Conectar
Multidrug-resistant tuberculosis (MDR-TB) is an urgent public health challenge in Namibia, with profound socioeconomic consequences. The high burden of both tuberculosis and HIV complicates treatment and underscores the need for optimised drug therapies. Precision medicine, which leverages patient-specific genetic and molecular information, offers promise for improving MDR-TB outcomes. However, its effective application relies on population-specific data, particularly understanding how individuals metabolise tuberculosis drugs and how genetic diversity drives variability in treatment response. Currently, no pharmacokinetic (PK) or pharmacogenetic (PG) data on TB treatment exist for Namibian populations. This gap is particularly concerning, given the country’s genetic diversity, environmental factors and comorbidities that may uniquely influence drug metabolism. This study aims to generate PK and PG data to inform dose optimisation and support personalised treatment strategies for MDR-TB in Namibia. The findings will contribute to improved patient care and inform health system strengthening based on locally relevant evidence.
This cross-sectional study will consist of 100 Namibian participants with matched human DNA and PK data of MDR-TB cases receiving isoniazid, clofazimine, bedaquiline and the fluoroquinolones (levofloxacin or moxifloxacin). PK sampling will be divided as follows: 30 individuals will undergo intensive PK sampling, while the remaining (n=70) will undergo sparse PK sampling. DNA will be extracted at Stellenbosch University (SU), and samples will be genotyped using the H3Africa microarray. Sequences will be aligned to the human reference genome, hg38 (GRCh38p13), using the freely available Burrows-Wheeler Aligner. A subset of the samples (n=20–30) will undergo whole genome sequencing (WGS) to verify imputation results and identify novel genetic variants potentially affecting PK in this population.
Quality control and variant call format file generation will be performed using the Genome Analysis Toolkit best practices (V.3.5). Intensive and sparse PK data will be pooled for the development of a population PK (popPK) model using a non-linear mixed-effects modelling approach. The popPK model will characterise the relationship between TB drug dose and exposure, including quantifying covariates, including genetic variation, explaining PK variability, providing a foundation for dose optimisation and personalised treatment strategies.
Ethics approval was obtained from the University of Namibia Human Research Ethics Committee for Health (Ref. SOM18/2024), the Ministry of Health and Social Services (Ref. 22/4/2/3), the SU Health Research Ethics Committee (Ref. N21/11/136) and the University of Cape Town Human Research Ethics Committee (Ref. 500/2022).
Optimising post-operative pain management is crucial for recovery in orthopaedic surgery. Methadone has attracted interest due to its long half-life, N-methyl-D-aspartate -receptor antagonism and potential to reduce post-operative opioid consumption. Existing reviews combine multiple surgical populations, limiting applicability to orthopaedic settings. This protocol outlines a systematic review assessing the analgesic efficacy and safety of peri-operative methadone in adult and adolescent orthopaedic patients.
This review will include randomised controlled trials evaluating intravenous peri-operative methadone vs placebo or standard analgesic regimens in orthopaedic surgery. Primary outcomes are post-operative rescue opioid consumption and pain intensity within 72 hours. Secondary outcomes include adverse events, mobility scores and the length of hospital stay. If available data permit, a methadone dose–response pattern may be investigated. Searches will be conducted in MEDLINE (Ovid), Embase (Ovid), CINAHL, CENTRAL, Web of Science and ClinicalTrials.gov without date restrictions. Two reviewers will independently screen studies, extract data and assess risk of bias using the Cochrane risk-of-bias tool for randomised trials. When appropriate, random-effects meta-analysis methods will be performed. Certainty of evidence will be assessed using Grading of recommendations assesment, development and Evaluation (GRADE).
As this study uses previously published data, ethical approval is not required. Findings will be disseminated through a peer-reviewed publication and conference presentations.
CRD42025616291.
The aim of this study was to develop an educational video introducing an innovative panel survey approach to facilitate guideline panels in making inferences about patient values and preferences.
A user testing of the educational video through one-on-one interviews and iterative refinement of the video through brainstorming meetings.
Interviews and brainstorming meetings were conducted through Zoom.
The participants of the interviews include guideline panellists who had used the panel survey approach, and guideline panellists who had not used the approach but would or would not participate in a panel survey soon. The participants of the brainstorming meetings were a steering committee with expertise in guideline methodology and qualitative research.
The understandability and usefulness of the educational video.
