Commentary on: Nobels A, Meersman C, Lemmens G, Keygnaert I. ‘Just something that happened?’: mental health impact of disclosure and framing of sexual violence in older victims. Int J Geriatr Psychiatry. 2023;38. https://doi.org/10.1002/gps.6036.
Implications for practice and research Healthcare professionals need training to provide supportive and effective responses to disclosures of sexual violence in older adults. Further studies should explore the impact of positive responses to disclosures on the mental health outcomes of older victims.
Sexual violence (SV) remains a critical issue affecting mental health globally, defined as coerced sexual acts, unwanted advances or trafficking. Research indicates that an estimated 81% of women and 48% of men in Belgium have experienced SV in their lifetime.
Commentary on: Goto R, Pinchuk I, Kolodezhny O, et al (2024). Mental health of adolescents exposed to the war in Ukraine. JAMA Pediatrics, 178 (5), 480-488. doi: 10.1001/jamapediatrics.2024.0295.
Implications for practice and research Individuals screening positive require diagnostic evaluation to inform psychiatric treatment decisions and mental health interventions. Future research should expand these findings with objective measures of war/trauma exposure and full diagnostic assessment.
The study by Goto et al screened adolescents across Ukraine for mental health consequences of war.
by Hellen W. Kinyi, Charles Kato Drago, Lucy Ochola, Gertrude N. Kiwanuka
Macronutrients serve as principal sources of energy, structural components, and regulators of physiological processes. However, the optimal macronutrient combination for health remains unclear. While previous studies indicate that dietary macronutrient composition influences immune function, many have examined individual nutrients in isolation, failing to reflect the interactive effects of macronutrients. This study addresses this gap by examining how varying ratios of dietary carbohydrates, proteins, and lipids modulate serum cytokine responses to lipopolysaccharide challenge in Swiss albino mice. Male and female Swiss albino mice (n = 6 per group), aged 6–8 weeks, were randomly assigned to six purified isocaloric diets with differing macronutrient ratios for 15 weeks. Body weights were monitored to assess nutritional status. Serum levels of TNF-α, IL-6, IL-1β, and IL-10 were measured in unchallenged mice and after three hours of intraperitoneal LPS administration. Mice fed high-carbohydrate, low-protein diets had the highest weight (33.1 g ± 1.1), while those on high-lipid, low-protein diets had the lowest (28.3 g ± 0.6). Plasma levels of TNF-α and IL-10 varied significantly (pTo analyse trends and characteristics of multidrug-resistant (MDR) bacteria over the past 7 years, in relation to patterns of antimicrobial use, to inform rational antimicrobial use and strengthen hospital infection control measures.
Retrospective cohort study.
A large teaching hospital in Tianjin, a major metropolitan city in northern China.
A total of 190 352 inpatients aged >18 years, admitted between 1 January 2017 and 31 December 2023, were included. Patients were eligible if they had complete clinical data and met the five quality control indicators for multidrug-resistant bacteria (QC-MRB), defined in the ‘Hospital Infection Surveillance Specifications’ (WS/T 312–2023). Patients with MDR infections before admission or those with duplicate results from multiple specimens were excluded.
Statistical analysis revealed a detection rate of 12.11% for the five QC-MRB and an incidence rate of 0.20%. The findings also indicated an upward trend in the detection and incidence rates of carbapenem-resistant Enterobacteriaceae, despite a relatively stable rate of antimicrobial use over 7 years. A positive correlation was observed between the incidence of MDR bacteria and the intensity of antimicrobial use within the hospital setting.
The hospital’s bacterial data align with national trends. It established an interdisciplinary management framework for clinical data analysis and prediction of antimicrobial resistance. This approach enhances infection control measures and supports the rational use of antimicrobials.
Sodium-glucose cotransporter-2 inhibitors have demonstrated cardiorenal protective effects in adults with chronic kidney disease (CKD), but their efficacy and safety in paediatric CKD remain uncertain. Treatment for hereditary kidney disease in children is limited. This DAPA-PedHKD study aims to evaluate the effectiveness and safety of combining renin-angiotensin-aldosterone system inhibitors (RAASi) with dapagliflozin compare to RAASi alone in children with hereditary kidney disease accompanied by proteinuria.
