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Autism outcomes and neurobehavioural markers in young children born to mothers with HIV in Kenya: a protocol for the Alama project

Por: Oyungu · E. · Keehn · B. · McHenry · M. S. · Monahan · P. O. · Joseph · R. M. · Yoon · S.-Y. · Carlucci · J. G. · Saina · C. · Khaitan · A. · Baliddawa · J. · McNally Keehn · R.
Introduction

The over 14 million African children who are HIV-exposed but uninfected (CHEU) are at risk for poor health outcomes, including neurodevelopmental conditions such as autism; however, no study to date has examined autism in CHEU in Africa, where the vast majority of these children live. Scalable diagnostic and neurobehavioural tools, including powerful, low-cost approaches such as eye-tracking, for detection and study of mechanistic neural processes are necessary to advance autism research in these settings. The objective of this study is to examine autism diagnostic outcomes and eye-tracking biomarkers in relation to CHEU while at the same time building capacity for neuro-health research in Kenya.

Methods and analysis

This study will leverage a longitudinally assessed cohort of CHEU and children who are HIV-unexposed and uninfected (CHUU) with well characterised HIV-related and contextual exposures. We will first determine and compare autism diagnostic outcomes between young CHEU and CHUU across a large cohort (n=850) of Kenyan children using research-grade autism assessment tools, and, second, determine whether neurobehavioural eye-tracking markers predict autism outcomes across this cohort.

Ethics and dissemination

Human subjects approvals have been obtained from Moi University Institutional Review and Ethics Committee (IREC; IREC/909/2024; Approval #0004835), Kenya’s National Commission for Science, Technology and Innovation (NACOSTI; Reference #NACOSTI/P/25/415028), the Institutional Review Board of the Indiana University School of Medicine (Protocol #23171), with reliance agreements executed with Purdue University and Boston University. Dissemination of findings will occur through multiple channels within the research and clinical community, including peer-reviewed journal publications and conference abstracts and presentations. As part of capacity building efforts, the research team will also communicate study results to policy makers, the lay public and other health systems involved in the care of young children with disabilities via study-hosted workshops and conferences.

Using flow cytometry for paediatric leukaemia diagnosis in Kenya: a protocol for mixed methods study

Por: Severance · T. · Lotodo · T. · Serem · E. · Njuguna · F. · Melly · B. · Orido · M. · Tonui · R. · Olbara · G. · Koima · R. · Kigen · N. · Kussick · S. · Ratliff · V. · Holl · E. · Monahan · P. O. · Boova · T. · Vik · T.
Introduction

Each year, an estimated 1700 children should be diagnosed with cancer in western Kenya, with leukaemia making up nearly one-third of cases. However, far fewer are actually diagnosed, highlighting significant delays or errors in diagnosis. Flow cytometry, which the WHO considers essential for leukaemia diagnosis, remains underused across sub-Saharan Africa due to high costs, outdated equipment and a lack of trained personnel. In Kenya, decades-old cytometers have been adapted for leukaemia detection, but these systems are now outdated. Newer platforms, such as simplified single-tube multiparametric assays, provide a scalable and sustainable alternative. This study presents a protocol to evaluate the accuracy of diagnosis and the potential for implementing a streamlined flow cytometry assay using peripheral blood, supported by a regional educational initiative.

Methods and analysis

This prospective, mixed-methods implementation study has three aims: (1) to assess the concordance between the Beckman Coulter ClearLLab 10C gold standard 4-tube assay and the streamlined ClearLLab LS 1-tube assay using paired bone marrow and peripheral blood samples; (2) to evaluate the feasibility of peripheral facility referrals and transport logistics with couriered peripheral blood samples from referring sites across western Kenya; and (3) to measure training effectiveness and knowledge gain through a multimodal educational programme using the Project ECHO (Extension for Community Healthcare Outcomes) model. Up to 300 patients at Moi Teaching and Referral Hospital in Eldoret, Kenya, will be enrolled in Aim 1. A separate sample of 100 patients from peripheral facilities will be included in Aim 2. Surveys, knowledge assessments and structured interviews will be used to evaluate training impact under Aim 3. Diagnostic concordance, sensitivity, specificity and knowledge gain will be measured through appropriate quantitative and qualitative methods.

Ethics and dissemination

The protocol has received approval from institutional ethics committees at Moi University, MTRH and Indiana University. De-identified data will be analysed and shared through peer-reviewed publications, stakeholder presentations and educational platforms.

Caring beyond the procedure: a qualitative study on thoracic surgery nurses perspectives on chronic illness experiences of individuals with myasthenia gravis undergoing thymectomy

Por: Missel · M. · Donsel · P. O. · Nielsen · T. F. · Secher · E. L. · Medeiros · E. B. Z. · Rude · K. · Hojgaard · J. L. S. · Viby · N.-E. · Birnbaum · S. · Andersen · L. K. · Petersen · R. H. · Witting · N.
Objectives

To explore how thoracic surgical nurses perceive and respond to the chronic illness needs of individuals with myasthenia gravis undergoing thymectomy.

