Category: Statistics

BMC Musculoskelet Disord. 2026 May 29. doi: 10.1186/s12891-026-09975-8. Online ahead of print.

ABSTRACT

BACKGROUND: We aimed to evaluate the positional changes in the deep femoral artery (DFA) during intramedullary nail surgery. We hypothesized that the femur and DFA may be closer due to the medial compression of the thigh on a traction table during the surgery.

METHODS: This within-subject comparative study included 20 patients with femoral trochanteric fracture (five males, 15 females; mean age: 83 ± 10.2) who underwent intramedullary nailing. Procedures were performed by five orthopedic surgeons. We performed computed tomography (CT) scans on the healthy thigh in the neutral and surgical limb positions. In the surgical limb position, we performed CT scans 2 weeks postoperatively in the lateral recumbent position with a simulated groin post-compression. Axial images 135 mm distal to the greater trochanter were reconstructed to evaluate the position of the DFA relative to the femur and the transverse locking screw axis. The distance from the medial femur edge to the DFA, medial soft tissue thickness, and the angle between the screw and the DFA were measured. Statistical analyses were performed to compare these parameters between the two positions.

RESULTS: The femur-DFA distance significantly decreased from 19.4 ± 3.5 mm in the neutral position to 12.5 ± 3.6 mm in the surgical position (P < 0.001). Medial soft tissue thickness also significantly reduced from 44.7 ± 15.0 mm to 31.0 ± 12.1 mm (P < 0.001). The two positions had no significant difference in the DFA angle (neutral: -23.1 ± 11.1°, surgical: -20.0 ± 10.6°; P = 0.17). The DFA was consistently positioned posterior to the screw insertion axis.

CONCLUSIONS: The surgical position during intramedullary nail insertion significantly reduces the femur-DFA distance and compresses soft tissues, which may increase the risk of DFA injury. Therefore, maintaining the hip joint in a neutral position during transverse locking screw insertion should be considered. Extra caution is warranted for taller patients and males owing to anatomical factors. Future studies should validate these findings and optimize surgical techniques.

PMID:42216179 | DOI:10.1186/s12891-026-09975-8

BMC Nurs. 2026 May 29. doi: 10.1186/s12912-026-04818-2. Online ahead of print.

ABSTRACT

BACKGROUND: Nurses play a crucial role in preventing deterioration-related morbidity and mortality among hospitalized patients. This study assessed nurses’ knowledge and reported practices of identifying early warning signs of critical illness among adult patients in general wards and contextual factors that influence these practices.

METHODS: An analytical cross-sectional study involving general ward nurses was conducted in three tertiary referral hospitals. A self-administered questionnaire was distributed to 235 randomly selected participants. Data was analyzed using Statistical Package for Social Sciences (SPSS) version 25. Descriptive statistics and inferential tests, including independent sample t-test and ANOVA, were used to examine associations between knowledge and demographic/workplace factors.

RESULTS: Knowledge of early warning signs was low (mean = 41.5%, SD = 10.41). Scores were significantly higher among bachelor’s-prepared nurses and those working at the national referral hospital (p = 0.007; p = 0.003, respectively). Nurses mainly identified deterioration using vital signs, monitoring, and response to deterioration practices varied, and resource availability was inconsistently perceived. Heavy workload, inadequate training, and resource constraints were common barriers despite generally positive self-ratings of ward practices. Job satisfaction was the only significant independent predictor of knowledge (B = 2.847, p = 0.006). Other variables were not significant. The model explained 6.4% of the variance (R² = 0.064, F(5, 229) = 3.114, p = 0.010).

CONCLUSIONS: Despite nurses’ positive reported practices in identifying patient deterioration, nurses’ overall knowledge of early warning signs of critical illness was low. Staff training, protocol standardization, and resource enhancement are essential to enhance nurses’ ability to recognize and respond effectively to early signs of deterioration and critical illness. Given the limited awareness and utilization of structured early warning systems identified in this study, there is a need for training, contextual adaptation, and phased implementation of standardized tools such as National Early Warning Score (NEWS).

CLINICAL TRIAL NUMBER: Not applicable.

PMID:42216174 | DOI:10.1186/s12912-026-04818-2

BMC Cancer. 2026 May 29. doi: 10.1186/s12885-026-16068-1. Online ahead of print.

