Cancer is the leading cause of death and morbidity among children and adolescents worldwide. Functionality-based interventions are relevant among children and adolescents with an oncological diagnosis, whence studies summarising evidence on this topic are needed. This systematic review will summarise evidence on the effect of interventions to improve functionality indicators among paediatric patients diagnosed with cancer.
This protocol will follow Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA)-Protocols reporting guidelines. The systematic review will be conducted according to the Cochrane Handbook and PRISMA 2020. Studies will be searched in MEDLINE (PubMed), Embase, Web of Science, CENTRAL, LILACS and PEDro. Additional searches will include Google Scholar, reference lists of included studies, relevant reviews and trial registries. Studies will be included if they implement a functionality-based intervention. They must evaluate effects among paediatric patients with an oncological diagnosis. Secondary outcomes will include health-related quality of life. There will be no limits to language or year of publication, and articles published in peer-reviewed journals will be accepted. Only randomised controlled trials will be included. Risk of bias will be assessed using the Cochrane Risk of Bias Tool 2. Two independent reviewers will select studies, extract data and assess risk of bias. A narrative synthesis and meta-analysis will be conducted if studies are clinically and methodologically homogeneous. Statistical heterogeneity will be assessed using Higgins’ inconsistency test (I²). Meta-analysis may estimate combined effects using random-effects and the inverse variance method. The R statistical software will be used. The certainty of evidence will be evaluated for each outcome using the Grading of Recommendations Assessment, Development and Evaluation system.
This study used data from previously published studies, thus waiving submission to an Ethics Committee. Scientific dissemination strategies will include publication in peer-reviewed journals, conference presentations and workshops for the public.
CRD42024462833.
The optimal strategy for induction of labour (IOL) in cases of prelabour rupture of membranes (PROM) with an unfavourable cervix is elusive. No study conducted in nulliparous women has shown any one induction method to be superior to any other. In this project, we seek to determine whether IOL with balloon catheter and oxytocin can (1) increase rate of delivery
We are conducting a multicentre, randomised, controlled, open-label therapeutic trial with two parallel arms on nulliparous women with unfavourable cervix showing PROM at term without spontaneous labour.
After 12 hours of PROM, women are randomly assigned to one of two study groups. One group is treated with a balloon catheter for 12 hours, with oxytocin administered after 6 hours. If the balloon is expelled earlier than 6 hours after insertion and the cervix is still unfavourable, another balloon is placed. The other group (control) is treated with 25 µg oral PGE1 every 2 hours until labour starts. After a maximum of eight administrations and a timelapse of 4 hours, if there are no effective uterine contractions, the induction is continued with oxytocin infusion and epidural analgesia if the patient requests it. A total of 520 women will be recruited in five university hospitals in France and randomised at a 1:1 ratio with stratification by study centre.
Main inclusion criteria are nulliparous women with gestational age ≥37 weeks, PROM without labour beyond 12 hours, unfavourable cervix (Bishop score
The hierarchical primary endpoints are: (1) Proportion of patients vaginally delivered
The RUBAPRO2 trial was approved by the French national agency for drug safety and committee for protection of persons involved in biomedical research on 15 September 2022. Informed written consent will be obtained from all participants.
Venous ulcers are the most prevalent among those affecting the lower limbs, with high economic and quality of life impact. Due to the chronicity of venous disease, healing and recurrence cycles are common. Patient adherence to self-care activities to prevent recurrence is very low, so it is crucial to reflect on nurses' experiences with this phenomenon. A qualitative and descriptive study was developed to analyse nurses' perceptions about preventing venous ulcer recurrence. According to the inclusion criteria, focus groups with nurses were implemented. Three focus groups were conducted through the Colibri platform, ensuring all ethical assumptions. Content analysis was performed according to thematic criteria, using the WebQda software. Three main themes emerged: integration of care, context of care, and relationship. The participants emphasised the importance of holistic assessment and the establishment of common goals to promote adherence to fundamental recurrence prevention care. Understanding and respecting individual values, empathy and active listening, considering the established relationship, anticipating the person's needs, and trust are essential to overcoming barriers to implementing recurrence prevention care and to its continuity. Taking these aspects into consideration implies that the professional is part of the process of preventing the recurrence of venous ulcers.
