Category: Statistics

Ann Ital Chir. 2024;95(4):534-541. doi: 10.62713/aic.3416.

ABSTRACT

AIM: Esophageal cancer is a disease with high morbidity and mortality, exploring effective treatment methods is the key to the treatment of this disease. This study aims to compare the clinical efficacy and safety of multi-band mucosectomy (MBM) and endoscopic submucosal dissection (ESD) in the treatment of single early esophageal cancer (EEC) and precancerous lesions, and whether MBM can achieve better clinical effect as an effective treatment method.

METHODS: The clinical data of 70 patients with EEC and precancerous lesions who were treated with MBM and ESD in the Fourth Affiliated Hospital of China Medical University from May 2021 to May 2023 and could be followed up were retrospectively analyzed. They were divided into two groups according to different treatment methods: MBM group (31 cases) and ESD group (39 cases). The general data, perioperative conditions, endoscopic treatment effect and pathological results of the two groups were compared.

RESULTS: The duration of endoscopic treatment in MBM group was shorter than that in ESD group [36 (25~39) min vs 46 (41~57) min, p < 0.05], and there was no significant difference in the intraoperative bleeding rate between the two groups (12.90% vs 7.69%, p > 0.05). There was no significant difference in the rate of intraoperative perforation between the two groups (3.23% vs 7.69%, p > 0.05), and the hospitalization time in MBM group was shorter than that in ESD group [5 (4~7) days vs 8 (7~12) days, p < 0.05]. The hospitalization cost was less [2535 (2423~2786) dollars vs 4485 (3858~5794) dollars, p < 0.05]. No postoperative bleeding occurred in both groups. There was no statistically significant difference in postoperative stenosis rate between MBM group and ESD group (3.23% vs 12.82%, p > 0.05), and no statistically significant difference in postoperative local recurrence rate (12.90% vs 5.13%, p > 0.05). There was no significant difference in the rate of additional surgery (9.68% vs 2.56%, p > 0.05). The en bloc resection rate of MBM group was lower than that of ESD group (77.42% vs 97.44%, p < 0.05), but there was no significant difference in the complete resection rate between the two groups (87.10% vs 97.44%, p > 0.05). The postoperative pathological results of MBM group showed 13 cases of low-grade intraepithelial neoplasia (LGIN), 11 cases of high-grade intraepithelial neoplasia (HGIN), and 7 cases of canceration, while the postoperative pathological results of ESD group showed 10 cases of LGIN, 14 cases of HGIN, and 15 cases of canceration, with no statistical significance (p > 0.05).

CONCLUSIONS: MBM and ESD are effective methods for the treatment of EEC and precancerous lesions. MBM has the advantages of short hospital stay, quick recovery and low cost. However, compared with MBM, ESD can improve the complete resection rate of the lesion, avoid the occurrence of positive incisal margin, and reduce the risk of secondary treatment and additional surgery.

PMID:39186346 | DOI:10.62713/aic.3416

Ann Ital Chir. 2024;95(4):699-707. doi: 10.62713/aic.3459.

ABSTRACT

AIM: Patients with permanent colostomy need continuous nursing management measures. Therefore, this study aimed to investigate the impact of discharge planning combined with “Internet home ostomy care platform” on post-discharge complications, self-management abilities, quality of life, and satisfaction of patients with permanent colostomy after rectal cancer surgery.

METHODS: This retrospective analysis included 72 rectal cancer patients who underwent permanent colostomy in Zhejiang Provincial People’s Hospital between January 2021 and December 2021. Patients receiving routine nursing management were included in the control group (n = 36), and those receiving discharge planning combined with “Internet home ostomy care platform” were included in the study group (n = 36). We collected baseline data, complication rate, self-management behavior questionnaire for Chinese enterostomy patients (SBQ-CEP), and Chinese version of the City of Hope Quality of Life-Ostomy Questionnaire (COH-QOL-OQ) and Medical Experience Scale for Outpatient Care of Enterostomy (MES-OCE) score. The complication rate, self-management ability, quality of life, and satisfaction of the two groups were statistically compared and analyzed.

