Which patients received a ReSPECT form, what was documented and what were the patient outcomes? A protocol for a retrospective observational study investigating the impact of the COVID-19 pandemic on the implementation of the ReSPECT process

INTRODUCTION: Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) is a UK advance care planning (ACP) initiative aiming to standardise the process of creating personalised recommendations for a person’s clinical care in a future emergency and therefore improve person-focused care. Implementation of the ReSPECT process across a large geographical area, involving both community and secondary care, has not previously been studied. In particular, it not known whether such implementation is associated with any change in outcomes for those patients with a ReSPECT form. Implementation of ReSPECT in the Bristol, North Somerset and South Gloucestershire (BNSSG) Clinical Commissioning Group (CCG) area overlapped with the first UK COVID-19 wave. It is unclear what impact the pandemic had on the implementation of ReSPECT and if this affected the type of patients who underwent the ReSPECT process, such as those with specific diagnoses or living in care homes. Patterns of clinical recommendations documented on ReSPECT forms during the first year of its implementation may also have changed, particularly with reference to the pandemic. To determine the equity and potential benefits of implementation of the ReSPECT form process in BNSSG and contribute to the ACP evidence base, this study will describe the characteristics of patients in the BNSSG area who had a completed ReSPECT form recorded in their primary care medical records before, during and after the first wave of the COVID-19 pandemic; describe the content of ReSPECT forms; and analyse outcomes for those patients who died with a ReSPECT form. METHODS AND ANALYSIS: We will perform an observational retrospective study on data, collected from October 2019 for 12 months. Data will be exported from the CCG Public Health Management data resource, a pseudonymised database linking data from organisations providing health and social care to people across BNSSG. Descriptive statistics of sociodemographic and health-related variables for those who completed the ReSPECT process with a clinician and had a documented ReSPECT form in their notes, in addition to their ReSPECT form responses, will be compared between before, during and after first COVID-19 wave groups. Additionally, routinely collected outcomes for patients who died in our study period will be compared between those who completed the ReSPECT process with a community clinician, hospital clinician or not at all. These include emergency department attendances, emergency hospital admissions, community nurse home visits, hospice referrals, anticipatory medication prescribing, place of death and if the patient died in preferred place of death. ETHICS AND DISSEMINATION: Approval has been obtained from a National Health Service Research Ethics Committee (20/YH/0185). Findings will be disseminated to policy decision-makers, care providers and the public through scientific meetings and peer-reviewed publication

Healthcare professionals’ priorities for training to identify and manage distress experienced by young people with a stoma due to inflammatory bowel disease: a consensus study using online nominal group technique

Young people with a stoma due to inflammatory bowel disease (IBD) commonly experience distress; however, this is not always well managed in clinical settings. More effective support may/is likely to reduce the possibility of individuals experiencing sustained distress, which may engender depression or anxiety. This study aimed to gain consensus among a multidisciplinary group of healthcare professionals (HCPs) on priorities for training in the identification and management of distress in this population. One of the authors is a young person with a stoma. Design Participants were recruited through Twitter (X) and the researchers’ clinical/research contacts. Two consensus group meetings were conducted using Nominal Group Technique, involving participants generating, discussing and rating on a Likert scale, topics for inclusion in an HCP training package. Setting Online video conferencing. Participants were located across England, with one based in the USA. Participants Nineteen HCPs participated: three general practitioners, three stoma nurses, two IBD nurses, nine clinical psychologists and two gastroenterologists. Results Twenty-five topics were generated by participants; 19 reached consensus of ≥80%, that is, a mean of ≥5.6 on a 7-point Likert scale. These included: recognising and validating different levels of, and variation in, distress; tackling stigma and normalising having a stoma; everyday practicalities of stoma management, including food and sleep; opening and holding conversations about stoma-related distress; considering the impact of different cultural beliefs on adaptation after stoma surgery; training in simple techniques for gauging the patient’s distress during clinical encounters; having conversations about body image; and myth-busting common fears, such as odour. Conclusions This study is the first to identify HCP training priorities for managing stoma-related distress in young people. Consensus was reached for 19 topics, reflecting the varied needs of young people with a stoma. Findings will inform development of a training package for HCPs treating young people with IBD and a stoma.peer-reviewe

