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Publication Open Access Individualised immunosuppression with intravenously administered donor-derived modified immune cells compared with standard of care in living donor kidney transplantation (TOL-2 Study): protocol for a multicentre, open-label, phase II, randomised controlled trial(BMJ Publishing Group, 2022) Morath, C.; Schmitt, A.; Schmitt, M.; Wang, L.; Kleist, C.; Opelz, G.; Tran, T.H.; Scherer, S.; Schwenger, V.; Kemmner, S.; Fischereder, M.; Stangl, M.; Hauser, I.A.; Sommerer, C.; Nusshag, C.; Kalble, F.; Speer, C.; Benning, L.; Bischofs, C.; Sauer, S.; Schubert, M.L.; Kunz, A.; Hückelhoven-Krauss, A.; Neuber, B.; Mehrabi, A.; Schwab, C.; Waldherr, R.; Sander, A.; Büsch, C.; Czock, D.; Böhmig, G.A.; Reiser, J.; Roers, A.; Müller-Tidow, C.; Terness, P.; Zeier, M.; Daniel, V.; Schaier, M.; Süsal, Caner; Other; Koç University Research Center for Translational Medicine (KUTTAM) / Koç Üniversitesi Translasyonel Tıp Araştırma Merkezi (KUTTAM); School of Medicine; 351800Introduction: donor-derived modified immune cells (MIC) induced long-term specific immunosuppression against the allogeneic donor in preclinical models of transplantation. In a phase I clinical trial (TOL-1 Study), MIC treatment resulted in a cellular phenotype that was directly and indirectly suppressive to the recipient's immune system allowing for reduction of conventional immunosuppressive therapy. Here, we describe a protocol for a randomised controlled, multicentre phase-IIb clinical trial of individualised immunosuppression with intravenously administered donor MIC compared with standard-of-care (SoC) in living donor kidney transplantation (TOL-2 Study). Methods and analysis: sixty-three living donor kidney transplant recipients from six German transplant centres are randomised 2:1 to treatment with MIC (MIC group, N=42) or no treatment with MIC (control arm, N=21). MIC are manufactured from donor peripheral blood mononuclear cells under Good Manufacturing Practice conditions. The primary objective of this trial is to determine the efficacy of MIC treatment together with reduced conventional immunosuppressive therapy in terms of achieving an operational tolerance-like phenotype compared with SoC 12 months after MIC administration. Key secondary endpoints are the number of patient-relevant infections as well as a composite of biopsy-proven acute rejection, graft loss, graft dysfunction or death. Immunosuppressive therapy of MIC-treated patients is reduced during follow-up under an extended immunological monitoring including human leucocyte antigen-antibody testing, and determination of lymphocyte subsets, for example, regulatory B lymphocytes (Breg) and antidonor T cell response. A Data Safety Monitoring Board has been established to allow an independent assessment of safety and efficacy. Ethics and dissemination: ethical approval has been provided by the Ethics Committee of the Medical Faculty of the University of Heidelberg, Heidelberg, Germany (AFmu-580/2021, 17 March 2022) and from the Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Institute, Langen, Germany (Vorlage-Nr. 4586/02, 21 March 2022). Written informed consent will be obtained from all patients and respective donors prior to enrolment in the study. The results from the TOL-2 Study will be published in peer-reviewed medical journals and will be presented at symposia and scientific meetings. Trial registration number NCT05365672.Publication Open Access Postoperative atrial fibrillation in adults with obstructive sleep apnea undergoing coronary artery bypass grafting in the RICCADSA cohort(Multidisciplinary Digital Publishing Institute (MDPI), 2022) Holtstrand-Hjalm, H.; Glantz, H.; Thunström, E.; Peker, Yüksel; Çelik, Yeliz; Faculty Member; Researcher; Koç University Research Center for Translational Medicine (KUTTAM) / Koç Üniversitesi Translasyonel Tıp Araştırma Merkezi (KUTTAM); School of Medicine; Graduate School of Health Sciences; 234103; N/APostoperative atrial fibrillation (POAF) occurs in 20-50% of patients with coronary artery disease (CAD) after coronary artery bypass grafting (CABG). Obstructive sleep apnea (OSA) is also common in adults with CAD, and may contribute to POAF as well to the reoccurrence of AF in patients at long-term. In the current secondary analysis