FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
Ayer — Junio 14th 2026Tus fuentes RSS

Driving factors and barriers to irrational antibiotic prescribing in Pakistan: a qualitative study of physicians, pharmacists and nurses perspectives in public and private hospitals

Por: Khan · M. E. · Jamil · E. · Abubakar · M. · Javed · A. · Abbas · D. · Nawaz · E. · Atiq · B. · Razi · B. H. · Saeed · A. R. · Rasool · H. · Zubair · M. · Rasool · H. · Khan · S. W. · Shoul · A. · Batool · A. · Khan · M. U. · Ullah · M.
Background

Irrational prescribing is a major global health concern, contributing significantly to increased morbidity, mortality and antimicrobial resistance (AMR). Despite existing knowledge and awareness, irrational antibiotic use remains prevalent among healthcare professionals.

Objectives

This qualitative study aimed to explore the contributing factors to irrational antibiotic prescribing, understand healthcare professionals’ perceptions, identify barriers to rational use and gather suggestions for improving rational antibiotic use.

Study design and participants

A qualitative study using semi-structured interviews was conducted with participants. A total of 60 healthcare professionals (20 physicians, 20 pharmacists and 20 nurses) participated after providing verbal consent.

Methodology

Semi-structured interviews were conducted with healthcare professionals across various clinical settings in Pakistan until data saturation was reached. The Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist was used to ensure transparent reporting. An inductive thematic analysis approach was employed and themes and subthemes were developed from the data.

Results

The findings revealed a generally good understanding of irrational prescribing. Contributing factors included prescriber-related issues, patient expectations, weak regulatory oversight and underutilisation of pharmacists. Key barriers identified were financial constraints, lack of awareness and insufficient resources. Suggestions for improvement included regular audits, public awareness campaigns, an integrated healthcare system, interprofessional collaboration, drug utilisation reviews, adverse drug reaction reporting, standardising hospital policies and strengthening regulatory frameworks.

Conclusion

This study highlights critical factors and barriers contributing to irrational antibiotic prescribing and presents practical suggestions to improve rational use. Implementing evidence-based approaches, updating clinical guidelines, and promoting awareness among healthcare professionals are essential steps toward improving prescribing practices and combating AMR.

AnteayerTus fuentes RSS

Hypertension and altitude in community-dwelling older adults: an epidemiological study in northwest China

Por: Maimaitiwusiman · Z. · Xuekelati · S. · Wumaier · A. · Bai · X. · Ma · L. · Li · Y. · Aerken · A. · Yang · Y. · Wang · H.
Objectives

Hypertension is a major risk factor for cardiovascular and cerebrovascular diseases, and a relationship between altitude and hypertension has been demonstrated. To better characterise this relationship, this study investigated the prevalence of hypertension and its association with altitude in community-dwelling older adults living at different altitudes in Xinjiang, northwest China.

Design

A cross-sectional study.

Setting

Xinjiang, China.

Participants

50 778 community-dwelling older adults residing at varying altitudes across Xinjiang.

Measures

A multistage stratified sampling method was used to conduct an epidemiological survey from January 2019 to December 2019 among 50 778 community-dwelling older adults aged ≥60 years who were long-term residents of Kashgar (1289 m), Hami (738 m) and Turpan (35 m), Xinjiang. Logistic regression analysis was conducted to evaluate the association between altitude and hypertension risk.

Results

Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) showed significant variations (both p

Conclusions

In community-dwelling older adults residing in lowland to mid-elevation zones (35–1289 m) of Xinjiang, the prevalence and risk of hypertension were found to be inversely associated with residential altitude. These findings may reflect an environmental gradient effect specific to mid-to-low altitude settings, and their generalisability may be limited to populations at higher altitudes (>1500 m) or regions with distinct ethnic, genetic or healthcare backgrounds. Furthermore, it should be emphasised that this association likely reflects altitude-related environmental factors rather than direct physiological effects of hypoxia. Additional studies are warranted to further elucidate these complex relationships.

Workplace Incivility and Nurses' Job Satisfaction and Leaving Intentions in Taiwan: A Cross‐Sectional Study

ABSTRACT

Background

Workplace incivility is a pervasive challenge in healthcare. Few studies drew on theoretical concepts to simultaneously examine organisational correlates of incivility and its associations with nurses' work outcomes.

Aim

This study examined workplace incivility among nurses, focusing on job control, psychological job demands and workplace justice as workplace characteristics, and assessing its association with job satisfaction and intentions to leave.

Methods

A cross-sectional survey was conducted among 528 full-time nurses at a medical centre in Taiwan. Validated questionnaires assessed workplace incivility (the Workplace Incivility Scale), workplace characteristics, job satisfaction and intentions to leave. Multivariable linear regression examined associations of workplace characteristics with incivility, and associations of incivility with job satisfaction and intentions to leave, adjusting for demographic and workplace factors.

Results

High workplace incivility was reported by 41.1% of nurses. In adjusted analyses, lower job control and lower workplace justice were associated with higher incivility scores. After adjustment for demographic and workplace factors, workplace incivility was negatively associated with job satisfaction and positively associated with leaving intentions. Among workplace characteristics, psychological job demands showed strong associations with both job satisfaction and leaving intentions.

Conclusions

Workplace incivility reflects underlying organisational conditions and is associated with lower job satisfaction and greater leaving intentions. Addressing job demands, autonomy and fairness may reduce incivility and sustain the nursing workforce.

