Multicentre, randomised controlled trial of PDSAFE, a physiotherapist-delivered fall prevention programme for people with Parkinson's.

OBJECTIVE: To estimate the effect of a physiotherapist-delivered fall prevention programme for people with Parkinson's (PwP). METHODS: People at risk of falls with confirmed Parkinson's were recruited to this multicentre, pragmatic, investigator blind, individually randomised controlled trial with prespecified subgroup analyses. 474 PwP (Hoehn and Yahr 1-4) were randomised: 238 allocated to a physiotherapy programme and 236 to control. All participants had routine care; the control group received a DVD about Parkinson's and single advice session at trial completion. The intervention group (PDSAFE) had an individually tailored, progressive home-based fall avoidance strategy training programme with balance and strengthening exercises. The primary outcome was risk of repeat falling, collected by self-report monthly diaries, 0-6 months after randomisation. Secondary outcomes included Mini-BESTest for balance, chair stand test, falls efficacy, freezing of gait, health-related quality of life (EuroQol EQ-5D), Geriatric Depression Scale, Physical Activity Scale for the Elderly and Parkinson's Disease Questionnaire, fractures and rate of near falling. RESULTS: Average age is 72 years and 266 (56%) were men. By 6 months, 116 (55%) of the control group and 125 (61.5%) of the intervention group reported repeat falls (controlled OR 1.21, 95% CI 0.74 to 1.98, p=0.447). Secondary subgroup analyses suggested a different response to the intervention between moderate and severe disease severity groups. Balance, falls efficacy and chair stand time improved with near falls reduced in the intervention arm. CONCLUSION: PDSAFE did not reduce falling in this pragmatic trial of PwP. Other functional tasks improved and reduced fall rates were apparent among those with moderate disease. TRIAL REGISTRATION NUMBER: ISRCTN48152791.

Giving hope, ticking boxes or securing services? A qualitative study of respiratory physiotherapists' views on goal-setting with people with chronic obstructive pulmonary disease.

OBJECTIVE: To explore respiratory physiotherapists' views and experiences of using goal-setting with people with chronic obstructive pulmonary disease in rehabilitation settings. PARTICIPANTS: A total of 17 respiratory physiotherapists with ⩾12 months current or previous experience of working with patients with chronic obstructive pulmonary disease in a non-acute setting. Participants were diverse in relation to age (25-49 years), sex (13 women), experience (Agenda for Change bands 6-8) and geographic location. METHOD: Data were collected via face-to-face qualitative in-depth interviews (40-70 minutes) using a semi-structured interview guide. Interview locations were selected by participants (included participants' homes, public places and University). Interviews followed an interview guide, were audio-recorded and transcribed verbatim. DATA ANALYSIS: Data were analysed using thematic analysis; constant comparison was made within and between accounts, and negative case analysis was used. RESULTS: Three themes emerged through the process of analysis: (1) 'Explaining goal-setting'; (2) 'Working with goals'; and (3) 'Influences on collaborative goal-setting'. Goal-setting practices among respiratory physiotherapists varied considerably. Collaborative goal-setting was described as challenging and was sometimes driven by service need rather than patient values. Lack of training in collaborative goal-setting at both undergraduate and postgraduate level was also seen as an issue. CONCLUSION: Respiratory physiotherapists reflected uncertainties around the use of goal-setting in their practice, and conflict between patients' goals and organisational demands. This work highlights a need for wider discussion to clarify the purpose and implementation of goal-setting in respiratory rehabilitation.

Factors associated with alcohol reduction in harmful and hazardous drinkers following alcohol brief intervention in Scotland: a qualitative enquiry.

BACKGROUND: Alcohol Brief Intervention (ABI) uses a motivational counselling approach to support individuals to reduce excessive alcohol consumption. There is growing evidence on ABI's use within various health care settings, although how they work and which components enhance success is largely unknown. This paper reports on the qualitative part of a mixed methods study. It explores enablers and barriers associated with alcohol reduction following an ABI. It focuses on alcohol's place within participants' lives and their personal perspectives on reducing consumption. There are a number of randomised controlled trials in this field though few ABI studies have addressed the experiences of hazardous/harmful drinkers. This study examines factors associated with alcohol reduction in harmful/hazardous drinkers following ABI. METHODS: This qualitative study was underpinned by a realist evaluation approach and involved semi-structured interviews with ten harmful or hazardous alcohol drinkers. Participants (n = 10) were from the intervention arm of a randomised controlled trial (n = 124). All had received ABI, a 20 min motivational counselling interview, six months previously, and had reduced their alcohol consumption. Interviews were recorded, transcribed verbatim and thematically analysed. RESULTS: Participants described their views on alcohol, its' place in their lives, their personal perspectives on reducing their consumption and future aspirations. CONCLUSIONS: The findings provide an insight into participants' views on alcohol, ABI, and the barriers and enablers to change. Participants described a cost benefit analysis, with some conscious consideration of the advantages and disadvantages of reducing intake or abstaining from alcohol. Findings suggest that, whilst hospital admission can act as a catalyst, encouraging individuals to reflect on their alcohol consumption through ABI may consolidate this, turning this reflective moment into action. Sustainability may be enhanced by the presence of a 'significant other' who encourages and experiences benefit. In addition having a purpose or structure with activities linked to employment and/or social and leisure pursuits offers the potential to enhance and sustain reduced alcohol consumption. TRIAL REGISTRATION: Trial registration number TRN NCT00982306 September 22nd 2009.

