Maintaining independence in individuals with dementia at home after a fall: a protocol for the UK pilot cluster randomised controlled trial MAINTAIN.

INTRODUCTION: Individuals with dementia face an increased risk of falls. Falls can cause a decline in the individual's overall functionality. All types of falls, including those that do not result in injury, can lead to psychosocial consequences, such as diminished confidence and a fear of falling. Projections indicate a rising trend in dementia diagnoses, implying an increase in fall incidents. Yet, there is a lack of evidence to support interventions for people living with dementia who have fallen. Our objective is to test the feasibility of a falls intervention trial for people with dementia. METHOD AND ANALYSIS: This is a UK-based two-arm pilot cluster randomised controlled trial. In this study, six collaborating sites, which form the clusters, will be randomly allocated to either the intervention arm or the control arm (receiving treatment as usual) at a 1:1 ratio. During the 6 month recruitment phase, each cluster will enrol 10 dyads, comprising 10 individuals with dementia and their respective carers, leading to a total sample size of 60 dyads. The primary outcomes are the feasibility parameters for a full trial (ie, percentage consented, follow-up rate and cost framework). Secondary outcomes include activities of daily living, quality of life, fall efficacy, mobility, goal attainment, cognitive status, occurrence of falls, carer burden and healthcare service utilisation. Outcome measures will be collected at baseline and 28 weeks, with an additional assessment scheduled at 12 weeks for the healthcare service utilisation questionnaire. An embedded process evaluation, consisting of interviews and observations with participants and healthcare professionals, will explore how the intervention operates and the fidelity of study processes. ETHICS AND DISSEMINATION: The study was approved by the NHS and local authority research governance and research ethics committees (NHS REC reference: 23/WA/0126). The results will be shared at meetings and conferences and will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN16413728.

Comparing Research Priority-Setting Partnerships for Older Adults Across International Health Care Systems: A Systematic Review.

OBJECTIVES: Priority setting partnerships (PSPs) attempt to shape the research agenda to address the needs of local populations of interest. We reviewed the PSPs for older adults, with a focus on exemplar health care systems: United Kingdom (UK; publicly funded), United States (private health insurance-based), South Korea (national health insurance-based), and Africa (out-of-pocket). DESIGN: Systematic review. SETTING AND PARTICIPANTS: We searched databases and sources (January 2011-October 202l; updated in February 2023) for PSPs of older adults' health care. METHODS: Based on the British geriatric medicine curriculum, we extracted and categorized the PSP topics by areas and the research priorities by themes, and generated evidence maps depicting and comparing the research gaps across the systems. We evaluated PSP quality using the Nine Common Themes of Good Clinical Practice. RESULTS: We included 32 PSPs (United Kingdom: n = 25; United States: n = 7; South Korea and Africa: n = 0) and identified priorities regarding 27 conditions or service arrangements in the United Kingdom and 9 in the United States (predominantly in neurology/psychiatry). The UK priorities focused on treatments and interventions whereas the US on prognostic/predictive factors. There were notable research gaps within the existing PSPs, including common geriatric conditions like continence and frailty. The PSP quality evaluation revealed issues around lacking inclusion of ethnic minorities. CONCLUSIONS AND IMPLICATIONS: Research priorities for older adult health care vary internationally, but certain health care systems/countries have no available PSPs. Where PSPs are available, fundamental aspects of geriatric medicine have not been included. Future researchers should conduct prioritizations in different countries, focus on core geriatric syndromes, and ensure the inclusion of all relevant stakeholder groups.

Feasibility, reliability and safety of self-assessed orthostatic blood pressure at home.