RESULTS: The study group demonstrated significantly higher medical compliance behavior, dietary behavior, symptom management behavior, psychosocial behavior, information management behavior scores, and SBQ-CEP total scores compared to the control group six months after discharge (p < 0.05). However, the study group showed a significantly lower incidence of complications than the control group at 1 week, 2 weeks, 1 month, 3 months, and 6 months after discharge (p < 0.05). Furthermore, the study group demonstrated significantly lower psychological well-being, physical well-being, spiritual well-being, social well-being scores, and COH-QOL-OQ total scores compared to the control group 6 months after discharge (p < 0.05). Additionally, the study group indicated significantly higher environment and process, service attitude, health guidance, diagnosis and treatment effect, overall evaluation of treatment experience scores, and MES-OCE total scores compared to the control group 6 months after discharge (p < 0.05).

CONCLUSIONS: Discharge planning combined with “Internet home ostomy care platform” can effectively reduce the risk of complications in patients with permanent colostomy after rectal cancer surgery. It improves patients’ self-management abilities, quality of life, and satisfaction. This finding provides an ongoing guarantee for the quality of rehabilitation at home for patients with permanent colostomy.

PMID:39186342 | DOI:10.62713/aic.3459

Ann Ital Chir. 2024;95(4):435-447. doi: 10.62713/aic.3511.

ABSTRACT

AIM: Complex anal fistula poses a significant challenge for anorectal surgeons due to its high risks of recurrence and incontinence. A sphincter-preserving procedure named endorectal advancement flap (ERAF) is gradually being applied to clinical practice. Therefore, this meta-analysis aims to evaluate the efficacy and safety of ERAF in managing anal fistula.

METHODS: We searched PubMed, Embase, Cochrane, and Web of Science databases for relevant manuscripts published from 29 August 2003 to 29 August 2023. Among these studies, outcomes included healing rate, recurrence rate, incontinence rate, and complications. Furthermore, the quality of the included studies was assessed using the Newcastle-Ottawa Scale (NOS) and the Cochrane risk-of-bias tool. The heterogeneity was determined using the chi-squared test and I2 statistic. A random effects model was applied if significant heterogeneity (p < 0.05 and I2 > 50%) was observed. Sensitivity analysis was conducted by excluding studies with a high risk of bias.

RESULTS: Thirty-eight studies were included in the present analysis, involving 1559 participants. The pooled healing rate and recurrence rate of ERAF were 65.5% (95% confidence intervals (CI): 57.6%-73.4%) and 19.6% (95% CI: 14.8%-24.4%), respectively. The pooled incontinence rate was 10.6% (95% CI: 6.0%-15.1%). According to the subgroup analysis, the healing rate, recurrence rate, and incontinence rate of ERAF for fistula associated with inflammatory bowel disease (IBD) were 53.9% (95% CI: 38.1%-69.7%), 32.6% (95% CI: 21.3%-43.8%), and 2.8% (95% CI: 0%-10.6%), respectively. For patients without IBD, the healing rate, recurrence rate, and incontinence rate of ERAF were 70.6% (95% CI: 63.9%-77.4%), 15.7% (95% CI: 9.9%-21.5%), and 16.5% (95% CI: 8.1%-24.9%), respectively. We observed that bleeding, local infection or abscess, flap dehiscence, and haematomas were the common complications, with incidences of 2.2% (95% CI: 0%-4.5%), 9.5% (95% CI: 4.7%-14.4%), 10.4% (95% CI: 0.0%-21.6%), and 12.4% (95% CI: 0%-27.6%), respectively.

CONCLUSIONS: ERAF may be an optional treatment for anal fistula from the perspective of effectiveness and safety.

SYSTEMATIC REVIEW REGISTRATION: PROSPERO: CRD42023451451.

PMID:39186335 | DOI:10.62713/aic.3511

Ann Ital Chir. 2024;95(4):552-560. doi: 10.62713/aic.3546.

ABSTRACT

AIM: Minimally invasive spinal trauma surgery includes percutaneous pedicle screw fixation and miniature open anterolateral retractor-based approaches, which can improve surgical outcomes by reducing blood loss, operative time, and postoperative pain. Therefore, this study aimed to evaluate the effect of minimally invasive surgery on pain scores, functional recovery, and postoperative complications in patients with spinal trauma.