We interviewed 18 guideline panellists from eight different guideline panels, all of whom carefully reviewed the video. Most participants found the video useful in explaining the panel survey approach and its role in incorporating patient values and preferences. Participants suggested improvements, including clarifying key concepts and using plain language instead of technical terminology to make the content more accessible. The major change the steering committee decided to make through brainstorming meetings was to add clarification, refine the wording and replace some text with animation.
User testing resulted in an improved educational video that is more useful and understandable for guideline panellists. Wider implementation of this resource has the potential to enhance the incorporation of patient values and preferences in guideline recommendations, supporting more patient-centred decision-making.
The number of people living with obesity is increasing rapidly worldwide, and the WHO estimates approximately 5 million deaths yearly from non-communicable diseases related to elevated body mass index (BMI). The most effective treatment for weight loss is bariatric surgery, but due to the associated risks and the need for lifelong care, this is not a viable treatment for every patient. With the advent of gut-hormone-based medications to treat obesity, the effectiveness of non-surgical treatment is approaching that of surgical interventions. We therefore aim to investigate the beneficial and harmful effects of laparoscopic bariatric surgery versus any non-surgical treatment.
We will conduct a systematic review with meta-analysis applying our eight-step procedure to assess thresholds for clinical significance and trial sequential analysis to mitigate the risk of random errors. To identify relevant trials, we will search for both published and unpublished trials, without any language restriction, in major medical databases (CENTRAL, MEDLINE, EMBASE, LILACS, SCI-EXPANDED and CPCI-S) and trial registries. The date range covered by the search is from database inception until final search date—within 3 months prior to submission of final results manuscript. Two review authors will independently screen references, extract data and perform risk-of-bias assessment using the Cochrane Risk of Bias Tool 2 and the Grading of Recommendations, Assessment, Development and Evaluations. We will include randomised clinical trials comparing laparoscopic surgery currently in use with any non-surgical comparator in adults or adolescents with BMI >30 kg/m2. Quasi-randomised studies or non-randomised studies will not be included. Our critical outcomes are all-cause mortality, serious adverse events and quality of life, and our important outcomes are major cardiovascular events, weight at follow-up, physical function and glycaemic control. In addition, we have two explorative outcomes: metabolic syndrome or Z-score and reported incident of alcohol abuse or other addictive disorder or self-inflicted harm.
This review will collect and perform secondary analysis of data from publicly available sources and ethical approval is therefore not required. The findings will be published in peer-reviewed journals and presented at relevant scientific conferences. We will strive to publish with open access. Awareness will be made through social media platforms. This review aims to help clinicians in identifying best practices in the wide-spanning field of obesity treatment.
CRD420251135341.
To explore the experiences of significant others of patients with severe burn injury in the intensive care unit. Specifically, how severe burn injury impacted the significant other and their role within their loved one's life.
This qualitative study employed a Narrative Inquiry approach.
Interviews were undertaken during 2021–2022 with 17 participants who were the significant others of a patient with severe burn injury in the Intensive Care Unit. Recruitment occurred in New South Wales, Australia, from two tertiary hospitals providing care for people with major burns. A narrative inquiry approach was utilised, capturing stories through semi-structured interviews.
Significant others experienced necessary changes in their life in response to the catastrophe. These included advocating, being present and ensuring their loved one's needs were met, while often neglecting themselves. Significant others contemplated their future as a carer to their loved one with severe burn injury, and adjusting their own career, finances and lifestyle, often as a long-term measure. The shifting of their role to carer ultimately transformed and redefined their relationships and lives.
Significant others endure immense trauma when a loved one sustains a severe burn injury. They require support but prioritise the patient by virtue of their critical illness. The life of the significant other is changed as they take on the role of carer and provide support. It is, therefore, imperative that the support needs of significant others are recognised, understood and addressed to ensure their well-being while processing the trauma.
With increased understanding of the significant others' experiences, healthcare providers can adopt a consultative approach, where roles and boundaries can be clearly identified. Through this process, healthcare providers can strengthen rapport and provide targeted support for significant others, as they navigate this traumatic life-altering event.
No patient or public contribution.
This study explores the lived experiences of critical care nurses who are also mothers, focusing on their challenges with breastfeeding and pumping at work.