BACKGROUND: A postural blood pressure assessment is required to diagnose Orthostatic Hypotension. With increasing remote consultations, alternative methods of performing postural blood pressure assessment are required. OBJECTIVE: Determine whether postural blood pressure measurement at home, without a clinician, is reliable, feasible and safe. DESIGN: Service improvement project within a falls and syncope service in Northeast England. SUBJECTS: Eligibility criteria: aged ≥60 years; postural blood pressure measurement is indicated and is physically and cognitively able to perform. Exclusion criteria: nursing home residents, attending clinic in person. METHODS: Postural blood pressure measurements were performed in patients' homes under clinical observation. Patient-led assessments were performed independent of the clinician, following written guidance. This was followed by a clinical-led assessment after 10-minute supine rest. OUTCOMES: Agreement between patient and clinician derived postural blood pressure values and diagnosis of Orthostatic Hypotension; intervention safety, feasibility and acceptability. RESULTS: Twenty-eight patients were eligible and 25 participated (mean age 75, median Clinical Frailty Score five).There was 95% agreement (Cohen's kappa 0.90 (0.70, 1.00)) between patient and clinician derived readings to diagnose orthostatic hypotension.Postural systolic blood pressure drop correlated strongly (r = 0.80), with patient derived readings overestimating by 1 (-6, 3) mmHg. Limits of agreement, determined via Bland Altman analysis, were +17 and -20 mmHg, greater than pre-determined maximum clinically important difference (±5 mmHg).Twenty participants performed valid postural blood pressure assessments without clinical assistance. CONCLUSIONS: Patient-led postural blood pressure assessment at home is a reliable, safe and acceptable method for diagnosing Orthostatic Hypotension.

Is fear of falling key to identifying gait and balance abnormalities in community-dwelling older adults? Protocol of a mixed-methods approach.

INTRODUCTION: The ageing population poses an increasing burden to public health systems, particularly as a result of falls. Falls have been associated with poor gait and balance, as measured by commonly used clinical tests for poor gait and balance. Falls in older adults have the potential to lead to long-term issues with mobility and a fear of falling (FoF). FoF is measured by a variety of instruments; the Falls Efficacy Scale International (FES-I) version is widely used within clinical and research arenas. The ability of the FoF, as measured by the FES-I to predict gait and balance abnormalities (GABAb) has not previously been measured; this study aims to be the first to investigate this prospective relationship. METHODS AND ANALYSES: To investigate the ability of the FES-I to predict GABAb a mixed-methods approach will be used, including quantitative, qualitative and health economics approaches. Initially the ability of the FES-I to identify poor gait and balance will be investigated, along with whether the measure is able to assess change in gait and balance in response to exercise training. The ability of an online FES-I tool to assess poor gait and balance in an alternative pre-existing online strength and balance programme will also be investigated. Interviews will be carried out to investigate participant experiences and motivations of those that are offered Age UK Strength and Balance Training, along with the views of healthcare professionals and Age UK staff involved within the process. ETHICS AND DISSEMINATION: NHS REC Approval has been granted (IRAS ID 314705). Study participation is voluntary; participants will be provided with all necessary information within the participant information sheet, with written consent being sought. Study findings will be disseminated through manuscripts in peer-reviewed journals, at scientific conferences and in a short report to participants and the funding body.

Should We Ever Pace for Carotid Sinus Syndrome?

Carotid sinus syndrome has been associated with transient loss of consciousness for millennia, and while steeped in cardiovascular lore, there is little in the way of solid evidence to guide its main treatment modality, permanent cardiac pacing. This article reviews the history of the condition in the context of its contemporary understanding before examining three key concepts in the consideration of what constitutes a manageable disease: first, is there a pathophysiologic rationale for the disease (in this case carotid sinus syndrome)? Second, is there a good diagnostic test that will identify it reliably? And finally, is there a convincingly evidence-based treatment for the disease? Relevant literature is reviewed, and recommendations made in how we view pacing in the context of this intriguingly opaque condition.

Machine learning as a diagnostic decision aid for patients with transient loss of consciousness.

BACKGROUND: Transient loss of consciousness (TLOC) is a common reason for presentation to primary/emergency care; over 90% are because of epilepsy, syncope, or psychogenic non-epileptic seizures (PNES). Misdiagnoses are common, and there are currently no validated decision rules to aid diagnosis and management. We seek to explore the utility of machine-learning techniques to develop a short diagnostic instrument by extracting features with optimal discriminatory values from responses to detailed questionnaires about TLOC manifestations and comorbidities (86 questions to patients, 31 to TLOC witnesses). METHODS: Multi-center retrospective self- and witness-report questionnaire study in secondary care settings. Feature selection was performed by an iterative algorithm based on random forest analysis. Data were randomly divided in a 2:1 ratio into training and validation sets (163:86 for all data; 208:92 for analysis excluding witness reports). RESULTS: Three hundred patients with proven diagnoses (100 each: epilepsy, syncope and PNES) were recruited from epilepsy and syncope services. Two hundred forty-nine completed patient and witness questionnaires: 86 epilepsy (64 female), 84 PNES (61 female), and 79 syncope (59 female). Responses to 36 questions optimally predicted diagnoses. A classifier trained on these features classified 74/86 (86.0% [95% confidence interval 76.9%-92.6%]) of patients correctly in validation (100 [86.7%-100%] syncope, 85.7 [67.3%-96.0%] epilepsy, 75.0 [56.6%-88.5%] PNES). Excluding witness reports, 34 features provided optimal prediction (classifier accuracy of 72/92 [78.3 (68.4%-86.2%)] in validation, 83.8 [68.0%-93.8%] syncope, 81.5 [61.9%-93.7%] epilepsy, 67.9 [47.7%-84.1%] PNES). CONCLUSIONS: A tool based on patient symptoms/comorbidities and witness reports separates well between syncope and other common causes of TLOC. It can help to differentiate epilepsy and PNES. Validated decision rules may improve diagnostic processes and reduce misdiagnosis rates. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for patients with TLOC, patient and witness questionnaires discriminate between syncope, epilepsy and PNES.