Implications for the Profession and/or Patient Care

Workplace incivility is associated with lower job satisfaction and greater leaving intentions, and may co-occur with lower job control and perceived organisational justice, highlighting the need for organisational strategies that foster fairness and supportive work environments to enhance nurse retention.

Reporting Method

The authors adhered to the STROBE guidelines.

Patient or Public Contribution

No patient or public involvement.

Differential treatment effects across subgroups in immunomodulatory drugs for sepsis: protocol for a systematic review

Por: Ding · L. · Bai · C. · Jian · L. · Hu · D. · Xiong · J. · Zhang · Z. · He · Q. · Wang · Y. · Xu · J. · Ge · L. · Wang · W. · Sun · X.
Introduction

Sepsis, a life-threatening organ dysfunction caused by a dysregulated host response to infection, may benefit from immunomodulatory drugs. Nevertheless, numerous clinical trials of these drugs have failed to demonstrate efficacy, partly due to substantial heterogeneous treatment responses. Subgroup analyses from these trials are frequently employed to investigate different treatment effects across subgroups. However, which drugs might have different effects across subgroups and how credible these findings are have not been well summarised and evaluated. Additionally, the differences in the characteristics and results of subgroup analyses based on whether the primary trial’s main effect is statistically significant remain unclear. We will conduct a systematic review to comprehensively address these questions.

Methods and analysis

We will include randomised controlled trials (RCTs) evaluating immunomodulatory drugs for adult sepsis and exclude quasi-randomised trials, single-arm studies, animal research, conference abstracts, study protocols and non-English publications. To comprehensively search for subgroup analyses, we will search both RCTs and their published secondary analyses across PubMed, Embase, Web of Science, ClinicalTrials.gov and the Cochrane Library from their inception. Four reviewers will independently screen eligible studies and only one subgroup analysis will be selected for data extraction using standardised forms. The credibility of subgroup effects will be assessed using the Instrument for assessing the Credibility of Effect Modification Analyses. We will analyse the proportion and characteristics of subgroup analyses reported in trials. We will qualitatively summarise the results of subgroup analyses, focusing on findings with a subgroup-specific p value2 test or Fisher’s exact test, as appropriate.

Ethics and dissemination

No ethical approval is required because the data we will use do not include individual patient data. Findings will be disseminated through publication in a peer-reviewed journal.

Trial registration number

CRD420251089737.

Sino-Canadian Healthy Life Trajectories Initiative in China: an economic evaluation protocol

Por: Zhou · Y. · Zhou · H. · Huang · H.-F. · Fraser · W. D. · Fan · J. · Baillargeon · J.-P. · Poder · T. G. · Wu · B.
Introduction

Childhood overweight and obesity (OWO) in China, especially in urban areas, has become a significant public health challenge. Recent studies indicate a high prevalence of OWO in both children and adults, exacerbated by urbanisation and economic development. This trend poses a threat to health outcomes, including neurocognitive functioning, socio-emotional development and risk of chronic conditions. Recognising the limitations of high-income country prevention models, the Sino-Canadian Healthy Life Trajectories Initiative (SCHeLTI) was established to evaluate a multifaceted intervention aimed at mitigating childhood OWO and related non-communicable disease risks. This protocol outlines the economic evaluation component of the SCHeLTI trial.

Methods and analysis

A within-trial economic evaluation and long-term model from both a healthcare/personal social services perspective and a broader societal perspective will be undertaken alongside the SCHeLTI study, comparing the multifaceted intervention to usual care. Costs will include intervention provision, implementation and household expenditures. Outcome measures span child and maternal health-related quality of life, growth indicators, cognitive and behavioural development, nutritional status and metabolic dysfunction indicators. Cost-effectiveness and cost-utility analyses will be performed, with incremental cost-effectiveness ratios calculated for primary outcomes and quality-adjusted life years. A decision-analytical model will also project long-term economic and health impacts. Equity impact analysis will assess the intervention’s effects across socioeconomic strata. Sensitivity analyses, including one-way and probabilistic approaches, will be conducted to ensure robust results.

Ethics and dissemination

The study has been approved by the Medical Research Ethics Committees of the International Peace Maternity and Child Health Hospital in Shanghai, China (GKLW2017-01) and the CIUSSS de l’Estrie-CHUS in Sherbrooke, Canada (MP-31-2019–2967). Results will be disseminated through academic publications, policy briefs, stakeholder meetings and community engagement to inform early childhood development policy in China and similar settings globally.

Trial registration number

ChiCTR1800017773.

Patient preferences and willingness-to-pay for AI-enabled blended type 2 diabetes care by digital experience and socioeconomic status: a discrete-choice experiment in China

Por: Sun · H. · Shi · Z. · Xia · Y. · Bai · Y. · Yu · M. · Liu · R. · He · P.
Objectives

To elicit stated preferences and willingness-to-pay (WTP) for artificial intelligence (AI)-enabled blended care in type 2 diabetes mellitus (T2DM), and to examine preference heterogeneity by digital experience and socioeconomic status (SES).

Design

Cross-sectional discrete choice experiment (DCE).

Setting

12 community health centres in Jiaozuo and Puyang, Henan Province, China. Data were collected between June and August 2025.

Participants

423 adults diagnosed with T2DM for at least 6 months, recruited using consecutive convenience sampling from routine follow-up appointments. Of 769 participants who completed the survey, 346 were excluded following prespecified data quality criteria (retention rate: 55.0%).

Outcome measures

Outcome measures included preference weights and WTP (in Chinese Yuan, ¥) for five DCE attributes: monthly subscription fee, recommendation source, feedback modality, in-person follow-up frequency and expert oversight, estimated using mixed logit models. Simulated uptake probabilities for tailored service packages across four user profiles were computed.

