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.

Interventions for preventing falls in people after stroke.

BACKGROUND: Falls are one of the most common complications after stroke, with a reported incidence ranging between 7% in the first week and 73% in the first year post stroke. This is an updated version of the original Cochrane Review published in 2013. OBJECTIVES: To evaluate the effectiveness of interventions aimed at preventing falls in people after stroke. Our primary objective was to determine the effect of interventions on the rate of falls (number of falls per person-year) and the number of fallers. Our secondary objectives were to determine the effects of interventions aimed at preventing falls on 1) the number of fall-related fractures; 2) the number of fall-related hospital admissions; 3) near-fall events; 4) economic evaluation; 5) quality of life; and 6) adverse effects of the interventions. SEARCH METHODS: We searched the trials registers of the Cochrane Stroke Group (September 2018) and the Cochrane Bone, Joint and Muscle Trauma Group (October 2018); the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 9) in the Cochrane Library; MEDLINE (1950 to September 2018); Embase (1980 to September 2018); CINAHL (1982 to September 2018); PsycINFO (1806 to August 2018); AMED (1985 to December 2017); and PEDro (September 2018). We also searched trials registers and checked reference lists. SELECTION CRITERIA: Randomised controlled trials of interventions where the primary or secondary aim was to prevent falls in people after stroke. DATA COLLECTION AND ANALYSIS: Two review authors (SD and WS) independently selected studies for inclusion, assessed trial quality and risk of bias, and extracted data. We resolved disagreements through discussion, and contacted study authors for additional information where required. We used a rate ratio and 95% confidence interval (CI) to compare the rate of falls (e.g. falls per person-year) between intervention and control groups. For risk of falling we used a risk ratio and 95% CI based on the number of people falling (fallers) in each group. We pooled results where appropriate and applied GRADE to assess the quality of the evidence. MAIN RESULTS: We included 14 studies (of which six have been published since the first version of this review in 2013), with a total of 1358 participants. We found studies that investigated exercises, predischarge home visits for hospitalised patients, the provision of single lens distance vision glasses instead of multifocal glasses, a servo-assistive rollator and non-invasive brain stimulation for preventing falls.Exercise compared to control for preventing falls in people after strokeThe pooled result of eight studies showed that exercise may reduce the rate of falls but we are uncertain about this result (rate ratio 0.72, 95% CI 0.54 to 0.94, 765 participants, low-quality evidence). Sensitivity analysis for single exercise interventions, omitting studies using multiple/multifactorial interventions, also found that exercise may reduce the rate of falls (rate ratio 0.66, 95% CI 0.50 to 0.87, 626 participants). Sensitivity analysis for the effect in the chronic phase post stroke resulted in little or no difference in rate of falls (rate ratio 0.58, 95% CI 0.31 to 1.12, 205 participants). A sensitivity analysis including only studies with low risk of bias found little or no difference in rate of falls (rate ratio 0.88, 95% CI 0.65 to 1.20, 462 participants). Methodological limitations mean that we have very low confidence in the results of these sensitivity analyses.For the outcome of number of fallers, we are very uncertain of the effect of exercises compared to the control condition, based on the pooled result of 10 studies (risk ratio 1.03, 95% CI 0.90 to 1.19, 969 participants, very low quality evidence). The same sensitivity analyses as described above gives us very low certainty that there are little or no differences in number of fallers (single interventions: risk ratio 1.09, 95% CI 0.93 to 1.28, 796 participants; chronic phase post stroke: risk ratio 0.94, 95% CI 0.73 to 1.22, 375 participants; low risk of bias studies: risk ratio 0.96, 95% CI 0.77 to 1.21, 462 participants).Other interventions for preventing falls in people after strokeWe are very uncertain whether interventions other than exercise reduce the rate of falls or number of fallers. We identified very low certainty evidence when investigating the effect of predischarge home visits (rate ratio 0.85, 95% CI 0.43 to 1.69; risk ratio 1.48, 95% CI 0.71 to 3.09; 85 participants), provision of single lens distance glasses to regular wearers of multifocal glasses (rate ratio 1.08, 95% CI 0.52 to 2.25; risk ratio 0.74, 95% CI 0.47 to 1.18; 46 participants) and a servo-assistive rollator (rate ratio 0.44, 95% CI 0.16 to 1.21; risk ratio 0.44, 95% CI 0.16 to 1.22; 42 participants).Finally, transcranial direct current stimulation (tDCS) was used in one study to examine the effect on falls post stroke. We have low certainty that active tDCS may reduce the number of fallers compared to sham tDCS (risk ratio 0.30, 95% CI 0.14 to 0.63; 60 participants). AUTHORS' CONCLUSIONS: At present there exists very little evidence about interventions other than exercises to reduce falling post stroke. Low to very low quality evidence exists that this population benefits from exercises to prevent falls, but not to reduce number of fallers.Fall research does not in general or consistently follow methodological gold standards, especially with regard to fall definition and time post stroke. More well-reported, adequately-powered research should further establish the value of exercises in reducing falling, in particular per phase, post stroke.

