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☐ ☆ ✇ BMJ Open

Protocol for a biomarker discovery study to identify correlates of risk for future tuberculosis disease progression in South African children (INTREPID)

Por: Hamilton · M. S. · Derks · I. P. · Kaforou · M. · Dunbar · R. · McNamara · R. P. · Fortune · S. M. · Basu-Roy · R. · van Deventer · A. · Bosch · C. · Dunican · C. · van der Zalm · M. M. · Levin · M. · Schaaf · H. S. · Altin · J. A. · Hesseling · A. C. · Seddon · J. A. — Febrero 10th 2026 at 14:17
Introduction

Young children and children living with HIV are at high risk of progressing to tuberculosis (TB) disease following Mycobacterium tuberculosis (Mtb) exposure and infection, and also of developing severe forms of disease and TB-related mortality. Identifying children who have very early (sub-clinical) TB disease, prior to progression to clinically apparent TB, would mean that TB preventive treatment (TPT) could be more efficiently targeted to this group. Identifying biomarker changes on drug therapy in children with Mtb infection or very early disease could pave the way for the development of tests that can identify which children have viable bacilli and are therefore at increased risk of disease progression.

Methods and analysis

The INTREPID study will use already collected samples taken from well-phenotyped paediatric cohorts in three clinical studies conducted in South Africa in children Mtb exposure to disease and from children treated for Mtb infection and early TB disease, as well as targeted Mtb antibody analysis. Data on viral co-infections and relevant clinical and epidemiological parameters will be integrated and evaluated to identify the optimal biosignatures that can predict future progression to clinically overt disease in children below 5 years of age, including those living with HIV.

Ethics and dissemination

The study protocol received ethical approval from the Stellenbosch University Health Research Ethics Committee (N23/03/025). The study findings will be disseminated through peer-reviewed publications, scientific conferences and formal presentations to healthcare professionals and to local communities, in collaboration with the Desmond Tutu TB Centre Community Advisory Board.

☐ ☆ ✇ BMJ Open

Protocol for a multimethods study evaluating a transition pathway between hospital settings and postsecondary institutions: the NavigateCAMPUS study

Por: Cleverley · K. · Brennenstuhl · S. · Davies · J. · Ewing · L. · Sainsbury · K. · Salman · S. · Levinson · A. · Chiasson · C.-A. · Nasir · S. · Bartha · C. · Ma · C. · de Oliveira · C. · Mason · J. · Barbic · S. P. · Dimitropoulos · G. · Freeland · A. · Halladay · J. · Hamza · C. A. · Lam — Febrero 9th 2026 at 15:19
Introduction

The surge in postsecondary students reporting mental health concerns, coupled with increased utilisation of on-campus and hospital-based mental healthcare, highlights a need to understand effective service navigation. To address this system gap, the University of Toronto and the Centre for Addiction and Mental Health (CAMH) leveraged their unique expertise and resources to develop the University of Toronto Navigation (UTN) service. UTN introduces care navigators to facilitate postsecondary student transitions from acute mental health services to community or campus mental healthcare. There has been limited implementation and evaluation of navigator models specific to the postsecondary context to date, which hinders scalability. This paper describes the study protocol of Navigation to Enhance Post-Secondary Students’ Acute Mental Health Care Transitions, a study that aims to collaborate with students, navigators and clinicians to evaluate the UTN service.

Methods and analysis

A one-stage, single-arm multimethods study design will be used to evaluate the UTN service. We will recruit 103 students following their UTN intake appointment. Students will complete quantitative measures assessing health outcomes, experiences of care and service utilisation at baseline and at three subsequent time points across a 6-month follow-up period. The quantitative data will be linked to administrative healthcare data. The primary evaluation outcome will be defined as attending an appointment with an appropriate care provider (in person or virtually) within 30 days of discharge from the hospital. We will conduct interviews with students and referring clinicians to gather perspectives regarding their experiences and satisfaction with the UTN service in greater depth.

Ethics and dissemination

Research ethics board approvals have been obtained from the University of Toronto and CAMH. Results will be disseminated through publications and presentations, and a toolkit will be cocreated to support implementation and adaptation of hospital-based navigator interventions in postsecondary contexts.

