Conectar
Characterised by chronic inflammation of the gastrointestinal tract, inflammatory bowel disease (IBD) symptoms including diarrhoea, abdominal pain and fatigue can significantly impact patient’s quality of life. Therapeutic developments in the last 20 years have revolutionised treatment. However, clinical trials and real-world data show primary non-response rates up to 40%. A significant challenge is an inability to predict which treatment will benefit individual patients.
Current understanding of IBD pathogenesis implicates complex interactions between host genetics and the gut microbiome. Most cohorts studying the gut microbiota to date have been underpowered, examined single treatments and produced heterogeneous results. Lack of cross-treatment comparisons and well-powered independent replication cohorts hampers the ability to infer real-world utility of predictive signatures.
IBD-RESPONSE will use multi-omic data to create a predictive tool for treatment response. Future patient benefit may include development of biomarker-based treatment stratification or manipulation of intestinal microbial targets. IBD-RESPONSE and downstream studies have the potential to improve quality of life, reduce patient risk and reduce expenditure on ineffective treatments.
This prospective, multicentre, observational study will identify and validate a predictive model for response to advanced IBD therapies, incorporating gut microbiome, metabolome, single-cell transcriptome, human genome, dietary and clinical data. 1325 participants commencing advanced therapies will be recruited from ~40 UK sites. Data will be collected at baseline, week 14 and week 54. The primary outcome is week 14 clinical response. Secondary outcomes include clinical remission, loss of response in week 14 responders, corticosteroid-free response/remission, time to treatment escalation and change in patient-reported outcome measures.
Ethical approval was obtained from the Wales Research Ethics Committee 5 (ref: 21/WA/0228). Recruitment is ongoing. Following study completion, results will be submitted for publication in peer-reviewed journals and presented at scientific meetings. Publications will be summarised at www.ibd-response.co.uk.
Trauma contributes to the greatest loss of disability-adjusted life-years for adolescents and young adults worldwide. In the context of global abdominal trauma, the trauma laparotomy is the most commonly performed operation. Variation likely exists in how these patients are managed and their subsequent outcomes, yet very little global data on the topic currently exists. The objective of the GOAL-Trauma study is to evaluate both patient and injury factors for those undergoing trauma laparotomy, their clinical management and postoperative outcomes.
We describe a planned prospective multicentre observational cohort study of patients undergoing trauma laparotomy. We will include patients of all ages who present to hospital with a blunt or penetrating injury and undergo a trauma laparotomy within 5 days of presentation to the treating centre. The study will collect system, patient, process and outcome data, following patients up until 30 days postoperatively (or until discharge or death, whichever is first). Our sample size calculation suggests we will need to recruit 552 patients from approximately 150 recruiting centres.
The GOAL-Trauma study will provide a global snapshot of the current management and outcomes for patients undergoing a trauma laparotomy. It will also provide insight into the variation seen in the time delays for receiving care, the disease and patient factors present, and patient outcomes. For current standards of trauma care to be improved worldwide, a greater understanding of the current state of trauma laparotomy care is paramount if appropriate interventions and targets are to be identified and implemented.
Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions.
The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare.
The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.
Many adverse events are identified as nursing-sensitive indicators (NSIs) and have evidence-based care bundles known to reduce risk of occurrence. Kamishibai cards are a tool from the manufacturing industry used for practice auditing and improvements. Use of Kamishibai cards is believed to be common in the healthcare setting, but true evidence-based guidelines do not yet exist to guide their implementation.
The aim of this integrative review was to identify best practices around the implementation of Kamishibai cards in the healthcare setting for improvement in NSI-associated outcomes.
Eleven nurses at three facilities worked through the evidence using the Johns Hopkins Evidence-Based Practice Model.
Ten articles were included for this review. Broad themes included direct observation with non-punitive and timely feedback, clearly visualized results, use of evidence-based care bundles, pre-implementation education, and both leadership and frontline-staff involvement. All facilities showed improvement in NSI-associated outcomes after the implementation of K-cards.
In health care, K-cards can be implemented and designed with additional focus on the bundles of care they are intended to audit and staff support, but further evidence would better define guidelines around implementation.