DAPA-PedHKD is a multicentre, randomised, crossover, open-label clinical trial. Patients aged 6–18 years with hereditary kidney disease will be eligible. All patients must have received stable RAASi therapy for at least 4 weeks, with a baseline estimated glomerular filtration rate (eGFR) of ≥60 mL/min/1.73 m2, and either a 24-hour urinary protein level of >0.2 g or a urinary protein-to-creatinine ratio (UPCR) of >0.2 mg/mg. Participants will be randomised in a 1:1 ratio to receive either dapagliflozin in addition to standard RAASi therapy or RAASi therapy alone for 12 weeks. After a 4-week washout period with continued RAASi therapy, participants will crossover to the other treatment for another 12 weeks. Outcome assessments will be conducted at baseline and at weeks 2, 6, 12, 16, 18, 22 and 28. The primary outcome is the change in 24-hour urinary protein excretion from baseline to week 12. Secondary outcomes include changes in the UPCR, urinary albumin-to-creatinine ratio, serum albumin, eGFR, blood pressure and body weight from baseline to week 12. Neither participants nor investigators are blinded to treatment allocation, and placebo control is not used.
This study has been approved by the Ethics Committee of the Children’s Hospital of Fudan University and 11 local ethics committees. We will publish results in peer-reviewed journals and present at international conferences.
Patients undergoing anterior cruciate ligament reconstruction (ACLR) and patellar fracture frequently present with substantial pain, swelling and inflammation. These pathophysiological changes not only intensify postoperative pain but also compromise the intra-articular environment via mechanical compression and localised microcirculatory deficits, thereby impeding recovery. Conventional interventions for postoperative swelling, such as cryotherapy and physical agent modalities, are commonly applied yet exhibit limited efficacy. Multilayer low-stretch bandage (MLB), with its gradient compression properties, has recently demonstrated superior swelling control and functional restoration; however, existing research primarily assesses short-term outcomes and lacks a systematic analysis across the postoperative continuum—acute, subacute and chronic phases—as well as long-term follow-up. This study therefore employs a multi-temporal intervention design and extended follow-up to evaluate the effectiveness of MLB in managing swelling, modulating pain and enhancing long-term knee function and activities of daily living across different recovery stages. The findings aim to furnish high-level evidence for knee rehabilitation protocols, refine clinical practice and ultimately improve patient quality of life.
This prospective, single-blind, randomised controlled trial will enrol 36 patients following ACLR and patellar fracture. Participants will be allocated at a 1:1 ratio through computerised randomisation to either an experimental group receiving MLB plus conventional rehabilitation, or a control group receiving conventional rehabilitation alone. The study spans 12 weeks, with follow-up assessments scheduled at baseline (T0), 4 weeks (T1), 8 weeks (T2) and 12 weeks (T3). Outcome measures comprise the Hospital for Special Surgery (HSS) Knee Rating Score, affected limb oedema regression rate, Visual Analogue Scale (VAS) pain score, knee range of motion, quadriceps and hamstring muscle strength, centre of pressure (COP) displacement parameters, proprioceptive testing, the 36-Item Short Form Health Survey (SF-36) and the Holden Walking Function Classification. A subsequent 1-year follow-up will assess long-term efficacy and patient satisfaction, while adverse events are strictly monitored throughout the entire study period. Adherence to Consolidated Standards of Reporting Trials guidelines is maintained, and a single-blind design ensures that both participants and assessors remain unaware of group assignments. This trial aims to establish an evidence-based foundation for optimising postoperative rehabilitation in this patient population.
Ethical approval for the study was obtained from the Medical Ethics Committee of Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School (2025-0141-01). The results of the study will be published in a peer-reviewed medical journal.
ClinicalTrials.gov chiCTR2500100566. Registration date is 10 April 2025.
The sustainable employability of healthcare workers is associated with quality of care and vice versa, but how both interact remains largely unknown. This study aims to better understand the underlying mechanisms that explain the interconnectedness between healthcare workers’ sustainable employability and quality of care by examining organisational practices in two hospital teams that work on improving specific clinical processes.
A qualitative study was conducted, where team leaders, department managers and healthcare teams were observed and interviewed about their experiences with, and perspectives on, the (organisation of the) respective clinical process and daily (quality improvement) work. Transcripts and field notes were analysed in accordance with reflexive thematic analysis.
The emergency room and operating room of a recently merged Dutch hospital.
