Prevalence of Mental Health Disorders and Their Associated Risk Factors Among People Living with HIV in Rwanda: A Cross-Sectional Study.

While life expectancy of people living with HIV is increasing, their burden of non-communicable diseases, including mental health disorders, is growing as well. The aim of this study is to investigate the prevalence and identify the risk factors associated with mental health disorders among this population in Rwanda. This cross-sectional study enrolled people living with HIV from 12 HIV clinics across Rwanda using random sampling. Trained HIV nurses conducted the Mini International Neuropsychiatric Interview to estimate the prevalence of major depressive episode, post-traumatic stress disorder, and generalized anxiety disorder. Sociodemographic, psychosocial, and HIV-related data were also collected. Associated risk factors for being diagnosed with one of the mental health disorders were assessed using modified Poisson regression with robust error variance. Of 428 participants, 70 (16.4%) had at least one mental health disorder with major depressive episode being most prevalent (n = 60, 14.0%). Almost all participants were adherent to antiretroviral therapy (n = 424, 99.1%) and virally suppressed (n = 412, 96.9%). Of those diagnosed with a mental health disorder, only few were aware of (n = 4, 5.7%) or under treatment for this mental health disorder (n = 5, 7.2%). Mental health disorders were associated with experiences of HIV-related stigma and discrimination (aRR = 2.14, 95%CI 1.30-3.53, p = 0.003). The results demonstrate underdiagnosis and undertreatment of mental health disorders among Rwandan People Living with HIV. Using HIV nurses to diagnose mental health disorders could serve as a low-cost strategy for integrating mental health care with existing HIV services and could inspire the implementation in other low-resource settings.

Effectiveness of structured group psychoeducation for people with bipolar disorder in Rwanda: A randomized open-label superiority trial.

BACKGROUND: Psychoeducation is a cornerstone as an add-on to pharmacotherapy in standard care for individuals with bipolar disorder. However, evidence of the effectiveness of psychoeducation in low-resource settings is scarce. AIMS: We aimed to assess the effectiveness of structured group psychoeducation versus waiting list on relapse prevention for individuals with bipolar disorder in Rwanda, a low-income country. METHODS: This was a randomized open-label superiority trial. Participants aged 18 years or older with bipolar disorder were recruited at the two referral hospitals for mental health in Rwanda and randomly assigned 12 sessions of group psychoeducation or a waiting list. The program was tailored to the setting and co-designed with patients and clinicians. The follow-up period was 12 months, and the primary outcome mean number of psychiatric hospitalizations. RESULTS: In February and March 2021, 154 participants were randomly assigned to receive group psychoeducation (n = 78) or to a waiting list (n = 76). The retention rate was high, with only three discontinuing the psychoeducation once they had received a session. Despite limited use of first-line pharmacotherapy, the psychoeducation reduced the risk of hospitalization by half during the 12-month follow-up (RR: 0.50(95 % CI 0.26-0.95)). Yet, no change in medical adherence was observed. LIMITATION: Weekly assessment of clinical status was not feasible. CONCLUSION: Structured group psychoeducation for bipolar disorder in a low-resource setting has a protective effect against readmission despite limited access to first-line pharmacotherapy. Further studies are needed to assess the effectiveness of the program in more decentralized settings with less highly trained staff. TRIAL REGISTRATION: NCT04671225.

Plasma Levels of Pentraxin 3: A Potential Prognostic Biomarker in Urinary Bladder Cancer Patients.

Urinary bladder cancer (BC) represents a major health issue, and identifying novel biomarkers for early disease detection and outcome prediction is paramount. It has already been established that the immune system plays a role in tumour initiation and progression in which the inflammatory marker pentraxin 3 (PTX3) might be involved, presenting a variety of functions in different cancers. The aim of this study was to investigate whether plasma levels of PTX3 could be used as a biomarker for patients with BC. Plasma levels of PTX3 were determined in 118 BC patients and 50 controls by ELISA. Patients with BC had significantly higher PTX3 levels compared to controls. The value as a diagnostic biomarker is probably limited, however, since no significant difference in PTX3 levels was seen between patients with non-muscle-invasive BC and controls; they were seen only between patients with muscle-invasive disease and controls. However, the potential value of PTX3 as a prognostic biomarker was indicated by significantly higher PTX3 levels in patients who developed metastatic disease during follow-up compared to patients who did not develop metastatic disease. The conclusions from this study are that plasma levels of PTX3 have limited value as a diagnostic biomarker, although they have potential as a prognostic biomarker for patients with BC.

