Anxiety is a common non-motor symptom of Parkinson’s disease (PD). There is no specific pharmacological intervention for people with PD who experience anxiety. Current non-pharmacological treatments have mixed or inconclusive results and there does not appear to be a non-pharmacological intervention for people with PD disease and anxiety that focuses on activity and participation.
To co-produce an occupation-focused complex intervention to help people with PD live well with anxiety that community-based occupational therapists can deliver.
Six-stage complex intervention development was conducted using online logic modelling and a participatory approach to organise the new intervention’s key inputs, processes and outcomes important to people with PD living with anxiety.
Data were collected via online logic modelling sessions involving people with Parkinson’s, care partners and occupational therapists across the UK from April 2022 to June 2022.
34 participants were recruited (people with PD n=14, care partners n=9, occupational therapists n=11) for the online logic modelling sessions.
Resources to support the new intervention (‘inputs’) include adequate resourcing, education for professionals and people with PD, flexibility of delivery methods and goal setting. The intervention’s actions to produce outcomes (‘processes’) should include 1:1 support, lifestyle management, providing meaningful information, collaborative goal setting, therapeutic use of everyday activities, and involvement of friends and families. The intended results (‘outcomes’) should include a reduction in anxiety symptoms, people with PD enjoying more meaningful activities, increased understanding of anxiety and PD, improvement in clinical outcomes and improvement of service-level outcomes. These key aspects were incorporated into an intervention manual, educational material and training video.
We have systematically coproduced a new occupation-focused complex intervention to help people with PD to live well with anxiety. This provides the basis for the next project in which this intervention will be tested for feasibility.
Mobile health (mHealth) technologies have become increasingly popular for monitoring mental health symptoms and lifestyle behaviours, and are largely reported to be feasible and acceptable to users. However, to date, the efficacy of such technologies to improve perinatal mental health outcomes has been mixed. Within the perinatal context, much of this work has been done in the context of postpartum depression, stemming from electronic health records as well as cohort studies. There is, however, a dearth of studies focusing on depression in pregnancy, and machine learning-based clinical decision support systems remain underexplored. The HappyMums application has been developed to meet this need, and its use across Europe will be tested in this study.
A total of 1000 pregnant people currently suffering from, or at risk of, antenatal depression will be recruited across six countries. All participants will be between 13 and 28 weeks’ gestation and will be given access to the new purposefully developed HappyMums mobile application, to use from enrolment until 2 months postpartum. The application leverages passively collected data from smartphone sensors relating to physical activity and behaviour, as well as requiring active engagement from the user to complete mental health questionnaires and ‘game-like’ activities. Digital data types will be combined with traditional mental health measurement methods, such as standardised questionnaires and interviews, to develop novel predictive models capable of identifying mental health trajectories in women at risk of developing antenatal depression and to test the app’s utility for use as personalised risk prediction and depression identification tool. The primary outcome of this study is to determine what proportion of users will continue to use the mobile application and engage with its tasks and activities at least weekly, while secondary exploratory outcomes include assessing usability of the app and testing the predictive ability of a novel machine learning-based model. These outcomes will, for the first time, be assessed by integrating active as well as passive data.
Ethical approval has been granted by local research ethics committees in each recruiting centre. At King’s College London (leading the clinical study), the study was reviewed by the East of England—Essex Research Ethics Committee and granted favourable opinion (REC reference 24/EE/0129). All other sites collecting participant data have the study approved for local delivery. Findings relating to the primary and secondary outcomes will be submitted for publication in open access, peer-reviewed journals, as well as presentations at conferences as symposia or posters. Findings will be made available to a non-specialist audience through open access digital mental health magazines and promotion on social media.
