Evaluating a stepped care model of psychological support for adults affected by adversity: study protocol for a randomised controlled trial in Jordan.

BACKGROUND: The burden of common mental disorders in low and middle-income countries (LMICs) is growing with little known about how to allocate limited resources to reach the greatest number of people undergoing instances of significant psychological distress. We present a study protocol for a multicentre, parallel-group, superiority, randomised controlled trial. METHODS AND ANALYSIS: Adults with significant psychological distress (K10 score ≥20) will be randomised to receive a stepped care programme involving a self-guided course (Doing What Matters) followed by a more intensive group programme (Problem Management Plus) or the self-guided course alone, both of which will take place in addition to enhanced treatment as usual comprising of a follow-up referral session to available services within the community. We will include 800 participants. An intent-to-treat and completer analysis will explore the impact of the stepped model of care on anxiety and depression symptoms (as measured by the Hopkins Symptom Checklist; HSCL-25) at 24 weeks from baseline. Secondary outcomes include positive psychological well-being, agency, changes in patient-identified problems, quality of life and cost-effectiveness. Linear mixed models will be used to assess the differential impact of the conditions over time. Analyses will focus on the primary outcome (HSCL-25) and secondary outcomes (agency subscale, WHO Well-Being Index, WHO Disability Assessment Schedule V.2.0, EQ-5D, Psychological Outcomes Profiles Scale) for both conditions, with the main outcome time point being the 3-month follow-up, relative to baseline. ETHICS AND DISSEMINATION: This will be the first randomised controlled trial to assess the benefits of a stepped model of care to addressing psychological distress in a LMIC setting. Results will provide important insights for managing limited resources to mental healthcare in these settings and will be accordingly disseminated to service providers and organisations via professional training and meetings, and via publication in relevant journals and conference presentations. We will also present these findings to the Jordanian Ministry of Health, where this institute will guide us on the most appropriate format for communication of findings, including written reports, verbal presentations and/or brochures. Ethical approval was obtained from the University of Jordan School of Nursing Research Ethics Committee (number: PF.22.10). TRIAL REGISTRATION NUMBER: ACTRN12621000189820p; Australian New Zealand Clinical Trials Registry.

Views and experiences of migrants and stakeholders involved in social and health care for migrants in Italy during the COVID-19 pandemic: a qualitative study.

BACKGROUND: The COVID-19 pandemic has had major and potentially long-lasting effects on mental health and wellbeing across populations worldwide. However, these impacts were not felt equally, leading to an exacerbation of health inequalities, especially affecting vulnerable populations such as migrants, refugees and asylum seekers. Aiming to inform the adaptation and implementation of psychological intervention programmes, the present study investigated priority mental health needs in this population group. METHODS: Participants were adult asylum seekers, refugees and migrants (ARMs) and stakeholders with experience in the field of migration living in Verona, Italy, and fluent in Italian and English. A two-stage process was carried out to examine their needs using qualitative methods including free listing interviews and focus group discussions, according to Module One of the DIME (Design, Implementation, Monitoring, and Evaluation) manual. Data were analyzed using an inductive thematic analyses approach. RESULTS: A total of 19 participants (12 stakeholders, 7 ARMs) completed the free listing interviews and 20 participants (12 stakeholders and 8 ARMs) attended focus group discussions. Salient problems and functions that emerged during free listing interviews were discussed during the focus group discussions. During the COVID-19 pandemic, ARMs struggled with many everyday living difficulties in their resettlement country due to social and economic issues, revealing a strong influence of contextual factors in determining mental health. Both ARMs and stakeholders highlighted a mismatch between needs, expectations and interventions as factors that may hamper proper implementation of health and social programmes. CONCLUSIONS: The present findings could help in the adaptation and implementation of psychological interventions targeting the needs of asylum seekers, refugees and migrants aiming to find a match between needs, expectations, and the corresponding interventions. TRIAL REGISTRATION: Registration number 2021-UNVRCLE-0106707, February 11 2021.

Mental health problems and needs of frontline healthcare workers during the COVID-19 pandemic in Spain: A qualitative analysis.