Using interpretive phenomenology, grounded in Martin Heidegger's work, semi-structured interviews were conducted with critical care nurses (N = 54) who were also breastfeeding mothers in the United States in 2024. Data were transcribed verbatim and analysed using Patricia Benner's interpretation of the hermeneutic circle in nursing data analysis to identify the essence of lived experiences in breastfeeding as a critical care nurse mother.
Four main themes emerged during the analysis. They are as follows: (1) The Impact of Workplace Environment on Breastfeeding Nurse Mothers and Their Children, (2) The Role of Organisational Support and Resources in Retaining Breastfeeding Nurse Mothers in Critical Care, (3) Team Dynamics and Career Implications of Breastfeeding for Nurse Mothers in Critical Care and (4) Organisational and Systemic Approaches to Supporting Breastfeeding Nurse Mothers in Critical Care.
The findings highlight critical gaps in workplace policies and support systems for breastfeeding nurses. Addressing these inequities through the provision of adequate lactation facilities, flexible pumping schedules and a supportive workplace culture is essential to reducing stress and enabling nurse mothers to continue breastfeeding successfully. This study underscores the need for systemic reforms to support breastfeeding in the nursing profession.
This study did not include patient or public involvement in its design, conduct or reporting.
To develop and validate the Internalised Stigma Scale for Gestational Diabetes Mellitus (ISS-GDM), a questionnaire measuring self-reported internalised stigma among women with prior gestational diabetes mellitus (GDM). We hypothesised that internalised GDM stigma could be reliably and validly assessed through a short psychometric instrument.
Cross-sectional validation study.
Follow-up data from the Danish, multicentre Face-it trial for women with prior GDM and their families.
In total, 248 women completed the ISS-GDM approximately 1 year after their GDM affected pregnancy.
The primary outcome was psychometric properties of the ISS-GDM, assessed using Cronbach’s alpha, confirmatory factor analysis (CFA) and Rasch analysis (RA). Secondary outcomes included identification of item anomalies (local response dependence, differential item functioning).
A large proportion of respondents endorsed statements reflecting self-disappointment, self-blame and an altered self-perception. Less endorsed statements included feeling inferior to other mothers or guilt towards family members due to GDM. The ISS-GDM demonstrated satisfactory psychometric properties. CFA indicated that item 2 assessing self-perceived capabilities as a mother did not load onto the main factor, while CFA and RA identified local response dependence and differential item functioning by body mass index. After adjustments, a two-factor solution supported calculating a sum score of items 1 and 3–11, with item 2 retained as a stand-alone indicator of perceived parenting capabilities. The 10-item scale demonstrated acceptable reliability (Cronbach’s alpha=0.78).
The ISS-GDM is a reliable and valid tool for assessing internalised stigma among women with prior GDM. Our findings further suggest that a substantial proportion of women with prior GDM experience self-blame and an altered self-perception due to their diagnosis. The ISS-GDM scale enables research into its prevalence, severity and consequences.
To report how person-centred care principles are applied to care planning and to explore the contextual factors affecting their implementation in older adult care homes in England.
A combined framework analysis and quantitative content analysis study.
Using a semi-structured questionnaire, we interviewed 22 care home managers in England, exploring topics around care planning processes. Audio recordings were transcribed verbatim. Transcripts were analysed through a combined framework approach and content analysis.
Most care home managers discussed person-centred care planning in terms of understanding residents' values and preferences and their engagement in decision-making. Factors facilitating person-centred planning implementation included accessible planning tools, supportive care home leadership, effective communication and collaborative partnerships. Inhibiting factors included regulatory and care practice misalignment, time constraints and adverse staffing conditions.
Differences between care home practitioners' understanding and practice of person-centred care planning require further examination to improve understanding of the sector's complexity and to develop suitable care planning instruments.
Findings demonstrate a need for improved staff access to specialised person-centred care training and an opportunity for care home nursing practitioners to lead the co-development of digital person-centred care planning tools that reflect the reality of long-term care settings.
Identifying factors influencing the implementation of holistic approaches to care planning makes clear the need for modernising long-term care policy and practice to adapt to the contemporary challenges of the care home sector.
Study reporting was guided by the Standards for Reporting Qualitative Research.
Two public involvement advisors with lived experience of caring for a relative living in a care home contributed to the development of the interview guide, advised on care home engagement, guided the interpretation of the findings and commented on the drafted manuscript.
