Supporting people with Motor Neuron Disease (MND) to make decisions about gastrostomy feeding tube placement: a survey of UK healthcare professionals' practice and beliefs.

OBJECTIVE: Understand the practice and beliefs of healthcare professionals (HCPs) supporting the decision-making of people with MND (pwMND) about gastrostomy placement, including identifying differences between professions. METHODS: An online cross-sectional survey disseminated to HCPs who support the decision-making of pwMND about gastrostomy placement. RESULTS: A total of 139 participants completed the survey including representation from a range of healthcare professions. A third (36/101, 36%) initiated discussions about gastrostomy later in practice than they believed was ideal. In relation to the outcome of declining compared to accepting gastrostomy, participants were more likely to discuss aspiration (80% vs. 68%), choking (76% vs. 58%) and prognosis (36% vs. 22%). Participants believed gastrostomies should be placed after a mean 8.1% weight loss since symptom-onset. More participants favored gastrostomy placement before pwMND presented with respiratory symptoms (45%) compared to onset of dysphagia (11%). Half believed pwMND placed gastrostomies too late. Participants were more likely to 'often'/'always' recommend pwMND to have a gastrostomy (23%) than continue without (7%) or decline (4%) gastrostomy, when believing these were the best option for pwMND. Nurses and dietitians discussed the broadest range of information, while doctors were more likely to discuss mortality risk and prognosis. CONCLUSION: There is variation in HCPs practice and beliefs about initiating discussions, the sharing of information and recommendations, and timing, about gastrostomy placement. The information shared varies by profession and there is evidence of sub-optimal communication between HCPs. Further research is required to understand how these findings may impact on the decision-making of pwMND about gastrostomy.

Appropriate handling and storage reduce the risk of bacterial growth in enteral feeding systems reused within 24 hours.

BACKGROUND: Enteral tube feeding can require considerable amounts of plastic equipment including delivery sets and containers, often disposed of after a single feeding session because of bacterial contamination concerns. The aim of this research was to assess whether reuse of delivery sets and containers for up to 24 h is safe from a microbiological perspective. METHODS: Four enteral tube feeding systems (FS) were tested under hygienic controlled or repeated inoculation challenge conditions using key foodborne pathogens, to assess bacterial growth over time (FS1: ready-to-hang, closed 1-L system with delivery set reused, stored at room temperature [RT]; FS2: a prepared, powdered, open 1-L system with delivery set and container reused, stored at RT; FS3 and FS4: prepared, powdered, open 200-ml bolus systems with delivery set and container reused, stored at RT [FS3] and refrigeration [FS4]). Feed samples were cultured at 0.5, 6.5, 12.5, 18.5, and 24.5 h with >2 Δlog considered significant bacterial growth. RESULTS: Under hygienic control, FS1, FS3, and FS4 were below the level of enumeration (<5 CFU/g) for all bacteria tested, at all time points. In FS2, significant bacterial growth was observed from 18.5 h. Under repeated bacterial inoculation challenge, no significant growth was observed in FS1 and FS4 over 24.5 h; however, significant growth was observed in FS2 after 6.5 h and in FS3 after 10-12 h. CONCLUSION: With hygienic handling technique, there is limited bacterial growth with reuse of delivery sets and containers over 24 h. Refrigeration between feeding sessions and using boluses of reconstituted powdered feed reduce bacterial growth risk.

Factors influencing decisions people with motor neuron disease make about gastrostomy placement and ventilation: A qualitative evidence synthesis.