This scoping review aims to map evidence or literature on improvement strategies used by health leaders and professionals to strengthen the safety climate in the operating room.
A scoping review was performed on the basis of the method proposed by the Joanna Briggs Institute and applied to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews (PRISMA-ScR) extension.
16 academic and grey literature data sources were searched using search terms on 17 January 2025, namely, Medical Literature Analysis and Retrieval System Online via Pubmed, Latin American and Caribbean Literature on Health Sciences via the Virtual Health Library, Cumulative Index to Nursing and Allied Health Literature, Scopus, Web of Science, Embase, PsycINFO, Cochrane Library, WorldCat, Digital Library of Theses and Dissertations, Brazilian Association of Surgical Center Nurses, Center for Material and Sterilization and Anesthetic Recovery, Association of Portuguese Operating Room Nurses, Association of PeriOperative Registered Nurses, Institute for Healthcare Improvement, WHO and Agency for Healthcare Research and Quality.
Study selection, data extraction and synthesis were based on the following eligibility criteria based on the acronym PCC (participants, concept, context): participants (health leaders and professionals), concept (strategies to improve the safety climate) and context (operating room). This scoping review considered studies published from 2009 onwards.
Information on the objective, method and findings addressing improvement strategies employed to strengthen the safety climate in the surgical centre was retrieved. The findings are presented in tables and in a qualitative thematic summary.
A total of 26 studies were analysed, published between 2009 and 2024, with the USA as the country of origin of the publications with the highest number (11 studies). As for the methodological approach, intervention and quasi-experimental studies stand out. When the studies in this review were mapped, strategies that strengthened the safety climate in the operating room were identified and grouped into two main axes that are interrelated: communication tools and training programmes.
It is evident that the implementation of tools that promote communication and training programmes enhances safe surgical care, as they contribute substantially to the domains of the safety culture. The use of communication protocols in the operating room is recommended as a perioperative safety tool.
This scoping review adhered to a protocol previously published in this journal and that is registered on the Open Science Framework website (https://osf.io/zg8nu/).
To analyse the comfort needs of patients following renal transplantation, guided by Kolcaba's Theory of Comfort.
A qualitative design was employed.
This study was conducted at a Brazilian university hospital's renal transplant outpatient clinic. Forty-six post-transplant patients were purposively sampled by age, transplant time and clinic attendance. Face-to-face interviews were audio-recorded, transcribed and conducted using a semi-structured script. Data were analysed through thematic content analysis, guided by Kolcaba's Comfort Theory and relevant literature.
Participant narratives were categorised according to the contexts outlined by Kolcaba's Theory of Comfort: Physical, Environmental, Sociocultural and Psychospiritual. In the physical context, pain was identified as a major factor diminishing comfort after renal transplantation. In the environmental context, elements such as light, odour, sound, temperature and uncomfortable furnishings contributed to discomfort. In the sociocultural context, family support was highlighted as essential. In the psychospiritual context, religiosity played a key role in enhancing the comfort of transplant recipients.
Spirituality, strengthened social support networks and non-pharmacological comfort measures are essential for promoting comfort among patients following renal transplantation. These findings underscore the importance of integrated care approaches that address physical, emotional and social aspects to improve quality of life for this population.
Conceptual models in nursing provide a critical perspective for care and support the delivery of effective, evidence-based interventions. By identifying the multidimensional comfort needs of post-renal transplant patients, this study informs the development of targeted, holistic strategies for nursing and multidisciplinary practice in outpatient settings.
This study examined the multidimensional comfort needs of post-renal transplant patients and found that comfort is shaped by physical, environmental, sociocultural and psychospiritual factors. The results may guide global nursing and multidisciplinary outpatient care by informing integrated approaches that enhance the quality of life of transplant recipients.
This study was reported according to the COREQ framework.
No patient or public contribution.