Post-COVID syndrome manifests with a diverse array of symptoms for which no standard care plan currently exists. Many questions were raised by patients, which underscored the need for a validated patient-reported outcome measure (PROM). Therefore, a post-COVID module was developed to be included in the Assessment of Burden of Chronic Conditions (ABCC-) tool. The ABCC-tool evaluates and visualises the perceived physical, emotional and social burden of one or multiple chronic disease(s) using a balloon diagram and aims to facilitate person-centred care and structured discussions between patients and healthcare professionals. This study explores the patients’ perspective on the content of the ABCC-tool for post-COVID and the tool’s usability in a home-based setting.
All patients who completed the ABCC-tool for post-COVID were invited for an online semi-structured interview. We selected post-COVID patients who had used the tool in the past three months. Interviews were audio recorded and analysed using a thematic approach with Atlas.ti version 23.
Nineteen post-COVID patients (10 males, mean age 56) were interviewed between May and August 2024. The tool was regarded as user-friendly, and patients indicated they would use the tool again in the future. Patients valued the tool’s broad range of topics, some of which are often overlooked in standard healthcare consultations. The tool was comprehensible and relevant according to all patients. The balloon diagram was easy to understand, but a legend explaining the colours of the balloons was preferred. Other suggestions for improvement included adding open-text fields and periodic reminders to increase usability and adding long-term data.
The ABCC-tool is a promising instrument for post-COVID patients, offering a structured way to monitor and communicate experienced burden in addition to standard healthcare consultations. Refinements addressing usability and comprehensiveness are recommended to facilitate its integration into clinical practices.
Cardiovascular diseases, overweight, type 2 diabetes and chronic kidney disease increase the risk of cardiovascular events.
Glucagon-like peptide-1 analogues are recommended by the European Society of Cardiology and the American College of Cardiology to lower the risk of death and progression of cardiovascular disease in patients with cardiovascular disease and type 2 diabetes. Semaglutide, tirzepatide and liraglutide are approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of type 2 diabetes mellitus and overweight. CagriSema is currently not approved, but several phase III trials are ongoing.
No previous systematic review has investigated the effects of semaglutide, tirzepatide, CagriSema and liraglutide, which may not be disease-specific, on hard binary outcomes for all trial populations at increased risk of cardiovascular events.
We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, Latin American and Caribbean Health Sciences Literature, Science Citation Index Expanded, Conference Proceedings Citation Index—Science) and clinical trial registries from their inception and onwards to identify relevant randomised trials. We expect to perform the literature search in December 2025. Two review authors will independently extract data and assess the risk of bias. We will include randomised trials assessing the effects of semaglutide, tirzepatide, CagriSema and/or liraglutide in participants with an increased risk of cardiovascular events. The primary outcome will be all-cause mortality. Secondary outcomes will be myocardial infarction, stroke and all-cause hospitalisation. Data will be synthesised by aggregate data meta-analyses, Trial Sequential Analyses and network meta-analysis, risk of bias will be assessed with Cochrane Risk of Bias tool V. 2, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations and the Confidence in Network Meta-Analysis approach.
This protocol does not present any results. Findings of this systematic review will be published in international peer-reviewed scientific journals.
CRD42024623312.
The EPHOR-NIGHT cohort was established to investigate how night shift work influences biological pathways and chronic disease risk using a comprehensive working-life exposome approach, focusing on cardiometabolic, mental health, cognitive and biological ageing outcomes.
The cohort includes 937 workers aged 20–65 years (88% female), primarily from the healthcare sector (96%) in Spain, Sweden, Denmark and the Netherlands. Participants were categorised as permanent day (39%), permanent night (35%) or rotating/other shift workers (26%). Data collection included questionnaires, daily ecological momentary assessments, wearable sensors tracking light, physical activity, heart rate and environmental exposures and biological samples (blood collected once and saliva collected during five points across the day), with harmonised protocols across countries.
From the 937 participants contributing data to the cohort, 708 had complete information from questionnaires, sensors and blood and saliva, with subsets undergoing advanced biological analyses, including genomics, targeted and genome-wide DNA methylation, telomere length and mtDNA copy number, metabolomics, transcriptomics, proteomics, hormone profiling and inflammatory biomarkers and blood metals. Many reported prevalent chronic conditions, including anxiety (27%), depression (18%) and metabolic disturbances. Night shift and rotating shift workers had greater exposure to long shifts and more scheduled rest days compared with day workers. Sleep duration and quality were poorest among permanent night shift workers.
