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Efficacy, moderators and mediators of cognitive behavioural analysis system of psychotherapy (CBASP) versus behavioural activation (BA) in persistently depressed treatment-resistant inpatients: study protocol for the multicentre, randomised controlled cha

Por: Brakemeier · E.-L. · Klein · J. P. · Zimmermann · J. · Hollandt · M. · Reinhard · M. A. · Boger · S. · Daldrup · L. · Eldem · L. · Gebhardt · P. · Heinrich · S. · Hirsmueller · M. · Millerowski · J. · Richter · M. · Ridderbusch · I. C. · Suerig · S. · Schroeter · L. · Velten-Schurian
Introduction

Up to 30% of individuals with depression develop persistent depressive disorder (PDD), an often disabling and difficult to treat condition. The Cognitive Behavioural Analysis System of Psychotherapy (CBASP) is the only psychotherapy developed specifically for treating individuals with PDD. While several randomised controlled trials (RCTs) have demonstrated its efficacy in outpatient settings, evidence for its use in inpatient settings remains limited. Pilot studies of CBASP inpatient programmes in Germany have shown promising feasibility and effectiveness; however, no RCTs to date have systematically evaluated their outcomes. This study represents the first RCT to compare the short- and long-term efficacy and safety of CBASP with Behavioural Activation (BA), a first-line psychotherapy for depression, within an intensive multimodal inpatient setting.

Methods and analysis

In this prospective, multicentre, rater-blinded RCT with an active control group, we aim to recruit 396 adults (aged 18–70 years) with treatment-resistant PDD at eight German university hospitals. Participants will be randomly assigned to receive either (1) CBASP or (2) BA within an intensive treatment programme consisting of 10 weeks acute treatment in an inpatient and/or day clinic setting, followed by 6 weeks of outpatient continuation treatment. Primary and secondary outcome assessments will be conducted at multiple time points: baseline (T0), treatment onset (T1), after 5 and 10 weeks of acute treatment (T2, T3), at the end of continuation treatment (T4, week 16) and every 2 months up to week 64 (T5, naturalistic follow-up).

The primary outcome measure will be the change in depression severity, as assessed by the Hamilton Depression Rating Scale (24-item version), after 16 weeks of treatment (from T0 to T4). Secondary outcomes will include response, remission, deterioration and relapse rates, self-reported depression and anxiety symptoms and additional psychological variables. A cost-benefit analysis will evaluate the health-economic benefits of both interventions. Additionally, this RCT will explore personalised treatment selection and mechanisms of change, including potential moderators and mediators of treatment effects. The findings from this trial are expected to provide clinicians with evidence-based guidance on choosing CBASP versus BA for inpatients with treatment-resistant PDD.

Ethics and dissemination

This study has received ethical approval from the ethics committees of all participating university hospitals. All participants will provide written informed consent before enrolment. Study findings will be published in peer-reviewed journals and presented at national and international conferences. We have involved people with lived experience from the earliest pilots onward, using their feedback to refine our study design. Ongoing consultation at conferences and public events has further ensured that our research remains grounded in patient perspectives.

Trial registration number

NCT04996433.

Nurse Educators' Background, Education, and Experience in Digital Competence Profiles: A Descriptive Comparative Cross‐Sectional Study in Four Countries

ABSTRACT

Aim

To identify and compare the digital competence profiles of nurse educators, the background variables associated with profiles, and the self-assessed level of digital competence in four European countries.

Design

A descriptive comparative cross-sectional study.

Methods

Data were collected from nurse educators (n = 263) in 36 nursing education organisations in Finland, Malta, Slovakia and Spain. Partitioning around medoids (PAM) clustering was used to identify competence groups, and descriptive and inferential statistics were used to examine the association of nurse educators' background variables.

Results

The clustering analysis resulted in two nurse educator digital competence profile groups: high and moderate. The profiles differed based on completed pedagogical studies and teaching experience, with an emphasis on the high competence profile. Educators in the high competence profile group showed greater interest in using educational technology and self assessed their digital competence at a higher level compared to educators in the moderate competence profile group. Nurse educators' lowest digital competence was in the safe and responsible use of technology, such as knowing copyright laws.

Conclusion

Despite the heterogeneous background of nurse educators, international continuing professional development needs in digital competence are identified. Nurse educators' continuing education should support the utilisation of technology through pedagogical approaches, and educators' competence in the safe and responsible use of technology (e.g., how to protect digital materials) must be enhanced in nursing education organisations.

Implications for the Profession

This study highlights the need to further develop nurse educators' digital competence. Continuing professional development should target preparation in safe and responsible technology use and include pedagogical studies and mentoring from experienced peers.

Reporting Method

The STROBE checklist was adhered to in reporting the results.

Patient or Public Contribution

Each participating educational organisation assigned a contact person to distribute the survey to the nurse educators.