Sleep in infants and toddlers with Down syndrome compared to typically developing peers: looking beyond snoring.

AIMS: To compare sleep in infants and toddlers with Down syndrome (DS) to typically developing controls, including differences in snoring and sleep ecology (sleep setting and parent behaviors). METHODS: Parents of 104 children with DS and 489 controls aged 6-36 months completed the Brief Infant Sleep Questionnaire (BISQ). We explored group differences, controlling for demographic variables. RESULTS: Parents of children with DS reported more sleep problems (45% v 19%), snoring (19% vs 2%), room-sharing (37% vs 17%), as well as less night-time sleep (55 mins) and total sleep over 24 h (38 mins). They were more likely to be present when their child fell asleep (OR 4.40). Snoring increased night waking but did not limit night-time/24-hour sleep. However, parental presence was associated with 55 min less night-time and 64 min less 24-hour sleep. After controlling for snoring and parental presence, children with DS slept less at night (38 mins) but more during the day (21 mins) with no significant difference in 24-hour sleep. CONCLUSIONS: Overall, significant differences in sleep patterns, problems, and ecology were found between children with DS and controls. Parental presence at settling, not snoring, explained most differences, including over an hour's less 24-hour sleep. Early intervention programmes that promote self-soothing skills could prevent the burden of sleep loss in young children with DS.

Hospital nurse staffing and staff-patient interactions: an observational study.

BACKGROUND: Existing evidence indicates that reducing nurse staffing and/or skill mix adversely affects care quality. Nursing shortages may lead managers to dilute nursing team skill mix, substituting assistant personnel for registered nurses (RNs). However, no previous studies have described the relationship between nurse staffing and staff-patient interactions. SETTING: Six wards at two English National Health Service hospitals. METHODS: We observed 238 hours of care (n=270 patients). Staff-patient interactions were rated using the Quality of Interactions Schedule. RN, healthcare assistant (HCA) and patient numbers were used to calculate patient-to-staff ratios. Multilevel regression models explored the association between staffing levels, skill mix and the chance of an interaction being rated as 'negative' quality, rate at which patients experienced interactions and total amount of time patients spent interacting with staff per observed hour. RESULTS: 10% of the 3076 observed interactions were rated as negative. The odds of a negative interaction increased significantly as the number of patients per RN increased (p=0.035, OR of 2.82 for ≥8 patients/RN compared with >6 to <8 patients/RN). A similar pattern was observed for HCA staffing but the relationship was not significant (p=0.056). When RN staffing was low, the odds of a negative interaction increased with higher HCA staffing. Rate of interactions per patient hour, but not total amount of interaction time, was related to RN and HCA staffing levels. CONCLUSION: Low RN staffing levels are associated with changes in quality and quantity of staff-patient interactions. When RN staffing is low, increases in assistant staff levels are not associated with improved quality of staff-patient interactions. Beneficial effects from adding assistant staff are likely to be dependent on having sufficient RNs to supervise, limiting the scope for substitution.

Cardiorespiratory sleep studies at home: experience in research and clinical cohorts.

