by Priscilla Kapombe, Choolwe Jacobs, Mark W. Tenforde, Kashala Kamalonga, Diane Morof, Terrence Lo, Mweene Cheelo, Lloyd Mulenga, Sombo Fwoloshi, Cordilia M. Himwaze, Patrick Musonda, Mpundu Makasa, Jonas Z. Hines
Zambia has achieved improvements in life expectancy among persons living with HIV (PLHIV) because of high antiretroviral therapy (ART) coverage, which should improve survival due to reductions in AIDS-defining conditions. However, recent estimates of the most common causes of death are not widely available. We utilized mortality surveillance data to report on common causes of death among persons with HIV who died in community settings in Zambia. The Zambian Ministry of Health conducted sentinel mortality surveillance of community deaths in 45 hospitals in 33 of 116 districts from January 2020 through December 2023. Verbal autopsies (VA) were conducted through interviews with relatives or close associates of deceased persons using the 2016 World Health Organization tool. HIV status was reported. A probable cause of death was assigned by a validated computer algorithm (InterVA5). We describe the top assigned causes of death stratified by HIV status. Verbal autopsies were conducted for 67,079 community deaths, of which 11,475 (17.1%) were persons with HIV. The mean age at death was 45 years among persons with HIV and 48 years for persons without HIV (T-test pTo explore cardiac rehabilitation (CR) professionals’ perspectives on kinesiophobia in patients with cardiovascular diseases. This study aims to understand the perspectives of healthcare professionals (HCPs) regarding their perceptions, assessments and management of kinesiophobia.
A qualitative descriptive study using in-depth interviews and thematic analysis.
The study was carried out through online interviews at a university teaching hospital in South India.
HCPs involved in CR, from around the world, were invited to participate through advertisements on social media and through professional forums. 12 HCPs, including CR nurses (n=1), CR physicians (n=1), cardiac surgeons (n=1), cardiac electrophysiologists (n=1), rehabilitation physicians (n=1), cardiologists (n=2), exercise physiologists (n=2) and physiotherapists (n=3), agreed to participate.
Not applicable (qualitative study without interventions).
Qualitative data collected through in-depth interviews focused on HCP perceptions regarding kinesiophobia and its assessment, management and awareness within CR.
Thematic analysis generated 337 codes, which formed seven subthemes: the perceived burden of kinesiophobia, reasons for kinesiophobia, HCP experiences with kinesiophobia, methods of assessing kinesiophobia, management strategies, reasons why kinesiophobia is overlooked and the importance of promoting awareness of kinesiophobia.
CR professionals recognise kinesiophobia as a significant issue among patients with heart disease but do not recognise the term or perceive it as a separate condition; instead, they view it as part of the overall clinical presentation. There is a strong need to advocate for early recognition and assessment of kinesiophobia and for the development of structured management strategies and its inclusion into CR programmes to improve patient outcomes during recovery.
The study was prospectively registered in the Clinical Trial Registry of India (CTRI/2022/05/042502). This study received approval from the Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research) with reference number IEC2:13/2022.
To systematically examine how structural vulnerability has been defined and operationalised in United States-based health research, identify conceptual consistencies and methodological gaps, and propose core dimensions of structural vulnerability along with implications for future application in health research.
A systematic mixed-studies review using a parallel-results convergent synthesis design.
PubMed, Embase, Scopus and CINAHL were searched from first publication through 2024 using the terms ‘structural* vulnerab*’ AND health.
Peer-reviewed English-language empirical studies conducted in the United States that applied the concept of structural vulnerability were identified. The Mixed Methods Appraisal Tool was used to assess study quality. Study content was analysed to identify how structural vulnerability was defined and operationalised.