Understanding influences of care-seeking behaviours for diarrhoeal illnesses: a qualitative meta-synthesis

Por: Miller · M. H. · Hilbert · S. M. · Rosser · E. N. · Sinko · L. · Lee · E. C. · Wiens · K. E.
Objectives

Diarrhoeal illnesses remain a leading cause of morbidity and mortality worldwide. Understanding when and where individuals seek healthcare is essential for accurately assessing disease burden and improving access to appropriate care. We conducted a meta-synthesis of qualitative research examining barriers and facilitators to care-seeking for diarrhoeal illness among individuals and caregivers of children.

Design

We systematically reviewed qualitative studies examining the motivations for seeking care for diarrhoeal illness and conducted a thematic analysis to synthesise findings across studies.

Data sources

PubMed, Embase, Web of Science and Global Index Medicus were searched through 3 September 2024.

Eligibility criteria for selecting studies

We included qualitative studies that used interviews and/or focus group discussions to examine care-seeking decisions for diarrhoeal illness.

Data extraction and synthesis

Two independent reviewers assessed studies for eligibility, extracted study information and coded factors influencing care-seeking decisions. The two researchers then independently created thematic trees based on patterns in the coded data and, through discussion with the full research team, synthesised findings into a thematic framework.

Results

In total, 47 studies met our inclusion criteria, 36 of which focused on caregiver decision-making for children with diarrhoea in low- and middle-income countries. Our meta-synthesis identified several key factors that influenced whether and when individuals sought care. Sociocultural norms, including locally held beliefs about disease causation, were frequently cited as influencing decisions to seek or delay formal care. Additional barriers included long travel distances to health facilities, transportation costs, limited trust in healthcare providers, negative feelings and inconsistent availability of care. Conversely, episodes perceived as severe were more likely to prompt care-seeking outside the home.

Conclusions

These findings highlight the importance of contextually grounded interventions that improve physical and financial access to care, foster trust in healthcare providers through consistent and effective service delivery and strengthen community engagement around recognising signs of severe illness and the potential benefits of timely treatment. They also underscore the need for future studies to define diarrhoea in locally relevant terms and to clearly define sources of care-seeking, as variation in these definitions can limit our full understanding of who is affected and how individuals respond to illness.

Health visitor and community health nurse perspectives of supporting parents caring for unsettled babies: a qualitative interview study

Por: Smith · L. · Hornsey · S. J. · Latter · S. · Dobson · A. · Miller · S. · Henaghan-Sykes · K. · Adams · S. · Santer · M. · Muller · I.
Objectives

The aims of this study were to explore how health visitors (HVs) and community health nurses (CHNs) assess unsettled baby behaviours, how their perceptions of these behaviours influence decisions about support offered, and how able they feel to deliver support to families of unsettled babies.

Design

Qualitative semi-structured interviews were conducted, recorded and transcribed. Data were analysed using Reflexive Thematic Analysis.

Setting

Potential participants were invited nationally via social media and via Health Visiting Service managers from an NHS Trust. Interviews took place remotely.

Participants

17 HVs and 3 CHNs were purposively selected to include a wide range of perspectives.

Results

Three themes were developed, (1) HVs’ perceptions of parents’ sense-making which explains how HVs/CHNs understand parents’ beliefs around unsettled babies; (2) care pathway which highlights the importance HVs place on creating emotional space for the baby, the parent and the health visitor within the pathway (containment); and (3) service delivery decline, which outlines the impact of funding cuts to the services on the HVs’ ability to provide support for families. Lastly, a new concept – the Tipping Point model - was created to holistically conceptualise the experiences of HVs providing support for unsettled babies in the UK.

Conclusions

Policy makers need to organise services to value and support the role of the health visiting team in ‘containment’. HVs identified a training need around assessing and advising about unsettled babies to place them in a stronger position to support families. Further research is needed into different models of support for families of unsettled babies from the wider primary care team and/or from digital services.

Pathogenic bacterial species and the microbiome of cat fleas (<i>Ctenocephalides felis</i>) inhabiting flea-infested homes

by Taylor E. Gin, Charlotte O. Moore, Trey Tomlinson, Grace Wilson, Amiah Gray, Cameron Sutherland, Kamilyah Miller, Krista Li, Michael Canfield, Brian Herrin, Erin Lashnits, Benjamin Callahan

Background

Ctenocephalides felis is a common ectoparasite of dogs and cats and can transmit a variety of pathogens including Bartonella and Rickettsia species. These bacteria, along with the known endosymbiont Wolbachia, are well-documented members of the C. felis microbiome, but species-level information is limited. Additionally, little is known about the variation in the C. felis microbiome in fleas from different sources and when different sequencing methods are applied to the same samples.

Objective

This study aimed to characterize the flea microbiome using both short-read (V3/V4) and long-read (full-length) 16S rRNA gene sequencing, determine whether long-read sequencing improves species-level identification especially in known pathogenic genera, and evaluate differences in microbial composition between fleas collected from cats, dogs, and environmental traps.

Methods

Fleas were collected from cats, dogs, and traps in flea-infested homes in Florida, pooled by source, and sequenced using short- (V3/V4) and long-read (full-length) 16S rRNA gene sequencing. Microbial prevalence and abundance were compared across sequencing approaches. Community composition was evaluated for differences between sources and houses. Candidate members of the flea microbiome were identified based on a combination of prevalence, abundance, and statistical signatures of potential contaminant origin. For Rickettsia and Bartonella, species-level taxonomic assignments were refined using a phylogenetic approach.

