital Frailty Risk Score and prefracture mobility/residence. RESULTS: Overall, 73% were female and 40% had high frailty risk. Patients who received ≥2 hours of physiotherapy (versus less) had 3% (95% Confidence Interval: 0-6%), 4% (2-6%), and 6% (1-11%) higher adjusted probabilities of discharge home, survival, and outdoor mobility recovery, and 3% (0-6%) lower adjusted probability of readmission. Recipients of exercise (versus mobilisation alone) had 6% (1-12%), 3% (0-7%), and 11% (3-18%) higher adjusted probabilities of discharge home, survival, and outdoor mobility recovery, and 6% (2-10%) lower adjusted probability of readmission. Recipients of 6-7 days physiotherapy (versus 0-2 days) had 8% (5-11%) higher adjusted probability of survival. For patients with dementia, improved probability of survival, discharge home, readmission and indoor mobility recovery were observed with greater physiotherapy access. CONCLUSION: Greater access to physiotherapy was associated with a higher probability of positive outcomes. For every 100 patients, greater access could equate to an additional eight patients surviving to 30-days and six avoiding 30-day readmission. The findings suggest a potential benefit in terms of home discharge and outdoor mobility recovery. CONTRIBUTION OF THE PAPER.

Stroke in Sierra Leone: Case fatality rate and functional outcome after stroke in Freetown.

BACKGROUND: There is limited information on long-term outcomes after stroke in sub-Saharan Africa (SSA). Current estimates of case fatality rate (CFR) in SSA are based on small sample sizes with varying study design and report heterogeneous results. AIMS: We report CFR and functional outcomes from a large, prospective, longitudinal cohort of stroke patients in Sierra Leone and describe factors associated with mortality and functional outcome. METHODS: A prospective longitudinal stroke register was established at both adult tertiary government hospitals in Freetown, Sierra Leone. It recruited all patients ⩾ 18 years with stroke, using the World Health Organization definition, from May 2019 until October 2021. To reduce selection bias onto the register, all investigations were paid by the funder and outreach conducted to raise awareness of the study. Sociodemographic data, National Institute of Health Stroke Scale (NIHSS), and Barthel Index (BI) were collected on all patients on admission, at 7 days, 90 days, 1 year, and 2 years post stroke. Cox proportional hazards models were constructed to identify factors associated with all-cause mortality. A binomial logistic regression model reports odds ratio (OR) for functional independence at 1 year. RESULTS: A total of 986 patients with stroke were included, of which 857 (87%) received neuroimaging. Follow-up rate was 82% at 1 year, missing item data were <1% for most variables. Stroke cases were equally split by sex and mean age was 58.9 (SD: 14.0) years. About 625 (63%) were ischemic, 206 (21%) primary intracerebral hemorrhage, 25 (3%) subarachnoid hemorrhage, and 130 (13%) were of undetermined stroke type. Median NIHSS was 16 (9-24). CFR at 30 days, 90 days, 1 year, and 2 years was 37%, 44%, 49%, and 53%, respectively. Factors associated with increased fatality at any timepoint were male sex (hazard ratio (HR): 1.28 (1.05-1.56)), previous stroke (HR: 1.34 (1.04-1.71)), atrial fibrillation (HR: 1.58(1.06-2.34)), subarachnoid hemorrhage (HR: 2.31 (1.40-3.81)), undetermined stroke type (HR: 3.18 (2.44-4.14)), and in-hospital complications (HR: 1.65 (1.36-1.98)). About 93% of patients were completely independent prior to their stroke, declining to 19% at 1 year after stroke. Functional improvement was most likely to occur between 7 and 90 days post stroke with 35% patients improving, and 13% improving between 90 days to 1 year. Increasing age (OR: 0.97 (0.95-0.99)), previous stroke (OR: 0.50 (0.26-0.98)), NIHSS (OR: 0.89 (0.86-0.91)), undetermined stroke type (OR: 0.18 (0.05-0.62)), and ⩾1 in-hospital complication (OR: 0.52 (0.34-0.80)) were associated with lower OR of functional independence at 1 year. Hypertension (OR: 1.98 (1.14-3.44)) and being the primary breadwinner of the household (OR: 1.59 (1.01-2.49)) were associated with functional independence at 1 year. CONCLUSION: Stroke affected younger people and resulted in high rates of fatality and functional impairment relative to global averages. Key clinical priorities for reducing fatality include preventing stroke-related complications through evidence-based stroke care, improved detection and management of atrial fibrillation, and increasing coverage of secondary prevention. Further research into care pathways and interventions to encourage care seeking for less severe strokes should be prioritized, including reducing the cost barrier for stroke investigations and care.