Since 2018, WHO has endorsed the use of whole-genome sequencing (WGS) of Mycobacterium tuberculosis complex isolates to detect drug-resistant tuberculosis (DR-TB). This endorsement was based on the assumption that a faster and more detailed description of the resistance profile would improve treatment prescription for DR-TB by healthcare providers, and hence the treatment outcomes of patients. Nonetheless, this assumption has not been tested in routine clinical practice and different scenarios. In Brazil, WGS is not routinely used for the diagnosis of DR-TB, having been carried out in only a few centres for research purposes. With this trial, we will evaluate whether a WGS-based drug-resistance report improves treatment adequacy in patients with pulmonary DR-TB, compared with the current standard-of-care diagnostic methods used in the state of São Paulo, Brazil.
We will conduct a non-randomised controlled clinical trial with two arms to compare the intervention group (ie, individuals receiving a WGS-based report) with a historical control group (i.e., individuals who received resistance diagnostics based on the standard of care of conventional genotyping and phenotyping techniques). The primary outcome will be the proportion of patients whose treatment scheme was adequate based on complete resistance profile determined by WGS and/or phenotypic drug-susceptibility testing (pDST). Other secondary outcomes will also be considered. The target sample size is 88 eligible patients per group. The intervention group will be prospectively recruited over 18 months and the control group will be composed of patients diagnosed with pulmonary DR-TB up to 2 years before the start of the trial. To ensure comparability, isolates from the control group will undergo WGS retrospectively, and pDST will be performed retrospectively in both groups. This clinical trial will take place in six medical centres for the treatment of DR-TB in the state of São Paulo. This study is intended to support the implementation of the WGS in the routine diagnosis of DR-TB in the state of São Paulo.
Ethical approval was obtained from the Human Research Committee of the Institute of Biomedical Sciences, University of São Paulo, Brazil (CAAE: 79497924.1.1001.5467). Study results will be published in peer-reviewed journals and disseminated to policymakers and stakeholders.
U1111-1308-4669.
by Emmanuel O. Adewuyi, Asa Auta, Olumuyiwa Omonaiye, Mary I. Adewuyi, Victory Olutuase, Kazeem Adefemi, Olumide A. Odeyemi, Yun Zhao, Gizachew A. Tessema, Gavin Pereira
IntroductionNigeria currently has the highest maternal mortality ratio and one of the highest neonatal mortality rates worldwide. Home birth—childbirth outside health facilities, often without skilled attendance or timely access to emergency obstetric care—may contribute to these disproportionate and avoidable adverse maternal and neonatal outcomes. National estimates often mask substantial sub-national disparities. This study examines the prevalence of home birth and associated factors across national, rural, and urban settings in Nigeria.
MethodsWe analysed data from the nationally representative cross-sectional Nigeria Demographic and Health Survey 2018, guided by Andersen’s Behavioural Model. Multivariable logistic regression was used to examine the associations between home birth and various predictor variables at the national level, as well as separately for rural and urban areas in Nigeria.
ResultsNationally, 58.1% (95% CI: 56.5, 59.7) of mothers gave birth at home, with prevalence twice as high in rural areas (72.4%, 95% CI: 70.7, 74.0) compared to urban areas (36.1%, 95% CI: 33.6, 38.7) (p Conclusion
Home birth remains highly prevalent in Nigeria, particularly in rural settings and in the northern and South-South regions, where prevalence is disproportionately high. Reducing home births requires a comprehensive approach that addresses the interplay of factors identified in this study. From a social justice and health determinants perspective, these factors are interconnected and can influence both access to and use of services. In rural areas, policies should enhance women’s decision-making autonomy, reduce distance barriers, and address region-specific challenges (e.g., insecurity in northern regions). In urban areas, it is essential to address financial barriers, support young mothers, and provide culturally and religiously sensitive care. Nationally, efforts should focus on improving education, expanding and strengthening antenatal care, and increasing access to media and the internet. From an equity perspective, interventions must be tailored to specific contexts to reduce unsafe home births and ensure that all mothers, regardless of location, have equitable access to skilled, respectful, and high-quality childbirth care.
To observe and compare the environmental impacts of different types of infant feeding, considering the use of formula, infant feeding accessories, potentially increased maternal dietary intake during breastfeeding (BF) and food consumption habits.
An observational cross-sectional multicentre study conducted in the Barcelona Metropolitan Area of the Catalan Institute of Health.
