Cost-effectiveness of the PDSAFE personalised physiotherapy intervention for fall prevention in Parkinson's: an economic evaluation alongside a randomised controlled trial.

BACKGROUND: PDSAFE is an individually-tailored, physiotherapist-delivered, balance, strength and strategy training programme aimed at preventing falls among people with Parkinson's. We evaluated the cost-effectiveness of PDSAFE compared with usual care for people with Parkinson's at higher risk of falling, from a UK National Health Service and Personal Social Service perspective. METHODS: Resource use and quality of life data (EQ-5D-3L) were collected from 238 participants randomised to the PDSAFE intervention and 236 participants randomised to control, at baseline, 3 months, 6 months (primary outcome), and 12 months. Adjusted cost and quality-adjusted life-years (QALYs) were estimated using generalised linear models and uncertainty estimated using a non-parametric bootstrap. RESULTS: Over 6 months, the PDSAFE intervention was associated with an incremental cost of £925 (95% CI £428 to £1422) and a very small and statistically insignificant QALY gain of 0.008 (95% CI - 0.006 to 0.021). The resulting incremental cost-effectiveness ratio (ICER) was £120,659 per QALY and the probability of the intervention being cost-effective at a UK threshold of £30,000/QALY was less than 1%. The ICER varied substantially across subgroups although no subgroup had an ICER lower than the £30,000 threshold. The result was sensitive to the time horizon with the ICER reducing to £55,176 per QALY when adopting a 12-month time horizon and assuming a sustained treatment effect on QoL, nevertheless, the intervention was still not cost-effective according to the current UK threshold. CONCLUSIONS: Evidence from this trial suggests that the PDSAFE intervention is unlikely to be cost-effective at 6 months. The 12-month analysis suggested that the intervention became closer to being cost-effective if quality of life effects were sustained beyond the intervention period, however this would require confirmation. Further research, including qualitative studies, should be conducted to better understand the treatment effect of physiotherapy and its impact on quality of life in people with Parkinson's given existing mixed evidence on this topic. TRIAL REGISTRATION: ISRCTN48152791. Registered 17 April 2014. http://www.isrctn.com/ISRCTN48152791.

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.

Impact of stroke-associated infection on long-term survival: a cohort study.

BACKGROUND AND OBJECTIVE: The effects of stroke-associated infection (SAI) on long-term survival are unclear. We performed a prospective evaluation to explore risk factors of SAI, and compared survival status over the 3 years following stroke onset between those who experienced SAI and those who did not. METHODS: Consecutive patients with acute stroke admitted to a stroke unit between April 2005 and December 2006 were invited to participate. We prospectively collected data on demographics, pathological and clinical stroke subtype, stroke severity, and neurological and functional consequences, and abstracted additional data on occurrence and timing of SAI in hospital from medical notes. Survival status 3 years after stroke onset was obtained. RESULTS: We recruited 413 acute stroke patients, 161 (39%) experienced SAI. After excluding patients with infection at onset, patients with intracerebral haemorrhage (p=0.014), dysphagia (p=0.003) and urinary incontinence/catheterisation (p=0.000) were at higher risk of infection after controlling for case mix. The risk of death in hospital was greater following an SAI (HR 3.56; 95% CI 1.94 to 6.53; p=0.000), as was risk of death calculated over the whole 3-year follow-up period among those acquiring SAI within 2 weeks of onset (HR 1.66; 95% CI 1.14 to 2.40; p=0.031). CONCLUSIONS: SAIs have long-lasting effects on patient survival. This serves to emphasise the importance of immediate access to organised stroke unit care for people with acute stroke, with active physiological monitoring and protocols for early detection and treatment of SAIs.

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.

"Staying safe" - a narrative review of falls prevention in people with Parkinson's - "PDSAFE".