Development and Validation of Multivariable Prediction Models for In-Hospital Death, 30-Day Death, and Change in Residence After Hip Fracture Surgery and the "Stratify-Hip" Algorithm.

BACKGROUND: To develop and validate the stratify-hip algorithm (multivariable prediction models to predict those at low, medium, and high risk across in-hospital death, 30-day death, and residence change after hip fracture). METHODS: Multivariable Fine-Gray and logistic regression of audit data linked to hospital records for older adults surgically treated for hip fracture in England/Wales 2011-14 (development n = 170 411) and 2015-16 (external validation, n = 90 102). Outcomes included time to in-hospital death, death at 30 days, and time to residence change. Predictors included age, sex, pre-fracture mobility, dementia, and pre-fracture residence (not for residence change). Model assumptions, performance, and sensitivity to missingness were assessed. Models were incorporated into the stratify-hip algorithm assigning patients to overall low (low risk across outcomes), medium (low death risk, medium/high risk of residence change), or high (high risk of in-hospital death, high/medium risk of 30-day death) risk. RESULTS: For complete-case analysis, 6 780 of 141 158 patients (4.8%) died in-hospital, 8 693 of 149 258 patients (5.8%) died by 30 days, and 4 461 of 119 420 patients (3.7%) had residence change. Models demonstrated acceptable calibration (observed:expected ratio 0.90, 0.99, and 0.94), and discrimination (area under curve 73.1, 71.1, and 71.5; Brier score 5.7, 5.3, and 5.6) for in-hospital death, 30-day death, and residence change, respectively. Overall, 31%, 28%, and 41% of patients were assigned to overall low, medium, and high risk. External validation and missing data analyses elicited similar findings. The algorithm is available at https://stratifyhip.co.uk. CONCLUSIONS: The current study developed and validated the stratify-hip algorithm as a new tool to risk stratify patients after hip fracture.

The provision of person-centred care for care home residents with stroke: An ethnographic study.

Care home residents with stroke have higher levels of disability and poorer access to health services than those living in their own homes. We undertook observations and semi-structured interviews (n = 28 participants) with managers, staff, residents who had experienced a stroke and their relatives in four homes in London, England, in 2018/2019. Thematic analysis revealed that residents' needs regarding valued activity and stroke-specific care and rehabilitation were not always being met. This resulted from an interplay of factors: staff's lack of recognition of stroke and its effects; gaps in skills; time pressures; and the prioritisation of residents' safety. To improve residential care provision and residents' quality of life, care commissioners, regulators and providers may need to re-examine how care homes balance safety and limits on staff time against residents' valued activity, alongside improving access to specialist healthcare treatment and support.

The effectiveness of rehabilitation interventions including outdoor mobility on older adults' physical activity, endurance, outdoor mobility and falls-related self-efficacy: systematic review and meta-analysis.

