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Does luteal phase support in MOH-IUI treatment improve cumulative live birth rates in couples with unexplained subfertility? Study protocol of the LUMO study: a centre, randomised, double-blind, controlled trial with cost-effectiveness analysis

Por: Preesman · E. · Drechsel · K. · Crommelin · H. · Broekmans · F. · Verpoest · W. · Broer · S. · On behalf of the LUMO Study Group · LUMO Study Group · Musters · Cantineau · Heusden · Heteren · Koks · Koning · Lashley · Kuijper · Santbrink · Janse · Mol · Tecklenburg · Krom · Verhoe
Introduction

Couples diagnosed with unexplained subfertility are advised to start mild ovarian hyperstimulation and intrauterine insemination (MOH-IUI) as a primary treatment. Natural feedback mechanisms and hormone release are affected by artificially stimulated cycles and induced ovulation. Additional luteal support could positively affect progesterone patterns in the luteal phase. The LUMO study evaluates whether the addition of exogenous progesterone in the luteal phase following MOH-IUI treatment cycle will improve pregnancy and live birth rates.

Methods and analysis

A multicentre randomised, double-blind, controlled trial will be conducted in Dutch fertility clinics, academic and non-academic hospitals. There are two treatment arms: group A progesterone luteal phase support; group B placebo, without crossover. All initiated MOH-IUI cycles within 6 months after randomisation are included (study period). Participants will start study medication, applying a daily dosage of 2dd 300 mg progesterone (Utrogestan) or 2dd 300 mg placebo in vaginal capsules on the second day after the IUI procedure. Treatment is continued until the onset of menstruation, a negative pregnancy test (IUI+14 days), a miscarriage or until 7 weeks of gestation in case of a viable pregnancy. Follow-up ends at 12 months after the end of study period (18 months after study randomisation). The primary outcome is cumulative pregnancy rate, achieved within 6 months after randomisation, leading to live birth. A total of 1008 patients (504 patients in each group) will be included.

Ethics and dissemination

The study was approved by the Central Committee on Research Involving Human Subjects on 30 January 2023. All participating sites have the approval of the local Board of Directors to participate in the LUMO study. An informed consent form will be signed by all participants. Study results will be presented at (inter)national conferences and published in peer-reviewed journals. It is expected that the results of this trial will be used to draft national guidelines on this issue.

Trial registration number

The study is registered in the EU CTIS trial register (2022-501534-33-00), the Dutch trial registry (registration number: LTR 24508), ClinicalTrials.gov (NCT05080569) and the WHO registry (universal trial number: U1111-1280-9461).

Experiences of Continuity of Care Among Registered Nurses Caring for Patients With Chronic Obstructive Pulmonary Disease in Primary Care: A Qualitative Study

ABSTRACT

Aim

To explore Registered Nurses' experiences of continuity of care for patients with chronic obstructive pulmonary disease in primary care.

Design

An inductive, descriptive qualitative study.

Methods

Data were collected through semi-structured interviews with 11 purposively sampled Registered Nurses of varying levels of experience from eight regions in Sweden. The audiotaped interviews were conducted over a 5-month period (December 2023–April 2024), transcribed verbatim and analysed using interpretive description.

Results

Registered Nurses' experiences of continuity of care for patients with chronic obstructive pulmonary disease are described by three themes (seven subthemes): Patient continuity (Building personal relationships: Being accessible and enabling trust and confirmation), Collaborator continuity (Having a colleague to lean on: Colleagues can lean on me: Feeling alone with my expertise) and Continuity with myself (Trusting my own competence: Carrying a burden alone).

Reporting Method

Consolidated Criteria for Reporting Qualitative Research Guidelines.

Conclusion

This study provides an understanding of Registered Nurses' experiences of continuity of care in primary care. The results may help improve future care since nurses play an essential role in the care of chronic obstructive pulmonary disease within primary care.

Implications for the Profession and Patient Care

To enhance continuity of care for patients with chronic obstructive pulmonary disease, the relationship between the nurse and the patient is important, as is collaboration with colleagues. This collaborative approach allows these nurses to maintain continuity with both the patients and themselves, fostering a more stable and effective care environment.

