Cochlear implants (CIs) are the standard of care for profound deafness, yet clinical success is often measured solely by speech recognition scores. These metrics provide an incomplete picture; they indicate what a patient hears but fail to account for the mental workload required to achieve that performance.

The primary goal of this meta-analysis is to quantitatively compare the magnitude of listening effort in post-lingually deafened adults using cochlear implants (CIs) versus normal-hearing controls. Secondary goals are to: (1) evaluate within-group CI contrasts under varying task demands and signal-to-noise ratios; (2) compare the sensitivity and effect sizes of listening effort across subjective, behavioural and physiological measurement domains and (3) conduct planned subgroup analyses to assess the impact of clinical characteristics on listening effort.

This protocol adheres to Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Protocols (PRISMA-P) guidelines. A comprehensive systematic search will be conducted from inception to the present across MEDLINE, Embase, Scopus, CINAHL, PsycInfo and Cochrane Central. The review focuses on post-lingually deafened adults (≥ 12 months device experience and ≥18 years of age). We will employ a measure-specific meta-analytical approach, synthesising data separately across three domains: subjective (eg, self-reported scales), behavioural (eg, dual-task paradigms), and physiological (eg, pupillometry). Pooled effect sizes (Hedges’ g) will be calculated using a random-effects model. Statistical heterogeneity will be assessed via I² and X² statistics, while the certainty of evidence will be evaluated using the GRADE approach. By quantifying the disparity between speech accuracy and mental workload, this review provides an evidence-based framework for clinicians to identify patients at risk of chronic communicative fatigue, regardless of speech perception scores. Furthermore, this synthesis will guide future research by identifying which measurement modalities are most sensitive for monitoring the neurocognitive demands unique to auditory rehabilitation via CIs.

As this study involves the secondary analysis of publicly available data, external ethical approval is not required. The findings will be disseminated through a peer-reviewed publication.

CRD420261278088

Case reports (CRs) are essential in physiotherapy, yet reporting remains heterogeneous and insufficiently standardised. The 2013 CAse REport (CARE) guideline improves transparency but lacks physiotherapy-specific detail. This study aimed to develop a consensus-driven extension of the CARE reporting guideline to support structured reporting of physiotherapy CRs, encompassing physiotherapy-specific assessments and interventions.

An e-Delphi consensus process study following the ACcurate COnsensus Reporting Document (ACCORD) guidelines.

Online.

Forty-four international experts in physiotherapy practice, research and education, along with six core committee members.

Experts objectively scored items for relevance (5-point Likert scale) and provided open-ended responses for each item of the drafts. Scores and responses were analysed to facilitate iterative refinement of the Physiotherapy CAse REport (PhyCARE) reporting guidelines. Consensus was predetermined at over 70% agreement.

Round 1 had the majority of items achieving ≥70% agreement, except two items that did not meet the threshold were revised and replaced with an alternative. Five new items addressing physiotherapy-specific reporting needs were added, and 10 items were relocated. In round 2, all 35 items across 13 domains achieved 84%–100% agreement. The nomenclature of one domain was revised to ‘Outcomes and Follow-up’. Following two e-Delphi rounds, consensus was achieved, and suggestions from online meeting, piloting led to item rephrasing, after which the PhyCARE guidelines were finalised.

The PhyCARE guidelines have the potential to provide a physiotherapy-specific extension of CARE to support structured, transparent and reproducible reporting of physiotherapy CRs.

Cardiovascular diseases (CVDs) are a leading cause of mortality in Nepal. Risk perception is crucial for the prevention of CVD-related behaviours. This study assessed CVD risk perceptions and the stages of preventive behaviours among adults in Pokhara Metropolitan, Nepal by integrating two theoretical models—the Health Belief Model and the Transtheoretical Model.

This study used a cross-sectional design with data collected through a survey using a semistructured questionnaire.