OBJECTIVE: To determine the effectiveness of community-based rehabilitation interventions which incorporate outdoor mobility on physical activity, endurance, outdoor mobility and falls-related self-efficacy in older adults. DESIGN: MEDLINE, Embase, CINAHL, PEDro and OpenGrey were searched systematically from inception to June 2021 for randomised controlled trials (RCTs) of community-based rehabilitation incorporating outdoor mobility on physical activity, endurance, outdoor mobility and/or falls-related self-efficacy in older adults. Duplicate screening, selection, extraction and appraisal were completed. Results were reported descriptively and with random-effects meta-analyses stratified by population (proactive [community-dwelling], reactive [illness/injury]). RESULTS: A total of 29 RCTs with 7,076 participants were identified (66% high bias for at least one domain). The outdoor mobility component was predominantly a walking programme with behaviour change. Rehabilitation for reactive populations increased physical activity (seven RCTs, 587 participants. Hedge's g 1.32, 95% CI: 0.31, 2.32), endurance (four RCTs, 392 participants. Hedges g 0.24; 95% CI: 0.04, 0.44) and outdoor mobility (two RCTs with 663 participants. Go out as much as wanted, likelihood of a journey) at intervention end versus usual care. Where reported, effects were preserved at follow-up. One RCT indicated a benefit of rehabilitation for proactive populations on moderate-to-vigorous activity and outdoor mobility. No effect was noted for falls-related self-efficacy, or other outcomes following rehabilitation for proactive populations. CONCLUSION: Reactive rehabilitation for older adults may include walking programmes with behaviour change techniques. Future research should address the potential benefit of a walking programme for proactive populations and address mobility-related anxiety as a barrier to outdoor mobility for both proactive and reactive populations.

Gait rehabilitation for foot and ankle impairments in early rheumatoid arthritis: a feasibility study of a new gait rehabilitation programme (GREAT Strides).

BACKGROUND: Foot impairments in early rheumatoid arthritis are common and lead to progressive deterioration of lower limb function. A gait rehabilitation programme underpinned by psychological techniques to improve adherence, may preserve gait and lower limb function. This study evaluated the feasibility of a novel gait rehabilitation intervention (GREAT Strides) and a future trial. METHODS: This was a mixed methods feasibility study with embedded qualitative components. People with early (< 2 years) rheumatoid arthritis (RA) and foot pain were eligible. Intervention acceptability was evaluated using a questionnaire. Adherence was evaluated using the Exercise Adherence Rating Scale (EARS). Safety was monitored using case report forms. Participants and therapists were interviewed to explore intervention acceptability. Deductive thematic analysis was applied using the Theoretical Framework of Acceptability. For fidelity, audio recordings of interventions sessions were assessed using the Motivational Interviewing Treatment Integrity (MITI) scale. Measurement properties of four candidate primary outcomes, rates of recruitment, attrition, and data completeness were evaluated. RESULTS: Thirty-five participants (68.6% female) with median age (inter-quartile range [IQR]) 60.1 [49.4-68.4] years and disease duration 9.1 [4.0-16.2] months), were recruited and 23 (65.7%) completed 12-week follow-up. Intervention acceptability was excellent; 21/23 were confident that it could help and would recommend it; 22/23 indicated it made sense to them. Adherence was good, with a median [IQR] EARS score of 17/24 [12.5-22.5]. One serious adverse event that was unrelated to the study was reported. Twelve participants' and 9 therapists' interviews confirmed intervention acceptability, identified perceptions of benefit, but also highlighted some barriers to completion. Mean MITI scores for relational (4.38) and technical (4.19) aspects of motivational interviewing demonstrated good fidelity. The Foot Function Index disability subscale performed best in terms of theoretical consistency and was deemed most practical. CONCLUSION: GREAT Strides was viewed as acceptable by patients and therapists, and we observed high intervention fidelity, good patient adherence, and no safety concerns. A future trial to test the additional benefit of GREAT Strides to usual care will benefit from amended eligibility criteria, refinement of the intervention and strategies to ensure higher follow-up rates. The Foot Function Index disability subscale was identified as the primary outcome for the future trial. TRIAL REGISTRATION: ISRCTN14277030.