Many people living with dementia experience sleep disturbance and there are no known effective treatments. Non-pharmacological treatment options should be the first-line sleep management. For family carers, relatives’ sleep disturbance leads to interruption of their sleep, low mood and breakdown of care. Our team developed and delivered DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives), a multimodal non-pharmacological intervention, showing it to be feasible and acceptable. The aim of this randomised controlled trial is to establish whether DREAMS START is clinically cost-effective in reducing sleep disturbances in people living with dementia living at home compared with usual care.
We will recruit 370 participant dyads (people living with dementia and family carers) from memory services, community mental health teams and the Join Dementia Research Website in England. Those meeting inclusion criteria will be randomised (1:1) either to DREAMS START or to usual treatment. DREAMS START is a six-session (1 hour/session), manualised intervention delivered every 1–2 weeks by supervised, non-clinically trained graduates. Outcomes will be collected at baseline, 4 months and 8 months with the primary outcome being the Sleep Disorders Inventory score at 8 months. Secondary outcomes for the person with dementia (all proxy) include quality of life, daytime sleepiness, neuropsychiatric symptoms and cost-effectiveness. Secondary outcomes for the family carer include quality of life, sleep disturbance, mood, burden and service use and caring/work activity. Analyses will be intention-to-treat and we will conduct a process evaluation.
London—Camden & Kings Cross Ethics Committee (20/LO/0894) approved the study. We will disseminate our findings in high-impact peer-reviewed journals and at national and international conferences. This research has the potential to improve sleep and quality of life for people living with dementia and their carers, in a feasible and scalable intervention.
To present the pooled estimated prevalence of adverse events in pronated intubated adult COVID-19 patients.
A systematic review and meta-analysis.
This study used the Cochrane Library, CINAHL, Embase, LILACS, Livivo, PubMed, Scopus, and Web of Science databases as data sources.
The studies were meta-analysed using JAMOVI 1.6.15 software. A random-effects model was used to identify the global prevalence of adverse events, confidence intervals and the heterogeneity data. Risk of bias was assessed using the Joanna Briggs Institute tool, and the certainty of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation approach.
Of the 7904 studies identified, 169 were included for full reading, and 10 were included in the review. The most prevalent adverse events were pressure injuries (59%), haemodynamic instability (23%), death (17%) and device loss or traction (9%).
The most prevalent adverse events in mechanically ventilated pronated patients with COVID-19 are pressure injuries, presence of haemodynamic instability, death and device loss or traction.
The evidence identified in this review can help improve the quality and safety of patient care by helping to design care protocols to avoid the development of adverse events that can cause permanent sequelae in these patients.
This systematic review addressed the adverse events related to prone position in intubated adult COVID-19 patients. We identified that the most prevalent adverse events in these patients were pressure injuries, haemodynamic instability, device loss or traction and death. The results of this review may influence the clinical practice of nurses who work in intensive care units and, consequently, the nursing care provided not only to COVID-19 patients but for all intubated patients due to other reasons in intensive care units.
This systematic review adhered to the PRISMA reporting guideline.
As this is a systematic review, we analysed data from primary studies conducted by many researchers. Thus, there was no patient or public contribution in this review.
The Bronchiolitis Endotracheal Surfactant Study (BESS) is a randomised controlled trial to determine the efficacy of endo-tracheal surfactant therapy for critically ill infants with bronchiolitis. To explore acceptability of BESS, including approach to consent within a limited time frame, we explored parent and staff experiences of trial involvement in the first two bronchiolitis seasons to inform subsequent trial conduct.
A mixed-method embedded study involving a site staff survey, questionnaires and interviews with parents approached about BESS.
Fourteen UK paediatric intensive care units.
Of the 179 parents of children approached to take part in BESS, 75 parents (of 69 children) took part in the embedded study. Of these, 55/69 (78%) completed a questionnaire, and 15/69 (21%) were interviewed. Thirty-eight staff completed a questionnaire.
