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Relationship patterns in social networks of patients with depression in physical and online interactions: a sequential qualitative approach

Por: Mayer · G. · Selic · M. · Schultz · J.-H.
Objectives

First, to understand social needs in different mental disorders. Second, to determine patterns of social behaviour for either physical and online encounters in patients with depression.

Design

Sequential qualitative design: (1) exploratory qualitative interview study investigating social needs of mentally disordered patients, followed by (2) qualitative network analysis of patients and healthy controls, analysed using inductive coding and triangulation for data aggregation and network visualisation. Standards for Reporting Qualitative Research (SRQR) were followed.

Setting

(1) Professionals from inpatient and outpatient mental health services of psychosomatic medicine, psychotherapy and psychiatry. (2) Patients from outpatient services, healthy controls from various settings.

Participants

(1) Nine mental health professionals with seven physicians and two psychological psychotherapists took part in interviews. (2) Network interviews were conducted with 10 patients with a diagnosis of depression given within the past year and nine healthy controls with matching sociodemographic characteristics.

Results

Social relationships influence both the illness history and symptom profile of patients with depression. Patients reported less encounters compared with controls, although the frequency of their encounters was higher. Patients reported positive and trustful, yet more ambivalent relationships. Patients perceived less trust, but more influence on personal well-being by their encounters. Online contacts were described as more superficial by both groups.

Conclusions

Qualitative network analysis reveals patterns of social needs in physical and online encounters and their visualisation allows for direct group comparisons. Biopsychosocial research designs with a larger sample size are recommended. Targeted interventions have to regard the complexity of relationship patterns in physical and online interactions.

Effect of adjunctive intraoral balance appliance in the usual care of patients with chronic temporomandibular joint disorders using Korean medicine in South Korea: study protocol for a randomised controlled trial

Por: Shin · W.-C. · Kim · S. y. · Cho · W. · Park · J. · Kim · H. · Chung · W.-S. · Song · M.-y. · Cho · J.-H.
Introduction

Temporomandibular disorders (TMDs) are a group of conditions affecting the temporomandibular joint (TMJ), masticatory muscles and associated structures, often leading to pain, dysfunction and a significant impact on quality of life. Epidemiological studies have estimated that up to 75% of the population in the USA exhibits at least one sign of TMD. Although conservative treatments, such as acupuncture and occlusal splints, have been recommended, evidence for their effectiveness remains inconclusive, and the combined effects of these interventions are not well understood.

This study aims to evaluate the efficacy of an intraoral balance appliance (IBA) combined with standard Korean medicine care, compared to Korean medicine care alone, in patients with chronic, painful TMD with myalgia.

Methods and analysis

A single-centre, two-arm, parallel, practitioner-blinded and evaluator-blinded, randomised controlled trial with a 1:1 allocation ratio will be designed to test the interventions. 76 patients with TMD with myalgia will be recruited and randomised. The interventions will include manual acupuncture and physical therapy for both groups, with the addition of IBA in the treatment group for 3 weeks. The primary outcomes of the study will be the Numeric Rating Scale (NRS) for pain and discomfort at the final visit at week 4. Secondary outcomes will include overall functional assessment of the TMJ using several scales, as well as evaluations of quality of life, patient satisfaction and AEs.

The recruitment started on 18 July 2024, and 37 patients were included as of 8 July 2025.

Ethics and dissemination

Ethical approval is obtained from the Kyung Hee University Korean Medicine Hospital Institutional Review Board (IRB number: KOMCIRB 2023-06-001). The result from this study will be actively disseminated through manuscript publications and conference presentations.

Trial registration number

The protocol was registered with the Clinical Research Information Service (CRiS), Republic of Korea, on 30 October 2023, CRiS number KCT0008906 prior to the initiation of the study, and was revised on 7 July 2025 (https://cris.nih.go.kr/cris/search/detailSearch.do?seq=30270&search_page=M&search_lang=&class_yn=).

Predicting 14-day readmission in middle-aged and elderly patients with pneumonia using emergency department data: a multicentre retrospective cohort study with a survival machine learning approach

Por: Nhu · N. T. · Kang · J.-H. · Yeh · T.-S. · Chang · J.-H. · Tzeng · Y.-T. · Chan · T.-C. · Wu · C.-C. · Lam · C.
Objectives

Unplanned pneumonia readmissions increase patient morbidity, mortality and healthcare costs. Among pneumonia patients, the middle-aged and elderly (≥45 years old) have a significantly higher risk of readmission compared with the young. Given that the 14-day readmission rate is considered a healthcare quality indicator, this study is the first to develop survival machine learning (ML) models using emergency department (ED) data to predict 14-day readmission risk following pneumonia-related admissions.

Design

A retrospective multicentre cohort study.

Setting

This study used the Taipei Medical University Clinical Research Database, including data from patients at three affiliated hospitals.

Participants

11 989 hospital admissions for pneumonia among patients aged ≥45 years admitted from 2014 to 2021.