ABSTRACT

BACKGROUND: Nanomaterials (NMs) with tunable physicochemical and redox properties offer powerful tools for probing cellular regulatory pathways. Accumulating evidence suggests that nanoparticles (NPs) exposure can engage autophagy, a conserved lysosome‑dependent stress‑adaptation process. In this context, iron oxide-gold core-shell nanoparticles (Fe₂O₃/Au NPs) provide a rational platform to investigate nanoparticle‑mediated modulation of autophagy‑related gene (ATG) expression in cancer cells.

METHODS: MCF-7 breast cancer cells and human umbilical vein endothelial cells (HUVECs) were cultured under standard conditions and treated with Fe₂O₃/Au core-shell NPs (20 µg/mL). Nanoparticle uptake was quantified by inductively coupled plasma mass spectrometry (ICP-MS). Gene expression of Beclin1 (BECN1), autophagy-related gene 5 (ATG5), autophagy-related protein light chain 3 (LC3-II), Sequestosome 1 (SQSTM1 or p62), and NBR1 was measured using quantitative polymerase chain reaction (RT-qPCR), normalized to Glyceraldehyde-3-phosphate dehydrogenase (GAPDH), and analyzed via the 2^-ΔΔCt method. Statistical analyses were conducted with GraphPad Prism 6, with significance set at p < 0.05. Bioinformatics validation was performed using Gene Expression Omnibus (GEO) dataset GSE116436, focusing on five ATGs.

RESULTS: ICP-MS confirmed efficient nanoparticle internalization, with higher uptake in MCF-7 cells than in HUVECs. In MCF-7 cells, Fe₂O₃/Au NPs significantly upregulated BECN1, ATG5, and LC3-II, while p62 and NBR1 were downregulated (p < 0.05), indicating considerable autophagy activation and enhanced without direct flux validation. In contrast, HUVECs showed only mild, non-significant changes, consistent with partial or protective autophagy (p > 0.05). Bioinformatic analysis of the GEO dataset GSE116436 confirmed significant dysregulation of five core ATGs (BECN1, ATG5, SQSTM1/p62, NBR1, and MAP1LC3B) in chemotherapy‑resistant MCF‑7 cells, with BECN1 and ATG5 showing the strongest statistical significance. Gene ontology/ Kyoto Encyclopedia of Genes and Genomes (GO/KEGG) enrichment indicated involvement of autophagy, mechanistic target of rapamycin (mTOR), p53, and stress‑response pathways. Kaplan-Meier (KM) survival analysis in the Cancer Genome Atlas-breast cancer (TCGA‑BRCA) cohort revealed gene‑specific, heterogeneous prognostic associations higher BECN1 and NBR1 linked to improved survival, while elevated ATG5 and SQSTM1 correlated with poorer outcomes. STRING‑based protein-protein interaction (PPI) analysis highlighted enrichment of growth factor signaling, extracellular matrix (ECM) organization, and focal adhesion networks, supporting functional coordination among dysregulated genes and associated stromal‑adaptive signaling modules.

CONCLUSION: Fe₂O₃/Au core-shell NPs selectively altered the transcription of key ATGs in MCF‑7 breast cancer cells, with minimal effects in non‑malignant HUVECs. Bioinformatic analyses in chemotherapy‑resistant MCF‑7 models confirmed persistent dysregulation of the same ATGs and enrichment of stress‑adaptive pathways. Collectively, these findings indicate a cancer‑selective, autophagy‑associated transcriptional response and support a hypothesis‑generating link to adaptive features of resistant breast cancer cells.

PMID:42216165 | DOI:10.1186/s12885-026-16068-1

BMC Infect Dis. 2026 May 29. doi: 10.1186/s12879-026-13595-x. Online ahead of print.

ABSTRACT

OBJECTIVE: Complicated urinary tract infections (c-UTI) are expensive and frequently require hospitalization. This study estimated the impact of patient comorbidities, readmissions and treatment delay on the costs of complicated urinary tract infections in both inpatient and outpatient settings. A related aim is to provide the first estimates of the potential savings of treating patients currently treated as inpatients that have clinical characteristics similar to, though less complicated, to patients treated as outpatients.

DESIGN: Using one of the largest national claims data sets (30 million lives per year) on privately insured adults and dependents between 2019 and 2022, with regression models we estimate the treatment costs of complicated urinary tract infection (c-UTI) patients identified and treated in the hospital, identified and treated in an outpatient setting and identified in an outpatient setting but subsequently admitted. We statistically estimate potential savings associated with treating inpatient cases in the outpatient setting.

