A systematic review of Behaviour Change Interventions to improve exercise self-efficacy and adherence in people with Parkinson's disease using the Theoretical Domains Framework.

Physical activity and exercise can limit the development of sarcopenia in Parkinson's Disease. This review aims to evaluate the potential effects of behavioural change (BC) interventions on exercise self-efficacy and adherence in people with Parkinson's. We searched nine databases and included randomised and non-randomised studies reporting exercise self-efficacy, quality of life (QoL), physical function and/or exercise adherence. Two reviewers independently screened, data extracted, and assessed risk of bias and certainty of evidence. The interventions were mapped to the Theoretical Domains Framework. Eleven studies (n=901) were included. Four were randomised trials and risk of bias was mixed. Most interventions were multi-component, including education, behavioural techniques, and support groups. The most effective domains appear to be Behavioural regulation, Belief about Capabilities, Social influences, Reinforcement and Goals. Future research should examine multi-component BC interventions encompassing the five most effective TDF domains.

Healthy aging, self-care, and choice in India: Class-based engagements with globally circulating ideologies.

Euro-American notions of successful and healthy aging are taking root globally, shaped and inflected by local cultural and political contexts. India is one place where globally inflected discourses of healthy, active, and successful aging are on the rise. However, notions about just what constitutes healthy aging and how to achieve such a goal do not play out the same way across the globe. This article explores how older Indians of diverse social classes are thinking about their own lives in relation to broader discourses of healthy aging circulating within India and abroad. Analyses of in-depth interviews with 25 individuals (11 women and 14 men, ages 57 to 81, across a range of social classes) reveal that while many among the urban elite are enjoying participating in a globally informed healthy-aging culture, such trends are not at all widespread among the non-elite. Moreover, Indians across social classes tend to interpret their own "healthy aging" goals in ways at odds with their perceptions of Western paradigms of healthy and successful aging, sometimes incorporating critiques of the West into their own reflections about health and well-being in later life. By examining how healthy-successful aging ideologies play out across divergent national-cultural and social-class contexts, our aim is to challenge universalizing models and heighten understanding of social inequalities while opening up a wider set of possibilities for imagining what it is to live meaningfully in later life.

How can we improve Comprehensive Geriatric Assessment for older people living with frailty in primary care and community settings? A qualitative study.

OBJECTIVE: With advancing age comes the increasing prevalence of frailty and increased risk of adverse outcomes (eg, hospitalisation). Evidence for comprehensive geriatric assessment (CGA), a multidimensional holistic model of care, is mixed in community settings. Uncertainties remain, such as the key components of CGA, who delivers it, and the use of technology. This study aimed to understand the perspectives, beliefs and experiences, of both older people and health professionals, to improve the current CGA and explore factors that may impact on CGA delivery in community settings. DESIGN: A qualitative interview study was conducted with older people and healthcare professionals (HCPs) identified using a maximum variation strategy. Data were analysed using an abductive analysis approach. The non-adoption, abandonment, scale-up, spread and sustainability framework and the theoretical framework of acceptability guided the categorisation of the codes and identified categories were mapped to the two frameworks. SETTING: England, UK. RESULTS: 27 people were interviewed, constituting 14 older people and 13 HCPs. We identified limitations in the current CGA: a lack of information sharing between different HCPs who deliver CGA; poor communication between older people and their HCPs and a lack of follow-up as part of CGA. When we discussed the potential for CGA to use technology, HCPs and older people varied in their readiness to engage with it. CONCLUSIONS: Viable solutions to address gaps in the current delivery of CGA include the provision of training and support to use digital technology and a designated comprehensive care coordinator. The next stage of this research will use these findings, existing evidence and stakeholder engagement, to develop and refine a model of community-based CGA that can be assessed for feasibility and acceptability.

Mediators of the effects of exercise and manual therapy for people with knee and hip osteoarthritis: A secondary, exploratory analysis of the MOA trial.

Objective: To explore whether pain beliefs and functional strength mediate the treatment effect of manual therapy (MT) and exercise therapy (ET) on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) composite scores and its subscales in individuals with hip and/or knee osteoarthritis in the MOA trial. Design: Secondary analysis of a randomised controlled trial that compared the incremental effects of supervised MT and ET in addition to usual care in patients with osteoarthritis of the hip or knee. 206 participants enrolled in the MOA trial were analysed. The primary outcome measure was the WOMAC composite score after 1 year. Results: Pain belief mediated the effect of MT (b: -10.7, 95 â€‹% CI: -22.3, -0.9), ET (b: -14.5 95%CI: -26.0, -4.4). Functional strength did not mediate the effect of MT, ET, or MT â€‹+ â€‹ET. Mediation sensitivity analyses suggest findings are likely to change if small confounding between those mediators and WOMAC composite score is present. Conclusions: We identified possible mediators of MT and ET. Future confirmatory studies could be designed to assess the mechanisms through which manual therapy and exercise cause improvements in pain and function scores in patients with hip or knee osteoarthritis.