Sertraline versus venlafaxine combined with psychotherapy in trauma-affected refugees - a follow-up study on a pragmatic randomised trial.

BACKGROUND: Research on long-term pharmacotherapy for trauma-affected refugees is scarce. The purpose of this follow-up study of a randomised trial was to investigate the effects of sertraline compared to venlafaxine in combination with psychotherapy, 6 and 18 months after end of trial. METHOD: The primary outcome was PTSD symptoms, measured by the Harvard Trauma Questionnaire (HTQ). The secondary outcomes included: Hopkins Symptom Checklist-25 (HSCL-25), somatisation items of the Symptoms Checklist-90 (SCL), pain on a visual analogue scale, well-being on the WHO-5, Sheehan Disability Scale, Hamilton Depression and Anxiety scales and Global Assessment of Functioning. Moreover, the shorter version of the Recent Life Events (IRLE) was adopted to obtain information regarding the patients' treatment and life events between the follow-up periods. RESULTS: Out of 195 patients eligible for intention-to-treat analyses during trial, 116 participated in the 6-month follow-up and 97 participated in the 18-month follow-up. The results of our intention-to-treat analyses revealed no significant long-term differences between the groups on the primary outcome assessing PTSD symptoms (HTQ). For the secondary outcomes significant differences were found at the 18-month follow-up in favour of venlafaxine assessing symptoms of anxiety, depression and somatisation (HSCL-25 and SCL), although only in intention-to-treat and not per-protocol analyses. CONCLUSIONS: No conclusions could be drawn due to conflicting results between our intention-to-treat and per-protocol analyses.

Factors affecting adherence to psychotropics in trauma-affected refugees: data from a randomized controlled trial.

Non-adherence to psychotropic drugs may reduce treatment effectiveness and may cause exacerbation of illness. Among migrant populations, studies have identified low adherence to psychotropic drugs. This study aimed to identify factors that were associated with the three basic components of adherence: non-initiation, non-implementation (blood sample), and discontinuation in a clinical sample of trauma-affected refugees diagnosed with posttraumatic stress disorder. The data for this study is derived from a randomized controlled trial (n = 108). Based on existing literature, individual sociodemographic and clinical candidate predictor variables that may affect the initiation, continuation, and implementation to psychotropics were selected as exposure variables. Logistic regression was used to assess the risk relation between non-initiation, non-implementation, discontinuation, and the individual sociodemographic and clinical factors. Three factors - level of education, turn-up rate for medical doctor sessions, and discomfort in relation to the psychotropics - were associated with non-initiation, non-implementation, or discontinuation. The relatively small sample size poses a limitation. Furthermore, factors not examined in the current study may have affected non-initiation, non-implementation, and discontinuation. The study identified level of education, turn-up rate for medical doctor sessions, and discomfort in relation to medicine as important factors in relation to treatment with psychotropics in trauma-affected refugees. Factors contributing to a low turn-up rate, and factors that are consequences of a low turn-up rate, as well as communication and trust in the patient-provider interaction need further research attention. Furthermore, there is a need for research on interventions addressing adherence for refugees with mental illness.

Exploring expectations of neurofeedback treatment among trauma-affected refugees.

BACKGROUND: The use of Neurofeedback (NF) to assist individuals in learning to regulate their brain wave activity has shown promising results in reducing symptoms of posttraumatic stress disorder (PSTD). However, few studies have focused on the patients' understandings of NF and even fewer explore the perspective of refugees. PURPOSE: To evaluate NF treatment for trauma-affected refugees by focusing on their expectations and understanding of NF. METHODS: This qualitative study was a part of a mixed method study carried out at an outpatient mental health centre in Denmark, offering 34 trauma-affected refugees 12 sessions of NF. In this qualitative study, a subsample of seven participants was interviewed. Using in-depth semi-structured interviews, the participants' thoughts and expectations prior to participating in NF treatment were examined. The analysis was carried out in four steps, using a hermeneutic and phenomenological approach. RESULTS: The analysis resulted in two themes: (1) Rationale and working mechanisms of NF and (2) Motivators for participating in the study. CONCLUSION: The findings show that NF treatment for trauma affected refugees was challenged by difficulties in communicating the message about the NF equipment capabilities as well as the expected treatment outcome. These challenges included e.g. health professionals' ability to explain and the participants' cultural frame of reference. This is consistent with previous research, showing that compared to the native population, the dissemination of health information to refugees is more difficult and comprehensive. Further studies on how to ensure mutual understanding of the content of NF and expected treatment outcome are needed. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT05055037. Retrospectively registered on the 06/07-2021.

