Conectar
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).
The overarching aim was to explore women registered nurses' perceptions of gender discrimination in the workplace.
A descriptive cross-sectional exploratory survey within a sequential explanatory mixed methods study.
Between September and December 2023, data were collected from 173 registered nurses who self-identified as women. The survey captured demographic data, attitudes to gender discrimination in society using the ‘Contemporary Gender Discrimination Attitude Scale’ and perceptions of workplace gender discrimination in nursing across four dimensions, assessed using the ‘Perception of Workplace Gender Discrimination for Women Nurses Scale’ (PWGD-WN). Descriptive statistics presented as means and standard deviations were used to describe and interpret data. Regression analysis and chi-square tests were employed to examine associations between key variables.
The mean score on the Contemporary Gender Discrimination Attitude Scale was 4.56 (on a 6-point scale), indicating that on average respondents agreed that gender discrimination remains an issue in society. The PWGD-WN scale mean scores for the dimensions of gender discrimination (5-point scale) from lowest to highest were: ‘Gender bias from other women’ (Mean: 3.13, SD: 1.147), ‘Interpersonal discrimination’ (Mean: 3.30, SD: 1.135), ‘Glass escalator’ (Mean: 3.77, SD: 0.946) and ‘Primary carer’ (Mean: 3.86, SD: 0.796); higher scores indicated agreement with items. ‘Primary carer’ was the strongest predictor of attitude, followed by the ‘Glass escalator’. Highest qualification obtained was highlighted as a key predictor of nurses' perceptions of workplace discrimination.
The results of this study highlight that women in nursing perceive that systemic and multidimensional discrimination exists in the workplace.
The results can be utilised to understand how discrimination manifests in the workplace for women in a woman-dominated profession.
This research provides the first quantitative measure of perceived workplace gender discrimination for Australian women registered nurses.
We have adhered to relevant EQUATOR guidelines—STROBE.
This study did not include patient or public involvement in its design, conduct or reporting.
Hospital falls persist as a major threat to patient safety. This study aimed to develop an interprofessional reference standard to prevent, manage and report hospital falls.
A Delphi consensus methodology, informed by the Conducting and Reporting Delphi Studies guideline, was used to design the reference standard. An interprofessional expert panel (n=47) of health professionals, researchers, policymakers and consumers participated in three Delphi rounds. Following the review of clinical guidelines, an e-Delphi survey was developed and piloted to derive 60 initial items for the standard. Two iterative rounds of e-Delphi surveys were distributed via Research Electronic Data Capture and included free-text questions and 9-point Likert scales. An online consensus meeting followed, to ratify the final standard.
In the first Delphi round, there was over 80% agreement for 44/60 items to be included in the reference standard. This increased to 48/60 items in Round 2. At the final consensus meeting, 12 items still did not reach consensus for inclusion and one was added, yielding 49 items. Items that replicated text according to falls with injury/without injury were combined, resulting in 42 items in the final reference standard. Agreed items included: (1) brief screening of falls risk on hospital admission; (2) comprehensive falls assessment for inpatients who are older, frailer or have complex conditions; (3) single interventions (such as environmental adaptations and exercise); (4) multifactorial interventions; (5) education of patients, families and staff; (6) optimising local falls hospital policies, procedures and leadership capability; (7) optimising documentation and reporting; (8) improving accreditation processes; (9) workforce redesign to augment falls education. Items that did not reach agreement (n=12) pertained to alarms, bed rails, grip socks, artificial intelligence, volunteers and care bundles.
This new reference standard provides a checklist for staff, patients, managers and policymakers to reduce unwanted variations in prevention, management and reporting of hospital falls.