This study was conducted from July 2024 to August 2024; among community people aged ≥20 residing in 11 wards of Pokhara Metropolitan.

A total of 384 community people residing in Pokhara Metropolitan, Nepal.

The primary outcome measure was stage of preventive behaviours of CVDs using Fuster BEWAT components (blood pressure, exercise, weight, diet and tobacco), while explanatory variables were sociodemographic characteristics and CVD Health Beliefs.

A total of 384 adults participated (response rate=95%). The mean age was 42.3 years (SD±14.5), with equal representation of males and females. More than half of the participants (55.5%) perceived low susceptibility to CVDs, 40.4% perceived high severity, 78.4% perceived high benefits and 49.5% perceived moderate barriers. Most respondents were in the precontemplation stage for blood pressure control (43%) and weight management (30.5%), whereas maintenance was most common for physical activity (41.1%), healthy diet (51.3%) and smoking abstinence (80.1%).

Ordinal logistic regression revealed that low perceived benefits significantly hindered behavioural progression (p=0.001–0.012), where low perceived barriers significantly facilitated advancement across all behaviours (p

Perceived benefits and barriers were key predictors of progression in CVD prevention behaviours. While many adults maintained healthy diets, physical activity and smoking abstinence, most were in the early stage for blood pressure and weight control strategies. Strengthening perceived benefits and reducing barriers can enhance the adoption of healthy behaviours in Nepal.

To identify stakeholder perceived challenges and facilitators for implementing a clean fuel and clean stove intervention to reduce household air pollution and hypertension in Lagos, Nigeria.

Qualitative study guided by the Exploration and Preparation phases of the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework, using focus group discussions and in-depth semi-structured interviews with inductive and deductive thematic analysis.

Peri-urban communities across the five administrative divisions of Lagos State, Nigeria.

128 stakeholders from 32 communities, including community, religious, market and youth leaders, primary healthcare staff, and household decision makers. Approximately half were female.

This was a pre-implementation needs assessment that included demonstrations of the clean stove and fuel.

Thematic domains describing barriers and enablers to adoption and implementation, mapped to EPIS inner, outer, and bridging factors.

Stakeholders reported barriers that included stove stacking, upfront stove cost, concerns about long-term fuel price and availability, equipment durability and maintenance, safety, mistrust of new technology, and uncertainty about stove performance for dishes requiring high heat and long cooking times. Reported facilitators included payment flexibility and subsidies, opportunities to test the stove, perceived benefits of cleaner and faster cooking with less soot, endorsement by community leaders, and interest in local retail and distribution to improve access.

Implementation planning for clean fuel and clean stove programmes should address affordability, reliable fuel supply chains, durability and service, culturally relevant cooking needs, and trust building through community leadership. These findings inform adaptation strategies for scale-up in similar low-resource settings.

NCT05048147.

To assess the feasibility of conducting a cluster randomised controlled trial comparing the effects of Advanced Trauma Life Support (ATLS) and Primary Trauma Care (PTC) with standard care on patient outcomes.

This was a pilot pragmatic three-armed parallel, cluster randomised, controlled trial conducted between April 2022 and February 2023. Patients were followed up for 30 days.

Tertiary care hospitals across metropolitan areas in India.

Adult trauma patients and residents managing these patients were included.

ATLS or PTC training was provided for residents in the intervention arms.

The outcomes were the consent rate, loss to follow-up rate, missing data rates, differences in the distribution between observed data and data extracted from medical records, and the resident pass rate.

Two hospitals were randomised to the ATLS arm, two to the PTC arm and three to the standard care arm. We included 376 patients and 22 residents. The percentage of patients who consented to follow-up was 77% and the percentage of residents who consented to receive training was 100%. The loss to follow-up rate was 14%. The pass rate was 100%. Overall, the amount of missing data for key variables was low. The data collected through observations were similar to data extracted from medical records, but there were more missing values in the extracted data.