Parents and staff found the trial acceptable. All constructs of the Adapted Theoretical Framework of Acceptability were met. Parents viewed surfactant as being low risk and hoped their child’s participation would help others in the future. Although parents supported research without prior consent in studies of time critical interventions, they believed there was sufficient time to consider this trial. Parents recommended that prospective informed consent should continue to be sought for BESS. Many felt that the time between the consent process and intervention being administered took too long and should be ‘streamlined’ to avoid delays in administration of trial interventions. Staff described how the training and trial processes worked well, yet patients were missed due to lack of staff to deliver the intervention, particularly at weekends.
Parents and staff supported BESS trial and highlighted aspects of the protocol, which should be refined, including a streamlined informed consent process. Findings will be useful to inform proportionate approaches to consent in future paediatric trials where there is a short timeframe for consent discussions.
by Ashley G. Holtz, Troy L. Lowe, Yusuke Aoki, Yutaro Kubota, Robert M. Hoffman, Steven G. Clarke
The methionine addiction of cancer cells is known as the Hoffman effect. While non-cancer cells in culture can utilize homocysteine in place of methionine for cellular growth, most cancer cells require exogenous methionine for proliferation. It has been suggested that a biochemical basis of this effect is the increased utilization of methionine for S-adenosylmethionine, the major methyl donor for a variety of cellular methyltransferases. Recent studies have pointed to the role of S-adenosylmethionine-dependent protein arginine methyltransferases (PRMTs) in cell proliferation and cancer. To further understand the biochemical basis of the methionine addiction of cancer cells, we compared protein arginine methylation in two previously described isogenic cell lines, a methionine-addicted 143B human osteosarcoma cell line and its less methionine-dependent revertant. Previous work showed that the revertant cells were significantly less malignant than the parental cells. In the present study, we utilized antibodies to detect the asymmetric dimethylarginine (ADMA) and symmetric dimethylarginine (SDMA) products of PRMTs in polypeptides from cellular extracts and purified histone preparations of these cell lines fractionated by SDS-PAGE. Importantly, we observed little to no differences in the banding patterns of ADMA- and SDMA-containing species between the osteosarcoma parental and revertant cell lines. Furthermore, enzymatic activity assays using S-adenosyl-ʟ-[methyl-3H] methionine, recombinantly purified PRMT enzymes, cell lysates, and specific PRMT inhibitors revealed no major differences in radiolabeled polypeptides on SDS-PAGE gels. Taken together, these results suggest that changes in protein arginine methylation may not be major contributors to the Hoffman effect and that other consequences of methionine addiction may be more important in the metastasis and malignancy of osteosarcoma and potentially other cancers.To describe patterns of virtual and in-person outpatient mental health service use and factors that may influence the choice of modality in a child and adolescent service.
A pragmatic mixed-methods approach using routinely collected administrative data between 1 April 2020 and 31 March 2022 and semi-structured interviews with clients, caregivers, clinicians and staff. Interview data were coded according to the Consolidated Framework for Implementation Research (CFIR) and examined for patterns of similarity or divergence across data sources, respondents or other relevant characteristics.
Child and adolescent outpatient mental health service, Nova Scotia, Canada.
IWK Health clinicians and staff who had participated in virtual mental healthcare following its implementation in March 2020 and clients (aged 12–18 years) and caregivers of clients (aged 3–18 years) who had received treatment from an IWK outpatient clinic between 1 April 2020 and 31 March 2022 (n=1300). Participants (n=48) in semi-structured interviews included nine clients aged 13–18 years (mean 15.7 years), 10 caregivers of clients aged 5–17 years (mean 12.7 years), eight Community Mental Health and Addictions booking and registration or administrative staff and 21 clinicians.
During peak pandemic activity, upwards of 90% of visits (first or return) were conducted virtually. Between waves, return appointments were more likely to be virtual than first appointments. Interview participants (n=48) reported facilitators and barriers to virtual care within the CFIR domains of ‘outer setting’ (eg, external policies, client needs and resources), ‘inner setting’ (eg, communications within the service), ‘individual characteristics’ (eg, personal attributes, knowledge and beliefs about virtual care) and ‘intervention characteristics’ (eg, relative advantage of virtual or in-person care).
