'Shared efforts, brighter smiles: a protocol for a randomised controlled study on the effectiveness of a parent-child orofacial myofunctional therapy programme post-adenoidectomy

Introduction
Adenoid hypertrophy has a high prevalence in children, often causing early orofacial muscle dysfunction that worsens facial deformities over time. While adenoidectomy (AT) alleviates airway obstruction, it only partially addresses the condition, leaving persistent neuromuscular habits. Orofacial myofunctional therapy is necessary for post-AT recovery but faces challenges such as poor adherence and ineffective parent-child communication. Dyadic interventions, which actively involve both parents and children, have shown advantages in improving treatment adherence and enhancing orofacial muscle function. Evidence suggests that dyadic intervention addresses both the child’s recovery needs and the caregiving capacity of parents, offering a more comprehensive solution for long-term intervention. Therefore, our team developed a parent-child dyadic orofacial myofunctional therapy (PCD-OMT) programme, offering insights into its potential application in paediatric healthcare to support comprehensive family-centred care.

Method and analysis
This two-arm, parallel-design, randomised controlled trial will recruit 80 dyads whose children performed AT from two hospitals in Qingdao, China. Dyads will be randomly allocated to two arms. Dyads randomly assigned to the intervention group will receive the PCD-OMT programme. Dyads randomly assigned to the control group will receive regular care. The primary outcomes are orofacial myofunction in children and parental care abilities. The secondary outcomes are children’s engagement and parental functioning. A feasibility and acceptability process will be employed to evaluate the viability in clinical practice. Outcomes will be collected at three checkpoints: baseline (T0), postintervention (T1) and after a 12-week follow-up phase (T2).

Ethics and dissemination
This study was approved by the Ethics Committee of Medical College of Qingdao University (QDU-HEC-2023216). The results will be published in peer-reviewed publications and presented in international conferences.

Trial registration number
ChiCTR2400091466.

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Maggio 2025

Cost-effectiveness of massed versus spaced trauma-focused treatment as first-line treatment for post-traumatic stress disorder in adults with multiple trauma exposure: protocol for a single-blind non-inferiority randomised controlled trial

Introduction
Post-traumatic stress disorder (PTSD) is a serious disorder that burdens individuals and society. The current standard of first-line treatment for PTSD is spaced trauma-focused treatment (S-TFT), involving weekly sessions. While effective, S-TFT may take relatively long to complete, especially in patients exposed to multiple potentially traumatic events (PTEs). Massed trauma-focused treatment (M-TFT), involving increased session frequency, potentially results in faster symptom reduction and restoration of quality of life, as well as in a reduction of societal costs. However, M-TFT is not recommended as first-line treatment. This paper describes the research protocol of a single-blind, multicentre randomised controlled trial (RCT) aimed at investigating: (1) the clinical and cost-effectiveness of M-TFT versus S-TFT in employed, multiply traumatised patients who seek first-line treatment for PTSD and (2) predictive and moderating factors related to treatment response.

Methods and analysis
186 participants are recruited from five centres and will be included if they are ≥18 years old, meet criteria for a Diagnostic and Statistical Manual of Mental Disorders Fifth Edition PTSD diagnosis based on ≥two PTEs, seek treatment for the first time and are employed. Patients with specified comorbid disorders and insufficient Dutch language proficiency are excluded. Participants are randomised to 800 min of either M-TFT or S-TFT. M-TFT consists of two once-weekly preparatory sessions, 10 twice-daily sessions of prolonged exposure, eye movement desensitisation and reprocessing therapy for 2 weeks and two once-weekly closing sessions. S-TFT consists of weekly sessions of one of five evidence-based treatment interventions. Outcomes are assessed at baseline and at 7 weeks, 17 weeks, 6 months and 9 months after baseline. Primary outcomes are clinical effectiveness in terms of PTSD symptom severity and cost-effectiveness based on quality of life measures and societal costs. Data will be analysed with linear mixed models.

Ethics and dissemination
This study protocol was approved by the Medical Ethics Review Board of the Amsterdam University Medical Center (NL86057.018.24). Participants will provide informed consent before enrolment in the trial. Results will be published in peer-reviewed journals and will be released to clinicians, patient groups and the general community.

Trial registration number
This protocol is registered at Overview of Medical Research in the Netherlands (OMON; trial register number 56960) and ClinicalTrials.gov (NCT06700590).