BACKGROUND: People with motor neuron disease (pwMND) are routinely offered gastrostomy feeding tube placement and (non-invasive and invasive) ventilation to manage the functional decline associated with the disease. This study aimed to synthesise the findings from the qualitative literature to understand how individual, clinical team and organisational factors influence pwMND decisions about these interventions. METHODS: The study design was guided by the enhancing transparency in reporting the synthesis of qualitative research (ENTREC) statement. The search of five bibliography databases and an extensive supplementary search strategy identified 27 papers that included qualitative accounts of pwMND, caregivers and healthcare professionals' (HCPs) experiences of making decisions about gastrostomy and ventilation. The findings from each study were included in a thematic synthesis. FINDINGS: Making decisions about interventions is an emotional rather than simply a functional issue for pwMND. The interventions can signal an end to normality, and increasing dependence, where pwMND consider the balance between quality of life and extending survival. Interactions with multiple HCPs and caregivers can influence the process of decision-making and the decisions made. These interactions contribute to the autonomy pwMND are able to exert during decision-making. HCPs can both promote and threaten pwMND perceived agency over decisions through how they approach discussions about these interventions. Though there is uncertainty over the timing of interventions, pwMND who agree to interventions report reaching a tipping point where they accept the need for change. CONCLUSION: Discussion of gastrostomy and ventilation options generate an emotional response in pwMND. Decisions are the consequence of interactions with multiple external agents, including HCPs treading a complex ethical path when trying to improve health outcomes while respecting pwMND right to autonomy. Future decision support interventions that address the emotional response and seek to support autonomy have the potential to enable pwMND to make informed and timely decisions about gastrostomy placement and ventilation. PATIENT OR PUBLIC CONTRIBUTION: The lead author collaborated with several patient and participant involvement (PPI) groups with regards to the conceptualisation and design of this project. Decisions that have been influenced by discussions with multiple PPI panels include widening the scope of decisions about ventilation in addition to gastrostomy placement and the perceptions of all stakeholders involved (i.e., pwMND, caregivers and HCPs).

Adolescent Gender Differences in Tic- and Non-Tic-Related Impairments in Tourette Syndrome.

We aimed to compare tic- and non-tic-related impairment experienced by adolescent girls and boys (ages 13 through 17) with Tourette syndrome and associations with age. We extracted from the electronic health record child and parental responses to the mini-Child Tourette Syndrome Impairment Scale (mini-CTIM) and other questionnaire data reflective of tic- and non-tic-related impairment of adolescents with Tourette syndrome presenting to our clinic over a 12-month period. We identified a total of 132 (49 female, 83 male) unique adolescent encounters. Mini-CTIM scores did not differ significantly between genders. Tic- and non-tic-related impairment were lower in older boys, but not older girls. Obsessive-compulsive symptoms correlated with parent-reported non-tic-related impairment experienced by adolescent girls but not boys. During adolescence, tic- and non-tic-related impairments may be less likely to improve with age in girls. Future longitudinal studies are needed to confirm this finding.

What is the current provision of service for gastrostomy insertion in England?

Background: Significant morbidity and mortality can be associated with gastrostomy insertion, likely influenced by patient selection, indication and aftercare. We aimed to establish what current variation in practice exists and how this has improved by comparison to our previously published British Society of Gastroenterology survey of 2010. Methods: We approached all National Health Service (NHS) hospitals in England (n=198). Email and web-based questionnaires were circulated. These data were correlated with the National Endoscopy Database (NED). Results: The response rate was 69% (n=136/198). Estimated Percutaneous Endoscopic Gastrostomy (PEG) placements in the UK are currently 6500 vs 17 000 in 2010 (p<0.01). There is a dedicated PEG consultant involved in 59% of the centres versus 30% in 2010 (p<0.001). Multidisciplinary team meeting (MDT) discussion occurs in 66% versus 40% in 2010 (p<0.05). Formal aftercare provision occurs in 83% versus 64% in 2010 (p<0.001). 74/107 respondents (69%) reported feeling pressurised to authorise a gastrostomy. Conclusion: This national survey, validated by the results from NED, demonstrates a reduction of over 60% for PEG insertion rates compared with previous estimates. There has also been an increase in consultant involvement, MDT discussion and aftercare provision. However, two-third of responders described 'pressure' to insert a gastrostomy. Perhaps further efforts are needed to include and educate other specialty teams, patients and next of kin.

Patient, carer and healthcare professional perspectives on increasing calorie intake in Amyotrophic Lateral Sclerosis.