A total of 49 hours of observations and 10 interviews were conducted with team leaders, department managers, (scrub) nurses, physicians and other allied health professionals. Interviewees were purposively recruited when they were involved in, or considered knowledgeable about, the clinical processes.
This study identified three mechanisms as a result of different organisational practices that affected healthcare workers’ sustainable employability and quality of care separately and set in motion their interconnectedness: routinely overburdened staff, prolonged perceived distance between staff and regular disregard of raised concerns by staff. Over time, as these mechanisms remained unaddressed, undertows of slumbering sentiments—discontent, distrust and inertia—emerged. These sentiments proved hard to bring to the surface and to resolve and, in turn, may further compromise sustainable employability of healthcare workers and quality of care.
In this study, we show how the relationship between the sustainable employability of healthcare workers and quality of care is set in motion by seemingly unrelated organisational practices. To benefit both healthcare workers and patients, leadership and healthcare teams are urged to prevent (undertows of) slumbering sentiments by recognising sentiments as important signals of dysfunctional circumstances and by effectively organising participatory practices that enable healthcare workers’ voice and input.
This study aimed to identify and validate risk factors for suicidal ideation (SI) and non-suicidal self-injury (NSSI) among nursing staff through the development and application of a risk model and nomogram.
A cross-sectional online survey was conducted in Dehong District to collect relevant data.
A total of 1774 Chinese nursing staff members were enrolled in this study.
Multiple factors were independently associated with SI among nursing staff. These included divorce or other non-marital status (OR=2.42, 95% CI 1.07 to 5.44), drinking frequency (OR=1.34, 95% CI 1.001 to 1.79), loneliness (OR=1.26, 95% CI 1.11 to 1.44), depressive symptoms (OR=1.13, 95% CI 1.09 to 1.18), childhood trauma (OR=1.03, 95% CI 1.02 to 1.05) and life quality satisfaction (OR=0.63, 95% CI 0.49 to 0.80). Similarly, for NSSI among nursing staff, independent risk factors were identified, such as smoking frequency (OR=1.37, 95% CI 1.01 to 1.85), drinking frequency (OR=1.42, 95% CI 1.05 to 1.91), loneliness (OR=1.21, 95% CI 1.05 to 1.39), depressive symptoms (OR=1.13, 95% CI 1.09 to 1.18) and childhood trauma (OR=1.03, 95% CI 1.01 to 1.05). A nomogram for assessing SI/NSSI was established and demonstrated good calibration, with a Concordance Index of 0.82 (95% CI 0.79 to 0.86) for SI and 0.81 (95% CI 0.78 to 0.85) for NSSI.
The findings of this study can be used to identify nursing staff at risk of developing SI/NSSI. By using the developed nomograms for self-assessment, individuals might gain a better understanding of their occupational stress levels while performing routine work tasks. However, it should be noted that the study lacks external validation, which limits the generalisability of the findings at this stage.
Evaluation of the impact of atherosclerotic cardiovascular disease (ASCVD), particularly polyvascular disease, on 30-day and 365-day mortality among intensive care unit (ICU) patients diagnosed with sepsis.
Retrospective cohort study.
This study was conducted using data from the Medical Information Mart for Intensive Care IV, a publicly available critical care database from a tertiary care hospital in the US.
A total of 7895 adult ICU patients with sepsis were included between 2008 and 2022. Among them, 3314 (41.97%) had ASCVD, defined by International Classification of Diseases (ICD) codes for coronary artery disease, peripheral artery disease or stroke.
The primary outcomes were all-cause mortality at 30 and 365 days following ICU admission.
ASCVD patients with a greater number of disease beds tend to be male, older, have lower body mass index, heart rates, mean blood pressure, respiratory rate and temperature, compared with non-ASCVD patients. Before propensity-score matching, patients with ASCVD (3314) had significantly higher 30-day (29.21% vs 24.14%, p
Integrated management of sepsis and ASCVD—using targeted interventions such as tailored pharmacotherapy and risk factor modification—may reduce mortality and morbidity in this high-risk population.