A 2-year follow-up was completed in June 2025, including the collection of additional biomarker data, psychosocial work environment data and data related to female sexual and reproductive health. Findings from the EPHOR-NIGHT study aim to inform prevention strategies and occupational health policies. Data will be made available to support broader research efforts on shift work and health.
Current pharmacological treatment options for painful diabetic neuropathy (PDN) often fail to provide adequate pain relief. However, in the recent SENZA-PDN study, high-frequency 10 kHz spinal cord stimulation (SCS) demonstrated significant long-term improvements in lower limb pain and health-related quality of life (HRQoL) in a PDN population. Furthermore, more than half of 10 kHz SCS recipients showed improved sensory function based on non-blinded clinical assessments in post hoc analysis. We report the design of the PDN-Sensory study, which aims to evaluate changes in pain and neurological function with 10 kHz SCS in the treatment of PDN. The study will include objective measures of neurological function, including the modified Toronto Clinical Neuropathy Score (mTCNS) and intraepidermal nerve fibre density (IENFD).
This multicentre, prospective, randomised controlled trial will compare conventional medical management (CMM) with 10 kHz SCS+CMM in individuals with diabetes and chronic, intractable lower limb pain due to PDN. Participants will be randomised 1:1 to CMM alone or 10 kHz SCS+CMM, with optional crossover at 6 months. The primary outcome is the proportion of participants at 6 months achieving ≥50% pain relief from baseline. The key secondary endpoint is the proportion of participants at 6 months with a reduction in mTCNS of ≥3 points from baseline (excluding changes in foot pain). Additional endpoints at 6 and 12 months include changes from baseline in mTCNS, IENFD, 7-day averaged pain score, pain-related interference, HRQoL, sleep, psychological outcomes, functional status and metabolic parameters.
The study protocol received central approval from the Western Institutional Review Board (IRB #20230954). Local IRB approval will be required before initiation of the study at each participating clinical site. The study complies with Good Clinical Practice guidelines (ISO 14155), the Declaration of Helsinki, and all applicable national, federal and local regulatory requirements. Dissemination plans include presentations at national and international conferences and publication in a peer-reviewed journal with open access.
Assess US registered nurse genomic competency.
Administered the Genetics and Genomics Nursing Practice Survey (GGNPS).
GGNPS assesses genomic knowledge, skills, attitudes, confidence, and utilization in nursing practice. Distributed by the American Nurses Association via email and online to US registered nurses. Results are analyzed using descriptive statistics and compared to 2010 data.
1065 registered nurses responded. Most (41%) were Master's prepared, actively seeing patients (51%) and 66% considered it very important to learn more about genomics. Most (55%) reported their genomic knowledge was poor yet 51% reported a patient initiated a genetic discussion with them in the past 3 months. 66% completed all knowledge score items with a median score of 9/12, no change from 2010. Only 26% had heard of the Essential Competencies. Most reported no genomic curricular content (64%); had not attended a genomic course since licensure (64%); intended to learn more about genomics (70%); and would attend a course on their own time (79%).
Nurses felt genomics was important but have capacity deficits. Despite genomic discoveries and evidence-based practice guidelines that impact healthcare quality and safety, 20 years after the Genomic Competencies were established (2005) nursing genomic practice capacity remains low.
Genomics is critical to the safe, quality nursing practice regardless of the level of academic training, clinical role, or specialty.
Data quality in epidemiological studies is a basic requirement for good scientific research. The aim of this study was to examine an important indicator of data quality, data completeness, by investigating predictors of missing data.
Baseline data of a cohort study, the population-based Hamburg City Health Study, were used. Missingness was investigated at the levels of a whole research unit, on the two segments of health service utilisation and psychosocial variables, and two sensitive items (income and number of sexual partners). Predictors for missingness were sociodemographic variables, cognitive abilities and the mode of data collection. Associations were estimated using binary and multinomial logistic regression models.
Of 10 000 participants (mean age=62.4 years; 51.1% women), 32.9% had complete data at the unit level, 66.8% had partially missing data and 0.3% missed all items. The highest proportions of missing values were found for income (27.8%) and the number of sexual partners (36.7%). At both the unit, segment and item level, older age, female sex, low education, a foreign mother language and cognitive impairment were significant predictors for missingness.
For analysing population-based data, dealing with missingness is equally important at all levels of analysis. During the design and conduct of the study, the identified groups may be targeted to reach higher levels of data completeness.