Shared decision-making regarding treatment modality (virtual vs in-person) requires consideration of client, caregiver, clinician, appointment, health system and public health factors across episodes of care to ensure accessible, safe and high-quality mental healthcare.
To assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery.
Two-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study.
National Health Service (NHS) providers in five English hospitals.
Community-dwelling adults, aged 60 years and over, who undergo hip fracture surgery and their informal caregivers.
Usual care: usual NHS care. Experimental: usual NHS care plus a caregiver–patient dyad training programme (HIP HELPER). This programme comprised three, 1 hour, one-to-one training sessions for a patient and caregiver, delivered by a nurse, physiotherapist or occupational therapist in the hospital setting predischarge. After discharge, patients and caregivers were supported through three telephone coaching sessions.
Central randomisation was computer generated (1:1), stratified by hospital and level of patient cognitive impairment. There was no blinding.
Data collected at baseline and 4 months post randomisation included: screening logs, intervention logs, fidelity checklists, acceptability data and clinical outcomes. Interviews were conducted with a subset of participants and health professionals.
102 participants were enrolled (51 patients; 51 caregivers). Thirty-nine per cent (515/1311) of patients screened were eligible. Eleven per cent (56/515) of eligible patients consented to be randomised. Forty-eight per cent (12/25) of the intervention group reached compliance to their allocated intervention. There was no evidence of treatment contamination. Qualitative data demonstrated the trial and HIP HELPER programme was acceptable.
The HIP HELPER programme was acceptable to patient–caregiver dyads and health professionals. The COVID-19 pandemic impacting on site’s ability to deliver the research. Modifications are necessary to the design for a viable definitive RCT.
Ankle Brachial Pressure Index (ABPI) measurement has long been considered the gold standard of vascular assessment for people with lower limb ulceration. Despite this, only around 15% of patients in the United Kingdom who require an ABPI measurement undergo the assessment. The Lanarkshire Oximetry Index (LOI) is a cheaper and arguably more accessible approach to vascular assessment and was initially proposed as an alternative to the ABPI in 2000. No synthesis of evidence related to the LOI has been performed since its introduction into the literature. Primary studies were sought to determine the clinimetric properties of the LOI and its level of agreement with ABPI assessments. Systematic searches of MEDLINE, CINAHL, Cochrane Central Register of Controlled Trials, BNI, ProQuest Health and Medicine, Science Direct, Google Scholar and the British Library (online search) were conducted. Reference lists of identified studies were also reviewed to identify additional studies. Three primary studies met the inclusion criteria, reporting data from 307 patients and 584 limbs assessed using both the LOI and ABPI. All three studies reported fair to moderate kappa values for interrater reliability (κ = 0.290–0.747) and statistically significant positive correlation coefficients (r = 0.37, p < 0.001 in two studies) between the LOI and ABPI. The combined data from the three studies indicated a sensitivity of 52% (41.78–62.1, 95% confidence interval [CI]) and specificity of 96.08% (93.4–97.9, 95% CI) for the LOI using the ABPI as a reference. Additional data are required to indicate the safety of the LOI in practice. Data are also required to determine if the LOI is more acceptable to clinicians compared to the ABPI and whether there are any barriers/enablers to its implementation in practice. Given the relatively low specificity of the LOI, it may be beneficial to combine measurement of the LOI with a subjective clinical risk assessment tool to improve the sensitivity of this alternative approach to vascular assessment.
To generate qualitative data on the views of Occupational Therapists and Physiotherapists about why people do not receive the Royal College of Physicians’ recommended minimum of 45 minutes (min) of daily therapy after stroke, in order to inform a Delphi study.
Focus group study.
Stroke services in the South of England.
A total of nine participants, in two groups, including therapists covering inpatient and Early Supported Discharge (ESD) services with awareness of the 45 min guideline.
Thematic analysis of focus group data identified five factors that influence the amount of therapy a person receives: The Person (with stroke), Individual Therapist, Stroke Multidisciplinary Team, the Organisation and the Guideline. Study findings suggest that the reasons why a person does not receive the therapy recommendation in inpatient and ESD services relate to either the suitability of the guideline for the person with stroke, or the ability of the service to deliver the guideline.