SETTING: Our study was a retrospective analysis of claims data among privately insured adults and dependents with claims from February 1, 2019, to May 31,2022. Our analysis relies on the Merative- MarketScan Commercial Claims and Encounter database which is among the largest commercially insured set of claims data covering adults and dependents in the U.S. that included de-identified person-level claims data including inpatient, outpatient, and prescription drugs use and spending. It also included health plan spending, patient demographics, diagnosis, procedure and national drug codes covering more than 30 million active employees, early retirees, COBRA extenders, and dependents with data contributed by more than 160 employers and 40 health plans nationally each year.

PARTICIPANTS: Data were obtained for 93,228 c-UTI patients treated in both inpatient and outpatient settings in the United States.

RESULTS: Treatment costs are highly positively skewed with a mean cost per episode of those identified in hospital of $42,000 and median cost of $27,784. High costs were in part linked to long lengths of stay for roughly 10% of patients of 15 days or longer. At the other extreme we found that many low-acuity patients were hospitalized. Switching antibiotics also increased treatment costs. The results show that 27% of c-UTI patients admitted to the hospital were low-acuity patients that potentially could be treated in an outpatient setting for over $31,000 per case less.

CONCLUSIONS: The results highlight several areas of opportunity to reduce dramatically the costs of treating c-UTI including treating currently hospitalized low-acuity patients without complications in an outpatient setting, reducing readmissions, and length of stay.

PMID:42216163 | DOI:10.1186/s12879-026-13595-x

BMC Oral Health. 2026 May 30. doi: 10.1186/s12903-026-08723-7. Online ahead of print.

ABSTRACT

BACKGROUND: Bisphosphonates are widely prescribed for osteoporosis, Paget’s disease, and malignancy-related bone disease. While effective in reducing skeletal complications, they are associated with medication-related osteonecrosis of the jaw (MRONJ), a serious but preventable condition. Medical practitioners play a central role in initiating therapy, educating patients, and coordinating referrals, yet data on awareness and practices in Malaysia remain limited.

OBJECTIVE: This study assessed the awareness, prescribing practices, and perceived roles of medical practitioners at a university hospital concerning oral health risks associated with bisphosphonate therapy.

METHODS: A cross-sectional survey was conducted among 130 medical practitioners at a university hospital using a validated questionnaire. Participants included medical officers, Clinical Master’s trainees, and specialists in medicine, orthopaedics, and primary care. The questionnaire assessed demographics, awareness of oral complications, prescribing patterns, referral behaviours, and perceived roles. Data were analysed using descriptive statistics and chi-square tests.

RESULTS: Most respondents (96.2%) were aware that bisphosphonates may cause oral complications, and 94.6% identified MRONJ. However, only 58.5% reported awareness of clinical guidelines, and 23.8% felt adequately informed to manage affected patients. Oral bisphosphonates were the most frequently prescribed (77.7%), primarily for osteoporosis (95.4%), while intravenous forms were less common; at osteoporosis dosing, the risk of MRONJ with intravenous zoledronate remains very low compared to oncology regimens. Alternative therapies were considered by 67.7% of practitioners, most often denosumab and teriparatide. Preventive practices were inconsistent: 73.8% educated patients about MRONJ, 49.2% advised pretreatment dental evaluation, and 52.3% referred patients for dental screening. Awareness was significantly associated with prescribing frequency, while referral behaviours varied by department, position, and age.

CONCLUSION: Medical practitioners demonstrated high recognition awareness of MRONJ but notable gaps in guideline literacy, preventive practices, and interprofessional collaboration. These findings highlight the need for structured education, clearer referral protocols, and stronger integration between medical and dental teams to ensure early prevention and optimal patient care.

PMID:42216162 | DOI:10.1186/s12903-026-08723-7

BMC Endocr Disord. 2026 May 29. doi: 10.1186/s12902-026-02329-4. Online ahead of print.

ABSTRACT

BACKGROUND: Diabetic ketoacidosis (DKA) is one of the most serious acute complications of diabetes mellitus in children, often leading to severe dehydration, altered consciousness, and death if not promptly managed. The burden of DKA is increasing globally and in Ethiopia, placing substantial strain on pediatric emergency and inpatient care services. Despite its clinical and public health importance, evidence on time to resolution of DKA and its predictors remains limited in Ethiopia, particularly in the northeastern region. This study aimed to assess the time to resolution of DKA and its predictors in children with type 1 diabetes.