Thirty-seven predominantly high-quality studies published between 2011 and 2024 met inclusion criteria. Structural vulnerability was consistently defined through two interrelated dimensions: as a social positionality (characterised by constrained resilience, limited agency and imposed risks rooted in systemic discrimination and social hierarchies) and as a critical analytic framework for examining structural determinants of health. Quantitative studies predominantly used individual-level indicators (e.g., income, housing) and cross-sectional designs. Qualitative studies focused on experiences of structural vulnerability in relation to health outcomes and infrequently translated findings into structural interventions. The most frequently studied outcomes were infectious disease, substance use and mental health.
Structural vulnerability, as a conceptual and empirical lens, reveals how systems produce—and can potentially reduce—health risks. Findings underscore the need for geographically diverse and longitudinal studies, as well as multidimensional measures. Advancing health equity demands critiquing systemic causes of inequities and pursuing justice-oriented interventions.
Nursing, positioned at the intersection of public health, social sciences and policy, is uniquely equipped to engage structural vulnerability as a critical analytic tool to address health inequities, design interventions and advocate for policy reform.
What problem did the study address? This study addressed a lack of clarity in the definition and operationalization of structural vulnerability in health research.
What were the main findings? The definition of structural vulnerability is consistent across quantitative and qualitative studies, but there are marked variations in its operationalization. Quantitative studies predominantly rely on individual-level indicators, while qualitative studies use it as a theoretical framework to guide analysis, interpret findings and examine structural determinants of health.
Where and on whom will the research have an impact? This review offers a clear framing for integrating structural vulnerability in health research in efforts to advance health equity.
PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) reporting guideline.
This study did not include patient or public involvement in its design, conduct or reporting.
To examine the direct and indirect predictors of thriving at work and its impact on intention to leave the organisation or profession among early career nurses.
A repeated cross-sectional design.
A sub-study of early career nurses as part of an Australian longitudinal follow up study, commenced in 2018, was conducted. The sub-study asked early career nurses between their second and sixth year after graduating to complete a structured online questionnaire assessing thriving at work and several predictor variables. Data were analysed using Pearson's correlation, multiple linear regression, and path analysis.
Among the 67 participants (response rate of 42.9%), thriving at work was positively correlated with occupational hardiness, social support from colleagues, and wellbeing, while negatively correlated with compassion fatigue. Thriving at work and perceived organisational support were the significant predictors of intention to leave the organisation, while perceived organisational support was the only significant predictor of intention to leave the profession.
The importance of strong collegial relationships, compassion fatigue, and improving wellbeing to enhance thriving at work are highlighted. Fostering an environment where employees can thrive is crucial to reduce the intentions to leave an organisation. Relationships with the managers and quality of care provision also play a crucial role in reducing turnover and leave intentions. Perceived organisational support enhances employee wellbeing, thereby reducing turnover intentions. Future strategies should focus on comprehensive support systems to retain nurses in their organisation and the profession.
Enhancing thriving at work and perceived organisational support can reduce early career nurses' intention to leave their organisation. However, job stressors and interpersonal conflicts also influence professional leave decisions.
This study has adhered to the STROBE guidelines.
No Patient or Public Contribution.
Metacognitive strategy training is a crucial approach for addressing metacognitive deficits and enhancing metacognitive abilities, which can help mitigate age-related cognitive decline and optimise cognitive functioning. The present scoping review aims to systematically examine and synthesise the existing evidence on metacognitive strategy training programmes designed for both neurotypical adults and individuals with cognitive-communication disorders (CCDs).
A scoping review following the JBI methodology.
A literature search was conducted systematically across PubMed, Embase and Web of Science between June and August 2024.
Studies involving metacognitive strategy training for neurotypical adults or individuals with CCDs, measuring cognition, communication or metacognitive skills.
Two reviewers independently screened studies in a two-step process, that is, title and abstract screening followed by full-text screening. Data extraction included study characteristics, participant demographics, intervention details and outcome measures.