Positioning Children's Voice in Clinical Trials Research: A New Model for Planning, Collaboration, and Reflection.

Following the United Nations Convention on the Rights of the Child, there has been considerable growth in research with children about health and services that affect them. Creative methods to engage with children have also been developed. One area where progress has been slower is the inclusion of children's perspectives in qualitative research in the context of clinical trials or feasibility studies. Addressing this gap, this article discusses experiences of, and reflections on, the process of researching children's views as part of a clinical feasibility study. The article considers what worked well and highlights remaining dilemmas. A new continuum of children's engagement in research is presented, designed to assist researchers to make explicit the contingent demands on their research, and to suggest a range of techniques from within the broader fields of health, childhood studies, and education research that could be used to forward qualitative research in clinical contexts.

A multi-centre, randomised controlled trial of the effectiveness of PDSAFE to prevent falls among people with Parkinson's: study protocol.

BACKGROUND: Falls amongst people with Parkinson's (PwP) result in significant disability and reduced quality of life. There is emerging evidence that exercise-based and physiotherapeutic interventions are of benefit for improving fall risk factors, such as balance. However, the benefit, in terms of preventing falls, is mixed. The development of effective interventions has been identified as the highest research priority for this population. The aim of this trial is to establish the effectiveness and cost-effectiveness of a novel, home-based physiotherapy programme, compared with usual care, on falls amongst PwP. METHODS/DESIGN: A UK multi-centre, community-based, single blind, randomised controlled trial with twelve month follow-up, and nested economic evaluation and qualitative studies will be undertaken. Six hundred PwP who live in their own home, have had one or more falls in the previous year and an MMSE score of ≥24 will be recruited. Those living in care homes and those needing assistance from another person to walk indoors will not be eligible. The intervention is a physiotherapist delivered, individually tailored and progressive, home-based programme (PDSAFE) comprising task orientated movement strategy training, functional lower limb strengthening and balance training, of six months duration. Unsupervised daily home exercises and strategies will be practised and supported using technology. Control participants will receive usual care. Data collection will include falls, cognitive state, balance and mobility, fear of falling, freezing of gait, mood, quality of life, carer quality of life and resource use. Data will be collected at baseline, three, six and twelve months. Longitudinal semi-structured interviews will be undertaken with forty participants to explore the expectations and experiences of participants. The primary outcome is risk of repeat falling at six months post-randomisation. DISCUSSION: The aims of this trial are to establish the effectiveness and cost-effectiveness of a novel, home-delivered physiotherapy intervention (PDSAFE) compared with usual care on risk of falling for PwP who have a history of falling. PDSAFE is a novel intervention that builds upon the existing literature and targeting known risk factors, being the first study that uses a novel delivery modus (technology) in conjunction with traditional physiotherapeutic approaches. TRIAL REGISTRATION: Current Controlled Trials ISRCTN48152791.

The causes of falls: views of older people with visual impairment.

BACKGROUND: Sight impairment increases with age and, compared with the general older population, older people with sight impairment are more likely to fall. There is a growing body of evidence on the views and perceptions of older people about falls, but little is published on the views of older people with sight impairment. OBJECTIVE: To explore what older people with sight impairment believe to be the causes of falls. DESIGN: A qualitative design was used, incorporating focus groups and interviews in which participants discussed falls and falls prevention. Framework analysis was employed to identify themes arising from participants' discussions of the causes of falls. SETTING AND PARTICIPANTS: Fifty-four community dwelling men and women with sight impairment, aged 65 and over, were recruited from across Greater Manchester, UK. RESULTS: Five types of factors were identified that were believed to cause falls: (i) health issues and changes in balance caused by ageing; (ii) cognitive and behavioural factors; (iii) the impact of sight impairment on getting around the home; (iv) the impact of sight impairment on negotiating the environment away from home; and (v) unexplained falls. DISCUSSION AND CONCLUSIONS: Older people with sight impairment reported many researched risk factors previously identified by older people without sight impairment but also described many perceived risks unique to people with sight impairment. There are few interventions to prevent falls aimed at older people with sight impairment, and the results of this study allow further tailoring of such interventions based on views of older people with sight impairment.

A pilot randomised controlled trial to compare changes in quality of life for participants with early diagnosis dementia who attend a 'Living Well with Dementia' group compared to waiting-list control.