Impact

This study offers valuable insights into the experiences of Registered Nurses in maintaining continuity of care within primary care, particularly for patients with chronic obstructive pulmonary disease. By highlighting the critical role of Registered Nurses in managing these patients, the study underscores the importance of strong nurse–patient relationships and effective collaboration among healthcare professionals.

Patient or Public Contribution

No Patient or Public Contribution.

Evaluation of a commercial pressure cooker for the preparation of agar media for a diagnostic microbiology laboratory

by Joseph E. Rubin, Florence Huby, Roshan P. Madalagama, Shyamali de Alwis, Melinda Wyshynski, Rasika Jinadasa

The ability to prepare sterilized media is a critical capability of any microbiology lab. Diagnostic labs in low-resource settings, which lack autoclave facilities, are therefore severely limited in their ability to perform basic assays such as bacterial culture or biochemical tests. This investigation aimed to validate the use of a commercially available pressure cooker as an autoclave substitute to produce agar plates. First, a Geobacillus stearothermophilus biological indicator was used to confirm adequate sterilization. Next, the colony morphology of several important bacterial species were compared on MacConkey and 5% sheep’s blood agar plates prepared using the pressure cooker with those made in an autoclave. Finally, disc diffusion susceptibility testing was performed to determine whether the sterilization method impacts the inhibitory zone diameters. Overall, the morphology of colonies was similar on media prepared in both ways; key phenotypic characteristics (lactose fermentation, colour, shape, hemolysis and smell) were the same. Kirby-Bauer disc diffusion test results were nearly identical. These findings indicate that a commercially available pressure cooker may be suitable to prepare media in low-resource laboratories.

Nursing Interventions to Support Family Caregivers of Patients on Haemodialysis: A Mixed‐Methods Systematic Review

ABSTRACT

Aims

To identify and synthesise nursing interventions directed at family caregivers of patients with end-stage renal disease undergoing haemodialysis.

Design

A convergent-integrated mixed-methods systematic review.

Data Sources

A comprehensive search was conducted in EBSCOHost databases (Academic Search Complete, CINAHL Complete, MEDLINE with Full Text, MedicLatina, ERIC) and the PubMed database. Studies were appraised using the Mixed-Methods Appraisal Tool (MMAT), and interventions were classified using the Cochrane Effective Practice and Organisation of Care taxonomy.

Review Methods

Quantitative data were narratively synthesised and transformed into textual descriptions to enable integration with qualitative findings. A thematic synthesis was conducted to group similar concepts.

Results

Twenty-three studies met the inclusion criteria. Most were quantitative or mixed methods with moderate-to-high methodological quality. Interventions were primarily classified as disease management (n = 10) or self-management support (n = 9). Common components included education, coping strategies, empowerment, and psychosocial support. Positive effects were observed on caregiver quality of life, anxiety, depression, and self-efficacy. Caregiver burden outcomes were mixed, potentially influenced by time and intervention intensity. Additional benefits were noted from relaxation techniques and intradialytic exercise. Qualitative data revealed culturally embedded coping strategies such as spiritual practices, time management and seeking social support.

Conclusion

Educational and empowerment-based nursing interventions—particularly those supporting dyadic coping and family-centred care—can improve caregiver outcomes. Frameworks such as the Roy Adaptation Model and the ‘Timing it Right’ approach enhance intervention design and relevance.

Impact

By addressing caregiver needs through structured education, psychosocial support and contextually sensitive approaches, nurses can mitigate caregiver burden and promote long-term caregiver well-being and patient adherence to treatment.

Patient or Public Contribution

Although patients and caregivers were not directly involved, this review contributes to improving nursing care for family caregivers of individuals with ESRD, aiming to enhance their quality of life.

Confidential Conversations in Palliative Care: An Ethnographic Exploration of Trust and Interpersonal Relationship Between Nurse and Patient

ABSTRACT

Aim

To explore aspects of interpersonal relationships in palliative care nursing, focusing on confidential conversations between patients and registered nurses (RN).

Design

A qualitative study employing focused ethnography.

Methods

Data were collected through unstructured participant observations, field notes and interviews with patients and RN in specialist palliative care. Data were analysed using reflective thematic analysis.