METHODS: This retrospective study included 100 spinal trauma patients treated in Suzhou Hospital of Integrated Traditional Chinese and Western Medicine between May 2019 and May 2022. Patients who underwent traditional open surgery were included in the traditional group, and those who received percutaneous pedicle screw internal fixation combined with posterior minimally invasive small incision decompression were included in the research group, each comprising 50 patients. The effectiveness of these two surgical approaches was determined by assessing their outcome measures, including surgery-related indices, postoperative pain, spinal morphology, functional recovery, and postoperative complications.

RESULTS: Minimally invasive surgery was associated with significantly shorter surgical wounds, length of hospital stay, operative time, and postoperative time-lapse before off-bed activity, and less intraoperative hemorrhage volume and postoperative drainage volume compared to open surgery (p < 0.001). Compared to open surgery, patients with minimally invasive surgery showed significantly lower visual analogue scale (VAS) scores at 3 days, 3 months, and 6 months after surgery and lower Oswestry dysfunction index (ODI) at 7 days and 3 months after surgery (p < 0.05). Furthermore, the difference in the spine morphology between the two arms did not achieve statistical significance (p > 0.05). Additionally, minimally invasive surgery resulted in a significantly lower incidence of postoperative complications than open surgery (p < 0.05).

CONCLUSIONS: Minimally invasive surgery causes less surgical damage for patients with spinal trauma, improves surgery-related indexes, alleviates postoperative pain, and provides better morphological and functional recovery of the spine.

PMID:39186331 | DOI:10.62713/aic.3546

J Med Internet Res. 2024 Aug 26;26:e46936. doi: 10.2196/46936.

ABSTRACT

BACKGROUND: The presence of bias in artificial intelligence has garnered increased attention, with inequities in algorithmic performance being exposed across the fields of criminal justice, education, and welfare services. In health care, the inequitable performance of algorithms across demographic groups may widen health inequalities.

OBJECTIVE: Here, we identify and characterize bias in cardiology algorithms, looking specifically at algorithms used in the management of heart failure.

METHODS: Stage 1 involved a literature search of PubMed and Web of Science for key terms relating to cardiac machine learning (ML) algorithms. Papers that built ML models to predict cardiac disease were evaluated for their focus on demographic bias in model performance, and open-source data sets were retained for our investigation. Two open-source data sets were identified: (1) the University of California Irvine Heart Failure data set and (2) the University of California Irvine Coronary Artery Disease data set. We reproduced existing algorithms that have been reported for these data sets, tested them for sex biases in algorithm performance, and assessed a range of remediation techniques for their efficacy in reducing inequities. Particular attention was paid to the false negative rate (FNR), due to the clinical significance of underdiagnosis and missed opportunities for treatment.

RESULTS: In stage 1, our literature search returned 127 papers, with 60 meeting the criteria for a full review and only 3 papers highlighting sex differences in algorithm performance. In the papers that reported sex, there was a consistent underrepresentation of female patients in the data sets. No papers investigated racial or ethnic differences. In stage 2, we reproduced algorithms reported in the literature, achieving mean accuracies of 84.24% (SD 3.51%) for data set 1 and 85.72% (SD 1.75%) for data set 2 (random forest models). For data set 1, the FNR was significantly higher for female patients in 13 out of 16 experiments, meeting the threshold of statistical significance (-17.81% to -3.37%; P<.05). A smaller disparity in the false positive rate was significant for male patients in 13 out of 16 experiments (-0.48% to +9.77%; P<.05). We observed an overprediction of disease for male patients (higher false positive rate) and an underprediction of disease for female patients (higher FNR). Sex differences in feature importance suggest that feature selection needs to be demographically tailored.

CONCLUSIONS: Our research exposes a significant gap in cardiac ML research, highlighting that the underperformance of algorithms for female patients has been overlooked in the published literature. Our study quantifies sex disparities in algorithmic performance and explores several sources of bias. We found an underrepresentation of female patients in the data sets used to train algorithms, identified sex biases in model error rates, and demonstrated that a series of remediation techniques were unable to address the inequities present.

PMID:39186324 | DOI:10.2196/46936

J Med Internet Res. 2024 Aug 26;26:e54034. doi: 10.2196/54034.

ABSTRACT

BACKGROUND: Social media platforms are increasingly used to recruit patients for clinical studies. Yet, patients’ attitudes regarding social media recruitment are underexplored.

OBJECTIVE: This mixed methods study aims to assess predictors of the acceptance of social media recruitment among patients with hepatitis B, a patient population that is considered particularly vulnerable in this context.