OBJECTIVES: The aim of this paper is to report a pilot study in which participants who had recently received a diagnosis of dementia were randomised to either a 10-week group intervention or a waiting-list control. METHOD: Memory clinic staff with limited previous experience of group therapy were trained to lead a 10-week group therapy intervention called 'Living Well with Dementia'. Fifty-eight participants, all of whom had received a diagnosis of Alzheimer's disease, vascular or Lewy body dementia within the previous 18 months, were randomised to receive either the intervention or treatment as usual (waiting-list control). Data collection occurred at baseline, within two weeks after the intervention finished and at 10-week follow-up. RESULTS: The study met its recruitment targets, with a relatively low attrition rate for the intervention arm. The acceptability of the intervention and research methods was examined qualitatively and will be reported on elsewhere. For the primary outcome, measure of quality of life in Alzheimer's disease (QoL-AD), and secondary outcome, self-esteem, there was some evidence of improvement in the intervention group compared to the control group. There was, also, evidence of a reduction in cognitive functioning in the treatment group compared to the control. Such reported differences should be treated with caution because they are obtained from a pilot and not a definitive study. CONCLUSION: This pilot study succeeded in collecting data to inform a future definitive cost effectiveness clinical trial of Living Well with Dementia group therapy.

Environmental and behavioural interventions for reducing physical activity limitation in community-dwelling visually impaired older people.

BACKGROUND: Impairment of vision is associated with a loss of function in activities of daily living. Avoidance of physical activity and consequent reduced functional capacity is common in older people with visual impairment and an important risk factor for falls. Indeed, the rate of falls and fractures is higher in older people with visual impairment than age-matched visually normal older people. Depression and anxiety is common in older people with vision impairment and leads to further restriction of activity, reduced social contact and reduced quality of life. Possible mechanisms to reduce activity restriction and therefore improve mobility and activity include environmental and behavioural interventions delivered by a number of health professionals, including occupational therapists. OBJECTIVES: The objective of this review was to assess the effectiveness of environmental and behavioural interventions in reducing activity limitation and improving quality of life amongst visually impaired older people. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 10), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE, (January 1950 to November 2012), EMBASE (January 1980 to November 2012), Cumulative Index to Nursing and Allied Health Literature (CINAHL) (January 1937 to November 2012), Allied and Complementary Medicine Database (AMED) (January 1985 to November 2012), OT Seeker (inception to November 2012), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 9 November 2012. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-randomised controlled trials (Q-RCTs) that compared environmental interventions, behavioural interventions or both, versus control (placebo control or no intervention or usual care), and trials comparing different types of environmental or behavioural interventions, in older people (aged 60 and over) with irreversible visual impairment living independently or in residential settings. To be eligible for inclusion the primary aim of studies must be reducing physical activity limitation and must include a measure of physical activity. Secondary outcome measures included falls, fear of falling, quality of life. DATA COLLECTION AND ANALYSIS: Two authors independently read abstracts retrieved by the search to identify eligibility and study quality. We contacted study authors for additional information. MAIN RESULTS: Our searches found no RCTs or Q-RCTs that met the eligibility criteria for this review. AUTHORS' CONCLUSIONS: We are unable to reach any conclusion about the effectiveness of environmental or behavioural interventions for reducing physical activity limitation in community-dwelling visually impaired older people, as no eligible studies were found. However a number of studies reviewed included only the secondary outcome measures of this review. Although behavioural interventions delivered by occupational therapists have been shown to reduce the rate of falls, we are unable to conclude if this is due to reduced activity restriction (increased mobility) or reduced activity (lessening exposure to risk). There are inconclusive and conflicting results from trials evaluating the effectiveness of behavioural and environmental interventions aimed at improving quality of life. Further research is necessary (such as ongoing Dutch and UK trials considering the effectiveness of orientation and mobility training on activity restriction, physical activity, falls, fear of falling and quality of life in older adults with low vision, and the effect of an occupational therapist delivering home safety modification, coping strategies and exercise with older people with low vision) before any conclusions can be reached.

Characteristics of outdoor falls among older people: a qualitative study.

BACKGROUND: Falls are a major threat to older people's health and wellbeing. Approximately half of falls occur in outdoor environments but little is known about the circumstances in which they occur. We conducted a qualitative study to explore older people's experiences of outdoor falls to develop understanding of how they may be prevented. METHODS: We conducted nine focus groups across the UK (England, Wales, and Scotland). Our sample was from urban and rural settings and different environmental landscapes. Participants were aged 65+ and had at least one outdoor fall in the past year. We analysed the data using framework and content analyses. RESULTS: Forty-four adults aged 65 - 92 took part and reported their experience of 88 outdoor falls. Outdoor falls occurred in a variety of contexts, though reports suggested the following scenarios may have been more frequent: when crossing a road, in a familiar area, when bystanders were around, and with an unreported or unknown attribution. Most frequently, falls resulted in either minor or moderate injury, feeling embarrassed at the time of the fall, and anxiety about falling again. Ten falls resulted in fracture, but no strong pattern emerged in regard to the contexts of these falls. Anxiety about falling again appeared more prevalent among those that fell in urban settings and who made more visits into their neighbourhood in a typical week. CONCLUSIONS: This exploratory study has highlighted several aspects of the outdoor environment that may represent risk factors for outdoor falls and associated fear of falling. Health professionals are recommended to consider outdoor environments as well as the home setting when working to prevent falls and increase mobility among older people.