Findings

Confidential conversations in palliative care are founded on trust that is fragile and develops dynamically through consistent interactions. Small talk, presence and silence are essential for initiating and maintaining trust and the interpersonal relationship. The environment, patient condition and RN emotional presence and competence shape these conversations. As the relationship evolves, conversations adapt to the patient's changing needs. Missed signals or interruptions can disrupt flow, but the potential for repair remains, allowing for restoration and strengthening of trust and connection.

Conclusion

Confidential conversations in palliative care are grounded in fragile, dynamic trust, necessitating ongoing presence, sensitivity and adaptability from RN. To support these interactions, healthcare environments must prioritise privacy, relational continuity and communication training. Future research should investigate how organisational structures and clinical settings influence confidential conversations.

Implications for the Profession and/or Patient Care

Healthcare environments should facilitate confidential conversations by ensuring relational continuity and minimising distractions. Communication training that emphasises presence and management of silence can strengthen nurse–patient relationships, enhancing patient care and emotional support.

Impact

This study explores key aspects of confidential conversations in palliative care, emphasising trust and emotional sensitivity. It addresses a research gap in palliative care using rare observational methods to deepen understanding of nursing relational aspects. The findings offer practical guidance for enhancing communication and relational skills, informing training and policy development and ultimately, improving emotional support and care.

Reporting Method

Findings are reported in accordance with the Consolidated Criteria for Reporting Qualitative Research guidelines.

Patient or Public Contribution

This study did not involve patient or public participation in its design, conduct or reporting.

Cardiovascular disease and beta-cell function at diagnosis of serologically defined adult-onset type 1 and type 2 diabetes in two Swedish cohorts 15 years apart

Por: Ritsinger · V. · Gunnarsson · R. · Melin · E. · Hillman · M. · Stogianni · A. · Holmberg · S. · Johansson · K. · Nilsson Neumark · A.-S. · Krol · H. · Rööst · M. · Landin-Olsson · M. · Neumark · T. · Wanby · P. · Thunander · M.
Objectives

To describe the prevalence of cardiovascular disease (CVD) at the time of diagnosis of adult-onset type 1 (T1D) and type 2 (T2D) diabetes, in a recent cohort and compare to a previous cohort from the same region. Further, to explore factors influencing the prevalence of pre-existing CVD, including age, sex, body mass index (BMI) and C-peptide; in the later cohort also heart failure, hyperlipidaemia, tobacco use and physical activity.

Design

Two prospective cross-sectional cohort studies compared.

Setting

All primary health care centres and hospitals in Kalmar and Kronoberg counties in Southeastern Sweden.

Participants

Adults with newly diagnosed T1D or T2D (classified by combination of islet antibodies and C-peptide) in 1998–2001 and 2016–2017.

Primary and secondary outcome measures

Prevalence of hypertension and CVD at diagnosis of diabetes, and associations with beta-cell function, in two cohorts collected 15 years apart. Further, to explore factors influencing the prevalence of hypertension and CVD, and level of C-peptide.

Results

In patients with newly diagnosed T2D, mean age-at-onset had decreased (66±14.1 years vs 63±12.6, p≤0.001) and mean BMI had increased (29.0±5.4 vs 31.4±5.8 kg/m2, p≤0.001). Prevalence of pre-existing myocardial infarction had decreased in both T1D (18% vs 7%, p=0.03) and T2D (25% vs 11%, p≤0.001). Pre-existing hypertension had increased in both T1D (23% vs 40%, p=0.01) and T2D (44% vs 61%, p≤0.001). C-peptide level was lower and was associated with several cardiovascular conditions in newly diagnosed T2D in 2016–2017 (p=0.048 p≤0.001).

Conclusions

Patients with newly diagnosed T2D were younger, with higher BMI, compared with 15 years earlier, a challenge for diabetes care. Prevalence of pre-existing myocardial infarction had decreased notably, in line with, but still less than in the general population; while pre-existing hypertension had increased, in both diabetes types. C-peptide was associated with several cardiovascular conditions in newly diagnosed T2D in the recent cohort, which warrants further investigation.