Results

Among 423 participants, 80.6% had never used AI tools. Price was the dominant driver of choice (62.7% relative attribute importance). Profound preference heterogeneity emerged across subgroups: rural residents (n=78) were highly price-sensitive but preferred physician endorsement (WTP ¥17.58 (US$2.55), 95% CI ¥5.98 to ¥29.17); female participants (n=224) valued guideline recommendations (WTP ¥18.45 (US$2.67), 95% CI ¥7.81 to ¥29.40); and diabetes app users (n=34) were the least price-sensitive but showed a negative preference for AI instant feedback, instead preferring human dietitian feedback. Expert oversight carried a consistent negative WTP across all profiles. Targeting tailored service bundles to intended subgroups increased uptake by 8–16 percentage points compared with non-targeted bundles.

Conclusions

A ‘digital experience paradox’ exists whereby digitally experienced users view human interaction as a premium service, while underserved groups rely on specific trust markers such as physician endorsement. To avoid widening the digital divide, AI-enabled blended diabetes care must move beyond standardised models towards configurable, equity-driven service pathways.

Clinical efficacy, safety and applicability of home-based bright light therapy in outpatient adolescents with major depressive disorder in China: protocol for a randomised controlled trial

Por: Zhao · Z. · Zhou · T. · Liu · M. · Wang · N. · Li · Y. · Yang · C. · Qiu · Y. · Wang · J. · Wu · W. · Bai · Y. · Su · Y. · He · Y. · Zhang · Y. · Chen · L. · Shi · Z. · Xie · T. · Wang · J. · Yuan · J. · Dang · W. · Dong · W. · Chen · Z. · Yu · X. · Lv · X.
Introduction

Major depressive disorder (MDD) is a leading cause of disability among adolescents, yet available treatments remain limited. Bright light therapy (BLT) is a non-pharmacological intervention with demonstrated efficacy in adults. However, its clinical utility and underlying neural mechanisms in adolescents remain unclear. This trial aims to evaluate the clinical efficacy, time to onset, safety and applicability of home-based BLT in outpatient adolescents with MDD, and to explore its underlying neural mechanisms using functional near-infrared spectroscopy (fNIRS).

Methods and analysis

This is a randomised, placebo-controlled, three-arm multicentre clinical trial. A total of 126 outpatient adolescents aged 13–17 years with MDD will be randomly assigned to receive high-intensity BLT, medium-intensity BLT or placebo dim red light using a portable light box in a home-based setting for 40 min each morning over 4 weeks, followed by a 2-week follow-up. 42 age-matched and gender-matched healthy controls will also be enrolled for baseline assessments only, serving as normative references for comparison. The primary outcome will be the change in total scores on the 17-item Hamilton Rating Scale for Depression from baseline to week 4. All analyses will follow an intention-to-treat framework to ensure methodological rigour. The primary outcome will be analysed using analysis of covariance and linear mixed-effects models. Secondary outcomes will include response and remission rates, time to onset, maintenance of efficacy, self-reported depressive symptoms, sleep quality, cognitive function, anxiety, irritability, suicidal ideation, non-suicidal self-injury, self-efficacy and the overall safety profile of BLT. Prefrontal cortical activity will be measured using fNIRS at baseline and week 4 to explore potential neural mechanisms. Approximately 15% of participants will additionally take part in a qualitative substudy exploring experiences and acceptability of BLT.

Ethics and dissemination

The study protocol has been approved by the Ethics Committee of Peking University Sixth Hospital (approval number: 2025–24). Written informed consent will be obtained from all participants and their legal guardians prior to enrolment. Study findings will be disseminated through peer-reviewed journals and conference presentations.

Trial registration number

NCT06913309.

Responsible preoperative opioid use for hip or knee arthroplasty (OpioidHALT): a protocol for a randomised clinical trial of pharmacist-partnered opioid tapering prior to hip or knee arthroplasty

Por: Penm · J. · Liu · S. · Adie · S. · Ashton-James · C. E. · Bailey · K. A. · Brady · B. · Chaar · B. · Chen · J. · Descallar · J. · Englezos · K. · Genel · F. · Gillespie · D. · Gnjidic · D. · Hoang · T. · Jansson · A. · Jauregui · K. J. · Keehan · M. · Lin · C.-W. C. · Lintzeris · N. · Luckie
Introduction

Despite limited evidence of efficacy, opioid analgesics are frequently used by patients for chronic pain while awaiting total hip or knee arthroplasty (THA or TKA). Preoperative use of opioids is problematic as it increases the likelihood of postoperative opioid-related adverse drug events and postoperative complications and is the strongest predictor of persistent opioid use post surgery. Opioid tapering prior to elective surgery has been proposed as a strategy for mitigating harms and improving postoperative outcomes. This protocol describes a randomised clinical trial, which aims to determine the effectiveness of a preoperative pharmacist-partnered opioid tapering programme compared with standard care for patients awaiting elective THA or TKA on postoperative outcomes including persistent opioid use.