OBJECTIVES: Research suggests that higher Body Mass Index is associated with improved survival in people with Amyotrophic Lateral Sclerosis (pwALS). Yet, understanding of the barriers and enablers to increasing calorie intake is limited. This study sought to explore these issues from the perspective of pwALS, informal carers, and healthcare professionals. METHODS: Interviews with 18 pwALS and 16 informal carers, and focus groups with 51 healthcare professionals. Data were analysed using template analysis and mapped to the COM-B model and Theoretical Domains Framework (TDF). RESULTS: All three COM-B components (Capability, Opportunity and Motivation) are important to achieving high calorie diets in pwALS. Eleven TDF domains were identified: Physical skills (ALS symptoms); Knowledge (about high calorie diets and healthy eating); Memory, attention, and decision processes (reflecting cognitive difficulties); Environmental context/resources (availability of informal and formal carers); Social influences (social aspects of eating); Beliefs about consequences (healthy eating vs. high calorie diets); Identity (interest in health lifestyles); Goals (sense of control); Reinforcement (eating habits); and Optimism and Emotion (low mood, poor appetite). DISCUSSION: To promote high calorie diets for pwALS, greater clarity around the rationale and content of recommended diets is needed. Interventions should be tailored to patient symptoms, preferences, motivations, and opportunities.

Disruption of the autism-associated gene SCN2A alters synaptic development and neuronal signaling in patient iPSC-glutamatergic neurons.

SCN2A is an autism spectrum disorder (ASD) risk gene and encodes a voltage-gated sodium channel. However, the impact of ASD-associated SCN2A de novo variants on human neuron development is unknown. We studied SCN2A using isogenic SCN2A-/- induced pluripotent stem cells (iPSCs), and patient-derived iPSCs harboring a de novo R607* truncating variant. We used Neurogenin2 to generate excitatory (glutamatergic) neurons and found that SCN2A+/R607* and SCN2A-/- neurons displayed a reduction in synapse formation and excitatory synaptic activity. We found differential impact on actional potential dynamics and neuronal excitability that reveals a loss-of-function effect of the R607* variant. Our study reveals that a de novo truncating SCN2A variant impairs the development of human neuronal function.

Understanding the current nutritional management for people with amyotrophic lateral sclerosis - A mapping review.

BACKGROUND & AIMS: Poor nutritional outcomes are observed in people with Amyotrophic Lateral Sclerosis (pwALS) including weight loss and poor dietary intake. Surveys of healthcare professionals have highlighted the lack of evidence and knowledge regarding nutritional management of ALS throughout the disease course. Furthermore, national evidence-based guidance is lacking. This mapping review aims to understand the structure and input of nutritional management services for pwALS. METHODS: Systematic searches were conducted across eight electronic databases to identify qualitative and quantitative research on structure and input of nutritional care in ALS. Supplementary searches included grey literature, citation and reference list searching of included studies and key reviews, web searching and contacting experts and organisations that provide ALS services to identify guidelines. Study selection and data extraction were undertaken independently by at least two reviewers. Data was synthesised using a narrative approach. RESULTS: One hundred and nine documents were identified. These consisted of journal articles, guidelines and related documents that contributed evidence towards mapping of nutritional management of pwALS. No evidence on commissioning of nutritional care was identified. Guidelines provided high-level overviews and gave general guidance or recommendations for care; however, these typically focused on gastrostomy with limited guidance on broader aspects, including oral nutrition support. Evidence from primary studies found nutritional care delivery in ALS consisted of multiple types of nutritional management, at different time points during the disease course and involving a range of professionals. There was little evidence relating to proactive nutritional care. Details of healthcare setting, number of professionals involved in care, team composition and how services were delivered in community settings were sparse. Although the role of the speech and language therapist in swallowing assessment and provision of advice on the management of swallowing difficulties was consistent; there was limited evidence on care provided by dietitians. In addition, a small number of studies reported on the use of screening tools. Overall, evidence was consistent that weight management, including monitoring of weight change by professionals and patients, was central and recommended that this should be part of nutritional assessment and follow-up. CONCLUSIONS: The evidence identified in this mapping review has highlighted the requirement for further primary research providing specific details on how nutritional management of pwALS is structured and delivered.

A method for machine learning generation of realistic synthetic datasets for validating healthcare applications.