Primary and secondary outcome measures

The dataset was randomly split into training (80%), validation (10%) and independent test (10%) sets. Input features included demographics, comorbidities, clinical events, vital signs, laboratory results and medical interventions. Four survival ML models—CoxNet, Survival Tree, Gradient Boosting Survival Analysis and Random Survival Forest—were developed and compared on the validation set. The best performance model was tested on the independent test set.

Results

The RSF model outperformed the other models. Validation on an independent test set confirmed the model’s robustness (C-index=0.710; AUC=0.693). The most important predictive features included creatinine levels, age, haematocrit levels, Charlson Comorbidity Index scores, and haemoglobin levels, with their predictive value changing over time.

Conclusions

The RSF model effectively predicts 14-day readmission risk among pneumonia patients. The ED data-based model allows clinicians to estimate readmission risk before ward admission or discharge from the ED, enabling timely interventions. Accurately predicting short-term readmission risk might also further support physicians in designing the optimal healthcare programme and controlling individual medical status to prevent readmissions.

Multicentre pragmatic embedded stepped wedge cluster randomised trial comparing glucose 5% with sodium chloride 0.9% as the default drug diluent in the ICU: the sweet-water trial protocol

Por: Hardenberg · J.-H. B. · Hinz · R. M. · Pigorsch · M. · Uhrig · A. · Müller-Redetzky · H. · Nee · J. · Schroeder · T. · Witzenrath · M. · Trost · U. · Zickler · D. · Hunsicker · O. · Weiss · B. · Weber-Carstens · S. · Spies · C. · Tampe · B. · Borgstedt · R. · Abu-Tair · M. · Zarbock · A
Introduction

Hypernatraemia, defined as a plasma sodium concentration >145 mmol/L, is a frequent complication in critically ill patients treated in the intensive care unit (ICU) (= ICU-acquired hypernatraemia), with reported prevalence ranging from 4% to 26%. Hypernatraemia adversely affects various physiological functions and is associated with delirium, prolonged length of stay and increased ICU and post-discharge mortality. The sodium load from intravenous drug diluents significantly contributes to ICU-acquired hypernatraemia, with drug infusions comprising about 30% of the daily fluid volume of an average ICU patient. This study aims to investigate if using glucose 5% solution as the default drug diluent, instead of sodium chloride 0.9%, can reduce the prevalence of ICU-acquired hypernatraemia and improve patient outcomes.

Methods and analysis

To test the effectiveness of glucose 5% solution as the default drug diluent, we will conduct a multicentre, pragmatic, embedded, open-label, stepped-wedge, cluster-randomised trial. The study will include twelve clusters (ICUs and one intermediate care unit) across six hospitals in Germany, with a projected total sample size of 4485 patients. In line with the stepped-wedge cluster-randomised design, one ICU will transition every 4 weeks, in a randomised sequence, from using sodium chloride 0.9% as the default drug diluent to glucose 5%.

The primary endpoint is the prevalence of hypernatraemia >150 mmol/L through day 28. The number of days alive and free of the ICU through day 28 will be tested hierarchically as a key secondary endpoint. Other exploratory endpoints include ICU mortality, ICU-free days, hospital-free days and other clinical outcomes. The primary endpoint will be analysed using a logistic mixed-effects model.

Ethics and dissemination

The trial was approved by the Charité—Universitätsmedizin Berlin Ethics Board and by the ethics board of each enrolled hospital. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

Trial registration number

The trial protocol was registered with the German Clinical Trials Register on 21 June 2024 prior to initiation of patient enrolment (DRKS00033397).

Epidemiology and risk of psychiatric disorders in patients with polymyositis and dermatomyositis: a nationwide population-based cohort study in Taiwan

Por: Lee · I.-P. · Lee · Y.-T. · Wu · F.-Y. · Su · C.-F. · Kao · J.-H. · Lin · S.-H. · Chang · Y.-S.
Objectives

To evaluate the incidence and risk factors for psychiatric disorders, including depression and anxiety, and assess the risk of suicide in patients with polymyositis (PM) and dermatomyositis (DM).

Design

Retrospective cohort study.

Setting

Data were obtained from Taiwan’s National Health Insurance Research Database (NHIRD) between 2000 and 2018.

Participants

A total of 3477 patients with PM/DM and 13 908 age- and sex-matched non-PM/DM controls were included in the study.

Primary and secondary outcome measures

The primary outcome was the incidence and risk of psychiatric disorders in patients with PM/DM compared with controls. Secondary outcomes included the identification of risk factors for psychiatric disorders, mortality and suicide risk in the PM/DM cohort.

Results

The incidence rate ratio (IRR) of psychiatric disorders was significantly higher in the PM/DM cohort than in controls (IRR 1.62, 95% CI 1.39 to 1.89), with depression being the most prevalent disorder (IRR 2.25, 95% CI 1.83 to 2.75). Key risk factors included female sex, intravenous steroid therapy, and high-dose oral steroid use. Additionally, the PM/DM cohort exhibited a higher mortality rate (IRR 3.4, 95% CI 3.15 to 3.67) and elevated suicide risk (IRR 1.99, 95% CI 0.96 to 3.86) compared with controls.