OBJECTIVE: To evaluate the success rates of home cardiorespiratory polygraphy in children under investigation for sleep-disordered breathing and parent perspectives on equipment use at home. DESIGN: Prospective observational study. SETTING: Sheffield, Evelina London and Southampton Children's Hospitals. PATIENTS: Data are reported for 194 research participants with Down syndrome, aged 0.5-5.9 years across the three centres and 61 clinical patients aged 0.4-19.5 years from one centre, all of whom had home cardiorespiratory polygraphy including respiratory movements, nasal pressure flow, pulse oximetry, body position and motion. MAIN OUTCOME MEASURES: Percentage of home cardiorespiratory studies successfully acquiring ≥4 hours of artefact-free data at the first attempt. Parental report of ease of use of equipment and preparedness to repeat home diagnostics in the future. RESULTS: 143/194 (74%; 95% CI 67% to 79%) of research participants and 50/61 (82%; 95% CI 71% to 90%) of clinical patients had successful home cardiorespiratory polygraphy at the first attempt. Some children required multiple attempts to achieve a successful study. Overall, this equated to 1.3 studies per research participant and 1.2 studies per clinical child. The median artefact-free sleep time for successful research studies was 515 min (range 261-673) and for clinical studies 442 min (range 291-583). 84% of research and 87% of clinical parents expressed willingness to repeat home cardiorespiratory polygraphy in the future. 67% of research parents found the equipment 'easy or okay' to use, while 64% of clinical parents reported it as 'easy' or 'very easy'. CONCLUSIONS: Home cardiorespiratory polygraphy offers an acceptable approach to the assessment of sleep-disordered breathing in children.

Home oximetry to screen for obstructive sleep apnoea in Down syndrome.

OBJECTIVE: Children with Down syndrome are at high risk of obstructive sleep apnoea (OSA) and screening is recommended. Diagnosis of OSA should be confirmed with multichannel sleep studies. We aimed to determine whether home pulse oximetry (HPO) discriminates children at high risk of OSA, who need further diagnostic multichannel sleep studies. DESIGN: Cross-sectional prospective study in a training sample recruited through three UK centres. Validation sample used single-centre retrospective analysis of clinical data. PATIENTS: Children with Down syndrome aged 0.5-6 years. INTERVENTION: Diagnostic multichannel sleep study and HPO. MAIN OUTCOME MEASURES: Sensitivity and specificity of HPO to predict moderate-to-severe OSA. RESULTS: 161/202 children with Down syndrome met quality criteria for inclusion and 25 had OSA. In this training sample, the best HPO parameter predictors of OSA were the delta 12 s index >0.555 (sensitivity 92%, specificity 65%) and 3% oxyhaemoglobin (SpO2) desaturation index (3% ODI)>6.15 dips/hour (sensitivity 92%, specificity 63%). Combining variables (delta 12 s index, 3% ODI, mean and minimum SpO2) achieved sensitivity of 96% but reduced specificity to 52%. All predictors retained or improved sensitivity in a clinical validation sample of 50 children with variable loss of specificity, best overall was the delta 12 s index, a measure of baseline SpO2 variability (sensitivity 92%; specificity 63%). CONCLUSIONS: HPO screening could halve the number of children with Down syndrome needing multichannel sleep studies and reduce the burden on children, families and health services alike. This approach offers a practical universal screening approach for OSA in Down syndrome that is accessible to the non-specialist paediatrician.

Compassionate care intervention for hospital nursing teams caring for older people: a pilot cluster randomised controlled trial.

