Fidelity, pragmatism and the "grey line" in between-exploring the delivery of a pragmatic physical activity randomised controlled trial-a secondary analysis.

BACKGROUND: Intervention fidelity in health services research has been poor with a reported lack of understanding about what constitutes pragmatic adaptation of interventions and what constitutes failure to maintain intervention fidelity. However, the challenges facing those delivering such interventions have not been thoroughly explored. The aims of this study were to critically explore the challenges in maintaining fidelity experienced by physiotherapy staff and support workers when delivering a complex intervention for older people living with frailty. METHODS: This study is a secondary analysis of data from a process evaluation of a large randomised controlled trial (RCT). The process evaluation employed qualitative methodologies with mixed methods including a variety of data collection methods, including participant observation, semi-structured interviews and documentary analysis. Thematic analysis was used to make sense of the data. RESULTS: Many therapy staff felt ongoing confusion about what was acceptable to adapt and what needed to follow the protocol exactly. We found that some therapy staff were able to embrace the challenges of pragmatically adapting interventions while maintaining intervention fidelity, others stuck rigidly to the protocol and failed to adapt interventions where it was necessary. CONCLUSION: It was clear that the understanding of fidelity and pragmatism was poor. While pragmatic trials are vital to replicate real world clinical practice, further guidance may need to be developed in order to guide the level of adaptation that is acceptable before fidelity is undermined.

Older people's perception of being frail - a qualitative exploration.

BACKGROUND: Frailty is a suggested consequence of ageing, but with a variety of different definitions the understanding of what it means to be frail is challenging. There is a common belief that frailty results in a reduction of physical functioning and ability and therefore is likely to significantly affect a person's quality of life. The aim of this study was to explore the understanding of older people about the meaning of frailty and the potential consequences of being classified as frail. METHODS: This paper forms a secondary analysis of a process evaluation of a complex intervention that was embedded within the individually randomised Home-based Extended Rehabilitation of Older people (HERO) trial. A maximum variation, purposive sampling strategy sought to recruit participants with a wide range of characteristics. Data collection included observations of the delivery of the intervention, documentary analysis and semi-structured interviews with participants. Thematic analysis was used to make sense of the observational and interview data, adopting both inductive and deductive approaches. RESULTS: Ninety three HERO trial participants were sampled for the process evaluation with a total of 60 observational home visits and 35 interviews were undertaken. There was a wide range in perceptions about what it meant to be classified as frail with no clear understanding from our participants. However, there was a negative attitude towards frailty with it being considered something that needed to be avoided where possible. Frailty was seen as part of a negative decline that people struggled to associate with. There was discussion about frailty being temporary and that it could be reduced or avoided with sufficient physical exercise and activity. CONCLUSION: Our study provides insight into how older people perceive and understand the concept of frailty. Frailty is a concept that is difficult for patients to understand, with most associating the term with an extreme degree of physical and cognitive decline. Having a label of being "frail" was deemed to be negative and something to be avoided, suggesting the term needs to be used cautiously. TRIAL REGISTRATION: ISRCTN 13927531. Registered on April 19, 2017.

Hip and knee replacement in lower limb amputees: a scoping review.

BACKGROUND: There are many consequences of lower limb amputation, including altered biomechanics of gait. It has previously been shown that these can lead to increased rates of osteoarthritis (OA). A common and successful treatment for severe OA is joint replacement. However, it is unclear whether amputees undergoing this surgery can expect the same outcomes or complication profile compared with non-amputees. Furthermore, there are key technical challenges associated with hip or knee replacement in lower limb amputees. This scoping review aimed to identify and summarise the existing evidence base. METHODS: This was a systematic scoping review performed according to PRISMA guidelines. An electronic database search of MEDLINE (PubMed), Cochrane Library, EMBASE and CINAHL was completed from the date of inception to 1st April 2023. All peer reviewed literature related to hip or knee replacement among lower limb amputees was included. RESULTS: Of the 931 records identified, 40 studies were included in this study. The available literature consisted primarily of case reports and case series, with generally low level of evidence. In total, there were 265 patients of which 195 received total hip replacement (THR), 51 received total knee replacement (TKR) and 21 received hip hemiarthroplasty. The most common reason for amputation was trauma (34.2%), and the main indication for joint replacement was OA (77.1%), occurring more frequently in the contralateral limb (66.7%). The outcomes reported varied widely between studies, with most suggesting good functional status post-operatively. A variety of technical tips were reported, primarily concerned with intra-operative control of the residual limb. CONCLUSION: There is a need for more observational studies to clearly define the association between amputation and subsequent need for joint replacement. Furthermore, comparative studies are needed to identify whether amputees can be expected to achieve similar functional outcomes after surgery, and if they are at higher risk of certain complications.