Data were collected from 419 postpartum women on infant feeding type (formula milk and accessories), maternal dietary intake (24-h register) and food consumption habits from November 2022 to April 2023. The environmental impacts (climate change (CC), water consumption and water scarcity) of the infant feeding types and maternal diet were calculated using the IPCC, ReCiPE and AWARE indicators, respectively. The differences in impacts were calculated by Kruskal–Wallis test.
Significant differences for the three environmental impacts were observed. The CC impact of formula milk and feeding accessories was 0.01 kg CO2eq for exclusive BF, 1.55 kg CO2eq for mixed feeding and 4.98 kg CO2eq for formula feeding. While BF mothers consumed an extra 238 kcal, no significant differences were found related to maternal diet across feeding types.
Exclusive BF was the most sustainable type of infant feeding, considering formula and infant feeding accessories. In our study, the difference between the impacts of BF and non-BF mothers' diet was insignificant.
Offer informative and educational support for midwives and other healthcare professionals on BF and a healthy, sustainable diet to transfer this knowledge to the general public.
Raise the general public's awareness about BF and a healthy, sustainable diet. To reduce environmental impacts through behavioural changes.
STROBE.
Patients of the Catalan Health Service reviewed the content of the data collection tools.
Trial Registration: (for the whole GREEN MOTHER project): NCT05729581 (https://clinicaltrials.gov)
by Ariene Silva do Carmo, Paulo César Pereira de Castro Júnior, Thais Cristina Marquezine Caldeira, Daniela Silva Canella, Rafael Moreira Claro, Luiza Delazari Borges, Larissa Loures Mendes
The present study analyzed the prices of food sold in canteens of Brazilian private schools and described price-based marketing strategies, according to the NOVA food classification system. This is a mixed methods study combining a cross-sectional component and time series analysis, with data from 2,241 canteens in private elementary and secondary schools in the 26 capitals of Brazil and the Federal District, collected between June 2022 and June 2024. Price data collected for unprocessed, minimally processed, or processed foods and culinary preparations based on these foods (UMPCP), and ultra-processed foods and culinary preparations based on these foods (UpCP) sold in school canteens and from the National System of Consumer Price Indices (SNIPC), were used to create a data set containing deflated monthly prices for food and beverages sold between August 2022 and July 2024. Calculations were made for adjusted prices (R$/100 g or ml) and absolute prices (R$ per portion), and frequency of use of strategies such as combos and promotions. UMPCP showed lower adjusted price, but higher absolute price than UpCP, especially for solid foods. About 27% of the study canteens implemented pricing strategies for both food groups. Most of these strategies did not exclusively favor healthy foods, indicating that promotions and combos were used without distinction. The affordability of healthy foods is disadvantaged in school canteens when considering the price per portion, which may negatively influence students’ food choices. The findings show that current prices for food sold in most canteens discourage the purchase of healthy items, but favor the purchase of unhealthy ones. These results reinforce the importance of interventions for promoting healthy foods and making them more affordable.Patient involvement in healthcare has become increasingly important, not only as an expression of respect for autonomy but also as a means of empowering individuals to safeguard their care. In blood transfusion, informed consent is a critical tool for shared decision-making. This protocol outlines a scoping review to map how transfusion consent processes and forms are used globally and to characterise their key features. We aim to identify technologies used to obtain consent, evaluate compliance with international recommendations, describe practices in special populations and examine patients’ and families’ understanding of the consent process.
Following the Joanna Briggs Institute methodology, we will search PubMed, Embase, LILACS, Web of Science and Scopus; grey literature will be explored via Google Scholar and the Open Access Theses and Dissertations platform. No language or date restrictions will be applied. Reference lists of included studies will also be screened. Two reviewers will independently screen studies and chart data; disagreements will be resolved by a third reviewer. Synthesis will be diagrammatic/tabular with structured narrative, reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses: extension for Scoping Reviews. Where data allow, findings will be stratified by clinical setting. A stakeholder consultation with two transfusion medicine experts and two patient representatives will be undertaken to validate and refine interpretations.
Only publicly available sources will be used; research ethics approval is not required. Findings will be submitted to a peer-reviewed journal and presented at scientific meetings.
10.17605/OSF.IO/NU69J.