Effect of a Home-Based, Walking Exercise Behavior Change Intervention vs Usual Care on Walking in Adults With Peripheral Artery Disease: The MOSAIC Randomized Clinical Trial.

Importance: Home-based walking exercise interventions are recommended for people with peripheral artery disease (PAD), but evidence of their efficacy has been mixed. Objective: To investigate the effect of a home-based, walking exercise behavior change intervention delivered by physical therapists in adults with PAD and intermittent claudication compared with usual care. Design, Setting, and Participants: Multicenter randomized clinical trial including 190 adults with PAD and intermittent claudication in 6 hospitals in the United Kingdom between January 2018 and March 2020; final follow-up was September 8, 2020. Interventions: Participants were randomized to receive a walking exercise behavior change intervention delivered by physical therapists trained to use a motivational approach (n = 95) or usual care (n = 95). Main Outcomes and Measures: The primary outcome was 6-minute walking distance at 3-month follow-up (minimal clinically important difference, 8-20 m). There were 8 secondary outcomes, 3 of which were the Walking Estimated Limitation Calculated by History (WELCH) questionnaire (score range, 0 [best performance] to 100), the Brief Illness Perceptions Questionnaire (score range, 0 to 80 [80 indicates negative perception of illness]), and the Theory of Planned Behavior Questionnaire (score range, 3 to 21 [21 indicates best attitude, subjective norms, perceived behavioral control, or intentions]); a minimal clinically important difference was not defined for these instruments. Results: Among 190 randomized participants (mean age 68 years, 30% women, 79% White race, mean baseline 6-minute walking distance, 361.0 m), 148 (78%) completed 3-month follow-up. The 6-minute walking distance changed from 352.9 m at baseline to 380.6 m at 3 months in the intervention group and from 369.8 m to 372.1 m in the usual care group (adjusted mean between-group difference, 16.7 m [95% CI, 4.2 m to 29.2 m]; P = .009). Of the 8 secondary outcomes, 5 were not statistically significant. At 6-month follow-up, baseline WELCH scores changed from 18.0 to 27.8 in the intervention group and from 20.7 to 20.7 in the usual care group (adjusted mean between-group difference, 7.4 [95% CI, 2.5 to 12.3]; P = .003), scores on the Brief Illness Perceptions Questionnaire changed from 45.7 to 38.9 in the intervention group and from 44.0 to 45.8 in the usual care group (adjusted mean between-group difference, -6.6 [95% CI, -9.9 to -3.4]; P < .001), and scores on the attitude component of the Theory of Planned Behavior Questionnaire changed from 14.7 to 15.4 in the intervention group and from 14.6 to 13.9 in the usual care group (adjusted mean between-group difference, 1.4 [95% CI, 0.3 to 2.5]; P = .02). Thirteen serious adverse events occurred in the intervention group, compared with 3 in the usual care group. All were determined to be unrelated or unlikely to be related to the study. Conclusions and Relevance: Among adults with PAD and intermittent claudication, a home-based, walking exercise behavior change intervention, compared with usual care, resulted in improved walking distance at 3 months. Further research is needed to determine the durability of these findings. Trial Registrations: ISRCTN Identifier: 14501418; ClinicalTrials.gov Identifier: NCT03238222.

Do changes in outcomes following primary and revision hip replacement differ and relate to markers of socioeconomic status? A 1-year population-based cohort study.