Physical activity and health-related quality of life of patients with chronic knee pain after total knee replacement: Analysis of the PEP-TALK trial.

BACKGROUND: Chronic pain is a major challenge for some people after total knee replacement (TKR). The changing impact of this complication during the first post-operative year remains unclear. This analysis aimed to examine how physical activity and health-related quality of life (HRQoL) evolved over the first year after TKR for patients with and without post-operative chronic knee pain. METHODS: We conducted a secondary analysis of data from a randomised controlled trial (PEP-TALK), which tested the effectiveness of a behaviour change physiotherapy intervention compared with usual rehabilitation after TKR. Mean UCLA Activity Score and EQ-5D-5L for participants with and without chronic knee pain (14 points or lower in the Oxford Knee Score Pain Subscale (OKS-PS) at six months post-TKR) were compared at six and 12 months post-TKR. RESULTS: Data from 83 participants were analysed. For those with chronic knee pain, UCLA Activity Score remained unchanged between baseline to six months (mean: 3.8 to 3.8), decreasing at 12 months (3.0). Those without post-operative chronic knee pain reported improved physical activity from baseline to six months (4.0 vs 4.9), plateauing at 12 months (4.9). Participants with chronic knee pain reported lower baseline HRQoL (0.28 vs 0.48). Both groups improved health utility over one year. Of those without chronic pain at six months, 8.5% returned to chronic pain by 12 months. CONCLUSIONS: Monitoring clinical outcomes after six months may be indicated for those at risk of chronic pain post-TKR. Further, sufficiently powered analyses are warranted to increase the generalisability of this exploratory analyses' results.

Exercise treatments for lumbar spinal stenosis: A systematic review and intervention component analysis of randomised controlled trials.

OBJECTIVE: To analyse the components used in exercise interventions for people with symptoms of neurogenic claudication due to lumbar spinal stenosis and identify components associated with successful interventions. DATA SOURCES: Eligible papers published up to April 2023 from MEDLINE, EMBASE, CINAHL, PEDro, CENTRAL, Web of Science, and trial registry websites. REVIEW METHODS: Literature searches were performed by an Information Specialist. We searched for randomised trials evaluating exercise interventions for people with neurogenic claudication symptoms (the primary symptom of lumbar spinal stenosis). Two authors independently performed study selection, data extraction, and quality assessments using the Cochrane Risk of Bias tool Version 2 and the TIDieR checklist for intervention reporting. Details of intervention components were extracted, tabulated, and synthesised using an intervention component analysis approach. RESULTS: We found thirteen trials reporting 23 exercise interventions delivered to 1440 participants. These featured 60 different components. Most exercise interventions included supervision and flexion-based exercises. Balance exercises were rarely included. Exercise components featured more frequently in successful interventions included stretches, strength or trunk muscle exercises, fitness exercises, especially cycling, and psychologically informed approaches. Interpretation is limited by low study numbers and heterogeneity. No conclusions could be drawn about exercise supervision or dose. DISCUSSION: Exercise interventions for people with neurogenic claudication typically feature multiple components. Common features such as supervision, lumbar flexion, and aerobic fitness exercises and also less common features such as stretches, strengthening exercises, and psychologically informed approaches warrant consideration for inclusion when designing and optimising exercise interventions for people with lumbar spinal stenosis.

Hospital-based caregiver intervention for people following hip fracture surgery (HIP HELPER): multicentre randomised controlled feasibility trial with embedded qualitative study in England.