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Maggio 2025

Investigating biographical post-bariatric surgery uncertainties in the light of changes in bodily practices: a mixed-method, multicentric and longitudinal research protocol

Introduction
The effects of bariatric surgery have largely been studied from a medical viewpoint, seeking to measure changes in anthropometric, physiological or quality-of-life factors after the operation. Few studies, however, have focused on the dynamics of lifestyle changes. Yet we know that changing lifestyle habits—which are often part of the established social configurations at the origin of morbid obesity—is essential for a sustainable recovery from obesity. We also know that the major bodily transformations that occur in the six to twelve months following surgery produce a high degree of biographical uncertainty and affect social interactions. From a sociological perspective, the authors propose to study the processes of disruption and re-establishment of lifestyle habits in the first 24 months following bariatric surgery.

Methods and analysis
The ChiBarAPS study relies on a mixed-method longitudinal survey, comprising three components: qualitative, quantitative, literature and data review. It aims to document three main dimensions, which must be articulated to understand the dynamics of change: (1) the work undertaken by patients on themselves in order to identify and measure the evolutionary effects of surgery, as well as to adapt to them; (2) the experience of using pre- and post-surgery information and support systems, and evaluating their effects on the agency of the people who have undergone surgery; (3) the evolution of social participation and lifestyle habits. The qualitative component concerns a cohort of 30 patients, interviewed in depth (2 hours) on these three dimensions, 6 months, 12 months and 24 months after the operation. The quantitative part uses questionnaires applied to a second group of 200 patients, following the same timeline.

Ethics and dissemination
This study complies with reference methodology MR004 of the French National Data Protection Authority and was registered by the Data Protection Officer of the University of Montpellier on the activity registry of the institution (24 April 2024). Ethics approval has been obtained from the University of Montpellier ethics research board (n°UM2024-037). Informed consent will be obtained from all participants before data collection. The project has received funding from the French National Research Agency (n°ANR-23-CE41-0020-01) from February 2024 to the end of January 2028. The first results of the research will be disseminated from 2026 onwards to researchers, health professionals and patient support organisations. The results of the study will then be published in peer-reviewed scientific journals, both national and international.

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Maggio 2025

Neuromodulation through brain stimulation-assisted cognitive training in patients with post-chemotherapy subjective cognitive impairment (Neuromod-PCSCI) after breast cancer: study protocol for a double-blinded randomised controlled trial

Introduction
Breast cancer is the most common form of cancer in women. A considerable number of women with breast cancer who have been treated with chemotherapy subsequently develop neurological symptoms such as concentration and memory difficulties (also known as ‘chemobrain’). Currently, there are no validated therapeutic approaches available to treat these symptoms. Cognitive training holds the potential to counteract cognitive impairment. Combining cognitive training with concurrent transcranial direct current stimulation (tDCS) could enhance and maintain the effects of this training, potentially providing a new approach to treat post-chemotherapy subjective cognitive impairment (PCSCI). With this study, we aim to investigate the effects of multi-session tDCS over the left dorsolateral prefrontal cortex in combination with cognitive training on cognition and quality of life in women with PCSCI.

Methods and analysis
The Neuromod-PCSCI trial is a monocentric, randomised, double-blind, placebo-controlled study. Fifty-two women with PCSCI after breast cancer therapy will receive a 3-week tDCS-assisted cognitive training with anodal tDCS over the left dorsolateral prefrontal cortex (target intervention), compared with cognitive training plus sham tDCS (control intervention). Cognitive training will consist of a letter updating task. Primary outcome will be the performance in an untrained task (n-back task) after training. In addition, feasibility, safety and tolerability, as well as quality of life and performance in additional untrained tasks will be investigated. A follow-up visit will be performed 1 month after intervention to assess possible long-term effects. In an exploratory approach, structural and functional MRI will be acquired before the intervention and at post-intervention to identify possible neural predictors for successful intervention.

Ethics and dissemination
Ethical approval was granted by the ethics committee of the University Medicine Greifswald (BB236/20). Results will be available through publications in peer-reviewed journals and presentations at national and international conferences.

Trial registration number
ClinicalTrials.gov; NCT04817566, registered on 26 March 2021.

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Maggio 2025

Augmentation of trauma-focused psychotherapy for post-traumatic stress disorder: a protocol for a systematic review and meta-analysis

Introduction
Despite the established status of trauma-focused psychotherapy (TFP) as a first-line treatment for post-traumatic stress disorder (PTSD), a substantial proportion of individuals do not achieve clinically significant improvement or discontinue treatment. Exploring augmentation strategies to enhance treatment outcomes is essential to reduce the overall burden PTSD puts on individuals and society. This protocol outlines a systematic review and meta-analysis of randomised controlled trials (RCTs) evaluating the efficacy of non-pharmacological augmentation strategies in addition to TFP for PTSD treatment.