Conducting a full-scale cluster randomised controlled trial comparing the effects of ATLS, PTC and standard care on patient outcomes appears feasible, especially if such a trial would use data and outcomes available in medical records.

NCT05417243.

A ‘7-1-7’ timeliness metric, developed for hastening the response to infectious disease outbreaks/pandemics, was adapted to improve screening and managing household contacts (HHCs) of pulmonary tuberculosis (TB) patients. The feasibility, enablers, challenges and utility of implementing this modified metric through TB Champions (TB survivors) for HHC management were assessed.

This was an explanatory mixed-methods study with a cohort design (quantitative) followed by a descriptive design with focus group discussions (qualitative).

The study was conducted within routine programmatic settings in public health facilities in six districts from three states of India.

In total, 595 drug-susceptible index pulmonary TB patients registered for treatment in the selected health facilities, and their listed 2108 HHCs were included in the study between December 2022 and August 2023. All 17 TB Champions involved in implementation participated in the focus group discussions.

The primary outcome measures were the percentage of eligible participants receiving the desired service within the ‘7-1-7’ timeliness metric and challenges in achieving the timeliness metrics.

In 89% of 595 index patients, their HHCs were line-listed within 7 days of initiating anti-TB treatment (‘First-7’). In 90% of 2108 HHCs, screening outcomes were ascertained within 1 day of line-listing (‘Next-1’). In 42% of 2073 HHCs eligible for further evaluation, anti-TB treatment, TB preventive treatment (TPT) or a decision to not receive medication were made within 7 days of screening (‘Second-7’). Barriers to TPT uptake included lack of money and daily wage losses for travelling to clinics, reluctance of asymptomatic contacts to take medication and fear of adverse events. TB Champions felt timeliness metrics improved performance in the systematic and timely management of HHCs.

TB Champions found ‘7-1-7’ timeliness metrics were feasible and useful, and national TB programmes should consider their operationalisation.

Community participatory modelling merges participatory research approaches with mathematical modelling. Participatory approaches are grounded in the engagement of people with lived experience (eg, who are affected by the health condition under study) throughout the research process. Mathematical modelling of infectious disease (ID) dynamic transmissions is increasingly used as a tool for public health decision-making, generating predictions, inferring mechanisms and estimating the impact of potential interventions—all of which guide policies, strategies and resource allocation as part of the preparation and response to ID epidemics. However, little is known about the engagement of people with lived experience and affected communities in the ID modelling process. We will map the literature to explore participatory approaches undertaken in ID modelling (practical aspects of formalising participatory modelling), levels of participation and the potential influence from the perspective of communities engaged.

The scoping review will follow the Joanna Briggs Institute Manual for Evidence Synthesis. The search strategy includes three electronic bibliographic databases (MEDLINE, Scopus and Embase), no language restrictions and sources published from 2000 to present. We will implement the search with and without the participatory keyword, as we recognise that some studies do not explicitly term community engagement as participatory modelling. After deduplication, two authors will independently screen the titles, abstracts and full texts, with discrepancies resolved with a third team member. We will extract the relevant information from the main text, parameter tables, supplemental files, bibliography, acknowledgment and author affiliation sections. The data extraction will follow a deductive content analysis where we draw from community-based participatory research approaches and established mathematical modelling steps. We will also extract data to assess whether there was equitable engagement of knowledge users by checking for indicators of three equitable engagement domains as outlined by the Ward framework (equity within partnership (eg, whether knowledge user influenced modelling decisions or remuneration), capacity to engage in future partnerships and shift in power/influence (eg, coauthorship). We will supplement our narrative analyses with summaries in tabular format and using appropriate data visualisations.

No ethics approval will be required for this scoping review because we will map evidence from publicly available literature sources. We will develop multilingual abstracts or one-page lay summaries of the findings (English, French and Swahili), a policy brief and will coauthor an open-access journal article. A summary of the findings will be shared via knowledge user-led presentations at the Maisha HIV and AIDS Conference and with other community-based organisations at the quarterly peer-to-peer support meetings.