Including older people in health and social care research: best practice recommendations based on the INCLUDE framework.

BACKGROUND: Older people are often explicitly or implicitly excluded from research, in particular clinical trials. This means that study findings may not be applicable to them, or that older people may not be offered treatments due to an absence of evidence. AIMS: The aim of this work was to develop recommendations to guide all research relevant to older people. METHODS: A diverse stakeholder group identified barriers and solutions to including older people in research. In parallel, a rapid literature review of published papers was undertaken to identify existing papers on the inclusion of older people in research. The findings were synthesised and mapped onto a socio-ecological model. From the synthesis we identified themes that were developed into initial recommendations that were iteratively refined with the stakeholder group. RESULTS: A range of individual, interpersonal, organisational, community and policy factors impact on the inclusion of older people in research. A total of 14 recommendations were developed such as removing upper age limits and comorbidity exclusions, involving older people, advocates and health and social care professionals with expertise in ageing in designing the research, and considering flexible or alternative approaches to data collection to maximise opportunities for participation. We also developed four questions that may guide those developing, reviewing and funding research that is inclusive of older people. CONCLUSION: Our recommendations provide up to date, practical advice on ways to improve the inclusion of older people in health and care research.

Behaviour change interventions to increase physical activity in hospitalised patients: a systematic review, meta-analysis and meta-regression.

BACKGROUND: Low physical activity levels are a major problem for people in hospital and are associated with adverse outcomes. OBJECTIVE: This systematic review, meta-analysis and meta-regression aimed to determine the effect of behaviour change interventions on physical activity levels in hospitalised patients. METHODS: Randomised controlled trials of behaviour change interventions to increase physical activity in hospitalised patients were selected from a database search, supplemented by reference list checking and citation tracking. Data were synthesised with random-effects meta-analyses and meta-regression analyses, applying Grades of Recommendation, Assessment, Development and Evaluation criteria. The primary outcome was objectively measured physical activity. Secondary measures were patient-related outcomes (e.g. mobility), service level outcomes (e.g. length of stay), adverse events and patient satisfaction. RESULTS: Twenty randomised controlled trials of behaviour change interventions involving 2,568 participants (weighted mean age 67 years) included six trials with a high risk of bias. There was moderate-certainty evidence that behaviour change interventions increased physical activity levels (SMD 0.34, 95% CI 0.14-0.55). Findings in relation to mobility and length of stay were inconclusive. Adverse events were poorly reported. Meta-regression found behaviour change techniques of goal setting (SMD 0.29, 95% CI 0.05-0.53) and feedback (excluding high risk of bias trials) (SMD 0.35, 95% CI 0.11-0.60) were independently associated with increased physical activity. CONCLUSIONS: Targeted behaviour change interventions were associated with increases in physical activity in hospitalised patients. The trials in this review were inconclusive in relation to the patient-related or health service benefits of increasing physical activity in hospital.

Physical interventions for people with more advanced dementia - a scoping review.

BACKGROUND: Dementia is a neuro-degenerative condition resulting in cognitive and physical decline over time. In the early stages of the condition, physical decline may be slow, but in the later stages, it may become more pronounced. Physical interventions may be employed to try and reduce the physical decline that people experience, yet it is unclear what interventions may be effective. The aim of this study was to explore the breadth and quantity of evidence that exists in relation to the delivery of physical interventions for people with advanced dementia. METHODS: We undertook a scoping review in order to map the current literature. All types of study design were included in the search in order to gain a comprehensive scope of the literature. We searched a variety of databases from inception until March 2021, focusing on physical interventions. Double screening and data extraction were employed in order to increase the reliability of the results. RESULTS: Our review found four studies which focused on physical interventions aimed at improving physical outcomes for people with more advanced dementia. The majority of studies were excluded as their interventions were not specific to people with advanced dementia. The studies that were included incorporated functional activities and, despite small sample sizes, suggested statistically significant improvements in outcomes for people with advanced dementia. CONCLUSION: There is currently limited evidence relating to physical rehabilitation interventions for people with more advanced dementia, however, the evidence we presented suggests potential benefits for physical outcomes. Future research should focus on robust research to determine the most effective and cost-effective interventions that meet the needs of this population.