A total of 32 studies met the selection criteria, revealing diverse metacognitive training approaches that varied in component and dosage. The most frequently used approaches are the Cognitive Orientation to Occupational Performance approach and the Multicontext approach. The reported outcome measures included cognitive outcomes, metacognitive outcomes, well-being measures and feasibility measures. The majority of interventions targeted occupational goals, followed by cognitive skills, with fewer studies addressing cognitive-communicative skills. Studies have focused primarily on individuals with CCDs, with only a few targeting neurotypical adults.
Studies examining the efficacy of metacognitive strategy training are heterogeneous in terms of population, intervention approaches, and outcome measures. There is significant potential to expand the focus of these interventions to include neurotypical adults, aiming to counteract age-related cognitive-communicative disorders. The limited research within the field of speech-language pathology presents a valuable opportunity for speech-language pathologists to broaden the application of metacognitive strategy training, particularly in enhancing cognitive-communicative abilities.
by Jasmine J. Su, Vasco S. Kupua, Daniel Cummings, Kathryn H. Jacobsen
ObjectivesAngola is one of the countries with the highest prevalence of sickle cell disease (SCD). Neonatal SCD testing is recommended by the Angolan government, but it is not routinely performed. Nearly all previous studies of SCD have been conducted in cities. We implemented a neonatal SCD screening program in a referral hospital in Huíla province to examine the epidemiology of SCD in this Umbundu-speaking population and to demonstrate the feasibility of using point-of-care (POC) tests for SCD in a rural setting.
MethodsBetween October 2024 and February 2025, we screened 353 infants less than one month old at Hospital Evangélico de Caluquembe for the hemoglobin S (HbS) gene using HemoTypeSC rapid diagnostic tests. We also reviewed all pediatric outpatient visits from 2024 to identify newly-diagnosed SCD cases.
ResultsTwenty-one (6.0%) of the 353 neonates had sickle cell trait (HbAS); none had SCD (HbSS). The outpatient register review identified 26 incident cases of SCD.
ConclusionsThe prevalence of HbS is lower in Caluquembe than in Luanda and Cabinda, but the combined results of our newborn screening and pediatric records provide evidence that there is a burden of disease from SCD in Caluquembe and the surrounding areas. Sickle cell screening and treatment programs should be available in all high-burden areas, not just large cities. The per-test costs may still be too expensive for universal newborn screening to be scaled up nationwide, but our pilot study demonstrates that POC tests can be a cost-effective method that yields immediate results.
To assess and compare the patterns of smoked and smokeless tobacco use in India and to identify demographic and socioeconomic factors associated with tobacco use through secondary data analysis of National Family Health Survey (NFHS-4) (2015–2016) and (NFHS-5) (2019–2021) datasets.
A comparative weighted sample secondary data analysis was conducted using individual sampling weights in SPSS V.29.0, encompassing all 29 states and 7 union territories of India.
A total of 8 11 808 individuals from NFHS-4 (699 686 women aged 15–49 years and 1 12 122 men aged 15–54 years) and 825 954 individuals from NFHS-5 (724 115 women aged 15–49 years and 101 839 men aged 15–54 years), were included in the analysis.
Changes in smoked and smokeless tobacco use between the two survey rounds, stratified by age, gender, residency, socioeconomic status, and education.
Prevalence estimates were summarised as percentages with 95% CIs. Differences between NFHS-4 and NFHS-5 were assessed using the Z test for proportions, with significance at p
Bidi and cigarette use declined modestly among men, while gutkha/paan masala use showed the sharpest reduction among women. The overall prevalence of tobacco use declined from 45.5% to 40.8% among men (–4.7 points) and from 6.8% to 4.0% among women (–2.8 points). Bidi use showed the steepest reduction in the study. Among men, it was (14.9%–14.2%), while cigarette use declined modestly (13.7%–13.3%). Rare smoked forms such as pipe, hookah and cigar remained uncommon. Among women, the prevalence of smoked tobacco was negligible, whereas smokeless forms were more frequent but that too showed decline, with the largest reduction observed in gutkha/paan masala (2.2%–1.4%).