Conclusion

Patients with PM/DM face a significantly higher risk of psychiatric disorders, mortality and suicide. Integrating mental healthcare into the routine management of PM/DM is crucial to improving patient outcomes and reducing mortality. Future research should focus on the impact of early psychiatric interventions on survival outcomes in this population.

Rationale and design of 'discontinuing statins in multimorbid older adults without cardiovascular disease (STREAM): study protocol of a randomised non-inferiority clinical trial

Por: Aebi · P. S. · Adam · L. · Haller · M. · Bardoczi · J. B. · Gencer · B. · Bonnet · F. · Beer · J.-H. · Carballo · S. · Christ-Crain · M. · Feller · M. · Gabutti · L. · Haynes · A. G. · Moutzouri · E. · Chocano-Bedoya · P. O. · Bassetti · S. · Escher · R. · Egger · M. · Poortvliet · R. K.
Introduction

Statins are among the most widely used drugs. While they are effective for primary and secondary prevention of cardiovascular (CV) disease in middle-aged subjects, their benefits for prevention in older adults (aged ≥70 years) without CV disease are uncertain, particularly for those with multimorbidity. Statin side effects and drug interactions are common in older patients and may negatively impact quality of life. To date, the only randomised controlled trial (RCT) investigating statin discontinuation in older adults has demonstrated no difference in survival but did note a small improvement in quality of life for those who discontinued statins. However, this trial exclusively enrolled patients with a life expectancy

Methods and analysis

This study is a multicentre, randomised, non-inferiority trial conducted in both inpatient and outpatient settings in Switzerland, France and the Netherlands, targeting patients using statins for primary prevention. 1800 participants are randomly assigned 1:1 to either discontinue (intervention arm) or continue (control arm) statin therapy. The primary objective is to compare the primary composite endpoint of major CV events (non-fatal myocardial infarction or non-fatal ischaemic stroke) and all-cause death between the control and intervention groups over a follow-up duration of up to 48 months. We hypothesise that discontinuing statins does not result in shorter event-free survival, with a non-inferiority margin set at 5.2 weeks over a 2-year observation period. Secondary objectives are to compare patient-centred outcomes (health-related quality of life, muscle pain symptoms, falls and sarcopenia) and all-cause death, non-CV death, major CV events and coronary and peripheral artery revascularisation. The study is open-labelled, with blinded outcome adjudication of the primary endpoints.

Ethics and dissemination

The trial protocol has received approval from the local ethics committees in Switzerland, France and the Netherlands. Results will be published in a peer-reviewed journal.

Trial registration number

Clinicaltrials.gov: NCT05178420; BASEC (Swiss Ethics Commission): 2021-01513; FOPH (Swiss national portal): SNCTP000005172; Netherlands Trial Register: NL83907.058.23; France Trial Register: 22.04747.000158– IDRCB 2022-A02481-42.

Enhancing dyadic outcomes of stroke survivors and caregivers: protocol for a randomised controlled trial

Por: Lin · Y.-N. · Hsu · S.-P. · Kang · J.-H. · Liou · T.-H. · Han · D.-S. · Ni · P. · Chiu · V. · Rodakowski · J. · Chang · F.-H.
Introduction

Stroke is a leading cause of death and disability worldwide. Stroke survivors and their caregivers often face profound social isolation and various participation restrictions, resulting in frustration and adverse health outcomes. Dyad-focused interventions, which address both survivor and caregiver needs, are essential during the transition process. However, few interventions equally prioritise the outcomes of both survivors and caregivers. This study aims to evaluate the efficacy of a newly developed dyad-focused strategy training intervention in enhancing participation among stroke survivors and their caregivers.

Methods and analysis

This study employs a single-blind, parallel-group randomised controlled trial with allocation concealment and assessor blinding. We aim to enrol 138 stroke survivor-caregiver dyads, randomly assigned in a 1:1 ratio to either the experimental intervention group or the control group. Both groups will receive their usual rehabilitation plus 45–60 min sessions of the intervention twice weekly for a total of 12 sessions. Outcome measures, including the Participation Measure-3 Domains, 4 Dimensions, General Self-Efficacy Scale and Activity Measure for Post-Acute Care, will be collected at baseline, post-intervention and at 3-month, 6-month and 12-month follow-ups. Data will be analysed using multiple linear regression and mixed-effects regression models. Qualitative indepth interviews with participants, caregivers and therapists will be conducted post intervention, transcribed and thematically analysed.

Ethics and dissemination

Ethics approval was obtained from the Ethics Committee of Taipei Medical University (approval number: N202203083), National Taiwan University Hospital (approval number: 202207096RINA) and Taipei Tzu Chi Hospital (approval number: 11 M-107). Findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals.

Trial registration number

NCT05571150; Preresults.

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