Method and analysis

Eligible participants must be aged ≥18 years; awaiting elective unilateral or bilateral THA or TKA; speak and read English; use prescription opioid analgesics at least 4 days a week and have access to internet or telephone. The participants will be excluded if they are undergoing a repeat surgery (same procedure within 6 months), are using opioids for cancer, palliative care or substance use disorder; have previously or are currently undergoing an opioid tapering programme or active medication review or have cognitive impairment. Enrolled participants will be randomised in a 1:1 ratio in permuted blocks of two and four to: (1) intervention or (2) standard care. A total of 314 participants will be recruited into the study. The intervention will include a pharmacist-partnered opioid tapering programme in which a pharmacist will work with participants to reduce their opioid dose over a 3-month period before surgery. Standard care will involve review by the hospital preadmission clinic multidisciplinary team to assess medical, physical and psychological health prior to surgery and education sessions for preoperative and postoperative care. The primary outcome assessed is persistent opioid use 3 months post surgery. The key secondary outcome is total Western Ontario and McMaster Universities Arthritis Index score. Data analysis will be performed using an estimand framework, with a generalised estimating equation model for the primary outcome from 1 day to 3 days presurgery to 3 months post surgery and a multilevel model for the main secondary outcome from baseline to 3 months after surgery. Cost-effectiveness and cost-utility analyses will be conducted to determine whether the intervention is cost-effective from the healthcare system perspective.

Ethics and dissemination

Ethics approval for this study was granted by a Human Research Ethics Committee (approval number: 2023/ETH01042). Results will be disseminated in peer reviewed journals, at international scientific meetings as well as meetings with key stakeholders and via the media.

Trial registration number

ACTRN12623000685617.

Effectiveness of Nurse‐Led Interventions in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta‐Analysis

ABSTRACT

Background

The rising prevalence of cognitive impairment has made it a critical public health priority. Nurses are central to chronic disease management, yet the efficacy of the interventions in older adults with cognitive disorders remains uncertain.

Objective

To evaluate the efficacy of nurse-led interventions in older adults with cognitive disorders.

Methods

A comprehensive search was conducted across seven electronic databases from their inception to August 2025. This meta-analysis focused on nurse-led interventions. The primary outcome was cognitive function, and secondary outcomes included depressive symptoms and quality of life. Due to the heterogeneity of the studies, we employed a random effects model for the meta-analysis.

Results

The results indicated that nurse-led interventions significantly improved cognition (SMD = 0.64; 95% CI, 0.39–0.88; p < 0.05), substantially alleviated depressive symptoms (SMD = −0.32; 95% CI, −0.53–0.11; p < 0.05) and enhanced quality of life (QoL) (SMD = 0.40; 95% CI, 0.17–0.64; p < 0.05).

Conclusions

The results of this study indicate that nurse-led interventions are highly beneficial for elderly individuals with mild cognitive impairment (MCI) or dementia. In future research, it is necessary to comprehensively consider the roles that nurses undertake. They should play an active role in the recovery from chronic diseases. These findings provide an important basis for policymakers and clinicians.

Trial Registration

PROSPERO Registration number: CRD42024619016

Protocol for EACH-ADHF trial: efficacy and safety of early comprehensive rehabilitation in patients with acute decompensated heart failure - a multicentre, randomised controlled trial

Por: Xu · M. · Chang · J. · Guo · L. · Bai · B. · Wang · R. · Liu · X. · Du · Q. · Mao · Y. · Xue · A. · Su · M. · Wang · Y. · Lin · K. · Ma · H.
Introduction

Acute decompensated heart failure (ADHF) is associated with high mortality rates and significant decline in physical function following hospitalisation. Although exercise-based cardiac rehabilitation is recognised as a key component of comprehensive heart failure management, clinical evidence supporting its application in patients with ADHF remains limited. The trial aims to evaluate the efficacy and safety of an early initiated comprehensive rehabilitation in patients with ADHF.

Methods and analysis

This is a prospective, multicentre, randomised, open-label, parallel-group clinical trial. A total of 140 patients hospitalised with ADHF will be enrolled and randomised in a 1:1 ratio to receive either comprehensive rehabilitation intervention or attention control. The intervention group will receive a supervised, 6-week structured comprehensive rehabilitation programme consisting of progressive balance, endurance, strength and inspiratory muscle training. Rehabilitation therapy commences after admission and continues into the outpatient period with a total of 18 sessions. The control group will receive standard usual care supplemented by fortnightly non-rehabilitation-related contact from study personnel to control for attention. Coprimary outcomes are changes in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score and in maximum inspiratory pressure expressed as a percentage of predicted value (PImax%pred) at 6 weeks postrandomisation. Secondary outcomes include changes in the Short Physical Performance Battery score, frailty phenotype, pulmonary function tests and 6-month all-cause rehospitalisation.

Ethics and dissemination

The Early Comprehensive Rehabilitation in patients with ADHF (EACH-ADHF) trial was granted by the Medical Research Ethics Committee of Guangdong Provincial People’s Hospital (KY-Q-2022-487). Findings will be disseminated to patients, clinicians and commissioning groups through peer-reviewed publication.

Trial registration number

NCT06161987.

Multidimensional effects of virtual reality on motor dysfunction in patients who had a stroke: study protocol for a prospective, randomised, controlled clinical trial

Por: Yang · Z. · Lu · Q. · Chen · D. · Tang · L. · Ran · T. · Yang · L. · Bai · D.
Introduction

Poststroke motor dysfunction places a heavy burden on individuals and society. Virtual reality (VR) offers enhanced motor skill transfer and active rehabilitation by overcoming the scenario-specific constraints of conventional therapies. Validating the efficacy of VR rehabilitation could lead to scalable and cost-effective solutions, potentially enabling home-based rehabilitation. However, the widespread clinical application remains constrained by the lack of rehabilitation-specific VR and multidimensional quantitative assessments. The aim of this study was to investigate the multidimensional effects and neural mechanisms of VR rehabilitation in poststroke motor recovery.

