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The Communication and Symbolic Behaviour Scales Developmental Profile Infant–Toddler Checklist (CSBS DP ITC) is a screening tool designed to identify early deficits in social communication, expressive speech/language and symbolic functioning in children aged 6–24 months. This study aimed to translate and content validate the CSBS DP ITC into Modern Standard Arabic.
Methodological study involving translation and content validation.
The study was conducted in the United Arab Emirates.
The translation process involved five bilingual translators and one monolingual Arabic language expert. Ten experts participated in the content validation phase, and 10 parents of young children participated in the face validity assessment.
Content Validity Indices (CVIs), including the Item-level CVI (I-CVI), the Scale-level CVI by Average (S-CVI/Ave) and the S-CVI by Universal Agreement (S-CVI/UA), along with modified kappa statistics, were calculated to assess item-level and scale-level clarity, relevance and comprehensiveness.
Expert panel ratings showed high clarity (I-CVI: 0.8–1, S-CVI/Ave: 0.98, S-CVI/UA: 0.88) and similar relevance scores. Face validity assessments yielded clarity I-CVI scores of 0.9–1, with S-CVI/Ave at 0.98 and S-CVI/UA at 0.8. The modified kappa statistic ranged from 0.89 to 1, indicating strong agreement among parents.
The CSBS DP ITC was effectively translated and content validated into Modern Standard Arabic. The calculated CVI values ranged from excellent to acceptable. This step establishes a foundation before proceeding to full psychometric testing of the instrument, paving the way for a reliable and culturally appropriate tool to identify early communication delays for use across the Arab-speaking population.
Cognitive behavioural therapy (CBT) and interpersonal psychotherapy (IPT) are both efficacious treatments for depression, but it is less clear how both compare on outcome domains other than depression and in the longer term. Moreover, it is unclear which of these two psychotherapies works better for whom. This article describes the protocol for a systematic review and individual participant data (IPD) meta-analysis that aims to compare the efficacy of CBT and IPT for adults with depression on a range of outcomes in both the short and long term, and to explore moderators of the treatment effect. This study can enhance our understanding of treatments for depression and inform treatment personalisation.
Systematic literature searches will be conducted in PubMed, PsycINFO, EMBASE and the Cochrane Library from inception to 1 January 2026, to identify randomised clinical trials (RCTs) comparing CBT and IPT for adult depression. Researchers of eligible studies will be invited to contribute their participant-level data. One-stage IPD meta-analyses will be conducted with mixed-effects models to examine (a) treatment efficacy on all outcome measures that are assessed at post-treatment or follow-up in at least two studies, and (b) various baseline participant characteristics as potential moderators of depressive symptom level at treatment completion.
Ethical approval is not required for this study since it will be based on anonymised data from RCTs that have already been completed. The findings of the present study will be disseminated through a peer-reviewed journal or conference presentation.
Essential care partners (ECPs), also known as family caregivers, play a critical role in the Canadian healthcare system across the continuum of care, particularly in managing complex conditions like stroke. With the rising number of stroke incidents occurring in Canada each year, there is an increased need for caregiver assistance to help manage the care needs of stroke survivors as they transition to home and community services. Although existing research has highlighted the practical and psychosocial needs of stroke ECPs, these challenges have been mainly overlooked. The lack of integrated intersectoral care services across stroke care pathways places additional significant burdens on caregivers, leading to increased stress, social isolation and a decreased quality of life. Nelson and colleagues’ novel Discharge Assistance and Supports at Home model uses community-based interventions mobilised through intersectoral partnerships and volunteers as human resources to facilitate grassroots solutions to the discharge and transition challenges often faced by stroke survivors. As an extension of this work, this rapid review will investigate and detail community-involved or community-led interventions that have been proven effective in addressing the unmet needs of stroke ECPs during critical care transitions. The findings of this review will identify what works, for whom and in what context regarding community-involved caregiver-centred transition interventions to inform the creation of an actionable Research Agenda—DASH-Caregiver.