METHODS: Using a mixed methods approach, the hypotheses for our survey were developed based on a qualitative interview study with 6 patients with hepatitis B and 30 multidisciplinary experts. Thematic analysis was applied to qualitative interview analysis. For the cross-sectional survey, we additionally recruited 195 patients with hepatitis B from 3 clinical centers in Germany. Adult patients capable of judgment with a hepatitis B diagnosis who understood German and visited 1 of the 3 study centers during the data collection period were eligible to participate. Data analysis was conducted using SPSS (version 28; IBM Corp), including descriptive statistics and regression analysis.

RESULTS: On the basis of the qualitative interview analysis, we hypothesized that 6 factors were associated with acceptance of social media recruitment: using social media in the context of hepatitis B (hypothesis 1), digital literacy (hypothesis 2), interest in clinical studies (hypothesis 3), trust in nonmedical (hypothesis 4a) and medical (hypothesis 4b) information sources, perceiving the hepatitis B diagnosis as a secret (hypothesis 5a), attitudes toward data privacy in the social media context (hypothesis 5b), and perceived stigma (hypothesis 6). Regression analysis revealed that the higher the social media use for hepatitis B (hypothesis 1), the higher the interest in clinical studies (hypothesis 3), the more trust in nonmedical information sources (hypothesis 4a), and the less secrecy around a hepatitis B diagnosis (hypothesis 5a), the higher the acceptance of social media as a recruitment tool for clinical hepatitis B studies.

CONCLUSIONS: This mixed methods study provides the first quantitative insights into social media acceptance for clinical study recruitment among patients with hepatitis B. The study was limited to patients with hepatitis B in Germany but sets out to be a reference point for future studies assessing the attitudes toward and acceptance of social media recruitment for clinical studies. Such empirical inquiries can facilitate the work of researchers designing clinical studies as well as ethics review boards in balancing the risks and benefits of social media recruitment in a context-specific manner.

PMID:39186322 | DOI:10.2196/54034

Aging Ment Health. 2024 Aug 26:1-8. doi: 10.1080/13607863.2024.2394591. Online ahead of print.

ABSTRACT

OBJECTIVES: Various dementia risk scores exist that assess different factors. We investigated the association between the Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) score and modifiable risk factors in the Lifestyle for Brain Health (LIBRA) score in a German population at high risk of Alzheimer’s disease.

METHOD: Baseline data of 807 participants of AgeWell.de (mean age: 68.8 years (SD = 4.9)) were analysed. Stepwise multivariable regression was used to examine the association between the CAIDE score and additional risk factors of the LIBRA score. Additionally, we examined the association between dementia risk models and cognitive performance, as measured by the Montreal Cognitive Assessment.

RESULTS: High cognitive activity (β = -0.016, p < 0.001) and high fruit and vegetable intake (β = -0.032, p < 0.001) correlated with lower CAIDE scores, while diabetes was associated with higher CAIDE scores (β = 0.191; p = 0.032). Although all were classified as high risk on CAIDE, 31.5% scored ≤0 points on LIBRA, indicating a lower risk of dementia. Higher CAIDE and LIBRA scores were associated with lower cognitive performance.

CONCLUSION: Regular cognitive activities and increased fruit and vegetable intake were associated with lower CAIDE scores. Different participants are classified as being at-risk based on the dementia risk score used.

PMID:39186318 | DOI:10.1080/13607863.2024.2394591

JAMA Netw Open. 2024 Aug 1;7(8):e2427441. doi: 10.1001/jamanetworkopen.2024.27441.

ABSTRACT

IMPORTANCE: Few studies have investigated whether the associations between pregnancy-related factors and breast cancer (BC) risk differ by underlying BC susceptibility. Evidence regarding variation in BC risk is critical to understanding BC causes and for developing effective risk-based screening guidelines.

OBJECTIVE: To examine the association between pregnancy-related factors and BC risk, including modification by a of BC where scores are based on age and BC family history.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study included participants from the prospective Family Study Cohort (ProF-SC), which includes the 6 sites of the Breast Cancer Family Registry (US, Canada, and Australia) and the Kathleen Cuningham Foundation Consortium (Australia). Analyses were performed in a cohort of women enrolled from 1992 to 2011 without any personal history of BC who were followed up through 2017 with a median (range) follow-up of 10 (1-23) years. Data were analyzed from March 1992 to March 2017.