OBJECTIVES: To assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery. DESIGN: Two-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study. SETTING: National Health Service (NHS) providers in five English hospitals. PARTICIPANTS: Community-dwelling adults, aged 60 years and over, who undergo hip fracture surgery and their informal caregivers. INTERVENTION: Usual care: usual NHS care. EXPERIMENTAL: usual NHS care plus a caregiver-patient dyad training programme (HIP HELPER). This programme comprised three, 1 hour, one-to-one training sessions for a patient and caregiver, delivered by a nurse, physiotherapist or occupational therapist in the hospital setting predischarge. After discharge, patients and caregivers were supported through three telephone coaching sessions. RANDOMISATION AND BLINDING: Central randomisation was computer generated (1:1), stratified by hospital and level of patient cognitive impairment. There was no blinding. MAIN OUTCOME MEASURES: Data collected at baseline and 4 months post randomisation included: screening logs, intervention logs, fidelity checklists, acceptability data and clinical outcomes. Interviews were conducted with a subset of participants and health professionals. RESULTS: 102 participants were enrolled (51 patients; 51 caregivers). Thirty-nine per cent (515/1311) of patients screened were eligible. Eleven per cent (56/515) of eligible patients consented to be randomised. Forty-eight per cent (12/25) of the intervention group reached compliance to their allocated intervention. There was no evidence of treatment contamination. Qualitative data demonstrated the trial and HIP HELPER programme was acceptable. CONCLUSIONS: The HIP HELPER programme was acceptable to patient-caregiver dyads and health professionals. The COVID-19 pandemic impacting on site's ability to deliver the research. Modifications are necessary to the design for a viable definitive RCT. TRIAL REGISTRATION NUMBER: ISRCTN13270387.

Comparison of different statistical models for the analysis of fracture events: findings from the Prevention of Falls Injury Trial (PreFIT).

BACKGROUND: Fractures are rare events and can occur because of a fall. Fracture counts are distinct from other count data in that these data are positively skewed, inflated by excess zero counts, and events can recur over time. Analytical methods used to assess fracture data and account for these characteristics are limited in the literature. METHODS: Commonly used models for count data include Poisson regression, negative binomial regression, hurdle regression, and zero-inflated regression models. In this paper, we compare four alternative statistical models to fit fracture counts using data from a large UK based clinical trial evaluating the clinical and cost-effectiveness of alternative falls prevention interventions in older people (Prevention of Falls Injury Trial; PreFIT). RESULTS: The values of Akaike information criterion and Bayesian information criterion, the goodness-of-fit statistics, were the lowest for negative binomial model. The likelihood ratio test of no dispersion in the data showed strong evidence of dispersion (chi-square = 225.68, p-value < 0.001). This indicates that the negative binomial model fits the data better compared to the Poisson regression model. We also compared the standard negative binomial regression and mixed effects negative binomial models. The LR test showed no gain in fitting the data using mixed effects negative binomial model (chi-square = 1.67, p-value = 0.098) compared to standard negative binomial model. CONCLUSIONS: The negative binomial regression model was the most appropriate and optimal fit model for fracture count analyses. TRIAL REGISTRATION: The PreFIT trial was registered as ISRCTN71002650.

Lower limb muscle strength and balance in older adults with a distal radius fracture: a systematic review.

BACKGROUND: Distal radius fractures are common fractures in older adults and associated with increased risk of future functional decline and hip fracture. Whether lower limb muscle strength and balance are impaired in this patient population is uncertain. To help inform rehabilitation requirements, this systematic review aimed to compare lower limb muscle strength and balance between older adults with a distal radius fracture with matched controls, and to synthesise lower limb muscle strength and balance outcomes in older adults with a distal radius fracture. METHODS: We searched Embase, MEDLINE, and CINAHL (1990 to 25 May 2022) for randomised and non-randomised controlled clinical trials and observational studies that measured lower limb muscle strength and/or balance using instrumented measurements or validated tests, in adults aged ≥ 50 years enrolled within one year after distal radius fracture. We appraised included observational studies using a modified Newcastle-Ottawa Scale and included randomised controlled trials using the Cochrane risk-of-bias tool. Due to the clinical and methodological heterogeneity in included studies, we synthesised results narratively in tables and text. RESULTS: Nineteen studies (10 case-control studies, five case series, and four randomised controlled trials) of variable methodological quality and including 1835 participants (96% women, mean age 55-73 years, median sample size 82) were included. Twelve included studies (63%) assessed strength using 10 different methods with knee extension strength most commonly assessed (6/12 (50%) studies). Five included case-control studies (50%) assessed lower limb strength. Cases demonstrated impaired strength during functional tests (two studies), but knee extension strength assessment findings were conflicting (three studies). Eighteen included studies (95%) assessed balance using 14 different methods. Single leg balance was most commonly assessed (6/18 (33%) studies). All case-control studies assessed balance with inconsistent findings. CONCLUSION: Compared to controls, there is some evidence that older adults with a distal radius fracture have impaired lower limb muscle strength and balance. A cautious interpretation is required due to inconsistent findings across studies and/or outcome measures. Heterogeneity in control participants' characteristics, study design, study quality, and assessment methods limited synthesis of results. Robust case-control and/or prospective observational studies are needed. REGISTRATION: International prospective register of systematic reviews (date of registration: 02 July 2020, registration identifier: CRD42020196274).