Coercive control and the effect on mental health of female victims.

Coercive control is a non-violent form of intimate partner violence (IPV) that is a pattern of behaviors aimed at gaining control over one's partner by dominating, restricting, and monitoring tactics. The phenomenon has recently been recognised as an independent form of IPV. A search in the present literature was conducted and identified ten relevant studies. Seven out of the ten included studies presented a significant association between exposure to coercive control and mental health problems such as symptoms of depression, anxiety, and PTSD as well as suicidal thinking.

Help-seeking patterns and level of care for individuals with bipolar disorder in Rwanda.

Most descriptive data on individuals with bipolar disorder originate from high-resource settings. Very little is known about the accessibility and service provision of intensive mental health care to persons living with bipolar disorder in low-resource settings. This information is needed to inform health systems and guide practitioners to improve standard treatment options and access to treatment. This cross-sectional study explored the level of care for outpatients with bipolar disorder and their help-seeking patterns at the two national referral hospitals in Rwanda. The study found that the majority, 93%, of outpatients with bipolar disorder in Rwanda were on prophylactic psychopharmacological treatment, but mainly first-generation antipsychotics and just 3% received lithium treatment. Furthermore, there was a lack of psychosocial intervention; consequently, 44% were not aware that they had bipolar disorder. Moreover, 1 in 5 participants utilized or had previously used traditional medicine. Awareness of own diagnostic status was not associated with educational level or use of traditional medicine. The study's sample size of 154 patients is relatively small, and the cross-sectional design does not provide causal inferences. The results demonstrate a considerable unmet need for improved mental health care services for individuals with bipolar disorder in Rwanda, including access to optimal medication and psychosocial interventions. Psychoeducation could be a possible starting point for improving the standard of care, informing the individual on their diagnosis and medication while empowering them to engage in their treatment plan. Trial registration: ClinicalTrials.gov NCT04671225. Registered on November 2020.

Elevated lipid class concentrations in females with anorexia nervosa before and after intensive weight restoration treatment-A lipidomics study.

OBJECTIVE: To study the plasma lipidome of patients with anorexia nervosa (AN) before and after weight restoration treatment and report associations with AN subtypes and oral contraceptive pill (OCP) usage. METHODS: Quantitative shotgun lipidomics analysis was used to study plasma lipids of 50 female patients with AN before and after weight restoration treatment and 50 healthy female controls (HC). The AN group was assessed with blood samples and questionnaires before and after weight restoration. RESULTS: In total we quantified 260 lipid species representing 26 lipid classes of which 13 lipid class concentrations were elevated in patients with AN at admission compared with HC. Lipid classes remained elevated after weight restoration treatment of 84 days (median; interquartile range 28), and only the concentration of the ceramide lipid class increased between pre- and post-treatment (p = .03), whereas lysophosphatidylcholine (LPC, p = .02), ether-linked Phosphatidylcholine (LPCO, p = .02), and lysophosphatidylethanolamine (LPE, p = .009) decreased. CONCLUSION: In AN, 13 out of 26 lipid class concentrations were elevated at admission and remained elevated post-treatment. Ceramides increased further between pre- and post-weight restoration treatment, which could be related to the rapid weight gain during re-nutrition. Further research is needed to elucidate the effects of weight restoration treatment on short- and long-term lipid profiles in individuals with AN. PUBLIC SIGNIFICANCE STATEMENT: Lipidomics research can increase the understanding of AN, a complex and potentially life-threatening eating disorder. By analyzing lipids, or fats, in the body, we can identify biological markers that may inform diagnosis and develop more effective treatments. This research can also shed light on the underlying mechanisms of the disorder, leading to a better understanding of the processes involved in eating behavior.