Young people’s priorities for the self-management of distress after stoma surgery due to inflammatory bowel disease: a consensus study using online nominal group technique

Abstract Introduction: The aim of this study was to gain consensus among young people with a stoma due to inflammatory bowel disease (IBD) on the priorities for the content of an intervention for the self-management of stoma-related distress. The current identification and management of distress in young people with a stoma is often sub-optimal in clinical settings and there is a need for improved support resources.Methods: Two consensus group meetings were carried out via online video conferencing, using Nominal Group Technique. Participants generated, rated on a Likert scale and discussed, topics for inclusion in a future self-management intervention.Results: Nineteen young people, aged 19-33, with a stoma due to IBD took part in one of two group meetings. Participants were located across England, Scotland, and Northern Ireland. Twenty-nine topics were generated by participants, seven of which reached consensus of &gt;80%, that is, a mean of &gt;5.6 on a 7-point Likert scale. These were: receiving advice from young people with lived experience of stoma surgery; advice on/ addressing concerns about romantic relationships, sex and intimacy; information about fertility and pregnancy related to stoma surgery; stoma ‘hacks’, e.g. useful everyday tips regarding clothing, making bag changes easier etc.; reflecting on and recognising own emotional response to surgery; tips on managing the stoma during the night; and processing trauma related to the illness and surgery journey.Conclusions: Findings extend previous research on young people’s experiences of stoma surgery, by generating consensus on young peoples’ priorities for managing distress related to surgery and living with a stoma. These priorities include topics not previously reported in the literature, including the need for information about fertility and pregnancy. Findings will inform the development of a self-management resource for young people with an IBD stoma and have relevance for the clinical management of stoma-related distress in this population.<br/

Defining the functional role of NaV1.7 in human nociception

Loss-of-function mutations in NaV1.7 cause congenital insensitivity to pain (CIP); this voltage-gated sodium channel is therefore a key target for analgesic drug development. Utilizing a multi-modal approach, we investigated how NaV1.7 mutations lead to human pain insensitivity. Skin biopsy and microneurography revealed an absence of C-fiber nociceptors in CIP patients, reflected in a reduced cortical response to capsaicin on fMRI. Epitope tagging of endogenous NaV1.7 revealed the channel to be localized at the soma membrane, axon, axon terminals, and the nodes of Ranvier of induced pluripotent stem cell (iPSC) nociceptors. CIP patient-derived iPSC nociceptors exhibited an inability to properly respond to depolarizing stimuli, demonstrating that NaV1.7 is a key regulator of excitability. Using this iPSC nociceptor platform, we found that some NaV1.7 blockers undergoing clinical trials lack specificity. CIP, therefore, arises due to a profound loss of functional nociceptors, which is more pronounced than that reported in rodent models, or likely achievable following acute pharmacological blockade

Objectively measured physical activity and sedentary behaviour and ankle brachial index: Cross-sectional and longitudinal associations in older men

AbstractBackgroundAssociations between bouts of physical activity (PA), sedentary behaviour (SB) and cardiovascular disease, and their mutual independence are not well defined. A low ankle brachial index (ABI ≤0.9) indicates peripheral arterial disease (PAD) and is predictive of cardiovascular events and functional impairment. We investigated the independence of PA and SB and the importance of bout duration in relation to ABI using objective measures.Methods945 men from the British Regional Heart Study, mean age 78.4 y, had concurrent measurements of ABI (Vicorder) and physical activity (Actigraph GT3X accelerometer); 427 men also had accelerometer measurements one year previously and contributed data to longitudinal analyses.Results and conclusionIn cross-sectional analyses, after adjusting for covariates each extra 10 min of moderate and vigorous PA per day was associated with an OR of 0.81 (95% CI 0.72, 0.91) for a low ABI, a stronger association than for light PA (OR 0.85, 95% CI 0.75, 0.98). Each extra 30 min of SB was associated with an OR of 1.19 (95% CI 1.07, 1.33) for a low ABI. Associations between moderate and vigorous PA and ABI persisted after adjustment for light PA or SB. Bout lengths for PA and SB were not associated with a low ABI. One year changes in PA or SB were not associated with low ABI.All physical activity and lower levels of SB, regardless of bout duration were inversely associated with ABI; more intense PA showed a stronger association. No associations between changes in PA and ABI were observed, but power may have been limited