Methods and analysis

This study is a prospective, randomised, controlled clinical trial protocol designed to evaluate the effects of multisensory VR training on motor dysfunction in patients who had a stroke using multidimensional assessments. The trial consists of a baseline assessment, a 4-week intervention period and an endpoint assessment. A total of 40 patients who had a stroke will be randomly allocated in a 1:1 ratio to either a VR combined with treadmill group or a treadmill-only group. The primary outcome measure is the Fugl-Meyer Assessment of Lower Extremity score, while secondary outcomes include three-dimensional gait analysis, the Berg Balance Scale score, the activities of daily living score and functional near-infrared spectroscopy results. Safety will be evaluated by monitoring the incidence of adverse events. This study aims to determine whether VR rehabilitation offers superior efficacy in improving motor function in patients who had a stroke by using a multidimensional assessment approach, including neural coupling function, muscle movement mechanics and clinical performance. The findings will provide robust, high-quality evidence to support the broader application of VR in clinical practice.

Ethics, registration and dissemination

The trial was approved by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University (2022–155). This study protocol was registered with the clinicaltrials.gov (NCT06275516). The results will be published in a peer-reviewed journal or presented at a conference.

Trial registration number

NCT06275516.

Health‐Promoting Lifestyle and Associated Factors Among Head and Neck Cancer Patients in Northeast China: A Cross‐Sectional Study

ABSTRACT

Objectives

Health-promoting lifestyle (HPL) is strongly associated with health outcomes. In clinical practice, health-promotion behaviours in patients with head and neck cancer (HNC) are not good, which seriously affects patients' prognosis. This study aims to investigate the current status and influencing factors of HPL in HNC patients.

Design

A cross-sectional study.

Methods

This study used a convenience sampling method to select 264 consecutive HNC patients who attended a tertiary hospital in northeast China from November 2023 to May 2024 for the survey. Data were collected using the Questionnaire for General Information, the Health-Promoting Lifestyle Profile Revised-II (HPLP-II R), the Health Literacy Management Scale (He LMS) and the Acceptance of Illness Scale (AIS).

Results

The HPLP-II R scores of HNC patients were generally average (93.10 ± 15.60), with the highest scores on the nutrition dimension and the lowest scores on the exercise dimension. HPL was significantly and positively correlated with health literacy and disease acceptance. Multiple linear regression analysis showed that educational level, cancer recurrence, health literacy and disease acceptance were the influencing factors of HPL among patients with HNC, which altogether explained 25.9% of the total variance.

Conclusion

The HPL of HNC patients is at an average level and still has much room for improvement. Patients with high literacy levels, cancer recurrence, high health literacy and disease acceptance levels had relatively high levels of HPL.

Implications for the Profession

HPL can enhance patients' internal motivation, enhance their self-management ability and improve their daily functional performance while reducing complications and improving their quality of life. This suggests that medical staff should give personalised health guidance according to patients' different health literacy in clinical work, improve patients' disease acceptance and pay attention to the development of HPL.

Reporting Method

STORBE guidelines.

Patient or Public Contribution

No patient or public contribution.

MULTIsite feasibility of MUSIc therapy to address Quality Of Life in Sickle cell disease (MULTI-MUSIQOLS): protocol for a mixed-methods randomised controlled trial at two US medical centres

Por: Rodgers-Melnick · S. N. · Gorthi · V. · Foss · A. · Erande · A. · DiFrancesco · K. · Owusu-Ansah · A. · Anim · S. · Bretz · S. · Ketter · P. · Fuqua · T. · Anderson · A. R. · Karasz · A. · Bailey · L. · Ezenwa · M. · Jenerette · C. · Dusek · J. A.
Introduction

Accessible, person-centred, non-pharmacologic modalities are needed to address chronic pain and health-related quality of life (HRQoL) among individuals with sickle cell disease (SCD). Building off prior single-site pilot studies of music therapy (MT) in SCD, the purpose of this study is to (1) examine the data collection processes and intervention implementation overall and across two sites and (2) evaluate the implementation of the MT and health education interventions using quantitative and qualitative data.

Methods and analysis

This three-arm, two-site, feasibility randomised controlled trial will include 90 individuals ≥14 years who have SCD, chronic pain and access to a mobile device who are not currently engaged in mind-body pain management interventions under the supervision of a healthcare professional. Participants will be randomised to six sessions over 8 weeks of either: (1) in-person MT, (2) hybrid (one in-person, five virtual) MT or (3) hybrid health education. Patient-reported outcome measures of HRQoL and self-efficacy will be assessed at baseline, post-intervention and 6 weeks post-intervention. 24 participants (eight per arm) and 20 stakeholders (eg, haematologists, music therapists, nurses) will be invited to complete semi-structured interviews to further examine intervention acceptability, perceived benefits and implementation. Sessions will be monitored for fidelity, and participants lacking access to home internet or videoconferencing technology will be provided tablets to engage in virtual sessions. Feasibility will be determined by rates of data completion, recruitment, retention, session attendance and home practice.

Ethics and dissemination

This study was approved by the University Hospitals Cleveland Medical Center Institutional Review Board (STUDY20231055). The dissemination plan includes presenting findings at national and international scientific conferences and publishing in peer-reviewed journals. All activities will be conducted in collaboration with SCD community stakeholders.

Trial registration number

NCT06853158.