This rapid review will be conducted using the updated guidance on methods used in Cochrane rapid reviews of effectiveness. The search strategy will be refined by the study team with assistance from an information specialist and applied to six databases: Medline, Cochrane, Embase, CINAHL and PubMed. Grey literature will be searched using Google search engines, targeted websites and consultation with knowledge holders. Two research team members will conduct a two-stage screening process to determine study eligibility. Data from eligible studies will be extracted using a piloted charting form and synthesised narratively.
This review protocol does not require ethics approval, as no data have been collected or analysed. The results will be shared with key knowledge holders through publications and presentations and incorporated into the team’s future research.
Patients who survive admission to intensive care unit (ICU) for critical illness are at high risk of developing muscle atrophy and weakness, commonly diagnosed as ICU-acquired weakness (ICUAW). The development of ICUAW is closely linked to long-term symptoms and impairments known as post-intensive care syndrome (PICS). Despite heightened recognition of impairments, there is limited research supporting effective interventions to improve muscle and physical outcomes after hospital discharge. Prior to developing and testing interventions for ICU survivors, it is imperative to understand the trajectory of muscle and physical function recovery following an ICU stay. The purpose of this study is to longitudinally investigate skeletal muscle health and physical function outcomes after ICU admission.
This protocol describes a single site, prospective, observational study in adult patients who have survived a critical illness (ie, sepsis or acute respiratory failure). Patients will participate in a battery of testing including primary outcomes: muscle power and physical function; and secondary outcomes: muscle strength, muscle size, endurance and physical activity (by accelerometry) at hospital discharge and 3, 6, and 12 months post-discharge. A subset of patients will participate in muscle biopsy and venipuncture. To examine if the trajectory of recovery predicts primary outcomes, we will perform multivariate linear regression models in 150 evaluable patients. To examine differences in molecular and cellular outcomes in plasma and muscle tissue, a control group of community-dwelling adults without history of an ICU stay will be enrolled as a comparator group. Enrolment started on 18 October 2022 with an estimated completion date of 1 August 2027.
This protocol was approved by the University of Kentucky Office of Research Integrity Medical Internal Review Board (# 77407), with patients providing informed written consent. We anticipate our findings to establish recovery trajectories, improving the classification of patients who experience sustained physical disability. Improved identification of recovery trajectories of muscle and physical function enables future studies to employ an individually targeted rehabilitation approach, that is, precision medicine, with the goal of improving patient outcomes. The cellular findings will support the development of novel interventions specifically designed for detecting underlying mechanisms. We intend to disseminate findings to patients, healthcare professionals, the public and other relevant groups via conference presentations and manuscripts without publication restrictions.
To examine the effects of 12 weeks group-based peer-led aquatic high-intensity interval training (AHIIT) compared with aquatic moderate continuous training (AMICT) on patient-reported outcome measures (PROMs) and quality-adjusted life-years (QALYs).
A single-blind, parallel-group, randomised trial with a 1:1 allocation ratio.
Community-based setting.
89 participants (mean age 62 (SD 13) years) with rheumatic and musculoskeletal diseases, including hip and knee osteoarthritis, fibromyalgia, rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, were randomly allocated to an AHIIT (n=44) or an AMICT (n=45) group.
The intervention consisted of AHIIT (four intervals of 4 min at high intensity, Borg scale 14–18) or AMICT (Borg scale 12–13), conducted twice weekly for 12 weeks.
Outcomes included disease activity (measured by the Patient Global Assessment), fatigue, pain and health-related quality of life (HRQoL), measured by the EQ-5D utility index (five-dimensional health status measure) and EQ VAS (self-rated overall health scale) for overall health, physical and social activities. All outcomes were assessed at baseline, 3 months and 6 months. To compare the overall benefit of these interventions, QALYs were estimated based on HRQoL. Linear mixed models for repeated measures were used to estimate the mean difference (95% CI) in outcomes.
No statistically significant differences between the groups were found in any outcomes at either three or 6 months (p>0.05).
No difference between the groups was found on PROMs and QALYs. Future research should include larger sample sizes and a non-exercising control group to better determine the efficacy of AHIIT and clarify the role of exercise intensity in symptom management.
In Tanzania, acute myocardial infarction (AMI) is underdiagnosed, and uptake of evidence-based care is suboptimal. Using an implementation science approach, an intervention was developed to address local barriers to care: the Multicomponent Intervention for Improving Myocardial Infarction Care in Tanzania (MIMIC).