of the Randomized Intervention with Continuous Positive Airway Pressure (CPAP) in Coronary Artery Disease and Obstructive Sleep Apnea (RICCADSA) trial (Trial Registry: ClinicalTrials.gov; No: NCT 00519597), we included 147 patients with CABG, who underwent a home sleep apnea testing, in average 73 +/- 30 days after the surgical intervention. POAF was defined as a new-onset AF occurring within the 30 days following the CABG. POAF was observed among 48 (32.7%) patients, occurring within the first week among 45 of those cases. The distribution of the apnea-hypopnea-index (AHI) categories < 5.0 events/h (no-OSA); 5.0-14.9 events/h (mild OSA); 15.0-29.9 events/h (moderate OSA); and >= 30 events/h (severe OSA), was 4.2%, 14.6%, 35.4%, and 45.8%, in the POAF group, and 16.2%, 17.2%, 39.4%, and 27.3%, respectively, in the no-POAF group. In a multivariate logistic regression model, there was a significant risk increase for POAF across the AHI categories, with the highest odds ratio (OR) for severe OSA (OR 6.82, 95% confidence interval 1.31-35.50; p = 0.023) vs. no-OSA, independent of age, sex, and body-mass-index. In the entire cohort, 90% were on beta-blockers according to the clinical routines, they all had sinus rhythm on the electrocardiogram at baseline before the study start, and 28 out of 40 patients with moderate to severe OSA (70%) were allocated to CPAP. During a median follow-up period of 67 months, two patients (none with POAF) were hospitalized due to AF. To conclude, severe OSA was significantly associated with POAF in patients with CAD undergoing CABG. However, none of those individuals had an AF-reoccurrence at long term, and whether CPAP should be considered as an add-on treatment to beta-blockers in secondary prevention models for OSA patients presenting POAF after CABG requires further studies in larger cohorts.Publication Open Access Comparison of oncological and surgical outcomes between formal pancreatic resections and parenchyma-sparing resections for small PanNETs (<2 cm): Pancreas2000 Research and Educational Program (Course 9) Study Protocol(Frontiers, 2020) Pehlevan, Özge Serçe; Benzer, Derya; Karatekin, Güner; Ovalı, Hüsnü Fahri; Tuncer, Ceren; Koç University Research Center for Translational Medicine (KUTTAM) / Koç Üniversitesi Translasyonel Tıp Araştırma Merkezi (KUTTAM)Pancreatic neuroendocrine tumors (PanNETs) are rare tumors but incidence is increasing. An increasing number of these tumors are diagnosed incidentally when they are small (<2 cm) and when patients are asymptomatic. The European Neuroendocrine Tumor Society (ENETS) recommends conservative watch and wait policy for these patients. However, best surgical approach (parenchyma-sparing or formal oncological resection) for these small tumors when surgery is indicated is currently unknown. Parenchyma-sparing resections such as enucleation is associated with higher risk of post-operative morbidity compared to formal oncological resections. They are also be associated with potentially inadequate surgical margin clearance and with lack of lymphadenectomy for full pathological staging. Method: this study is a retrospective study and the aim is to analyze pre-operative clinical predictors of nodal metastases for small PanNETs to identify which patients are at a lower risk of lymph node metastases and are therefore suitable for parenchyma-sparing resection. Conclusion: the primary endpoint of this study is to determine if pre-operative clinical predictors such as tumor size are associated with lymph node involvement in small PanNETs.Publication Open Access Interferon-inducible protein-10 as a marker to detect latent tuberculosis infection in patients with inflammatory rheumatic diseases(Multidisciplinary Digital Publishing Institute (MDPI), 2022) Ortaköylü, Mediha Gönenç; Bahadır, Ayşe; Buğdaycı, Derya Soy; Uysal, Mehmet Atilla; Paker, Nurdan; Onur, Seda Tural; İliaz, Sinem; Doctor; Koç University Hospital; 168584It is important to identify cases of latent tuberculosis infection (LTBI) who are at risk for tuberculosis (TB) reactivation. We aimed to evaluate the performance of interferon (IFN)-gamma-inducible protein 10 (IP-10) as a marker to detect LTBI in patients with inflammatory rheumatic diseases (IRD). This study comprised 76 consecutive subjects with IRD. Patients with a history of TB or