This study provides evidence for possible reasons why some people do not receive a minimum of 45 minutes of therapy, 5 days per week, related to (1) the suitability of the guideline for people with stroke and (2) services’ ability to deliver this amount of intervention. These two factors are related; therapists decide who should receive therapy and how much in the context of (a) resource availability and (b) people’s need and the benefit they will experience. The study findings, combined with the findings from other studies, will be used to initiate a Delphi study, which will establish consensus among therapists regarding the reasons why some people do not receive the guideline amount of therapy.
To gain a consensus among therapists for reasons why a person who had a stroke may not receive the Royal College of Physicians’ recommended minimum of 45 min of daily therapy.
Three-round remote e-Delphi study.
National study, based in the UK.
Occupational therapists and physiotherapists with experience of delivering therapy after stroke and awareness of the 45 min guideline.
Forty-five therapists consented to participate in the study. Thirty-five (78%) completed round one, 29 of 35 (83%) completed round 2 and 26 of 29 (90%) completed round three. A consensus (75%) was reached for 32 statements. Reasons why a person may not receive 45 min were related to the suitability of the guideline for the individual (based on factors like therapy tolerance or medical status) or the capability of the service to provide the intervention. In addition to the statements for which there was a consensus, 32 concepts did not reach a consensus. Specifically, there was a lack of consensus concerning the suitability of the guideline for people receiving Early Supported Discharge (ESD) services and a lack of agreement about whether people who need more than 45 min of therapy actually receive it.
Some people do not receive 45 min of therapy as they are considered unsuitable for it and some do not receive it due to services’ inability to provide it. It is unclear which reasons for guideline non-achievement are most common. Future research should focus on why the guideline is not achieved in ESD, and why people who require more than 45 min may not receive it. This could contribute to practical guidance for therapists to optimise therapy delivery for people after stroke.
We assessed how often National Health Service (NHS) hospitals reported that they had specific supportive services for patients with prostate cancer available onsite, including nursing support, sexual function and urinary continence services, psychological and genetic counselling, and oncogeriatric services. We identified groups of hospitals with similar patterns of supportive services.
We conducted an organisational survey in 2021 of all NHS hospitals providing prostate cancer services in England and Wales. Latent class analysis grouped hospitals with similar patterns of supportive services.
In 138 hospitals, an advanced prostate cancer nurse was available in 125 hospitals (90.6%), 107 (77.5%) had a clinical nurse specialist (CNS) attending all clinics, 103 (75.7%) had sexual function services, 111 (81.6%) had continence services and 93 (69.4%) psychological counselling. The availability of genetic counselling (41 hospitals, 30.6%) and oncogeriatric services (15 hospitals, 11.0%) was lower. The hospitals could be divided into three groups. The first and largest group of 85 hospitals provided the most comprehensive supportive services onsite: all hospitals had a CNS attending all clinics, 84 (98.8%) sexual function services and 73 (85.9%) continence services. A key characteristic of the second group of 31 hospitals was that none had a CNS attending all clinics. A key characteristic of the third group of 22 hospitals was that none had sexual function services available. The hospitals in the largest group were more likely to run joint clinics (p
There is considerable variation in supportive services for prostate cancer available onsite in NHS hospitals in England and Wales. Availability of genetic counselling and oncogeriatric services is low. The different patterns of supportive services among hospitals demonstrate that initiatives to improve the availability of the entire range of supportive services to all patients should be carefully targeted.
This study aims to illuminate the perspectives of informal caregivers who support people following hip fracture surgery.
A qualitative study embedded within a now completed multicentre, feasibility randomised controlled trial (HIP HELPER).
Five English National Health Service hospitals.
We interviewed 20 participants (10 informal caregivers and 10 people with hip fracture), following hip fracture surgery. This included one male and nine females who experienced a hip fracture; and seven male and three female informal caregivers. The median age was 72.5 years (range: 65–96 years), 71.0 years (range: 43–81 years) for people with hip fracture and informal caregivers, respectively.