ANZCTR 386960
Parkinson’s disease is a neurological disease with a rising incidence and prevalence. Patients with Parkinson’s disease may receive antipsychotics, for example, due to Parkinson’s disease psychosis. Parkinson’s disease psychosis is characterised by visual hallucinations and other psychotic symptoms. To date, no systematic review has evaluated the effects of antipsychotics in patients with Parkinson’s disease. Therefore, this review aims to assess the beneficial and harmful effects of antipsychotics for Parkinson’s disease.
This is a protocol for a systematic review. A search specialist will perform a search in major medical databases (eg, MEDLINE (Medical Literature Analysis and Retrieval System Online), EMBASE (Excerpta Medica database), CENTRAL (Cochrane Central Register of Controlled Trials)) and clinical trial registries. Published and unpublished randomised clinical trials comparing antipsychotics to any control (placebo, standard care or other antipsychotics) in patients with Parkinson’s disease will be included. Two review authors will independently extract data and conduct risk of bias assessments with the Cochrane Risk of Bias tool—V.2. Primary outcomes will be all-cause mortality, serious adverse events and significant falls. Secondary outcomes will be hospitalisations, non-serious adverse events, Unified Parkinson’s Disease Rating Scale total score and psychotic symptoms using any valid symptom scale. Data will be synthesised by aggregate meta-analysis, trial sequential analysis and network meta-analysis. Several subgroup analyses are planned. An eight-step procedure will be used to assess if the thresholds for clinical significance are crossed, and the certainty of the evidence will be assessed by GRADE (Grading of Recommendations Assessment, Development and Evaluations) and CiNeMA (Confidence in Network Meta-Analysis) approach.
This protocol does not include results, and ethics approval is not required for the project. The findings from the systematic review will be published in international peer-reviewed scientific journals.
PROSPERO ID: CRD42025633985. Available from https://www.crd.york.ac.uk/PROSPERO/view/CRD42025633985.
To increase the sustainability of healthcare, clinical trials must assess the environmental impact of interventions alongside clinical outcomes. This should be guided by Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) extensions, which will be developed by The Implementing Climate and Environmental Outcomes in Trials Group. The objective of the scoping review is to describe the existing methods for reporting and measuring environmental outcomes in randomised trials. The results will be used to inform the future development of the SPIRIT and CONSORT extensions on environmental outcomes (SPIRIT-ICE and CONSORT-ICE).
This protocol outlines the methodology for a scoping review, which will be conducted in two distinct sections: (1) identifying any existing guidelines, reviews or methodological studies describing environmental impacts of interventions and (2) identifying how environmental outcomes are reported in randomised trial protocols and trial results. A search specialist will search major medical databases, reference lists of trial publications and clinical trial registries to identify relevant publications. Data from the included studies will be extracted independently by two review authors. Based on the results, a preliminary list of items for the SPIRIT and CONSORT extensions will be developed.
This study does not include any human participants, and ethics approval is not required according to the Declaration of Helsinki. The findings from the scoping review will be published in international peer-reviewed journals, and the findings will be used to inform the design of a Delphi survey of relevant stakeholders.
Registered with Open Science 28 of February 2025.
The WHO has declared climate change the defining public health challenge of the 21st century. Incorporating climate and environmental outcomes in randomised trials is essential for enhancing healthcare treatments’ sustainability and safeguarding global health. To implement such outcomes, it is necessary to establish a framework for unbiased and transparent planning and reporting. We aim to develop extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2025) and Consolidated Standards of Reporting Trials (CONSORT 2025) statements by introducing guidelines for reporting climate and environmental outcomes.
This is a protocol for SPIRIT and CONSORT extensions on reporting climate and environmental outcomes in randomised trials termed SPIRIT-Implementing Climate and Environmental (ICE) and CONSORT-ICE. The development of the extensions will consist of five phases: phase 1—project launch, phase 2—review of the literature, phase 3—Delphi survey, phase 4—consensus meeting and phase 5—dissemination and implementation. The phases are expected to overlap. The SPIRIT-ICE and CONSORT-ICE extensions will be developed in parallel. The extensions will guide researchers on how and what to report when assessing climate and environmental outcomes.