Background: Parkinson's disease demonstrates a spectrum of motor and non-motor symptoms. Falling is common and disabling. Current medical management shows minimal impact to reduce falls or fall-related risk factors, such as deficits in gait, strength, and postural instability. Despite evidence supporting rehabilitation in reducing fall risk factors, the most appropriate intervention to reduce overall fall rate remains inconclusive. This article aims to 1) synthesise current evidence and conceptual models of falls rehabilitation in Parkinson's in a narrative review; and based on this evidence, 2) introduce the treatment protocol used in the falls prevention and multi-centre clinical trial "PDSAFE". Method: Search of four bibliographic databases using the terms "Parkinson*" and "Fall*" combined with each of the following; "Rehab*, Balanc*, Strength*, Strateg*and Exercis*" and a framework for narrative review was followed. A total of 3557 papers were identified, 416 were selected for review. The majority report the impact of rehabilitation on isolated fall risk factors. Twelve directly measure the impact on overall fall rate. Discussion: Results were used to construct a narrative review with conceptual discussion based on the "International Classification of Functioning", leading to presentation of the "PDSAFE" intervention protocol. Conclusions: Evidence suggests training single, fall risk factors may not affect overall fall rate. Combining with behavioural and strategy training in a functional, personalised multi-dimensional model, addressing all components of the "International Classification of Functioning" is likely to provide a greater influence on falls reduction. "PDSAFE" is a multi-dimensional, physiotherapist delivered, individually tailored, progressive, home-based programme. It is designed with a strong evidence-based approach and illustrates a model for the clinical delivery of the conceptual theory discussed. Implications for Rehabilitation Parkinson's disease demonstrates a spectrum of motor and non-motor symptoms, where falling is common and disabling. Current medical and surgical management have minimal impact on falls, rehabilitation of falls risk factors has strong evidence but the most appropriate intervention to reduce overall fall rate remains inconclusive. Addressing all components of the International Classification of Function in a multifactorial model when designing falls rehabilitation interventions may be more effective at reducing fall rates in people with Parkinson's than treating isolated risk factors. The clinical model for falls rehabilitation in people with Parkinson's should be multi-dimensional.

It takes two: the influence of dance partners on the perceived enjoyment and benefits during participation in partnered ballroom dance classes for people with Parkinson's.

PURPOSE: To explore the views of people with Parkinson's and their dance partners on the influence and issues surrounding dancing with an able-bodied dance partner during partnered ball room dance classes. METHODS: In depth, semi-structured interviews explored purposively selected participants' experiences and views about dance classes. Fourteen people with Parkinson's and their dance partners (six spouses, two friends/relatives, five volunteers) were interviewed within a month of completing the 10-week dance class program. Data were analyzed thematically. RESULTS: Generally, those partnered with a spouse or an experienced dancer, or when dance couples were able to develop good rapport, gained greater enjoyment and sense of achievement from dance classes in comparison to couples who did not enjoy dancing together or had clashing approaches to dance. Managing and negotiating who would "lead" in a dance was challenging for dance couples particularly among male people with Parkinson's. CONCLUSIONS: People with Parkinson's experience of the dance classes were influenced by the relationship and compatibility with their dance partner. Dance partnerships may impact on recruitment, enjoyment, outcome and continued participation in dance classes. Potential effects of partnerships should be analyzed and reported in studies evaluating the outcomes of dance classes. Implications for rehabilitation We recommend that health professionals consider involving spouses in Parkinson's dance classes as this may improve recruitment, adherence, enjoyment and overall outcome of the dance classes. If volunteers are needed, aim to recruit those who already have good dancing ability, convey a love of dancing and have the sensitivity and social skills to interact positively with the person with Parkinson's. Consider dance partnership issues when advertising and promoting dance classes. Address partnership issues through open communication and by changing partners if the dance partnership is not working well.

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.

Physical inactivity post-stroke: a 3-year longitudinal study.

PURPOSE: To explore change in activity levels post-stroke. METHODS: We measured activity levels using the activPAL™ in hospital and at 1, 2 and 3 years' post-stroke onset. RESULTS: Of the 74 participants (mean age 76 (SD 11), 39 men), 61 were assessed in hospital: 94% of time was spent in sitting/lying, 4% standing and 2% walking. Activity levels improved over time (complete cases n = 15); time spent sitting/lying decreased (p = 0.001); time spent standing, walking and number of steps increased (p = 0.001, p = 0.028 and p = 0.03, respectively). At year 3, 18% of time was spent in standing and 9% walking. Time spent upright correlated significantly with Barthel (r = 0.69 on admission, r = 0.68 on discharge, both p < 0.01) and functional ambulation category scores (r = 0.55 on admission, 0.63 on discharge, both p < 0.05); correlations remained significant at all assessment points. Depression (in hospital), left hemisphere infarction (Years 1-2), visual neglect (Year 2), poor mobility and balance (Years 1-3) correlated with poorer activity levels. CONCLUSION: People with stroke were inactive for the majority of time. Time spent upright improved significantly by 1 year post-stroke; improvements slowed down thereafter. Poor activity levels correlated with physical and psychological measures. Larger studies are indicated to identify predictors of activity levels. Implications for Rehabilitation Activity levels (measured using activPAL™ activity monitor), increased significantly by 1 year post-stroke but improvements slowed down at 2 and 3 years. People with stroke were inactive for the majority of their day in hospital and in the community. Poor activity levels correlated with physical and psychological measures. Larger studies are indicated to identify the most important predictors of activity levels.