Experience of patients and physiotherapists within the AFTER pilot randomised trial of two rehabilitation interventions for people aged 50 years and over post ankle fracture: a qualitative study.

OBJECTIVES: To explore patient and staff experience of best-practice rehabilitation advice (one session of face-to-face self-management advice with up to two additional optional sessions) compared with progressive functional exercise (up to six sessions of face-to-face physiotherapy) after ankle fracture. DESIGN: The study drew on phenomenology using interviews and a focus group. SETTING: Participants were from three NHS Trusts in England, UK. PARTICIPANTS: A purposive sample of 20 patients with ankle (malleolar) fractures from the Ankle Fracture Treatment: Enhancing Rehabilitation-pilot trial (now completed) were interviewed (median 50 min) from May 2019 to January 2020. They were 6 months post injury, over 50 years of age, (median 66, 12 females) and had received surgical or non-surgical treatment (seven internal fixation surgery, seven close contact casting, six walking boot). A focus group of five physiotherapists who had provided the study interventions (2.5 hours) was undertaken. RESULTS: The findings show the acceptability of both interventions through the themes, 'being helped' (for patients) and 'developing expertise' (for staff) with subthemes of choosing and progressing. Progressive exercise added value with a perceived increase in strength, motion, ability to undertake activities and continued use of the workbook. Both staff and patients valued physiotherapy expertise demonstrated through interpersonal skills, advice, individualised exercise plans and active monitoring of progression. Best practice advice was particularly helpful in the early stages of recovery and with the use of mobility aids. CONCLUSION: Both interventions were acceptable but progressive exercise was highly valued by patients. Developing expertise through experiential learning enabled staff to facilitate progression. Adjustments to the workbook and the addition of exercises for continued recovery in the best practice advice would enhance a future study. Research during treatment provision may provide further insights into the challenges of facilitating progression of exercise. TRIAL REGISTRATION: ISRCTN16612336; AFTER-pilot trial).

Clinicians' perspectives on planned interventions tested in the Otago MASTER feasibility trial: an implementation-based process evaluation study.

OBJECTIVES: This study reports a process evaluation of the Otago MASTER (MAnagement of Subacromial disorders of The shouldER) feasibility trial. This mixed-methods, process evaluation study was conducted parallel to the Otago MASTER feasibility trial. Our aims were to investigate: (1) supervised treatment fidelity of the interventions and (2) clinicians' perceptions of the trial interventions through a focus group. DESIGN: Nested process evaluation study using a mixed-methods approach. SETTING: Outpatient clinic. PARTICIPANTS: Five clinicians (two men, three women) aged 47-67 years, with clinical experience of 18-43 years and a minimum of postgraduate certificate training, were involved with the delivery of interventions within the feasibility trial. We assessed treatment fidelity for supervised exercises through audit of clinicians' records and compared those with the planned protocol. Clinicians took part in a focus group that lasted for approximately 1 hour. The focus group was transcribed verbatim and focus group discussion was analysed thematically using an iterative approach. RESULTS: The fidelity score for the tailored exercise and manual therapy intervention was 80.3% (SD: 7.7%) and for the standardised exercise intervention, 82.9% (SD: 5.9%). Clinicians' perspectives about the trial and planned intervention were summarised by one main theme 'conflict experienced between individual clinical practice and the intervention protocol', which was supported by three subthemes: (1) programme strengths and weaknesses; (2) design-related and administrative barriers; and (3) training-related barriers. CONCLUSION: This mixed-methods study assessed supervised treatment fidelity of interventions and clinicians' perceptions on planned interventions tested in the Otago MASTER feasibility trial. Overall, treatment fidelity was acceptable for both intervention arms; however, we observed low fidelity for certain domains within the tailored exercise and manual therapy intervention. Our focus group identified several barriers clinicians faced while delivering the planned interventions. Those findings are of relevance for planning the definite trial and for researchers conducting feasibility trials. TRIAL REGISTRATION NUMBER: ANZCTR: 12617001405303.

