To establish consensus definitions for necrotising otitis externa (NOE) to facilitate the diagnosis and exclusion of NOE in clinical practice and expedite future high-quality study of this neglected condition.
The work comprised of a systematic review of the literature, five iterative rounds of consultation via a Delphi process and open discussion within the collaborative. An expert panel analysed the results to produce the final outputs which were shared with and endorsed by national specialty bodies.
Secondary care in the UK.
UK clinical specialists practising in infection, ear nose and throat (ENT) surgery or radiology.
Definitions and statements meeting the following criteria were accepted: (a) minimum of 70% of respondents in agreement or strong agreement with a definition/statement AND (b)
Seventy-four UK clinicians specialising in ENT, Infection and Radiology with a special interest in NOE took part in the work which was undertaken between 2019 and 2021. The minimum response rate for a Round was 76%. Consensus criteria for all proposed case definitions, outcome definitions and consensus statements were met in the fifth round.
This work distills the clinical opinion of a large group of multidisciplinary specialists from across the UK to create practical definitions and statements to support clinical practice and research for NOE. This is the first step in an iterative process. Further work will seek to validate and test these definitions and inform their evolution.
To establish a James Lind Alliance (JLA) Priority Setting Partnership (PSP) to identify research priorities relevant to the health and social care needs of adults with lived experience of recent and/or historical sexual violence/abuse.
Adults (aged 18+ years) with lived experience of sexual violence/abuse (ie, ‘survivors’) were consulted for this PSP, alongside healthcare and social care professionals who support survivors across the public, voluntary, community, independent practice and social enterprise sectors.
In line with standard JLA PSP methodology, participants completed an initial online survey to propose research questions relevant to the health and social care needs of survivors. Research questions unanswered by current evidence were identified, and a second online survey was deployed to identify respondents’ priorities from this list. Questions prioritised through the second survey were presented at a consensus meeting with key stakeholders to agree the top 10 research priorities using a modified nominal group technique approach.
223 participants (54% survivors) provided 484 suggested questions. Seventy-five unique questions unanswered by research were identified and subsequently ranked by 343 participants (60% survivors). A consensus meeting with 31 stakeholders (42% survivors) examined the top-ranking priorities from the second survey and agreed the top 10 research priorities. These included research into forms of support and recovery outcomes valued by survivors, how to best support people of colour/black, Asian and minority ethnic and lesbian, gay, bisexual, transgender, and queer (LGBTQ+) survivors, improving access to high-quality psychological therapies, reducing public misconceptions/stigma, the impact of involvement in the criminal justice system on well-being, and how physical and mental health services can become more ‘trauma informed’.
These research priorities identify crucial gaps in the existing evidence to better support adult survivors of sexual violence and abuse. Researchers and funders should prioritise further work in these priority areas identified by survivors and the professionals who support them.
Many patients in the intensive care unit (ICU) require weaning from deep sedation (Spontaneous Awakening Trials, SATs) and mechanical ventilation (Spontaneous Breathing Trials, SBTs) in their journey to recovery. These procedures can be distressing for patients and their families. The presence of family members as ‘coaches’ during SATs/SBTs could provide patients with reassurance, reduce stress for patients and families and potentially improve procedural success rates.
This study will be executed in two phases:
Development of a coaching module: a working group including patient partners (i.e., former ICU patients or family members of former ICU patients), researchers, and ICU clinicians will develop an educational module on family coaching during SATs/SBTs (FamCAB). This module will provide families of critically ill patients basic information about SATs/SBTs as well as coaching guidance. Pilot testing: family members of ICU patients will complete the FamCAB module and provide information on: (1) demographics, (2) anxiety and (3) satisfaction with care in the ICU. Family members will then coach the patient through the next clinically indicated SATs and/or SBTs. Information around duration of time and success rates of SATs and/or SBTs (ability to conduct a complete assessment) alongside feedback will be collected. ICU clinical staff (including physicians and nurses) will be asked for feedback on practicality and perceived benefits or drawbacks of family coaching during these procedures. Feasibility and acceptability of family coaching in SATs/SBTs will be determined.
The results of this work will inform whether a larger study to explore family coaching during SATs/SBTs is warranted.
This study has received ethical approval from the University of Calgary Conjoint Health Research Ethics Board. Results from this pilot study will be made available via peer-reviewed journals and presented at critical care conferences on completion.
Children’s learning abilities suffer when their oral health is compromised. Inadequate oral health can harm children’s quality of life, academic performance, and future success and achievements. Oral health problems may result in appetite loss, depression, increased inattentiveness, and distractibility from play and schoolwork, all of which can lower self-esteem and contribute to academic failure. An oral health curriculum, in addition to the standard school curriculum, may instil preventive oral hygiene behaviour in school students, enabling them to retain good oral health for the rest of their lives. Because most children attend school, the school setting is the most effective for promoting behavioural change in children. A ‘health-promoting school’ actively promotes health by enhancing its ability to serve as a healthy place to live, learn and work, bringing health and education together. Making every school a health-promoting school is one of the joint objectives of the WHO and UNICEF. The primary objective of this proposed study is to assess the effectiveness of an oral health curriculum intervention in reducing dental caries incidence and improving oral hygiene behaviour among high school children in grades 8–10 of the Ernakulam district in Kerala, India. If found to be effective in changing children’s behaviour in a positive way, an oral health curriculum may eventually be incorporated into the school health curriculum in the future. Classroom interventions can serve as a cost-effective tool to increase children’s oral health awareness.