Participant expectations and experiences of a tailored physiotherapy intervention for people with Parkinson's and a history of falls.

PURPOSE: People with Parkinson's are twice as likely to fall as older people within the general population. This longitudinal qualitative study was part of a larger programme of research including a randomised controlled trial to test the effectiveness of a tailored physiotherapy intervention. Specific qualitative aims focused on a subsample of trial participants in the intervention arm of the trial, and comprised the following:To explore the expectations of participants about the intervention.To investigate participants' experiences of the intervention, and its perceived impacts.To understand the facilitators and barriers to engagement. METHODS: Two semi-structured interviews were completed with a theoretical sample of people with Parkinson's from the intervention arm, initially after randomisation but before the intervention commenced, and then again six months later. RESULTS: Forty-two participants out of a large clinical trial were interviewed initially, with 37 agreeing to a second interview at six months. Prior experience of rehabilitation plus information accessed through the trial consent procedure informed participants' realistic expectations. Most found the level of the intervention acceptable, and perceived a range of benefits. However, views about equipment provided were more equivocal. The biggest barriers to participation were time and motivation, whilst social support facilitated engagement with the intervention. CONCLUSIONS: This study is the first to capture expectations about participation in a programme of exercises and strategies. It highlights that previous challenges to engagement in physical exercises and activities are not a barrier to future participation and provides new insights into the role of equipment and technology in programmes of physical activity for people with Parkinson's. The challenge of ensuring that programmes of exercise and strategies become an embedded feature of everyday life is highlighted, particularly alongside busy social engagements and leisure pursuits.Implications for rehabilitationFor people with Parkinsons, a programme of exercises and strategies has the potential to reduce the risk of falls amongst those with a history of falling.Adherence to such programmes can prove challenging for a variety of reasons, even when participants have realistic expectations about the commitment and effort needed.Clear explanations about the role of equipment and technology within such programmes could enhance adherence.In order to further individualise programmes of exercise for people with Parkinsons, choice regarding social support, reminders and integration into everyday activities should be explored.

Exercise for improving balance in older people.

BACKGROUND: In older adults, diminished balance is associated with reduced physical functioning and an increased risk of falling. This is an update of a Cochrane review first published in 2007. OBJECTIVES: To examine the effects of exercise interventions on balance in older people, aged 60 and over, living in the community or in institutional care. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, CENTRAL (The Cochrane Library 2011, Issue 1), MEDLINE and EMBASE (to February 2011). SELECTION CRITERIA: Randomised controlled studies testing the effects of exercise interventions on balance in older people. The primary outcomes of the review were clinical measures of balance. DATA COLLECTION AND ANALYSIS: Pairs of review authors independently assessed risk of bias and extracted data from studies. Data were pooled where appropriate. MAIN RESULTS: This update included 94 studies (62 new) with 9,917 participants. Most participants were women living in their own home.Most trials were judged at unclear risk of selection bias, generally reflecting inadequate reporting of the randomisation methods, but at high risk of performance bias relating to lack of participant blinding, which is largely unavoidable for these trials. Most studies only reported outcome up to the end of the exercise programme.There were eight categories of exercise programmes. These are listed below together with primary measures of balance for which there was some evidence of a statistically significant effect at the end of the exercise programme. Some trials tested more than one type of exercise. Crucially, the evidence for each outcome was generally from only a few of the trials for each exercise category. 1. Gait, balance, co-ordination and functional tasks (19 studies of which 10 provided primary outcome data): Timed Up & Go test (mean difference (MD) -0.82 s; 95% CI -1.56 to -0.08 s, 114 participants, 4 studies); walking speed (standardised mean difference (SMD) 0.43; 95% CI 0.11 to 0.75, 156 participants, 4 studies), and the Berg Balance Scale (MD 3.48 points; 95% CI 2.01 to 4.95 points, 145 participants, 4 studies).2. Strengthening exercise (including resistance or power training) (21 studies of which 11 provided primary outcome data): Timed Up & Go Test (MD -4.30 s; 95% CI -7.60 to -1.00 s, 71 participants, 3 studies); standing on one leg for as long as possible with eyes closed (MD 1.64 s; 95% CI 0.97 to 2.31 s, 120 participants, 3 studies); and walking speed (SMD 0.25; 95% CI 0.05 to 0.46, 375 participants, 8 studies).3. 3D (3 dimensional) exercise (including Tai Chi, qi gong, dance, yoga) (15 studies of which seven provided primary outcome data): Timed Up & Go Test (MD -1.30 s; 95% CI -2.40 to -0.20 s, 44 participants, 1 study); standing on one leg for as long as possible with eyes open (MD 9.60 s; 95% CI 6.64 to 12.56 s, 47 participants, 1 study), and with eyes closed (MD 2.21 s; 95% CI 0.69 to 3.73 s, 48 participants, 1 study); and the Berg Balance Scale (MD 1.06 points; 95% CI 0.37 to 1.76 points, 150 participants, 2 studies).4. General physical activity (walking) (seven studies of which five provided primary outcome data). 5. General physical activity (cycling) (one study which provided data for walking speed). 6. Computerised balance training using visual feedback (two studies, neither of which provided primary outcome data). 7. Vibration platform used as intervention (three studies of which one provided primary outcome data).8. Multiple exercise types (combinations of the above) (43 studies of which 29 provided data for one or more primary outcomes): Timed Up & Go Test (MD -1.63 s; 95% CI -2.28 to -0.98 s, 635 participants, 12 studies); standing on one leg for as long as possible with eyes open (MD 5.03 s; 95% CI 1.19 to 8.87 s, 545 participants, 9 studies), and with eyes closed ((MD 1.60 s; 95% CI -0.01 to 3.20 s, 176 participants, 2 studies); walking speed (SMD 0.04; 95% CI -0.10 to 0.17, 818 participants, 15 studies); and the Berg Balance Scale ((MD 1.84 points; 95% CI 0.71 to 2.97 points, 80 participants, 2 studies).Few adverse events were reported but most studies did not monitor or report adverse events.In general, the more effective programmes ran three times a week for three months and involved dynamic exercise in standing. AUTHORS' CONCLUSIONS: There is weak evidence that some types of exercise (gait, balance, co-ordination and functional tasks; strengthening exercise; 3D exercise and multiple exercise types) are moderately effective, immediately post intervention, in improving clinical balance outcomes in older people. Such interventions are probably safe. There is either no or insufficient evidence to draw any conclusions for general physical activity (walking or cycling) and exercise involving computerised balance programmes or vibration plates. Further high methodological quality research using core outcome measures and adequate surveillance is required.