The structure of ICD-11 post traumatic stress disorder in a clinical sample of refugees based on the International Trauma Interview.

BACKGROUND: The ICD-11 proposes fundamental changes to the PTSD diagnostic criteria, prompting thorough validation. While this is ideally carried out based on diagnostic interviews, most-and in the case of transcultural psychiatry all-studies have relied on self-reported measures. In this study, we used the International Trauma Interview (ITI) to assess the factor structure of ICD-11 PTSD symptoms in a sample of trauma-affected refugees. METHOD: The ITI was administered with a sample of refugees (n = 198), originating mainly from the Greater Middle East. The symptom ratings were subjected to a confirmatory factor analysis (CFA), comparing the ICD-11 concordant three-factor model with alternative two- and one-factor models. RESULTS: The overall fit was adequate for both the two- and three-factor models, but favored the two-factor model. Results for both models indicated local misspecifications and that item 5, hypervigilance, displayed a suboptimal loading. CONCLUSION: The results generally support the use of the ITI in a severely trauma-affected refugee population, albeit with particular attention needed in the administration of item 5. The superior fit of a two-factor model warrants further testing across populations.

A balancing act: how interpreters affect the therapeutic alliance in psychotherapy with trauma-affected refugees-a qualitative study with therapists.

Objective: The therapeutic alliance (TA) has the highest predictive value concerning the success of psychotherapy. The presented study aimed to explore how the presence of an interpreter affects the TA when working with trauma-affected refugees. Method: Semi-structured interviews were conducted with seven psychologists working in an outpatient clinic specialized in mental health care for migrant and refugee patients with trauma-related mental health problems in Denmark. Interviews were transcribed verbatim and analyzed using a structuring content analysis approach. Results: TA has been described as a dynamic therapist-interpreter-patient alliance triangle consisting of three distinct but highly intertwined and mutually influential dyadic alliances. Specific factors affecting the quality of the TA were identified, e.g., interpreter being emotionally attuned yet not overly involved; interpreter being barely visible yet present as a human being. Characteristics of trauma-affected refugee patients affecting the TA formation were also identified, e.g., a high level of personal distrust, different understandings of mental disorders and psychotherapy, stigmatization, perceptions of authorities. Conclusion: The presence of interpreters was perceived ambivalently and the formation of a good TA seems to be a balancing act. Based on the findings, recommendations for forming and maintaining a good TA in interpreter-mediated psychotherapy are provided.

Penile cancer: long-term infectious and thromboembolic complications following lymph node dissection - a population-based study (Sweden).

PURPOSE: To assess the long-term risks of infectious and thromboembolic events following inguinal (ILND) and pelvic (PLND) lymph node dissection in men with penile cancer. MATERIAL AND METHODS: A total of 364 men subjected to ILND with or without PLND for penile cancer between 2000 and 2012 were identified in the Swedish National Penile Cancer Register. Each patient was matched based on age and county of residence with six penile cancer-free men. The Swedish Cancer Register and other population-based registers were used to retrieve information on treatment and hospitalisation for selected infectious and thromboembolic events. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated using Cox proportional hazard models with multiple imputation. RESULTS: The risk of infectious events remained increased for more than five years postoperatively in men with penile cancer compared with matched controls. The palpable nodal disease was the only predictor of these events, with risk increasing with the cN stage. The HR at one, three and five years and six months postoperatively was 8.60 (95% CI 5.16-14.34), 4.02 (95% CI 2.65-6.09) and 1.93 (95% CI 1.11-3.38), respectively. An increased risk of thromboembolic events persisted for three years postoperatively. The HR at one and three years postoperatively was 13.51 (95% CI 6.53-27.93) and 2.12 (95% CI 1.07-4.20). The results correspond well with the over-prescription of anticoagulants observed during this period. An association with bulky disease (cN3) was observed. CONCLUSIONS: Lymph node dissection for penile cancer is associated with an increased risk of infectious and thromboembolic events. The findings of this population-based study show that the risks of these events remain increased more than five years for infectious and three years for thromboembolic events. Improved awareness of long-term complications following ILND is of importance both among patients and care givers to ensure early detection and treatment.

Sleep impairments in refugees diagnosed with post-traumatic stress disorder: a polysomnographic and self-report study.