Methods

Data were collected through four focus group interviews using a semi-structured interview guide. The analysis followed a hermeneutic approach, identifying recurring themes through iterative interpretation and critical reflection. Nineteen thoracic surgical nurses from ward and postanaesthesia care unit settings participated, representing a diverse range of clinical experience. The study followed the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist for reporting the findings of this study.

Results

The analysis identified three overarching themes reflecting nurses’ experiences of caring for individuals with myasthenia gravis undergoing thymectomy. First, nurses described how the chronic aspects of the illness often ‘disappeared’ within the surgical care process, with attention focused mainly on procedural recovery, leaving patients’ broader illness needs unaddressed. Second, nurses experienced a dilemma between providing acute surgical care and responding to patients’ chronic illness understanding, highlighting uncertainty due to limited knowledge and lack of clear guidelines. Third, nurses emphasised the difficulty of managing the invisible and unpredictable symptoms of myasthenia gravis, which created a heightened need for vigilance but also uncertainty in symptom assessment and support. Across all themes, the findings suggest that surgical care practices may insufficiently recognise patients’ ongoing illness experiences, emphasising the need for greater knowledge, interdisciplinary collaboration and chronic illness-sensitive care approaches.

Conclusions

The study highlights the need for increased attention to chronic illness needs in surgical care, supporting interdisciplinary collaboration and tailored nursing practices that address the lived experiences of patients with chronic conditions.

Development of an educational video to support guideline panels in incorporating patient values and preferences into recommendation-making: qualitative one-on-one interviews and brainstorming meetings

Por: Zeng · L. · Li · R. · Li · S.-A. · Clarissa · S. · Agoritsas · T. · Chen · J. · Li · X. · Vandvik · P. O. · Brignardello-Petersen · R. · Li · X. · Zhang · L. · Guyatt · G.
Objectives

The aim of this study was to develop an educational video introducing an innovative panel survey approach to facilitate guideline panels in making inferences about patient values and preferences.

Design

A user testing of the educational video through one-on-one interviews and iterative refinement of the video through brainstorming meetings.

Setting

Interviews and brainstorming meetings were conducted through Zoom.

Participants

The participants of the interviews include guideline panellists who had used the panel survey approach, and guideline panellists who had not used the approach but would or would not participate in a panel survey soon. The participants of the brainstorming meetings were a steering committee with expertise in guideline methodology and qualitative research.

Primary and secondary outcome measures

The understandability and usefulness of the educational video.

Results

We interviewed 18 guideline panellists from eight different guideline panels, all of whom carefully reviewed the video. Most participants found the video useful in explaining the panel survey approach and its role in incorporating patient values and preferences. Participants suggested improvements, including clarifying key concepts and using plain language instead of technical terminology to make the content more accessible. The major change the steering committee decided to make through brainstorming meetings was to add clarification, refine the wording and replace some text with animation.

Conclusion

User testing resulted in an improved educational video that is more useful and understandable for guideline panellists. Wider implementation of this resource has the potential to enhance the incorporation of patient values and preferences in guideline recommendations, supporting more patient-centred decision-making.

Climate change, transactional sex, HIV/AIDS and sustainable livelihoods among fishing communities around Lake Victoria: a scoping review protocol

Por: Were · L. P. O. · Kachingwe · O. N. · Goldman · T. · Ma · Y. · Awuor · F. J. · Nyamweya · C. · Okechi · J. · Kaufman · L. · Gopal · S.
Background

The objective of this scoping review is to map out what has been published in the scientific literature on the relationship between climate change-related events and how these overlap with associated changes in resource availability, transactional sex and HIV incidence and prevalence, within fishing communities in the Lake Victoria basin. This objective is informed by the fact that climate change and the associated natural resource strains in the Lake Victoria region have exacerbated existing inequities within fishing communities. Vulnerable populations, especially women, engage in strategies such as transactional sex to cope with the uncertainty of natural resource-dependent livelihoods. This practice greatly increases women’s risk of contracting HIV in this region, with prevalence rates four to five times the national averages. This scoping review will thus show how the existing empirical literature reports on climate change, transformation in natural resources and livelihoods, and transactional sex and HIV in the Lake Victoria region.

Methods

Studies that meet the following inclusion criteria will be included: align with at least two of the major concepts of interest, including climate change, transactional sex, HIV/AIDS, Lake Victoria Basin and/or empirical studies; are published in English and after 2012; and focus on the Lake Victoria basin. The scoping review will be guided by the JBI Manual for Evidence Synthesis: Scoping Reviews, supported by the standard principles of Arksey and O’Malley. The specific search strategies to be implemented were developed with guidance from an experienced research librarian to align with the inclusion criteria. The search will be conducted in relevant global databases, with two reviewers screening the results and extracting relevant data points. Finally, results will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews flow diagram, and summarised in figures, tables and text.