Electronically delivered, multicomponent intervention to reduce unnecessary antibiotic prescribing for respiratory infections in primary care: a cluster randomised trial using electronic health records—REDUCE Trial study original protocol

Introduction Respiratory tract infections (RTIs) account for about 60% of antibiotics prescribed in primary care. This study aims to test the effectiveness, in a cluster randomised controlled trial, of electronically delivered, multicomponent interventions to reduce unnecessary antibiotic prescribing when patients consult for RTIs in primary care. The research will specifically evaluate the effectiveness of feeding back electronic health records (EHRs) data to general practices. Methods and analysis 2-arm cluster randomised trial using the EHRs of the Clinical Practice Research Datalink (CPRD). General practices in England, Scotland, Wales and Northern Ireland are being recruited and the general population of all ages represents the target population. Control trial arm practices will continue with usual care. Practices in the intervention arm will receive complex multicomponent interventions, delivered remotely to information systems, including (1) feedback of each practice's antibiotic prescribing through monthly antibiotic prescribing reports estimated from CPRD data; (2) delivery of educational and decision support tools; (3) a webinar to explain and promote effective usage of the intervention. The intervention will continue for 12?months. Outcomes will be evaluated from CPRD EHRs. The primary outcome will be the number of antibiotic prescriptions for RTIs per 1000 patient years. Secondary outcomes will be: the RTI consultation rate; the proportion of consultations for RTI with an antibiotic prescribed; subgroups of age; different categories of RTI and quartiles of intervention usage. There will be more than 80% power to detect an absolute reduction in antibiotic prescription for RTI of 12 per 1000 registered patient years. Total healthcare usage will be estimated from CPRD data and compared between trial arms. Ethics and dissemination Trial protocol was approved by the National Research Ethics Service Committee (14/LO/1730). The pragmatic design of the trial will enable subsequent translation of effective interventions at scale in order to achieve population impact. <br/

Healthcare professionals’ priorities for training to identify and manage distress experienced by young people with a stoma due to inflammatory bowel disease: a consensus study using online nominal group technique

Young people with a stoma due to inflammatory bowel disease (IBD) commonly experience distress; however, this is not always well managed in clinical settings. More effective support may/is likely to reduce the possibility of individuals experiencing sustained distress, which may engender depression or anxiety. This study aimed to gain consensus among a multidisciplinary group of healthcare professionals (HCPs) on priorities for training in the identification and management of distress in this population. One of the authors is a young person with a stoma. Design Participants were recruited through Twitter (X) and the researchers’ clinical/research contacts. Two consensus group meetings were conducted using Nominal Group Technique, involving participants generating, discussing and rating on a Likert scale, topics for inclusion in an HCP training package. Setting Online video conferencing. Participants were located across England, with one based in the USA. Participants Nineteen HCPs participated: three general practitioners, three stoma nurses, two IBD nurses, nine clinical psychologists and two gastroenterologists. Results Twenty-five topics were generated by participants; 19 reached consensus of ≥80%, that is, a mean of ≥5.6 on a 7-point Likert scale. These included: recognising and validating different levels of, and variation in, distress; tackling stigma and normalising having a stoma; everyday practicalities of stoma management, including food and sleep; opening and holding conversations about stoma-related distress; considering the impact of different cultural beliefs on adaptation after stoma surgery; training in simple techniques for gauging the patient’s distress during clinical encounters; having conversations about body image; and myth-busting common fears, such as odour. Conclusions This study is the first to identify HCP training priorities for managing stoma-related distress in young people. Consensus was reached for 19 topics, reflecting the varied needs of young people with a stoma. Findings will inform development of a training package for HCPs treating young people with IBD and a stoma.peer-reviewe

Molecular and cellular correlates of human nerve regeneration: ADCYAP1/PACAP enhance nerve outgrowth