Tobacco use in India declined modestly between NFHS-4 and NFHS-5, with greater reductions in smoked than in smokeless forms. Nonetheless, smokeless tobacco remains more prevalent among women, and significant disparities persist across gender, rural–urban residence and socioeconomic strata.
Platelet and fresh frozen plasma (FFP) transfusions are routinely employed in the management of severe dengue. Previous research has indicated a potential link between ABO blood groups and susceptibility to dengue, with evidence suggesting that mosquito vector feeding preferences may be influenced by host blood type. These factors could potentially impact transfusion demands during outbreaks. This retrospective study aimed to investigate the relationship between ABO blood groups and transfusion requirements in patients with dengue.
Retrospective study.
The study was conducted at a tertiary care hospital in Kerala.
Clinical and laboratory data were reviewed for 199 patients confirmed with dengue who received blood component transfusions and compared with two control groups: 200 randomly selected patients with dengue who did not require transfusions and 200 patients without dengue who required transfusions, over a period spanning January 2015 to March 2023.
Among transfused dengue cases, blood groups O (41.71%), A (28.14%) and B (23.12%) were most prevalent; however, no statistically significant association was observed between ABO blood group and transfusion requirement. Furthermore, the total volumes of FFP and platelet transfusions did not differ significantly across ABO groups among patients with dengue. Notably, platelet transfusions were significantly more frequent in dengue cases (92.0%) compared with transfused patients without dengue (35.5%), whereas FFP transfusions were more common in non-dengue transfused cases (84.5%) than in patients with dengue (44.7%). Patients with dengue also received significantly higher mean volumes of both FFP and platelets.
Despite earlier reports linking ABO blood types to dengue susceptibility, this study found no significant association with transfusion requirements, warranting confirmation through larger multicentre studies.
The primary objective was to determine whether a behaviour change intervention delivered to hospital staff would (1) improve the proportion of Aboriginal and/or Torres Strait Islander (Aboriginal) babies being registered and (2) reduce hospital admissions and emergency presentations for babies
Quasi-experimental design and cohort study.
Five tertiary birthing hospitals in WA.
The intervention was delivered to health service providers who were in the five tertiary birthing hospitals. Outcome data were collected on Aboriginal babies born between 1 January 2016 and 30 June 2018 who were delivered within these hospitals. Babies in the control group (n=226) were born 6 months before the intervention and intervention babies (n=232) were born 6 months following the intervention. For the secondary objective, there were 4573 babies included in the analysis.
A behaviour change intervention delivered to hospital staff in five hospitals.
The primary outcomes were the proportion of babies who were registered and whether a baby had been admitted to hospital or an emergency department by 3 and 6 months old. The secondary outcome was to determine factors that might influence the proportion of registered Aboriginal births in WA (cohort study).
There was evidence of a 38% reduction in emergency presentations within 6 months for babies born to hospitals 6 months following the staff training (OR 0.62, 95% CI 0.42 to 0.91), and little evidence of improvements in birth registrations, hospital admissions within 3 or 6 months of birth or emergency department presentations within 3 months of birth. Of the 4573 babies included in the cohort study, 3769 (82.4%) babies had their births registered and 804 (17.6%) babies did not. Factors that were associated with not having a birth registered included low birth weight babies with a 34% decrease in odds of having a registered birth compared with those with a normal birth weight (adjusted OR (aOR) 0.66, 95% CI 0.51 to 0.86). Timing of first antenatal visit was associated with reduced odds of having a birth registered if this occurred in the second (aOR 0.77, 95% CI 0.64 to 0.93) or third trimester (aOR 0.59, 95% CI 0.45 to 0.77) compared with the first trimester.
Our study identifies the complexities surrounding birth registrations and improved hospital utilisation for Aboriginal babies, the importance of targeted interventions and ongoing efforts needed to address this issue comprehensively.
ACTRN12615000976583.