EXPOSURES: Parity, number of full-term pregnancies (FTP), age at first FTP, years since last FTP, and breastfeeding.

MAIN OUTCOMES AND MEASURES: BC diagnoses were obtained through self-report or report by a first-degree relative and confirmed through pathology and data linkages. Cox proportional hazards regression models estimated hazard ratios (HR) and 95% CIs for each exposure, examining modification by PARS of BC. Differences were assessed by estrogen receptor (ER) subtype.

RESULTS: The study included 17 274 women (mean [SD] age, 46.7 [15.1] years; 791 African American or Black participants [4.6%], 1399 Hispanic or Latinx participants [8.2%], and 13 790 White participants [80.7%]) with 943 prospectively ascertained BC cases. Compared with nulliparous women, BC risk was higher after a recent pregnancy for those women with higher PARS (last FTP 0-5 years HR for interaction, 1.53; 95% CI, 1.13-2.07; P for interaction < .001). Associations between other exposures were limited to ER-negative disease. ER-negative BC was positively associated with increasing PARS and increasing years since last FTP (P for interaction < .001) with higher risk for recent pregnancy vs nulliparous women (last FTP 0-5 years HR for interaction, 1.54; 95% CI, 1.03-2.31). ER-negative BC was positively associated with increasing PARS and being aged 20 years or older vs less than 20 years at first FTP (P for interaction = .002) and inversely associated with multiparity vs nulliparity (P for interaction = .01).

CONCLUSIONS AND RELEVANCE: In this cohort study of women with no prior BC diagnoses, associations between pregnancy-related factors and BC risk were modified by PARS, with greater associations observed for ER-negative BC.

PMID:39186276 | DOI:10.1001/jamanetworkopen.2024.27441

JAMA Netw Open. 2024 Aug 1;7(8):e2428975. doi: 10.1001/jamanetworkopen.2024.28975.

ABSTRACT

IMPORTANCE: Online symptom monitoring through patient-reported outcomes can enhance health-related quality of life and survival. However, widespread adoption in clinical care remains limited due to various barriers including the need to reduce health care practitioners’ workload.

OBJECTIVE: To report the effects of patient-reported outcome (PRO) symptom monitoring on HRQOL and survival up to 1 year after initiation of any treatment in patients with lung cancer.

DESIGN, SETTING, AND PARTICIPANTS: SYMPRO-Lung is a multicenter stepped-wedge cluster randomized trial including patients with stage I to IV lung cancer. The inclusion period was from October 24, 2019, until September 16, 2021, and data collection ended October 8, 2022. Data analysis was conducted from November 9, 2023, until March 18, 2024.

INTERVENTION: Patients in the intervention group reported PRO symptoms weekly using the Patient Reported Outcomes version of the Common Toxicity Criteria for Adverse Events lung cancer subset. If symptoms exceeded a validated threshold, an alert was sent to the health care practitioner (active intervention subgroup) or to the patient (reactive intervention subgroup). Patients in the control group received standard care.

MAIN OUTCOMES AND MEASURES: Health-related quality of life was measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire at baseline, 15 weeks (T1), 6 months (T2), and 1 year (T3), with the summary score (SS) and physical functioning (PF) as primary end points. Linear mixed-effects modeling was used to assess mean differences over time. Effect size (ES) of 0.40 or greater was considered clinically relevant. Cox proportional hazards regression survival analyses were performed to estimate the effect of the intervention on progression-free survival and overall survival (OS). Data were analyzed on an intention-to-treat basis.