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.

Patient-initiated appointment systems for adults with chronic conditions in secondary care.

BACKGROUND: Missed hospital outpatient appointments is a commonly reported problem in healthcare services around the world; for example, they cost the National Health Service (NHS) in the UK millions of pounds every year and can cause operation and scheduling difficulties worldwide. In 2002, the World Health Organization (WHO) published a report highlighting the need for a model of care that more readily meets the needs of people with chronic conditions. Patient-initiated appointment systems may be able to meet this need at the same time as improving the efficiency of hospital appointments. OBJECTIVES: To assess the effects of patient-initiated appointment systems compared with consultant-led appointment systems for people with chronic or recurrent conditions managed in secondary care. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and six other databases. We contacted authors of identified studies and conducted backwards and forwards citation searching. We searched for current/ongoing research in two trial registers. Searches were run on 13 March 2019. SELECTION CRITERIA: We included randomised trials, published and unpublished in any language that compared the use of patient-initiated appointment systems to consultant-led appointment systems for adults with chronic or recurrent conditions managed in secondary care if they reported one or more of the following outcomes: physical measures of health status or disease activity (including harms), quality of life, service utilisation or cost, adverse effects, patient or clinician satisfaction, or failures of the 'system'. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all references at title/abstract stage and full-text stage using prespecified inclusion criteria. We resolved disagreements though discussion. Two review authors independently completed data extraction for all included studies. We discussed and resolved discrepancies with a third review author. Where needed, we contacted authors of included papers to provide more information. Two review authors independently assessed the risk of bias using the Cochrane Effective Practice and Organisation of Care 'Risk of bias' tool, resolving any discrepancies with a third review author. Two review authors independently assessed the certainty of the evidence using GRADE. MAIN RESULTS: The 17 included randomised trials (3854 participants; mean age 41 to 76 years; follow-up 12 to 72 months) covered six broad health conditions: cancer, rheumatoid arthritis, asthma, chronic obstructive pulmonary disease, psoriasis and inflammatory bowel disease. The certainty of the evidence using GRADE ratings was mainly low to very low. The results suggest that patient-initiated clinics may make little or no difference to anxiety (odds ratio (OR) 0.87, 95% confidence interval (CI) 0.68 to 1.12; 5 studies, 1019 participants; low-certainty evidence) or depression (OR 0.79 95% CI 0.51 to 1.23; 6 studies, 1835 participants; low-certainty evidence) compared to the consultant-led appointment system. The results also suggest that patient-initiated clinics may make little or no difference to quality of life (standardised mean difference (SMD) 0.12, 95% CI 0.00 to 0.25; 7 studies, 1486 participants; low-certainty evidence) compared to the consultant-led appointment system. Results for service utilisation (contacts) suggest there may be little or no difference in service utilisation in terms of contacts between the patient-initiated and consultant-led appointment groups; however, the effect is not certain as the rate ratio ranged from 0.68 to 3.83 across the studies (median rate ratio 1.11, interquartile (IQR) 0.93 to 1.37; 15 studies, 3348 participants; low-certainty evidence). It is uncertain if service utilisation (costs) are reduced in the patient-initiated compared to the consultant-led appointment groups (8 studies, 2235 participants; very low-certainty evidence). The results suggest that adverse events such as relapses in some conditions (inflammatory bowel disease and cancer) may have little or no reduction in the patient-initiated appointment group in comparison with the consultant-led appointment group (MD -0.20, 95% CI -0.54 to 0.14; 3 studies, 888 participants; low-certainty evidence). The results are unclear about any differences the intervention may make to patient satisfaction (SMD 0.05, 95% CI -0.41 to 0.52; 2 studies, 375 participants) because the certainty of the evidence is low, as each study used different questions to collect their data at different time points and across different health conditions. Some areas of risk of bias across all the included studies was consistently high (i.e. for blinding of participants and personnel and blinding of outcome assessment, other areas were largely of low risk of bias or were affected by poor reporting making the assessment unclear). AUTHORS' CONCLUSIONS: Patient-initiated appointment systems may have little or no effect on patient anxiety, depression and quality of life compared to consultant-led appointment systems. Other aspects of disease status and experience also appear to show little or no difference between patient-initiated and consultant-led appointment systems. Patient-initiated appointment systems may have little or no effect on service utilisation in terms of service contact and there is uncertainty about costs compared to consultant-led appointment systems. Patient-initiated appointment systems may have little or no effect on adverse events such as relapse or patient satisfaction compared to consultant-led appointment systems.