Tailored exercise management (TEMPO) versus usual care for people aged 80 years or older with hip/knee osteoarthritis: study protocol for a feasibility randomised controlled trial.

BACKGROUND: Exercise is recommended for all people with osteoarthritis. However, these recommendations are based on randomised clinical trials including people with an average age between 60 and 70 years, and these findings cannot reliably be generalised to people aged 80 years or older. Rapid loss of muscle occurs after 70 years of age, and older people are more likely to also have other health conditions that contribute to difficulties with daily activities and impact on their response to exercise. To improve care for people aged 80 or older with osteoarthritis, it is thought that a tailored exercise intervention targeting both osteoarthritis and any other health conditions they have, may be needed. The aim of this study will be to test if it is possible to conduct a randomised controlled trial (RCT) for people over 80 years of age with hip/knee osteoarthritis of a tailored exercise intervention. METHODS: A multicentre, parallel, 2-group, feasibility RCT with embedded qualitative study, conducted in ≥ 3 UK NHS physiotherapy outpatient services. Participants (n ≥ 50) with clinical knee and/or hip osteoarthritis and ≥ 1 comorbidity will be recruited by screening referrals to participating NHS physiotherapy outpatient services, via screening of general practice records and via identification of eligible individuals from a cohort study run by our research group. Participants will be randomised (computer-generated: 1:1) to receive either: a 12-week education and tailored exercise intervention (TEMPO); or usual care and written information. The primary feasibility objectives are to estimate: (1) ability to screen and recruit eligible participants; (2) retention of participants, measured by the proportion of participants who provide outcome data at 14-week follow-up. Secondary quantitative objectives are to estimate: (1) participant engagement assessed by physiotherapy session attendance and home exercise adherence; (2) sample size calculation for a definitive RCT. One-to-one semi-structured interviews will explore the experiences of trial participants and physiotherapists delivering the TEMPO programme. DISCUSSION: Progression criteria will be used to determine whether a definitive trial to evaluate the clinical and cost-effectiveness of the TEMPO programme is considered feasible with or without modifications to the intervention or trial design. TRIAL REGISTRATION: ISRCTN75983430. Registered 3/12/2021. https://www.isrctn.com/ISRCTN75983430.

Getting Recovery Right After Neck Dissection (GRRAND-F): Mixed-methods feasibility study to design a pragmatic randomised controlled trial.

Objective: To determine the feasibility of a randomised controlled trial to estimate the effectiveness and cost-effectiveness of a rehabilitation intervention following neck dissection (ND) after head and neck cancer (HNC). Design: Two-arm, open, pragmatic, parallel, multicentre, randomised controlled feasibility trial. Setting: Two UK NHS hospitals. Participants: People who had HNC in whom a ND was part of their care. We excluded those with a life expectancy of six months or less, pre-existing, long-term neurological disease affecting the shoulder and cognitive impairment. Intervention: Usual care (standard care supplemented with a booklet on postoperative self-management) was received by all participants. The GRRAND intervention programme consisted of usual care plus up to six individual physiotherapy sessions including neck and shoulder range of motion and progressive resistance exercises, advice and education. Between sessions, participants were advised to complete a home exercise programme. Randomisation: 1:1 randomisation. Allocation was based on minimisation, stratified by hospital site and spinal accessory nerve sacrifice. It was not possible to mask treatment received. Main outcome measures: Primary: Participant recruitment, retention and fidelity to the study protocol and interventions from study participants and staff at six months post-randomisation (and 12 months for those reaching that time-point). Secondary: clinical measures of pain, function, physical performance, health-related quality of life, health utilisation and adverse events. Results: 36 participants were recruited and enrolled. The study achieved five of its six feasibility targets. These included consent - 70% of eligible participants were consented; intervention fidelity - 78% participants discharged completed the intervention sessions; contamination - none - no participants in the control arm received the GRRAND-F intervention and retention - 8% of participants were lost to follow-up. The only feasibility target that was not achieved was the recruitment target where only 36 of the planned 60 participants were recruited over 18 months. This was principally due to the COVID-19 pandemic which caused all research activity to be paused or reduced, with a subsequent reduction in. Conclusions: Based on the findings a full-trial can now be designed to better understand whether this proposed intervention is effective. Clinical Trial Registration: https://www.isrctn.com/ISRCTN1197999, identifier ISRCTN11979997.

Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis: Protocol for 2 Independent Meta-Research Studies.