Results

Wolbachia, Rickettsia, and Bartonella were the most prevalent and abundant taxa. Spiroplasma was identified as a fourth core member of the flea microbiome. Long-read sequencing enabled better, but not perfect, species-level classification of Bartonella and Rickettsia compared to short-read sequencing. Important relationships between specific ASVs and flea sources were identified, for example fleas from cats harbored higher abundances of B. clarridgeiae and B. henselae than fleas from traps.

Culture media affects accuracy of prediction of metallo-β-lactamases mediated resistance to imipenem

by Kexuan Chen, Sarah Miller, Kristine Goy, Tina Lam, Marlène Maeusli, Rosemary She, Brad Spellberg, Brian Luna

Metallo-β-lactamases (MBLs) hydrolyze the beta-lactam ring in beta-lactam antibiotics, rendering them ineffective. Infections caused by MBL-harboring bacteria result in higher mortality, more costs and prolonged hospital stays due to the limited treatment options. Recently, antimicrobial susceptibility testing using RPMI-1640 has been found to have more accuracy in predicting in vivo efficacy due to its zinc deficiency. We sought to expand the previous studies of accessing in vivo efficacy using zinc-limited media versus conventional media to more antimicrobial agents and MBL-producing strains. The susceptibility of isolates was determined by performing minimum inhibitory concentration (MIC) assays using traditional cation-adjusted Mueller Hinton broth (CAMHB) or zinc-limited media. In vivo outcomes were evaluated using the Galleria mellonella infection model and neutropenic mouse thigh infection model. The MICs of MBL-harboring strains decreased in zinc-limited media compared to in nutrient-rich media, suggesting susceptibility of a subset of resistant strains when tested in zinc-limited media. Notably, we observed statistically significant MICs decreasing against imipenem, which demonstrated the best efficacy among the six tested antibiotics. Additionally, the outcomes of in vivo tests in both the G. mellonella model and the mouse model were better predicted with in vitro MIC assays performing in zinc-limited media. The use of zinc-limited media may lead to increased accuracy of the prediction of in vivo efficacy of beta-lactams against MBL-harboring bacteria.

Student Perceptions of Interprofessional Education Innovation to Address Pain Management and Substance Use: A Qualitative Descriptive Analysis

ABSTRACT

Aims

The aim of this study was to understand student perspectives regarding an interprofessional education (IPE) innovation using a single standardised patient (SP) in a large-group setting for a pain management and substance use simulation.

Design

A qualitative descriptive design was used.

Method

Students representing eight health science programs from four universities were invited to participate in a simulation-based IPE program blending asynchronous and synchronous learning. DNP students were one of the largest professions represented (n = 92, 30%) along with students enrolled in Doctor of Pharmacy (n = 111) and Doctor of Medicine (n = 69) programs. Students were invited to complete a post-activity survey asking what parts of the IPE activity were most valued and what could be improved. Student responses were themed using a qualitative descriptive approach with inductive coding and constant comparison.

Results

Of 304 participating students, 155 (51%) responded to one or both open-ended questions. Respondents highly valued interprofessional team diversity. Responses highlighted the importance of: (1) using simulation with student teams to foster active learning, (2) student preparation using relevant curricular resources and (3) grounding interprofessional collaboration activities in student engagement and professional respect.

Conclusion

Findings confirmed that a cost-effective IPE activity using one SP within deliberately planned interprofessional activities can be engaging and meaningful. Students valued team-based collaboration across the disciplines of nursing, pharmacy and medicine.

Impact

Educators gathered evidence on the merits of a replicable, cost-effective IPE structure intended to expand team-based simulation learning opportunities. High-priority public health topics such as pain and substance use require multidisciplinary, integrative care to maximise health outcomes. To better prepare nurses and their health science collaborators, novel pedagogy in IPE may optimise student learning experiences.

Reporting Method

We followed the Standards for Reporting Qualitative Research (SRQR).

Patient or Public Contribution

Health sciences faculty served as facilitators in the IPE sessions. Facilitators were provided 1 h of training and observed student team breakout rooms to ensure that students were engaged and understood the assigned task. They provided feedback to session leaders after the sessions.

Moral Distress Among Family Caregivers: A Concept Analysis

ABSTRACT

Aim

To examine and define the concept of moral distress among family caregivers by identifying its key attributes, antecedents and consequences.

Design

Concept analysis.

Methods

This study was guided by Walker and Avant's concept analysis framework. A comprehensive literature search was conducted to identify relevant studies, with 12 articles included in this analysis.

Data Sources

PubMed, CINAHL, Scopus and PsycINFO databases were searched for articles published between February 2000 and May 2025.

Results

Three defining attributes of moral distress in family caregivers were identified: self-directed negative emotions, internal conflict and feelings of powerlessness and helplessness. Antecedents included caregiving burden, role conflict, ethical dilemmas, complex decision-making and internal and external constraints. Consequences encompassed long-term health effects, social withdrawal, burnout and moral residue. These findings led to a conceptual definition of moral distress in family caregivers.