To achieve a deeper understanding of the results of a primary randomised controlled trial to clarify the potential effective mechanisms and barriers of a peer-mentor intervention.
Mixed methods process-outcome evaluation of the intervention.
Qualitative and quantitative data were collected during the intervention in a during-trial set-up, that is, a convergent design.
The qualitative and quantitative findings mostly confirmed and expanded each other, identifying several mechanisms that facilitate the effectiveness of peer-mentor support during cardiac rehabilitation, such as mentors' experience-based knowledge and motivation. However, barriers related to lifestyle changes among older, vulnerable patients (e.g., mentee concerns about heart-healthy diets) and psychological outcomes (e.g., mentees' resilience) may minimise the effectiveness.
Peer-mentoring holds potential for supporting older, vulnerable patients during cardiac rehabilitation. However, ensuring that peer-mentors are well-suited for their role and capable of providing motivational, experience-based support is crucial, as is the need for tailored mentorship and consideration of specific patient populations needing mentor-supported cardiac rehabilitation.
Cardiac rehabilitation faces challenges due to high drop-out rates, particularly among older individuals, females, and vulnerable patients. Peer mentoring, a low-cost intervention, holds promise for supporting these groups in cardiac rehabilitation programmes.
The study adheres to the ‘Systematic Development of Standards for Mixed Methods Reporting in Rehabilitation Health Sciences Research’, ‘Good Reporting of A Mixed Methods Study’ and ‘Template for Intervention Description and Replication’.
A group of patients with cardiovascular disease actively contributed to developing and implementing the intervention.
ClinicalTrials.gov Identifier: NCT04945486—prospectively registered before the first participant was recruited
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.
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.
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.
Many clinical practice guidelines (CPGs) claim to use Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, but its implementation varies. This suggests that CPG developers, methodologists and users would benefit from an instrument to evaluate the extent to which CPGs adhere to GRADE approach. Such a structured instrument is currently unavailable. Accordingly, this study will develop an evaluation instrument for assessing guideline adherence to the GRADE approach, which we have named ‘GRADE-Check’. The goal is to target items to which CPGs fail to adhere and that potentially have serious consequences resulting in inaccuracies in certainty of evidence and inappropriate direction or strength of recommendations, thereby discriminating across CPGs in issues of importance.
The panel will include up to 25 individuals with specific knowledge and expertise, including experienced authors, educators and methodologists on CPGs methodology and GRADE approach from relevant organisations. The instrument will focus on the key elements of GRADE, aiming for clarity for GRADE experts and non-GRADE experts to apply. The development process for GRADE-Check will consist of the following five phases: (1) recruitment of a panel of GRADE experts; (2) development of objectives and scope for the development of GRADE-Check and criteria for item selection; (3) generation of candidate items through a literature review and panel consultation; (4) panellist discussion to construct the initial draft and extended explanation manual and (5) user testing.
This study has been approved by the Medical Ethics Committee of Zhongnan Hospital of Wuhan University (no. (2025047K)). Our research findings will be published in peer-reviewed journal articles and presented at academic conferences. Additionally, the dissemination plan will include considerations for the development of implementation manuals, a dedicated project website and training tools.
To introduce a novel conceptual framework that differentiates peripheral intravenous catheters according to their dwell time and therapeutic purpose, in order to improve the suitability of material choice, safety and cost-effectiveness.
Concept based on clinical guidelines, expert consensus and recent peer-reviewed evidence.
A literature search was conducted in PubMed on November 25, 2024, using defined keywords related to peripheral intravenous catheters, device complications and duration of use. This search was supplemented by manual screening of references from relevant articles.
The analysis followed the SANRA quality criteria for narrative reviews. Evidence and recommendations from clinical guidelines, randomised trials and qualitative studies were synthesised using the Australian Clinical Care Standards to structure the proposed classification into ‘procedural’ and ‘therapy’ catheters.
Procedural catheters are used for less than 24 h, typically during procedures or short treatments, and are mainly linked to immediate risks like insertion failure and local trauma. Therapy catheters, defined as devices used beyond 24 h or expected to remain while the patient sleeps, carry cumulative risks, including delayed complications such as phlebitis, occlusion and infection. The framework supports more nuanced decisions on device choice, insertion site and maintenance.
This framework introduces a practical differentiation between short- and longer-term peripheral venous catheters, addressing a major oversight in existing guidelines and supporting context-sensitive vascular access decisions.