Obesity affects over a quarter of the UK population and can lead to serious health issues. NHS Specialist Weight Management Services (WMS) offer treatments including lifestyle advice, psychological support and medications, but access and availability vary by region. Although around 4 million people could be eligible for NHS Specialist WMS annually, capacity is limited to 35 000, severely limiting overall access for those who need it. While digital technology has started to be used in WMS, more evidence is needed to confirm its long-term effectiveness, acceptability and cost-effectiveness. This study explores the use of Gro Health W8Buddy, a digital platform and app providing remote Specialist WMS. It aims to determine the long-term health benefits of remote WMS pathway Gro Health W8Buddy compared with standard NHS WMS delivered in hospitals, and to improve patients access to services.
The study is a real-world evaluation with observational data collection. We will recruit 450 study participants from four NHS specialist WMS who will choose either standard NHS WMS or the digital pathway Gro Health W8Buddy. Participants are being given the option to choose their pathway to generate real-world evidence. We will measure and analyse health outcomes including weight loss, time taken to be treated and cost-effectiveness, at 18 months and follow up at 24 months for later analysis (outside of this core funding). We will gather experiential data from patients and healthcare professionals through surveys, observation and interviews.
Ethical approval has been obtained from NHS Health Research Authority (HRA) and Health and Care Research Wales (HCRW) (Supplementary Figure 3) (REC reference: 25/EM/0147). Our findings will be disseminated through academic publications, conference presentations and stakeholder engagement.
ISRCTN89168871; Pre-results.
To evaluate whether information about patients' poor sense of security in hypothetical vignette scenarios increases nurses' projected intent to report safety events.
Quantitative, cross-sectional factorial survey vignette experiment administered online.
A convenience sample of 60 nurses from adult inpatient hospital units at a Midwest academic medical center participated in February 2025. Participants responded to demographic questions and eight factorial vignettes, each describing a patient-reported safety breach and incorporating four patient-related factors. Four vignettes included information that the patient had a poor sense of security, and four did not, presented in random order. Following each vignette, participants rated their level of concern about the patient's report, perceived harm to the patient, and likelihood of reporting the patient's concern. A linear mixed-effects modelling approach, accounting for clustering within participants, was used to estimate the effects of the sense of security information factor on nurses' responses.
The sense of security information was associated with higher ratings of (a) degree of concern, (b) perceived harm to the patient, and (c) intent to report the patient's concern, after adjusting for vignette- and participant-level covariates. The vignette patient's perception of physical harm was positively associated with all three ratings. Nurses' greater hospital experience was associated with lower ratings across outcomes.
Obtaining information that the patient felt insecure was associated with heightened concern about the safety event, greater perceived harm, and increased intent to report the concern.
Sense of security assessment may be a risk-agnostic, patient-centered intervention that nurses can routinely perform, regardless of the safety event circumstances.
Although a system of evidence-based practices within a safety culture is essential to hospital safety efforts, nurses' judgements of and responses to patient safety concerns play a critical role and should not be overlooked.
STROBE guidelines.
This study did not include patient or public involvement in its design, conduct, or reporting.
To explore the experiences of qualified nurses who have lived experience of self-harm (with or without suicidal intent) during nursing training or practice. Specifically, to examine characteristics and contributing factors and ideas for tailored suicide prevention interventions.
Exploratory qualitative study.
Individual semi-structured interviews were conducted with eight qualified female nurses who had self-harmed during nursing training or practice. Participants were recruited from three NHS hospital Trusts. Data were collected between June and September 2023 and analysed using reflexive thematic analysis.
Four themes were generated: (1) ‘I don't think work triggered it, but I don't think it helped’: characteristics and contributors to self-harm, (2) ‘You're a nurse now you can't talk about that’: nursing culture and barriers to workplace support seeking, (3) ‘Are you a nurse or are you a lived experience practitioner – can you be both?’: navigating a dual identity as a nurse with lived experience and (4) ‘We need the permission that it's ok to put us first’: workplace support and suggestions for suicide prevention.
Participants described their experiences of self-harm, including citing a range of contributory factors, with occupational issues being particularly salient. Cultural expectations and stigma prevented help-seeking and unique challenges regarding being both a clinician and an individual who has self-harmed were described. Reflections and perspectives on workplace and independent mental health support for nurses were shared.