Developing an Intervention for Fall-Related Injuries in Dementia (DIFRID): an integrated, mixed-methods approach.

BACKGROUND: Falls in people with dementia can result in a number of physical and psychosocial consequences. However, there is limited evidence to inform how best to deliver services to people with dementia following a fall. The aim of the DIFRID study was to determine the feasibility of developing and implementing a new intervention to improve outcomes for people with dementia with fall-related injuries; this encompasses both short-term recovery and reducing the likelihood of future falls. This paper details the development of the DIFRID intervention. METHODS: The intervention was designed using an integrated, mixed-methods approach. This involved a realist synthesis of the literature and qualitative data gathered through interviews and focus groups with health and social care professionals (n = 81). An effectiveness review and further interviews and observation were also conducted and are reported elsewhere. A modified Delphi panel approach with 24 experts was then used to establish a consensus on how the findings should translate into a new intervention. After feedback from key stakeholders (n = 15) on the proposed model, the intervention was manualised and training developed. RESULTS: We identified key components of a new intervention covering three broad areas: • Ensuring that the circumstances of rehabilitation are optimised for people with dementia • Compensating for the reduced ability of people with dementia to self-manage • Equipping the workforce with the necessary skills and information to care for this patient group Consensus was achieved on 54 of 69 statements over two rounds of the Delphi surveys. The statements were used to model the intervention and finalise the accompanying manual and protocol for a feasibility study. Stakeholder feedback was generally positive and the majority of suggested intervention components were approved. The proposed outcome was a 12-week complex multidisciplinary intervention primarily based at the patient's home. CONCLUSIONS: A new intervention has been developed to improve outcomes for people with dementia following a fall requiring healthcare attention. The feasibility of this intervention is currently being tested. TRIAL REGISTRATION: ISRCTN41760734 (16/11/2015).

Value of witness observations in the differential diagnosis of transient loss of consciousness.

OBJECTIVE: This retrospective study explores to what extent additional information from event witnesses provided using the novel 31-item Paroxysmal Event Observer (PEO) Questionnaire improves the differentiation among epilepsy, syncope, and psychogenic nonepileptic seizures (PNES) achievable with information provided by patients alone. METHODS: Patients with transient loss of consciousness caused by proven epilepsy (n = 86), syncope (n = 79), or PNES (n = 84) attending specialist neurology/syncope services in the United Kingdom and event observers provided Paroxysmal Event Profile (PEP), PEO, and personal information (PI) (e.g., sex, age, medical history) data. PEO data were subjected to exploratory factor analysis (EFA) followed by confirmatory factor analysis (CFA). PEO, PEP, and PI data were used separately and in combination to differentiate diagnoses by pairwise and multinomial logistic regressions. Predicted diagnoses were compared with gold standard medical diagnoses. RESULTS: EFA/CFA identified a 4-factor structure of the PEO based on 26/31 questionnaire items with loadings ≥0.4. Observer-reported factors alone differentiated better between syncope and epilepsy than patient-reported factors (accuracy: 96% vs 85%, p = 0.0004). Observer-reported data improved accuracy over differentiation based on patient-reported data alone from 90% to 100% between syncope and epilepsy (p = 0.005), 76% to 83% between epilepsy and PNES (p = 0.006), and 93% to 95% between syncope and PNES (p = 0.098). CONCLUSIONS: Information from observers can make an important contribution to the differentiation of epilepsy from syncope or PNES but adds less to that of syncope from PNES.

