A realist evaluation of a multifactorial falls prevention programme in care homes.

BACKGROUND: falls in care homes are common, costly and hard to prevent.Multifactorial falls programmes demonstrate clinical and cost-effectiveness, but the heterogeneity of the care home sector is a barrier to their implementation. A fuller appreciation of the relationship between care home context and falls programme delivery will guide development and support implementation. METHODS: this is a multi-method process evaluation informed by a realist approach.Data include fidelity observations, stakeholder interviews, focus groups, documentary review and falls-rate data. Thematic analysis of qualitative data and descriptive statistics are synthesised to generate care home case studies. RESULTS: data were collected in six care homes where a falls programme was trialled. Forty-four interviews and 11 focus groups complemented observations and document review.The impact of the programme varied. Five factors were identified: (i) prior practice and (ii) training may inhibit new ways of working; (iii) some staff may be reluctant to take responsibility for falls; (iv) some may feel that residents living with dementia cannot be prevented from falling; and, (v) changes to management may disturb local innovation.In some care homes, training and improved awareness generated a reduction in falls without formal assessments being carried out. CONCLUSIONS: different aspects of the falls programme sparked different mechanisms in different settings, with differing impact upon falls.The evaluation has shown that elements of a multifactorial falls programme can work independently of each other and that it is the local context (and local challenges faced), which should shape how a falls programme is implemented.

The Cognition and Flow Study (CogFlowS): A Mixed Method Evaluation of a Randomized Feasibility Trial of Cognitive Training in Dementia.

BACKGROUND: Cognitive training (CT) may be beneficial in delaying the onset or slowing dementia progression. CT has been evaluated quantitatively and qualitatively, but none have used mixed methods approaches. OBJECTIVE: The aim of this study was to use a mixed methods approach to identify those who may selectively benefit from CT. METHODS: This was an explanatory sequential mixed methods study involving a quantitative randomized trial of 12 weeks multi-domain CT in healthy older adults (HC, n = 20), and people living with mild cognitive impairment (MCI; n = 12) and dementia (n = 24). Quantitative outcomes included: cognition, mood, quality of life, and activities of daily living. 28 (10 HC, 6 MCI, 12 dementia) training participants completed semi-structured interviews with their carer. Quantitative and qualitative data were integrated using joint displays. RESULTS: Three participants dropped out from the training early-on, leaving 25 participants with follow-up data for full integration (10 HC, 6 MCI, 9 dementia). Dropouts and lower adherence to training were more common in dementia participants with greater non-modifiable barriers. High adherers were more resilient to negative emotions, and poorer or fluctuating performance. Integrated analysis found the majority of participants (n = 24) benefited across outcomes, with no clear profile of individuals who benefited more than others. Participants made a number of key recommendations to improve adherence and minimize dropout to CT. CONCLUSION: Reasons for dropout and low adherence were identified, with recommendations provided for the design of CT for dementia. An individual approach to training should be adopted and low adherence should not preclude engagement with CT.

Qualitative Analysis of the Cognition and Flow (CoGFlowS) Study: An Individualized Approach to Cognitive Training for Dementia Is Needed.

BACKGROUND: Cognitive training (CT) may have benefits for both healthy older adults (HC) and those with early cognitive disorders [mild cognitive impairment (MCI) and dementia]. However, few studies have qualitatively evaluated home-based, computerized CT programs. OBJECTIVE: We present the qualitative arm of a feasibility randomized controlled trial evaluating a CT program for HC and people living with MCI or dementia. METHODS: Participants underwent semi-structured interviews after 12 weeks of CT. Where possible, participants were interviewed with their carers. The interview schedule and analysis were underpinned by the health belief model. Interviews were audio-recorded, transcribed, open-coded, and categorized into themes. The analytical framework was developed, and themes were condensed under five major categories: benefits, barriers, threat, self-efficacy, and cues to action. RESULTS: 37 participants underwent interviews. CT was feasible and acceptable to participants. Benefits included: enjoyment, improved awareness, benchmarking cognitive function, reassurance of abilities and giving back control. Barriers were more prevalent among those with dementia: problems with technology, frustration, conflict between patients and carers, apathy and lack of insight, anxiety or low mood, and lack of portability. HC and MCI perceived the severity of dementia risk as high, partially mitigated by CT. Participants living with dementia valued a more individualized approach to training, accounting for baseline characteristics. CONCLUSION: CT was a feasible intervention for HC and people living with dementia and MCI. Benefits were present, but the identified barriers need to be addressed for CT to be implemented successfully.