Exploring the relationship between mental health and urban green space soundscapes: A scoping review

by Elham Ahmadi, Sophia Baierl, Stephan Voss, Ida Asenkerschbaumer, Ursula Berndt, Leonie Bernhard, Anita Hennig, Anna-Lena Würfele, Michaela Coenen

Urban soundscapes, particularly those experienced in green spaces, have been increasingly recognized as factors that influence human mental health. This scoping review explores the existing literature on soundscapes within urban green spaces and their associated mental health outcomes. It aims to classify the methodologies used in this domain, identify mental health outcomes related to urban green space soundscapes, and examine specific soundscape elements and their correlations with mental health. A systematic search of peer-reviewed studies was conducted. After screening titles, abstracts, and full texts, 22 studies met the inclusion criteria. Diverse methodological approaches were identified, with an emphasis on quantitative multi-method designs. Commonly studied mental health outcomes include stress reduction, mood enhancement, perceived restorativeness, and cognitive restoration. Standardized psychometric tools, such as the Perceived Stress Scale (PSS-14), Positive and Negative Affect Schedule (PANAS) and Perceived Restorativeness Soundscape Scale (PRSS) are frequently used as outcome measures. Natural soundscape elements such as birdsong, water sounds, and rustling leaves had a positive association with relaxation and perceived mental restoration throughout all studies, while mechanical sounds, such as traffic noise were linked to adverse mental health outcomes. These findings highlight that natural soundscapes in urban green spaces have a potential positive relationship with mental health by reducing stress and enhancing mood. However, the cross-sectional design and methodological heterogeneity of the included studies limit causal interpretation. Future research should explore multi-sensory experiences and examine soundscapes in diverse urban contexts to provide more robust insights into their relationship with mental health. The practical implications suggest that urban planners should prioritize integrating natural sound elements into urban areas to improve mental health. The study protocol of this scoping review had been registered at OSF (osf.io/4r7gd).

Assessment of health-related quality of life, cognitive, physical and psychological impairments in critically ill adults after status epilepticus (POSEIDON 2): protocol for a multicentre longitudinal study

Por: Legriel · S. · Bernard · C. · Sboui · G. · Sigaud · F. · Lascarrou · J.-B. · Mayenco-Cardenal · N. · Chelly · J. · Bruel · C. · Mongardon · N. · Marzouk · M. · Quenot · J.-P. · Hugues · R. · Schnell · D. · Beuret · P. · Bailly · P. · Lesieur · O. · Argaud · L. · Chambon · R. · Jacq · G.
Introduction

Status epilepticus (SE) in adults is a serious neurological emergency that can lead to high morbidity and mortality rates. Although functional outcomes are often assessed using general scoring systems, limited data on health-related quality of life (HRQoL) in patients admitted to intensive care units (ICUs) are still limited. Furthermore, comprehensive evaluations of patient-reported physical, cognitive, mental health and psychological outcomes are lacking in this population. POSEIDON 2 aims to assess HRQoL and cognitive, physical and psychological impairments at 3 and 12 months after ICU discharge following SE and quantify caregiver burden.

Methods and analysis

POSEIDON 2 is a prospective, multicentre, longitudinal study conducted in 19 French ICUs. The study combines data from the SE ICTAL Registry with data from patients who survived admission to the ICU for SE, who will be recruited for the study. The study also includes patient-reported outcome (PRO) data collected 3 (M3) and 12 (M12) months after discharge from the ICU using validated instruments. The Zarit scale will be used to measure the burden on caregivers at M3 and M12. The primary endpoint is the prevalence of overall HRQOL impairment at M3 and M12, as defined by dichotomous scores on the physical and mental components of the 36-Item Short Form Health Survey compared with those of the general population. Secondary endpoints include domain-specific impairments, such as cognitive function, dependence, mental health and patient experiences. The sample size has been calculated based on an estimated prevalence of 75% for HRQoL impairment, with a planned sample size of 140 patients.

Ethics and dissemination

The POSEIDON 2 study protocol received ethical approval from the ethics committee ‘Comité de Protection des Personnes Ouest VI’ on 5 October 2023 (#2023-A01223-42). The study is conducted in accordance with the Declaration of Helsinki, Good Clinical Practice and the regulatory requirements of France. Written informed consent is obtained from participants, who are able to decline participation or withdraw from the study at any time. Findings will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences.

Trial registration number

NCT06100978.

Imaging the choroidal microvasculature in intensive and high dependency care unit patients: a pilot study

Por: Cooper · G. M. · Burke · J. · Hamid · C. · Godden · E. · Dhaun · N. · King · S. · MacGillivray · T. · Baillie · K. · Griffith · D. M. · MacCormick · I. J. C.
Objectives

Microcirculatory dysfunction drives the end-organ pathophysiology of circulatory shock but is not reflected within existing clinical indices of perfusion, such as blood pressure. The choroidal vasculature of the retina can be measured non-invasively and we hypothesised that this may reflect dysfunction in other organs. We tested the feasibility of measuring the choroid in intensive care and explored associations between choroidal measurements and clinical parameters.

Design

A pilot study of optical coherence tomography conducted in a sample of general intensive care unit (ICU) patients.

Setting

A tertiary mixed ICU within the UK.

Participants

15 patients were recruited. One patient was excluded following withdrawal of active treatment. 12/14 (86%) of the remaining patients had successful baseline imaging and 6 (40%) of these had follow-up imaging within intensive care. These patients had a mean age of 56.3 years, were 71% (10/14) male and mean Acute Physiology and Chronic Health Evaluation 2 (APACHE2) score on ICU admission was 20.4.