This protocol presents a cluster randomised trial design. It is a parallel-group comparative trial with two arms having a 1:1 distribution—groups A and B with oral health curriculum intervention from a dental professional and a schoolteacher, respectively. High schools (grades 8–10) will be selected as clusters for the trial. The minimum cluster size is 20 students per school. The total sample size is 2000 high school children. Data will be collected at three time points, including baseline, after 1 year (mid-term) and 2 years (final), respectively. The outcome measures are Decayed, Missing and Filled Teeth Index; Oral Hygiene Index-Simplified; and knowledge, attitude and behaviour. Data collection will be done by clinical oral examination and questionnaire involving oral health-related knowledge, attitude and behaviour items.
Ethical approval was obtained from the Institutional Ethics Committee of Amrita Institute of Medical Sciences and Research Centre (dated 19 July 2022, no: IEC-AIMS-2022-ASD-179).
Clinical Trial Registry of India (CTRI/2022/09/045410).
To assess the experiences and knowledge of nurses in the area of iron deficiency.
A cross-sectional, exploratory study using online survey.
Data were collected from nurses working at various primary, secondary and tertiary Australian health practices and organisations.
Australian nurses currently in practice.
Australian nurses currently in practice were invited to complete an online survey about their work background, personal experiences with iron deficiency and iron-deficiency identification and treatment. The survey included a nine-item questionnaire to assess knowledge of iron-deficiency risk factors and biochemistry.
A total of 534 eligible nurses participated in the survey. Participants were more likely to be female, aged 55–64 years, and working in general practice. Just under half (45.1%) reported being diagnosed with iron deficiency themselves. Unusual fatigue or tiredness was the most frequent symptom that alerted nurses to potential iron deficiency in patients (reported by 91.9% of nurses). Nurses who had participated in formal training around iron deficiency in the last 5 years demonstrated a significantly higher knowledge score (4.2±2.1) compared with those who had not or were not sure about their formal training status (3.7±1.9, p=0.035). Knowledge around the understanding of functional iron deficiency was limited.
Nurses report personal experiences of iron deficiency and show good knowledge of symptoms, demonstrating the potential for them to take a leading role in managing iron deficiency in patients. Educational programmes are required to address knowledge gaps and should be offered via various methods to accommodate a diverse nurse cohort. Our research highlights the potential for an expanded scope of practice for nurses in the primary care setting in the area of iron deficiency.
Performance of maternal death surveillance and response (MDSR) relies on the system’s ability to identify and notify all maternal deaths and its ability to review all maternal deaths by a committee. Unified definitions for indicators to assess these functions are lacking. We aim to estimate notification and review coverage rates in 30 countries between 2015 and 2019 using standardised definitions.
Repeat cross-sectional surveys provided the numerators for the coverage indicators; United Nations (UN)-modelled expected country maternal deaths provided the denominators.
30 low-income and middle-income countries responding to the Maternal Health Thematic Fund annual surveys conducted by the UN Population Fund between 2015 and 2019.
Notification coverage rate (
The average annual
MDSR systems that count and review all maternal deaths can deliver real-time information that could prompt immediate actions and may improve maternal health. Consistent and systematic documentation of MDSR efforts may improve national and global monitoring. Assessing the notification and review functions using coverage indicators is feasible, not affected by fluctuations in data completeness and reporting, and can objectively capture progress.
To assess the impact of the COVID-19 pandemic on venous leg ulcer (VLU) management by the UK’s health services and associated outcomes.
Retrospective cohort analysis of the electronic records of patients from The Health Improvement Network database.
Clinical practice in primary and secondary care.
A cohort of 1946 patients of whom 1263, 1153 and 733 had a VLU in 2019, 2020 and 2021, respectively.
Clinical outcomes and wound-related healthcare resource use.
VLU healing rate in 2020 and 2021 decreased by 16% and 42%, respectively, compared with 2019 and time to heal increased by >85%. An estimated 3% of patients in 2020 and 2021 had a COVID-19 infection. Also, 1% of patients in both years had VLU-related sepsis, 0.1%–0.2% developed gangrene and 0.3% and 0.6% underwent an amputation on part of the foot or lower limb in 2020 and 2021 (of whom 57% had diabetes), respectively. The number of community-based face-to-face clinician visits decreased by >50% in both years and >35% fewer patients were referred to a hospital specialist. In 2020 and 2021, up to 20% of patients were prescribed dressings without compression compared with 5% in 2019. The total number of wound care products prescribed in 2020 and 2021 was >50% less than that prescribed in 2019, possibly due to the decreased frequency of dressing change from a mean of once every 11 days in 2019 to once every 21 days in 2020 and 2021.