Digital health applications can improve quality and effectiveness of healthcare, by offering a number of new tools to users, which are often considered a medical device. Assuring their safe operation requires, amongst others, clinical validation, needing large datasets to test them in realistic clinical scenarios. Access to datasets is challenging, due to patient privacy concerns. Development of synthetic datasets is seen as a potential alternative. The objective of the paper is the development of a method for the generation of realistic synthetic datasets, statistically equivalent to real clinical datasets, and demonstrate that the Generative Adversarial Network (GAN) based approach is fit for purpose. A generative adversarial network was implemented and trained, in a series of six experiments, using numerical and categorical variables, including ICD-9 and laboratory codes, from three clinically relevant datasets. A number of contextual steps provided the success criteria for the synthetic dataset. A synthetic dataset that exhibits very similar statistical characteristics with the real dataset was generated. Pairwise association of variables is very similar. A high degree of Jaccard similarity and a successful K-S test further support this. The proof of concept of generating realistic synthetic datasets was successful, with the approach showing promise for further work.

Clinical evaluation of a novel subcutaneous lactate monitor.

Lactate levels are commonly used as an indirect measure to assess metabolic stress in clinical conditions like sepsis. Dynamic lactate measurements are recommended to assess and guide treatment in patients with shock and other critical care conditions. A minimally invasive, continuous lactate monitor has potential to improve clinical decisions and patient care. The purpose of the study was to evaluate continuous lactate measurements of a novel enzymatic Continuous Lactate Monitor (CLM) developed in our laboratory. Lactate levels were monitored during incremental cycling exercise challenges as a tool for hyperlactatemia. Six healthy individuals 18-45 y/o (4 males, 2 females) participated in the study. CLM devices were inserted subcutaneously in the postero-lateral trunk below the renal angle, one hour before the exercise challenge. Each exercise challenge consisted of a 3 to 12-min warm up period, followed by up to 7, 4-min incremental workload bouts separated by rest intervals. Continuous lactate measurements obtained from CLM were compared with commercial lactate analyzer (Abbott iSTAT) measurements of venous blood (plasma) drawn from the antecubital vein. Blood was drawn at up to 25 time points spanning the duration of before exercise, during exercise, and up to 120 min post exercise. Area under the curve (AUC), and delay time were calculated to compare the CLM readings with plasma lactate concentration. Average plasma lactate concentration increased from 1.02 to 16.21 mM. Ratio of AUC derived from CLM to plasma lactate was 1.025 (0.990-1.058). Average dynamic delay time of CLM to venous plasma lactate was 5.22 min (2.87-10.35). Insertion sites examined 48 h after CLM removal did not show signs of side effects and none required medical attention upon examination. The newly developed CLM has shown to be a promising tool to continuously measure lactate concentration in a minimally invasive fashion. Results indicate the CLM can provide needed trends in lactate over time. Such a device may be used in the future to improve treatment in clinical conditions such as sepsis.

The nutritional management of people living with amyotrophic lateral sclerosis: A national survey of dietitians.

BACKGROUND: People living with amyotrophic lateral sclerosis (ALS) face many challenges with respect to taking adequate nutrition. Growing evidence links weight loss with negative prognostic outcomes. We aimed to explore the practice of dietitians in the UK with regard to the nutritional management of ALS. METHODS: A national online survey was disseminated via professional groups, social media and newsletters to UK healthcare professionals between September and November 2018. The survey examined the nutritional management of ALS. Dietitian responses are reported in the present study. RESULTS: In total, 130 dietitians responded to the survey. Two-thirds reported that ALS comprised less than 20% of their total patient caseload. Forty-two percent reported that nutritional screening took place in their organisation. One-half of dietitians reported that patients were referred for dietetic assessment at 'about the right time', although 44% reported referrals were made too late. The majority (83%) of dietitians used resting energy expenditure predictive equations not validated in ALS. When setting weight goals, dietitians reported most frequently recommending weight maintenance if the patient's body mass index was 18.5-25 kg m-2 (72%), 25-30 kg m-2 (98%), and > 30 kg m-2 (79%). In addition, 43% reported that people with ALS were not weighed sufficiently frequently. CONCLUSIONS: Although the importance of early nutritional assessment is recognised, the timeliness of dietetic input and on-going monitoring of nutritional status in ALS care might not currently be ideal. Dietitians report using energy requirement predictive equations and setting weight goals that may not promote positive outcomes. Further research is required to understand the optimal nutritional management of ALS.

