Using functional near-infrared spectroscopy to study effects of virtual reality intervention for adolescents with depression in a clinical setting in China: study protocol for a prospective, randomised, controlled trial

Introduction
Adolescent depression has been shown to be associated with many devastating psychosocial outcomes. However, there are many barriers that may prevent depressed individuals from receiving specialised treatment. Virtual reality (VR) technology has shown promise as one avenue for overcoming these challenges. This study first aims to evaluate the effectiveness of VR intervention on adolescent depression symptoms, and second, to determine the intervention’s underlying mechanism of effect using functional near-infrared spectroscopy (fNIRS).

Methods and analysis
This is a single-centre, prospective, randomised controlled clinical trial. Sixty-six eligible adolescents aged 12–18 years with a diagnosis of depression will be randomised in a 1:1 ratio to either the VR treatment group or the conventional treatment group. All patients for both groups will receive usual treatment during a 4-week intervention period. In addition, patients randomised to VR treatment group (n=33) will complete three 20 min VR sessions including attention, executive function and relaxation training per week. Moreover, 33 healthy adolescents will be recruited as the general population. Primary outcome (ie, depressive symptoms) and secondary outcomes (ie, anxiety symptoms, executive function, treatment emergent symptoms, haemoglobin changes measured by fNIRS) will be collected at preintervention, immediately postintervention and at 4 weeks follow-up. The data assessor and analyst will be blinded to group membership.

Ethics and dissemination
Ethical approval has been obtained from the Ethics Committee of Lishui Second People’s Hospital. Written informed consent will be obtained for all participants. Results will be disseminated through peer-reviewed journals, national or international conference presentations, media outlets, the internet and various community activities.

Trial registration number
ChiCTR2300067747.

Leggi
Dicembre 2023

Lisdexamphetamine versus methylphenidate for paediatric patients with attention-deficit hyperactivity disorder and type 1 diabetes (LAMAinDiab): protocol for a multicentre, randomised cross-over clinical trial in an outpatient telemedicine-supported setting

Introduction
Attention deficit hyperactivity disorder (ADHD) affects 5%–10% of paediatric population and is reportedly more common in children with type 1 diabetes (T1D), exacerbating its clinical course. Proper treatment of ADHD in such patients may thus provide neurological and metabolic benefits. To test this, we designed a non-commercial second phase clinical trial comparing the impact of different pharmacological interventions for ADHD in children with T1D.

Methods and analysis
This is a multicentre, randomised, open-label, cross-over clinical trial in children and adolescents with ADHD and T1D. The trial will be conducted in four reference paediatric diabetes centres in Poland. Over 36 months, eligible patients with both T1D and ADHD (aged 8–16.5 years, T1D duration >1 year) will be offered participation. Patients’ guardians will undergo online once-weekly training sessions behaviour management for 10 weeks. Afterward, children will be randomised to methylphenidate (long-release capsule, doses 18-36-54 mg) versus lisdexamphetamine (LDX, 30-50-70 mg). Pharmacotherapy will continue for 6 months before switching to alternative medication. Throughout the trial, the participants will be evaluated every 3 months by their diabetologist and online psychological assessments. The primary endpoint (ADHD symptom severity, Conners 3.0 questionnaire) will be assessed by a blinded investigator. Secondary endpoints will include HbA1c, continuous glucose monitoring indices and quality-of-life (PedsQL).

Ethics and dissemination
The trial is approved by Bioethical Committee at Medical University of Lodz and Polish regulatory agency (RNN/142/22/KE, UR/DBL/D/263/2022). The results will be communicated to the research and clinical community, and Polish agencies responsible for healthcare policy. Patient organisations focused on paediatric T1D will be notified by a consortium member. We hope to use the trial’s results to promote collaboration between mental health professionals and diabetes teams, evaluate the economic feasibility of using LDX in patients with both diseases and the long run improve ADHD treatment in children with T1D.

Trial registration numbers
EU Clinical Trials Register (EU-CTR, 2022-001906-24) and NCT05957055.

Leggi
Dicembre 2023

Cross-sectional study assessing health outcome priorities of older adults with multimorbidity at a primary care setting in Singapore

Objectives
Managing older adults with multimorbidity may be challenging due to the conflicting benefits and harms of multiple treatments. Thus, it is important to identify patients’ health outcome priorities to align treatment goals with their health preferences. This study aimed to use the Outcome Prioritisation Tool (OPT) to describe the health outcome priorities of older adults with multimorbidity and determine the factors associated with these priorities. Additionally, it aimed to assess the ease of completing the OPT in Singapore’s primary care population.

Design
Cross-sectional study conducted from January to March 2022.

Setting
A public primary care centre in Singapore.

Participants
65 years and older with multimorbidity.

Outcome measures
Primary outcome measure was the most important health outcome priorities on the OPT. Secondary outcome measures were factors affecting these priorities and ease of completing the OPT.

Results
We enrolled 180 participants (mean age: 73.2±6.1 years). Slightly more than half (54.4%) prioritised ‘staying alive’, while the remainder (45.6%) prioritised ‘maintaining independence’ (25.6%), ‘relieving pain’ (10.6%) and ‘relieving other symptoms’ (9.4%). Participants with six or more chronic conditions were three times (OR 3.03 (95% CI1.09 to 8.42)) more likely to prioritise ‘staying alive’ compared with participants with three conditions. Most participants (69.4%) agreed that the OPT was easy to complete, and the mean time taken to complete the OPT was 3.8±1.6 minutes.