Outcome measures

Choroidal anatomy, including choroidal and suprachoroidal thickness, as well as volumetric analysis of intrachoroidal blood vessels, was assessed using automated image segmentation along with clinical, physiological and biochemical data at ICU admission and after an interval of 12–72 hours. Feasibility and safety data were assessed throughout ICU admission.

Results

Baseline choroidal vascular index and choroidal thickness were positively associated with fluid balance, and negatively with APACHE2 score, haematocrit and albumin content. A measurable suprachoroidal space was seen in nine (75%) patients (range 25.0–110.0 microns) and was inversely associated with heart rate. There was substantial intraindividual variation in choroidal measurements over time. There were no safety concerns.

Conclusions

Measuring the choroid is feasible in patients with Intensive Care Society Level 2 or Level 3 requirements. The suprachoroidal space may be markedly enlarged in these patients. Exploratory associations with systemic variables suggest that the choroid may provide information about the microvascular function of other major organs. Size and change of choroidal measurements may reflect perfusion pressure and vascular leakage.

Mechanisms of SGLT inhibitor action and physiological mediators: systematic review and protocol for the MOSAIC collaborative meta-analysis

Por: Kugathasan · L. · Nardone · M. · Muskiet · M. · Diaz Martinez · J. P. · Lovblom · L. E. · Orchanian-Cheff · A. · Nielsen · S. · Rotbain · V. · Kazup · A. · Cersosimo · E. · Gullaksen · S. · Vernstrom · L. · van Baar · M. J. B. · van Bommel · E. · Kannenkeril · D. · Scholtes · R. · Hesp
Introduction

Sodium-glucose cotransporter (SGLT) inhibitors have shown substantial benefit in reducing cardiovascular and kidney events across diverse clinical populations, but the underlying physiological mechanisms remain unclear. However, existing mechanistic studies on renal and cardiovascular haemodynamics show variability in design, have limited statistical power and yield inconsistent outcomes, thus limiting the ability to draw generalisable conclusions. To address this gap, we conducted a systematic review and proposed the first meta-analysis to aggregate individual participant-level data from mechanistic studies to identify consistent physiological patterns and enhance understanding of the therapeutic effects of SGLT inhibition.

Methods and analysis

Gold-standard measured glomerular filtration rate (mGFR) was selected as the primary outcome for this systematic review, which aimed to identify all completed mechanistic studies investigating the effects of SGLT inhibition. Electronic databases including Ovid MEDLINE; Ovid Embase; Cochrane Database of Systematic Reviews; and Cochrane Central Register of Controlled Trials were searched using a detailed search strategy. In total, 24 studies (n=1296) were identified. This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Key variables including demographics, medical history, concomitant medications, vital signs, mGFR, renal haemodynamics, urine and plasma biochemistry, tubular sodium handling, echocardiography, cardiac output monitoring, arterial stiffness and fluid volume will be extracted. A one-stage individual participant data meta-analysis under a Bayesian framework will be conducted, using hierarchical models to simultaneously analyse data from all eligible studies. The risk of bias due to missing results will be assessed. Sensitivity analyses and subgroup evaluations will be incorporated to explore sources of heterogeneity and assess robustness of findings.

Ethics and dissemination

Ethics approval was obtained from University Health Network, Toronto, Canada. Findings from the Mechanisms of SGLT Inhibitor Action and Physiological Mediators (MOSAIC) meta-analysis will be published in peer-reviewed journals and results will be disseminated at scientific conferences.

PROSPERO registration number

CRD420251001413.

Associations of oxidative balance score with mortality and cardiovascular events: cohort study from NHANES and UK Biobank

Por: Zhang · H. · Chen · S. · Bai · X. · Zhou · X. · Zhang · F. · Wang · X. · Chen · L. · Wang · X.
Objective

To investigate the associations of oxidative balance score (OBS) with all-cause mortality, cardiovascular mortality and cardiovascular disease (CVD) incidence in two large, population-based cohorts.

Design

Cohort study and cross-sectional study were used.

Setting

The US National Health and Nutrition Examination Survey (NHANES) and the UK Biobank.

Participants

A total of 33 566 adults from NHANES (1998–2018) and 55 760 adults from the UK Biobank were included.

Main outcome measures

All-cause mortality, cardiovascular mortality and CVD. Mortality outcomes were ascertained through national death registries. Prevalent CVD was identified in NHANES through questionnaire, and incident CVD events were identified in the UK Biobank using linked hospital admission and death registry data.

Results

Higher OBS was consistently associated with lower all-cause and cardiovascular mortality in both cohorts. In NHANES, participants in the highest OBS quartile (Q4) had a 39% lower risk of all-cause mortality (adjusted HR: 0.61, 95% CI 0.52 to 0.72) and a 45% lower risk of cardiovascular mortality (adjusted HR: 0.55, 95% CI 0.41 to 0.74) compared with those in Q1. Similarly, in the UK Biobank, Q4 was associated with an 18% lower risk of all-cause mortality (adjusted HR: 0.82, 95% CI 0.74 to 0.91) and a 41% lower risk of cardiovascular mortality (adjusted HR: 0.59, 95% CI 0.4 to 0.87). In NHANES, Q4 was associated with lower odds of prevalent CVD (adjusted OR: 0.56, 95% CI 0.46 to 0.67), whereas in the UK Biobank, Q4 was associated with a 19% lower risk of incident CVD during follow-up (adjusted HR: 0.81, 95% CI 0.74 to 0.9). Subgroup analyses in NHANES indicated heterogeneity by ethnicity and socioeconomic status, whereas associations in the UK Biobank followed an L-shaped pattern with a flattening of estimated risk at moderate OBS levels.