Delivery of nutritional management services to people with amyotrophic lateral sclerosis (ALS).

OBJECTIVES: The aim of this study was to investigate how nutritional management services for people with Amyotrophic Lateral Sclerosis (pwALS) are structured in the UK, in order to gain insight into current practice and identify key barriers and enablers to delivering and providing services. Methods: A three-part, sequential mixed-methods study was conducted that comprised (i) a thematic analysis of data from five focus groups (with 47 ALS health professionals from 41 UK organizations and four service user representatives), (ii) a nationwide cross-sectional survey (281 ALS healthcare professionals) and (iii) a freedom of information request (251 organizations). Results: UK nutritional management services for pwALS are coordinated from specialist (n = 22) and non-specialist care centers (n = 89), with national variability in the organization and delivery of services. Multidisciplinary working was highlighted to facilitate the coordination of nutritional care. However, the need to provide evidence-based continuing education for HCPs was evident. Overall, the lack of clear guidelines on the nutritional management of people with ALS was identified as a key barrier to the delivery of effective nutritional care, as was the lack of transparency and consistency in the commissioning of nutritional services. Further concerns over the timeliness of the dietetic intervention and equity of access and provision were raised. Conclusions: Our findings suggest that development of guidelines for nutritional management, particularly at diagnosis and pre-gastrostomy, could drive standardization of high quality nutritional care for pwALS. Such guidance has the potential to reduce inequalities in geographical provision by providing clarity for those commissioning specialist nutrition services.

A Real-Time Blood Flow Measurement Device for Patients with Peripheral Artery Disease.

PURPOSE: To evaluate the feasibility of a new optical device that measures peripheral blood flow as a diagnostic and monitoring tool for patients with peripheral artery disease (PAD). MATERIALS AND METHODS: In this prospective study, 167 limbs of 90 patients (mean age, 76 y; 53% men) with suspected PAD were evaluated with the FlowMet device, which uses a new type of dynamic light-scattering technology to assess blood flow in real time. Measurements of magnitude and phasicity of blood flow were combined into a single-value flow-waveform score and compared vs ankle-brachial index (ABI), toe-brachial index (TBI), and clinical presentation of patients per Rutherford category (RC). Receiver operating characteristic curves were constructed to predict RC. Area under the curve (AUC), sensitivity, and specificity were compared among flow-waveform score, ABI, and TBI. RESULTS: Qualitatively, the FlowMet waveforms were analogous to Doppler velocity measurements, and degradation of waveform phasicity and amplitude were observed with increasing PAD severity. Quantitatively, the flow, waveform, and composite flow-waveform scores decreased significantly with decreasing TBI. In predicting RC ≥ 4, the flow-waveform score (AUC = 0.83) showed a linear decrease with worsening patient symptoms and power comparable to that of TBI (AUC = 0.82) and better than that of ABI (AUC = 0.71). Optimal sensitivity and specificity pairs were found to be 56%/83%, 72%/81%, and 89%/74% for ABI, TBI, and flow-waveform score, respectively. CONCLUSIONS: The technology tested in this pilot study showed a high predictive value for diagnosis of critical limb ischemia. The device showed promise as a diagnostic tool capable of providing clinical feedback in real time.

Effect of skin optical absorption on speckleplethysmographic (SPG) signals.