Discussion

The scoping review is designed to comprehensively scope the existing literature and document the coverage of linkages between transactional sex, HIV/AIDS and sustainable livelihoods in the context of climate change with a view to informing health systems responses to human health specific to the HIV epidemic.

Scoping review registration

The proposed scoping review is registered with the Open Science Foundation (OSF), registration number:https://doi.org/10.17605/OSF.IO/9DTW4.

From international guidelines to practice: a multimethod evaluation of BMJ Rapid Recommendations focusing on suitability for adaptation and implementation

Por: Seterelv · S. S. · Gupta · S. · Kouri · A. · Florez · I. D. · Agoritsas · T. · Vandvik · P. O. · Van de Velde · S.
Objectives

We aimed to assess usage and explore factors influencing the suitability of British Medical Journal (BMJ) Rapid Recommendations—a set of international guidelines meeting standards of trustworthiness—for adaptation and implementation, further defined as implementability.

Design

Qualitative descriptive study with a multimethod approach.

Participants

We used citation screening and a survey to identify groups that had used any of a sample of 14 BMJ Rapid Recommendations in adoption, adaptation, de novo guideline development or implementation.

Setting

12 participants from a range of country income levels were interviewed, using semistructured interviews.

Methods

Interviews were analysed using thematic analysis to identify themes related to implementability of the guidelines. We compared these findings with those from a critical appraisal conducted using three different appraisal tools.

Results

BMJ Rapid Recommendations are used in high-income, middle-income and low-income countries. We identified 33 instances of use. Our thematic analysis of the interviews uncovered 14 challenges to implementability, categorised under perceived trustworthiness, comprehensibility and practical relevance. The critical appraisals gave the BMJ Rapid Recommendations high scores on validity, but low scores on implementability and measurability. The challenges found in the interviews were generally corroborated by the appraisals, but the comparison also exposed tensions such as the complex interaction between methodological rigour and perceived credibility, the balance between novelty and compatibility with current practice, and the difficulty of offering globally applicable yet locally practical guidance.

Conclusion

Implementability challenges may limit effective use of international guidelines globally. Recognising and reflecting on tensions between rigour, credibility and contextual feasibility may help improve their uptake and value. The next phase of this research will explore strategies to enhance guideline implementability during their development.

Pragmatic trial of a virtual dementia collaborative care management program: protocol for the Aging Brain Care Virtual (ABCV) program

Por: Sauerteig-Rolston · M. R. · Fowler · N. R. · Sachs · G. A. · Boustani · M. · Slaven · J. · Monahan · P. O. · Burke · E. S. · Higbie · A. · Torke · A. M.
Introduction

Providing care management, treatment and support to patients with Alzheimer’s Disease and Related Dementias (ADRD) is a difficult task for health systems. Over the past 20 years, interventions designed to improve outcomes for patients living in the community with dementia and their care partners have moved progressively, but separately, from large scale trials and pragmatic models of collaborative care. Given the projected increase in the number of people living with dementia coupled with the realignment of payment for services to be value-based and provided in the community, system-level approaches are needed to address the complex needs of patients with a dementia diagnosis and their care partners. We designed a statewide, pragmatic trial to evaluate virtual delivery of an evidence-based dementia collaborative care program on patient healthcare utilization and medication use.

Methods and analysis

The Aging Brain Care Virtual (ABCV) program is a 12-month embedded, cluster randomized, usual care controlled trial designed to test the effectiveness of a virtual dementia collaborative care program in 24 Indiana University Health primary care clinics (12 intervention, 12 control) across the state of Indiana, enrolling 860 persons living with dementia (430 intervention, 430 control) and their care partners. ABCV relies on a tailored approach in which dyad needs are identified during virtual visits and addressed with standardized protocols previously tested in a randomized controlled trial delivered in person. The ABCV trial will measure emergency department utilization (primary outcome) and appropriate medication use (secondary outcome) at 12 months using electronic medical record data. Additionally, this study will use semi-structured interviews with care partners and clinicians to explore the implementation context, process and outcomes of the ABCV program.

Ethics and dissemination

Ethics approval was obtained from the Indiana University Institutional Review Board (20249). Research findings will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number

NCT06245499.

