Footwear characteristics and foot problems in community dwelling people with stroke: a cross-sectional observational study.

PURPOSE: To explore footwear characteristics and foot problems in community dwelling people with stroke as most research to date focused on the general elderly population. METHODS: Thirty people with mild to moderate stroke (nine men, mean age 68, mean time since onset 67 months) attended a single session to assess footwear and foot problems using established podiatry foot (wear) and ankle assessments. RESULTS: Most participants wore slippers indoors (n = 17, 57%) and walking shoes outdoors (n = 11, 37%). Over half wore unsupportive ill-fitting shoes indoors and 47% of outdoor shoes fitted badly. All participants had foot problems (mean 6.5 (3.1), 95% CI: 5.4-7.7), including impaired single limb heel raise (93%), reduced range of movement (77%), sensation (47%), and muscle strength (43%). Many had foot-pain, hallux valgus (both 50%), or swollen feet (40%). Foot problems were associated with reduced balance confidence, activity, and community participation (all p < 0.05). A greater proportion of fallers (13/16) than non-fallers (4/14) reported foot problems (p = 0.029). CONCLUSIONS: Many community-dwelling people with stroke wore poorly fitting shoes; all had foot problems. Foot problems were linked to reduced mobility. Finding more effective pathways to support people with stroke to select supportive, well-fitting indoor and outdoor footwear is indicated.Implications for rehabilitationPeople with stroke often wear unsupportive ill-fitting shoes and experience foot problems.Assessment of foot problems and footwear advice should be considered during stroke rehabilitation particularly when interventions target fall prevention or improvements in balance and mobility.Information on appropriate footwear and signposting that new shoe purchases should include measuring feet to ensure a good fit is recommended.

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.

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.

The trouble with footwear following stroke: a qualitative study of the views and experience of people with stroke.

Purpose: Foot problems and suboptimal footwear are risk factors for falls among the elderly. Footwear choice may, therefore, be important for people with balance impairment following stroke, but little is known about their experience. This study explored foot problems experienced following stroke, factors influencing footwear choices and views of footwear in use.Methods: Semi-structured interviews with 15 people with stroke, purposively sampled from respondents to a screening survey.Results: Participants typically experienced impaired mobility with balance problems and felt at risk of falling. Stroke related foot problems, including altered sensation, edema, and foot drop, predominantly on the stroke affected side, influenced footwear priorities. Footwear choices prioritized comfort, security, and convenience, sometimes in tension with concern about appearance. Challenges included choosing appropriate indoor footwear and finding shoes to accommodate their orthoses and edema. Participants highlighted perceived lack of footwear advice from health care professionals and variable experience of shoe shopping.Conclusions: Foot problems, as well as gait and balance impairment, have implications for footwear priorities following stroke, but people felt unsupported in making healthy footwear choices. Health care professionals could be trained to routinely deliver footwear assessment and advice and facilitate referrals to podiatrist, when appropriate.Implications for rehabilitationFoot problems, as well as gait and balance impairment, have implications for footwear priorities following stroke.People with stroke perceive a lack of professional advice about footwear and feel unsupported making healthy footwear choices.Health care professionals could be trained to routinely deliver an initial footwear assessment and advice as part of stroke rehabilitation.A greater transparency and knowledge of referral pathways into podiatry services for Health care professionals and patients would give access to specialist advice where appropriate.

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.

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.

Follow-up care after treatment for prostate cancer: evaluation of a supported self-management and remote surveillance programme.

BACKGROUND: Alternative models of cancer follow-up care are needed to ameliorate pressure on services and better meet survivors' long-term needs. This paper reports an evaluation of a service improvement initiative for the follow-up care of prostate cancer patients based on remote monitoring and supported self-management. METHODS: This multi-centred, historically controlled study compared patient reported outcomes of men experiencing the new Programme with men experiencing a traditional clinic appointment model of follow-up care, who were recruited in the period immediately prior to the introduction of the Programme. Data were collected by self-completed questionnaires, with follow up measurement at four and eight months post-baseline. The primary outcome was men's unmet survivorship needs, measured by the Cancer Survivors' Unmet Needs Survey. Secondary outcomes included cancer specific quality of life, psychological wellbeing and satisfaction with care. The analysis was intention to treat. Regression analyses were conducted for outcomes at each time point separately, controlling for pre-defined clinical and demographic variables. All outcome analyses are presented in the paper. Costs were compared between the two groups. RESULTS: Six hundred and twenty-seven men (61%) were consented to take part in the study (293 in the Programme and 334 in the comparator group.) Regarding the primary measure of unmet survivorship needs, 25 of 26 comparisons favoured the Programme, of which 4 were statistically significant. For the secondary measures of activation for self-management, quality of life, psychological well-being and lifestyle, 20 of 32 comparisons favoured the Programme and 3 were statistically significant. There were 22 items on the satisfaction with care questionnaire and 13 were statistically significant. Per participant costs (British pounds, 2015) in the 8 month follow up period were slightly lower in the programme than in the comparator group (£289 versus £327). The Programme was acceptable to patients. CONCLUSION: The Programme is shown to be broadly comparable to traditional follow-up care in all respects, adding to evidence of the viability of such models.

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.

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.

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 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.

Follow-up care after treatment for prostate cancer: protocol for an evaluation of a nurse-led supported self-management and remote surveillance programme.

BACKGROUND: As more men survive a diagnosis of prostate cancer, alternative models of follow-up care that address men's enduring unmet needs and are economical to deliver are needed. This paper describes the protocol for an ongoing evaluation of a nurse-led supported self-management and remote surveillance programme implemented within the secondary care setting. METHODS/DESIGN: The evaluation is taking place within a real clinical setting, comparing the outcomes of men enrolled in the Programme with the outcomes of a pre-service change cohort of men, using a repeated measures design. Men are followed up at four and 8 months post recruitment on a number of outcomes, including quality of life, unmet need, psychological wellbeing and activation for self-management. An embedded health economic analysis and qualitative evaluation of implementation processes are being undertaken. DISCUSSION: The evaluation will provide important information regarding the effectiveness, cost effectiveness and implementation of an integrated supported self-management follow-up care pathway within secondary care.

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.