Transoral robotic surgery (TORS) is a minimally invasive technique for surgical removal of tumours of the tonsil and lateral oropharynx. Surgical defects after TORS lateral oropharyngectomy are traditionally left open to heal by secondary intention, resulting in significant postoperative pain and secondarily resulting in delayed swallowing and discharge. Although multimodal analgesia can improve postoperative pain control, no studies to date have assessed the impact of adjunct surgical interventions for reducing postoperative pain after TORS. Buccal fat rotation flap is a regional reconstruction option after TORS lateral oropharyngectomy and provides immediate coverage of the open surgical wound. However, the impact of buccal fat rotation flap reconstruction on postoperative pain and swallowing remains unclear. This trial aims to compare postoperative pain outcomes in patients who undergo TORS lateral oropharyngectomy with and without buccal fat rotation reconstruction.
This protocol outlines a single centre, parallel, unblinded, phase II, randomised control trial. Inclusion criteria include adult patient (≥18 years) undergoing TORS lateral oropharyngectomy for early to intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/–) or early to intermediate stage salivary gland tumours of the palatine tonsils. Exclusion criteria include a history of prior head and neck squamous cell carcinoma, prior head and neck radiotherapy, retropharyngeal lymphadenopathy, bilateral lymphadenopathy, need for bilateral neck dissection, baseline trismus, opioid use or drug addiction, need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap, and pregnancy. All patients are planned for a TORS lateral oropharyngectomy. The intervention group will have a buccal fat rotation flap reconstruction, and the control group will be allowed to heal via secondary intention. The allocation sequence will be created using a computer-generated random sequence with a permuted block strategy. The allocation sequence will be concealed until the time of assignment. The primary outcome is postoperative pain intensity during rest and swallowing using the visualised analogue scale. Secondary outcomes include postoperative complications, other adverse events, patient-reported speech and swallowing, opioid usage, length of hospital stay, feeding tube dependence and blood glucose levels. The trial has a target sample size of 40 patients. Statistical analysis of the primary outcome will be analysed in an intention to treat analysis using a linear mixed effects model.
The study was approved by the University Health Network Coordinated Approval Process for Clinical Research. Study number CAPCR ID: 24-5894. All participants will be required to provide written informed consent to participate. Findings will be presented at national conferences and published in medical journals.
This study aimed to identify potential categories of rotation stress among nurses undergoing standardised training and to explore the relevant factors associated with each profile.
Cross-sectional study.
Data were collected in November 2024 from three hospitals in Zunyi City, Guizhou Province, China.
Nurses undergoing standardised training were recruited for this study.
Convenience sampling method was used to recruit standardised training nurses in November 2024 from three hospitals in Zunyi City, Guizhou Province. The survey instruments used included demographic characteristics questionnaire, the Nursing Job Rotation Stress Scale and the Maslach Burnout Inventory. Latent profile analysis method was used to analyse rotation stress characteristics of nurses during standardised training. Additionally, logistic regression was performed to identify the factors influencing different characteristics.
A total of 493 nurses completed the questionnaires, of which 453 were valid, resulting in a validity rate of 91.88%. Rotation stress was classified into two profiles: ‘Low Emotional Response–Stress Adaptation Group’ (21.5%) and ‘High Emotional Response–Stress Distress Group’ (78.5%). Univariate analysis showed that highest degree (2=11.389, p=0.001), monthly night shifts (2=33.913, p2=20.858, p2=12.319, p2=35.754, p2=15.357, p=0.002) significantly influenced the two subgroups. Multivariable regression analysis revealed significant associations of monthly night shifts, pretraining work experience, training duration and burnout level (p
Nurses undergoing standardised training exhibit two distinct rotation stress profiles. Monthly night shifts, pretraining work experience, training duration and burnout are significant factors. Nursing managers should implement targeted interventions such as mindfulness, laughter therapy and emotional freedom techniques to mitigate stress and thereby enhance the quality of standardised training.
To assess how preoperative anaemia affects surgical outcomes in elderly patients within a resource-limited setting.
Prospective cohort study.
Two comprehensive specialised hospitals in Ethiopia.
Participants consisted of 224 patients aged 65 years and older who underwent surgery between 1 December 2024 and 29 March 2025.
Perioperative blood transfusions were the primary outcome. Secondary outcomes included intensive care unit (ICU) admission, risk of postoperative complications, prolonged hospitalisation, poor recovery quality and in-hospital mortality.