Nursing and allied health professionals' views about using health literacy screening tools and a universal precautions approach to communication with older adults: a qualitative study.

Purpose: Health literacy describes individuals' abilities to access, understand and use health information. Lower health literacy is associated with poor health outcomes, is more common among older adults and impacts on the effectiveness of rehabilitation/self-management interventions. This research explored nursing and allied healthcare professionals' views about identifying and responding to older adults' health literacy needs.Methods: Qualitative focus groups were conducted with a purposive sample of 22 UK nursing and AHPs working with older adults. Focus groups were audio-recorded, transcribed verbatim and analyzed using framework approach.Results: Participants used a variety of practices to identify older patients' health literacy levels, but primarily relied on subtle cues. Participants lacked knowledge and confidence in identifying and addressing health literacy needs. Participants expressed concerns about patient reactions and described practical barriers to using recommended health literacy strategies.Conclusions: Participants recognized the importance of addressing patients' health literacy needs, but do not routinely use health literacy strategies, lack confidence and have reservations about recommended health literacy strategies. This impacts on healthcare professionals' abilities to support patients to self-manage and participate in rehabilitation. Health literacy education for health professionals should consider barriers to using health literacy strategies and be tailored to accommodate variation in teams and professions.Implications for rehabilitationRehabilitation professionals need to standardise their practice to health literacy, using strategies which can be easily integrated into routine practice.To meet older adults' health literacy needs, rehabilitation professionals should use clear and accessible tailored communication, build trust, assess understanding and involve patients' social networks.Rehabilitation professionals would benefit from further education regarding health literacy to build their knowledge/confidence and address their concerns about implementing health literacy strategies.Professional education regarding health literacy needs to accommodate variation between individuals and teams.

Self-management of a musculoskeletal condition for people from harder to reach groups: a qualitative patient interview study.

Background: This study recorded the functional health literacy levels of people with musculoskeletal (MSK) conditions from harder to reach groups and explored their experiences in engaging with health care professionals to self-manage their MSK condition.Methods: We recruited participants, identified by key health and social care contacts as likely to have lower health literacy levels, and used semi-structured interviews to collect data. Thematic analysis was used to identify the main key themes arising from the transcribed interviews.Results: Eighteen participants were identified and recruited from harder to reach community populations, 10 were scored as having inadequate functional health literacy on the Short Form Rapid Estimate of Adult Literacy Measure. Three themes were identified in relation to participants' experiences of MSK self-management approaches: engaging with health care services; interpreting the health care providers' message; and facilitating participation in MSK self-management.Conclusions: Our findings indicate that people with a MSK condition, from harder to reach groups, experience multi-morbidity, find health care systems complicated and hear from health care professionals that their MSK condition cannot be cured. People interpreted that a lack of cure meant that nothing could be done to help their MSK pain. Engaging with self-management strategies was not seen as a priority for our participants. Strategies to simplify health communication, more time to process health information and supportive social networks helped our participants to understand and manage their MSK health on a day-to-day basis. Implications for RehabilitationMSK conditions are long term and prevalent in the UK with substantial impact on people's daily life.Currently self-management strategies for MSK conditions are poorly communicated and many patients believe that nothing can be done to help their MSK pain.Good clinician communication that supports self-management is needed so that key messages can be effectively understood and used by patients with a range of literacy skills.Health services need to be even more accessible to help all individuals from a range of backgrounds better self-manage their MSK conditions.