A design to investigate the feasibility and effects of partnered ballroom dancing on people with Parkinson disease: randomized controlled trial protocol.

BACKGROUND: Self-help and physical leisure activities has become increasingly important in the maintenance of safe and functional mobility among an increasingly elderly population. Preventing the cycle of deterioration, falling, inactivity, dependency, and secondary complications in people with Parkinson disease (PD) is a priority. Research has shown that people with PD are interested in dance and although the few existing trials are small, initial proof of principle trials from the United States have demonstrated beneficial effects on balance control, gait, and activity levels. To our knowledge, there has been no research into long-term effects, cost effectiveness, the influence on spinal posture and turning, or the personal insights of dance participants. OBJECTIVE: The purpose of this study was to determine the methodological feasibility of conducting a definitive phase III trial to evaluate the benefits of dance in people with PD. We will build on the proof of principle trials by addressing gaps in knowledge, focusing on areas of greatest methodological uncertainty; the choice of dances and intensity of the program; for the main trial, the availability of partners, the suitability of the currently envisaged primary outcomes, balance and spinal posture; and the key costs of delivering and participating in a dance program to inform economic evaluation. METHODS: Fifty participants (mild-to-moderate condition) will be randomized to the control (usual care) or experimental (dance plus usual care) groups at a ratio of 15:35. Dance will be taught by professional teachers in a dance center in the South of England. Each participant in the experimental group will dance with his or her spouse, a friend, or a partner from a bank of volunteers. A blinded assessor will complete clinical measures and self-reported ability at baseline, and at 3 and 6 months after randomization. A qualitative study of a subgroup of participants and partners will examine user's views about the appropriateness and acceptability of the intervention, assessment protocol, and general trial procedures. Procedures for an economic evaluation of dance for health care will be developed for the main trial. RESULTS: Recruitment began in January 2013 and the last participant is expected to complete the trial follow-up in June 2014. CONCLUSIONS: Findings from our study may provide novel insights into the way people with PD become involved in dance, their views and opinions, and the suitability of our primary and secondary outcomes. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 63088686; http://www.controlled-trials.com/ISRCTN63088686/63088686 (Archived by WebCite at http://www.webcitation.org/6QYyjehP7).

Self reported adherence to a home-based exercise programme among people with Parkinson's disease.

BACKGROUND: There is an extensive literature addressing compliance with medication, techniques to measure, and ways to improve it. In comparison the literature concerning adherence to exercise programmes agreed with a physiotherapist is limited. OBJECTIVE: We estimate the percentage of exercise repetitions completed of those agreed with a physiotherapist in the context of a six week personalized exercise programme to reduce falling in people with Parkinson's disease, and examine patient characteristics that predict adherence. METHODS: Secondary analysis of data collected during a randomized controlled trial. Participants allocated to receive the exercise programme self-reported the number of repetitions of prescribed strengthening, range of movement and balance exercises they had completed in daily dairies. Indoor or outdoor walking was also prescribed but in terms of target distances or lengths of time, and was not included in our analysis. RESULTS: On average the 70 participants allocated to the exercise programme reported completing 79% (95% confidence interval 73%-86%) of the prescribed number of repetitions of their exercises. The percentage of exercises completed varied depending on the specific exercise prescribed, and on participant characteristics: those who were older, in poorer health and with anxiety, depression, or mental heath problems reported lower adherence to exercise. CONCLUSION: Several of the factors we found to reduce adherence to exercise have been shown by others to reduce compliance with antiparkinsonian medication, but we found adherence decreased with age in contrast to the pattern of better compliance with medication amongst older people with Parkinson's disease reported previously.

In-hospital recruitment to observational studies of stroke.

The objective of this study was to examine recruitment in three observational follow-up studies of patients with stroke, focusing on reasons for nonparticipation and the role of potential factors in explaining recruitment rates. It comprised secondary analysis of the three studies. Recruitment rates varied between the studies. Between 10 and 50% of those screened participated. In one study with no eligibility criteria other than informed consent being obtained and a confirmed diagnosis of stroke, we recruited only 50% (95% confidence interval 47 to 54%) of those screened. Recruitment is particularly difficult when restricted to a time window around discharge from hospital. We recommend that potential participants should be approached for consent as soon as possible, so that data tracking their hospital stay can be retained. Even where effectively no eligibility criteria are used, recruitment is limited by the necessity to gain informed consent, particularly amongst patients with severe disease.