Background: Healthcare workers (HCWs) from COVID-19 hotspots worldwide have reported poor mental health outcomes since the pandemic's beginning. The virulence of the initial COVID-19 surge in Spain and the urgency for rapid evidence constrained early studies in their capacity to inform mental health programs accurately. Here, we used a qualitative research design to describe relevant mental health problems among frontline HCWs and explore their association with determinants and consequences and their implications for the design and implementation of mental health programs. Materials and methods: Following the Programme Design, Implementation, Monitoring, and Evaluation (DIME) protocol, we used a two-step qualitative research design to interview frontline HCWs, mental health experts, administrators, and service planners in Spain. We used Free List (FL) interviews to identify problems experienced by frontline HCWs and Key informant (KI) interviews to describe them and explore their determinants and consequences, as well as the strategies considered useful to overcome these problems. We used a thematic analysis approach to analyze the interview outputs and framed our results into a five-level social-ecological model (intrapersonal, interpersonal, organizational, community, and public health). Results: We recruited 75 FL and 22 KI interviewees, roughly balanced in age and gender. We detected 56 themes during the FL interviews and explored the following themes in the KI interviews: fear of infection, psychological distress, stress, moral distress, and interpersonal conflicts among coworkers. We found that interviewees reported perceived causes and consequences across problems at all levels (intrapersonal to public health). Although several mental health strategies were implemented (especially at an intrapersonal and interpersonal level), most mental health needs remained unmet, especially at the organizational, community, and public policy levels. Conclusions: In keeping with available quantitative evidence, our findings show that mental health problems are still relevant for frontline HCWs 1 year after the COVID-19 pandemic and that many reported causes of these problems are modifiable. Based on this, we offer specific recommendations to design and implement mental health strategies and recommend using transdiagnostic, low-intensity, scalable psychological interventions contextually adapted and tailored for HCWs.

Impact of displacement context on psychological distress in refugees resettled in Australia: a longitudinal population-based study.

AIMS: Refugees typically spend years in a state of protracted displacement prior to permanent resettlement. Little is known about how various prior displacement contexts influence long-term mental health in resettled refugees. In this study, we aimed to determine whether having lived in refugee camps v. community settings prior to resettlement impacted the course of refugees' psychological distress over the 4 years following arrival in Australia. METHODS: Participants were 1887 refugees who had taken part in the Building a New Life in Australia study, which comprised of five annual face-to-face or telephone surveys from the year of first arrival in Australia. RESULTS: Latent growth curve modelling revealed that refugees who had lived in camps showed greater initial psychological distress (as indexed by the K6) and faster decreases in psychological distress in the 4 years after resettling in Australia, compared to those who had lived in community settings. Investigation of refugee camp characteristics revealed that poorer access to services in camps was associated with greater initial distress after resettlement, and greater ability to meet one's basic needs in camps was associated with faster decreases in psychological distress over time. CONCLUSIONS: These findings highlight the importance of the displacement context in influencing the course of post-resettlement mental health. Increasing available services and meeting basic needs in the displacement environment may promote better mental health outcomes in resettled refugees.

Using an ecological momentary assessment protocol to understand problem anger in veterans.

BACKGROUND AND OBJECTIVES: Problem anger is highly destructive, and is one of the most commonly reported issues in military and veteran populations. The goal of this study was to use ecological momentary assessment (EMA) to explore and characterize moment-to-moment experiences of problem anger in a sample of Australian veterans. METHODS: Sixty veterans with problem anger (measured on the Dimensions of Anger Reactions Scale) completed measures of anger and anger rumination, before and after a 10-day EMA period which assessed the frequency, intensity, and expression of momentary anger experiences. RESULTS: Findings showed that 75% of respondents indicated some level of anger during EMA monitoring. In 25% of cases, anger was reported as severe. Moreover, anger was expressed verbally in 43% of cases, and expressed physically in 27% of cases. While anger fluctuated frequently during the day, more severe anger was more likely to be reported in the late afternoon/early evening. Problem anger symptoms decreased significantly over time, from pre-EMA to post EMA (p < .001). LIMITATIONS: The generalizability of findings is limited to a predominantly male sample, with low levels of risk of harm or violence. The study was also limited in the selection of outcome variables assessed and the lack of a control group; other momentary factors could influence experience of problem anger and provide further explanation of study results. CONCLUSIONS: EMA is a valuable assessment tool for individuals with problem anger, and the potential for EMA as an intervention needs to be explored further.

The Use of Digital Pathology and Artificial Intelligence in Histopathological Diagnostic Assessment of Prostate Cancer: A Survey of Prostate Cancer UK Supporters.