Exercise- and strategy-based physiotherapy-delivered intervention for preventing repeat falls in people with Parkinson's: the PDSAFE RCT.

BACKGROUND: People with Parkinson's disease are twice as likely to experience a fall as a healthy older person, often leading to debilitating effects on confidence, activity levels and quality of life. OBJECTIVE: To estimate the effect of a physiotherapy programme for fall prevention among people with Parkinson's disease. DESIGN: A multicentre, pragmatic, investigator-masked, individually randomised controlled trial (RCT) with prespecified subgroup analyses. SETTING: Recruitment from NHS hospitals and clinics and community and social services in eight English regions with home-based interventions. PARTICIPANTS: A total of 474 people with Parkinson's disease (i.e. Hoehn and Yahr scale stages 1-4) were recruited: 238 were assigned to a physiotherapy programme and 236 were assigned to usual care. Random allocation was 50 : 50. INTERVENTIONS: All participants received routine care; the usual-care group received an information digital versatile disc (DVD) and a single advice session at trial completion. The intervention group had an individually tailored, progressive, home-based fall avoidance strategy training programme with balance and strengthening exercises: PDSAFE. MAIN OUTCOME MEASURES: The primary outcome was the risk of repeat falling, collected by self-report monthly diaries between 0 and 6 months after randomisation. Secondary outcomes included near-falls, falls efficacy, freezing of gait (FoG), health-related quality of life, and measurements taken using the Mini-Balance Evaluation Systems Test (Mini-BESTest), the Chair Stand Test (CST), the Geriatric Depression Scale, the Physical Activity Scale for the Elderly and the Parkinson's Disease Questionnaire. RESULTS: PDSAFE is the largest RCT of falls management among people with Parkinson's disease: 541 patients were screened for eligibility. The average age was 72 years, and 266 out of 474 (56%) participants were men. Of the 474 randomised participants, 238 were randomised to the intervention group and 236 were randomised to the control group. No difference in repeat falling within 6 months of randomisation was found [PDSAFE group to control group odds ratio (OR) 1.21, 95% confidence interval (CI) 0.74 to 1.98; p = 0.447]. An analysis of secondary outcomes demonstrated better balance (Mini-BESTest: mean difference 0.95, 95% CI 0.24 to 1.67; p = 0.009), functional strength (CST: p = 0.041) and falls efficacy (Falls Efficacy Scale - International: mean difference 1.6, 95% CI -3.0 to -0.19; p = 0.026) with near-falling significantly reduced with PDSAFE (OR 0.67, 95% CI 0.53 to 0.86; p = 0.001) at 6 months. Prespecified subgroup analysis (i.e. disease severity and FoG) revealed a PDSAFE differing effect; the intervention may be of benefit for people with moderate disease but may increase falling for those in the more severe category, especially those with FoG. LIMITATIONS: All participants were assessed at primary outcome; only 73% were assessed at 12 months owing to restricted funding. CONCLUSIONS: PDSAFE was not effective in reducing repeat falling across the range of people with Parkinson's disease in the trial. Secondary analysis demonstrated that other functional tasks and self-efficacy improved and demonstrated differential patterns of intervention impact in accordance with disease severity and FoG, which supports previous secondary research findings and merits further primary evaluation. FUTURE WORK: Further trials of falls prevention on targeted groups of people with Parkinson's disease are recommended. TRIAL REGISTRATION: Current Controlled Trials ISRCTN48152791. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 36. See the NIHR Journals Library website for further project information. Sarah E Lamb is funded by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) at Oxford Health NHS Foundation Trust, the NIHR Oxford Biomedical Research Centre at the Oxford University Hospitals NHS Foundation Trust and CLAHRC Oxford. Victoria A Goodwin is supported by the NIHR Collaborations for Leadership in Applied Health Research and Care in the South West Peninsula (PenCLAHRC). Lynn Rochester is supported by the NIHR Newcastle Biomedical Research Centre based at Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University. The research was also supported by the NIHR Newcastle Clinical Research Facility Infrastructure funding. Helen C Roberts is supported by CLAHRC Wessex and the NIHR Southampton Biomedical Research Centre.