Recent advances in optical technology have emerged for measuring blood flow in the extremities using speckleplethysmography (SPG), which may address needs in vascular medicine and other fields. SPG has demonstrated a highly linear response with flow rate, but the susceptibility to differences in skin tone is unclear. Two validation studies using skin-simulating phantoms and a simple clinical protocol were conducted to determine the impact of absorbing skin layers on SPG measurements. Benchtop results demonstrated that the coefficient of determination between known flow rate and SPG was highly linear (R2 = 0.990) and was unaffected by the addition of skin-phantom layers with variable absorption (R2 = 0.996-0.999). Additionally, no significant trend was found between the fit residuals of SPG and flow rate with increasing skin-phantom absorption (R2=0.025, p = 0.29). In clinical testing, no significant difference was found using both a 4-way ANOVA between demographic classifications (F = 0.89, p = 0.45), and a 2-way ANOVA test between lower- and higher-melanin subclassifications (F = 0.4, p = 0.52).

Safety Justification of Healthcare Applications Using Synthetic Datasets.

BACKGROUND: Increasing numbers of intelligent healthcare applications are developed by analysing big data, on which they are trained. It is necessary to assure that such applications will be safe for patients; this entails validation against datasets. But datasets cannot be shared easily, due to privacy, and consent issues, resulting in delaying innovation. Realistic Synthetic Datasets (RSDs), equivalent to the real datasets, are seen as a solution to this. OBJECTIVE: To develop the outline for safety justification of an application, validated with an RSD, and identify the safety evidence the RSD developers will need to generate. METHOD: Assurance case argument development approaches were used, including high level data related risk identification. RESULT: An outline of the justification of such applications, focusing on the contribution of the RSD. CONCLUSIONS: Use of RSD will require specific arguments and evidence, which will affect the adopted methods. Mutually supporting arguments can result in a compelling justification.

Using FRAM to explore sources of performance variability in intravenous infusion administration in ICU: A non-normative approach to systems contradictions.

Systems contradictions present challenges that need to be effectively managed, e.g. due to conflicting rules and advice, goal conflicts, and mismatches between demand and capacity. We apply FRAM (Functional Resonance Analysis Method) to intravenous infusion practices in an intensive care unit (ICU) to explore how tensions and contradictions are managed by people. A multi-disciplinary team including individuals from nursing, medical, pharmacy, safety, IT and human factors backgrounds contributed to this analysis. A FRAM model investigation resulting in seven functional areas are described. A tabular analysis highlights significant areas of performance variability, e.g. administering medication before a prescription, prioritising drugs, different degrees of double checking and using sites showing early signs of infection for intravenous access. Our FRAM analysis has been non-normative: performance variability is not necessarily wanted or unwanted, it is merely necessary where system contradictions cannot be easily resolved and so adaptive capacity is required to cope.

A bench-top model of middle ear effusion diagnosed with optical tympanometry.

OBJECTIVES: To assess the validity of a bench-top model of an optical tympanometry device to diagnose in vitro model of middle ear effusion (MEE). METHODS AND MATERIALS: We illuminated an in vitro model of ear canal and tympanic membrane with broadband light and relayed remitted light to a spectrometer system. We then used our proprietary algorithm to extract spectral features that, together with our logistic regression classifiers, led us to calculate a set of simplified indices related to different middle ear states. Our model included a glass vial covered with a porcine submucosa (representing the tympanic membrane) and filled with air, water, or milk solution (representing different MEE), and a set of cover-glass slips filled with either blood (representing erythema) or cerumen. By interchanging fluid types and cover-glass slips, we made measurements on combinations corresponding to normal healthy ear and purulent or serous MEE. RESULTS: Each simulated condition had a distinct spectral profile, which was then employed by our algorithm to discriminate clean and cerumen-covered purulent and serous MEE. Two logistic purulent and serous MEE classifiers correctly classified all in vitro middle ear states with 100% accuracy assessed by leave-one-out and k-fold cross validation. CONCLUSIONS: This proof-of-concept in vitro study addressed an unmet need by introducing a device that easily and accurately can assess middle ear effusion. Future in vivo studies aimed at collecting data from clinical settings are warranted to further elucidate the validity of the technology in diagnosing pediatric acute otitis media.

Survival following the placement of gastrostomy tube in patients with multiple sclerosis.