Preoperative inflammatory mediators and postoperative delirium: systematic review and meta-analysis.

BACKGROUND: Postoperative delirium has eluded attempts to define its complex aetiology and describe specific risk factors. The role of neuroinflammation as a risk factor, determined by measuring blood levels of preoperative 'innate' inflammatory mediator levels, has been investigated. However, results have been conflicting. We conducted a systematic review and meta-analysis of the evidence on associations between preoperative blood levels of inflammatory mediators and postoperative delirium in the older person. Influence of type of surgery was also assessed. METHODS: Original, low risk of bias studies, published in peer-reviewed journals, which fulfilled the eligibility criteria were included. Seventeen articles fulfilled study criteria. Data extraction, synthesis, and risk of bias analysis were guided by Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) and quality in prognostic studies guidelines. Meta-analyses used a random-effects model. Inflammatory mediators included C-reactive protein, interleukin-6, -8, and -10, tumour necrosis factor-α, insulin-like growth factor-1, cortisol, and neopterin. Surgical groups were cardiac, noncardiac, and hip fracture. RESULTS: Higher preoperative interleukin-6 was associated with postoperative delirium with a standardised mean difference (95% confidence interval) of 0.33 (0.11-0.56) and P=0.003. Higher neopterin was also associated with postoperative delirium. CONCLUSIONS: The association of preoperative blood levels of inflammatory mediators with postoperative delirium may be influenced by the type of surgery and the specific mediator. The potential modulating effect of type of surgery, intrinsic brain vulnerability, and the complex interactions between inflammatory mediators and binding proteins will need to be considered in future studies. CLINICAL TRIAL REGISTRATION: CRD42019159471 (PROSPERO).

Learning from a successful process evaluation in care homes.

INTRODUCTION: process evaluations (PE) are increasingly used in parallel with randomised controlled trials (RCT) to inform the implementation of complex health interventions. This paper explores the learning accrued from conducting a PE within the Falls in Care Homes Study (FinCH), a large UK RCT. METHODS: in the FinCH study, six purposively sampled care homes provided data for the PE, which followed a realist approach. In this study researchers kept written diaries of their experiences in completing the interviews, focus groups and observations. We have reflected on these and present the main themes for discussion. FINDINGS: care home staff were enthusiastic to participate in the PE but researchers found it difficult to collect data due to staff not having time to take part, environmental factors such as no space for focus groups and low levels of research understanding. Researchers found that the expectations of the PE protocol were often unrealistic due to these limitations. Flexible and pragmatic approaches such as interviews in place of focus groups enabled data collection but required a reduced sample size and length of data collection to be accepted by researchers. CONCLUSION: to enable care home staff to participate in successful PEs, researchers should build flexibility into research schedules, spend time building trust, collaborate with all levels of care home staff prior to data collection, increase research capacity in care home staff and co-design research projects.

Effects of brain training on brain blood flow (The Cognition and Flow Study-CogFlowS): protocol for a feasibility randomised controlled trial of cognitive training in dementia.