BACKGROUND: Journal articles describing randomized controlled trials (RCTs) and systematic reviews with meta-analysis of RCTs are not optimally reported and often miss crucial details. This poor reporting makes assessing these studies' risk of bias or reproducing their results difficult. However, the reporting quality of diet- and nutrition-related RCTs and meta-analyses has not been explored. OBJECTIVE: We aimed to assess the reporting completeness and identify the main reporting limitations of diet- and nutrition-related RCTs and meta-analyses of RCTs, estimate the frequency of reproducible research practices among these RCTs, and estimate the frequency of distorted presentation or spin among these meta-analyses. METHODS: Two independent meta-research studies will be conducted using articles published in PubMed-indexed journals. The first will include a sample of diet- and nutrition-related RCTs; the second will include a sample of systematic reviews with meta-analysis of diet- and nutrition-related RCTs. A validated search strategy will be used to identify RCTs of nutritional interventions and an adapted strategy to identify meta-analyses in PubMed. We will search for RCTs and meta-analyses indexed in 1 calendar year and randomly select 100 RCTs (June 2021 to June 2022) and 100 meta-analyses (July 2021 to July 2022). Two reviewers will independently screen the titles and abstracts of records yielded by the searches, then read the full texts to confirm their eligibility. The general features of these published RCTs and meta-analyses will be extracted into a research electronic data capture database (REDCap; Vanderbilt University). The completeness of reporting of each RCT will be assessed using the items in the CONSORT (Consolidated Standards of Reporting Trials), its extensions, and the TIDieR (Template for Intervention Description and Replication) statements. Information about practices that promote research transparency and reproducibility, such as the publication of protocols and statistical analysis plans will be collected. There will be an assessment of the completeness of reporting of each meta-analysis using the items in the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) statement and collection of information about spin in the abstracts and full-texts. The results will be presented as descriptive statistics in diagrams or tables. These 2 meta-research studies are registered in the Open Science Framework. RESULTS: The literature search for the first meta-research retrieved 20,030 records and 2182 were potentially eligible. The literature search for the second meta-research retrieved 10,918 records and 850 were potentially eligible. Among them, random samples of 100 RCTs and 100 meta-analyses were selected for data extraction. Data extraction is currently in progress, and completion is expected by the beginning of 2023. CONCLUSIONS: Our meta-research studies will summarize the main limitation on reporting completeness of nutrition- or diet-related RCTs and meta-analyses and provide comprehensive information regarding the particularities in the reporting of intervention studies in the nutrition field. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43537.

Targeting patient recovery priorities in degenerative cervical myelopathy: design and rationale for the RECEDE-Myelopathy trial-study protocol.

INTRODUCTION: Degenerative cervical myelopathy (DCM) is a common and disabling condition of symptomatic cervical spinal cord compression secondary to degenerative changes in spinal structures leading to a mechanical stress injury of the spinal cord. RECEDE-Myelopathy aims to test the disease-modulating activity of the phosphodiesterase 3/phosphodiesterase 4 inhibitor Ibudilast as an adjuvant to surgical decompression in DCM. METHODS AND ANALYSIS: RECEDE-Myelopathy is a multicentre, double-blind, randomised, placebo-controlled trial. Participants will be randomised to receive either 60-100 mg Ibudilast or placebo starting within 10 weeks prior to surgery and continuing for 24 weeks after surgery for a maximum of 34 weeks. Adults with DCM, who have a modified Japanese Orthopaedic Association (mJOA) score 8-14 inclusive and are scheduled for their first decompressive surgery are eligible for inclusion. The coprimary endpoints are pain measured on a visual analogue scale and physical function measured by the mJOA score at 6 months after surgery. Clinical assessments will be undertaken preoperatively, postoperatively and 3, 6 and 12 months after surgery. We hypothesise that adjuvant therapy with Ibudilast leads to a meaningful and additional improvement in either pain or function, as compared with standard routine care. STUDY DESIGN: Clinical trial protocol V.2.2 October 2020. ETHICS AND DISSEMINATION: Ethical approval has been obtained from HRA-Wales.The results will be presented at an international and national scientific conferences and in a peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN Number: ISRCTN16682024.

Environmental interventions for preventing falls in older people living in the community.