There has been particular interest in the deployment of digital pathology (DP) and artificial intelligence (AI) in the diagnosis of prostate cancer, but little is known about the views of the public on their use. Prostate Cancer UK supporters were invited to an online survey which included quantitative and qualitative questions exploring views on the use of DP and AI in histopathological assessment. A total of 1276 responses to the survey were analysed (response rate 12.5%). Most respondents were supportive of DP (87%, 1113/1276) and of testing AI in clinical practice as a diagnostic adjunct (83%, 1058/1276). Respondents saw DP as potentially increasing workflow efficiency, facilitating research, education/training and fostering clinical discussions between clinician and patient. Some respondents raised concerns regarding data security, reliability and the need for human oversight. Among those who were unsure about AI, information was requested regarding its performance and others wanted to defer the decision to use it to an expert. Although most are in favour of its use, some are unsure, and their concerns could be addressed with more information or better communication. A small minority (<1%) are not in favour of the testing of the use of AI in histopathology for reasons which are not easily addressed.

Scalable psychological interventions for Syrian refugees in Europe and the Middle East: STRENGTHS study protocol for a prospective individual participant data meta-analysis.

INTRODUCTION: 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.

Common Mental Disorders and Economic Uncertainty: Evidence from the COVID-19 Pandemic in the U.S.

Mental health disorders represent an enormous cost to society, are related to economic outcomes, and have increased markedly since the COVID-19 outbreak. Economic activity contracted dramatically on a global scale in 2020, representing the worst crisis since the Great Depression. This study used the COVID Impact Survey to provide insights on the interactions of mental illness and economic uncertainty during COVID-19. We used a probability-based panel survey, COVID Impact Survey, conducted in the U.S. over three waves in the period April-June 2020. The survey covered individual information on employment, economic and financial uncertainty, mental and physical health, as well as other demographic information. The prevalence of moderate mental distress was measured using a Psychological Distress Scale, a 5-item scale that is scored on a 4-point scale (total range: 0-15). The mental distress effect of employment, economic, and financial uncertainty, was assessed in a logit regression analysis conditioning for demographic and health information. It is found that employment, health coverage, social security, and food provision uncertainty are additional stressors for mental health. These economic factors work in addition to demographic effects, where groups who display increased risk for psychological distress include: women, Hispanics, and those in poor physical health. A decrease in employment and increases in economic uncertainty are associated with a doubling of common mental disorders. The population-representative survey evidence presented strongly suggests that economic policies which support employment (e.g., job keeping, job search support, stimulus spending) provide not only economic security but also constitute a major health intervention. Moving forward, the economic uncertainty effect ought to be reflected in community level intervention and prevention efforts, which should include strengthening economic support to reduce financial and economic strain.

Feasibility trial of a scalable transdiagnostic group psychological intervention for Syrians residing in a refugee camp.

Background: Approximately 10% of Syrian refugees currently reside in camp settings, which can impose additional post-migration stressors. With elevated rates of psychological distress and few available resources, task-shifting psychosocial programmes are necessary to provide adequate care. One such programme developed by the World Health Organization (WHO) is Group Problem Management Plus (GroupPM+). Objective: This study aimed to test the safety and acceptability of GroupPM+ in a refugee camp and to identify areas for adaptation in preparation for a definitive RCT. Method: A feasibility randomized controlled trial (RCT) was conducted in Azraq refugee camp in Jordan. Inclusion criteria were: (1) Syrian adults aged ≥18 years, (2) parent of a child aged 10-16 years, (3) experiencing psychological distress as defined by a score of ≥16 on the Kessler Distress Scale, and (4) ≥17 on the WHO Disability Assessment Schedule 2.0. Following baseline assessments, participants were randomized to receive GroupPM+ or enhanced treatment-as-usual. Post-assessments were conducted one week following the last GroupPM+ session. Primary outcomes were feasibility and acceptance of GroupPM+; symptoms of anxiety, depression, PTSD, prodromal psychosis, grief, and child's self-reported psychological distress were also assessed. Results: Of the 207 persons screened, 64 (31%) screened positive for psychological distress. Of the 35 randomized into the GroupPM+ intervention, 24 (69%) completed the intervention. No adverse events were reported throughout the trial. Children whose parents received GroupPM+ had greater reductions in internalizing and externalizing symptoms at posttreatment. 55 (86%) participants completed the post-assessment follow-up. These results demonstrate both the feasibility of conducting the trial in a camp and acceptance of the GroupPM+ intervention by Syrian refugees. Conclusions: Following the feasibility trial, both the implementation procedures and intervention were safe and culturally acceptable. The results support the readiness for a definitive RCT to determine the effectiveness and cost-effectiveness of the intervention in camp settings.