☐ ☆ ✇ International Wound Journal

Pressure Injuries and Skin Failure: The Search for Clarity

Por: Jeffrey M. Levine — Febrero 11th 2026 at 06:23

ABSTRACT

Skin failure is increasingly recognised across healthcare settings, yet its definition, diagnostic criteria and relationship to pressure injuries remain inconsistent with little interdisciplinary consensus. This lack of clarity complicates bedside assessment, documentation and quality reporting. Historically, pressure injuries were viewed as preventable events associated with inadequate care, but growing evidence shows that some wounds develop despite optimal preventive measures, particularly in patients with multimorbidity or limited physiological reserve. This article will review the historical development of skin failure and how it is intertwined with contrasting theories of pressure injury formation that began in the 19th century. We will track the proliferation of definitions and overlapping terms that muddle contemporary documentation and classification, and demonstrate why a unified definition is urgently needed. Skin failure represents the intersection of tissue deformation with systemic vulnerability including hypoperfusion, inflammation, vascular dysfunction, oedema, medication effects, immune compromise, nutritional depletion and age-related changes. A meaningful and practical definition must span all healthcare environments and patient populations, supporting accurate diagnosis and equitable evaluation of care quality. We outline a call to action that includes interdisciplinary consensus, standardised terminology and the development of predictive tools that integrate physiologic data, advanced analytics, and patient-centered outcomes across the healthcare continuum.

☐ ☆ ✇ BMJ Open

Study protocol for a randomised controlled trial to determine the efficacy of lisdexamfetamine for the treatment of acute methamphetamine withdrawal in inpatient settings

Por: Acheson · L. S. · Siefried · K. J. · Lintzeris · N. · Dunlop · A. J. · Haber · P. S. · Arunogiri · S. · Christmass · M. · Doyle · M. · Donoghoe · M. · Nagle · J. · Clifford · B. · McKetin · R. · Lubman · D. I. · Brett · J. · Taylor · N. · Carr · A. · Levin · F. R. · Shoptaw · S. · Ezard · N — Noviembre 28th 2025 at 03:17
Introduction

Harms due to methamphetamine use disorder (MAUD) are rising globally. Untreated withdrawal symptoms perpetuate the cycle of dependence and are a barrier to treatment. There is no pharmacotherapy approved for methamphetamine withdrawal. Lisdexamfetamine (LDX) dimesylate has potential as an agonist therapy to ameliorate symptom severity during acute methamphetamine withdrawal and increase duration of initial abstinence and retention in treatment.

Methods and analysis

We will conduct a double-blind, randomised, controlled trial to evaluate the efficacy of LDX in reducing symptom severity during acute methamphetamine (MA) withdrawal. One hundred eighty-four adults with moderate to severe MAUD presenting to a health service requesting MA withdrawal treatment who report use of MA within the last 72 hours will be recruited. Participants will be randomised 1:1 to receive a tapering dose of lisdexamfetamine (250 mg on day 1, reducing by 50 mg per day to 50 mg on day 5, followed by 2 days of placebo washout on days 6 and 7), or placebo for 7 days. The study will be conducted over 7 days in an inpatient unit, and all participants will also receive standard inpatient withdrawal care. Participants will be followed up in the community to day 84. The primary outcome is efficacy, defined as the between-group difference in average withdrawal severity measured over the 7-day admission by the Amphetamine Withdrawal Questionnaire. Secondary outcomes are retention in treatment, treatment satisfaction, sleep and concomitant medication use (symptomatic medications and medications for other indications to day 7); safety, craving for MA, post-treatment withdrawal symptoms, depression, anxiety and stress, insomnia and cost effectiveness (to day 28) and MA use, mental, physical and social health and post-withdrawal treatment utilisation (to day 84). A First Nations qualitative substudy will assess the experiences of Aboriginal and Torres Strait Islander participants, ensuring the treatment meets the needs of First Nations people.

Ethics and dissemination

This protocol was first approved by the St Vincent’s Hospital Human Research Ethics Committee on 15/05/2024 (2024/ETH00788). All participants will be provided with a participant information sheet and consent form, be fully informed about the study and given ample time to consider participation. Results will be published in peer-reviewed journals and presented at national and international conferences. Findings will be presented such that individual participants will not be identifiable.

Trial registration number

ACTRN12624001061527.

☐ ☆ ✇ BMJ Open

Motor learning principles reported in stroke trials of upper limb task-oriented training: a scoping review

Por: Durairaj · S. · Sardesai · S. · Solomon · J. M. · Levin · M. F. — Noviembre 14th 2025 at 06:04
Objective

Upper limb task-oriented training (UL-TOT) is a complex intervention in which practice conditions related to motor learning principles are applied to enhance upper limb motor recovery after stroke. The Template for Intervention Description and Replication guidelines suggest that detailed reporting of a complex intervention is essential in published studies. Therefore, this review aimed to determine the extent to which practice conditions related to motor learning principles were reported in UL-TOT stroke clinical trials.