BACKGROUND: Around a third of people with multiple sclerosis (MS) experience dysphagia. There is a need for disease-specific information on survival following placement of gastrostomy tube in people with MS. OBJECTIVE: We aimed to study survival following gastrostomy in patients with MS. METHODS: We reviewed medical records, home enteral feeding database and death certificates of people with MS who had gastrostomy from 2005 to 2017. Cox regression analysis was performed to identify independent predictors associated with mortality after gastrostomy. RESULTS: Median survival of 53 patients with MS after gastrostomy was 21.73 months. Median duration of hospital stay after gastrostomy was 14 days (IQR 5.25, 51.5). Survival at 30 days, 3 months, 1, 2, 5 and 10 years were 100% (53/53), 98.1% (52/53), 81.1% (43/53), 54.7% (29/53), 22.4% (11/49) and 6.8% (3/44), respectively. Of 53 patients, 24 died due to respiratory tract infection. Patients who had gastrostomy tube before 50 years of age survived longer (median 28.48 months) compared with those who had the gastrostomy after age 50 years (median 17.51 months) (p = 0.040). CONCLUSION: Around 54% of patients with MS survived two or more years following gastrostomy. Younger patients had better survival. The most frequent cause of death was respiratory infection.

Development and piloting of a software tool to facilitate proactive hazard and risk analysis of Health Information Technology.

Health Information Technology is now widely promoted as a means for improving patient safety. The technology could also, under certain conditions, pose hazards to patient safety. However, current definitions of hazards are generic and hard to interpret, particularly for large Health Information Technology in complex socio-technical settings, that is, involving interacting clinical, organisational and technological factors. In this article, we develop a new conceptualisation for the notion of hazards and implement this conceptualisation in a tool-supported methodology called the Safety Modelling, Assurance and Reporting Toolset (SMART). The toolset aims to support clinicians and engineers in performing hazard identification and risk analysis and producing a safety case for Health Information Technology. Through a pilot study, we used and examined the toolset for developing a safety case for electronic prescribing in three acute hospitals. Our results demonstrate the ability of the approach to ensure that the safety evidence is generated based on explicit traceability between the clinical models and Health Information Technology functionality. They also highlight challenges concerning identifying hazards in a consistent way, with clear impact on patient safety in order to facilitate clinically meaningful risk analysis.

Interventions to promote oral nutritional behaviours in people living with neurodegenerative disorders of the motor system: A systematic review.

BACKGROUND & AIMS: Weight loss is common in people with neurodegenerative diseases of the motor system (NDMS), such as Parkinson's disease and Amyotrophic Lateral Sclerosis, and is associated with reduced quality of life, functional ability and survival. This systematic review aims to identify interventions and intervention components (i.e. behaviour change techniques [BCTs] and modes of delivery [MoDs]) that are associated with increased effectiveness in promoting oral nutritional behaviours that help people with NDMS to achieve a high calorie diet. METHODS: Eight electronic databases including MEDLINE and CINAHL were searched from inception to May 2018. All interventions from included studies were coded for relevant BCTs and MoDs. Methodological quality of studies was assessed using the Cochrane risk of bias tool. RESULTS: Fourteen studies were included. Of these, eight studies reported interventions to assist with swallowing difficulties and six studies reported interventions targeting dietary content. Beneficial effects in managing swallowing difficulties were observed with video assisted swallowing therapy, lung volume recruitment and swallowing management clinics with outpatient support. In contrast, studies reporting effectiveness of chin down posture, use of thickened liquids and respiratory muscle training were inconclusive. Positive effects in interventions targeting dietary content included the use of food pyramid tools, individualised nutritional advice with nutritional interventions, electronic health applications, face-to-face dietary counselling and high fat, high carbohydrate and milk whey protein supplements. Individualised nutritional advice with weekly phone contact did not appear to be effective. Most frequently coded BCTs were 'instructions on how to perform the behaviour', 'self-monitoring' and 'behavioural practice/rehearsal'. Most commonly identified MoDs were 'human, face-to-face' and 'somatic therapy'. However, the robustness of these findings are low due to the small number of studies, small sample sizes and large between-study variability. CONCLUSIONS: Despite the limited evidence, these findings may help inform the development of more effective interventions to promote oral nutritional behaviours in people with NDMS. However, further research is needed to demonstrate which interventions, or intervention components, yield most benefit.