Feasibility of trial procedures for a randomised controlled trial of a community based group exercise intervention for falls prevention for visually impaired older people: the VIOLET study.

BACKGROUND: Visually impaired older people (VIOP) have a higher risk of falling than their sighted peers, and are likely to avoid physical activity. The aim was to adapt the existing Falls Management Exercise (FaME) programme for VIOP, delivered in the community, and to investigate the feasibility of conducting a definitive randomised controlled trial (RCT) of this adapted intervention. METHODS: Two-centre randomised mixed methods pilot trial and economic evaluation of the adapted group-based FaME programme for VIOP versus usual care. A one hour exercise programme ran weekly over 12 weeks at the study sites (Newcastle and Glasgow), delivered by third sector (voluntary and community) organisations. Participants were advised to exercise at home for an additional two hours over the week. Those randomised to the usual activities group received no intervention. Outcome measures were completed at baseline, 12 and 24 weeks. The potential primary outcome was the Short Form Falls Efficacy Scale - International (SFES-I). Participants' adherence was assessed by reviewing attendance records and self-reported compliance to the home exercises. Adherence with the course content (fidelity) by instructors was assessed by a researcher. Adverse events were collected in a weekly phone call. RESULTS: Eighteen participants, drawn from community-living VIOP were screened; 68 met the inclusion criteria; 64 participants were randomised with 33 allocated to the intervention and 31 to the usual activities arm. 94% of participants provided data at the 12 week visit and 92% at 24 weeks. Adherence was high. The intervention was found to be safe with 76% attending nine or more classes. Median time for home exercise was 50 min per week. There was little or no evidence that fear of falling, balance and falls risk, physical activity, emotional, attitudinal or quality of life outcomes differed between trial arms at follow-up. CONCLUSIONS: The intervention, FaME, was implemented successfully for VIOP and all progression criteria for a main trial were met. The lack of difference between groups on fear of falling was unsurprising given it was a pilot study but there may have been other contributory factors including suboptimal exercise dose and apparent low risk of falls in participants. These issues need addressing for a future trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN ID: 16949845 Registered: 21 May 2015.

New Horizons in orthostatic hypotension.

Background: orthostatic hypotension (OH) is a common disabling condition associated with increased morbidity and mortality. Much of the evidence available is derived from younger populations with chronic neurological disease leading to uncertainty for the diagnosis and management of older people. Objective: to provide an overview of recent and emerging evidence for the diagnosis, management and prognosis of OH in older persons. Methods: a narrative review of recent studies, emerging therapies and relevant regulatory updates. Findings: revisions to the diagnostic criteria for OH include the duration of the blood pressure drop, specific criteria for initial and delayed OH and OH with hypertension. Non-drug therapies remain the first-line treatment option and Comprehensive Geriatric Assessment appears to result in lower rates of OH. Recent evidence concerning withdrawal of causative medication is inconsistent. Midodrine has recently become the only licenced medication for OH in the UK. Other emerging treatments include atomoxetine and droxidopa but these require further evaluation. Many other agents may be used but are not supported by high-quality evidence. The increase in mortality associated with OH is less apparent in older people. Summary: OH remains common in older people, the new diagnostic criteria address some of the previous uncertainty but evidence concerning withdrawal of antihypertensives is conflicting. Midodrine is now the only licenced medication for OH in the UK, but non-drug therapies remain first line and fludrocortisone may be considered before midodrine. We may see other agents such as droxidopa becoming increasingly used over the coming years.

A Novel Approach to Proactive Primary Care-Based Case Finding and Multidisciplinary Management of Falls, Syncope, and Dizziness in a One-Stop Service: Preliminary Results.