The anaemic group required transfusions of three or more units more frequently than the non-anaemic group (10.5% vs 2.6%; absolute risk difference 8.0%). Their perioperative transfusion rates were significantly higher (42.3% vs 18.4%; p
Preoperative anaemia significantly increases the risk of transfusion, poor recovery, ICU admission, prolonged hospitalisation and in-hospital mortality in older patients who underwent surgery. In resource-limited settings, improving perioperative outcomes should prioritise the early detection and treatment of anaemia.
Shoulder osteoarthritis most commonly affects older adults, causing pain, reduced function and quality of life. Total shoulder replacements (TSRs) are indicated once other non-surgical options no longer provide adequate pain relief. Two main types of TSRs are widely used: anatomic TSR (aTSR) and reverse TSR (rTSR). It is not clear whether one TSR type provides better short- or long-term outcomes for patients, and which, if either, is more cost-effective for the National Health Service (NHS).
RAPSODI-UK is a multi-centre, pragmatic, two-parallel arm, superiority randomised controlled trial comparing the clinical- and cost-effectiveness of aTSR versus rTSR for adults aged 60+ with a primary diagnosis of osteoarthritis, an intact rotator cuff and bone stock suitable for TSR. Participants in both arms of the trial will receive usual post-operative rehabilitation. We aim to recruit 430 participants from approximately 28 NHS sites across the UK. The primary outcome is the Shoulder Pain and Disability Index (SPADI) at 2 years post-randomisation. Outcomes will be collected at 3, 6, 12, 18 and 24 months after randomisation. Secondary outcomes include the pain and function subscales of the SPADI, the Oxford Shoulder Score, health-related quality of life (EQ-5D-5L), complications, range of movement and strength, revisions and mortality. The between-group difference in the primary outcome will be derived from a constrained longitudinal data analysis model. We will also undertake a full health economic evaluation and conduct qualitative interviews to explore perceptions of acceptability of the two types of TSR and experiences of recovery with a sample of participants.
Ethics committee approval for this trial was obtained (London - Queen Square Research Ethics Committee, Rec Reference 22/LO/0617) on 4 October 2022. The results of the main trial will be submitted for publication in a peer-reviewed journal and using other professional and media outlets.
This study assessed the association between fine particulate matter (PM2.5) exposure during pregnancy and stillbirth in Pakistan. We hypothesised that higher PM2.5 exposure is linked to increased stillbirth risk.
A cross-sectional study using secondary data from the 2017 to 2018 Pakistan Demographic and Health Survey (PDHS), combined with satellite-derived PM2.5 exposure data.
The study covered urban and rural areas across Pakistan, including all four provinces (Punjab, Sindh, Khyber Pakhtunkhwa and Baluchistan) and administrative regions (Gilgit-Baltistan (GB), Islamabad, Federally Administered Tribal Areas and Azad Jammu Kashmir).
The study included 9172 married women aged 15–49 with at least one birth in the past 5 years. Women with incomplete pregnancy outcome data were excluded.
PM2.5 exposure was estimated using satellite data, matching PDHS clusters with the nearest air quality point via MATLAB. Monthly average exposure was categorised into quartiles.
Stillbirth, defined as pregnancy loss at ≥28 weeks gestation.
Multivariable logistic regression was used to assess the association between PM2.5 and stillbirth, adjusting for maternal age, gravidity, wealth index, birth interval, previous adverse pregnancy outcome and region of residence. The stillbirth rate in Pakistan for the most recent pregnancy was 17.0 (14.5–19.9) per 1000 births, with highest rates (28.9) in Baluchistan province. The mean level of PM2.5 exposure in Pakistan was 53.96 (SD 20.42; range 5.9–209.4) µg/m3. PM2.5 exposure was higher for urban (56.43) than rural (51.87) pregnancies, highest in Sindh (78.06) and lowest in GB (13.41) provinces. For every 1 µg/m3 average increase in PM2.5 during the pregnancy period, there was approximately 1% increase in stillbirth.
Increased PM2.5 exposure was strongly associated with stillbirth risk. This underscores the need for targeted public health interventions, such as government regulations, emission controls and clean energy initiatives to protect pregnant women in high-risk areas.
Achieving physical activity recommendations for health as part of mental healthcare for adults with severe mental illness (SMI) could enhance clinical, functional and quality of life outcomes. We have co-designed a protocol to evaluate the impact of an intervention which combines High Intensity Interval Training (HIIT) and Vigorous Intermittent Lifestyle Physical Activity (VILPA) on clinical, functional and quality of life outcomes in people who have SMI.