Tailoring catheter management to expected dwell time may reduce complications and costs, enhance workflow, and improve patient comfort.
By addressing the lack of temporal distinction in current practice, this framework offers a simple yet transformative tool applicable across care settings, with the potential to improve patient outcomes, resource utilisation and costs.
This project is a concept analyses; no patient or public contribution was necessary.
To report on women's experiences of perimenopause and menopause.
A mixed-methods design using an online survey and interviews.
Data were collected simultaneously between April and July 2022. Women over the age of 18 who self-identified as being in perimenopause or menopause were invited to complete an online survey. Women who completed the survey were also invited to participate in an interview to discuss their experiences in more detail. Quantitative data were analysed using descriptive statistics. Qualitative data were transcribed verbatim and thematically analysed.
Four hundred and eleven women completed the survey in its entirety. Twenty-five women who self-identified as being in perimenopause and menopause participated in one-on-one interviews. Both quantitative and qualitative data are presented under three themes: (1) The unexpected sequelae on daily life; (2) Experiencing stigma and shame; and (3) Feeling dismissed and devalued.
Gender inequality, silence and stigma negatively impact the health and well-being of women experiencing perimenopause and menopause. Encouraging conversations and challenging existing negative attitudes to perimenopause and menopause can reduce stigma, improve health literacy and enhance women's experiences of this life transition.
Further education for nurses and other health care professionals about perimenopause and menopause is required to better diagnose, treat and support women. Nurse-led models of care could provide timely access to menopause care. Workplaces could enhance the productivity and work satisfaction of women experiencing perimenopause and menopause by changing policy to ensure flexibility in the workplace and implementing measures to ensure their comfort.
Women are largely unprepared for the impact perimenopause/menopause has on their everyday lives. The stigma and shame associated with perimenopause and menopause limits women's access to support and contributes to negative outcomes for their health and well-being. Health professionals often have inadequate knowledge about perimenopause and menopause and can be dismissive of women experiencing this transition.
Reporting of the study was guided by The Good Reporting of a Mixed Methods Study (GRAMMS) checklist.
This study did not include patient or public involvement in its design, conduct or reporting.
Mental disorders are among the leading causes of the global burden of disease and are often associated with severe functional impairment and high societal costs. Psychotherapeutic, psychopharmacological and internet-based mental health interventions have proven to be helpful, but challenges remain, including only moderate response rates, high relapse rates and barriers to accessing mental healthcare. Much of the existing evidence stems from studies conducted in controlled, often standardised settings that only partially reflect real-world conditions, contributing to a ‘scientist-practitioner gap’. Moreover, the mechanisms of change, such as the interaction between treatment intensity, common factors (eg, the therapeutic relationship) and specific intervention techniques, have not been sufficiently investigated. In particular, the relationship of changes in personality functioning (PF) with mental and physical health has not yet been extensively researched.
The PSYMPACT (Psychological Impact Factors of Mental Health Treatments) study will use a longitudinal study design with a naturalistic sample (N 3000) to examine changes in psychopathology, PF and allostatic load in psychotherapeutic, psychopharmacological and internet-based treatments. The aim is to identify factors contributing to improvements and deteriorations in mental and physical health across different settings, including common and specific factors. Additionally, to provide patient perspectives, qualitative interviews will be conducted with individuals with varying levels of severity of mental health problems. Allostatic load will be assessed using repeated hair cortisol measurements. Furthermore, ecological momentary assessment will be used to examine the diurnal variability of PF as well as its more momentary correlates and longer-term outcomes. The central research questions and aims include (1) the assessment of common factors across different treatment settings, (2) associations of specific and common factors with improvements in mental health, including PF, (3 and 4) the importance of treatment intensity and interaction effects with common and specific factors, (5) the association of changes in psychopathology with changes in allostatic load, (6) the trait and state variability of PF, (7) the identification of patients who deteriorate under specific treatments and (8) patients’ perspectives on the effectiveness of different treatment modalities.
Approval was obtained from the Ethics Committee of the Department of Education and Psychology at the Freie Universität Berlin, Germany. Results will be submitted to peer-reviewed specialised journals and presented at national and international conferences.
Before data collection started in November 2024, the study was registered in the German Clinical Trials Register (https://www.drks.de/search/de/trial/DRKS00035560).
FreshRSS 