Antecedentes: Aproximadamente el 10% de refugiados sirios reside actualmente en campos de refugiados, lo que puede imponer estresores adicionales después de la migración. Con tasas elevadas de angustia psicológica y pocos recursos disponibles, los programas psicosociales de rotación de tareas son necesarios para brindar un cuidado adecuado. Uno de estos programas, desarrollado por la Organización Mundial de la Salud (OMS), es el Programa Grupal para el Manejo de Problemas Plus ('Group Problem Management Plus', o GroupPM+).Objetivos: Este estudio tuvo como objetivo el probar la seguridad y la aceptabilidad del GroupPM+ en un campo de refugiados e identificar las áreas de adaptación en preparación para un ensayo clínico controlado y aleatorizado (ECA).Métodos: Se llevó a cabo un ensayo clínico controlado y aleatorizado (ECA) de viabilidad en el campo de refugiados de Azraq en Jordania. Los criterios de inclusión fueron (1) ser un adulto sirios con una edad ≥ 18 años, (2) ser padre de un niño de 10 a 16 años, (3) experimentar angustia psicológica, definida mediante un puntaje ≥ 16 en la Escala de Malestar Psicológico de Kessler, y (4) un puntaje ≥ 17 en el Cuestionario para la Evaluación de la Discapacidad 2.0 de la OMS. Después de las evaluaciones iniciales, los participantes fueron distribuidos aleatoriamente para recibir la intervención mediante el GroupPM+ o para recibir el tratamiento usual optimizado. Las evaluaciones posteriores fueron conducidas una semana después de la última sesión del GroupPM+. Los resultados principales fueron la viabilidad y la aceptación del GroupPM+; los síntomas de ansiedad, de depresión, del trastorno de estrés postraumático (TEPT), la psicosis prodrómica, el duelo, y también se evaluó el auto-reporte de la angustia psicológica por parte del niño.Resultados: De las 207 personas evaluadas, 64 (31%) dieron positivo en presentar angustia psicológica. De las 35 personas incluidas de manera aleatoria en el grupo de intervención mediante el GroupPM+, 24 (69%) completaron la intervención. No se reportaron eventos adversos durante el ensayo clínico. Los niños cuyos padres recibieron la intervención mediante el GroupPM+ tuvieron una mayor reducción en los síntomas internalizantes y externalizantes después del tratamiento. 55 (86%) participantes completaron el seguimiento posterior a la evaluación. Estos resultados demuestran tanto la viabilidad de conducir el ensayo clínico en un campo de refugiados, como la aceptación de la intervención mediante el GroupPM+ por parte de los refugiados sirios.Conclusiones: De acuerdo con el ensayo de viabilidad, tanto los procedimientos de implementación como la intervención fueron seguros y culturalmente aceptables. Los resultados apoyan la preparación para un ECA definitivo para determinar la efectividad y costo-efectividad de la intervención en los campos de refugiados.

Prescribing patterns for medical treatment of suspected prostatic obstruction: a longitudinal register-based study of the Scottish Health and Social Care Open Data.

BACKGROUND: The diagnosis of lower urinary tract symptoms related to suspected bladder outflow obstruction from benign prostate hyperplasia/enlargement in men is increasing. This is leading to high demand on healthcare services; however, there is limited knowledge of differences in pharmacotherapy prescribing for this condition based on geography. OBJECTIVE: To investigate potential variation in drug prescribing for suspected bladder outflow obstruction in Scotland, based on analysis of publicly available data, to identify trends and inform future prescribing. STUDY DESIGN: A longitudinal register-based data study of prescribing and patient data publicly available from Scottish registries. All information is available as monthly aggregates at the level of single general practices. SETTING AND PARTICIPANTS: 903 (97%) general practices in Scotland, over a 50-month period (October 2015 to November 2019). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We analysed numbers of daily doses of drugs for suspected bladder outflow obstruction prescribed per month using a Bayesian Poisson regression analysis, incorporating random effects to account for spatial and temporal elements. RESULTS: Prescriptions for suspected bladder outflow obstruction medications increased during the observation period (overall average rate of change 1.24±0.28, ranging from 0.893 in Orkney to 1.95 in Lanarkshire). While some determinants of health inequality regarding prescribing practices across health boards are consistent with those known from the literature, other inequalities remain unexplained after accounting for practice-specific and patient-specific characteristics such as deprivation and rurality. CONCLUSIONS: Inequalities in prescribing for suspected bladder outflow obstruction medications exist in Scotland, partially ascribable to accepted sociodemographic and geographic factors.

Ductal adenocarcinoma of the prostate: A systematic review and meta-analysis of incidence, presentation, prognosis, and management.