Conclusion

Higher OBS was associated with more favourable mortality and cardiovascular outcomes. These findings indicate that OBS is a composite indicator associated with cardiovascular health at the population level.

Womens health and well-being over the life course: conceptual framing supported by a scoping review

Por: Iyer · A. · Sen · G. · Rao Seshadri · S. · Snow · R. · Ataullahjan · A. · Liang · M. · Baird · S. · Drake · J. K. · Sharafi · L. · Bhutta · Z.

As a framework to conceptualise well-being, the capability approach (CA) combines structural drivers with personal freedoms, making it a compelling approach for understanding women’s health and well-being (WHW). The WHW Project of the Exemplars in Global Health initiative chose the CA for its conceptual framing, while emphasising the influential role of gender and other intersecting inequalities (intersectional gender inequality) in shaping health and well-being over the life course. We discuss the Exemplars in Global Health – Women’s Health and Well-being (EGH-WHW) Framework and a scoping review that supports it.

Objectives

  • To identify well-established and/or validated CA-based frameworks and measures attuned to intersectional gender inequality that analyse women’s well-being over the life course and across multiple geographies.

  • If needed, to develop a new conceptual framework to analyse WHW over the life course through an intersectional gender inequality lens.

  • Design

    The scoping review, which was carried out between January and May 2024 and re-run in May 2025, adhered to the methodology by Arksey and O’Malley, Levac et al and Daudt et al, and the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) checklist. The EGH-WHW Framework was developed by a multidisciplinary Working Group comprising representatives of organisations in the WHW Project consortium.

    Data sources

    The review drew upon database searches (Scopus, PubMed) and targeted online hand searches for CA-based frameworks and measures.

    Eligibility criteria

    All CA-based frameworks and measures of multidimensional well-being were included. CA-based empirical research was considered if it applied a framework or measure; or if it analysed multidimensional well-being across multiple geographies.

    Data extraction and synthesis

    Information about each type of CA-based application—its choice of well-being dimensions, methods, focus on inequality, intersectionality and the life course—was recorded in a data charting form. Thematic summative syntheses of publications about each CA-based framework or measure led up to an overall evaluative synthesis of the fit between existing work and our requirements.

    Results

    The review culminated in 94 publications, including six frameworks and 14 measures that met only some of the WHW Project’s requirements: multidimensionality of well-being; attention to intersectional gender inequality and the life course; as well as demonstrated and intended measurements across multiple geographies.

    Discussion

    The review reaffirms the need for the EGH-WHW Framework, which recognises that WHW depend on their freedom ‘to be’ and ‘to do’, and proposes three interconnected clusters of dimensions depicting key capabilities, agency and functionings that are sensitive to intersectional gender inequality and the life course. Each dimension is mapped to specific indicators to support comparative assessments of country performance and drivers of progress across low-income and middle-income countries.

    Conclusion

    The EGH-WHW Framework distinguishes itself from other CA-based frameworks by incorporating both an intersectional gender lens and a life course perspective. The framework’s conceptualisation of multidimensional well-being allows for a rich and nuanced foundation on which to build policies and programmes that address the complex determinants of health, well-being and human rights of different groups of girls and women.

    Randomised-controlled feasibility study evaluating the REgulate your SItting Time (RESIT) intervention for reducing sitting in individuals with type 2 diabetes: a process evaluation

    Por: Biddle · S. J. H. · Brierley · M. L. · Castle · E. · Hunt · E. R. · Chater · A. · Edwardson · C. · Bailey · D.
    Objectives

    The REgulate your SItting Time (RESIT) is a tailored intervention targeting reductions and breaks in sitting in adults with type 2 diabetes mellitus (T2DM). A feasibility trial of RESIT had been conducted and the purpose of this paper is to report findings from the process evaluation.

    Design

    A mixed-methods process evaluation within a randomised controlled feasibility trial.

    Setting

    The study was conducted remotely in the community.

    Participants

    Ambulatory individuals with T2DM aged 18–85 years.

    Intervention

    A tailored intervention comprising an online education session, regular health coaching and technology for self-monitoring behaviour and prompting breaks in sitting.

    Primary and secondary outcome measures

    Questionnaires (intervention participants n=22 at both 3 and 6 months; control participants n=21 at 3 months, n=29 at 6 months) and interviews (n=30, with n=13 intervention participants, n=12 control participants, n=5 health coaches) to assess perceptions of the intervention components, strategies and barriers for sitting less, the role of the study evaluation measures, and reasons for taking part.

    Results

    The trial operated a largely successful online education element for those in the intervention group (82% completion; ≥76% engagement in individual educational elements). There was good use of self-monitoring and prompt technology (apps and wearables) with 73% of participants reporting using these at 6 months. Health coaching had high engagement and was perceived as enjoyable and useful. Data revealed strategies used for behaviour change (eg, active functional tasks) alongside barriers to change (eg, restrictions at work). There were also potential behavioural influences from the study evaluation measures (eg, activity measures increasing awareness and execution of behaviours) for both intervention and control participants.

    Conclusions

    A comprehensive process evaluation identified successful intervention elements (ie, online education, health coaching, wearables and smartphone apps) alongside strategies and barriers to behaviour change. These findings can inform future sedentary behaviour interventions for adults with T2DM and a definitive randomised controlled trial evaluating RESIT.

    Trial registration number

    ISRCTN14832389.

    ❌