OBJECTIVE: Compassionate care continues to be a focus for national and international attention, but the existing evidence base lacks the experimental methodology necessary to guide the selection of effective interventions for practice. This study aimed to evaluate the Creating Learning Environments for Compassionate Care (CLECC) intervention in improving compassionate care. SETTING: Ward nursing teams (clusters) in two English National Health Service hospitals randomised to intervention (n=4) or control (n=2). Intervention wards comprised two medicines for older people (MOPs) wards and two medical/surgical wards. Control wards were both MOPs. PARTICIPANTS: Data collected from 627 patients and 178 staff. EXCLUSION CRITERIA: reverse barrier nursed, critically ill, palliative or non-English speaking. All other patients and all nursing staff and Health Care Assistant HCAs were invited to participant, agency and bank staff were excluded. INTERVENTION: CLECC, a workplace intervention focused on developing sustainable leadership and work-team practices to support the delivery of compassionate care. CONTROL: No educational activity. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary-Quality of Interaction Schedule (QuIS) for observed staff-patient interactions. Secondary-patient-reported evaluations of emotional care in hospital (PEECH); nurse-reported empathy (Jefferson Scale of Empathy). RESULTS: Trial proceeded as per protocol, randomisation was acceptable. Some but not all blinding strategies were successful. QuIS observations achieved 93% recruitment rate with 25% of patient sample cognitively impaired. At follow-up there were more total positive (78% vs 74%) and less total negative (8% vs 11%) QuIS ratings for intervention wards versus control wards. Sixty-three per cent of intervention ward patients scored lowest (ie, more negative) scores on PEECH connection subscale, versus 79% of control. This was not a statistically significant difference. No statistically significant differences in nursing empathy were observed. CONCLUSIONS: Use of experimental methods is feasible. The use of structured observation of staff-patient interaction quality is a promising outcome measure inclusive of hard to reach groups. TRIAL REGISTRATION NUMBER: ISRCTN16789770.

A comparison of different ways of including baseline counts in negative binomial models for data from falls prevention trials.

A common design for a falls prevention trial is to assess falling at baseline, randomize participants into an intervention or control group, and ask them to record the number of falls they experience during a follow-up period of time. This paper addresses how best to include the baseline count in the analysis of the follow-up count of falls in negative binomial (NB) regression. We examine the performance of various approaches in simulated datasets where both counts are generated from a mixed Poisson distribution with shared random subject effect. Including the baseline count after log-transformation as a regressor in NB regression (NB-logged) or as an offset (NB-offset) resulted in greater power than including the untransformed baseline count (NB-unlogged). Cook and Wei's conditional negative binomial (CNB) model replicates the underlying process generating the data. In our motivating dataset, a statistically significant intervention effect resulted from the NB-logged, NB-offset, and CNB models, but not from NB-unlogged, and large, outlying baseline counts were overly influential in NB-unlogged but not in NB-logged. We conclude that there is little to lose by including the log-transformed baseline count in standard NB regression compared to CNB for moderate to larger sized datasets.

Reliability, feasibility, and validity of the quality of interactions schedule (QuIS) in acute hospital care: an observational study.

BACKGROUND: Research into relational care in hospitals will be facilitated by a focus on staff-patient interactions. The Quality of Interactions Schedule (QuIS) uses independent observers to measure the number of staff-patient interactions within a healthcare context, and to rate these interactions as 'positive social'; 'positive care'; 'neutral'; 'negative protective'; or 'negative restrictive'. QuIS was developed as a research instrument in long term care settings and has since been used for quality improvement in acute care. Prior to this study, its use had not been standardised, and reliability and validity in acute care had not been established. METHODS: In 2014 and 2015 a three - phase study was undertaken to develop and test protocols for the use of QuIS across three acute wards within one NHS trust in England. The phases were: (1) A pilot of 16 h observation which developed implementation strategies for QuIS in this context; (2) training two observers and undertaking 16 h of paired observation to inform the development of training protocols; (3) training four nurses and two lay volunteers according to a finalised protocol followed by 36 h of paired observations to test inter-rater agreement. Additionally, patients were asked to rate interactions and to complete a shortened version of the Patient Evaluation of Emotional Care during Hospitalisation (PEECH) questionnaire. RESULTS: Protocols were developed for the use of QuIS in acute care. Patients experienced an average of 6.7 interactions/patient/h (n = 447 interactions). There was close agreement between observers in relation to the number of interactions observed (Intraclass correlation coefficient (ICC) = 0.97) and moderate to substantial agreement on the quality of interactions (absolute agreement 73%, kappa 0.53 to 0.62 depending on weighting scheme). There was 79% agreement (weighted kappa 0.40: P < 0.001; indicating fair agreement) between patients and observers over whether interactions were positive, negative or neutral. CONCLUSIONS: Observers using clear QuIS protocols can achieve levels of agreement that are acceptable for the use of QuIS as a research instrument. There is fair agreement between observers and patients' rating of interactions. Further research is needed to explore the relationship between QuIS measures and reported patient experience.