Stroke volume is a major determinant of tissue perfusion and, therefore, a key parameter to monitor in patients with haemodynamic instability and hypoperfusion. Left ventricular outflow tract (LVOT) velocity-time integral (VTI) measurement using pulsed-wave Doppler is widely used as an estimation of stroke volume and should be a competence required for every intensive care unit (ICU) physician. Artificial intelligence (AI) applied to ultrasound facilitates the acquisition of adequate images. The aim of the present study is to evaluate the interchangeability of LVOT VTI measurements obtained by minimally trained operators and expert physicians, both guided by AI.
This is a prospective multicentre randomised controlled trial. ICU patients in whom fluid administration is considered necessary will be included. A minimally trained operator and an expert will independently measure LVOT VTI, guided by the UltraSight AI software to obtain the best five-chamber view, before and after a 250 mL fluid challenge. The order of acquisition between each operator will be randomised. 100 patients will be included.
The primary endpoint is the relative difference in LVOT VTI between operators. Secondary outcomes include the concordance of the therapeutic decision made by the blinded physician in charge of the patient based on the measures obtained by each operator, and the agreement between absolute values of LVOT VTI obtained by minimally trained and expert operators.
The study has been reviewed and approved by a regional ethics committee (Comité de Protection des Personnes—Ile de France II—n°24.00671.000291). An information note will be given to the participant before he or she participates in the study. The present study will be disseminated through peer-reviewed publications and academic and medical conferences.
Knee osteoarthritis (OA) is a leading cause of disability in older adults, with health and economic impacts. Despite pharmacological advances, exercise continues to be a fundamental pillar in the management of OA, with lower limb strength training showing significant benefits. Virtual reality (VR)-based interventions have emerged as innovative tools, providing immersive environments to facilitate functional movement exercises. VR offers pain relief, improved functionality and reduced fall risks, although its efficacy in OA management requires further exploration. The main aim of the study is to assess whether a VR-based intervention provides superior improvements in pain, stiffness, physical function and movement biomechanics compared with conventional therapeutic exercise in adults aged 60 years and older with knee OA.
This is a protocol for a randomised controlled trial comparing the effects of immersive VR interventions with conventional therapeutic exercises in individuals aged 60 years and older with knee OA. Participants are allocated 1:1 to experimental (VR) and control groups. The VR intervention involves 18 supervised sessions over 8 weeks, using Meta Quest 3 goggles to perform functional movements in virtual environments. The control group follows standard therapeutic exercise protocols per Osteoarthritis Research Society International guidelines. Outcomes include OA-related symptoms, kinematic performance, pain intensity, kinesiophobia and fall risk. Secondary measures assess cybersickness, depressive symptoms, medication use and comorbidities. Assessments occur at baseline, ninth week, sixth and 12th months. Data analysis employs intention-to-treat principles, leveraging descriptive statistics, t-tests and multiple imputations for missing data.
This study was approved by the A Coruña-Ferrol Research Ethics Committee (reference: 2023/557), under the Galician Health Service. All participants will be required to provide written informed consent prior to their inclusion in the study. Participant data will be pseudonymised and securely stored. Additionally, anonymised datasets will be deposited in open-access repositories (Zenodo).
Ageing impairs the respiratory system, increasing hospitalisation rates for respiratory problems in older adults. In cases of bronchial congestion, a weak cough in older inpatients challenges respiratory physiotherapy. Mechanical insufflation-exsufflation (MI-E) is one of the promising solutions. However, its effects have not yet been evaluated in this population. Therefore, we aim to compare the effects of MI-E and manual respiratory physiotherapy on cough peak flow (CPF), spirometry measures, dyspnoea and session discomfort in hospitalised older adults.
We will conduct a multicentre randomised controlled trial in four hospitals in France. A total of 120 older inpatients with bronchial congestion and a weak cough will be recruited from either intensive care units or conventional wards. All participants will receive three sessions of respiratory physiotherapy over one and a half days: MI-E for the experimental group and conventional manual respiratory therapy for the control group. Assessments will include CPF, forced vital capacity (FVC), maximum inspiratory and expiratory pressures, forced expiratory volume in one second (FEV1), FEV1/FVC ratio and the modified Borg scale for dyspnoea, measured before and immediately after each session. Discomfort will be assessed using a numerical (0–10) scale immediately after each session. Between-group comparisons will be performed using a linear mixed model for continuous outcomes and a generalised linear model for categorical variables.