Conclusion

Moral distress in family caregivers is a significant and underrecognised issue that affects caregiver well-being and the quality of care they provide. This concept analysis offers a clear conceptual definition, providing a foundation for developing research instruments and interventions.

Implications for the Profession and/or Patient Care

Healthcare professionals should recognise moral distress in family caregivers as a key factor impacting both caregiver well-being and patient care. Support through education, counselling and peer groups can reduce moral distress and foster more ethical, collaborative care environments.

Impact

This study addressed the lack of clarity surrounding moral distress in family caregivers. It identified key attributes, antecedents, and consequences, and developed a clear conceptual definition. These insights will inform research, practice and policy. The findings will benefit caregivers, improve patient care and support healthcare teams.

Reporting Method

This study followed Walker and Avant's framework and employed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines in article selection.

Patient or Public Contribution

No patient or public involvement.

Temperature-dependence of early development of zebrafish and the consequences for laboratory use and animal welfare

by Angelina Miller, Katja Lisa Schröder, Karsten Eike Braun, Caitlin Steindorf, Richard Ottermanns, Martina Roß-Nickoll, Henner Hollert, Thomas Backhaus

Zebrafish (Danio rerio) are widely used in biological research, but the impact of incubation temperatures on developmental endpoints is still insufficiently studied. This study quantifies developmental differences in zebrafish embryos incubated at 26°C and 28°C, focusing on key endpoints (heartbeat onset, hatching time, eye size, yolk sac consumption, and body length). For this purpose, we recorded a high-resolution time series comprising hourly observations of early developmental stages and key events and bi-hourly observations of body length until 120 hours post fertilization. Additionally, we recorded a low-resolution time series at 72, 96, and 119 hours post fertilization for detailed measurements of eye size, yolk sac area, and body length. Embryos incubated at 26°C showed consistent delays in developmental stages compared to those at 28°C, with delays becoming more pronounced at later stages. Yolk sac consumption was delayed by about 19.8 hours at 26°C by 119 hours post fertilization, suggesting a delayed onset of independent feeding. These findings suggest that time-based regulatory limits for rearing zebrafish, such as the 120-hour threshold in German regulations (TierSchVerV), do not fully account for temperature-dependent development. The results emphasize the need for guidelines linking incubation temperatures to developmental progress.

Redirecting patients from the pediatric emergency department to community locations for care: A qualitative study of healthcare professional and leader perspectives

by Erica Qureshi, Quynh Doan, Jessica Moe, Steven P. Miller, Garth Meckler, Brett Burstein, Jehannine (J9) Austin

Objectives

Emergency department (ED) to community (ED2C) programs, which redirect patients from the pediatric ED to community healthcare professionals represent a promising strategy to reduce the impact of non-urgent visits on the pediatric ED. Given an ED2C program’s potential impact on various care professionals, we completed a qualitative study to explore key informants’ attitudes and perceptions of pediatric ED2C programs.

Methods

We conducted one-on-one semi-structured interviews with key informants in British Columbia, Canada. Participants included: pediatric ED staff – triage nurses and physicians; community professionals – pediatricians and family physicians; and health system leaders responsible for pediatric and emergency care in British Columbia. Interviews were recorded, transcribed verbatim, de-identified, and analyzed using reflexive thematic analysis within an interpretive description framework. A visual model was developed to depict key themes in attitudes and perceptions towards pediatric ED2C programs.

Results

We interviewed 24 participants: 6 community professionals, 11 pediatric ED professionals, and 7 healthcare leaders. Participants viewed the ED2C program as a valuable solution to address pediatric system strain provided that systemic barriers are addressed, and both emergency and community settings are equipped with adequate training and resources. Participants emphasized the need for clear guidelines on eligibility and operations to build confidence and enhance program effectiveness.

Conclusions

Our findings suggest there is support for ED2C programs as a means to reduce the impact of non-urgent pediatric ED visits and strengthen community-based care. Successful implementation will require coordinated planning, resource investment, and clear operational frameworks.

Efficacy of an acute bout of isometric wall squat exercise on pain sensitivity and clinical pain intensity in adults with knee osteoarthritis: a randomised controlled trial in outpatient physiotherapy clinics in Saudi Arabia

Por: Zabarmawi · J. · Miller · C. T. · Owen · P. J. · Mundell · N. L. · Meny · A. · Aldhafri · S. · Banjar · R. · Alzahrani · H.
Objective

To investigate the efficacy of two volumes of acute isometric wall squat exercise on pain sensitivity (primary outcome: pressure pain threshold (PPT)) and intensity (secondary outcome) in adults with knee osteoarthritis.

Design

A parallel-group randomised controlled trial.

Setting

Outpatient physiotherapy clinics at hospitals in Saudi Arabia.

Participants

Participants (n = 90; mean (SD) age 49.0 (13.0) years) with chronic knee osteoarthritis, diagnosed by a specialist orthopaedic physician using radiographic evidence and clinical judgement, were recruited via two tertiary hospitals in Saudi Arabia.