We only have a rudimentary understanding of the molecular and cellular determinants of nerve regeneration and neuropathic pain in humans. This cohort study uses the most common entrapment neuropathy (carpal tunnel syndrome) as a human model system to prospectively evaluate the cellular and molecular correlates of neural regeneration and its relationship with clinical recovery. In 60 patients undergoing carpal tunnel surgery [36 female, mean age 62.5 (standard deviation 12.2) years], we used quantitative sensory testing and nerve conduction studies to evaluate the function of large and small fibres before and 6 months after surgery. Clinical recovery was assessed with the global rating of change scale and Boston Carpal Tunnel Questionnaire. Twenty healthy participants provided normative data [14 female, mean age 58.0 (standard deviation 12.9) years]. At 6 months post-surgery, we noted significant recovery of median nerve neurophysiological parameters (P &amp;lt; 0.0001) and improvements in quantitative sensory testing measures of both small and large nerve fibre function (P &amp;lt; 0.002). Serial biopsies revealed a partial recovery of intraepidermal nerve fibre density [fibres/mm epidermis pre: 4.20 (2.83), post: 5.35 (3.34), P = 0.001], whose extent correlated with symptom improvement (r = 0.389, P = 0.001). In myelinated afferents, nodal length increased postoperatively [pre: 2.03 (0.82), post: 3.03 (1.23), P &amp;lt; 0.0001] suggesting that this is an adaptive phenomenon. Transcriptional profiling of the skin revealed 31 differentially expressed genes following decompression, with ADCYAP1 (encoding pituitary adenylate cyclase activating peptide, PACAP) being the most strongly upregulated (log2 fold-change 1.87, P = 0.0001) and its expression was associated with recovery of intraepidermal nerve fibres. We found that human induced pluripotent stem cell-derived sensory neurons expressed the receptor for PACAP and that this peptide could significantly enhance axon outgrowth in a dose-dependent manner in vitro [neurite length PACAP 1065.0 µm (285.5), vehicle 570.9 μm (181.8), P = 0.003]. In conclusion, carpal tunnel release is associated with significant cutaneous reinnervation, which correlates with the degree of functional improvement and is associated with a transcriptional programme relating to morphogenesis and inflammatory processes. The most highly dysregulated gene ADCYAP1 (encoding PACAP) was associated with reinnervation and, given that this peptide signals through G-protein coupled receptors, this signalling pathway provides an interesting therapeutic target for human sensory nerve regeneration

Effectiveness and safety of electronically delivered prescribing feedback and decision support on antibiotic use for respiratory illness in primary care:REDUCE cluster-randomised trial

Objectives: To evaluate the effectiveness and safety at population-scale of electronically delivered prescribing feedback and decision support interventions at reducing antibiotic (AB) prescribing for self-limiting respiratory infections (RTI).Design: Open-label, two-arm, cluster randomised controlled trialSetting: UK general practices in the Clinical Practice Research DatalinkParticipants: 79 general practices (582,675 patient-years) randomised (1:1) to antimicrobial stewardship (AMS) intervention or usual care.Interventions: The AMS intervention comprised a brief training webinar, automated monthly feedback reports of AB prescribing, and electronic decision support tools to inform appropriate AB prescribing over 12 months. Intervention components were delivered electronically, supported by a local practice ‘champion’.Main outcome measures: The primary outcome was the rate of AB prescriptions for RTI from electronic health records. Serious bacterial complications were evaluated for safety. Analysis was by Poisson regression with general practice as a random effect, adjusting for covariates. Pre-specified sub-group analyses by age-group are reported.Results: There were 41 AMS trial arm practices (323,155 patient-years) and 38 usual care trial arm practices (259,520 patient-years). AB prescribing rate ratios (RR) were: unadjusted, 0.89 (0.86 to 1.16); and adjusted, 0.88 (95% CI, 0.78 to 0.99, P=0.04); with AB prescribing rates of 98.7 per 1,000 patient-years for AMS (31,907 AB prescriptions) and 107.6 per 1,000 for usual care (27,923 AB prescriptions). AB prescribing was reduced most in adults aged 15-84 years (adjusted RR 0.84, 95%CI 0.75 to 0.95), with one antibiotic prescription per year avoided for every 62 (40 to 200) patients. There was no evidence of effect for children less than 15 years (adjusted RR 0.96, 0.82 to 1.12) or adults aged 85 years and older (adjusted RR 0.97, 0.79 to 1.18). There was no evidence that serious bacterial complications increased (adjusted RR 0.92, 0.74 to 1.13).Conclusions: Electronically-delivered interventions, integrated into practice workflow result in moderate reductions AB prescribing for RTI in adults, which are likely to be of importance for public health. Antibiotic prescribing to children or older people requires further evaluation.Trial registration: ISRCTN95232781<br/