METHODS: A retrospective follow-up study was conducted using 494 medical records of children with type 1 diabetes mellitus treated at Dessie Comprehensive Specialized Hospital between January 1, 2020, and December 31, 2024. Patient charts were selected using a simple random sampling technique. Data were extracted through a structured checklist based on registry and medical chart reviews. Kaplan-Meier survival analysis was employed to estimate time to resolution from DKA, and differences in survival distributions across categories of explanatory variables were assessed using the log-rank test. Cox proportional hazards regression was applied to identify predictors of time to resolution of DKA. Variables with a p-value < 0.25 in the bivariable analysis were included in the multivariable Cox regression model, adjusted hazard ratio (AHR) with its 95% confidence interval and p-value ≤ 0.05 in the multivariable analysis were considered statistically significant.

RESULTS: A total of 487 children were followed for 12,279 person-hours of observation. Of these, 406 children recovered, yielding a resolution proportion of 83.37% (95% CI: 80.06-86.67), while 81 (16.63%) were censored during the follow-up period. The overall incidence rate of resolution from DKA was 3.30 per 100 person-hours (95% CI: 2.99-3.64), with a median time to resolution of 22 h (95% CI: 18.32-25.67). In the multivariable Cox regression analysis, baseline random blood sugar (RBS) levels > 500 mg/dL (AHR = 0.77; 95% CI: 0.62-0.96), presence of infection (AHR = 0.65; 95% CI: 0.47-0.90), newly diagnosed diabetes mellitus (AHR = 0.79; 95% CI: 0.63-0.99 and DKA duration ≥ 24 h (AHR = 0.08; inverse of < 24 h) were associated with a longer time to resolution of DKA. Conversely, mild DKA (AHR = 1.37; 95% CI: 1.01-1.84) and DKA duration < 24 h (AHR = 11.96; 95% CI: 7.71-18.55) were significantly associated with a shorter time to resolution of DKA.

CONCLUSION AND RECOMMENDATIONS: The study identified a relatively prolonged resolution time of DKA among children in the study area. Baseline random blood sugar level > 500 mg/dL, presence of infection and newly diagnosed diabetes had negative relationship (delayed resolution) while mild DKA severity, and duration of DKA < 24 h had positive relationship (faster resolution). These findings highlight the need for healthcare providers and caregivers to address these factors to accelerate resolution and improve clinical outcomes.

TRIAL REGISTRATION: Clinical trial number: Not applicable.

PMID:42216154 | DOI:10.1186/s12902-026-02329-4

BMC Anesthesiol. 2026 May 30. doi: 10.1186/s12871-026-03954-1. Online ahead of print.

ABSTRACT

BACKGROUND: Inadequate postoperative pain management predisposes patients to delayed recovery, impairs mother-infant interaction, prolongs hospital stay, and increases the risk of chronic pain development. In resource-limited settings, postoperative pain management remains challenging because of inadequate administration of analgesics and a high patient-to-nurse ratio, which limits adequate pain assessment and timely management.

OBJECTIVE: To assess the incidence and predictors of moderate to severe postoperative pain after cesarean delivery among parturients receiving spinal anesthesia at two Southern Governmental teaching Hospitals between March1 and May 30, 2023.

METHODS: A multicenter prospective cohort study involving 205 parturients was conducted after ethical approval was obtained from the institutional review board. Participants were selected using a systematic sampling technique. Postoperative pain severity was assessed using the Numeric Rating Scale within the first 24 h after surgery. Binary logistic regression was used to identify independent risk factors for postoperative pain. A p value of 0.05 was considered the cutoff point to test for statistical significance in multivariate logistic regression analysis.

RESULTS: In our study, the incidence of moderate to severe postoperative pain after cesarean delivery was 71.2% within the first 24 h. On the basis of the multivariable analysis, preoperative anxiety (AOR: 2.849, 95% CI: 1.276, 6.359), previous cesarean delivery (AOR: 3.571, 95% CI: 1.536, 8.300) and transverse incision (AOR: 6.965, 95% CI: 2.469, 19.652) were significantly associated with moderate to severe postoperative pain after cesarean delivery. Abdominal field blocks were associated with a reduced likelihood of postoperative pain (AOR = 0.035, 95% CI: 0.009-0.139).

CONCLUSION: A high proportion of parturients experienced moderate to severe postoperative pain after cesarean delivery. Preoperative anxiety, previous cesarean delivery, and transverse incision were significant predictors of postoperative pain, whereas abdominal field blocks had a protective effect. Routine postoperative pain assessment and the implementation of multimodal analgesic strategies, including regional analgesic techniques, are recommended to improve post-cesarean pain management.