Prevalence and predictors of obstructive sleep apnoea in young children with Down syndrome.

BACKGROUND: Children with Down syndrome (DS) are vulnerable to obstructive sleep apnoea (OSA) because of their unique craniofacial anatomy and hypotonia. Understanding the predictors of OSA in DS may enable targeted screening. METHODS: Children with DS (n = 202) aged from six months to below six years (110 boys) were recruited from three UK children's hospitals. The clinical assessment included height, weight and tonsillar size. The parents either set up cardiorespiratory polygraphy at home or chose laboratory studies. Studies with less than four hours of interpretable data were repeated where possible. American Academy of Sleep Medicine (AASM) 2012 scoring criteria were used to derive an obstructive apnoea/hypopnoea index (OAHI). Predictors of moderate to severe OSA were examined. RESULTS: In total, 188/202 (93%) participants were successfully studied. Of these, 169 studies were completed at home and 19 in a sleep laboratory. Moderate to severe OSA, defined by an OAHI of >5/h, was found in 14% and mild to moderate OSA (1/h≥OAHI <5/h) was found in 59% of the children. Male gender and habitual snoring predicted OSA but did not have independent predictive power in the presence of the other factors. Age in months, body mass index (BMI) centile and tonsillar size did not predict OSA. CONCLUSIONS: Moderate to severe OSA is common in very young children with DS. Examination of tonsillar size did not predict OSA severity. Population-based screening for OSA is recommended in these children, and domiciliary cardiorespiratory polygraphy is an acceptable screening approach. Further research is required to understand the natural history, associated morbidity, optimal screening methodology and treatment modality for OSA in these children.

Inter-rater reliability of the QuIS as an assessment of the quality of staff-inpatient interactions.

BACKGROUND: Recent studies of the quality of in-hospital care have used the Quality of Interaction Schedule (QuIS) to rate interactions observed between staff and inpatients in a variety of ward conditions. The QuIS was developed and evaluated in nursing and residential care. We set out to develop methodology for summarising information from inter-rater reliability studies of the QuIS in the acute hospital setting. METHODS: Staff-inpatient interactions were rated by trained staff observing care delivered during two-hour observation periods. Anticipating the possibility of the quality of care varying depending on ward conditions, we selected wards and times of day to reflect the variety of daytime care delivered to patients. We estimated inter-rater reliability using weighted kappa, κ w , combined over observation periods to produce an overall, summary estimate, [Formula: see text]. Weighting schemes putting different emphasis on the severity of misclassification between QuIS categories were compared, as were different methods of combining observation period specific estimates. RESULTS: Estimated [Formula: see text] did not vary greatly depending on the weighting scheme employed, but we found simple averaging of estimates across observation periods to produce a higher value of inter-rater reliability due to over-weighting observation periods with fewest interactions. CONCLUSIONS: We recommend that researchers evaluating the inter-rater reliability of the QuIS by observing staff-inpatient interactions during observation periods representing the variety of ward conditions in which care takes place, should summarise inter-rater reliability by κ w , weighted according to our scheme A4. Observation period specific estimates should be combined into an overall, single summary statistic [Formula: see text], using a random effects approach, with [Formula: see text], to be interpreted as the mean of the distribution of κ w across the variety of ward conditions. We draw attention to issues in the analysis and interpretation of inter-rater reliability studies incorporating distinct phases of data collection that may generalise more widely.

Effect of active Aß immunotherapy on neurons in human Alzheimer's disease.