Semistructured, virtual interviews were undertaken between November 2021 and March 2022, with caregiver dyads (person with hip fracture and their informal caregiver). Data were analysed thematically.
We identified two main themes: expectations of the informal caregiver role and reality of being an informal caregiver; and subthemes: expectations of care and services; responsibility and advocacy; profile of people with hip fracture; decision to be a caregiver; transition from hospital to home.
Findings suggest informal caregivers do not feel empowered to advocate for a person’s recovery or navigate the care system, leading to increased and unnecessary stress, anxiety and frustration when supporting the person with hip fracture. We suggest that a tailored information giving on the recovery pathway, which is responsive to the caregiving population (ie, considering the needs of male, younger and more active informal caregivers and people with hip fracture) would smooth the transition from hospital to home.
ISRCTN13270387.Cite Now
Investigate trends in continuity of care with a general practitioner (GP) before and during the COVID-19 pandemic. Identify whether continuity of care is associated with consultation mode, controlling for other patient and practice characteristics.
Retrospective cross-sectional and longitudinal observational studies.
Primary care records from 389 general practices participating in Clinical Practice Research Datalink Aurum in England.
In the descriptive analysis, 100 000+ patients were included each month between April 2018 and April 2021. Modelling of the association between continuity of care and consultation mode focused on 153 475 and 125 298 patients in index months of February 2020 (before the pandemic) and February 2021 (during the pandemic) respectively, and 76 281 patients in both index months.
The primary outcome measure was the Usual Provider of Care index. Secondary outcomes included the Bice-Boxerman index and count of consultations with the most frequently seen GP.
Continuity of care was gradually declining before the pandemic but stabilised during it. There were consistent demographic, socioeconomic and regional differences in continuity of care. An average of 23% of consultations were delivered remotely in the year to February 2020 compared with 76% in February 2021. We found little evidence consultation mode was associated with continuity at the patient level, controlling for a range of covariates. In contrast, patient characteristics and practice-level supply and demand were associated with continuity.
We set out to examine the association of consultation mode with continuity of care but found that GP supply and patient demand were much more important. To improve continuity for patients, primary care capacity needs to increase. This requires sufficient, long-term investment in clinicians, staff, facilities and digital infrastructure. General practice also needs to transform ways of working to ensure continuity for those that need it, even in a capacity-constrained environment.
Breastfeeding has health benefits for infants and mothers, yet the UK has low rates with marked social inequalities. The Assets-based feeding help Before and After birth (ABA) feasibility study demonstrated the acceptability of a proactive, assets-based, woman-centred peer support intervention, inclusive of all feeding types, to mothers, peer supporters and maternity services. The ABA-feed study aims to assess the clinical and cost-effectiveness of the ABA-feed intervention compared with usual care in first-time mothers in a full trial.
A multicentre randomised controlled trial with economic evaluation to explore clinical and cost-effectiveness, and embedded process evaluation to explore differences in implementation between sites. We aim to recruit 2730 primiparous women, regardless of feeding intention. Women will be recruited at 17 sites from antenatal clinics and various remote methods including social media and invitations from midwives and health visitors. Women will be randomised at a ratio of 1.43:1 to receive either ABA-feed intervention or usual care. A train the trainer model will be used to train local Infant Feeding Coordinators to train existing peer supporters to become ‘infant feeding helpers’ in the ABA-feed intervention. Infant feeding outcomes will be collected at 3 days, and 8, 16 and 24 weeks postbirth. The primary outcome will be any breastfeeding at 8 weeks postbirth. Secondary outcomes will include breastfeeding initiation, any and exclusive breastfeeding, formula feeding practices, anxiety, social support and healthcare utilisation. All analyses will be based on the intention-to-treat principle.
The study protocol has been approved by the East of Scotland Research Ethics Committee. Trial results will be available through open-access publication in a peer-reviewed journal and presented at relevant meetings and conferences.
To understand advanced nurse and midwife practitioners' experience of interprofessional collaboration in implementing evidence-based practice into routine care.
A qualitative interpretative phenomenological analysis.