Intervention

Participants were stratified by sex and randomly allocated to one of three groups: isometric single-repetition wall-squat (ISO-SR; one repetition of a 3-min wall squat or to volitional fatigue at a 100° knee joint angle), isometric multiple-repetition wall-squat (ISO-MR; three repetitions of the same intervention) and control (quiet sitting for 7 min).

Primary and secondary outcome measures

PPT was measured at the calf (primary site of interest), lumbar spine and forearm using a pressure algometer. Pain intensity was assessed using a visual analogue scale. Primary analyses compared changes between intervention and control groups. All participants were included in the ITT analysis.

Results

The ISO-MR group had higher mean PPT ratings immediately postintervention in the calf (mean difference=9.4 (95% CI 5.6 to 13.2), p

Conclusions

Both the ISO-SR and ISO-MR exercises to volitional fatigue reduced pain sensitivity in patients with knee osteoarthritis. Neither exercise volume changed clinical pain intensity.

Trial registration number

ClinicalTrials.gov registry (ID: NCT05605444).

Trajectories of Recovery after ACutE and cRitical illness (TRACER): a prospective observational study protocol

Por: Gonzalez-Seguel · F. · Summers · L. A. · Fresenko · L. E. · Long · D. E. · Scott · L. N. · Slone · S. A. · Shankara Bhaktula · S. · Wen · Y. · Miller · B. F. · Morris · P. E. · Salyer · A. L. · Kalema · A. G. · Montgomery-Yates · A. A. · Dupont-Versteegden · E. E. · Mayer · K. P. · T
Introduction

Patients who survive admission to intensive care unit (ICU) for critical illness are at high risk of developing muscle atrophy and weakness, commonly diagnosed as ICU-acquired weakness (ICUAW). The development of ICUAW is closely linked to long-term symptoms and impairments known as post-intensive care syndrome (PICS). Despite heightened recognition of impairments, there is limited research supporting effective interventions to improve muscle and physical outcomes after hospital discharge. Prior to developing and testing interventions for ICU survivors, it is imperative to understand the trajectory of muscle and physical function recovery following an ICU stay. The purpose of this study is to longitudinally investigate skeletal muscle health and physical function outcomes after ICU admission.

Methods and analysis

This protocol describes a single site, prospective, observational study in adult patients who have survived a critical illness (ie, sepsis or acute respiratory failure). Patients will participate in a battery of testing including primary outcomes: muscle power and physical function; and secondary outcomes: muscle strength, muscle size, endurance and physical activity (by accelerometry) at hospital discharge and 3, 6, and 12 months post-discharge. A subset of patients will participate in muscle biopsy and venipuncture. To examine if the trajectory of recovery predicts primary outcomes, we will perform multivariate linear regression models in 150 evaluable patients. To examine differences in molecular and cellular outcomes in plasma and muscle tissue, a control group of community-dwelling adults without history of an ICU stay will be enrolled as a comparator group. Enrolment started on 18 October 2022 with an estimated completion date of 1 August 2027.

Ethics and dissemination

This protocol was approved by the University of Kentucky Office of Research Integrity Medical Internal Review Board (# 77407), with patients providing informed written consent. We anticipate our findings to establish recovery trajectories, improving the classification of patients who experience sustained physical disability. Improved identification of recovery trajectories of muscle and physical function enables future studies to employ an individually targeted rehabilitation approach, that is, precision medicine, with the goal of improving patient outcomes. The cellular findings will support the development of novel interventions specifically designed for detecting underlying mechanisms. We intend to disseminate findings to patients, healthcare professionals, the public and other relevant groups via conference presentations and manuscripts without publication restrictions.

Trial registration number

NCT05537298.

Pursuing Reduction in Fatigue After COVID-19 via Exercise and Rehabilitation (PREFACER): a protocol for a randomised feasibility trial

Por: Billias · N. · Pouliopoulou · D. V. · Lawson · A. · DAlessandro · V. · Bryant · D. M. · Peters · S. · Rushton · A. B. · Miller · E. · Brunton · L. · McGuire · S. · Nicholson · M. · Birmingham · T. B. · MacDermid · J. C. · Quinn · K. L. · Razak · F. · Goulding · S. · Galiatsatos · P. · Sa
Introduction

Over 777 million COVID-19 infections have occurred globally, with data suggesting that 10%–20% of those infected develop Long COVID. Fatigue is one of the most common and disabling symptoms of Long COVID. We aim to assess the feasibility and safety of a new, remotely delivered, multimodal rehabilitation intervention, paced to prevent post-exertional malaise (PEM), to support the conduct of a future, definitive randomised trial.

Methods and analysis

We will conduct a randomised, two-arm feasibility trial (COVIDEx intervention vs usual care). Sixty participants with Long COVID will be recruited and randomised prior to giving informed consent under a modified Zelen design using 1:1 allocation with random permuted blocks via central randomisation to receive either the COVIDEx intervention or usual care. The 50-minute, remotely delivered, COVIDEx intervention will occur twice weekly for 8 weeks. All participants will wear a non-invasive device throughout their entire study participation, to track heart rate, blood oxygen saturation, steps, sleep and monitor PEM. The primary feasibility objectives will be recruitment rates, intervention fidelity, adherence, acceptability (intervention and design), retention, blinding success and outcome completeness. Secondary objectives will include refined estimates for the standard deviation and correlation between baseline and follow-up measurements of fatigue. Feasibility and clinical outcomes will be collected at baseline, 4, 8, 12 and 24 weeks. Qualitative interviews with participants and physiotherapists will explore intervention acceptability and barriers/facilitators.