Assessment of social cognition in patients with amyotrophic lateral sclerosis: protocol for a cross-sectional comparative study at Angers University Hospital

Por: Faure-de Baets · J. · Besnard · J. · Cassereau · J. · Emmelin · E. · Allain · P.
Introduction

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder primarily affecting motor neurons. In addition to motor impairments, ALS frequently involves cognitive and behavioural disturbances, including deficits in social cognition, which can impact interpersonal interactions and decision-making. Despite increasing recognition of these impairments, existing assessment tools often rely on static stimuli, limiting their ecological validity.

Methods and analysis

This cross-sectional, single-centre study aims to assess social cognition abilities in patients with ALS compared with healthy controls using a combination of dynamic and static neuropsychological tools. The primary outcome measure will be performance on the Movie for the Assessment of Social Cognition, an ecologically valid test evaluating theory of mind. Secondary outcomes will include emotion recognition (static and dynamic tasks: Ekman Faces and French Emotion Evaluation Test), mood assessments (Hospital Anxiety and Depression Scale) and clinical variables such as disease severity (ALS Functional Rating Scale-Revised), cognitive function (Edinburgh Cognitive and Behavioural Screen, Mini–Mental State Examination) and disease staging (King’s ALS Clinical Staging System). A total of 74 participants (37 patients with ALS and 37 matched healthy controls) will be recruited. Group differences will be analysed using analysis of variance, while regression models will explore associations between social cognitive deficits and clinical markers of ALS progression.

Ethics and dissemination

This study has been approved by the French Ethics Committee (CPP) Ouest I under reference 2020-A01213-36. Data collection and processing comply with French and European data protection regulations (GDPR, Loi Informatique et Libertés). Findings will be disseminated through peer-reviewed journals and scientific conferences and will contribute to improving neuropsychological assessment methods for ALS.

Trial registration number

NCT04406675.

Comorbid Diabetes Is Associated With Dyspnea Severity and Cardiometabolic Biomarkers in Black Adults With Heart Failure

imageBackground Comorbidities such as Type 2 diabetes mellitus significantly and adversely influence heart failure outcomes, especially in Black adult populations. Likewise, heart failure has a negative effect on diabetes and cardiometabolic outcomes. Dyspnea, a common symptom of heart failure, often correlates with disease severity and prognosis. However, the relationship between comorbid diabetes, dyspnea severity, and cardiometabolic biomarkers in Black adults with heart failure remains understudied. Objectives The purpose of this pilot study was to examine differences in the distressing heart failure symptom of dyspnea and in cardiometabolic and inflammatory biomarkers in Black adults living with heart failure with and without diabetes. Methods Black adults with heart failure were enrolled in this cross-sectional pilot study. Cardiometabolic and inflammatory biomarkers were measured via multiplex immunoassay. Univariate general liner models were used to identify group differences between persons with heart failure with comorbid diabetes and those without, controlling for age, sex, and comorbid burden. Results Participants were mostly female with a mean age of 55 years and mean left ventricular ejection fraction of 33%. Participants with diabetes exhibited higher dyspnea scores compared to those without diabetes, indicating greater symptom burden. Moreover, individuals with comorbid diabetes demonstrated higher levels of cardiometabolic and inflammatory markers. Discussion Comorbid diabetes was associated with higher dyspnea severity and adverse cardiometabolic profiles in Black adults with heart failure. These findings underscore the importance of targeted interventions addressing diabetes management and cardiometabolic risk factors to improve symptom control and outcomes in this high-risk population. Further research is warranted to elucidate the underlying mechanisms and develop tailored therapeutic strategies for managing comorbidities in persons with heart failure, particularly in minoritized communities.