having active TB were excluded. In all patients, IP-10 level was measured and tuberculin skin test (TST) and QuantiFERON-TB Gold In-Tube test (QFT-GIT) were performed. Seventy patients with complete test results were analyzed. Twenty-one (30%) QFT-GIT-positive patients were defined as having LTBI. IP-10 yielded 2197 pg/mL cut-off point. At this cut-off point, IP-10 showed 89% specificity with a sensitivity of 91% (AUC: 0.950, 95% CI 0.906-0.994). TST, QFT-GIT, and IP-10 were positive in 77.1%, 30%, and 44.3% of the patients, respectively. Concordance among the results of TST, QFT-GIT, and IP-10 tests was evaluated. Agreement was poor between IP-10 and TST (58.6%, k = 0.19), whereas it was good between QFT-GIT and IP-10 (84.3%, k = 0.65). The results of the present study demonstrated that sensitivity and specificity of released IP-10 were as high as those of QFT-GIT in indicating LTBI in IRD patient group.Publication Open Access Cohort profile: a collaborative multicentre study of retinal optical coherence tomography in 539 patients with neuromyelitis optica spectrum disorders (CROCTINO)(BMJ Publishing Group, 2020) Specovius, Svenja; Zimmermann, Hanna G.; Oertel, Frederike Cosima; Chien, Claudia; Bereuter, Charlotte; Cook, Lawrence J.; Lana Peixoto, Marco Aurelio; Fontenelle, Mariana Andrade; Kim, Ho Jin; Hyun, Jae-Won; Jung, Su-Kyung; Palace, Jacqueline; Roca-Fernandez, Adriana; Diaz, Alejandro Rubio; Leite, Maria Isabel; Sharma, Srilakshmi M.; Ashtari, Fereshte; Kafieh, Rahele; Dehghani, Alireza; Pourazizi, Mohsen; Pandit, Lekha; Dcunha, Anitha; Aktas, Orhan; Ringelstein, Marius; Albrecht, Philipp; May, Eugene; Tongco, Caryl; Leocani, Letizia; Pisa, Marco; Radaelli, Marta; Martinez-Lapiscina, Elena H.; Stiebel-Kalish, Hadas; Hellmann, Mark; Lotan, Itay; Siritho, Sasitorn; de Seze, Jerome; Senger, Thomas; Havla, Joachim; Marignier, Romain; Tilikete, Caroline; Cobo Calvo, Alvaro; Bichuetti, Denis Bernardi; Tavares, Ivan Maynart; Asgari, Nasrin; Soelberg, Kerstin; Yıldırım, Rengin; Tanrıverdi, Uygur; Jacob, Anu; Huda, Saif; Rimler, Zoe; Reid, Allyson; Mao-Draayer, Yang; de Castillo, Ibis Soto; Yeaman, Michael R.; Smith, Terry J.; Brandt, Alexander U.; Paul, Friedemann; GJCF Int Clinical Consortium NMOSD; Altıntaş, Ayşe; Faculty Member; School of Medicine; 11611Purpose: optical coherence tomography (OCT) captures retinal damage in neuromyelitis optica spectrum disorders (NMOSD). Previous studies investigating OCT in NMOSD have been limited by the rareness and heterogeneity of the disease. The goal of this study was to establish an image repository platform, which will facilitate neuroimaging studies in NMOSD. Here we summarise the profile of the Collaborative OCT in NMOSD repository as the initial effort in establishing this platform. This repository should prove invaluable for studies using OCT to investigate NMOSD. Participants: the current cohort includes data from 539 patients with NMOSD and 114 healthy controls. These were collected at 22 participating centres from North and South America, Asia and Europe. The dataset consists of demographic details, diagnosis, antibody status, clinical disability, visual function, history of optic neuritis and other NMOSD defining attacks, and OCT source data from three different OCT devices. Findings to date: the cohort informs similar demographic and clinical characteristics as those of previously published NMOSD cohorts. The image repository platform and centre network continue to be available for future prospective neuroimaging studies in NMOSD. For the conduct of the study, we have refined OCT image quality criteria and developed a cross-device intraretinal segmentation pipeline. Future plans: we are pursuing several scientific projects based on the repository, such as analysing retinal layer thickness measurements, in this cohort in an attempt to identify differences between distinct disease phenotypes, demographics and ethnicities. The dataset will be available for further projects to interested, qualified parties, such as those using specialised image analysis or artificial intelligence applications.Publication Open Access Cost of disease of heart failure in Turkey: a Delphi panel-based analysis of direct and indirect costs(Galenos Yayınevi, 2022) Çavuşoğlu, Yüksel; Altay, Hakan; Aras, Dursun; Çelik, Ahmet; Ertaş, Fatih