Potential avenues for suicide prevention interventions tailored for the nursing profession may include challenging nursing culture and promoting help-seeking, peer support opportunities and implementation of education surrounding mental health and well-being in nursing curricula.
Reporting complied with the COREQ.
The topic guide and participant information sheet were developed in consultation with a group of qualified and student nurses with lived experience of suicidal thoughts and behaviours.
In Canada, many families want to breastfeed, but there are several common challenges they may encounter. Currently, 91% of Canadian families initiate breastfeeding after giving birth, yet only 38% of babies are breastfed exclusively to 6 months. In 1991, the Breastfeeding Committee for Canada (BCC) was established to implement the World Health Organization’s Ten-Step Baby-Friendly Hospital Initiative, a series of evidence-based in-hospital practices to support families to breastfeed. Then, in recognition of the need to support breastfeeding beyond the hospital setting, the BCC expanded the Baby-Friendly Initiative (BFI) to apply the Ten Steps to both hospitals and community health settings. However, uptake of the BFI Ten Steps in community settings has been low and methodology on how to optimise implementation of the Ten Steps in community is not well developed. Therefore, the objective of this project is to develop and evaluate a quality improvement collaborative with 25 community health services from across Canada to learn how to best support the implementation of the BFI Ten Steps in community, with the ultimate goal of improving breastfeeding outcomes.
This protocol describes the activities of the Community Baby-Friendly Initiative Collaborative (CBFI-C) and the methods used to evaluate its effectiveness. We will use the Institute for Healthcare Information Breakthrough Series (IHI-BTS) model, a proven quality improvement model that has been widely used in clinical settings, but is not yet widely used in community settings. The IHI-BTS combines three virtual learning sessions with action cycles that allow the participating sites time to test and track small practice changes. Sites will be asked to track care indicator and breastfeeding outcome data, engage in monthly webinars, receive coaching from trained mentors, participate in focus groups and participate in a final summative workshop. We will use a multi-site case study approach, combining aggregate care indicator data and qualitative data from webinars, focus groups and workshops to evaluate how the CBFI-C model supports community sites in the process of implementing the BFI Ten Steps.
Ethics approval for this evaluation was obtained from the CHIPER Health Research Ethics Board (Number HS26947-H2025:157)). The results of the CBFI-C evaluation will be shared in a report, peer-reviewed publications and presentations to government and academic audiences. The findings will inform effective quality improvement strategies to enhance uptake of the BFI in community health settings.
Cervical cancer (CaCx) is a leading cause of cancer-related deaths among women in South Africa, often presenting at advanced stages and requiring chemoradiotherapy. In South Africa, the burden is disproportionately high among women living with HIV, with limited access to radiotherapy further compounding treatment challenges. Despite this documented disparity, limited data exist on patients in a South African context. This protocol describes the research methodology to assess patterns of care, treatment delays, interruptions and survival outcomes in patients with advanced CaCx, addressing an urgent need for local data in low-income and middle-income countries to provide evidence-based improvements in care.
The Cervical Cancer Cohort at Charlotte Maxeke Johannesburg Academic Hospital (CMJAH-CCC), initiated in 2023, is a mixed retrospective and prospective single-centre study investigating the characteristics, challenges and outcomes of patients with advanced CaCx. It includes women aged ≥18 years with a histopathological diagnosis of stage IB3–IVA CaCx treated at CMJAH Radiation Oncology. The retrospective component covers data from September 2018 to August 2023. Data collection is complete and the team is currently conducting quality control. The prospective component began in October 2023 and aims to enrol participants over 2 years, with follow-up for up to 3 years. The study is ongoing, and an extension for continued enrolment beyond September 2025 is being sought. Participants provide baseline data on demographics, socioeconomic status, cultural influences and healthcare access, with updates every 3 months. When necessary, the next of kin provides follow-up information. The study aims to inform strategies to improve outcomes and reduce the CaCx burden in South Africa.