Pragmatic clinical trial with an intervention and control arms. Participants will be recruited from two mental health services in two different cities in the same geographical area. Participants who meet the inclusion criteria (>18 years, SMI diagnosis, not at medical risk to practise vigorous physical activity, living in the community) will be included. Those from one service will be assigned to the intervention group and those from the other to the control group. The intervention will take place in the mental healthcare centre and will comprise 16 weeks of group-based HIIT, with transition to an individual lifestyle intervention VILPA over the next 12 weeks—for a total intervention period of 28 weeks. Primary outcome (clinical and functional and quality of life) measures and secondary (self-perception and device-measured fitness, physical activity and sedentary behaviour, and experience) measures will be assessed at baseline and at 16-week, 28-week and 40-week follow-ups. Group differences in change scores will be assessed using linear mixed-effects models with time, group and their interaction as fixed effects, accounting for within-subject correlations.
The study was approved by the Human Ethics Committee of the Institute for Research and Innovation in Life and Health Sciences in Central Catalonia (Spain, CEIm code: 24/007). Data will be shared following publication of results with no end date. Results will be disseminated in peer-reviewed journals and at national and international conferences and will inform the development of recovery protocols for people with SMI.
ClinicalTrials.gov NCT06338917.
Perioperative psychological symptoms are prevalent among patients undergoing lung surgery and can contribute to adverse clinical outcomes. Pharmacological interventions for these symptoms have inherent limitations. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a promising non-invasive therapeutic approach. This study aims to evaluate the efficacy of taVNS in managing perioperative psychological symptoms in patients undergoing elective thoracoscopic pneumonectomy under general anaesthesia.
This single-centre, prospective, randomised, double-blind, controlled trial will enrol 176 patients scheduled for elective thoracoscopic lung resection. Participants will be randomly allocated to either the active taVNS or the sham taVNS groups in a 1:1 ratio. Both groups will receive 30 min active or sham stimulation sessions at four time points: (1) the afternoon prior to surgery, (2) the morning of the surgery, (3) following extubation and (4) the first afternoon postsurgery. The primary outcome is the incidence of perioperative anxiety, assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale. Secondary outcomes include depression scores, stress index, sleep quality, pain scores, incidence of postoperative delirium, fatigue, cough symptoms and postoperative recovery quality, all evaluated through validated assessment tools. Analyses will be conducted using intention-to-treat and per-protocol populations.
The Ethics Committee of Affiliated Hospital of Xuzhou Medical University granted approval for the study with approval number: XYFY2024-KL444-01. Dissemination will be via national anaesthesia conferences and publication in the peer-reviewed literature.
ChiCTR2400090542.
Postictal agitation (PIA) is a common adverse effect following electroconvulsive therapy (ECT). Current pharmacological treatments for PIA have undesirable side effects, and interventions to prevent PIA are unsatisfactory. The aim of this study is to assess the effect of peri-interventional music on PIA for patients undergoing ECT. Additionally, the study will assess the impact of music on pretreatment anxiety and post-treatment cognitive impairment.
This multicentre, open-label, parallel randomised controlled trial (RCT) aims to include 92 patients from two centres in Rotterdam, the Netherlands. Participants will be randomised into two groups: a music intervention group and a control group. The music group listens to recorded music 30 min before and 12 min after each of the first six ECT sessions of the full ECT course, while the control group will receive standard care. The primary outcome is the presence of PIA, measured using the Richmond Agitation-Sedation Scale (RASS). Secondary outcomes include the severity and duration of PIA, pretreatment anxiety, recovery duration, peri-treatment medication requirements, cognitive impairment and depression severity. Data will be analysed according to an intention-to-treat principle.
This study protocol has been approved by the Medical Ethical Review Committee of the Erasmus Medical Centre on 28 January 2025 (MEC-2024–0467) and subsequently received local approval at Antes Parnassia group. The trial will be carried out following the Declaration of Helsinki principles. Study results will be reported in a peer-reviewed journal according to the Consolidated Standards of Reporting Trials guidelines.