A purposeful sample of 10 Registered Advanced Nurse and Midwife Practitioners from a range of practice settings in the Republic of Ireland participated in semi-structured interviews over a 10-month timeframe. Interviews were transcribed verbatim and data were analysed using a multi-stage approach in line with guidance for interpretative phenomenological analysis.
Six superordinate themes emerged: Understanding of advanced practice; ‘Treated as an equal and as a “nurse”’; Nursing management support; ‘A voice to implement anything new’; Confidence and Emotional intelligence. These factors impacted interprofessional relationships and the extent to which advanced practitioners could implement evidence-based practice.
There is scope to improve advanced practitioners' ability to collaborate with the interprofessional team in implementing evidence-based practice into routine care.
The study findings demonstrate that enhancing understanding of the advanced practice role; increasing organizational support for advanced practitioners and augmenting specific practitioner skills and attributes will increase their ability to collaborate effectively and implement evidence-based practice. Supporting advanced practitioners in this important aspect of their role will positively influence health outcomes for patients.
As numbers of both nurse and midwife practitioners increase globally, this study provides timely evidence from a range of practice settings to guide the design of education programmes and policies governing advanced practice.
Study recommendations have broad applicability to all healthcare professionals who are engaged in implementing evidence-based practice into routine care.
Consolidated criteria for reporting qualitative research (COREQ).
No patient or public contribution.
Training programmes for obstetrics and gynaecology (O&G) and general surgery (GS) vary significantly, but both require proficiency in laparoscopic skills. We sought to determine performance in each specialty.
Prospective, observational study.
Health Education England North-West, UK.
47 surgical trainees (24 O&G and 23 GS) were subdivided into four groups: 11 junior O&G, 13 senior O&G, 11 junior GS and 12 senior GS trainees.
Trainees were tested on four simulated laparoscopic tasks: laparoscopic camera navigation (LCN), hand–eye coordination (HEC), bimanual coordination (BMC) and suturing with intracorporeal knot tying (suturing).
O&G trainees completed LCN (p
GS trainees performed better than O&G trainees in core laparoscopic skills, and the structure of O&G training may require modification.
ClinicalTrials.gov Registry (NCT05116332).
To investigate whether intravenous immunoglobulin (IVIG) improves neurological outcomes in children with encephalitis when administered early in the illness.
Phase 3b multicentre, double-blind, randomised placebo-controlled trial.
Twenty-one hospitals in the UK.
Children aged 6 months to 16 years with a diagnosis of acute or subacute encephalitis, with a planned sample size of 308.
Two doses (1 g/kg/dose) of either IVIG or matching placebo given 24–36 hours apart, in addition to standard treatment.
The primary outcome was a ‘good recovery’ at 12 months after randomisation, defined as a score of≤2 on the Paediatric Glasgow Outcome Score Extended.
The secondary outcomes were clinical, neurological, neuroimaging and neuropsychological results, identification of the proportion of children with immune-mediated encephalitis, and IVIG safety data.
18 participants were recruited from 12 hospitals and randomised to receive either IVIG (n=10) or placebo (n=8) between 23 December 2015 and 26 September 2017. The study was terminated early following withdrawal of funding due to slower than anticipated recruitment, and therefore did not reach the predetermined sample size required to achieve the primary study objective; thus, the results are descriptive. At 12 months after randomisation, 9 of the 18 participants (IVIG n=5/10 (50%), placebo n=4/8 (50%)) made a good recovery and 5 participants (IVIG n=3/10 (30%), placebo n=2/8 (25%)) made a poor recovery. Three participants (IVIG n=1/10 (10%), placebo n=2/8 (25%)) had a new diagnosis of epilepsy during the study period. Two participants were found to have specific autoantibodies associated with autoimmune encephalitis. No serious adverse events were reported in participants receiving IVIG.
The IgNiTE (ImmunoglobuliN in the Treatment of Encephalitis) study findings support existing evidence of poor neurological outcomes in children with encephalitis. However, the study was halted prematurely and was therefore underpowered to evaluate the effect of early IVIG treatment compared with placebo in childhood encephalitis.
Clinical Trials.gov NCT02308982; ICRCTN registry
FreshRSS 