The protocol has been registered in Open Science Framework, DOI: https://doi.org/10.17605/OSF.IO/XQ2WP (December 2024).

Mitochondrial dysfunction and disrupted cerebral energy metabolism have been increasingly linked to the pathophysiology of schizophrenia. Preclinical studies suggest that certain atypical antipsychotics may exacerbate mitochondrial dysfunction by inhibiting respiratory complex I, contributing to adverse effects. Risperidone, a dopamine D2/serotonin 5-HT2 antagonist, and aripiprazole, a partial dopamine D2 agonist, were selected because of their contrasting pharmacological profiles and reported differential effects on mitochondrial complex I activity. Despite these findings, the clinical implications remain poorly understood. This randomised controlled trial aims to evaluate and compare the biochemical and clinical effects of risperidone and aripiprazole on mitochondrial dysfunction in patients with schizophrenia.

In this randomised, open-label, parallel-arm clinical trial, 60 patients with schizophrenia who were drug-naïve or had not taken any antipsychotic drugs for at least 4 weeks before recruitment were randomly assigned to risperidone or aripiprazole treatment for 12 weeks, with inclusion of an additional group of 30 healthy individuals for baseline comparisons. The primary outcome is the change in mitochondrial respiratory chain complex I concentration in platelets, and secondary outcomes include serum lactate, pyruvate, creatine kinase levels and Newcastle Mitochondrial Disease Adult Scale (NMDAS) scores. Clinical efficacy and safety are evaluated using the Positive and Negative Syndrome Scale (PANSS) and monitoring treatment-emergent adverse events. Intention-to-treat analysis will be done for all parameters using suitable statistical tools.

Ethical approval was obtained from the Institutional Ethics Committee and the study conformed to the provisions of the Declaration of Helsinki and ICMR’s national ethical guidelines for biomedical and health research involving human participants (2017). Written informed consent will be obtained from the legally authorised representative of the patients. Results will be disseminated through peer-reviewed publications and conferences to inform safer treatment strategies for schizophrenia.

NCT06236451.

In Africa, 75% of households are exposed to household air pollution (HAP), a key contributor to cardiovascular disease (CVD). In Nigeria, 90 million households rely on solid fuels for cooking, and 40% of adults have hypertension. Though clean fuel and clean stove (CF-CS) technologies can reduce HAP and CVD risk, their adoption in Africa remains limited.

Using the Exploration, Preparation, Implementation and Sustainment framework, this cluster-randomised controlled trial evaluates the implementation and effectiveness of a community mobilisation (CM) strategy versus a self-directed condition (i.e., receipt of information on CF-CS use without CM) on adoption of CF-CS technologies and systolic blood pressure (SBP) reduction among 1248 adults from 624 households across 32 peri-urban communities in Lagos, Nigeria. The primary outcome is CF-CS adoption at 12 months; secondary outcomes are SBP reduction at 12 months and sustainability of CF-CS use at 24 months. Adoption is assessed via objective monitoring of stove usage with temperature-triggered iButton sensors. SBP is assessed in 2 adults per household using validated automated blood pressure monitor. Generalised linear mixed-effects regression models will be used to assess study outcomes, accounting for clustering at the level of the peri-urban communities (unit of randomisation) and households. To date, randomisation is completed, and a total of 1248 households have enrolled in the study. The final completion of the study is expected in June 2026.

The study was approved by the Institutional Review Boards (IRB) of NYU Grossman School of Medicine (primary IRB of record; protocol ID: i21-00586; Version 6.0 approved on 4 June 2024), and Lagos State University Teaching Hospital (protocol ID: LREC 06/10/1621). Written consent was obtained from all participants. Findings will inform scalable and culturally appropriate strategies for reducing HAP and CVD risk in low-resource settings. Results will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagements.

NCT05048147