This sequential cohort design trial was conducted in a single northern Tanzanian emergency department (ED). During the preintervention phase (February–August 2023) and the postintervention phase (September 2023–August 2024), adults presenting with chest pain and/or dyspnoea were prospectively enrolled and their ED care was observed. AMI was defined by the Fourth Universal Definition criteria. Telephone follow-ups were conducted to ascertain 30-day mortality. Pearson’s ² was used to compare care before and after MIMIC implementation.
A total of 275 participants were enrolled in the preintervention phase and 577 were enrolled in the postintervention phase. Following MIMIC implementation, significant increases were observed in ECG testing (89.4% of postintervention participants vs 55.3% preintervention, OR 6.82, 95% CI 4.79 to 9.79, p
The MIMIC intervention was associated with large increases in uptake of AMI testing, case identification and evidence-based treatment in a single Tanzanian ED. Multisite studies are needed to evaluate the effect of MIMIC on AMI care in diverse settings across Tanzania.
To pilot a culturally tailored, peer-led, co-produced asset-based intervention workshop to encourage early diagnosis of prostate cancer for Black men.
Mixed-methods pilot study.
Community centres in the North-East of England and Scotland.
The intervention was delivered in November 2023 with Black African and Caribbean men (n=21), and again in February 2024 (n=41). Participants were highly educated and aged between 42 and 63 years. The intervention was qualitatively evaluated with 40 of the intervention participants.
Underpinned by the Integrated Screening Action Model (I-SAM), we co-produced a culturally tailored, peer-led 2-hour workshop consisting of multiple components, including small group discussions about barriers to accessing prostate cancer care, general practitioner (GP) health education, activities to facilitate effective communication with the GP and reception staff and videos with testimonials from survivors, women and religious leaders.
Knowledge, attitudes and intention to engage in prostate cancer testing were examined through a pre- and post-survey design. Intervention acceptability was qualitatively explored through focus groups.
Participants (n=41) reported that the workshop increased their confidence in engaging with healthcare providers to discuss prostate cancer testing (I-SAM component: psychological capability). Knowledge (I-SAM component: psychological capability: Z=4.939, p
Asset-based strategies, focusing on community strengths, including faith-based health promotion, can promote health behaviours in a culturally and spiritually meaningful way. The PROCAN-B intervention effectively targeted components within the I-SAM and shows potential to increase prostate cancer awareness and build confidence to engage in behaviours conducive to early diagnosis. However, the sample was small, and more robust effectiveness testing is needed.
Post-traumatic stress disorder (PTSD) is a heterogeneous psychiatric disorder, with symptom variation between patients.
We describe clinical and demographic characteristics of patients with PTSD based on real-world data.
This non-interventional, retrospective cohort study analysed de-identified electronic health records of patients from the Holmusk NeuroBlu database in the USA. Patients with ≥2 PTSD diagnoses captured in the database within 30 days between 2001 and 2020 were included. The index date was defined as the date of the first recorded PTSD diagnosis. In patients who were aged ≥18 years, demographic and clinical characteristics at baseline (index date ±14 days), in the 6 months prior to baseline and 12 months after baseline were described. Patients were stratified into four mutually exclusive subgroups according to treatment received: psychotherapy only, pharmacotherapy only, psychotherapy and pharmacotherapy, and untreated. Natural language processing models were used to derive PTSD symptoms from unstructured clinician-documented mental state examination data. Data were analysed descriptively.
A total of 37,449 patients had ≥2 PTSD diagnoses within 30 days between 2001 and 2020; 32,875 patients received care at clinical sites with both inpatient/outpatient units; 25,507 patients received psychotherapy and/or pharmacotherapy as per further prespecified criteria, and 17,234 were ≥18 years old and included in this analysis. Most patients (84.9%) received psychotherapy, pharmacotherapy or both during the first year post-baseline. Mean age (SD) was 37.7 (12.4) years, 73.4% of patients were female and 59.6% were White. At baseline, 98% of patients had ≥1 psychiatric comorbidity; major depressive disorder (42.2%), substance use disorder (35%) and anxiety disorder (30.7%) were most frequently reported. Reported suicidal ideation/attempts were most frequent in the pharmacotherapy only group compared with other subgroups at baseline. The most frequently prescribed drug classes were antidepressants (51.8%), second-generation antipsychotics (29.9%) and anxiolytics (23.3%) at baseline. Trazodone, clonazepam, quetiapine and sertraline were the most frequently prescribed medications.