Ethics and dissemination

Ethical approval for this study was obtained by the Western University Health Sciences Research Ethics Board (REB# 123902). Dissemination plans include sharing of trial findings at conferences and through open access publications and patient/community channels.

Trial registration number

NCT06156176

Changes in Breastfeeding Relationships When Frontline Essential Working Mothers Return to Work During the COVID‐19 Pandemic: A Longitudinal Qualitative Online Study

ABSTRACT

Aims

Many frontline essential working mothers returned to work outside of the home after maternity leave during the COVID-19 pandemic. The purpose of this study is to describe the changes in breastfeeding relationships.

Design

A longitudinal descriptive qualitative design was used.

Methods

Four open-ended questions were asked to explore breastfeeding experiences at home, mothers' thoughts and feelings during direct breastfeeding, strategies to solve their breastfeeding problems, and workplace breastfeeding support. Data were collected by an online survey at 1, 3, 5 and 6 months between June 2022 and August 2023. Data were analysed using inductive content analysis from 21 mothers in the United States who were directly breastfeeding at least once a day for the first 6 months. The trustworthiness of study results involved coding by consensus, peer debriefing, and maintenance of an audit trial.

Results

The core construct, “Changes in Breastfeeding Relationships When Frontline Essential Working Mothers Return to Work Outside of the Home” explained mothers' experience in four domains: (1) Breastfeeding changes, (2) Changes in sleep arrangements, (3) Social support to continue breastfeeding, and (4) Physical and emotional distress of mothers and infants.

Conclusion

Unrestricted direct breastfeeding upon reunion through the night along with co-sleeping was the strategy mothers used to restore breastfeeding relationships with their infants and continue direct breastfeeding. Scheduled feeding and solitary sleep resulted in less direct breastfeeding, had negative consequences such as low milk supply, slow infant weight gain, and maternal distress.

Impact

Even though frontline essential working mothers persevered with the complexities of their work during the COVID-19 pandemic, findings highlight challenges mothers faced with their breastfeeding experience. Nurses need to discuss with mothers expected challenges of less frequent direct breastfeeding along with emotional tolls while being separated from their infant and strategies to develop sustainable breastfeeding relationships and continuation of direct breastfeeding.

Patient or Public Contributions

None.

Evaluating the prognostic association between race and perineal trauma: a systematic review protocol

Por: Almalki · H. H. · Mowbray · F. I. · Buchholz · S. · Alnaimi · I. · Schlegel · E. C. · Miller · J. · Sender · J.
Introduction

Perineal trauma is one of the most common complications of childbirth, impacting approximately 9 out of 10 women who undergo a vaginal delivery. Perineal trauma is a public health issue leading to increased maternal morbidity and decreased quality of life. Although race is being studied as a potential risk factor and predictor of perineal trauma, other contributing factors like racism and social determinants of health have not been adequately studied in the same context. We set out to synthesise the available peer-reviewed evidence evaluating the prognostic association between race and perineal trauma.

Methods and analysis

This systematic review and meta-analysis adheres to the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) and PROGRESS (Prognosis Research Strategy) guidelines and is registered with PROSPERO. The review explores the association between racial status (non-Hispanic white vs non-white) and perineal birth trauma using the PECOTS (Population, Intervention/Exposure, Comparator, Outcome, Timing and Setting) framework. We will search PubMed, CINAHL, Web of Science and Embase. Peer-reviewed observational studies will be included. Data extraction and screening will be done in duplicate. Analyses will use random-effects models in R, reporting both unadjusted and adjusted risk differences. Risk of bias will be assessed using ROBINS-I (Risk of Bias in Non-randomised Studies of Interventions). Heterogeneity and certainty of evidence will be evaluated using I² and GRADE (Grading of Recommendations Assessment, Development and Evaluation), respectively.

Ethics and dissemination

This is a systematic review based on previously published data, and therefore ethical approval is not required. The findings of this review will be disseminated through publication in a peer-reviewed journal and presented at academic conferences.

PROSPERO registration number

CRD42025590093.