Sinan; Kılıçaslan, Barış; Nalbantgil, Sanem; Temizhan, Ahmet; Yıldırımtürk, Özlem; Yılmaz, Mehmet Birhan; Ural, Dilek; Faculty Member; School of Medicine; Koç University Hospital; 1057Background: heart failure (HF) is considered a significant public health issue with a substantial and growing epidemiologic and economic burden in relation to longer life expectancy and aging global population Aims: to determine cost-of-disease of heart failure (HF) in Turkey from the payer perspective. Study Design: cross-sectional cost of disease study. Methods: in this cost-of-disease study, annual direct and indirect costs of management of HF were determined based on epidemiological, clinical and lost productivity inputs provided by a Delphi panel consisted of 11 experts in HF with respect to ejection fraction (EF) status (HF patients with reduced EF (HFrEF), mid-range EF (HFmrEF) and preserved EF (HFpEF)) and New York Heart Association (NYHA) classification. Direct medical costs included cost items on outpatient management, inpatient management, medications, and non -pharmaceutical treatments. Indirect cost was calculated based on the lost productivity due to absenteeism and presenteeism. Results: 51.4%, 19.5%, and 29.1% of the patients were estimated to be HFrEF, HFmrEF, and HFpEF patients, respectively. The total annual direct medical cost per patient was $887 and non-pharmaceutical treatments ($373, 42.1%) were the major direct cost driver. Since an estimated nationwide number of HF patients is 1,128,000 in 2021, the total annual national economic burden of HF is estimated to be $1 billion in 2021. The direct medical cost was higher in patients with HFrEF than in those with HFmrEF or HFpEF ($1,147 vs. $555 and $649, respectively). Average indirect cost per patient was calculated to be $3,386 and was similar across HFrEF, HFmrEF and HFpEF groups, but increased with advanced NYHA stage. Conclusion: Our findings confirm the substantial economic burden of HF in terms of both direct and indirect costs and indicate that the non-pharmaceutical cost is the major direct medical cost driver in HF management, regardless of the EF status of HF patients.Publication Open Access CPAP intervention as an add-on treatment to lipid-lowering medication in coronary artery disease patients with obstructive sleep apnea in the RICCADSA trial(Multidisciplinary Digital Publishing Institute (MDPI), 2022) Çelik, Yeliz; Balcan, Mehmet Baran; Peker, Yüksel; Researcher; Faculty Member; Koç University Research Center for Translational Medicine (KUTTAM) / Koç Üniversitesi Translasyonel Tıp Araştırma Merkezi (KUTTAM); School of Medicine; Koç University Hospital; N/A; N/A; 234103Dyslipidaemia is a well-known risk factor for coronary artery disease (CAD), and reducing lipid levels is essential for secondary prevention in management of these high-risk individuals. Dyslip-idaemia is common also in patients with obstructive sleep apnea (OSA). Continuous positive airway pressure (CPAP) is the first line treatment of OSA. However, evidence of a possible lipid-lowering effect of CPAP in CAD patients with OSA is scarce. We addressed the effect of CPAP as an add-on treatment to lipid-lowering medication in a CAD cohort with concomitant OSA. This study was a secondary analysis of the RICCADSA trial (Trial Registry: ClinicalTrials.gov; No: NCT 00519597), that was conducted in Sweden between 2005 and 2013. In total, 244 revascularized CAD patients with nonsleepy OSA (apnea–hypopnea index ? 15/h, Epworth Sleepiness Scale score < 10) were randomly assigned to CPAP or no-CPAP. Circulating triglycerides (TG), total cholesterol (TC), high-density lipoprotein (HDL) and low-density lipoprotein (LDL) levels (all in mg/dL) were measured at baseline and 12 months after randomization. The desired TG levels were defined as circulating TG < 150 mg/dL, and LDL levels were targeted as <70 mg/dL according to the recent guidelines of the European Cardiology Society and the European Atherosclerosis Society. A total of 196 patients with available blood samples at baseline and 12-month follow-up were included (94 randomized to CPAP, 102 to no-CPAP). We found no significant between-group differences in circulating levels of TG, TC, HDL and LDL at baseline and after 12 months as well as in the amount of change from baseline. However, there was a significant decline