In the overall study population, most patients were female, with a high prevalence of psychiatric comorbidities. Demographic and clinical characteristics observed in this study varied across treatment subgroups. These insights may support patient-specific treatment planning and inform health-economic decision models in PTSD.
To determine the spatial-temporal patterns of natural hazards and disasters in the Greater Horn of Africa, including climate and environmentally sensitive diseases, and compare the reporting consistencies across multiple open-access databases.
Cross-sectional retrospective secondary analysis of natural hazard and disaster data.
Djibouti, Eritrea, Ethiopia, Kenya, Somalia, Sudan, South Sudan and Uganda.
Primary data from Emergency Events Database (EM-DAT), and comparative data from ReliefWeb, WHO Disease Outbreak News (WHO-DON), FloodList and Global Unique Disaster Identifier Number (GLIDE).
EM-DAT reported 228 natural hazards and disasters affecting 145.7 million people; highest numbers reported in Uganda (n=48), Kenya (n=46), Somalia (n=38) and Ethiopia (n=35); 175 geophysical, hydrological, meteorological and climatological hazards reported, including 118 floods, 26 droughts, 11 storms and 17 landslides; 46 epidemics reported, primarily bacterial (eg, cholera) or viral (eg, yellow fever, measles) diseases, with 20% preceded by a flood, drought or landslide within the previous 3 months. Reporting consistency and content varied considerably across the five databases.
Natural hazards and disasters affect millions of people. There is an urgent need to improve database connectedness to facilitate better monitoring and mapping, which can inform disease forecasting and decision tools to develop preparedness and intervention strategies.
The introduction of fentanyl and its analogues in the illicit drug supply has prompted greater emphasis on refining clinical treatment protocols to ensure sustained retention in opioid agonist treatment (OAT). Take-home dosing may lessen the treatment burden on clients and thus reduce the risk of treatment discontinuation. The evidence base supporting the use of take-home dosing, including the optimal duration of dispensations, is, however, limited. The objective of this study is to determine the comparative effectiveness of alternative take-home dosing schedules, as observed in clinical practice in British Columbia, Canada from 2010 to 2022.
We propose to emulate a target trial with a population-level retrospective study of individuals initiating methadone or buprenorphine/naloxone between 1 January 2010 and 31 December 2022 who are 18 years of age or older and not currently incarcerated or pregnant with no history of cancer or palliative care. Our study will draw on nine linked health administrative databases from British Columbia and will evaluate take-home doses of 2–5 days, 6 days or >6 days compared with continuous daily dosing. The primary outcomes include OAT discontinuation and all-cause mortality on treatment. A causal per-protocol analysis is proposed with longitudinal matching and inverse probability of censoring weighting approaches to adjust for time-fixed and time-varying confounding. A range of sensitivity analyses will be executed to determine the robustness of results.
The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. Results will be disseminated and shared with local advocacy groups and decision-makers, developers of national and international clinical guidelines, presented at national and international conferences and published in peer-reviewed journals electronically and in print.
Endometriosis is a chronic gynaecological condition affecting 2%–10% of women worldwide, often leading to severe pain, organ dysfunction and infertility. Despite its prevalence, diagnosis is frequently delayed, and treatment options remain limited. Mobile health (mHealth) applications have gained popularity as tools for symptom tracking, yet concerns about their accessibility, evidence-based content and inclusivity persist. Ensuring that these digital tools are culturally relevant, user-friendly and available to diverse populations is crucial for improving patient care and engagement. This study aims to systematically review mobile applications designed for tracking endometriosis symptoms, with a focus on content quality, inclusivity and functionality. The objective is to identify gaps in existing apps and provide recommendations for developing more inclusive digital health solutions.