Methods

A comprehensive search was done using appropriate keywords in PubMed, CINAHL, Web of Science, Scopus and Cochrane databases from 2000 to 2024. Two reviewers independently conducted title screening, abstract screening and full-text evaluation based on the inclusion and exclusion criteria. A third reviewer resolved the conflicts between the two reviewers during the screening process. Finally, the articles that fulfilled the criteria were included for data extraction.

Results

23 802 studies were retrieved, and 166 studies were retained. Practice conditions such as practice variability (98%), dosage (97%) and movement complexity (96%) were reported more frequently, task selection for practice (75%), challenging and progressive task practice (76%) were reported frequently, practice order (57%), practice distribution (51%), feedback type (44%) and timing (44%) were reported occasionally. Feedback frequency (37%) was reported rarely.

Conclusions

Practice conditions such as practice variability, dosage, movement complexity, task selection, challenging and progressive task practice were reported consistently, while practice distribution, order and feedback were reported inconsistently. Developing a standard checklist for practice conditions related to motor learning principles can improve detailed reporting of practice conditions in future UL-TOT stroke clinical trials. This can help researchers replicate and reliably implement the intervention in specific populations and build on and create more effective interventions.

☐ ☆ ✇ BMJ Open

COVID-19 vaccine information perspectives and needs of youth living with mental health concerns: a co-developed qualitative study based in Canada

Por: Abi-Jaoude · A. · Artna · E. · Buchman · D. Z. · Consalas · J. · Johnson · A. · Kozloff · N. · Narajos · A. · Perry · C. · Levinson · A. · Sockalingam · S. — Octubre 23rd 2025 at 09:28
Objectives

To characterise the information needs and experiences of receiving COVID-19 vaccine information by youth with mental health concerns.

Design

Thematic analysis of semistructured interview transcripts.

Setting

Semistructured interviews via WebEx video conferencing or by telephone.

Participants

46 youth aged 16–29 with one or more self-reported mental health concerns and six family members of youth.

Results

Our analysis generated four main themes: (1) information content and characteristics; (2) critical appraisal; (3) modulators of information-seeking behaviour; and (4) unmet information needs.

Conclusions

Our findings suggest that youth with mental health concerns have unique information needs and processing patterns influenced by their environments and experiences with mental health concerns. Participants identified barriers to receiving reliable health information and suggested ways to improve this process.

☐ ☆ ✇ BMJ Open

Diabetes and cognitive health in India: a nationally representative survey of adults aged 45 years and older

Por: Flood · D. · Green · H. · Gross · A. · Kobayashi · L. C. · Levine · D. A. · Lee · J. · Wixom · C. R. · Langa · K. M. — Julio 21st 2025 at 02:01
Objectives

Most research on the relationship between diabetes and cognitive health has used data from high-income countries. This study described this relationship in India, the world’s most populous country.

Design

Cross-sectional analysis of the baseline wave of the nationally representative Longitudinal Ageing Study in India, conducted from 2017 to 2019.

Setting

All 36 Indian states and union territories.

Participants

57 905 adults aged 45 years or older.

Main outcome measures

Scaled cognitive scores (mean of 0 and SD of 1) and cognitive impairment defined as a cognitive score 1.5 SD or below the age-matched and education-matched mean. Diabetes was defined as a self-report of a prior diabetes diagnosis made by a health professional or having a measured haemoglobin A1c ≥6.5%.

Results

In age-adjusted and sex-adjusted models, people with diabetes had cognitive scores that were 0.24 SD higher (95% CI 0.22 to 0.26) and had a 1.2% (95% CI 0.6% to 1.7%) lower prevalence of cognitive impairment than people without diabetes. Differences persisted even when adjusting for demographic, socioeconomic and geographical characteristics. Rural versus urban residence modified the relationships of diabetes with cognitive score (p=0.001) and cognitive impairment (p=0.003). In fully adjusted models, rural respondents with diabetes had 0.05 SD (95% CI 0.03 to 0.07) greater cognitive scores and 1.6% (95% CI 0.9% to 2.4%) lower prevalence of cognitive impairment than those without diabetes. In urban areas, respondents with and without diabetes had similar cognitive scores and prevalence of cognitive impairment.

Conclusions

Middle-aged and older adults with diabetes living in India had better cognitive health than those without diabetes. Rural versus urban area of residence modified this relationship. Urban–rural differences, the nutrition transition and social conditions likely influenced the cross-sectional relationship between diabetes and cognitive health in India, leading to different associations than reported in other countries.