regarding the proportion of patients with the desired TG levels from 87.2% to 77.2% in the CPAP group (p = 0.022), whereas there was an increase from 84.3% to 88.2% in the no-CPAP group (n.s.). The desired LDL levels remained low after 12 months in both groups (15.1% vs. 17.2% in CPAP group, and 20.8% vs. 18.8% in no-CPAP group; n.s.). In a multiple linear regression model, the increase in the TG levels was predicted by the increase in body-mass-index (? = 4.1; 95% confidence interval (1.0–7.1); p = 0.009) adjusted for age, sex and CPAP usage (hours/night). CPAP had no lipid-lowering effect in this revascularized cohort with OSA. An increase in body-mass-index predicted the increase in TG levels after 12 months, suggesting that lifestyle modifications should be given priority in adults with CAD and OSA, regardless of CPAP treatment.Publication Open Access Effectiveness of bendamustine in relapsed or refractory lymphoma cases: a Turkish Oncology Group study(Termedia Publishing, 2021) Karadurmuş Nuri; Paydaş, Semra; Esin, Ece; Sürmeli, Zeki Gökhan; Yıldız, Birol; Ertürk, İsmail; Nayır, Erdinç; Doğan, Mutlu; Sümbül, Ahmet Taner; Barışta, İbrahim; Gürkan, Emel; Öcal, Ramazan; Özgür, Gökhan; Karakaş, Yusuf; Laçin, Şahin; Özaydin, Şükrü; Petekkaya, Halil İbrahim; Üskent, Necdet; Ferhanoğlu, Ahmet Burhan; Faculty Member; School of Medicine; 18320Introduction: we aimed to investigate the efficacy and side effects of bendamustine in relapsed/refractory lymphoma patients in Turkey. Material and methods: in this retrospective study, we included relapsed/refractory Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL) patients who underwent multiple lines of chemotherapy. The primary endpoint was to determine the objective response and toxicity. Results: ninety-nine patients with a median age of 59.8 years were included in the study. Eighty-one patients had NHL (follicular lymphoma: 10, diffuse large B- cell lymphoma: 27, mantle-cell lymphoma: 18, marginal zone lymphoma: 9, small lymphocytic lymphoma/chronic lymphocytic leukemia: 17) and 18 patients had HL. The patients had previously received a median of three lines of chemotherapy (range: 2-8) except autologous stem cell transplantation (ASCT); 19 patients (HL: 11, NHL: 8) had undergone ASCT. The objective response rate (ORR) was 74.3%, the complete response rate was 57% (= 53), and the partial response rate was 16.6% (= 19). The overall survival (OS) rate at 1 year was 74.6%. The progression-free survival (PFS) rate at 1 year was 62.5%. The most common side effects were lymphopenia, anemia and neutropenia. Side effects which were observed as grade 3 and higher levels were lymphopenia (14.1%), neutropenia (10.1%) and fatigue (7.1%). Conclusions: objective response rate of bendamustine was found to be 74.3% in relapsed/refractory HL and NHL patients. It appears to be an effective option as a salvage treatment for patients who have previously received multiple lines of therapy.Publication Open Access Deep learning assisted automated assessment of thalassaemia from haemoglobin electrophoresis images(Multidisciplinary Digital Publishing Institute (MDPI), 2022) Salman, Khan M.; Khan, K.N.; Riaz, H.; Yousafzai, Y.M.; Rahman, T.; Chowdhury, M.E.H.; Abul Kashem, S.B.; N/A; Ullah, Azmat; Graduate School of Sciences and EngineeringHaemoglobin (Hb) electrophoresis is a method of blood testing used to detect thalassaemia. However, the interpretation of the result of the electrophoresis test itself is a complex task. Expert haematologists, specifically in developing countries, are relatively few in number and are usually overburdened. To assist them with their workload, in this paper we present a novel method for the automated assessment of thalassaemia using Hb electrophoresis images. Moreover, in this study we compile a large Hb electrophoresis image dataset, consisting of 103 strips containing 524 electrophoresis images with a clear consensus on the quality of electrophoresis obtained from 824 subjects. The proposed methodology is split into two parts: (1) single-patient electrophoresis image segmentation by means of the lane extraction technique, and (2) binary classification (normal or abnormal) of the electrophoresis images using state-of-the-art deep convolutional neural networks (CNNs) and using the concept of transfer learning. Image