This study follows a systematic review methodology proposed by Gasteiger et al. The research process consists of seven steps, including defining research questions, identifying relevant applications, determining eligibility criteria, selecting and analysing apps and synthesising results. The apps will be sourced from the Apple App Store and Google Play Store via predefined search strategies. The evaluation criteria include content accuracy, usability, inclusivity, privacy protection and adherence to evidence-based medical guidelines. Data extraction focuses on app characteristics, including language availability, user accessibility, evidence-based symptom tracking and adherence to health equity principles. The Mobile App Rating Scale will be used to assess usability, functionality, aesthetics and information quality. The findings will be systematically compared to identify strengths, limitations and areas for improvement in existing applications.
This systematic review of applications offers an overview of available apps that can be downloaded in Switzerland. Furthermore, it will present a detailed analysis of those that are specifically geared towards symptom tracking and will evaluate the level of evidence-based content, inclusivity, data protection and quality. A key strength of this review is its multidisciplinary approach, which involves engaging experts in healthcare, digital technology, inclusivity and individuals with lived experiences with endometriosis.
Approval from an ethics committee is not required. Data and material will be available on request from the authors.
This study examined the mental health literacy of perinatal healthcare professionals in the United Arab Emirates (UAE) and analysed how their knowledge, attitudes and confidence impact their clinical practices in addressing perinatal mental health disorders.
A qualitative study with a descriptive phenomenological design. Data were collected via semi-structured individual interviews and focus group discussions. The data were analysed inductively using Braun and Clarke’s six-step thematic analysis.
The study was conducted in Abu Dhabi, Dubai and Al Ain in the UAE. Participants were recruited from various healthcare facilities and professional educational events.
The participants consisted of perinatal healthcare professionals from seven disciplines, including lactation consultants, midwives, nurses, obstetricians, paediatricians, family medicine practitioners and psychiatrists/psychologists. All participants were required to be actively involved in providing care to perinatal patients and to have a minimum of one year of clinical experience. The study included three focus group discussions and 28 semistructured individual interviews, culminating in a sample of 43 participants for analysis.
Three key themes emerged: (1) Knowledge and awareness, highlighting variable understanding of perinatal mental health and reliance on instinct over formal screening; (2) Navigating professional roles and realities, showing empathy and willingness to support patients, yet role ambiguity, low confidence and societal stigma influence perinatal healthcare professionals’ responses and care practices and (3) Strengthening support systems and resources, where participants called for improved training, clear policies and psychosocial resources to overcome institutional and educational gaps and to enhance perinatal mental healthcare and patient outcomes.
The study reveals gaps in mental health literacy and institutional support that hinder the delivery of effective perinatal mental healthcare. Strengthening provider training, implementing standardised screening and referral pathways, and promoting culturally sensitive, multidisciplinary approaches are essential. Such interventions can enhance early detection and improve outcomes for mothers and infants. Further research should focus on developing and evaluating the efficacy of such interventions to enhance early detection and improve outcomes for mothers and infants.
The ventilatory ratio (VR) is a simple and accessible index that reflects ventilatory efficiency in critically ill patients. Although several studies have examined its potential as a prognostic marker in acute respiratory distress syndrome (ARDS), the results remain inconsistent and inconclusive. This systematic review and Bayesian meta-analysis aimed to evaluate the association between VR and mortality in adult patients with ARDS.
Two investigators will independently conduct systematic literature searches in the PubMed, Embase, Scopus, Cochrane Library and Latin American and Caribbean Health Sciences Literature / Literatura Latinoamericana y del Caribe en Ciencias de la Salud (LILACS) databases, covering all publications from database inception to July 2025.
This systematic review and meta-analysis will include prospective and retrospective cohort studies evaluating the association between the VR and mortality in adult patients with ARDS. Specifically, we aim to answer the following Patient, Population or Problem, Intervention, Comparison, and Outcome (PICO) question: In adult patients with ARDS (Population), is an elevated VR (Exposure), compared to lower or normal VR values (Comparison), associated with an increased risk of mortality (Outcome)?
The primary outcome will be mortality, as defined in each included study. Outcomes will be analysed according to the characteristics and reporting of the original publications.
The methodological quality of the included studies will be assessed using the Quality In Prognosis Studies tool, and the certainty of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach.