INTRODUCTION: Cognitive training is an emerging non-pharmacological treatment to improve cognitive and physical function in mild cognitive impairment (MCI) and early Alzheimer's disease (AD). Abnormal brain blood flow is a key process in the development of cognitive decline. However, no studies have explored the effects of cognitive training on brain blood flow in dementia. The primary aim of this study is to assess the feasibility for a large-scale, randomised controlled trial of cognitive training in healthy older adults (HC), MCI and early AD. METHODS AND ANALYSIS: This study will recruit 60 participants, in three subgroups of 20 (MCI, HC, AD), from primary, secondary and community services. Participants will be randomised to a 12-week computerised cognitive training programme (five × 30 min sessions per week), or waiting-list control. Participants will undergo baseline and follow-up assessments of: mood, cognition, quality of life and activities of daily living. Cerebral blood flow will be measured at rest and during task activation (pretraining and post-training) by bilateral transcranial Doppler ultrasonography, alongside heart rate (3-lead ECG), end-tidal CO2 (capnography) and beat-to-beat blood pressure (Finometer). Participants will be offered to join a focus group or semistructured interview to explore barriers and facilitators to cognitive training in patients with dementia. Qualitative data will be analysed using framework analysis, and data will be integrated using mixed methods matrices. ETHICS AND DISSEMINATION: Bradford Leeds Research Ethics committee awarded a favourable opinion (18/YH/0396). Results of the study will be published in peer-reviewed journals, and presented at national and international conferences on ageing and dementia. TRIALS REGISTRATION NUMBER: NCT03656107; Pre-results.

Frequent respiratory events in postoperative patients aged 60 years and above.

There is limited information on the occurrence of respiratory events in postoperative patients after discharge from the postanesthesia care unit. We studied the respiratory rate (RR) of 68 patients aged 60 years and above during the first 6 hours following elective surgery under general anesthesia to assess the frequency of respiratory events in the care unit and on the ward. RR was derived from the continuous RR counter RespiR8, measuring RR by quantifying the humidity of exhaled air. One-minute-averaged RRs were collected and analyzed to assess the frequency of postoperative bradypnea (RR 1-6 breaths/minute) and apnea (cessation of inspiratory flow ≥60 seconds). Values were median (interquartile range) or mean (SD). The median RR was 13 (10-15) breaths/minute. In the 6-hour postoperative period, 78% and 57% of patients experienced at least one bradypnea or apnea event, respectively. A median of ten (3.5-24) bradypnea and three (1-11) apnea events were detected per patient. The occurrence of respiratory events in the postanesthesia care unit (PACU) was a predictor of events on the ward (bradypnea, r2=0.4, P<0.001; apnea, r2=0.2, P<0.001). Morphine consumption correlated weakly with respiratory events in the PACU, but not on the ward. Patients with apnea had significantly larger neck circumference than patients without (39.6 [0.7] versus 37.4 [0.8] cm, P<0.05). Bradypneic or apneic respiratory events are frequent in postoperative elderly patients and even occur relatively late after surgery. Continuous respiratory monitoring on the ward, especially in patients with risk factors, such as early occurrence of events, opioid use, and larger neck circumference, is likely warranted.

Retesting the Hypothesis of a Clinical Randomized Controlled Trial in a Simulation Environment to Validate Anesthesia Simulation in Error Research (the VASER Study).

BACKGROUND: Simulation has been used to investigate clinical questions in anesthesia, surgery, and related disciplines, but there are few data demonstrating that results apply to clinical settings. We asked "would results of a simulation-based study justify the same principal conclusions as those of a larger clinical study?" METHODS: We compared results from a randomized controlled trial in a simulated environment involving 80 cases at three centers with those from a randomized controlled trial in a clinical environment involving 1,075 cases. In both studies, we compared conventional methods of anesthetic management with the use of a multimodal system (SAFERsleep; Safer Sleep LLC, Nashville, Tennessee) designed to reduce drug administration errors. Forty anesthesiologists each managed two simulated scenarios randomized to conventional methods or the new system. We compared the rate of error in drug administration or recording for the new system versus conventional methods in this simulated randomized controlled trial with that in the clinical randomized controlled trial (primary endpoint). Six experts were asked to indicate a clinically relevant effect size. RESULTS: In this simulated randomized controlled trial, mean (95% CI) rates of error per 100 administrations for the new system versus conventional groups were 6.0 (3.8 to 8.3) versus 11.6 (9.3 to 13.8; P = 0.001) compared with 9.1 (6.9 to 11.4) versus 11.6 (9.3 to 13.9) in the clinical randomized controlled trial (P = 0.045). A 10 to 30% change was considered clinically relevant. The mean (95% CI) difference in effect size was 27.0% (-7.6 to 61.6%). CONCLUSIONS: The results of our simulated randomized controlled trial justified the same primary conclusion as those of our larger clinical randomized controlled trial, but not a finding of equivalence in effect size.