Personalised Exercise Rehabilitation FOR people with Multiple long-term conditions (PERFORM): findings from a process evaluation of a randomised feasibility study

Por: Brown · S. E. · Simpson · S. A. A. · Greaves · C. · Daw · P. · Dean · S. G. · Evans · R. A. · Withers · T. M. · Ahmed · Z. · Barber · S. · Barwell · G. · Doherty · P. J. · Gardiner · N. · Ibbotson · T. · Jani · B. · Jolly · K. · Mair · F. · Manifield · J. R. · McIntosh · E. · Miller · D. · O
Objective

The number of people living with multiple long-term conditions (MLTCs or ‘multimorbidity’) is growing. Evidence indicates that exercise-based rehabilitation can improve health-related quality of life and reduce hospital admissions for a number of single long-term conditions. However, it is increasingly recognised that such condition-focused rehabilitation programmes do not meet the needs of people living with MLTCs. The aims for this study were to (1) evaluate the acceptability and feasibility of the newly developed Personalised Exercise Rehabilitation FOR people with Multiple long-term conditions (PERFORM) intervention; (2) assess the feasibility of study methods to inform progression to a definitive randomised controlled trial (RCT) and (3) refine our intervention programme theory.

Design

Semi-structured qualitative interviews were conducted with patients receiving and healthcare practitioners delivering the PERFORM intervention, to seek their experiences of the intervention and taking part in the study. Interviews were analysed thematically, informed by Normalisation Process Theory and the programme theory.

Setting

Three UK sites (two acute hospital settings, one community-based healthcare setting).

Participants

18 of the 60 PERFORM participants and 6 healthcare professionals were interviewed.

Intervention

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

Results

All participants and staff interviewed found PERFORM useful for physical and mental well-being and noted positive impacts of participation, although some specific modifications to the intervention delivery and training and study methods were identified. Scheduling, staffing and space limitations were barriers that must be considered for future evaluation and implementation. Key intervention mechanisms identified were social support, patient education, building routines and habits, as well as support from healthcare professionals.

Conclusions

We found the PERFORM intervention to be acceptable and feasible, with the potential to improve the health and well-being of people with MLTCs. The findings of the process evaluation inform the future delivery of the PERFORM intervention and the design of our planned full RCT. A definitive trial is needed to assess the clinical and cost-effectiveness.

Trial registration number

ISRCTN68786622.

Experiences of using a physical activity and exercise digital intervention to reduce respiratory tract infections: a qualitative process evaluation

Por: Dennis · A. · Joseph · J. · Greenwell · K. · Miller · S. · Vennik · J. · Dennison · L. · Holt · S. · Bradbury · K. · Ainsworth · B. · Yardley · L. · Little · P. · Geraghty · A. W. A.
Objectives

Increasing physical activity and effectively managing stress can positively impact immunity and may reduce the duration of respiratory tract infections (RTIs). As part of a larger trial, participants accessed a digital behavioural change intervention that encouraged physical activity and stress management to reduce RTIs. We aimed to understand the barriers and facilitators to engaging in physical activity and stress reduction.

Design

A qualitative process analysis from semistructured interviews of the behavioural intervention in a randomised control trial.

Setting

Primary care in the UK.

Participants

34 participants (aged 18–82 years) in the behavioural intervention arm.

Interventions

The larger trial involved four interventions: a gel-based antiviral nasal spray; a saline water-based nasal spray; a behavioural intervention; usual care. In this study, we focused on participants allocated to the behavioural intervention. The behavioural intervention included two components: one to increase physical activity (getting active) and another for stress management techniques (healthy paths) to reduce RTIs.

Results

We analysed the interviews using thematic analysis with a critical realist perspective (focusing on). We developed five themes: digital intervention engagement, views on intervention allocation, the role of getting active, the role of healthy paths and benefits reinforcing behaviour. Participants’ views on the relevance and benefit of the behavioural intervention shaped their engagement with the intervention website and behaviour. Facilitators of intervention engagement included awareness of inactivity, goal setting, increasing immunity, positive outcome expectations and benefits from changing behaviour. Barriers to engagement included negative outcome expectations, such as around efficacy of the behaviours.

Conclusions

Overall, the results highlighted the importance of positive expectations for a digital intervention promoting physical activity and stress management for RTI reduction. Future interventions should consider how to clearly communicate a broad range of perceived benefits to users.

Trial registrations

The trial was prospectively registered with International Standard Randomized Controlled Trial Number (ISRCTN) registry (17936080).

Minimum effective dose of a multicomponent behaviour change intervention to increase the physical activity of individuals on primary statin therapy: an adaptive study using the time-to-event continual reassessment method (TiTE-CRM)

Por: Goodwin · A. M. · Friel · C. · Miller · D. · Vicari · F. · Duer-Hefele · J. · Chandereng · T. · Davidson · K. W. · Alfano · C. M. · Cheung · Y. K. · Butler · M. J.
Objectives

To identify the minimum effective dose of a multi-behaviour change technique (BCT) intervention to increase physical activity among individuals on primary statin therapy using the time-to-event continual reassessment method (TiTE-CRM).

Setting

A large New York metropolitan area healthcare system comprising approximately 85 000 employees and 5.5 million patient encounters annually.

Participants

42 participants enrolled in 13 cohorts of 3 participants, 1 cohort of 2 participants and 1 cohort of 1 participant. The sample was composed of 16.7% individuals aged 66 and older (n=7), 64.3% women (n=27), 69.0% white individuals (n=29) and 7.1% Hispanic individuals (n=3).