The protocol was submitted to the Danish Research Ethics Committees, Denmark in June 2025. Ethics approval is expected in September 2025. The SPIRIT and CONSORT extensions will be published in international peer-reviewed journals.
Fathers of preterm infants wish to be actively involved and attentive in caring for their children. The positive impacts of paternal caregiving on preterm infants’ cognitive and social development have been recognised. Awareness of the need to support fathers during early parenthood is increasing, but fathers may feel excluded when their infants are in the neonatal intensive care unit. Here, we present the protocol for a study involving the development and national implementation of a complex intervention supporting first-time fathers of preterm infants in early parenthood.
The study adheres to the Medical Research Council framework for complex interventions. A multicentre, prospective, non-blinded, quasi-experimental design will be applied to evaluate the effect of a clinical and technology-based intervention targeting both nurses and the fathers. Outcomes from participants enrolled during the control (2023–2024) and intervention (2025–2026) periods, comprising 295 fathers and their partners, will be compared. Effects on parental confidence, stress, depression and mood and family and reflective functioning as well as infants’ emotional and social development will be assessed. A comprehensive process evaluation will be applied using both qualitative and quantitative methods.
The study has been registered at Clinicaltrials.org [no. NCT0 6 116 747 (The SUPPORTED study – First-time Fathers of Preterm Infants), approved on 3 November 2023]. The Danish Data Protection Agency has approved the study (P-2022–792). The findings will be disseminated through peer-reviewed publications.
Given that low retention rates are a prevalent challenge in clinical trials, which ultimately affects trial validity, it is recommended that interventions be developed and evaluated to increase trial retention. In the context of trial retention, incorporating behavioural science is endorsed, as it provides a theoretical foundation for considering human behaviour. We hypothesised that an intervention informed by self-determination theory could increase retention in a randomised allergy trial on intralymphatic immunotherapy, as the support of basic psychological needs for autonomy, competence and relatedness is anticipated to lead to more sustained engagement and better outcomes.
To assess the acceptability and feasibility of the intervention and evaluation design, following the complex intervention framework by the Medical Research Council, before proceeding to a randomised evaluation.
A parallel two-arm randomised feasibility study was conducted within the randomised allergy trial.
All participants at one Danish site were eligible for recruitment.
The intervention was a web app informed by self-determination theory to support the basic psychological needs through its thoughtfully designed features. Participants were allocated unblinded across treatment groups to complete daily online questionnaires over a 100-day period from May to August 2022. All participants received a daily text message with a link for the questionnaires. On completion, participants in the control group received a confirmation message, while participants in the intervention group had a browser with the menu of the web app opened for them. The features within the menu were voluntary to use.
The prespecified assessments included evaluating the recruitment rate, retention rate (which reflected both sustained participation and the proportion of completed daily questionnaire entries), the suitability of outcome measures and the acceptability of the intervention and evaluation design to both participants and staff. Qualitative data were collected through a collaborative learning process with participants from the intervention group in November 2022.
A total of 30 participants were invited, randomly assigned 1:1 and analysed, resulting in a recruitment rate of 100%. None were lost to follow-up as all remained in the study for the entire duration. The response rate was 84.5% in the intervention group and 79.1% in the control group, indicating satisfactory retention. Outcome measures were deemed appropriate. No unintended adverse events were identified. The collaborative learning meetings involved three participants in the first meeting and two in the second, comprising a total of five different individuals. Participants found the intervention acceptable. They used it differently but agreed that its components were useful. Technical issues needed fixing, and voluntary free text boxes and registration of medication dosage should be added.
The intervention and evaluation design were assessed as acceptable and feasible. Technical issues were fixed, and additional response options were added before a randomised evaluation.
ILIT.NU: EudraCT 2020-001060-28. ClinicalTrials.gov NCT05191186.
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.
FreshRSS 