To explore how coaching can facilitate the development of an Evidence-Based Quality Improvement (EBQI) learning culture within nursing teams in hospital and community care settings. This study also explores the specific contextual factors that influence effective outcomes.
Action research.
Nine teams, including 254 nurses were selected from four hospitals and two community care organisations to participate in the development of an EBQI-learning culture under the guidance of internal and external coaches. Data were gathered from 27 focus groups with 56 unique participants (of whom 31 participated multiple times) and six individual interviews with three external coaches. Transcripts of all interviews were subjected to abductive thematic analysis.
To promote an EBQI learning culture in nursing teams, it is essential that internal coaches effectively guide their team members. The internal coaches in this study focused on enhancing readiness for EBQI by providing support, encouraging involvement and motivating team members. They deepened innovation competencies including assessing daily care, implementing well-structured changes in care practices and embedding small steps in the change process in daily routines. It was found that barriers and facilitators within the team's context can influence the development of EBQI-learning culture and therefore need to be considered when seeking to make changes. The presence of external coaches served as a valuable resource and a motivator in supporting internal coaches to apply and improve their coaching skills.
To stimulate the development of an EBQI-learning culture, internal coaches need to focus on team readiness to work with EBQI. Priority needs to be given to enhancing the care change competencies of team members. Barriers to change must also be addressed. Internal coaches require external support and motivation to continually develop coaching skills.
The Standards for Reporting Qualitative Research.
No patient or public contribution.
Incontinence-associated dermatitis poses a significant risk for sacral pressure injuries, infection and morbidity in healthcare settings. Despite the availability of best practice guidelines, implementation remains a challenge.
To outline the implementation of a hospital-wide programme using the Integrated Promoting Action on Research Implementation in Health Services framework to prevent and manage incontinence-associated dermatitis and improve hospital-acquired pressure injuries.
This is an empirical research study using mixed methods.
The study, conducted across surgical, medical and critical care wards between June and October 2023, aimed to address knowledge gaps, enhance clinical practice and evaluate the effectiveness of interventions. The implementation strategy included education modules, engagement of staff through focus groups and targeted interventions such as individualised toileting plans and structured skin care regimens. Data collection involved audits, incident reporting and clinician knowledge surveys.
Findings indicate a reduction in hospital-acquired incontinence-associated dermatitis and pressure injuries postimplementation, with observed improvements in clinician knowledge. However, challenges including workload, skill mix and resource limitations were identified as barriers to implementation. The sustainability and scalability of the programme were emphasised, with ongoing monitoring and evaluation essential for long-term success.
This study underscores the importance of evidence-based interventions, interdisciplinary collaboration and leadership support in improving patient outcomes and reducing healthcare costs associated with preventable skin injuries. Further research is needed to assess implementation in community settings and scale up interventions across healthcare networks.
Analysing a hospital-wide programme using the Integrated Promoting Action on Research Implementation in Health Service framework to prevent and manage incontinence-associated dermatitis and improve hospital-acquired pressure injuries, could help identify the challenges for delivering patient-centred care.
No patient or public involvement.
To describe the implementation study, we referred to the StaRI Guideline.
Trial Registration: This intervention study was applied to the whole population and was therefore not a trial and did not require trial registration. The study was considered low risk and the Human Research Ethics Application (HREA) was approved
Transvaginal and transabdominal cerclage procedures have become established interventions to prevent mid-trimester pregnancy loss and preterm birth. Transabdominal cerclage seems to be superior to transvaginal cerclage in women with a history of a failed transvaginal cerclage. However, with the availability of a less invasive laparoscopic procedure, there is limited evidence concerning which type of cerclage to recommend to many other risk groups. The objective of this trial is to compare laparoscopic abdominal cerclage and transvaginal cerclage in women at moderate to high risk of spontaneous preterm birth.