processing techniques including filtering and morphological operations are applied for object detection and lane extraction to automatically separate the lanes and classify them using CNN models. Seven different CNN models (ResNet18, ResNet50, ResNet101, InceptionV3, DenseNet201, SqueezeNet and MobileNetV2) were investigated in this study. InceptionV3 outperformed the other CNNs in detecting thalassaemia using Hb electrophoresis images. The accuracy, precision, recall, f1-score, and specificity in the detection of thalassaemia obtained with the InceptionV3 model were 95.8%, 95.84%, 95.8%, 95.8% and 95.8%, respectively. MobileNetV2 demonstrated an accuracy, precision, recall, f1-score, and specificity of 95.72%, 95.73%, 95.72%, 95.7% and 95.72% respectively. Its performance was comparable with the best performing model, InceptionV3. Since it is a very shallow network, MobileNetV2 also provides the least latency in processing a single-patient image and it can be suitably used for mobile applications. The proposed approach, which has shown very high classification accuracy, will assist in the rapid and robust detection of thalassaemia using Hb electrophoresis images.Publication Open Access Scalable psychological interventions for Syrian refugees in Europe and the Middle East: STRENGTHS study protocol for a prospective individual participant data meta-analysis(BMJ Publishing Group, 2022) de Graaff, A.M.; Cuijpers, P.; Akhtar, A.; Alkneme, M.S.; Aoun, M.; Awwad, M.; Bawaneh, A.Y.; Brown, F.L.; Bryant, R.; Burchert, S.; Carswell, K.; Drogendijk, A.; Engels, M.; Fuhr, D.C.; Hansen, P.; van 't Hof, E.; Giardinelli, L.; Hemmo, M.; Hessling, J.M.; Jordans, M.J.D.; Kiselev, N.; Knaevelsrud, C.; Martinmaki, S.; McDaid, D.; Morina, N.; Naser, H.; Park, A.L.; Pfaltz, M.C.; Roberts, B.; Schick, M.; Schnyder, U.; Spaaij, J.; Steen, F.; Taha, K.; Uygun, E.; Ventevogel, P.; Whitney, C.; Witteveen, A.B.; Sijbrandij, M.; STRENGTHS consortium; Department of Psychology; Acartürk, Ceren; İlkkurşun, Zeynep; Kurt, Gülşah; Faculty Member; Master Student; Teaching Faculty; Department of Psychology; College of Social Sciences and Humanities; Graduate School of Social Sciences and Humanities; 39271; N/A; N/AIntroduction: The World Health Organization's (WHO) scalable psychological interventions, such as Problem Management Plus (PM+) and Step-by-Step (SbS) are designed to be cost-effective non-specialist delivered interventions to reduce symptoms of common mental disorders, such as anxiety, depression and post-traumatic stress disorder (PTSD). The STRENGTHS consortium aims to evaluate the effectiveness, cost-effectiveness and implementation of the individual format of PM+ and?its group version (gPM+), as well as of the digital SbS intervention among Syrian refugees in seven countries in Europe and the Middle East. This is a study protocol for a prospective individual participant data (IPD) meta-analysis to evaluate (1) overall effectiveness and cost-effectiveness and (2) treatment moderators of PM+, gPM+ and?SbS with Syrian refugees. Methods and analysis: Five pilot randomised controlled trials (RCTs) and seven fully powered RCTs conducted within STRENGTHS will be combined into one IPD meta-analytic dataset. The RCTs include Syrian refugees of 18 years and above with elevated psychological distress (Kessler Psychological Distress Scale (K10>15)) and impaired daily functioning (WHO Disability Assessment Schedule 2.0 (WHODAS 2.0>16)). Participants are randomised into the intervention or care as usual control group, and complete follow-up assessments at 1-week, 3-month and 12-month follow-up. Primary outcomes are symptoms of depression and anxiety (25-item Hopkins Symptom Checklist). Secondary outcomes include daily functioning (WHODAS 2.0), PTSD symptoms (PTSD Checklist for DSM-5) and self-identified problems (PSYCHLOPS). We will conduct a one-stage IPD meta-analysis using linear mixed models. Quality of evidence will be assessed using the GRADE approach, and the economic evaluation approach will be assessed using the CHEC-list. Ethics and dissemination: Local ethical approval has been obtained for each RCT. This IPD meta-analysis does not require ethical approval. The results of this study will be published in international peer-reviewed journals.
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