Methods and Analysis
We comprehensively searched PubMed, Embase, CENTRAL, PTSDpubs, PsycArticles, PsycINFO, PSYNDEX and CINAHL for RCTs without restrictions on publication dates or languages in October 2024. Study screening is currently ongoing. Additionally, we will perform forward and backward searches of the included studies and relevant reviews. Two reviewers will independently screen and select studies, extract data and assess the risk of bias. We will conduct a narrative review to qualitatively synthesise data and a meta-analysis to quantitatively compare the treatment efficacy of augmented TFP with TFP alone or TFP plus placebo. Primary outcomes will be both symptom severity and response rates. The secondary outcome will be dropout rates. We will explore sources of between-study heterogeneity and potential moderators through subgroup and meta-regression analyses. We will assess the overall quality of the included studies with the Grading of Recommendations Assessment, Development, and Evaluation system.

Ethics and dissemination
Ethical approval is not required. We intend to publish results in a peer-reviewed journal and provide materials and data through the Open Science Framework.

PROSPERO registration number
CRD42024549435.

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Maggio 2025

Exploring the causes of elevated kinesiophobia in post-coronary stenting patients: a qualitative analysis in a cardiac rehabilitation setting

Objectives
The primary aim of this study is to investigate the factors contributing to the development of kinesiophobia in patients following coronary artery stent implantation, integrating perspectives from both patients and healthcare professionals. The main hypothesis is that understanding and methods for effectively overcoming the fear of exercise and improving the effectiveness of cardiac rehabilitation require further exploration from both patient and professional viewpoints.

Design
This qualitative study used a semi-structured interview approach to gather data from participants.

Setting
The study was conducted at a hospital in Gansu province, China, focusing on the level of care provided to cardiac rehabilitation patients.

Participants
A total of 11 cardiac rehabilitation patients identified as having kinesiophobia (Tampa Scale for kinesiophobia Heart, TSK-SV Heart >37) through screening and nine healthcare professionals participated in the study. The selection criteria included patients undergoing cardiac rehabilitation and professionals involved in their care.

Results
The study identified a core theme, ‘Navigating Fear and Uncertainty’, encompassing five themes that elucidate how various factors contribute to the prevalent phenomenon of kinesiophobia among patients. These were further delineated into 11 subthemes: (1) physiological factors (fatigue, negative illness experiences), (2) psychological factors (hypervigilance, psychogenic anxiety and depression), (3) capacity factors (reduced physical abilities, lack of rehabilitation knowledge and skills), (4) motivational factors (low exercise self-efficacy, rehabilitation cognitive errors) and (5) support systems (primary caregivers, healthcare professionals and medical support). The results provide a qualitative understanding rather than quantitative measures, hence no CIs or statistical significance levels are provided.

Conclusions
The kinesiophobia observed in patients following coronary artery stent implantation stems from the combined influence of multiple factors, warranting early assessment and intervention by healthcare professionals. The study suggests that healthcare institutions should address the practical concerns faced by cardiac rehabilitation patients and enhance familial, medical and societal support systems to increase patient engagement and compliance with exercise rehabilitation. Further research is needed to develop and validate interventions based on these findings.

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Maggio 2025

Post-market quality assessment of antibiotics: findings from a cross-sectional study using standardised patients in Tabalong and Bekasi districts, Indonesia

Objectives
In Indonesia, antibiotics are often purchased without a prescription at community pharmacies, contrary to current regulations. This practice may increase the risk of out-of-specification (OOS) medicines being dispensed, potentially contributing to treatment failure and antibiotic resistance. To address this concern, we assessed the quality of antibiotics purchased without a prescription at private drug retail outlets (PDROs) in Indonesia.

Design and setting
We conducted a cross-sectional study in Tabalong and Bekasi, Indonesia, using standardised patients (SPs) who purchased antibiotics without a prescription for three clinical scenarios: upper respiratory tract infection (URTI), tuberculosis (TB) and child diarrhoea. The pharmacies and drug stores were randomly selected from each subdistrict based on the probability proportional method. We measured the active pharmaceutical ingredient (API) content of the antibiotic samples using high-performance liquid chromatography (HPLC).

Samples and analysis
The quality of 183 antibiotics including amoxicillin tablets (148/183, 80.9%, 95% CI 74.7% to 86.1%), amoxicillin dry syrup (12/183, 6.6%, 95% CI 3.6% to 10.8%), ampicillin tablets (5/183, 2.7%, 95% CI 1.1% to 5.9%) and ciprofloxacin tablets (18/183, 9.8%, 95% CI 6.2% to 14.8%) obtained from 117/166 (70.5%, 95% CI 62.8 to 77.2) PDROs were tested. Descriptive statistics were used to describe the characteristics of the purchased antibiotics, and the API content of each antibiotic was compared against the United States Pharmacopeia 43-National Formulary 38 (USP 43-NF 38) standards in absolute values and percentages.