Amyloid ß peptide (Aß) immunization of Alzheimer's disease (AD) patients has been reported to induce amyloid plaque removal, but with little impact on cognitive decline. We have explored the consequences of Aß immunotherapy on neurons in post mortem brain tissue. Eleven immunized (AN1792, Elan Pharmaceuticals) AD patients were compared to 28 non-immunized AD cases. Immunohistochemistry on sections of neocortex was performed for neuron-specific nuclear antigen (NeuN), neurofilament protein (NFP) and phosphorylated-(p)PKR (pro-apoptotic kinase detected in degenerating neurons). Quantification was performed for pPKR and status spongiosis (neuropil degeneration), NeuN-positive neurons/field, curvature of the neuronal processes and interneuronal distance. Data were corrected for age, gender, duration of dementia and APOE genotype and also assessed in relation to Aß42 and tau pathology and key features of AD. In non-immunized patients, the degree of neuritic curvature correlated with spongiosis and pPKR, and overall the neurodegenerative markers correlated better with tau pathology than Aß42 load. Following immunization, spongiosis increased, interneuronal distance increased, while the number of NeuN-positive neurons decreased, consistent with enhanced neuronal loss. However, neuritic curvature was reduced and pPKR was associated with Aß removal in immunized patients. In AD, associations of spongiosis status, curvature ratio and pPKR load with microglial markers Iba1, CD68 and CD32 suggest a role for microglia in neurodegeneration. After immunization, correlations were detected between the number of NeuN-positive neurons and pPKR with Iba1, CD68 and CD64, suggesting that microglia are involved in the neuronal loss. Our findings suggest that in established AD this form of active Aß immunization may predominantly accelerate loss of damaged degenerating neurons. This interpretation is consistent with in vivo imaging indicating an increased rate of cerebral atrophy in immunized AD patients.

Interventions for preventing falls in people after stroke.

BACKGROUND: Falls are one of the most common medical complications after stroke with a reported incidence of 7% in the first week after stroke onset. Studies investigating falls in the later phase after stroke report an incidence of up to 73% in the first year post-stroke. OBJECTIVES: To evaluate the effectiveness of interventions aimed at preventing falls in people after stroke. SEARCH METHODS: We searched the trials registers of the Cochrane Stroke Group (November 2012) and the Cochrane Bone, Joint and Muscle Trauma Group (May 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library 2012, Issue 5, MEDLINE (1950 to May 2012), EMBASE (1980 to May 2012), CINAHL (1982 to May 2012), PsycINFO (1806 to May 2012), AMED (1985 to May 2012) and PEDro (May 2012). We also searched trials registers, checked reference lists and contacted authors. SELECTION CRITERIA: Randomised controlled trials of interventions where the primary or secondary aim was to prevent falls in people after stroke. DATA COLLECTION AND ANALYSIS: Review authors independently selected studies for inclusion, assessed trial quality, and extracted data. We used a rate ratio and 95% confidence interval (CI) to compare the rate of falls (e.g. falls per person year) between intervention and control groups. For risk of falling we used a risk ratio and 95% CI based on the number of people falling (fallers) in each group. We pooled results where appropriate. MAIN RESULTS: We included 10 studies with a total of 1004 participants. One study evaluated the effect of exercises in the acute and subacute phase after stroke but found no significant difference in rate of falls (rate ratio 0.92, 95% CI 0.45 to 1.90, 95 participants). The pooled result of four studies investigating the effect of exercises on preventing falls in the chronic phase also found no significant difference for rate of falls (rate ratio 0.75, 95% CI 0.41 to 1.38, 412 participants).For number of fallers, one study examined the effect of exercises in the acute and subacute phase after stroke but found no significant difference between the intervention and control group (risk ratio 1.19, 95% CI 0.83 to 1.71, 95 participants). The pooled result of six studies examining the effect of exercises in the chronic phase also found no significant difference in number of fallers between the intervention and control groups (risk ratio 1.02, 95% CI 0.83 to 1.24, 616 participants).The rate of falls and the number of fallers was significantly reduced in two studies evaluating the effect of medication on preventing falls; one study (85 participants) compared vitamin D versus placebo in institutionalised women after stroke with low vitamin D levels, and the other study (79 participants) evaluated alendronate versus alphacalcidol in hospitalised people after stroke.One study provided single lens distance glasses to regular wearers of multifocal glasses. In a subgroup of 46 participants post-stroke there was no significant difference in the rate of falls (rate ratio 1.08, 95% CI 0.52 to 2.25) or the number of fallers between both groups (risk ratio 0.74, 95% CI 0.47 to 1.18). AUTHORS' CONCLUSIONS: There is currently insufficient evidence that exercises or prescription of single lens glasses to multifocal users prevent falls or decrease the number of people falling after being discharged from rehabilitation following their stroke. Two studies testing vitamin D versus placebo and alendronate versus alphacalcidol found a significant reduction in falls and the number of people falling. However, these findings should be replicated before the results are implemented in clinical practice.