People with Parkinson's disease fall often. Falls are scary and make moving about harder. The PDSAFE trial tested a new 'home physiotherapy' programme for reducing falls. People with Parkinson's disease were allocated to one of two groups by chance: they either received the PDSAFE exercises or just normal care. The costs were looked at and people were asked for their views of the PDSAFE exercises. To take part, people had to have Parkinson's disease, live in their own home, be able to walk, have had at least one fall in the previous year and pass a memory test. PDSAFE was taught by physiotherapists and included exercises and fall avoidance strategies. Everyone had to record falls on a monthly calendar, and balance, strength and walking were tested. To our knowledge, this was the largest falls trial looking at people with Parkinson's disease in the world: 541 people took part. The number of falls an individual reported differed a lot between people. When all people with Parkinson's disease in the trial were considered, the physiotherapy programme did not reduce falls in the first 6 months. However, it was found that some people had fewer falls after taking part in the exercises, whereas others did not. Those with more severe Parkinson's disease (i.e. problems with movement, memory and freezing of gait) fell more often after the PDSAFE intervention, even though their balance and confidence improved. Those with good memory, moderate disease and two or three falls in the previous year reacted well to PDSAFE and had fewer falls. It was found that PDSAFE reduced near-falls (about to fall but managed to save themselves) and improved balance and confidence. The physiotherapists and those who took part liked the programme and felt that it helped, but it was expensive to run. In conclusion, a falls prevention programme should be based on each person's needs and a different treatment should be used for those with more severe Parkinson's disease.

Environmental interventions to prevent falls in community-dwelling older people: a meta-analysis of randomized trials.

Objective. This study seeks to determine the efficacy of environmental interventions in reducing falls in community-dwelling older people. Method. A systematic review and meta-analysis of randomized trials was performed. Results. Pooled analysis of six trials (N = 3,298) demonstrated a 21% reduction in falls risk (relative risk [RR] = 0.79; 0.65 to 0.97). Heterogeneity was attributable to the large treatment effect of one trial. Analysis of a subgroup of studies with participants at high risk of falls (four trials, n = 570) demonstrated a clinically significant 39% reduction of falls (RR = 0.61; 0.47 to 0.79), an absolute risk difference of 26% for a number needed to treat four people. Discussion. Home assessment interventions that are comprehensive, are well focused, and incorporate an environmental-fit perspective with adequate follow-up can be successful in reducing falls with significant effects. The highest effects are associated with interventions that are conducted with high-risk groups.

A randomised controlled trial of a home based exercise programme to reduce the risk of falling among people with Parkinson's disease.

OBJECTIVE: To evaluate the effectiveness of a personalised home programme of exercises and strategies for repeat fallers with Parkinson's disease (PD). METHOD: Patients with a confirmed diagnosis of idiopathic PD, independently mobile, living at home in the community, experiencing more than one fall in the previous 12 months and with intact gross cognitive function were invited to participate in this randomised controlled trial. Usual care was compared with a personalised 6 week, home based exercise and strategy programme. The primary outcomes were rates of falling at 8 weeks and 6 months. Whether participants had repeat fallen, nearly fallen or experienced injurious falls were also examined. Functional Reach, the Berg Balance Test, PD Self-assessment Scale and the Euro Quol were rated by a blinded assessor. RESULTS: Participants were randomised to the exercise (n = 70) and control (n = 72) groups. There was a consistent trend towards lower fall rates in the exercise group at both 8 weeks and 6 months and lower rates of injurious falls needing medical attention at 6 months. Lower rates of repeat near falling were evident for the exercise group at 8 weeks (p = 0.004) and 6 months (p = 0.007). There was a positive effect of exercises at 6 months on Functional Reach (p = 0.009) and quality of life (p = 0.033). No significant differences were found on other secondary outcomes measures. CONCLUSION: There was a trend towards a reduction in fall events and injurious falls with a positive effect of exercises on near falls and quality of life.

Recruitment to a clinical trial from the databases of specialists in Parkinson's disease.

BACKGROUND: Many clinical trials involving elderly people living at home suffer from low recruitment. We report our experience of recruiting people with Parkinson's disease (PD) from specialist clinical databases, to a randomised controlled trial of personalized exercise. METHODS: We aimed to recruit 200 repeat fallers with PD. Subjects were recruited through the clinical registers of specialists in PD in two NHS trusts. They had to have a confirmed diagnosis of PD, be independently mobile, live in the community, be a repeat faller, and were screened for cognitive impairment. RESULTS: Out of 1107 patients on the registers, 457 did not meet the eligibility criteria for the trial. A further 151 were excluded for other reasons. Four hundred and ninety-nine were approached to have a home screening visit: 405 replied and 305 agreed to be screened for the trial. Of those screened, 126 were non-repeat fallers and 22 failed other eligibility criteria. Out of the remaining 157 patients, 18 (11%) decided not to participate in the trial which left 139 recruited to the trial. Seven more were recruited from a second screen of previous non-repeat fallers. In total 146 patients were recruited: 142 to the main trial and four to the initial pilot phase. CONCLUSION: The percentage of patients who participated in the main trial was only 13% (95% confidence interval 11% to 15%) of those on specialists' registers, considerably less than estimated, although the proportion of fallers and repeat fallers was similar to that previously reported.