Pneumonia remains a leading cause of under-5 mortality in sub-Saharan Africa, accounting for approximately 14% of deaths in this age group. In Malawi, pneumonia accounts for 12% of under-5 deaths, with recent data revealing a concerning trend of over 110 000 new cases reported in 6 months. The Malawi government has made significant strides in reducing childhood mortality through the Integrated Community Case Management (iCCM) strategy, resulting in an 11% reduction in under-5 mortality over a 5-year period. However, the current iCCM strategy does not include the management of chest indrawing pneumonia in children aged 2–59 months and fast-breathing pneumonia in infants aged up to 2 months. This implementation research aims to increase pneumonia treatment coverage for under-5 year-old children in Kasungu District, Malawi, by expanding the community-based management of pneumonia by the iCCM-trained Health Surveillance Assistants (HSAs).
The current implementation research using both qualitative and quantitative data collection methods will assess the feasibility and acceptability of iCCM-trained HSAs managing chest indrawing pneumonia and fast-breathing pneumonia in children under 5 with oral amoxicillin at the community level in district Kasungu using the existing district health system. The study will employ a district health system model, leveraging existing trained iCCM HSAs to enrol and manage infants aged 7–59 days with fast-breathing pneumonia and 2–59-month-old children with chest indrawing pneumonia in the community with 7-day and 5-day oral amoxicillin, respectively. HSAs will also use pulse oximetry to identify hypoxaemic children for prompt referral to a hospital for further care. Sociodemographic features of enrolled children will be documented. Enrolled children will be followed up on treatment compliance using follow-up forms. The pneumonia treatment coverage will be assessed using baseline, midline and end-line surveys using both qualitative and quantitative data collection methods.
Ethical approval was obtained from the National Health Research Sciences Committee and the WHO Ethics Committee. The implementation research findings will be disseminated to national-level stakeholders and specifically targeted at District Health Offices, which are responsible for implementing the interventions.
First-degree relatives of colorectal cancer (CRC) patients have a twofold to fourfold increased risk of CRC. Tailored communication interventions have shown efficacy in improving their risk awareness and screening participation. While computer-based tailoring systems offer convenience, they often overlook the integration of healthcare professionals’ verbal input, potentially limiting effectiveness and long-term impact. To address this gap, we developed ScreenTalk, an intelligent voice-interactive tailored communication system that employs intelligent speech interaction to automate the tailoring process, enhance message credibility and improve scalability within CRC screening workflows.
This study is a two-arm, cluster-randomised controlled trial with a hybrid type I design involving 314 participants across three tertiary general hospitals in Guangzhou, China. Participants in both groups will receive usual care. Additionally, the intervention group will receive a 1-month tailored intelligent voice-interactive intervention, whereas the control group will receive unrelated health education to control for attention. Screening uptake (primary outcomes) and health beliefs (secondary outcomes) are measured at baseline and at 3 months, 6 months, 9 months and 12 month post the intervention. Implementation outcomes including reach, implementation, adoption and maintenance will be assessed through questionnaire, qualitative interviews and tailored system record.
The trial has been approved by the Ethics Committee of the Sun Yat-sen University (IRB No. L2024SYSU-HL-054). Information on the purpose and process of this study will be provided to the participants before recruitment, and written signatures will be collected from all participants to ensure their voluntary participation and protection of their rights and privacy.
NCT06710860 on ClinicalTrials.gov. Registered 26 November 2024. Date and version: 3.0, 14 July 2025.
Diabetes distress (DD) constitutes a negative emotional experience for patients with diabetic retinopathy (DR), having a detrimental impact on their physical and mental health.
The aim of this study was to understand the current status and influencing factors of DD in patients with DR and to explore the relationship between self-efficacy, coping styles and DD.
A cross-sectional study.
The study was conducted at the Eye Hospital of Wenzhou Medical University, Zhejiang Province, China.
Patients diagnosed with DR.
The Diabetes Distress Scale was used to assess DD.
DD was present in more than half (53.07%) of patients with DR. There were significant differences in DD among patients with DR who reported different employment statuses, modes of residence and body mass index. Coping styles partially mediated the relationship between self-efficacy and DD, with the mediating effect accounting for 71% of the total effect.
Considering the high prevalence of DD among patients with DR, healthcare professionals should pay more attention to the psychological needs of patients with DR. Effective interventions could be used to promote self-efficacy and coping styles of patients with DR, leading to lower levels of DD.