The study was approved by the referred ethics committee (Comité de Protection des Personnes Ile de France XI, Identifier: 24.04832.000282) on 27 November 2024. Study results will be disseminated in peer-reviewed publications and at scientific meetings.
Paediatric hospitalisation, encompassing the period from admission to discharge, often involves feelings of pain, fear and anxiety, primarily due to clinical diagnoses and, more significantly, discomfort and stress-inducing procedures. Numerous methodologies and interventions have been investigated and implemented to alleviate these phenomena during paediatric hospitalisation. Virtual reality (VR), for example, has demonstrated efficacy in pain relief for hospitalised children in recent studies. This systematic review, therefore, aims to identify and evaluate the effectiveness of VR in alleviating pain, fear and anxiety in hospitalised children undergoing painful procedures.
This systematic review and meta-analysis will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols guidelines. A systematic search will be conducted in March and April 2025 across the following databases, with no restrictions on language or publication year: PubMed, Embase, Scopus, Web of Science, Cumulated Index in Nursing and Allied Health Literature, ClinicalTrials.gov and the Cochrane Central Register of Controlled Trials. Eligible studies will include randomised and quasi-randomised clinical trials involving children (aged 2–10 years) and adolescents (aged 10–18 years) who received VR interventions during painful procedures. Data will be managed and analysed using Review Manager software (RevMan 5.2.3). In cases of significant heterogeneity (I² > 50%), a random-effects model will be employed to combine studies and calculate the OR with a 95% CI. The methodological quality of the included studies will be assessed using the Cochrane Risk of Bias 2.0 tool, and the certainty of the evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluations framework.
This study will solely review published data; thus, ethical approval is not required. This systematic review is expected to provide subsidies, evidence and insights into the use of VR. It is also anticipated that the results will directly impact the improvement of care for these patients and the qualification of professional care.
CRD42024568297.
The standard treatment of oral cavity cancers (OCC) relies on surgery and postoperative radiotherapy (poRT) for advanced stages or poor factors. In more than 75% of cases, reconstructive surgery with a flap aims to restore the function lost with tumour resection. Current poRT planning and delineation guidelines omit the presence of a flap. It may be assumed that poRT with flap sparing may allow for reducing radio-induced toxicities and improving functional outcomes, without impairing local primary control. The OPTIFLAP trial assesses non-inferior locoregional control using flap sparing compared with conventional flap-agnostic radiotherapy in patients with OCC, while reducing treatment-related toxicity and improving functional outcomes.
The OPTIFLAP study is a French, multicentre, 1:1 randomised, phase III, controlled trial. It will recruit 348 patients with OCC with a flap. Recruitment is active with the first enrolment on 2 July 2025 and is planned over 48 months. The primary outcome is non-inferior 2-year locoregional control rate using flap sparing compared with flap-agnostic radiotherapy (as per standard routine practice) in completely resected OCCs undergoing poRT. Key secondary outcomes include rates of toxicities, locoregional relapse-free survival, progression-free survival, overall survival, quality of life, functional outcomes (assessed by the Performance Status Scales for Head and Neck Cancer, the MD Anderson Dysphagia Inventory (self-questionnaire) and the Phonation Handicap Index (self-questionnaire)), flap doses and outcomes between arms depending on dosimetric parameters. The trial incorporates translational ancillary studies addressing individual radiosensitivity, salivary microbiome evolution, radiomics and dosiomics of flap changes, as well as medico-economic evaluation.
The study protocol has been approved by the Medical Ethics Committee East III (January 2025; Ref 24.05832.000442) and the French Agency for Medical and Health Products Safety (December 2024; ID-RCB: 2024-A01764-43) and was validated by review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences.
Acute pain in the postoperative period of cardiac surgery is mostly treated with opioid analgesics. However, with the risk of adverse reactions and complications, strategies which do not involve opioid analgesics can be considered, such as aromatherapy. This systematic review aims to analyse the effectiveness of aromatherapy in relieving pain in post-cardiac surgery patients.