The review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A hierarchical Bayesian random-effects model will be used to synthesise the data, with effect sizes expressed as ORs and 95% credible intervals. Weakly informative priors will be applied to model parameters.
Between-study heterogeneity will be assessed through the estimation of the between-study variance (²) and the I² statistic. Subgroup analyses will be conducted based on study design and ARDS aetiology, and a bivariate meta-regression will explore potential effect modifiers. A leave-one-out sensitivity analysis will also be performed to assess the robustness of the findings.
Publication bias will be evaluated using a Bayesian funnel plot and an adapted version of Egger’s test.
This systematic review does not require ethics approval. The results will be published in scientific journals, presented at national and international conferences and shared on social media in accessible language.
CRD420251008773
This review aims to map oral health plans, programmes and policies worldwide in countries with universal health coverage.
This protocol describes a scoping review that will follow the Joanna Briggs Institute methodology and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Review checklist, guided by the PCC framework: Population—countries with universal health coverage (78 globally recognised); Concept—oral health plans, programmes and policies; Context—integration into health systems. Searches will be conducted in MEDLINE (PubMed), Scopus, Web of Science, Embase, Health System Evidence and Epistemonikos, with no restrictions on date, language or study type. Grey literature will be accessed through Google Scholar, OpenThesis and the Brazilian Digital Library of Theses and Dissertations. Official documents from ministries of health and international bodies, including the WHO and the International Monetary Fund, will also be reviewed. Two independent reviewers will screen titles and abstracts; a third will resolve disagreements. Eligible records will undergo full-text review. Data will be extracted into predefined categories reflecting health system components: population, structure, services, governance and oral health indicators. Results will be presented using tables, charts and figures to illustrate strategies and innovations.
This review does not involve primary data collection and does not require ethical approval. Results will be disseminated through a peer-reviewed publication and presentations at academic conferences and scientific events.
Open Science Framework (DOI 10.17605/OSF.IO/RCP8N).
Postpartum depression (PPD) is a debilitating condition affecting over 20% of postpartum women, with disproportionately higher rates among black and Latina women compared with their white counterparts. Current recommendations for PPD prevention demand significant healthcare system resources, highlighting the need for alternative, evidence-based interventions that minimise strain on these systems. Mindfulness has been shown to effectively reduce depressive symptoms and prevent relapse across various populations. However, no studies to date have evaluated the efficacy of a digitally delivered mindfulness intervention specifically for black and Latina women at increased risk of PPD.
This article presents the protocol for the Healthy Mama and Baby study, a randomised controlled trial (RCT). This trial evaluates whether a mobile-based (mHealth) mindfulness intervention tailored for pregnant women reduces depressive symptoms among pregnant black and Latina women at high risk for PPD.
We are conducting a fully remote RCT, recruiting 600 pregnant black and/or Latina women at risk of PPD from Kaiser Permanente Northern California (KPNC), an integrated healthcare delivery system. Participants are enrolled before 30 weeks’ gestation. They are randomised into either an mHealth mindfulness intervention arm, which receives access to a mindfulness app tailored specifically for pregnant and postpartum women, or a time-matched and attention-matched active control arm, which receives access to an online program of calming nature sounds. Both arms are instructed to engage in their assigned program for 5–20 min per day for 6 weeks. Outcome assessments are conducted online at baseline, post intervention and post partum (~7 weeks post partum) using validated questionnaires. Outcomes include depressive symptoms (primary) and anxiety, sleep and perceived stress (secondary).
All study procedures have been approved by the KPNC Institutional Review Board. The findings will be disseminated widely through peer-reviewed publications and conference presentations.
To explore the opportunities, challenges and perceived strategies for the uptake of OraQuick HIV self-testing (HIVST) among female sex workers in Ethiopia.
A phenomenological study design, with the Integrated Behavioural Model used as a framework for analysis and interpretation.
Woldia, North Wollo, Ethiopia, 13–30 February 2024.
Twenty female sex workers and 18 key informants in Woldia participated in in-depth interviews, key informant interviews and focus group discussions.