Interventions

A variable-duration, four-BCT text message intervention and a 2-week follow-up. Dose assignment relied on TiTE-CRM to adjust the duration of the intervention based on adherence of participants in prior cohorts. Five mechanisms of action (MoAs) were assessed: self-efficacy, intrinsic regulation, discrepancy in behaviour, motivation and barriers to activity.

Primary and secondary outcome measures

The primary outcome measure was the proportion of participants who achieved a 2000 step/day increase between baseline and follow-up. The secondary outcomes were within-participant changes in daily steps (examined as a continuous variable at the daily level) and potential MoAs for increased physical activity.

Results

Of the 40 participants who completed follow-up, 7 (17.5%) achieved the goal of 2000 or more steps per day during their follow-up period. Though participants did increase the number of steps they walked during the intervention (B(SE)=373.1 (154.7) steps; p=0.016), there was no association between increased intervention duration and increased daily average steps. The intervention was also associated with increases in self-efficacy (p=0.002), intrinsic regulation (p=0.037), discrepancy in behaviour (p

Conclusions

The results of this trial did not show a traditional dose-response curve to increasing the length of a multicomponent BCT intervention. Results did show that the intervention successfully increased steps during the intervention period and that the benefit of the intervention dwindled during follow-up. Further, potential MoAs for the intervention were confirmed.

Trial registration number

NCT05273723.

Understanding readmission after hip fracture: a mixed methods study protocol

Por: Sutton · E. · Rahman · U. · Reilly · H. · Miller · C. · Vedutla · T. · Melody · T. · Gudivada · R. · Topping · A. E.
Introduction

Around 75 000 people suffer from hip fractures yearly in the United Kingdom (UK) leading to significant mortality and morbidity. Although mortality has dropped from 8% to 5% between 2013 and 2023 after hip fractures, those undergoing surgery for hip fractures have a 30-day readmission rate which has remained stagnant at around 11% over the same decade in the UK.

This study protocol describes a mixed-methods investigation (The ARTHUR Study—avoiding readmission after hip fracture) which aims to understand and offer solutions to prevent avoidable 30-day readmission after hip fracture surgery. The study will focus on two hospitals in acute and community settings in a large urban and ethnically diverse city in the UK.

Methods and analysis

We describe two work packages.

Work Package One (WP1) involves analysis of 5 year’s worth of routinely collected health data provided by PIONEER, a Health Data Research UK data hub in Acute Care for our local population. Work Package Two (WP2) will involve semistructured interviews with patients, carers or family members as well as non-participant observations of hospital processes to understand systems-based issues related to readmissions after hip fracture surgery. Although recruitment may be an issue, our timeline for recruitment reflects this. We also aim to recruit a diverse population, which has often been under-represented in studies into hip fractures and aim to explore relevant interventions which can be widely generalisable.

Ethics and dissemination

This protocol was submitted via IRAS: 330074 and obtained UK NHS REC approval via the West Midlands Coventry and Warwickshire Research Ethics Committee (REC 23/WM/0242) on 25 January 2024. The results of this study will be published in relevant scientific journals and presented at orthopaedic, fragility fracture and geriatric specialty conferences and scientific meetings. A lay summary of the findings will be publicly available on the HRA website.

Longitudinal Fatigue Symptoms and Inflammatory Markers in African American Adults With Hypertension and Obstructive Sleep Apnea

imageBackground There is a dearth of research inclusive of African American adults living with obstructive sleep apnea (OSA) despite differences in symptom presentations compared to non-Hispanic White patient populations. Less is known regarding the potential effect of comorbidities, including hypertension, on commonly reported symptoms, such as fatigue, and their association with inflammatory biomarkers. Objective This longitudinal pilot study aimed to characterize fatigue symptom presentations among African American adults newly diagnosed with OSA and discern peripheral blood analytes linked to symptoms while accounting for co-occurring hypertension. Methods African American adults newly diagnosed with OSA with and without co-occurring hypertension were approached by study staff and recruited following their diagnostic visit with sleep medicine clinicians at two health systems and followed over 6 months after commencing continuous positive airway pressure treatment. Patient-Reported Outcomes Measurement Information System Fatigue surveys and plasma were collected every 3 months from 29 participants. Mixed-effects models examined changes in fatigue symptom presentations over time while accounting for plasma-based analytes and hypertension status. Results Despite higher fatigue symptom severity upon diagnosis, participants with co-occurring hypertension reported greater improvements in fatigue scores after commencing continuous positive airway pressure treatment for up to 6 months than those without hypertension. Inverse correlations were observed between fatigue scores, C-reactive protein, matrix metalloproteinase-8, and osteoprotegerin analyte levels among participants with/without hypertension. Across all participants, changes in interleukin-6 were associated with changes in fatigue scores in the first 3 months after diagnosis. Discussion Findings indicate that hypertension is linked to increased fatigue upon diagnosis of OSA in this sample of African American adults. Fatigue in persons with hypertension improved after treatment in this sample. These hypothesis-generating findings can inform future interventional studies aimed at improving fatigue among persons with OSA while leveraging markers linked to fatigue symptom severity as potential objective markers of improvements. Further research on the role of inflammatory markers, such as IL-6, on fatigue symptom presentations is warranted in persons with OSA.
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