Two researchers will independently and simultaneously conduct searches and select studies from the following databases: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Latin American and Caribbean Literature on Health Sciences, Scopus, Web of Science, Cochrane (Library) and clinical trial registries (clinicaltrials.com), with no language or publication date restrictions. Randomised and quasi-randomised clinical trials on the use of aromatherapy for pain relief in postcardiac surgery patients will be included. Then, two researchers will independently examine the studies based on inclusion criteria, extract data from the included studies and assess the risk of bias using the Risk of Bias 2 tool and the Risk of Bias in Non-randomized Studies of Interventions tool from Cochrane. Data will be synthesised using Review Manager software. The strength of the evidence will be evaluated using the Grading of Recommendation Assessment, Development and Evaluation approach. The literature search, study selection, review and meta-analysis stages will be conducted from early October 2025 to April 2026.
This study is based on secondary data, and therefore ethical approval from a research ethics committee was not required. The results will be disseminated through publication in a peer-reviewed scientific journal.
CRD42024568532.
A dashboard was developed with and for Irish general practitioners (GPs) to improve their understanding of practice data. The aim of this study was to design and develop interactive CARA dashboards to enable Irish GPs to visualise patient data and compare their data with other practices.
An interpretivist qualitative approach was taken to create a deeper understanding of how GPs view and engage with data. It included four stages: (a) problem formulation, (b) building, intervention and evaluation, (c) reflection and learning and (d) formalisation of learning. The process included interviews to explore what type of information GPs need, as well as iterative testing of the CARA dashboard prototype.
General practice.
GPs, design experts and domain experts (antibiotic prescribing and stewardship).
Key challenges identified from the interviews (context, sense-making, audits, relevance, action, engagement and ease of use) formed the basis for developing the CARA dashboard prototype. The first exemplar dashboard focused on antibiotic prescribing to develop and showcase the proposed platform, including automated audit reports, filters (within-practice) and between-practice comparisons, as well as a visual overview of practice demographics. The design thinking approach helped to capture and build an understanding of the GPs’ perspectives and identify unmet needs. This approach benefits the quality improvement methodology commonly adopted across healthcare, which aims to understand the process, not the users.
The development of a useful dashboard is based on two key elements: users’ requirements and their continued involvement in the development of content and overall design decisions. The next step will be an incremental inclusion of GPs using the dashboard and an exploratory study on dashboard engagement. Additional dashboards, such as for chronic disease, will be developed.
The evidence for the optimal duration of psychotherapy for borderline personality disorder (BPD) is scarce. Two previous trials have compared different durations of psychotherapy. The first compared 6 months versus 12 months of dialectical behaviour therapy for BPD (the FASTER trial). The second compared 5 months versus 14 months of mentalisation-based therapy for BPD (the MBT-RCT trial). The primary objective of the present study will be to provide an individual patient data pooled analysis of two randomised clinical trials by combining the two short-term groups and the two long-term groups from the FASTER and MBT-RCT trials, thereby providing greater statistical power than the individual trials. Accordingly, we will evaluate the overall evidence on the effects of short-term versus long-term psychotherapy for BPD and investigate whether certain subgroups might benefit from short-term versus long-term psychotherapy.
An individual patient data pooled analysis of the FASTER trial and the MBT-RCT trial will be conducted. The primary outcome will be a composite of the proportion of participants with a suicide, a suicide attempt or a psychiatric hospitalisation. The secondary outcome will be the proportion of participants with self-harm. Exploratory outcomes will be BPD symptoms, symptom distress, level of functioning and quality of life. We will primarily assess outcomes at 15 months after randomisation for the FASTER trial and at 16 months after randomisation for the MBT-RCT trial. Predefined subgroups based on the design variables in the original trials will be tested for interaction with the intervention as follows: trial, sex (male compared with female), age (below or at 30 years compared with above 30 years) and baseline level of functioning (Global Assessment of Functioning baseline score at 0–49 compared with 50–100).
The statistical analyses will be performed on anonymised trial data that have already been approved by the respective ethical committees that originally assessed the included trials. The final analysis will be published in a peer-reviewed scientific journal and the results will be presented at national seminars and international conferences.
CRD42024612840.