National and international evidence and guidelines on falls prevention and management in community-dwelling elderly adults recommend that falls services should be multifactorial and their interventions multicomponent. The way that individuals are identified as having had or being at risk of falls in order to take advantage of such services is far less clear. A novel multidisciplinary, multifactorial falls, syncope, and dizziness service model was designed with enhanced case ascertainment through proactive, primary care-based screening (of individual case notes of individuals aged ≥60) for individual fall risk factors. The service model identified 4,039 individuals, of whom 2,232 had significant gait and balance abnormalities according to senior physiotherapist assessment. Significant numbers of individuals with new diagnoses ranging from cognitive impairment to Parkinson's disease to urgent indications for a pacemaker were discovered. More than 600 individuals were found who were at high risk of osteoporosis according to World Health Association Fracture Risk Assessment Tool score, 179 with benign positional paroxysmal vertigo and 50 with atrial fibrillation. Through such screening and this approach, Comprehensive Geriatric Assessment Plus (Plus falls, syncope and dizziness expertise), unmet need was targeted on a scale far outside the numbers seen in clinical trials. Further work is needed to determine whether this approach translates into fewer falls and decreases in syncope and dizziness.

Cognitive-behavioural therapy-based intervention to reduce fear of falling in older people: therapy development and randomised controlled trial - the Strategies for Increasing Independence, Confidence and Energy (STRIDE) study.

BACKGROUND: Falls cause fear, anxiety and loss of confidence, resulting in activity avoidance, social isolation and increasing frailty. The umbrella term for these problems is 'fear of falling', seen in up to 85% of older adults who fall. Evidence of effectiveness of physical and psychological interventions is limited, with no previous studies examining the role of an individually delivered cognitive-behavioural therapy (CBT) approach. OBJECTIVES: Primary objective To develop and then determine the effectiveness of a new CBT intervention (CBTi) delivered by health-care assistants (HCAs) plus usual care compared with usual care alone in reducing fear of falling. Secondary objectives To measure the impact of the intervention on falls, injuries, functional abilities, anxiety/depression, quality of life, social participation and loneliness; investigate the acceptability of the intervention for patients, family members and professionals and factors that promote or inhibit its implementation; and measure the costs and benefits of the intervention. DESIGN: Phase I CBTi development. Phase II Parallel-group patient randomised controlled trial (RCT) of the new CBTi plus usual care compared with usual care alone. SETTING: Multidisciplinary falls services. PARTICIPANTS: Consecutive community-dwelling older adults, both sexes, aged ≥ 60 years, with excessive or undue fear of falling per Falls Efficacy Scale-International (FES-I) score of > 23. INTERVENTIONS: Phase I Development of the CBTi. The CBTi was developed following patient interviews and taught to HCAs to maximise the potential for uptake and generalisability to a UK NHS setting. Phase II RCT. The CBTi was delivered by HCAs weekly for 8 weeks, with a 6-month booster session plus usual care. MAIN OUTCOME MEASURES: These were assessed at baseline, 8 weeks, 6 months and 12 months. Primary outcome measure Fear of falling measured by change in FES-I scores at 12 months. Secondary outcome measures These comprised falls, injuries, anxiety/depression [Hospital Anxiety and Depression Scale (HADS)], quality of life, social participation, loneliness and measures of physical function. There were process and health-economic evaluations alongside the trial. RESULTS: Four hundred and fifteen patients were recruited, with 210 patients randomised to CBTi group and 205 to the control group. There were significant reductions in mean FES-I [-4.02; 95% confidence interval (CI) -5.95 to -2.1], single-item numerical fear of falling scale (-1.42; 95% CI -1.87 to 1.07) and HADS (-1; 95% CI -1.6 to -0.3) scores at 12 months in the CBTi group compared with the usual care group. There were no differences in the other secondary outcome measures. Most patients found the CBTi acceptable. Factors affecting the delivery of the CBTi as part of routine practice were identified. There was no evidence that the intervention was cost-effective. CONCLUSIONS: Our new CBTi delivered by HCAs significantly improved fear of falling and depression scores in older adults who were attending falls services. There was no impact on other measures. FURTHER WORK: Further work should focus on a joint CBTi and physical training approach to fear of falling, more rational targeting of CBTi, the possibility of mixed group and individual CBTi, and the cost-effectiveness of provision of CBTi by non-specialists. TRIAL REGISTRATION: Current Controlled Trials ISRCTN78396615. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 56. See the NIHR Journals Library website for further project information.

Syncope in the Older Person.

Syncope in the older person carries a high morbidity, mortality, and health economic burden. While neurally mediated disorders and orthostatic hypotension account for the majority of syncopal episodes in this age group, around a third of causes are cardiac, predominantly arrhythmic. Clinicians need to be aware of the management of potential comorbid issues such as osteoporosis and cognitive impairment and if not in a position to act on them, ensure that appropriate specialist help is sought. Further work is needed to understand the pathophysiology and hence the management of syncope in the older patient, with ongoing studies helping to tease out some of the treatment controversies.