BACKGROUND: Falls and fall-related injuries are common. A third of community-dwelling people aged over 65 years fall each year. Falls can have serious consequences including restricting activity or institutionalisation. This review updates the previous evidence for environmental interventions in fall prevention. OBJECTIVES: To assess the effects (benefits and harms) of environmental interventions (such as fall-hazard reduction, assistive technology, home modifications, and education) for preventing falls in older people living in the community. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, other databases, trial registers, and reference lists of systematic reviews to January 2021. We contacted researchers in the field to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials evaluating the effects of environmental interventions (such as reduction of fall hazards in the home, assistive devices) on falls in community-residing people aged 60 years and over.   DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Our primary outcome was rate of falls. MAIN RESULTS: We included 22 studies from 10 countries involving 8463 community-residing older people. Participants were on average 78 years old, and 65% were women. For fall outcomes, five studies had high risk of bias and most studies had unclear risk of bias for one or more risk of bias domains. For other outcomes (e.g. fractures), most studies were at high risk of detection bias. We downgraded the certainty of the evidence for high risk of bias, imprecision, and/or inconsistency.  Home fall-hazard reduction (14 studies, 5830 participants) These interventions aim to reduce falls by assessing fall hazards and making environmental safety adaptations (e.g. non-slip strips on steps) or behavioural strategies (e.g. avoiding clutter).  Home fall-hazard interventions probably reduce the overall rate of falls by 26% (rate ratio (RaR) 0.74, 95% confidence interval (CI) 0.61 to 0.91; 12 studies, 5293 participants; moderate-certainty evidence); based on a control group risk of 1319 falls per 1000 people a year, this is 343 (95% CI 118 to 514) fewer falls. However, these interventions were more effective in people who are selected for higher risk of falling, with a reduction of 38% (RaR 0.62, 95% CI 0.56 to 0.70; 9 studies, 1513 participants; 702 (95% CI 554 to 812) fewer falls based on a control risk of 1847 falls per 1000 people; high-certainty evidence). We found no evidence of a reduction in rate of falls when people were not selected for fall risk (RaR 1.05, 95% CI 0.96 to 1.16; 6 studies, 3780 participants; high-certainty evidence). Findings were similar for the number of people experiencing one or more falls. These interventions probably reduce the overall risk by 11% (risk ratio (RR) 0.89, 95% CI 0.82 to 0.97; 12 studies, 5253 participants; moderate-certainty evidence); based on a risk of 519 per 1000 people per year, this is 57 (95% CI 15 to 93) fewer fallers. However, for people at higher risk of falling, we found a 26% decrease in risk (RR 0.74, 95% CI 0.65 to 0.85; 9 studies, 1473 participants), but no decrease for unselected populations (RR 0.99, 95% CI 0.92 to 1.07; 6 studies, 3780 participants) (high-certainty evidence). These interventions probably make little or no important difference to health-related quality of life (HRQoL) (standardised mean difference 0.09, 95% CI -0.10 to 0.27; 5 studies, 1848 participants; moderate-certainty evidence). They may make little or no difference to the risk of fall-related fractures (RR 1.00, 95% 0.98 to 1.02; 2 studies, 1668 participants), fall-related hospitalisations (RR 0.96, 95% CI 0.87 to 1.06; 3 studies, 325 participants), or in the rate of falls requiring medical attention (RaR 0.91, 95% CI 0.58 to 1.43; 3 studies, 946 participants) (low-certainty evidence). The evidence for number of fallers requiring medical attention was unclear (2 studies, 216 participants; very low-certainty evidence). Two studies reported no adverse events. Assistive technology Vision improvement interventions may make little or no difference to the rate of falls (RaR 1.12, 95% CI 0.84 to 1.50; 3 studies, 1489 participants) or people experiencing one or more falls (RR 1.09, 95% CI 0.79 to 1.50) (low-certainty evidence). We are unsure of the evidence for fall-related fractures (2 studies, 976 participants) and falls requiring medical attention (1 study, 276 participants) because the certainty of the evidence is very low. There may be little or no difference in HRQoL (mean difference 0.40, 95% CI -1.12 to 1.92) or adverse events (falls while switching glasses; RR 1.00, 95% CI 0.98 to 1.02) (1 study, 597 participants; low-certainty evidence). Results for other assistive technology - footwear and foot devices, and self-care and assistive devices (5 studies, 651 participants) - were not pooled due to the diversity of interventions and contexts.  Education  We are uncertain whether an education intervention to reduce home fall hazards reduces the rate of falls or the number of people experiencing one or more falls (1 study; very low-certainty evidence). These interventions may make little or no difference to the risk of fall-related fractures (RR 1.02, 95% CI 0.96 to 1.08; 1 study, 110 participants; low-certainty evidence).  Home modifications We found no trials of home modifications that measured falls as an outcome for task enablement and functional independence. AUTHORS' CONCLUSIONS: We found high-certainty evidence that home fall-hazard interventions are effective in reducing the rate of falls and the number of fallers when targeted to people at higher risk of falling, such as having had a fall in the past year and recently hospitalised or needing support with daily activities. There was evidence of no effect when interventions were targeted to people not selected for risk of falling. Further research is needed to examine the impact of intervention components, the effect of awareness raising, and participant-interventionist engagement on decision-making and adherence.  Vision improvement interventions may or may not impact the rate of falls. Further research is needed to answer clinical questions such as whether people should be given advice or take additional precautions when changing eye prescriptions, or whether the intervention is more effective when targeting people at higher risk of falls. There was insufficient evidence to determine whether education interventions impact falls.