Knowledge, skills and attitudes of older people and staff about getting up from the floor following a fall: a qualitative investigation.

BACKGROUND: Falls are the most common reason for ambulance callouts resulting in non-conveyance. Even in the absence of injury, only half of those who fall can get themselves up off the floor, often remaining there over an hour, increasing risk of complications. There are recognized techniques for older people to learn how to get up after a fall, but these are rarely taught. The aim of this study was to develop an understanding of attitudes of older people, carers and health professionals on getting up following a fall. METHODS: A qualitative focus group and semi-structured interviews were conducted with 28 participants, including community-dwelling older people with experience of a non-injurious fall, carers, physiotherapists, occupational therapists, paramedics and first responders. Data were transcribed and analysed systematically using the Framework approach. A stakeholder group of falls experts and service users advised during analysis. RESULTS: The data highlighted three areas contributing to an individual's capability to get-up following a fall: the environment (physical and social); physical ability; and degree of self-efficacy (attitude and beliefs about their own ability). These factors fell within the wider context of making a decision about needing help, which included what training and knowledge each person already had to manage their fall response. Staff described how they balance their responsibilities, prioritising the individual's immediate needs; this leaves limited time to address capability in the aforementioned three areas. Paramedics, routinely responding to falls, only receive training on getting-up techniques from within their peer-group. Therapists are aware of the skillset to breakdown the getting-up process, but, with limited time, select who to teach these techniques to. CONCLUSION: Neither therapists nor ambulance service staff routinely teach strategies on how to get up, meaning that healthcare professionals largely have a reactive role in managing falls. Interventions that address the environment, physical ability and self-efficacy could positively impact on peoples' capability to get up following a fall. Therefore, a more proactive approach would be to teach people techniques to manage these aspects of future falls and to provide them easily accessible information.

Patients' and nurses' experiences of fundamental nursing care: A systematic review and qualitative synthesis.

AIMS AND OBJECTIVES: To systematically identify, appraise and synthesise patients', residents' and nurses' experiences of fundamental nursing care for nutrition, elimination, mobility and hygiene. BACKGROUND: The evidence base for effective nursing behaviours to assist people with their fundamental care needs is sparse, hampering the development of effective interventions. Synthesising data on patients' and nurses' experiences of fundamentals of nursing care could contribute to the development of such an intervention. METHODS: Systematic review and synthesis of qualitative data from qualitative studies on patients' and nurses' experiences of fundamental nursing care behaviours addressing peoples' nutrition, elimination, mobility and hygiene needs. We appraised study quality and relevance and used a narrative approach to data synthesis, fulfilling PRISMA criteria (Appendix S2). RESULTS: We identified 22,374 papers, and 47 met our inclusion criteria. Most papers were of low quality. Sixteen papers met our quality and relevance criteria and were included for synthesis. Papers were about nutrition (2) elimination (2), mobility (5), hygiene (5) and multiple care areas (2). We found nurses and patients report that fundamental nursing care practices involve strong leadership, collaborative partnerships with patients and cohesive organisational practices aligned to nursing care objectives and actions. CONCLUSIONS: To improve fundamental care and interventions suitable for testing may require attention to leadership, patient-nurse relationships and organisational coherence plus the fundamentals of care nursing interventions themselves. RELEVANCE TO CLINICAL PRACTICE: More rigorous mixed methods research about fundamental nursing care is needed to inform nursing practice and improve patient's experience. Nursing interventions should include effective nurse leadership and nurse-patient collaboration and a focus on fundamental care by the host organisation.

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.

A scoping review comparing two common surgical approaches to the hip for hemiarthroplasty.