The trial is an open, multicentre, superiority, parallel arm randomised controlled investigator-initiated trial with an embedded internal pilot. Women in whom the clinician has clinical equipoise between laparoscopic and transvaginal cerclage are randomised to either laparoscopic abdominal or transvaginal cerclage in a ratio of 1:1. The trial extends from sites in Denmark, Finland and Norway. The primary outcome is birth
The Central Denmark Region Committee on Biomedical Research Ethics, Denmark, Helsinki University Hospital Ethics committee, Finland and the Regional Committees for Medical and Health Research Ethics, Norway approved the trial. This protocol is published prior to complete data collection and analysis. Important protocol changes will be made publicly available on ClinicalTrials.org, on the trial website and distributed electronically to all active sites. Positive, inconclusive as well as negative results from the trial will be published in peer-reviewed international scientific journals.
Little research has been done on post-COVID symptoms at 24 months postinfection and on the association these may have on health-related quality of life (HRQOL).
We assessed the prevalence and severity of post-COVID symptoms and quantified EuroQol 5 Dimension 5 Level (EQ-5D-5L), self-perceived health question (EuroQol Visual Analogue Scale (EQ-VAS)) and health utility scores (HUS) up to 24 months follow-up.
The longitudinal multiple cohort CORona Follow-Up (CORFU) study combines seven COVID-19 patient cohorts and a survey among the general public. The participants received questionnaires on several time points. Participants were stratified by: without a known SARS-CoV-2 infection (control group), proven SARS-CoV-2 infection but non-hospitalised, proven SARS-CoV-2 infection hospitalised to the ward, and proven SARS-CoV-2 infection hospitalised to the intensive care unit (ICU).
In this study, data of seven COVID-19 patient cohorts and a survey among the general public are included.
Former COVID-19 patients and controls participated in this cohort study.
Former COVID-19 patients and non-COVID-19 controls were sent questionnaires on symptoms associated with post-COVID condition. The CORFU questionnaire included 14 symptom questions on post-COVID condition using a five-level Likert-scale format. Furthermore, HRQOL was quantified using the EuroQol EQ-5D-5L questionnaire: EQ-VAS and the EQ-5D-5L utility score. The EQ-5D-5L questionnaire includes five domains that are scored on a five-point Likert scale: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
A total of 901 participants (and 434 controls) responded at 24 months follow-up. In all former COVID-19 patients, the presence of post-COVID condition at 24 months was observed in 62 (42.5%, 95% CI 34.3% to 50.9%) of the non-hospitalised patients, 333 (65.0%, 95% CI 60.7% to 69.2%) of the hospitalised ward patients and 156 (63.2%, 95% CI 56.8% to 69.2%) of the ICU patients, respectively (p
Many former COVID-19 patients experience post-COVID symptoms at 24 months follow-up, with the highest prevalence in hospitalised participants. Also, former patients reported a lower HRQOL.
The CORFU study was registered at clinicaltrials.gov (registration number NCT05240742).
Although flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression can accurately rule out myelodysplastic neoplasms (MDS), it lacks reliability and efficiency due to the practical limitations of laboratory-developed liquid reagent-based assays. This study aimed to quantify the agreement and comparative discriminatory accuracy between a single-use flow cytometric lyophilised reagent tube (BD Lyotube Stain 468) and its laboratory-developed liquid reagent counterpart.
Cross-sectional diagnostic accuracy study of two index tests against a reference diagnosis.
A university hospital in France.
Consecutive adult patients with an indication for bone marrow aspiration due to suspected MDS and unexplained peripheral blood cytopenia.
MDS confirmed by cytomorphological evaluation of the bone marrow aspirate performed in duplicate by experienced haematopathologists blinded to the index test.
Of 103 participants enrolled between July 2020 and August 2021, 37 had MDS (prevalence, 36%). The median intra-individual robust coefficient of variation (RCV) for myeloperoxidase expression was 30.9% using the BD Lyotube Stain 468 and 31.2% using the laboratory-developed liquid reagent assay, with an intraclass correlation coefficient of 0.94 (95% CI 0.91 to 0.96). The areas under the receiver operating characteristic curves were 0.83 (95% CI 0.74 to 0.90) and 0.82 (95% CI 0.73 to 0.89), respectively. Using a prespecified threshold of 30.0%, the corresponding sensitivity estimates were 89% (95% CI 75% to 97%) and 95% (95% CI 82% to 99%).