The advantages related to OraQuick HIVST include its privacy, ease of use, reduced waiting time, lowered transportation costs, usability for immobile individuals, application in screening for index case testing programmes, providing confidence and reliability and the elimination of the need for healthcare providers during testing. Perceived possible challenges for the uptake of OraQuick HIVST included kit shortage, absence of policies or guidelines for HIVST, lack of post-test counselling and immediate treatment for positive individuals, potential psychological trauma such as suicidal ideation or attempts, lack of linkage to care for those with reactive results, inaccurate reporting of positive results or result concealment and doubts about reliability before education. Strategies perceived for enhancing the uptake of OraQuick HIVST included making the HIVST kit accessible to higher education communities, addressing HIVST-related doubts by including phone or email contact information, advocating and creating awareness about OraQuick HIVST and ensuring the availability of kits in easily accessible locations.
The study findings highlight many positive opportunities related to the uptake of OraQuick HIVST. Policymakers should prioritise addressing the challenges identified and implementing the proposed strategies to enhance the uptake of OraQuick HIVST, potentially leading to improved HIV testing rates and outcomes.
Muscle-invasive bladder cancer (MIBC) is an aggressive type of cancer. About 50% of patients will die from the disease within 5 years despite radical treatment. This implies that in many patients, the disease has already spread at the time of radical treatment, even though imaging shows no signs of metastasis. We hypothesise that the standard local staging method, transurethral resection of the bladder tumour (TURBT), is partly responsible for tumour cell spread. Furthermore, TURBT (and re-TURBT in many patients) contributes to a significant delay to definitive therapy. The aim of this randomised study is to determine whether multiparametric MRI (mpMRI) of the bladder, in combination with a single outpatient bladder tumour biopsy for histological confirmation, is a safer, faster, less costly and, therefore, more cost-effective diagnostic pathway than TURBT to detect or rule out MIBC.
BladParadigm is a two-arm multicentre randomised controlled trial (RCT) conducted in the Netherlands. Over a 3-year period, patients with clinically suspected MIBC without evidence of metastases will be recruited and randomised 1:1 to either TURBT or 3-Tesla mpMRI with same-day outpatient bladder biopsy. The Vesical Imaging Reporting and Data System (VI-RADS) will be used to standardise mpMRI reporting. Patients will undergo definitive treatment based on the results of the TURBT or mpMRI. The study is powered to demonstrate that the mpMRI-based strategy is at least non-inferior to standard TURBT in patients treated with radical cystectomy alone, assuming a relative hazard of 0.55. The required sample size is 360 patients (180 TURBT, 180 mpMRI). The primary outcome is 2-year progression-free survival. Progression will be assessed by imaging, according to the current standard of care. Secondary outcome measures are time to definitive treatment, quality of life (EuroQol 5D-5L), healthcare costs and cost-effectiveness.
This study has received ethical approval from the Medical Ethical Committee Oost-Nederland (NL83685.091.23). All participants will provide written informed consent prior to inclusion. Findings of this study will be disseminated through peer-reviewed, open-access publications, presentations at scientific conferences and stakeholder briefings.
Heart failure (HF) is a debilitating condition associated with high morbidity, mortality and healthcare resource use. Frailty in HF patients is associated with poorer outcomes, including increased morbidity, mortality and reduced quality of life (QoL). Nutritional disorders, such as malnutrition, are common in patients with HF and contribute to functional decline and increased mortality. The Meta-Analysis Global Group in Chronic HF (MAGGIC) risk score was developed to predict 1-year and 3-year hospitalization and mortality in patients with HF. This study aims to assess the added value of frailty, QoL and nutritional status to the MAGGIC risk score.
This prospective cohort study, conducted at a tertiary public hospital in southern Brazil, will include 316 patients with chronic HF who are followed up at the HF Outpatient Clinic. Frailty will be assessed using the Fried scale, health-related QoL will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and nutritional status will be assessed using the Mini Nutritional Assessment. These variables will be incorporated into the MAGGIC risk score. Continuous variables with a normal distribution will be described as mean±SD, skewed variables as median±IQR and categorical variables as absolute and relative frequencies. Survival analysis will be performed using the Kaplan-Meier method with log-rank test comparisons. The prognostic value of frailty, its components, the MLHFQ score and nutritional status will be assessed by Cox regression, which will be adjusted for the MAGGIC risk score. Net Reclassification Improvement and Integrated Discrimination Improvement will assess the accuracy of the MAGGIC score when including frailty, MLHFQ and nutritional status. A p value
This study adheres to the Declaration of Helsinki and was approved by the Institutional Committee for Scientific Ethics and Research (No 20220558) and the Brazilian Government Registry (No 66474223200005327). The data will be available on reasonable request from the corresponding author. The results will be disseminated via peer-reviewed manuscripts and shown at national and international conferences.