Cardiac Iodine-123-Meta-Iodo-Benzylguanidine Uptake in Carotid Sinus Hypersensitivity.

BACKGROUND: Carotid sinus syndrome is the association of carotid sinus hypersensitivity with syncope, unexplained falls and drop attacks in generally older people. We evaluated cardiac sympathetic innervation in this disorder in individuals with carotid sinus syndrome, asymptomatic carotid sinus hypersensitivity and controls without carotid sinus hypersensitivity. METHODS: Consecutive patients diagnosed with carotid sinus syndrome at a specialist falls and syncope unit were recruited. Asymptomatic carotid sinus hypersensitivity and non-carotid sinus hypersensitivity control participants recruited from a community-dwelling cohort. Cardiac sympathetic innervation was determined using Iodine-123-metaiodobenzylguanidine (123-I-MIBG) scanning. Heart to mediastinal uptake ratio (H:M) were determined for early and late uptake on planar scintigraphy at 20 minutes and 3 hours following intravenous injection of 123-I-MIBG. RESULTS: Forty-two subjects: carotid sinus syndrome (n = 21), asymptomatic carotid sinus hypersensitivity (n = 12) and no carotid sinus hypersensitivity (n = 9) were included. Compared to the non- carotid sinus hypersensitivity control group, the carotid sinus syndrome group had significantly higher early H:M (estimated mean difference, B = 0.40; 95% confidence interval, CI = 0.13 to 0.67, p = 0.005) and late H:M (B = 0.32; 95%CI = 0.03 to 0.62, p = 0.032). There was, however, no significant difference in early H:M (p = 0.326) or late H:M (p = 0.351) between the asymptomatic carotid sinus hypersensitivity group and non- carotid sinus hypersensitivity controls. CONCLUSIONS: Cardiac sympathetic neuronal activity is increased relative to age-matched controls in individuals with carotid sinus syndrome but not those with asymptomatic carotid sinus hypersensitivity. Blood pressure and heart rate measurements alone may therefore represent an over simplification in the assessment for carotid sinus syndrome and the relative increase in cardiac sympathetic innervation provides additional clues to understanding the mechanisms behind the symptomatic presentation of carotid sinus hypersensitivity.

Making sense of a cognitive behavioural therapy intervention for fear of falling: qualitative study of intervention development.

BACKGROUND: Fear of Falling (FoF) is commonly reported among older adults (up to 50%) and can impact negatively on physical and social activities, mood and quality of life. This paper explores the development, acceptability and feasibility of a cognitive behavioural therapy intervention (CBTi) for FoF. METHODS: The process evaluation of the CBTi development phase of an RCT (conducted in the UK) reported here, used ethnographic methods. Data included: interviews with patients and carers (n = 16), clinic staff (n = 6) and the psychologists developing the CBTi (n = 3); observational field notes and transcripts of intervention development meetings (n = 9) and stakeholder engagement meetings (n = 2); and informal discussions with staff developing the CBTi (n = 8). Data collection and thematic analysis were guided by Normalisation Process Theory (NPT). RESULTS: The process evaluation showed two domains of work necessary to develop a CBTi that made sense to stakeholders, and that could be delivered as part of an RCT. For the psychologists developing the content of the CBTi, a growing understanding of the complexity of FoF highlighted the need for an individualised rather than a manualised intervention. For the research team, the work involved adapting the structures and processes of the RCT to address preliminary concerns over the acceptability and feasibility of the proposed CBTi. CONCLUSIONS: Theory-based approaches to process evaluation can sensitise researchers to contested understandings about proposed interventions that could undermine implementation. Drawing on the coherence construct of NPT, this study emphasises the nature and extent of work required to ensure an intervention makes sufficient sense to key stakeholders in order to maximise chances of successful implementation.

Does the falls efficacy scale international version measure fear of falling: a reassessment of internal validity using a factor analytic approach.