Metabolic Pathways Associated With Obesity and Hypertension in Black Caregivers of Persons Living With Dementia

imageBackground In the United States, Black adults have the highest prevalence of obesity and hypertension, increasing their risk of morbidity and mortality. Caregivers of persons with dementia are also at increased risk of morbidity and mortality due to the demands of providing care. Thus, Black caregivers—who are the second largest group of caregivers of persons with dementia in the United States—have the highest risks for poor health outcomes among all caregivers. However, the physiological changes associated with multiple chronic conditions in Black caregivers are poorly understood. Objectives In this study, metabolomics were compared to the metabolic profiles of Black caregivers with obesity, with or without hypertension. Our goal was to identify metabolites and metabolic pathways that could be targeted to reduce obesity and hypertension rates in this group. Methods High-resolution, untargeted metabolomic assays were performed on plasma samples from 26 self-identified Black caregivers with obesity, 18 of whom had hypertension. Logistic regression and pathway analyses were employed to identify metabolites and metabolic pathways differentiating caregivers with obesity only and caregivers with both obesity and hypertension. Results Key metabolic pathways discriminating caregivers with obesity only and caregivers with obesity and hypertension were butanoate and glutamate metabolism, fatty acid activation/biosynthesis, and the carnitine shuttle pathway. Metabolites related to glutamate metabolism in the butanoate metabolism pathway were more abundant in caregivers with hypertension, while metabolites identified as butyric acid/butanoate and R-(3)-hydroxybutanoate were less abundant. Caregivers with hypertension also had lower levels of several unsaturated fatty acids. Discussion In Black caregivers with obesity, multiple metabolic features and pathways differentiated among caregivers with and without hypertension. If confirmed in future studies, these findings would support ongoing clinical monitoring and culturally tailored interventions focused on nutrition (particularly polyunsaturated fats and animal protein), exercise, and stress management to reduce the risk of hypertension in Black caregivers with obesity.

Western Diet and Inflammatory Mechanisms in African American Adults With Heart Failure

imageBackground Black adults have a higher risk for heart failure (HF) than others, which may be related to higher cardiovascular risk factors and also inflammatory dietary patterns. The Western diet is associated with inflammation and contributes to HF. Trimethylamine N-oxide is a diet-linked metabolite that contributes to inflammation and is associated with higher tumor necrosis factor-alpha (TNF-α) levels, especially in HF populations. The dietary inflammatory index score measures a diet’s inflammatory potential and food’s inflammatory effects. Objective The purpose of this pilot study was to explore associations between the Western diet, dietary inflammatory index, trimethylamine N-oxide, relevant covariates and variables, and TNF-α in Black persons with HF. Methods Thirty-one Black participants (mean age = 55 years, 68% women) with HF were enrolled. Trimethylamine N-oxide and TNF-α levels were analyzed using immunoassays. A food frequency questionnaire was completed, and dietary inflammatory index scores and food groups were calculated. Analyses included correlations and I-test statistics. Results Mean dietary inflammatory index score was −0.38, noting an anti-inflammatory diet with slightly higher inflammatory diet scores in men compared to women. The dietary inflammatory index score showed a negative association with dietary choline but not with trimethylamine N-oxide or TNF-α. Trimethylamine N-oxide and age were positively correlated, along with the correlation for TNF-α with a moderate effect size. No relationship was found among dietary inflammatory index, TNF-α, and trimethylamine N-oxide variables. Discussion A greater understanding of intake of inflammatory foods and relationships with immune factors is warranted to inform intervention development. In Black adults with HF, it is important to consider the intake of inflammatory foods as increased age may affect the retention of dietary metabolites. Metabolites may also increase the levels of inflammation. Knowledge about these relationships could lead to tailored dietary interventions based on diet, age, and culture patterns.

Hospital Experiences of Carers in Relation to the Comprehensive Care Standard: A Mixed Method Study

ABSTRACT

Aims

To explore the care experiences of informal carers of people with chronic conditions in hospitals and identify areas for improvement in the context of comprehensive care delivery.

Design

A explanatory sequential mixed-method study.

Methods

This study was conducted, involving a survey with 182 carers and interviews with 31 carers of individuals who attended an Australian hospital. Descriptive analysis of quantitative data was performed using RStudio, while thematic analysis of qualitative data was conducted using NVivo.

Results

The findings revealed seven overarching components of care that influenced carers' hospital experiences and their perceptions of care quality. Areas requiring improvement were identified within these categories.