BACKGROUND: Hemiarthroplasty for hip fracture is a common surgical procedure. A number of distinct approaches are used to access the hip joint. The most commonly used are the direct lateral approach (DLA), and the posterior approach (PA). Internationally there is little consensus on which of these approaches to use. Current guidance is based on a limited selection of evidence and choice of approach is frequently based on surgeon preference. Historically, recommendations have been made based on dislocation rates. In light of technical advancements and greater recognition of patient priorities, outcomes such as post-operative function and pain may be considered more important in the modern context. The aim of this scoping review was to summarise the literature pertaining to the comparison of common surgical approaches to the hip for hemiarthroplasty. METHODS: A scoping review methodology was used to examine the range and nature of primary research. Using systematic methods we searched for studies that directly compared the DLA and PA. Studies reporting the following outcomes were considered; dislocation, mortality, pain, activities of daily living, functionality, health-related quality of life, length of stay, surgeon assessment of difficulty, and adverse events. MEDLINE, EMBASE and The Cochrane Library were searched. Relevant information was extracted and synthesis of the retrieved data followed a basic content analytical approach. RESULTS: A total of 13 studies were retrieved: 12 observational studies and 1 randomised trial. The majority of studies were based at single sites. Larger observational studies using multi-site and national registry data have emerged in recent years. Reporting of technique and outcomes is inconsistent. A trend for higher rates of dislocation using the PA was observed and eight studies recommended the use of the DLA over the PA. CONCLUSIONS: This scoping review demonstrates that the existing evidence is highly heterogeneous in nature and not of a sufficient quality to inform practice recommendations. This issue would be best addressed by additional RCTs, and high quality national-level observational data. Standardisation of the recording of patient risk factors, surgical and post-operative intervention protocols, and outcomes in all study designs would strengthen the potential for valid comparison of future findings.

Are physiotherapists employing person-centred care for people with dementia? An exploratory qualitative study examining the experiences of people with dementia and their carers.

BACKGROUND: People with dementia may receive physiotherapy for a variety of reasons. This may be for musculoskeletal conditions or as a result of falls, fractures or mobility difficulties. While previous studies have sought to determine the effectiveness of physiotherapy interventions for people with dementia, little research has focused on the experiences of people receiving such treatment. The aim of this study was to gain an in-depth understanding of people's experiences of receiving physiotherapy and to explore these experiences in the context of principles of person-centred care. METHODS: Semi-structured interviews were undertaken with people with dementia or their carers between September 2016 and January 2017. A purposive sampling strategy recruited participants with dementia from the South West of England who had recently received physiotherapy. We also recruited carers to explore their involvement in the intervention. Thematic analysis was used to analyse the data. RESULTS: A total of eleven participants were recruited to the study. Six people with dementia were interviewed and five interviews undertaken separately with carers of people with dementia. Three themes were identified. The first explores the factors that enable exercises to be undertaken successfully, the second deals with perceived resource pressures, and the final theme "the physiotherapy just vanished" explores the feeling of abandonment felt when goals and expectations of physiotherapy were not discussed. When mapped against the principles of person-centred care, our participants did not describe physiotherapy adopting such an approach. CONCLUSION: Lack of a person-centred care approach was evident by ineffective communication, thus failing to develop a shared understanding of the role and aims of physiotherapy. The incorporation of person-centred care may help reduce the frustration and feelings of dissatisfaction that some of our participants reported.

Clinical rating systems in elbow research-a systematic review exploring trends and distributions of use.

BACKGROUND: Clinical rating systems are used as outcome measures in clinical trials and attempt to gauge the patient's view of his or her own health. The choice of clinical rating system should be supported by its performance against established quality standards. METHODS: A search strategy was developed to identify all studies that reported the use of clinical rating systems in the elbow literature. The strategy was run from inception in Medline Embase and CINHAL. Data extraction identified the date of publication, country of data collection, pathology assessed, and the outcome measure used. RESULTS: We identified 980 studies that reported clinical rating system use. Seventy-two separate rating systems were identified. Forty-one percent of studies used ≥2 separate measures. Overall, 54% of studies used the Mayo Elbow Performance Score (MEPS). For arthroplasty, 82% used MEPS, 17% used Disabilities of Arm, Shoulder and Hand (DASH), and 7% used QuickDASH. For trauma, 66.7% used MEPS, 32% used DASH, and 23% used the Morrey Score. For tendinopathy, 31% used DASH, 23% used Patient-Rated Tennis Elbow Evaluation (PRTEE), and 13% used MEPS. Over time, there was an increased proportional use of the MEPS, DASH, QuickDASH, PRTEE, and the Oxford Elbow Score. CONCLUSIONS: This study identified a wide choice and usage of clinical rating systems in the elbow literature. Numerous studies reported measures without a history of either a specific pathology or cross-cultural validation. Interpretability and comparison of outcomes is dependent on the unification of outcome measure choice. This was not demonstrated currently.