PMID:42216146 | DOI:10.1186/s12871-026-03954-1

BMC Nephrol. 2026 May 29. doi: 10.1186/s12882-026-05092-9. Online ahead of print.

ABSTRACT

BACKGROUND: Whether IgA nephropathy (IgAN) in patients with systemic lupus erythematosus (SLE) represents a coincidental comorbidity or a distinct clinico-pathological entity remains unclear. This study aimed to characterise the demographic, clinical, pathological, and prognostic features of this rare association.

METHODS: We conducted a systematic review of the PubMed and Embase databases to 31 May 2025 were conducted to identify all reported cases of biopsy-proven IgAN in patients with SLE, excluding cases with concomitant thrombotic microangiopathy, negative Gd-IgA1 immunostaining, prior IgA vasculitis, or ANA-negative disease. Study quality was assessed using the JBI checklist. Individual patient data were pooled; descriptive statistics summarized clinical features, and group comparisons were performed using Mann-Whitney U and Fisher’s exact tests. Individual patient data were extracted and analyzed as a single cohort. Renal outcomes were defined as either a ≥ 40% decline in estimated glomerular filtration rate (eGFR) from baseline or progression to end-stage renal disease.

RESULTS: Thirty-one patients (25.8% male; mean age 40.8 ± 15.8 years; 67.7% Asian) were included. Median proteinuria was 1.10 g/24 h, and 12.9% presented with nephrotic syndrome. Microscopic haematuria was observed in 93.5% of patients. Mean eGFR at biopsy was 84.0 ± 53.4 mL/min/1.73 m², with 12.9% exhibiting acute kidney injury (AKI). All patients were antinuclear antibody-positive, 64.5% were anti-dsDNA-positive, and 55.2% had hypocomplementaemia. Renal biopsy revealed dominant mesangial IgA and complement C3 deposition, with electron-dense deposits confined to the mesangium in all but one case. Immunosuppression (glucocorticoids 87.1%; cyclophosphamide 22.6%) yielded complete remission in 54.8% of patients. Over a median follow-up of 16.5 months, 27.8% of patients reached the renal endpoint, including three of four patients with AKI.

CONCLUSIONS: Limited by retrospective case report methodology, this largest cohort to date suggests IgAN complicating SLE manifests a distinctive phenotype that bridges features of primary IgAN and lupus nephritis. Although immunosuppression is effective, long-term renal risk remains non-negligible. Early recognition and targeted therapy may improve outcomes.

CLINICAL TRIAL NUMBER: Not applicable.

PMID:42216130 | DOI:10.1186/s12882-026-05092-9

BMC Nephrol. 2026 May 29. doi: 10.1186/s12882-026-05040-7. Online ahead of print.

ABSTRACT

BACKGROUND: Cardiorenal metabolic (CRM) disease, is identified by the co-location of multiple disorders including obesity, diabetes, hypertension, cardiovascular disease and chronic kidney disease (CKD). Early intervention is essential to slow CKD progression, reduce cardiovascular risk, and improve quality of life. The Harrow CRM Hub project established a personalised, multidisciplinary pathway to identify high-risk patients, optimise clinical management, and provide access to lifestyle and psychosocial support. This paper reports on the clinical outcomes achieved within the first year of implementation.

METHODS: A comprehensive logic model was co-developed to guide the design, delivery, and evaluation of the Harrow CRM programme. Two EHR-identified cohorts were invited: (1) adults aged 20-80 years with BMI >27.5-30 kg/m² (ethnicity-dependent) and non-diabetic hyperglycaemia ± hypertension (CRM Stage 2); and (2) adults with diabetes ± CKD or CVD (CRM Stage 4). Pre visit health questionnaire – using digital tools enabled detailed pre visit updates and tests. Protected consultations (lasting 30 to 45 minutes) followed a structured EHR template incorporating guideline-based optimisation of pharmacotherapy, risk calculators, and co-created lifestyle care plans. Data were extracted for paired analysis of systolic BP, HbA1c, and weight. A qualitative evaluation was undertaken to explore patient and staff experiences of the CRM pathway.