BACKGROUND: the Falls Efficacy Scale-International (FES-I) is a widely used measure of fear of falling that assesses concerns with respect to falls over a range of physical and social activities. In the original validation study, the methods used (self-selection by participants) were likely to over-represent those with a higher educational level and socio-economic grouping. In addition, the factor analysis method used was potentially less applicable to older individuals and may have been less likely to measure the construct of fear of falling. OBJECTIVE: to validate the internal validity of the FES-I and assess its suitability as a measure of fear of falling. DESIGN: cross-sectional survey. SETTING: community sample. METHODS: a random sample of 200 participants aged 60 years completed the FES-I by structured interview. We verify internal validity with a factor analytic approach not previously employed in this study design context, principal factor analysis on the matrix of polychoric correlations. RESULTS: we find no redundancy in the questions on the FES-I. All are found to strongly represent concerns about falling during social and physical activities. CONCLUSION: the FES-I is an appropriate tool to assess fear or concerns with respect to falls in the general elderly population, and more appropriately represents concern of falling than has previously been found. Future health services research with the FES-I should have its design informed by the results presented in this study, as the structure of the 'concern with falling' factor differs markedly from that found in previous validity testing.

Symptomatic presentation of carotid sinus hypersensitivity is associated with impaired cerebral autoregulation.

BACKGROUND: Carotid sinus hypersensitivity (CSH) is associated with syncope, unexplained falls, and drop attacks in older people but occurs asymptomatically in 35% of community-dwelling elders. We hypothesized that impaired cerebral autoregulation is associated with the conversion of asymptomatic CSH to symptomatic CSH. We therefore conducted a case-control study evaluating individuals with CSH with and without the symptoms of syncope or unexplained falls, as well as non-CSH controls, to determine whether the blood pressure and heart rate changes associated with CSH are associated with symptoms only when cerebral autoregulation is altered. METHODS AND RESULTS: Bilateral middle cerebral artery blood flow velocities (BFV) were measured in consecutive patients with symptomatic CSH (n=22) and asymptomatic controls with (n=18) and without CSH (n=14) using transcranial Doppler ultrasonography during lower body negative pressure-induced systemic hypotension. Within-group comparisons revealed significantly lower cerebrovascular resistance index (CVRi) at nadir for the asymptomatic CSH group (right, mean [95% CI]: 2.2 [1.8, 2.8] versus 2.6 [2.2, 3.0]; P=0.005; left: 2.8 [2.4, 3.3] versus 3.1 [2.7, 3.8]; P=0.016). Between-group comparisons showed higher mean BFV (right: estimated mean difference, B=5.49 [1.98, 8.80], P=0.003; left: 4.82 [1.52, 8.11], P=0.005) and lower CVRi (right: B=0.08 [0.03, 0.12], P=0.003, left: B=0.07 [0.02, 0.12], P=0.006) in asymptomatic CSH versus symptomatic CSH groups. There were no significant differences in bilateral mean BFV or right CVRi between the non-CSH and symptomatic CSH groups but differences were present for left CVRi (B=0.07 [0.02, 0.013], P=0.015). CONCLUSION: Cerebral autoregulation is altered in symptomatic CSH and therefore appears to be associated with the development of hypotension-related symptoms in individuals with CSH.

The STRIDE (Strategies to Increase confidence, InDependence and Energy) study: cognitive behavioural therapy-based intervention to reduce fear of falling in older fallers living in the community - study protocol for a randomised controlled trial.

BACKGROUND: Around 30% to 62% of older individuals fall each year, with adverse consequences of falls being by no means limited to physical injury and escalating levels of dependence. Many older individuals suffer from a variety of adverse psychosocial difficulties related to falling including fear, anxiety, loss of confidence and subsequent increasing activity avoidance, social isolation and frailty. Such 'fear of falling' is common and disabling, but definitive studies examining the effective management of the syndrome are lacking. Cognitive behavioural therapy has been trialed with some success in a group setting, but there is no adequately powered randomised controlled study of an individually based cognitive behavioural therapy intervention, and none using non-mental health professionals to deliver the intervention. METHODS/DESIGN: We are conducting a two-phase study examining the role of individual cognitive behavioural therapy delivered by healthcare assistants in improving fear of falling in older adults. In Phase I, the intervention was developed and taught to healthcare assistants, while Phase II is the pragmatic randomised controlled study examining the efficacy of the intervention in improving fear of falling in community-dwelling elders attending falls services. A qualitative process evaluation study informed by Normalization Process Theory is being conducted throughout to examine the potential promoters and inhibitors of introducing such an intervention into routine clinical practice, while a health economic sub-study running alongside the trial is examining the costs and benefits of such an approach to the wider health economy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN78396615.