BACKGROUND AND PURPOSE: There is little evidence on improvement after revision total hip replacement (THR). Moreover, improvements may be associated with socioeconomic status (SES). We investigated whether changes in Harris Hip Score (HHS) differ among patients undergoing primary and revision THR, and their association with markers of SES. PATIENTS AND METHODS: We conducted a populationbased cohort study on 16,932 patients undergoing primary and/or revision THR from 1995 to 2018 due to hip osteoarthritis. The patients were identified in the Danish Hip Arthroplasty Registry. Outcome was defined as mean change in HHS (0-100) from baseline to 1-year follow-up, and its association with SES markers (education, cohabiting, and wealth) was analyzed using multiple linear regression adjusting for sex, age, comorbidities, and baseline HHS. RESULTS: At 1-year follow-up, HHS improved clinically relevant for patients undergoing both primary THR: mean 43 (95% CI 43-43) and revision THR: mean 31 (CI 29-33); however, the increase was 12 points (CI 10-14) higher for primary THR. For primary THR, improvements were 0.9 points (CI 0.4-1.5) higher for patients with high educational level compared with low educational level, 0.4 points (CI 0.0-0.8) higher for patients cohabiting compared with living alone, and 2.6 points higher (CI 2.1-3.0) for patients with high wealth compared with low wealth. INTERPRETATION: Patients undergoing primary THR achieve higher improvements on HHS than patients undergoing revision THR, and the improvements are negatively related to markers of low SES. Health professionals should be aware of these characteristics and be able to identify patients who may benefit from extra rehabilitation to improve outcomes after THR to ensure equality in health.

Using the Barthel Index and modified Rankin Scale as Outcome Measures for Stroke Rehabilitation Trials; A Comparison of Minimum Sample Size Requirements.

OBJECTIVES: Underpowered trials risk inaccurate results. Recruitment to stroke rehabilitation randomised controlled trials (RCTs) is often a challenge. Statistical simulations offer an important opportunity to explore the adequacy of sample sizes in the context of specific outcome measures. We aimed to examine and compare the adequacy of stroke rehabilitation RCT sample sizes using the Barthel Index (BI) or modified Rankin Scale (mRS) as primary outcomes. METHODS: We conducted computer simulations using typical experimental event rates (EER) and control event rates (CER) based on individual participant data (IPD) from stroke rehabilitation RCTs. Event rates are the proportion of participants who experienced clinically relevant improvements in the RCT experimental and control groups. We examined minimum sample size requirements and estimated the number of participants required to achieve a number needed to treat within clinically acceptable boundaries for the BI and mRS. RESULTS: We secured 2350 IPD (18 RCTs). For a 90% chance of statistical accuracy on the BI a rehabilitation RCT would require 273 participants per randomised group. Accurate interpretation of effect sizes would require 1000s of participants per group. Simulations for the mRS were not possible as a clinically relevant improvement was not detected when using this outcome measure. CONCLUSIONS: Stroke rehabilitation RCTs with large sample sizes are required for accurate interpretation of effect sizes based on the BI. The mRS lacked sensitivity to detect change and thus may be unsuitable as a primary outcome in stroke rehabilitation trials.

Discharge after hip fracture surgery in relation to mobilisation timing by patient characteristics: linked secondary analysis of the UK National Hip Fracture Database.