RESULTS: Thus far, between November 2024 and September 2025, 2,641 patients were reviewed, with 2,300 included in paired analysis. Across the full cohort, mean changes were -3.65 mmHg in systolic BP (median -2.0 mmHg), -1.03 mmol/mol in HbA1c (median 0.0 mmol/mol), and -0.46 kg in weight (median 0.0 kg) (all p<0.001). For those with an improvement only – an average improvement of -14.12 mmHg (n=1,279) and an average deterioration of +10.61 mmHg among those whose readings worsened (n=895). HbA1c values showed a mean cohort wide reduction of -1.03 mmol/mol (median 0.0 mmol/mol), with mean changes of -8.08 mmol/mol among improvers (n=785) and +5.22 mmol/mol among those with deterioration (n=762). Weight trends showed a mean overall reduction of -0.46 kg (median 0.0 kg), comprising an average improvement of -3.63 kg among improvers (n=1,124) and deterioration of +3.93 kg among those with deterioration (n=761). Among those with paired readings, 33.4% achieved ≥5% BP reduction and 19.7% achieved ≥10%; 19.8% achieved ≥5% HbA1c improvement and 12.7% ≥10%; and 9.6% achieved ≥5% weight loss and 2.7% ≥10%. Overall, 73.9% improved in ≥1 parameter, while 10.4% improved across BP, HbA1c, and weight simultaneously. This real world review identified patients with improvements and deterioration in their health parameters. Qualitative findings showed patients valued extended consultations and holistic discussions, with vast majority of patients reporting greater understanding of their health and feeling more confident to manage it. A staff survey (n=14) provided supportive but preliminary quantitative evidence of having greater confidence in delivering CRM clinics and increased ability to access multidisciplinary expertise.

CONCLUSION: A personalised, multidisciplinary CRM model embedded within primary care was associated with statistically and clinically significant improvements in blood pressure, glycaemic control, and weight in a large, ethnically diverse population. Patients and clinicians both reported greater engagement, confidence, and satisfaction. The approach combining structured identification, extended consultations, co-produced care plans, and workforce education demonstrates a scalable, sustainable pathway to slow CKD progression, reduce CVD risk, and enhance patient wellbeing across diverse communities.

PMID:42216129 | DOI:10.1186/s12882-026-05040-7

BMC Psychiatry. 2026 May 29. doi: 10.1186/s12888-026-08241-4. Online ahead of print.

ABSTRACT

BACKGROUND: Syrian refugees across diverse host countries, including high-income European countries, face increased mental health needs. Digital interventions can scale support, but global scalability limits human guidance and contextual adaptations. We evaluated the effectiveness of a potentially scalable digital intervention (Step-by-Step; SbS) with minimal contact-on-demand (COD) in reducing psychological distress and functional impairment among Syrian refugees in Germany and Sweden. These trials were conducted in parallel with SbS studies in Egypt and Lebanon, using the same content to test broader contextual applicability without further adaptations.

METHODS: Separate two-arm pragmatic RCTs were conducted in Germany (N = 559) and Sweden (N = 184) with Syrians screening positive for elevated distress (K10 > 15) and impaired functioning (WHODAS 2.0 > 16). Participants were randomized to SbS (five sessions) + care-as-usual (CAU) or CAU-only. Primary outcomes were psychological distress (HSCL-25) and functioning (WHODAS 2.0) at 3-month follow-up. Secondary outcomes were PTSD symptoms (PCL-5 short) and self-defined problems (PSYCHLOPS). Intention-to-treat (ITT) analyses were run separately by trial. Exploratory per-protocol analyses combined datasets.

RESULTS: ITT analyses showed no statistically significant time × condition effects for any primary or secondary outcome in both trials. Dropout was high (Germany: 86.3%; Sweden: 82.1%). In per-protocol analyses (participants completing ≥ 4 of 5 sessions), the SbS + CAU arm showed significantly lower standardized mean scores at 3 months for psychological distress (HSCL-25; Hedges’ g = 0.31; p = .03) and PTSD symptoms (PCL-5 short; Hedges’ g = 0.27; p < .05). COD use was low (Germany: 15.1%; Sweden: 8.4%), leaving the intervention effectively unguided for most participants.

CONCLUSIONS: While limiting guidance and contextual tailoring can enhance scalability across borders, digital interventions may struggle with engagement, adherence, and contextual relevance. In high-income settings, an unguided approach for refugees may not work, showing that prioritizing scalability could potentially compromise clinical impact in this population. Some level of human guidance may be necessary to balance scalability and effectiveness, and it remains unclear how minimal that guidance can be without compromising outcomes.

TRIAL REGISTRATION: German Register for Clinical Studies (Germany: DRKS00022143-registered June 29th, 2020, and Sweden: DRKS00022144-registered July 1st, 2020).

PMID:42216127 | DOI:10.1186/s12888-026-08241-4