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.

Functional electrical stimulation with exercises for standing balance and weight transfer in acute stroke patients: a feasibility randomized controlled trial.

OBJECTIVES: To test parameters needed for the design of a larger trial including the following: 1) identifying eligible participants, recruitment, and retention rates; 2) the feasibility and acceptability of delivering functional electrical stimulation (FES) to the gluteus maximus and quadriceps femoris for acute stroke patients in a hospital rehabilitation setting; 3) the outcome measures; 4) obtaining initial estimates of effect size; and 5) clarifying the relevant control group. MATERIALS AND METHODS: Twenty-one people with acute stroke-mean age = 68 (min to max: 33-87) years; weeks postonset = 4.6 (min to max: 1-14)-were randomized to three groups to receive two weeks of balance training with FES, balance training alone, or usual care. Symmetry in normal standing, weight transfer onto the affected limb, balance, mobility, and speed of walking were assessed before, shortly after the end of training, and two weeks later by a blinded assessor. RESULTS: 1) FES was successfully delivered but not with the planned eight sessions; 2) no trends in favor of FES were found; and 3) 4% of those screened took part but approaching 20% might be recruited in the future, no single outcome measure was suitable for all participants, and more routine physiotherapy was delivered to the control group. CONCLUSIONS: FES is feasible in this patient group but further feasibility and definitive trials are required.

Design, objectives, execution and reporting of published open-label extension studies.

RATIONALE, AIMS AND OBJECTIVES: Open-label extension (OLE) studies following blinded randomized controlled trials (RCTs) of pharmaceuticals are increasingly being carried out but do not conform to regulatory standards and questions surround the validity of their evidence. OLE studies are usually discussed as a homogenous group, yet substantial differences in study design still meet the definition of an OLE. We describe published papers reporting OLE studies focussing on stated objectives, design, conduct and reporting. METHOD: A search of Embase and Medline databases for 1996 to July 2008 revealed 268 papers reporting OLE studies that met our eligibility criteria. A random sample of 50 was selected for detailed review. RESULTS: Over 80% of the studies had efficacy stated as an objective. The most common methods of allocation at the start of the OLE were for all RCT participants to switch to one active treatment or for only participants on the new drug to continue, but in three studies all participants were re-randomized at the start of the OLE. Eligibility criteria and other selection factors resulted in on average of 74% of participants in the preceding RCT(s) enrolling in the OLE and only 57% completed it. CONCLUSIONS: Published OLE studies do not form a homogenous group with respect to design or retention of participants, and thus the validity of evidence from an OLE should be judged on an individual basis. The term 'open label' suggests bias through lack of blinding, but slippage in relation to the sample randomized in the preceding RCT may be the more important threat to validity.

Questions asked and answered in pilot and feasibility randomized controlled trials.

BACKGROUND: In the last decade several authors have reviewed the features of pilot and feasibility studies and advised on the issues that should be addressed within them. We extend this literature by examining published pilot/feasibility trials that incorporate random allocation, examining their stated objectives, results presented and conclusions drawn, and comparing drug and non-drug trials. METHODS: A search of EMBASE and MEDLINE databases for 2000 to 2009 revealed 3652 papers that met our search criteria. A random sample of 50 was selected for detailed review. RESULTS: Most of the papers focused on efficacy: those reporting drug trials additionally addressed safety/toxicity; while those reporting non-drug trials additionally addressed methodological issues. In only 56% (95% confidence intervals 41% to 70%) were methodological issues discussed in substantial depth, 18% (95% confidence interval 9% to 30%) discussed future trials and only 12% (95% confidence interval 5% to 24%) of authors were actually conducting one. CONCLUSIONS: Despite recent advice on topics that can appropriately be described as pilot or feasibility studies the large majority of recently published papers where authors have described their trial as a pilot or addressing feasibility do not primarily address methodological issues preparatory to planning a subsequent study, and this is particularly so for papers reporting drug trials. Many journals remain willing to accept the pilot/feasibility designation for a trial, possibly as an indication of inconclusive results or lack of adequate sample size.