The importance of building trust and tailoring interactions when meeting older adults' health literacy needs.

PURPOSE: Health literacy is the ability to access, understand and use health information. This study qualitatively explored the views and experiences of older adults with varying health literacy levels who had attended a falls clinic on their overall experience of the falls clinic, access to the service and provider-patient interaction. METHODS: Individual semi-structured interviews were conducted with nine older adults using a falls clinic in England. Health literacy was assessed using the REALM and NVS-UK. Interviews were audio-recorded, transcribed verbatim and interrogated using interpretative phenomenological analysis (IPA). RESULTS: Two superordinate themes emerged from the analysis: The importance of trust and relationship building to achieve effective communication with older adults; and the importance of tailoring education and healthcare to older adults' individual health literacy needs and preferences. CONCLUSIONS: The findings corroborate previous research emphasising the importance of face-to-face communication in responding to older adults' individual health literacy needs. Building trust in the relationship and tailoring communication to older adults' individual attributes and preferred learning styles is essential. Healthcare practitioners and managers should consider how service organisation and communication methods can enhance positive and effective relationships with patients. Improved training could support healthcare providers in meeting patients' personal communication needs. Implications for Rehabilitation Rehabilitation professionals should be aware of their patients' individual health literacy needs and communication/learning preferences. It is important to build relationships and trust with older adults attending rehabilitation services. Further training for rehabilitation professionals could support them in meeting patients' personal communication needs.

Duration of intravenous antibiotic therapy for children with acute osteomyelitis or septic arthritis: a feasibility study.

BACKGROUND: There is little current consensus regarding the route or duration of antibiotic treatment for acute osteomyelitis (OM) and septic arthritis (SA) in children. OBJECTIVE: To assess the overall feasibility and inform the design of a future randomised controlled trial (RCT) to reduce the duration of intravenous (i.v.) antibiotic use in paediatric OM and SA. DESIGN: (1) A prospective service evaluation (cohort study) to determine the current disease spectrum and UK clinical practice in paediatric OM/SA; (2) a prospective cohort substudy to assess the use of targeted polymerase chain reaction (PCR) in diagnosing paediatric OM/SA; (3) a qualitative study to explore families' views and experiences of OM/SA; and (4) the development of a core outcome set via a systematic review of literature, Delphi clinician survey and stakeholder consensus meeting. SETTING: Forty-four UK secondary and tertiary UK centres (service evaluation). PARTICIPANTS: Children with OM/SA. INTERVENTIONS: PCR diagnostics were compared with culture as standard of care. Semistructured interviews were used in the qualitative study. RESULTS: Data were obtained on 313 cases of OM/SA, of which 218 (61.2%) were defined as simple disease and 95 (26.7%) were defined as complex disease. The epidemiology of paediatric OM/SA in this study was consistent with existing European data. Children who met oral switch criteria less than 7 days from starting i.v. antibiotics were less likely to experience treatment failure (9.6%) than children who met oral switch criteria after 7 days of i.v. therapy (16.1% when switch was between 1 and 2 weeks; 18.2% when switch was > 2 weeks). In 24 out of 32 simple cases (75%) and 8 out of 12 complex cases (67%) in which the targeted PCR was used, a pathogen was detected. The qualitative study demonstrated the importance to parents and children of consideration of short- and long-term outcomes meaningful to families themselves. The consensus meeting agreed on the following outcomes: rehospitalisation or recurrence of symptoms while on oral antibiotics, recurrence of infection, disability at follow-up, symptom free at 1 year, limb shortening or deformity, chronic OM or arthritis, amputation or fasciotomy, death, need for paediatric intensive care, and line infection. Oral switch criteria were identified, including resolution of fever for ≥ 48 hours, tolerating oral food and medicines, and pain improvement. LIMITATIONS: Data were collected in a 6-month period, which might not have been representative, and follow-up data for long-term complications are limited. CONCLUSIONS: A future RCT would need to recruit from all tertiary and most secondary UK hospitals. Clinicians have implemented early oral switch for selected patients with simple disease without formal clinical trial evidence of safety. However, the current criteria by which decisions to make the oral switch are made are not clearly established or evidence based. FUTURE WORK: A RCT in simple OM and SA comparing shorter- or longer-course i.v. therapy is feasible in children randomised after oral switch criteria are met after 7 days of i.v. therapy, excluding children meeting oral switch criteria in the first week of i.v. therapy. This study design meets clinician preferences and addresses parental concerns not to randomise prior to oral switch criteria being met. FUNDING: The National Institute for Health Research Health Technology Assessment programme.