Conclusion
‘Staying alive’ was the most important health outcome priority, especially for older adults with six or more chronic conditions. The OPT was easily completed among older adults with multimorbidity in primary care. Further qualitative studies can be conducted to understand the factors influencing patients’ priorities and explore the relevance of the OPT in guiding treatment decisions.

Leggi
Dicembre 2023

Factors associated with poor outcomes after congenital heart surgery in low-resource setting in Pakistan: insight from the IQIC Registry – a descriptive analysis

Objective
This study aimed to assess the International Quality Improvement Collaborative single-site data from a developing country to identify trends in outcomes and factors associated with poor outcomes.

Design
Retrospective descriptive study.

Setting
The National Institute of Cardiovascular Diseases, Karachi, Pakistan.

Participants
Patients undergoing surgery for congenital heart disease (CHD).

Outcome measure
Key factors were examined, including preoperative, procedural and demographic data, as well as surgical complications and outcomes. We identified risk factors for mortality, bacterial sepsis and 30-day mortality using multivariable logistic regression.

Results
A total of 3367 CHD surgical cases were evaluated; of these, 59.4% (2001) were male and 82.8% (2787) were between the ages of 1 and 17 years. Only 0.2% (n=6) were infants (≤30 days) and 2.3% (n=77) were adults (≥18 years). The in-hospital mortality rate was 6.7% (n=224), and 4.4% (n=147) and 0.8% (n=27) had bacterial sepsis and surgical site infections, respectively. The 30-day status was known for 90.8% (n=3058) of the patients, of whom 91.6% (n=2800) were alive. On multivariable analysis, the adjusted OR for in-hospital mortality was 0.40 (0.29–0.56) for teenagers compared with infancy/childhood and 1.95 (1.45–2.61) for patients with oxygen saturation

Leggi
Dicembre 2023

Healthcare professionals intention to adopt mobile phone-based SMS and its predictors for adherence support and care of TB patients in a resource-limited setting: a structural equation modelling analysis

Objective
To assess healthcare providers’ intentions and the associated factors to use mobile phone-based short message service (SMS) to support adherence and care of tuberculosis (TB) patients in the Oromia region of southwest Ethiopia.

Study design
An institutional-based cross-sectional study was conducted from October to November 2022.

Study setting
The study was conducted in public hospitals which include Mettu Karl referral hospital, Dembi Hospital, Bedelle Hospital, Darimu Hospital and Chora Hospital in Ilu Aba Bor and Buno Bedelle zones.

Participants
A total of 625 (54.9% male and 45.1% female) health professionals participated in the study. The study participants were selected using a simple random sampling technique. All health professionals permanently working in Ilu Aba Bor and Buno Bedelle zone hospitals were included in this study. However, health professionals with less than 6 months of experience and those who were not present during the data collection period were excluded from this study.

Outcome measure
The intention to use mobile phone-based SMS to support TB patients.

Results
Healthcare professionals’ intention to use mobile SMS was 54.4%. Effort expectancy had a significant direct effect on attitude (β=0.162, p

Leggi
Dicembre 2023

Predicting residual neoplasia after a non-curative gastric ESD: validation and modification of the eCura system in the Western setting: the W-eCura score

Objective
To evaluate the risk factors for lymph node metastasis (LNM) after a non-curative (NC) gastric endoscopic submucosal dissection (ESD) and to validate and eventually refine the eCura scoring system in the Western setting. Also, to assess the rate and risk factors for parietal residual disease.

Design
Retrospective multicentre multinational study of prospectively collected registries from 19 Western centres. Patients who had been submitted to surgery or had at least one follow-up endoscopy were included. The eCura system was applied to assess its accuracy in the Western setting, and a modified version was created according to the results (W-eCura score). The discriminative capacities of the eCura and W-eCura scores to predict LNM were assessed and compared.

Results
A total of 314 NC gastric ESDs were analysed (72% high-risk resection (HRR); 28% local-risk resection). Among HRR patients submitted to surgery, 25% had parietal disease and 15% had LNM in the surgical specimen. The risk of LNM was significantly different across the eCura groups (areas under the receiver operating characteristic curve (AUC-ROC) of 0.900 (95% CI 0.852 to 0.949)). The AUC-ROC of the W-eCura for LNM (0.916, 95% CI 0.870 to 0.961; p=0.012) was significantly higher compared with the original eCura. Positive vertical margin, lymphatic invasion and younger age were associated with a higher risk of parietal residual lesion in the surgical specimen.

Conclusion
The eCura scoring system may be applied in Western countries to stratify the risk of LNM after a gastric HRR. A new score is proposed that may further decrease the number of unnecessary surgeries.

Leggi
Dicembre 2023

Qualitative exploration of the constraints on mothers and pregnant womens ability to turn available services into nutrition benefits in a low-resource urban setting, South Africa

Objectives
Despite free primary healthcare services and social protection system for mothers and children, significant nutrition inequalities occur across the globe, including in South Africa. This study aimed to explore what determines mothers’ ability to access and turn available services into nutrition benefits.

Design
An exploratory qualitative study was conducted including semistructured interviews with employees from community-based organisations and focus groups with pregnant women and mothers. Discussions focused on existing services perceived as important to nutrition, differences in mothers’ ability to benefit from these services, and the underlying unmet needs contributing to these disparities. Data were analysed thematically using a novel social needs framework developed for this study where social needs are defined as the requisites that can magnify (if unmet) or reduce (if met) variation in the degree to which individuals can benefit from existing services.

Setting
A resource-constrained urban township, Soweto in Johannesburg.

Participants
Thirty mothers of infants (

Leggi
Novembre 2023