Results
Almost all samples produced in Indonesia (182/183, 99.5%, 95% CI 97.5% to 99.9%) were unbranded (123/183, 67.2%, 95% CI 60.2% to 73.7%) or branded generic (60/183, 32.8%, 95% CI 26.3% to 39.8%) and packaged in strips (165/183, 90.2%, 95% CI 85.2% to 93.8%). Around 12/183 (6.6%, 95% CI 3.6% to 10.8%) antibiotics were found to be OOS; these were mostly amoxicillin 125 mg dry syrup (6/12, 50%, 95% CI 24.3% to 75.7%) and ciprofloxacin 500 mg tablet (5/18, 27.8%, 95% CI 11.5% to 50.6%). Around 33% (4/12, 95% CI 12.5% to 61.2%) of amoxicillin 125 mg dry syrup samples had an API content above the label claim, the highest being 187%, whereas 16.7% (2/12, 95% CI 3.6% to 43.6%) were below the label claim, the lowest being 64%. About 27.8% (5/18, 95% CI 11.5% to 50.6%) of ciprofloxacin samples tested had an API content above the label claim; the highest was 120%.

Conclusion
While the proportion of OOS antibiotics identified was relatively small, at a population level, it represents a significant proportion of sub-optimally treated infections.

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Maggio 2025

[Articles] Effectiveness of introducing pulse oximetry and clinical decision support algorithms for the management of sick children in primary care in Kenya and Senegal on referral and antibiotic prescription: the TIMCI quasi-experimental pre-post study

When implemented in routine health systems at primary care level in Kenya and Senegal, pulse oximetry and CDSAs were not found to be associated with an increase in urgent referrals but likely mediated antibiotic prescription reductions. The absence of referral increase may stem from limited severe illness detection due to low hypoxaemia prevalence and barriers to referral, also affected in Senegal by a protracted post-intervention HCP strike. Strengthening the referral system and implementing broader antibiotic stewardship strategies are likely to be needed to improve the effectiveness of the intervention and its impact on child health outcomes.

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Maggio 2025

Factors influencing medication adherence for deep vein thrombosis prevention in post-discharge patients after joint replacement surgery: a qualitative study based on Protection Motivation Theory

Objectives
This study aims to identify factors influencing medication adherence for deep vein thrombosis (DVT) prophylaxis in post-discharge patients after joint replacement surgery using Protection Motivation Theory (PMT).

Design
This study employed qualitative semi-structured interviews with patients discharged after hip or knee replacement surgery.

Setting
Using purposive sampling to ensure a diverse representation of patient profiles, participants were recruited from patients who underwent total knee replacement surgery from April 2024 to May 2024 and were discharged 1-month prior.

Participants
12 patients who had undergone total knee replacement surgery participated in the study. The median (IQR) age of participants was 57.5 (55–67.25) years.

Analysis
Semi-structured interviews were conducted via online video calls. These interviews were audio recorded and transcribed verbatim. Data were analysed using Colaizzi’s seven-step method. Themes were identified based on the dimensions of the PMT: susceptibility, severity, internal rewards, external rewards, response efficacy, self-efficacy and response costs. Two researchers independently coded and extracted themes, with discrepancies resolved through team discussions and verification with respondents.

Results
Participants acknowledged the importance of adhering to anticoagulant medication to prevent DVT and its complications, understanding the severe consequences, such as the life-threatening nature of pulmonary embolism and the impact on daily activities. Perceived health status influenced adherence, with some participants feeling their good health negated the need for anticoagulants. External factors, including the desire to avoid side effects and financial constraints, also played significant roles in adherence decisions. Belief in the effectiveness of anticoagulants motivated adherence, but confidence in managing medication varied among participants. Practical barriers such as physical limitations and psychological burdens significantly impacted adherence.

Conclusions
Improving medication adherence requires a multifaceted approach addressing cognitive, motivational and practical barriers. Continuous education, financial assistance, support systems and tailored interventions are crucial. PMT provides a robust framework for understanding and enhancing adherence behaviours, ultimately improving health outcomes in post-discharge joint replacement patients.

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Maggio 2025

[Articles] Learning-based early detection of post-hepatectomy liver failure using temporal perioperative data: a nationwide multicenter retrospective study in China

Our model achieved state-of-the-art performance in accuracy, generalizability, interpretability, and versatility for early detection of PHLF within the first 24 h after surgery. This approach holds promise for transforming perioperative management of hepatectomy and improving the rescue of life-threatening PHLF.

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Maggio 2025