Conclusion

This review identifies common perspectives of informal carers of people with chronic conditions in hospital settings and highlights important areas that require attention to improve carers' hospital care experiences. Carers should be welcomed, involved, informed and supported during hospital attendance to foster the most positive care experiences.

Implications

Healthcare professionals should involve carers in assessment, shared decision-making and the care process and recognise and address carers' needs.

Impact

The findings revealed the carer's hospital experiences in the context of comprehensive care delivery and identified areas requiring improvement.

Reporting Method

The CROSS and the COREQ guidelines were followed.

Patient or Public Contribution

The study protocol was presented to stakeholders from two hospitals in Australia, a Patient and Carer Advisory Board (attached to the parent project: evaluating Quality of Care (eQC)) and the Australian Commission on Safety and Quality in Health Care, and discussions were held to assess the relevance and significance of this study to clinical practice and health policy.

Secure Messaging: Demonstration and Enrollment Patient Portal Program: Patient Portal Use in Vulnerable Populations

imageVulnerable populations face challenges gaining access to quality healthcare, which places them at a high risk for poor health outcomes. Using patient portals and secure messaging can improve patient activation, access to care, patient follow-up adherence, and health outcomes. Developing and testing quality improvement strategies to help reduce disparities is vital to ensure patient portals benefit all, especially vulnerable populations. This quality improvement initiative aimed to increase enrollment in a patient portal, use secure messages, and adhere to follow-up appointments. Before the project, no patients were enrolled in the portal at this practice site. Over 8 weeks, 61% of invited patients were enrolled in the patient portal. Eighty-five percent were Medicaid recipients, and the others were underinsured. Eight patients utilized the portal for secure messaging. The follow-up appointment attendance rate was better in the enrolled patients than in those who did not enroll. The majority of survey respondents reported satisfaction in using the patient portal. Patient portal utilization and adoption in vulnerable groups can improve when a one-on-one, hands-on demonstration and technical assistance are provided.

Parents' and nurses' perceptions and behaviours of family‐centred care during periods of busyness

Abstract

Purpose

Busyness as a construct within modern healthcare is complex and multidimensional. To date, few studies have sought to explore how busyness influences family-centred care. This study explored the influence of busyness on the delivery of family-centred care for nurses and parents.

Design and Method

Ethnography was selected as the research design. The study site was a metropolitan tertiary hospital inpatient paediatric unit in Sydney, Australia. Semi-structured interview and non-participant observation techniques were used for data collection. Ten paediatric nurses and 10 parents were interviewed and 40 h of non-participant observations were undertaken. The COREQ was used to report the study.

Results

The findings are presented as three key themes: (i) ‘Supporting family-centred care’ in which participants detail beliefs about the nurse-parent relationships and how despite busyness nurses sought out moments to engage with parents; (ii) ‘Being present at the bedside’ identified the challenges in optimising safety and how parents adapted their way of being and interacting on the unit; and (iii) ‘The emotional cost of busyness’ and how this influenced nurse-parent interactions, care delivery and family-centred care.

Conclusions

The ethnography has given shape to social understandings of busyness, the complexities of paediatric nursing and family-centred care. The culture of care changed in moments of busyness and transformed parent and nursing roles, expectations and collaborative care that at time generated internal emotional conflict and tension.

Practice implications

Given the increasing work demands across health systems, new agile ways of working need to ensure maintenance of a family-centred approach. Strategies need to be developed during periods of busyness to better support collaborative connections and the well-being of paediatric nurses and parents. At an organisational level, fostering a positive workplace culture that shares a vision for family-centred care and collaboration is essential.

Patient or Public Contribution

Parents of sick children admitted to an acute paediatric inpatient ward were invited to be a participant in a single interview. Parents were aware of the study through ward advertisement and informal discussions with the researchers or senior clinical staff. Engagement with parents was important as healthcare delivery in paediatrics is focused on the delivery of family-centred care. To minimise the risk of child distress and separation anxiety, children were present during the parent interview. Whist children and young people voices were not silenced during the interview process, for this study the parent's voice remained the focus. While important, due to limited resources, parents were not involved in the design analysis or interpretation of the data or in the preparation of this manuscript.

Data sharing

The data that support the findings of this study are available from the corresponding author upon reasonable request.

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