BD Lyotube Stain 468 performs as well as its laboratory-developed liquid reagent counterpart for the quantification of myeloperoxidase expression by peripheral blood neutrophils. It may obviate the need for invasive bone marrow aspiration in up to 40% of patients with suspected MDS.
Tuberculosis (TB) remains a significant public health challenge in many African communities, where underreporting and underdiagnosis are prevalent due to barriers in accessing care and inadequate diagnostic tools. This is particularly concerning in hard-to-reach areas with a high burden of TB/HIV co-infection, where missed or delayed diagnoses exacerbate disease transmission, increase mortality and lead to severe economic and health consequences. To address these challenges, it is crucial to evaluate innovative, cost-effective, community-based screening strategies that can improve early detection and linkage to care.
We conduct a prospective, community-based, diagnostic, pragmatic trial in communities of the Butha Buthe District in Lesotho and the Greater Edendale area of Msunduzi Municipality, KwaZulu-Natal in South Africa to compare two strategies for population-based TB screening: computer-aided detection (CAD) technology alone (CAD4TBv7 approach) versus CAD combined with point-of-care C reactive protein (CRP) testing (CAD4TBv7-CRP approach). Following a chest X-ray, CAD produces an abnormality score, which indicates the likelihood of TB. Score thresholds informing the screening logic for both approaches were determined based on the WHO’s target product profile for a TB screening test. CAD scores above a threshold prespecified for the CAD4TBv7 approach indicate confirmatory testing for TB (Xpert MTB/RIF Ultra). For the CAD4TBv7-CRP approach, a CAD score within a predefined window requires the conduct of the second screening test, CRP, while a score above the respective upper threshold is followed by Xpert MTB/RIF Ultra. A CRP result above the selected cut-off also requires a confirmatory TB test. Participants with CAD scores below the (lower) threshold and those with CRP levels below the cut-off are considered screen-negative. The trial aims to compare the yield of detected TB cases and cost-effectiveness between two screening approaches by applying a paired screen-positive design. 20 000 adult participants will be enrolled and will receive a posterior anterior digital chest X-ray which is analysed by CAD software.
The protocol was approved by National Health Research Ethics Committee in Lesotho (NH-REC, ID52-2022), the Human Sciences Research Council Research Ethics Committee (HSRC REC, REC 2/23/09/20) and the Provincial Health Research Committee of the Department of Health of KwaZulu-Natal (KZ_202209_022) in South Africa and from the Swiss Ethics Committee Northwest and Central Switzerland (EKNZ, AO_2022–00044). This manuscript is based on protocol V.4.0, 19 January 2024. Trial findings will be disseminated through peer-reviewed publications, conference presentations and through communication offices of the consortium partners and the project’s website (https://tbtriage.com/).
ClinicalTrials.gov (NCT05526885), South African National Clinical Trials Register (SANCTR; DOH-27-092022-8096).
Patients with stage III non-small cell lung cancer (NSCLC) are at high risk of developing post-treatment recurrences (50–78%) during follow-up. As more effective treatments are now available, especially for patients with oligometastatic disease, earlier detection of recurrences may prolong survival and health-related quality of life (HRQOL). With the use of 2'-deoxy-2'-[18F]fluoroglucose positron emission tomography/CT ([18F]FDG PET/CT) during follow-up, recurrences may be detected earlier. Therefore, the primary objective of this study is to compare the 3-year overall survival of patients with stage III NSCLC during follow-up surveillance with [18F]FDG PET/CT versus follow-up with conventional CT (usual care). Secondary objectives address the number, location and timing of recurrences, as well as HRQOL, cost-effectiveness and patient experiences of PET/CT scans.