Background: Post-traumatic stress disorder (PTSD) is the clinical manifestation of traumatic events and is associated with sleep disturbances. Sleep disturbances, if left untreated, may perpetuate or even worsen symptoms of PTSD. Previous studies of other PTSD populations show a higher incidence of sleep impairments and sleep disorders compared to healthy controls (HCs); however, this has never been investigated in trauma-affected refugees diagnosed with PTSD.Objectives: To examine subjective sleep quality, measure sleep architecture, and identify latent sleep disorders in refugees diagnosed with PTSD compared to HCs.Method: This comparative study included 20 trauma-affected refugees diagnosed with PTSD and 20 HC matched on age, sex, and body mass index. All participants completed self-report questionnaires assessing sleep quality, insomnia severity, and disturbing nocturnal behaviour, and all took part in a one-night polysomnography (PSG) assessment.Results: Patients reported significantly poorer subjective sleep quality, sleep latency, sleep duration, and sleep efficiency compared to HCs. Subjective reports on hours spent in bed were not significantly different between patients and HCs. Patients reported significantly higher nightmare frequency and severity compared to HCs. PSG measures showed that patients had significantly reduced sleep efficiency, more awakenings, and longer REM sleep latency, and spent more time awake, whereas there was no significant differences regarding total time in bed, total sleep time, or sleep latency. The prevalence of sleep disorders was equal between groups.Conclusions: The study identified significant impairments in several sleep domains, with a preponderance of disturbed regulation of sleep resulting in awakenings. These results indicate a need for more focus on hyperarousal and nightmares as key elements of disturbed sleep in PTSD. Furthermore, the study identified a discrepancy between subjective and objective measures concerning total sleep time, raising questions regarding the causes of 'sleep state misperception'.Trial registration: ClinicalTrials.gov identifier: NCT03535636..Trial registration: Sleep Impairments in Refugees Diagnosed with PTSD (PSG-PTSD). URL: https://clinicaltrials.gov/ct2/show/NCT03535636. ClinicalTrials.gov NCT03535636. Date of registration: 24/05/2018.

This is the first study assessing sleep impairments and sleep disorders in refugees diagnosed with post-traumatic stress disorder (PTSD) compared to healthy controls.The main finding is that both subjectively and objectively measured sleep is disrupted in refugees diagnosed with PTSD compared to healthy controls.The results suggest that these disturbances of sleep are significant targets in treatment of PTSD and stress the importance of focusing on treatment of sleep disturbances in PTSD.

Headache comorbidity in refugees and migrants with post-traumatic stress disorder.

BACKGROUND: Headache is often comorbid with post-traumatic stress disorder yet overlooked in health assessments of refugees. OBJECTIVES: To describe prevalence of severe headache among refugees with post-traumatic stress disorder and compare severity of post-traumatic stress disorder symptoms and treatment outcomes among those with and without severe headache. METHODS: This follow-up study used data from the Danish Database on Refugees with Trauma. Participants were recruited from 2009 to 2015 at a specialized psychiatric clinic. Prevalence of severe headache was computed by age, sex, and history of head injury or torture. Severe headache was defined as maximum headache scores on the Hopkins Symptom Checklist, Symptom Checklist-90 or the Visual Analogue Scale. Groups with and without severe headache were described according to validated questionnaires before and after 12-18 months of multidisciplinary treatment for post-traumatic stress disorder. Regression analyses were used to analyze associations between headache at start of treatment and symptom burden post-treatment, controlled for pre-treatment scores and possible confounders. RESULTS: Among 403 female and 489 male participants, nearly all (97.5%) complained of headaches. Severe headache prevalence was 31.4% to 50.0% (depending on which questionnaire was used) and was significantly more common among females and those aged 30-49 years. There was no clear relationship between headache and head injury or torture. Participants with severe headache had heavier symptom burdens compared to those without severe headache. Post-treatment, headache prevalence by age and sex did not change significantly. Those without severe headache showed a tendency toward improvement in outcome measures; this was not seen among those with severe headache. Pre-treatment headache scores were correlated with all outcome measures. Regression analyses controlled for pre-treatment scores of the outcome variables showed associations between pre-treatment headache scores (Hopkins Symptom Checklist or Symptom Checklist-90) and post-treatment scores for intrusion, numbing, hyperarousal, anxiety, disability, and quality of life (all p < 0.02). CONCLUSION: Headache is a prevalent comorbid condition among refugees with post-traumatic stress disorder. Measures of pre-treatment headache severity appear to predict post-traumatic stress disorder treatment outcomes. Severe headache adversely affects post-traumatic stress disorder prognosis. Assessment and treatment options should be studied further.