Efficacy of virtual reality in reducing pain, anxiety and fear in hospitalised children: a systematic review and meta-analysis protocol

Introduction

Paediatric hospitalisation, encompassing the period from admission to discharge, often involves feelings of pain, fear and anxiety, primarily due to clinical diagnoses and, more significantly, discomfort and stress-inducing procedures. Numerous methodologies and interventions have been investigated and implemented to alleviate these phenomena during paediatric hospitalisation. Virtual reality (VR), for example, has demonstrated efficacy in pain relief for hospitalised children in recent studies. This systematic review, therefore, aims to identify and evaluate the effectiveness of VR in alleviating pain, fear and anxiety in hospitalised children undergoing painful procedures.

Method and analysis

This systematic review and meta-analysis will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols guidelines. A systematic search will be conducted in March and April 2025 across the following databases, with no restrictions on language or publication year: PubMed, Embase, Scopus, Web of Science, Cumulated Index in Nursing and Allied Health Literature, ClinicalTrials.gov and the Cochrane Central Register of Controlled Trials. Eligible studies will include randomised and quasi-randomised clinical trials involving children (aged 2–10 years) and adolescents (aged 10–18 years) who received VR interventions during painful procedures. Data will be managed and analysed using Review Manager software (RevMan 5.2.3). In cases of significant heterogeneity (I² > 50%), a random-effects model will be employed to combine studies and calculate the OR with a 95% CI. The methodological quality of the included studies will be assessed using the Cochrane Risk of Bias 2.0 tool, and the certainty of the evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluations framework.

Ethics and dissemination

This study will solely review published data; thus, ethical approval is not required. This systematic review is expected to provide subsidies, evidence and insights into the use of VR. It is also anticipated that the results will directly impact the improvement of care for these patients and the qualification of professional care.

PROSPERO registration number

CRD42024568297.

Effectiveness of aromatherapy in pain relief postcardiac surgery: a systematic review and meta-analysis protocol

Introduction

Acute pain in the postoperative period of cardiac surgery is mostly treated with opioid analgesics. However, with the risk of adverse reactions and complications, strategies which do not involve opioid analgesics can be considered, such as aromatherapy. This systematic review aims to analyse the effectiveness of aromatherapy in relieving pain in post-cardiac surgery patients.

Methods and analysis

Two researchers will independently and simultaneously conduct searches and select studies from the following databases: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Latin American and Caribbean Literature on Health Sciences, Scopus, Web of Science, Cochrane (Library) and clinical trial registries (clinicaltrials.com), with no language or publication date restrictions. Randomised and quasi-randomised clinical trials on the use of aromatherapy for pain relief in postcardiac surgery patients will be included. Then, two researchers will independently examine the studies based on inclusion criteria, extract data from the included studies and assess the risk of bias using the Risk of Bias 2 tool and the Risk of Bias in Non-randomized Studies of Interventions tool from Cochrane. Data will be synthesised using Review Manager software. The strength of the evidence will be evaluated using the Grading of Recommendation Assessment, Development and Evaluation approach. The literature search, study selection, review and meta-analysis stages will be conducted from early October 2025 to April 2026.

Ethics and dissemination

This study is based on secondary data, and therefore ethical approval from a research ethics committee was not required. The results will be disseminated through publication in a peer-reviewed scientific journal.

PROSPERO registration number

CRD42024568532.

Prevalence and predisposing factors of retained drug needle fragments in people who inject drugs: a protocol for a preliminary cross-sectional multicentre observational study in Finland

Por: Laukkala · H. · Arponen · O. · Rinta-Kiikka · I. · Sumanen · M. · Nevalainen · O. P. O.
Introduction

Numerous published case reports have described retained drug needle fragments in soft tissue as causes of localised pain and infections in persons who inject drugs (PWIDs). Furthermore, there are case reports of PWIDs with lung and heart embolisations caused by needle emboli. Subcutaneously retained needles also pose a risk of needlestick injury to medical staff. There are no previous epidemiological attempts to evaluate how common X-ray-confirmed retained drug needle fragments are among community-dwelling PWIDs. Due to the unclear clinical relevance of needle fragment retentions, there is a need to systematically evaluate the prevalence of retained needles, related complications and risk factors predisposing needle fragmentations.

Methods and analysis

We have planned a prospective cross-sectional study covering multiple ambulatory clinics that manage PWIDs in Tampere, Finland. PWIDs will be asked to give their written informed consent prior to any study procedures. Initially, we aim to recruit a sample for a pilot study of 20 adults (≥18 years) who will be asked to fill out a questionnaire related to their drug use history and their suspicions of having retained needle fragments. Subsequently, participants will undergo X-ray imaging of the injection sites as part of the study. Female participants of childbearing age (

Ethics and dissemination

We submitted the study protocol for ethics review to the Tampere University Hospital Ethics Committee and received their favourable opinion (study code: R22037). We subsequently sought organisational permission from the clinics to conduct the study. To be enrolled, PWIDs must provide written informed consent. The study results will be published in international peer-reviewed journals and conference proceedings.

Trial registration number

NCT05679284.

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