BACKGROUND: Early mobilisation leads to a two-fold increase in the adjusted odds of discharge by 30-days compared to late mobilisation. Whether this association varies by patient characteristics identified as reasons for delayed mobilisation is unknown. METHODS: Audit data was linked to hospitalisation records for 133,319 patients 60 years or older surgically treated for hip fracture in England or Wales between 2014 and 2016. Adjusted proportional odds regression models tested whether the cumulative incidences of discharge differed between those mobilised early and those mobilised late for subgroups defined by dementia, delirium, hypotension, prefracture ambulation, and prefracture residence, accounting for the competing risk of death. RESULTS: Overall, 34,253 patients presented with dementia, 9818 with delirium, and 10,123 with hypotension. Prefracture, 100,983 were ambulant outdoors, 30,834 were ambulant indoors only, 107,144 were admitted from home, and 23,588 from residential care. 1502 had incomplete data for ambulation and 2587 for prefracture residence. 10, 8, 8, 12, and 12% fewer patients with dementia, delirium, hypotension, ambulant indoors only prefracture, or admitted from residential care mobilised early when compared to those who presented without dementia, delirium, hypotension, with outdoor ambulation prefracture, or admitted from home. The adjusted odds ratios of discharge by 30-days postoperatively among those who mobilised early compared with those who mobilised late were 1.71 (95% CI 1.62-1.81) for those with dementia, 2.06 (95% CI 1.98-2.15) without dementia, 1.56 (95% CI 1.41-1.73) with delirium, 2.00 (95% CI 1.93-2.07) without delirium, 1.83 (95% CI, 1.66-2.02) with hypotension, 1.95 (95% CI, 1.89-2.02) without hypotension, 2.00 (95% CI 1.92-2.08) with outdoor ambulation prefracture, 1.80 (95% CI 1.70-1.91) with indoor ambulation only prefracture, 2.30 (95% CI 2.19-2.41) admitted from home, and 1.64 (95% CI 1.51-1.77) admitted from residential care, accounting for the competing risk of death. CONCLUSION: Irrespective of dementia, delirium, hypotension, prefracture ambulation or residence, early compared to late mobilisation increased the likelihood of hospital discharge by 30-days postoperatively. However, fewer patients with dementia, delirium, or hypotension, poorer prefracture ambulation, or from residential care mobilised early. There is a need reduce this care gap by ensuring sufficient resource to enable all patients to benefit from early mobilisation.

A Prospective Stroke Register in Sierra Leone: Demographics, Stroke Type, Stroke Care and Hospital Outcomes.

Introduction: Stroke is the second most common cause of adult death in Africa. This study reports the demographics, stroke types, stroke care and hospital outcomes for stroke in Freetown, Sierra Leone. Methods: A prospective observational register recorded all patients 18 years and over with stroke between May 2019 and April 2020. Stroke was defined according to the WHO criteria. Pearson's chi-squared test was used to examine associations between categorical variables and unpaired t-tests for continuous variables. Multivariable logistic regression, to explain in-hospital death, was reported as odds ratios (ORs) and 95% confidence intervals. Results: Three hundred eighty-five strokes were registered, and 315 (81.8%) were first-in-a-lifetime events. Mean age was 59.2 (SD 13.8), and 187 (48.6%) were male. Of the strokes, 327 (84.9%) were confirmed by CT scan. Two hundred thirty-one (60.0%) were ischaemic, 85 (22.1%) intracerebral haemorrhage, 11 (2.9%) subarachnoid haemorrhage and 58 (15.1%) undetermined stroke type. The median National Institutes of Health Stroke Scale on presentation was 17 [interquartile range (IQR) 9-25]. Haemorrhagic strokes compared with ischaemic strokes were more severe, 20 (IQR 12-26) vs. 13 (IQR 7-22) (p < 0.001), and occurred in a younger population, mean age 52.3 (SD 12.0) vs. 61.6 (SD 13.8) (p < 0.001), with a lower level of educational attainment of 28.2 vs. 40.7% (p = 0.04). The median time from stroke onset to arrival at the principal referral hospital was 25 hours (IQR 6-73). Half of the patients (50.4%) sought care at another health provider prior to arrival. One hundred fifty-one patients died in the hospital (39.5%). Forty-three deaths occurred within 48 hours of arriving at the hospital, with median time to death of 4 days (IQR 0-7 days). Of the patients, 49.6% had ≥1 complication, 98 (25.5%) pneumonia and 33 (8.6%) urinary tract infection. Male gender (OR 3.33, 1.65-6.75), pneumonia (OR 3.75, 1.82-7.76), subarachnoid haemorrhage (OR 43.1, 6.70-277.4) and undetermined stroke types (OR 6.35, 2.17-18.60) were associated with higher risk of in-hospital death. Discussion: We observed severe strokes occurring in a young population with high in-hospital mortality. Further work to deliver evidence-based stroke care is essential to reduce stroke mortality in Sierra Leone.