Patients with metastatic oncogene-driven non-small cell lung cancer (NSCLC) are experiencing longer and uncertain trajectories of life-limiting illness due to advances in precision medicine. These advanced cancer survivors face new challenges related to living with uncertainty and desire more support to maximize their health and quality of life. Therefore, we developed a population-specific, blended palliative and survivorship care intervention to address the supportive care needs of patients recently diagnosed with advanced lung cancer and who are receiving targeted therapy for NSCLC with EGFR, ALK, ROS1 or RET driver mutations.
This study is a single-site, non-blinded pilot randomised controlled trial of an intervention for patients with metastatic oncogene-driven NSCLC, Patient-centred, Optimal Integration of Survivorship and palliative carE (POISE) versus usual care. POISE consists of a brief series of structured visits with a trained palliative care clinician to address coping with uncertainty, increase prognostic awareness and promote healthy lifestyle behaviours. We will recruit 60 patients from the Massachusetts General Hospital Cancer Center. Patients will be randomised into a 1:1 ratio to the intervention arm or the usual care arm. Patients randomised to the intervention arm will complete four 60 min virtual or in-person visits with a palliative care physician. The usual care arm will receive standard oncology care. Patients in both arms will complete survey assessments at enrolment, 12 weeks and 20 weeks after enrolment, and patients in the intervention group will complete an exit interview. The primary outcome measure of this trial is feasibility, which will be defined by ≥60% enrolment among eligible patients, ≥70% completion of all sessions for participants in the intervention arm and ≥70% completion of all surveys for all study participants. Exploratory outcomes include acceptability, emotional coping with prognosis, self-efficacy for chronic disease management, prognostic awareness, quality of life, anxiety, depression, intolerance of uncertainty and documentation of goals and values discussions in the electronic health record.
This study was approved by the Dana-Farber/Harvard Cancer Center’s institutional review board (protocol 20-722). The protocol is reported in accordance with the Standard Protocol Items: Recommendations for Interventional Trials guidelines, and the study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials.
Opioid use disorder (OUD) during pregnancy is associated with increased rates of adverse perinatal, foetal and neonatal health events. Opioid agonist treatment (OAT) can substantially reduce the risk of these potential harms. In British Columbia (BC), methadone and buprenorphine/naloxone are first-line treatment options for pregnant people with OUD. However, the comparative effectiveness of these regimens during pregnancy remains poorly understood, particularly in terms of how dosage may impact clinical outcomes. This protocol outlines a proposed population-based retrospective study to evaluate the comparative effectiveness of methadone compared with buprenorphine/naloxone during pregnancy on perinatal and neonatal health outcomes.
We propose to conduct a retrospective observational study using population-based data from individuals who received methadone or buprenorphine/naloxone during pregnancy between 1 April 2010 and 31 March 2022. Data will be collected from 10 linked population-level administrative databases. We will emulate target trials using intention-to-treat and per-protocol approaches. We will use a pooled logistic regression approach to assess the impact of methadone versus buprenorphine/naloxone on time to OAT episode discontinuation and a dose-response marginal structural model to evaluate neonatal health at delivery. An exploratory observational analysis will also be conducted to describe the impact of methadone vs buprenorphine exposure during the first trimester of pregnancy on congenital malformations and anomalies.
This study has been determined to meet the criteria for exemption per Article 2.5 of the 2018 Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Study databases have been made available by the BC Ministries of Health and Mental Health and Addiction as part of the provincial opioid overdose public health emergency response. Results will be disseminated to policymakers, clinical partners, community programmes and people with lived and living experience of substance use and published in peer-reviewed journals.
FreshRSS 