☐ ☆ ✇ BMJ Open

Patient-reported outcome measures for fatigue in patients with chronic kidney disease: a systematic review

Por: Hughes · A. · Ju · A. · Cazzolli · R. · Howell · M. · Guha · C. · Levin · A. · Manera · K. · Teixeira-Pinto · A. · Torrisi · L. G. · Wheeler · D. C. · Wong · G. · Wu · R. · Jaure · A. — Julio 16th 2025 at 09:42
Objective

Fatigue is a common and debilitating symptom that is associated with an increased risk of mortality, dialysis initiation and hospitalisation among patients with chronic kidney disease (CKD). The aim of this study was to identify the characteristics, content and psychometric properties of patient-reported outcome measures (PROMs) used to measure fatigue in patients with CKD not requiring kidney replacement therapy (KRT).

Design

Systematic review. The characteristics, dimensions of fatigue and psychometric properties of these measures were extracted and analysed.

Data sources

We searched MEDLINE, Embase, PsycINFO and CINAHL from database inception to February 2023.

Eligibility criteria for selecting studies

All studies that reported fatigue in patients with CKD stages 1–5 not receiving KRT.

Results

We identified 97 studies (20 (21%) randomised trials, 2 (2%) non-randomised trials and 75 (77%) observational studies). 27 different measures were used to assess fatigue, of which three were author-developed measures. The 36-Item Short Form Health Survey (SF-36) and Kidney Disease Quality of Life – Short Form (KDQOL-SF) were the most frequently used measures (41 (42%) and 24 (25%) studies, respectively). Six (22%) measures were specific to fatigue (Chalder Fatigue Questionnaire, Functional Assessment of Chronic Illness Therapy – Fatigue Scale, Functional Assessment of Cancer Therapy-Fatigue, Fatigue Severity Scale, and author developed Chen & Ku 1998, and Hao et al 2021) while 21 (78%) included a fatigue subscale or item within a broader construct for example, quality of life. Various content domains assessed included tiredness, ability to think clearly, level of energy, muscle weakness, ability to concentrate, verbal abilities, motivation, memory, negative emotions and life participation. Only two measures (Chronic Kidney Disease Symptom Index – Sri Lanka, Kidney Symptom Questionnaire) were developed specifically for CKD, but they were not specific to fatigue. Six measures (Chronic Kidney Disease Symptom Index – Sri Lanka, Functional Assessment of Cancer Therapy – Anemia, Revised Illness Perception Questionnaire, Kidney Symptom Questionnaire, Short Form 6 Dimension and 36-Item Short Form Health Survey) had been validated in patients with CKD not requiring KRT.

Conclusion

PROMs used to assess fatigue in patients with CKD vary in content and few were specific to fatigue in patients with CKD not requiring KRT. Data to support the psychometric robustness of PROMs for fatigue in CKD were sparse. A validated and content-relevant measure to assess fatigue in patients with CKD is needed.

☐ ☆ ✇ BMJ Open

Correlation between fatigue and pulmonary involvement in the post-COVID-19 condition: a cross-sectional study 6-12 months after hospital discharge

Por: Kajiwara · M. S. · Lamas · C. A. · Luna · L. A. V. d. · Yokoyama · T. S. · de Oliveira · P. R. · Chate · R. C. · Sawamura · M. V. Y. · Imamura · M. · Carvalho · C. R. R. d. · Salge · J. M. · HCFMUSP COVID-19 task force · Araujo · Segurado · Montal · Miethke-Morais · Levin · Peron — Julio 14th 2025 at 04:23
Introduction

Post-COVID-19 conditions (PCC) may include pulmonary sequelae, fatigue and other symptoms, but its mechanisms are not fully elucidated.

Objective

This study investigated the correlation between fatigue and the presence of pulmonary abnormalities in PCC patients with respiratory involvement 6–12 months after hospitalisation.

Design

Cross-sectional study.

Setting

A tertiary hospital in Brazil.

Participants

315 patients, aged ≥18 years, were considered eligible based on SARS-CoV-2 infection confirmed by reverse transcription-PCR.

Methods

Pulmonary function tests (PFT), cardiopulmonary exercise tests (CPET), chest CT and hand grip were performed. The following scales were applied: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, Euroqol 5 Dimensions quality of life (EQ-5D) and Hospital Anxiety and Depression Scale (HADS). Participants were divided between the fatigue group (FACIT-F≤30) and the non-fatigue group (FACIT-F>30). For the statistical analysis, the primary outcome was the difference in the diffusing capacity of the lungs for carbon monoxide (DLCO) between groups. Considered secondary outcomes were differences in PFT, CPET, chest CT, hand grip, EQ-5D and HADS.