Ethics approval for this study was obtained from the Human Research Ethics Committee (Medical) at the University of the Witwatersrand in Johannesburg, South Africa, with an ethical clearance certificate (MM221001 MED22-09-085). The results will be widely distributed through presentations at national and international conferences and published in peer-reviewed open-access journals, ensuring wide access to the results.
Monitoring physical rehabilitation is an essential component of patient recovery after knee arthroplasty. Monitoring can be remote, or clinic based. In India, unsupervised home-based physical rehabilitation is a common practice, but there is a lack of evidence to demonstrate the effectiveness of remote monitoring. Therefore, we developed and piloted a mobile application (TeleREhabilitation after knee ArThroplasty app) based on behaviour design thinking to support the recovery period. This trial aims to compare the effectiveness, acceptability, cost and safety of this app-supported home-based intervention against usual care using an open label, 1:1 individual randomised superiority trial at two tertiary care hospitals in India.
Consecutive adults undergoing partial or total, unilateral or bilateral knee arthroplasty who can use a smart phone will be invited to participate in this trial. Consenting individuals will be randomised to either an app-supported intervention or a usual home-based rehabilitation which typically consists of provision of oral or written instructions at discharge and follow-up check-up with the surgeon or physiotherapist at their discretion or as per individual need. We aim to recruit 300 individuals over a period of eighteen months. The primary objective is to compare patient-reported knee function between the two groups at 3 and 6 months postsurgery. Secondary objectives are to compare patient-reported outcomes (pain and activity), performance-based outcomes (lower limb strength and knee function), resource utilisation and quality of life. Fidelity of implementation, end-user experiences and challenges in implementing this intervention will be measured using both quantitative and qualitative methods. Quantitative data will be analysed in Stata, and group comparisons will be done using mixed effect linear regression. A mixed-methods approach will be used to analyse and interpret the process evaluation data. A modified intention-to-treat approach will be taken, which includes all those who were randomised irrespective of their adherence to trial protocol if they had at least one follow-up visit after enrolment.
The protocol has been approved by the ethics committees of the sponsor institute (The George Institute for Global Health) and the two clinical sites (All India Institute for Medical Sciences, Delhi & Indraprastha Apollo Hospitals, Delhi). The results will be disseminated via peer-reviewed publications, conference presentations and via plain language newsletters to the trial participants.
CTRI/2024/06/068838.
Imposter Phenomenon is characterised by persistent self-doubt despite objective success. It has been associated with anxiety, burnout and reduced job satisfaction. Little is known about imposter phenomenon’s presence and impact in Trauma and Orthopaedic surgery. This study aims to determine the prevalence and predictors of Imposter Phenomenon among UK orthopaedic surgeons, further mapping domains that affect leadership and professional development.
Cross-sectional survey using the validated Clance Imposter Phenomenon Scale (CIPS).
The survey was distributed to UK orthopaedic surgeons between 20 October 2023 and 28 February 2024 via Training Programme Directors and the British Orthopaedic Association.
Orthopaedic trainees and consultant surgeons (n=441)
Imposter Phenomenon severity measured using CIPS (mild: 41–60, moderate: 61–80 and severe: 81–100). Univariate and multivariate analyses identified predictors of this severity. Self-reported impact of Imposter Phenomenon assessed across personal and leadership domains.
92% of respondents reported moderate to intense Imposter Phenomenon symptoms (mean CIPS=65.17). Trainees had significantly higher mean scores (70.64±13.85) compared with consultants (59.82±15.71). Female surgeons reported significantly higher mean scores (72.57±13.35) than male surgeons (61.19±15.74). Female gender, non-consultant training grade and time out of training were predictors of severity (p
The Imposter Phenomenon is highly prevalent among UK orthopaedic surgeons; disproportionately affecting women, trainees and those taking career breaks. Imposter Phenomenon significantly impacts leadership aspirations and career development, potentially contributing to reduced diversity in surgical leadership. Targeted interventions addressing Imposter Phenomenon are needed to support equitable leadership development in Trauma and Orthopaedic surgery.