Fundamental nursing care: A systematic review of the evidence on the effect of nursing care interventions for nutrition, elimination, mobility and hygiene.

AIMS AND OBJECTIVES: To determine the effects of nursing interventions for people's nutrition, elimination, mobility and hygiene needs. BACKGROUND: Patient experience of health care is sensitive to nursing quality. A refocus on fundamental nursing care is undermined by lack of evidence of effectiveness for interventions in core areas such as elimination, nutrition, mobility and hygiene. DESIGN: Systematic review. METHODS: We searched for and included experimental studies on interventions by professionally qualified and unregistered nurses that addressed participants' nutrition, elimination, mobility and hygiene needs. We extracted data on scope, quality and results of studies followed by descriptive narrative synthesis of included study outcomes using a novel form of harvest plots. RESULTS: We included 149 studies, 35 nutrition, 56 elimination, 16 mobility, 39 hygiene and three addressing two or more areas simultaneously (67 randomised controlled trials, 32 non-randomised controlled trials and 50 uncontrolled trials). Studies into interventions on participant self-management of nutrition (n = 25), oral health (n = 26), catheter care (n = 23) and self-management of elimination (n = 21) were the most prevalent. Most studies focussed their outcomes on observational or physiological measures, with very few collecting patient-reported outcomes, such as quality of life, experience or self-reported symptoms. All but 13 studies were of low quality and at significant risk of bias. The majority of studies did not define primary outcomes, included multiple measures of identical concepts, used inappropriate analyses and did not conform to standard reporting quality criteria. CONCLUSIONS: The current evidence for fundamental nursing care interventions is sparse, of poor quality and unfit to provide evidence-based guidance to practising nurses. RELEVANCE TO CLINICAL PRACTICE: Researchers in nursing internationally should now undertake a programme of work to produce evidence for clinical practice in the fundamentals of care that is reliable, replicable and robust.

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.

Exploring residents' experiences of mealtimes in care homes: A qualitative interview study.

BACKGROUND: Many interventions aim to alleviate well-documented problems of malnutrition in residential care homes and improve residents' health and wellbeing. Despite some positive findings, little is known about how and why mealtime interventions might be effective, and in particular, what effects residents' experiences of mealtimes have on health outcomes. The aim of this study was to gain an insight into these experiences and explore some of the issues that may impact on residents' enjoyment of meals, and resulting health and wellbeing. METHODS: Semi-structured interviews were conducted with eleven residents from four care homes in the South West UK. Thematic analysis was used to derive content and meaning from transcribed interviews. Interviews were supplemented by researcher observations of mealtimes. RESULTS: The dining experience was a focal point for participants' broader experiences of residing in a care home. Three themes pertaining to residents' experiences were identified: (1) Emotional and psychological connections with other residents; (2) managing competing interests with limited resources; and (3) familiarity and routine. CONCLUSION: Mealtimes are a mainstay of life in a care home through which residents' experiences are characterised, exemplified and magnified. Understanding how residents interact with one another, accommodating their preferences and encouraging autonomy may enhance their mealtime experiences. It may also help to ease the transition from independent-living to life in care, which can be particularly stressful for some residents, and improve health and wellbeing over the long-term.

Attitudes, perceptions and experiences of mealtimes among residents and staff in care homes for older adults: A systematic review of the qualitative literature.

Addressing problems associated with malnutrition in care home residents has been prioritized by researchers and decision-makers. This review aimed to better understand factors that may contribute to malnutrition by examining the attitudes, perceptions and experiences of mealtimes among care home residents and staff. Five databases were searched from inception to November 2015: Medline, Embase, PsychINFO, AMED, and the Cochrane Database. Forward and backward citation checking of included articles was conducted. Titles, abstracts, and full texts were screened independently by two reviewers and quality was assessed using the Wallace criteria. Thematic analysis of extracted data was undertaken. Fifteen studies were included in the review, encompassing the views and opinions of a total of 580 participants set in nine different countries. Four main themes were identified: (1) organizational and staff support, (2) resident agency, (3) mealtime culture, and (4) meal quality and enjoyment. Organizational and staff support was an over-arching theme, impacting all aspects of the mealtime experience. Mealtimes are a pivotal part of care home life, providing structure to the day and generating opportunities for conversation and companionship. Enhancing the mealtime experience for care home residents needs to take account of the complex needs of residents while also creating an environment in which individual care can be provided in a communal setting. PROSPERO Registration: CRD42015025890.

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

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