'It Makes Me Feel Old': Understanding the Experience of Recovery From Ankle Fracture at 6 Months in People Aged 50 Years and Over.

Ankle fracture is a common injury, and depending on injury severity, treatment may be a support boot, cast or surgery. Older people, particularly those with severe injuries who are asked to restrict weight bearing, struggle with early recovery. To elicit older peoples' experience of recovery 6 months after injury, we drew on a phenomenological approach using interviews. Findings revealed that getting on with life was a way of accepting what it feels like to 'be vulnerable', needing to 'be safe' while determinedly working hard to 'be myself'. Being vulnerable identified endurance of inactivity, loneliness and dependency in the non-weight bearing period of recovery, followed by a struggle to weight bear while lacking confidence and being fearful of falling and causing further damage. Being safe conveyed fragility where sensations, pain and stiffness acted as bodily reminders of injury. Lack of function and awareness of danger led to carefulness where planning or curtailing of activities ensured their safety. Being myself showed a determination to push away from a disrupted self-identify of being older or disabled while being challenged by the continuous process of learning to be more mobile. A lack of readiness for old age created a drive to age well. Despite loss of ability, participants hoped to regain their pre-injury way of living. This study challenges practice that disregards the hard work required to recover from ankle fracture. As comorbidity increases with age, failure to consider this aspect may contribute to frailty in this group of older people.

Economic costs, health-related quality of life outcomes and cost-utility of a physical and psychological group intervention targeted at older adults with neurogenic claudication.

BACKGROUND: Emerging evidence suggests that structured and progressive exercise underpinned by a cognitive behavioural approach can improve functional outcomes in patients with neurogenic claudication (NC). However, evidence surrounding its economic benefits is lacking. OBJECTIVES: To estimate the economic costs, health-related quality of life outcomes and cost-effectiveness of a physical and psychological group intervention (BOOST programme) versus best practice advice (BPA) in older adults with NC. METHODS: An economic evaluation was conducted based on data from a pragmatic, multicentre, superiority, randomised controlled trial. The base-case economic evaluation took the form of an intention-to-treat analysis conducted from a UK National Health Service (NHS) and personal social services (PSS) perspective and separately from a societal perspective. Costs (£ 2018-2019 prices) were collected prospectively over a 12 month follow-up period. A bivariate regression of costs and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained and the incremental net monetary benefit (INMB) of the BOOST programme in comparison to BPA. Sensitivity and pre-specified subgroup analyses explored uncertainty and heterogeneity in cost-effectiveness estimates. RESULTS: Participants (N = 435) were randomised to the BOOST programme (n = 292) or BPA (n = 143). Mean (standard error [SE]) NHS and PSS costs over 12 months were £1,974 (£118) in the BOOST arm versus £1,827 (£169) in the BPA arm (p = 0.474). Mean (SE) QALY estimates were 0.620 (0.009) versus 0.599 (0.006), respectively (p = 0.093). The probability that the BOOST programme is cost-effective ranged between 67 and 83% (NHS and PSS perspective) and 79-89% (societal perspective) at cost-effectiveness thresholds between £15,000 and £30,000 per QALY gained. INMBs ranged between £145 and £464 at similar cost-effectiveness thresholds. The cost-effectiveness results remained robust to sensitivity analyses. CONCLUSIONS: The BOOST programme resulted in modest QALY gains over the 12 month follow-up period. Future studies with longer intervention and follow-up periods are needed to address uncertainty around the health-related quality of life impacts and cost-effectiveness of such programmes. Trial registration This study has been registered in the International Standard Randomised Controlled Trial Number registry, reference number ISRCTN12698674. Registered on 10 November 2015.