Potential advantages of combining randomized controlled trials with qualitative research in mood and anxiety disorders - A systematic review.

INTRODUCTION: Most randomized controlled trials (RCTs) of mood and anxiety disorders employ solely quantitative methods. Supplementing quantitative data with qualitative methods, a so-called mixed-method approach, would seem useful, however this area has not been rigorously reviewed. We undertook a systematic review of RCTs of mood and anxiety disorders that employed concurrent quantitative data collection and qualitative methods exploring the participants' perspective, with the aim of 1. determining the number of such studies, 2. describing study characteristics, and 3. identifying potential advantages of a mixed-method approach. METHODS: Following PRISMA guidelines, a systematic literature search for RCTs of mood and anxiety disorders, concurrently applying quantitative and qualitative methods, was conducted using EMBASE, PsycINFO and Pubmed, from their inception to February 2021. Categories of potential advantages of this mixed method approach were developed. RESULTS: A total of 45 RCTs were included. The qualitative components typically included 10-40 participants, mostly consisting of interviews after the intervention. The majority of papers did not state a specific rationale for using a mixed method approach. Four categories of advantages emerged: 1. determine acceptability/feasibility, 2. investigate efficacy, 3. inform implementation in clinical practice and 4. generate new hypotheses based on the combination of quantitative and qualitative data. LIMITATIONS: Lack of cross-referencing and consistent terminology challenged identification of relevant publications. CONCLUSION: There are a number of potential advantages of applying mixed method approaches in RCTs within psychiatric research. Intentional consideration of such advantages early in trial design may increase the likelihood of gaining added value.

The Impact of Religion and Spirituality on Suicide Risk in Veterans and Refugees With Posttraumatic Stress Disorder.

ABSTRACT: It has been suggested that religion and spirituality have a protective impact on suicide risk in populations living with posttraumatic stress disorder (PTSD). This review sought to examine the association between suicide risk among veterans and refugees with PTSD and religion or spirituality as a modifying factor. Two databases, PubMed and Embase, were searched and 10 publications were identified and included. Seven publications found that religion or spirituality was associated with lower suicide risk. The findings in this study suggest that religion and spirituality contain social as well as psychological domains, which should be considered in future interventions and in strategies of prevention of suicide in populations with PTSD. Further high-quality research with well-defined terms of religion and spirituality that investigates the connection to suicide risk of veterans and refugees with PTSD is recommended.

Psychotherapy readiness domains as predictors of psychotherapy outcome in trauma-affected refugees.

INTRODUCTION: Little is known about predictors of psychotherapy outcome in trauma-affected refugees. Knowledge on outcome predictors can help clinicians identify patients prior to treatment who are not likely to benefit from standardized psychotherapy and take additional measures to adjust treatment to the individual patient. Given the dynamic nature of psychotherapy readiness domains, they represent potential targets to be worked with in therapy in order to improve outcomes. METHODS: Psychotherapy readiness domains (locus of control, cognitive functioning, motivation for therapy, and personality functioning) were examined as potential predictors of psychotherapy outcome in trauma-affected refugees. Secondary analyses were conducted on data from a pragmatic randomized controlled trial. Study participants (N = 190) were refugees with PTSD who received flexible manual-based Cognitive Behavioral Therapy (CBT) at a psychiatric outpatient clinic in Denmark. Psychotherapy readiness domains were assessed via semi-structured interviews at the beginning of psychotherapy. Outcome variables were pre-post change in PTSD symptomology and global level of functioning. RESULTS: Multiple regression analyses revealed that higher motivation for psychotherapy predicted improvement in PTSD symptomology and global level of functioning. Moreover, higher cognitive functioning predicted improvement in global level of functioning. LIMITATIONS: The predictor rating scales need further psychometric evaluations in cross-cultural contexts. CONCLUSIONS: These findings highlight the importance of considering motivation in psychotherapy offered to trauma-affected refugees. Further research is needed to identify potential barriers to motivation in this diverse patient population and to determine whether motivational interventions can lead to improved treatment outcomes.