There was a significant trend towards decreasing care during 2020 and 2021, which was outside the boundaries considered to be good care. This led to poorer outcomes including lower VLU healing rates and increased risk of amputation. Hence, the COVID-19 pandemic appears to have had a deleterious impact on the health of patients with a VLU.
In this study, we aimed to investigate the characteristics of robot-assisted surgery studies registered on ClinicalTrials.gov and identify factors associated with early trial discontinuation and timely results reporting.
We searched ClinicalTrials.gov to identify interventional studies on robot-assisted surgery on 24 May 2021. All structured information of the potential studies was downloaded and reviewed. A descriptive analysis was performed. Logistic and Cox regression analyses were respectively performed to determine the significance of the association of study characteristics with results reporting and early discontinuation.
A total of 529 interventional studies on robot-assisted surgery were included, with 45 studies reporting results and 54 studies being stopped early. Of the 289 due studies, only 45 (16%) had submitted their results, and only 6 (2%) had submitted their results within the 1-year deadline. Funding source was associated with results reporting: academic funded were 63% less likely than industry to report results (OR=0.37, 95% CI: 0.16 to 0.83, p=0.02). Studies related to device feasibility were associated with greater risk of early discontinuation compared to treatment-related studies (HR=2.30, 95% CI: 1.08 to 4.89, p=0.03). Surprisingly, National Institutes of Health-funded studies were at greater hazard of discontinuation compared to industry-funded studies (HR=3.30, 95% CI: 1.09 to 10.00, p=0.04).
There was poor compliance with results reporting requirements for robot-assisted surgical studies. It is important that investigators remain informed about the regulatory requirements, and should be helped to develop a sense of responsibility for reporting results. Also, they need to ensure the careful design of the study protocol and adequate resources to reduce the risk of early discontinuation.
Increasing access to mental health support is a key factor for treating mental disorders, however, important barriers complicate help-seeking, among them, mental health related stigma being most prominent. We aimed to systematically review the current evidence for interventions focusing on reducing stigma related to mental health problems in small and medium enterprises (SMEs).
Systematic review with a focus on interventions targeting mental health related stigma in the workplace in accordance with PRISMA guidelines. The methodological quality of included articles was assessed using the Quality Assessment Tool for Quantitative Studies Scale.
PubMed, Ovid Medline, PsycINFO, Scopus, and Cochrane databases and Google Scholar were searched from January 2010 until November 2022.
We included experimental or quasi-experimental studies about workplace interventions aiming to reduce stigma, where the outcomes were measured in terms of stigmatisation against depression, anxiety and/or other mental health problems.
Records were screened by two independent reviewers after inspecting titles and abstracts and a full-text read of the articles to assess whether they meet inclusion criteria. The results were synthesised narratively.
We identified 22 intervention studies, 3 with high quality, 13 with moderate quality and 6 with weak quality. Only 2 studies included SMEs, but no study focused on SMEs exclusively . The mode of delivery of the intervention was face to face in 15 studies, online in 4 studies and mixed in 3 studies. We found a significant reduction in stigmatising attitudes in almost all studies (20/22), using 10 different instruments/scales. Effects seemed to be independent of company size. Online interventions were found to be shorter, but seemed to be as effective as face-to-face interventions.
Although we did not find interventions focusing exclusively on SMEs, it is likely that antistigma interventions also will work in smaller workplaces.
PROSPERO: ID: CRD42020191307
The clinical application of listening effort (LE) is challenging due to the lack of consensus regarding measuring the concept. Correlational analysis between different measuring instruments shows conditional and weak relationships, indicating they capture different dimensions of LE. Current research has suggested possible links between LE and downstream consequences such as fatigue, stress and confidence. One way to clinically measure LE would be to focus on its corollaries. Further research is needed to explore whether tools used to measure these downstream effects can be applied to capture LE. This study explores using existing questionnaire-based outcome instruments to evaluate LE and its associated consequences in children and young people (CYP), with and without hearing loss.
One hundred CYP aged 12–17 years with normal hearing and a range of hearing loss levels will be invited to complete a series of online questionnaires (Speech, Spatial and Qualities, Vanderbilt Fatigue Scale–Child, Perceived Stress Scale and Rosenberg Self-Esteem Scale) and a hearing test (Digits in Noise). They will complete the questionnaires at two time points (1) at the end of a rest day and (2) at the end of a workday. Standard demographic and hearing health information will be collected. The sample size was determined pragmatically due to a lack of comparable published data to power the study. Tests are exploratory and for generating hypotheses; therefore, the standard criterion of p
This study has been reviewed within the funding organisation (Cochlear Research and Development Limited) by an independent and relevant peer reviewer/committee. This study has had a favourable ethics committee review by both NHS ethics and University of Manchester ethics. The study will be disseminated through newsletters, publication and presentations at conferences. The results will be made available to participants on request.