Results

The fatigue group had 81 patients (25.7%) against 234 (74.3%). PFT and CPET showed no significant difference in DLCO and oxygen consumption peak values between groups. The fatigue group had a lower workload (mean 55.3±21.3 watts vs 66.5±23.2 watts, p=0.003), higher breathing reserve (median 41.9% (33.8–52.5) vs 37.7% (28.9–47.1), p=0.028) and lower prevalence of ground glass opacity (60.8% vs 77.7%, p=0.003) and reticulation (36.7% vs 54.9%, p=0.005) in chest CT. The fatigue group had higher anxiety (57% vs 24%, p

Conclusion

Fatigue in patients with PCC 6–12 months after hospitalisation is relatively common and had weak correlation with pulmonary disorders. Our results suggested fatigue could be strongly related with peripheral disorders such as reduced musculoskeletal strength or psychosocial limitations.

☐ ☆ ✇ Nursing Research

An Evaluation of the Multifactorial Model of Cancer-Related Cognitive Impairment

imageBackground Up to 45% of patients report cancer-related cognitive impairment (CRCI). A variety of characteristics are associated with the occurrence and/or severity of CRCI. However, an important gap in knowledge of risk factors for CRCI is the relative contribution of each factor. The multifactorial model of cancer-related cognitive impairment (MMCRCI) is a conceptual model of CRCI that can be used to evaluate the strength of relationships between various factors and CRCI. Objectives The purpose of this study was to use structural regression methods to evaluate the MMCRCI using data from a large sample of outpatients receiving chemotherapy (n = 1,343). Specifically, the relationships between self-reported CRCI and four MMCRCI concepts (i.e., social determinants of health, patient-specific factors, treatment factors, and co-occurring symptoms) were examined. The goals were to determine how well the four concepts predicted CRCI and determine the relative contribution of each concept to deficits in perceived cognitive function. Methods This study is part of a larger, longitudinal study that evaluated the symptom experience of oncology outpatients receiving chemotherapy. Adult patients were diagnosed with breast, gastrointestinal, gynecological, or lung cancer; had received chemotherapy within the preceding 4 weeks; were scheduled to receive at least two additional cycles of chemotherapy; were able to read, write, and understand English; and gave written informed consent. Self-reported CRCI was assessed using the attentional function index. Available study data were used to define the latent variables. Results On average, patients were 57 years of age, college educated, and with a mean Karnofsky Performance Status score of 80. Of the four concepts evaluated, whereas co-occurring symptoms explained the largest amount of variance in CRCI, treatment factors explained the smallest amount of variance. A simultaneous structural regression model that estimated the joint effect of the four exogenous latent variables on the CRCI latent variable was not significant. Discussion These findings suggest that testing individual components of the MMCRCI may provide useful information on the relationships among various risk factors, as well as refinements of the model. In terms of risk factors for CRCI, co-occurring symptoms may be more significant than treatment factors, patient-specific factors, and/or social determinants of health in patients receiving chemotherapy.
☐ ☆ ✇ Nursing Research

Distinct Profiles of Morning and Evening Fatigue Co-Occurrence in Patients During Chemotherapy

imageBackground Morning and evening fatigue are distinct and distressing symptoms experienced during chemotherapy that demonstrate a large amount of interindividual variability. Objectives The objectives of this study were to identify subgroups of patients with distinct morning and evening fatigue co-occurrence profiles and evaluate for differences among these subgroups in demographic, clinical, and symptom characteristics and quality of life. Methods Oncology patients (n = 1,334) completed the Lee Fatigue Scale to self-report morning and evening fatigue, six times over two cycles of chemotherapy. Latent profile analysis was used to identify subgroups of patients with distinct morning and evening physical fatigue profiles. Results Four distinct morning and evening fatigue profiles were identified (i.e., Both Low, Low Morning + Moderate Evening, Both Moderate, and Both High). Compared to the Both Low profile, the Both High profile was significantly younger, less likely to be married or partnered, more likely to live alone, had a higher comorbidity burden, and lower functional status. The Both High profile had higher levels of anxiety, depressive symptoms, sleep disturbance, and pain and lower levels of quality of life. Discussion The variability in the morning and evening severity scores among the four profiles supports the hypothesis that morning and evening fatigue are distinct but related symptoms. Clinically meaningful levels of both morning and evening fatigue were reported by 50.4% of our sample, which suggests that the co-occurrence of these two symptoms is relatively common. Patients in Both Moderate and Both High profiles experienced an extremely high symptom burden that warrants ongoing assessments and aggressive symptom management interventions.
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