Sentinel Node Identification with Hybrid Tracer-guided and Conventional Dynamic Sentinel Node Biopsy in Penile Cancer: A Prospective Study in 130 Patients from the Two National Referral Centres in Sweden.

BACKGROUND: Studies suggest that a hybrid indocyanine green (ICG)-99mTc-nanocolloid tracer improves sentinel node (SN) identification compared to conventional dynamic sentinel node biopsy (DSNB). OBJECTIVE: To investigate hybrid tracer-guided SN identification in a multicentre setting and determine false-negative (FN) and complication rates. DESIGN, SETTING, AND PARTICIPANTS: A total of 130 patients with penile cancer scheduled for DSNB were prospectively included between February 2016 and December 2017 at two national Swedish referral centres. ICG-99mTc-nanocolloid hybrid tracer was used in the standard DSNB protocol. INTERVENTION: SNs were identified intraoperatively using radioguidance, fluorescence imaging, and blue dye. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The number of SNs identified by each tracer and the rates of complications and nodal recurrence during median follow-up of 34 mo were recorded. Differences in proportions between groups were compared using χ2 and McNemar's tests. RESULTS AND LIMITATIONS: Overall, 453 SNs were identified preoperatively via single-photon emission computed tomography/computed tomography. Among the 425 SNs excised, radioguidance, fluorescence, and blue dye identified 414 (97%), 363 (85%), and 349 (82%), respectively. Fluorescence imaging helped to detect six SNs that were negative using the other tracers, two of which were from the same patient and contained metastases. Histopathological examination detected 33 metastatic SNs in 20/130 patients (15%). The FN rate was 12% per groin (95% confidence interval 8-16%). CONCLUSIONS: Identification of SNs in patients with penile cancer relies mainly on radioguidance, while fluorescence (ICG) and blue dye methods for optical SN identification are comparable. However, the value of fluorescence imaging should be further evaluated in studies with long-term follow-up. PATIENT SUMMARY: In this study, we investigated addition of a dye called indocyanine green (ICG) for assessment of lymph nodes in patients with cancer of the penis. ICG did not improve the rate of detection of nodes most likely to harbour cancer because of their location in the drainage pathway for lymphatic fluid, but did help in identifying additional metastases.

The effect of an integrated care intervention of multidisciplinary mental health treatment and employment services for trauma-affected refugees: study protocol for a randomised controlled trial.

BACKGROUND: The complexity of past trauma and ongoing post-migration stressors challenges the existing mental health treatment for trauma-affected refugees. Therefore, interventions are needed to accommodate these complex challenges in mental health treatment. This study examines the effect of an add-on integrated care intervention compared to treatment as usual (TAU) for trauma-affected refugees in a randomised controlled trial (RCT). METHODS: The study is carried out at a Danish outpatient clinic and will include 197 treatment-seeking refugees with post-traumatic stress disorder (PTSD) who are unemployed and affiliated with municipal employment services. Mental health TAU comprises 10 sessions with a medical doctor (pharmacological treatment and psychoeducation) and 16-20 sessions with a psychologist (manual-based cognitive behavioural therapy) for a period of 8 to 12 months. The add-on intervention strengthens coordination between mental health treatment and employment interventions with three cross-sectoral collaborative meetings during the mental health treatment. The integrated care intervention draws attention to the bidirectional impact of mental health problems and post-migration stressors and focuses on cross-sectoral shared plans. The primary outcome is functioning, measured by WHODAS 2.0, the interviewer-administered 12-item version, with secondary outcomes measuring quality of life, mental health symptoms, and post-migration stressors. DISCUSSION: The RCT is novel in intervention design for trauma-affected refugees and will bring forward new perspectives and knowledge of integrated care interventions for trauma-affected refugees. The integrated care intervention is expected to reduce post-migration stressors that negatively affect the treatment of trauma-related mental health problems, thereby improving preconditions for enhanced treatment outcomes. The intervention builds on existing practices in the Danish healthcare and employment sectors, which ensures high scalability and sustainability for future practices. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04244864 , registered 28 January 2020. PROTOCOL VERSION: 17 September 2022, version 2.