RESULTS: A total of 515 patients (266 [51.7%] men; mean [SD] age, 65.4 [9.4] years) were included in the study (266 in the control group; 249 in the pooled intervention group). Most baseline characteristics were balanced between groups; however, the most notable exception was the distribution in cancer staging: the intervention group had a higher proportion of patients with stage IV cancer compared with the control group (139 [56%] vs 118 [44%]). The pooled intervention group had a significantly better SS (mean difference T1, 5.22; 95% CI, 2.72-7.73; P < .001; ES = 0.33; mean difference T2, 6.28; 95% CI, 3.65-8.92; P < .001; ES = 0.40; mean difference T3, 3.97; 95% CI, 1.15-6.80; P = .006; ES = 0.25) compared with the control group. Group differences improved more in PF but did not meet the ES greater than or equal to 0.40 threshold (mean difference T1, 7.00; 95% CI, 3.65-10.35; P < .001; ES = 0.27; mean difference T2, 6.79; 95% CI, 3.26-10.31; P < .001; ES = 0.26; mean difference T3, 5.01; 95% CI, 1.23-8.79; P = .009; ES = 0.19). No significant differences in HRQOL were observed between the reactive (n = 89) and active (n = 160) intervention groups. The HR for progression-free survival for the active intervention group compared with the control group was 0.78 (95% CI, 0.58-1.04); the finding was not statistically significant. The HR for overall survival for both interventions groups compared with the control group were not statistically significant.(active: HR, 0.80; 95% CI, 0.55-1.15; reactive: HR, 0.69; 95% CI, 0.42-1.15).

CONCLUSIONS AND RELEVANCE: In this 1-year follow-up of a stepped-wedge cluster randomized trial, PRO symptom monitoring yielded improvements in long-term HRQOL in patients with lung cancer. The reactive approach proved equally effective as the active approach. A nonsignificant potential survival benefit was observed for the intervention group. These positive results provide further evidence for the usefulness of routine PRO symptom monitoring in lung cancer care.

TRIAL REGISTRATION: The Netherlands trial register Identifier: NL7897.

PMID:39186274 | DOI:10.1001/jamanetworkopen.2024.28975

JAMA Netw Open. 2024 Aug 1;7(8):e2429661. doi: 10.1001/jamanetworkopen.2024.29661.

ABSTRACT

IMPORTANCE: The global refugee crisis disproportionately affects the Muslim world. Forced displacement often results in trauma-related mental health issues. Effective psychotherapy exists, but there are barriers to uptake by refugee groups as well as a lack of culturally appropriate interventions.

OBJECTIVE: To examine the efficacy of a brief, lay-led, mosque-based intervention, Islamic Trauma Healing (ITH), adapting empirically supported cognitive behavioral principles to improve mental health and well-being.

DESIGN, SETTING, AND PARTICIPANTS: In a randomized clinical trial, 101 participants received ITH or active assessment but delayed intervention (waiting list [WL]) in mosques and virtually in Seattle, Washington, and Columbus, Ohio, and were assessed through 12-week follow-up. Data were collected from July 14, 2018, through July 14, 2022, and data analysis was conducted from March 13 to July 31, 2023. United States-based refugees from Somalia who experienced a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Criterion A trauma exposure and posttraumatic stress disorder (PTSD) reexperiencing or avoidance. Analyses were intention-to-treat, using full information likelihood for missing data.

INTERVENTION: Islamic Trauma Healing included psychoeducation, discussion of the lives of prophets who had undergone trauma, and informal prayer turning to Allah about the trauma, incorporating cognitive restructuring and imaginal exposure. Lay-leader training is purposely brief: two 4-hour sessions with weekly supervision.

MAIN OUTCOMES AND MEASURES: The primary outcome was PTSD severity (measured with the Posttraumatic Diagnostic Scale for DSM-5 [PDS-5]). Secondary outcomes included depression (Patient Health Questionnaire-9), somatic symptoms (Somatic Symptoms Severity-8), and quality of well-being (World Health Organization Five Well-Being Index). Analyses were intention-to-treat.

RESULTS: Analyses were based on all 101 randomized participants (92 [91.1%] women; 9 [8.9%] men; mean [SD] age, 46.5 [12.02] years) with baseline mean (SD) PDS-5 score of 31.62 (16.55) points. There were significant differences in PTSD severity (d = -0.67), depression (d = -0.66), and well-being (d = 0.71), comparing ITH vs WL after the intervention. Gains were maintained through 12-week follow-up. Islamic Trauma Healing was consistent with religious and cultural practices (mean [SD], 3.8 [0.43]) and promoted community reconciliation (mean [SD], 3.8 [0.42]).

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of a brief, lay-led mental health intervention, ITH proved superior to WL. The findings suggest that ITH has the potential to provide an easily trainable and scalable intervention, incorporating Islam and empirically supported principles, that addresses the psychological wounds of war and refugee trauma.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03502278.

PMID:39186273 | DOI:10.1001/jamanetworkopen.2024.29661