In this multicentre randomised controlled clinical trial, 690 patients with stage III NSCLC (8th edition International Association for the Study of Lung Cancer (IASLC) Tumor, Nodes, Metastasis (TNM) classification) who completed curative intended treatment and started follow-up care (which may include adjuvant therapy) will be randomised 1:1 to either the intervention ([18F]FDG PET/CT) or the control group (CT). Patients will undergo follow-up scans during visits at 6, 12, 18, 24 and 36 months. Data will be collected using validated questionnaires, electronic case report forms and data extractions from the electronic health records. Additionally, blood samples will be collected, and interviews will be conducted.
The study protocol has been approved by the Medical Ethical Committee of the Radboudumc and 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. Data will be published in a data repository or other online data archive.
Alliance ruptures constitute a high risk of premature treatment termination and poor psychotherapy outcome. The Alliance-Focused Training (AFT) is a promising transtheoretical approach to enhance therapists’ skills in dealing with alliance ruptures.
To evaluate the effectiveness of Modified AFT with doubling (MAFT-D), a randomised, patient and evaluator-blinded, multicentre trial was designed comparing MAFT-D (delivered to trainee therapists and supervisors) and psychotherapy training/treatment as usual (TAU) for therapists (n=120) and their patients with depressive disorders (n=240). A total of 17 cooperating centres, each offering either cognitive-behavioural or psychodynamic psychotherapy training, will contribute to recruitment. Stratification by centre (both for therapists and patients) and hence therapeutic approach (cognitive-behavioural vs psychodynamic psychotherapies), and by comorbid personality disorder (yes vs no, for patients) will be carried out. The two hierarchically ordered primary hypotheses are: In MAFT-D compared with TAU, a stronger reduction of depressive symptoms and a lower rate of patient dropout is expected from baseline to 20 weeks after baseline. Follow-up assessments are planned at 35 weeks, 20 months and 36 months postbaseline to evaluate the persistence of effects. Secondary patient-related and therapist-related outcomes as well as predictors, moderators and mediators of change will be investigated. Mixed models with repeated measures will be used for the primary analyses.
Ethical approvals were obtained by the institutional ethics review board of the main study centre as well as by review boards in each federal state where one or more cooperating centres are located (secondary votes). Following the Consolidated Standards of Reporting Trials statement for non-pharmacological trials, results will be reported in peer-reviewed scientific journals and disseminated to patient organisations and media.
DRKS00014842; https://drks.de/search/de/trial/DRKS00014842.
To analyse existing knowledge on the psychometric properties of the Braden Scale when used within the acute care setting.
Systematic review and narrative synthesis.
A database search was conducted in June 2023 and updated in February 2024, seeking studies testing the psychometric properties of the Braden scale in the acute care setting. Data were sourced from five electronic databases (CINAHL, EMBASE, MEDLINE, Scopus and Web of Science). Study selection, data extraction and assessment of risk of bias were completed, with two reviewers independently conducting each stage and an independent reviewer arbitrating discrepancies. Data were extracted using a customised template and synthesised narratively. Risk of bias was assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist.
Thirty-seven studies met the inclusion criteria. Internal consistency was reported between 0.64 and 0.78 (Cronbach's alpha). Inter-rater reliability was high, reported as ranging from 0.946 to 0.964 (intra-class correlations) or 0.86 to 0.949 (Pearson's correlation). Most validity studies tested predictive validity with wide variances reported.
The Braden Scale is reliable for assessing the risk of PI in acute care, but the validity of the scale is variable. Further research investigating validity beyond predictive validity is required.
Nurses working in acute care can use the Braden Scale with confidence of scale reliability. However, validity is variable and warrants a cautious approach. The true value resides in the capacity to trigger recognition of pressure injury risk.
Trial Registration: The protocol was registered a priori with the International Prospective Register of Systematic Reviews PROSPERO ref: CRD42023407545