Context: Ductal adenocarcinoma (DAC) is relatively rare, but is nonetheless the second most common subtype of prostate cancer. First described in 1967, opinion is still divided regarding its biology, prognosis, and outcome. Objectives: To systematically interrogate the literature to clarify the epidemiology, diagnosis, management, progression, and survival statistics of DAC. Materials and methods: We conducted a literature search of five medical databases from inception to May 04 2020 according to PRISMA criteria using search terms "prostate ductal adenocarcinoma" OR "endometriod adenocarcinoma of prostate" and variations of each. Results: Some 114 studies were eligible for inclusion, presenting 2 907 170 prostate cancer cases, of which 5911 were DAC. [Correction added on 16 January 2021 after the first online publication: the preceding statement has been corrected in this current version.] DAC accounts for 0.17% of prostate cancer on meta-analysis (range 0.0837%-13.4%). The majority of DAC cases were admixed with predominant acinar adenocarcinoma (AAC). Median Prostate Specific Antigen at diagnosis ranged from 4.2 to 9.6 ng/mL in the case series.DAC was more likely to present as T3 (RR1.71; 95%CI 1.53-1.91) and T4 (RR7.56; 95%CI 5.19-11.01) stages, with far higher likelihood of metastatic disease (RR4.62; 95%CI 3.84-5.56; all P-values < .0001), compared to AAC. Common first treatments included surgery (radical prostatectomy (RP) or cystoprostatectomy for select cases) or radiotherapy (RT) for localized disease, and hormonal or chemo-therapy for metastatic disease. Few studies compared RP and RT modalities, and those that did present mixed findings, although cancer-specific survival rates seem worse after RP.Biochemical recurrence rates were increased with DAC compared to AAC. Additionally, DAC metastasized to unusual sites, including penile and peritoneal metastases. Where compared, all studies reported worse survival for DAC compared to AAC. Conclusion: When drawing conclusions about DAC it is important to note the heterogenous nature of the data. DAC is often diagnosed incidentally post-treatment, perhaps due to lack of a single, universally applied histopathological definition. As such, DAC is likely underreported in clinical practice and the literature. Poorer prognosis and outcomes for DAC compared to AAC merit further research into genetic composition, evolution, diagnosis, and treatment of this surprisingly common prostate cancer sub-type. Patient summary: Ductal prostate cancer is a rare but important form of prostate cancer. This review demonstrates that it tends to be more serious at detection and more likely to spread to unusual parts of the body. Overall survival is worse with this type of prostate cancer and urologists need to be aware of the presence of ductal prostate cancer to alter management decisions and follow-up.

Active monitoring, radical prostatectomy and radical radiotherapy in PSA-detected clinically localised prostate cancer: the ProtecT three-arm RCT.

BACKGROUND: Prostate cancer is the most common cancer among men in the UK. Prostate-specific antigen testing followed by biopsy leads to overdetection, overtreatment as well as undertreatment of the disease. Evidence of treatment effectiveness has lacked because of the paucity of randomised controlled trials comparing conventional treatments. OBJECTIVES: To evaluate the effectiveness of conventional treatments for localised prostate cancer (active monitoring, radical prostatectomy and radical radiotherapy) in men aged 50-69 years. DESIGN: A prospective, multicentre prostate-specific antigen testing programme followed by a randomised trial of treatment, with a comprehensive cohort follow-up. SETTING: Prostate-specific antigen testing in primary care and treatment in nine urology departments in the UK. PARTICIPANTS: Between 2001 and 2009, 228,966 men aged 50-69 years received an invitation to attend an appointment for information about the Prostate testing for cancer and Treatment (ProtecT) study and a prostate-specific antigen test; 82,429 men were tested, 2664 were diagnosed with localised prostate cancer, 1643 agreed to randomisation to active monitoring (n = 545), radical prostatectomy (n = 553) or radical radiotherapy (n = 545) and 997 chose a treatment. INTERVENTIONS: The interventions were active monitoring, radical prostatectomy and radical radiotherapy. TRIAL PRIMARY OUTCOME MEASURE: Definite or probable disease-specific mortality at the 10-year median follow-up in randomised participants. SECONDARY OUTCOME MEASURES: Overall mortality, metastases, disease progression, treatment complications, resource utilisation and patient-reported outcomes. RESULTS: There were no statistically significant differences between the groups for 17 prostate cancer-specific (p = 0.48) and 169 all-cause (p = 0.87) deaths. Eight men died of prostate cancer in the active monitoring group (1.5 per 1000 person-years, 95% confidence interval 0.7 to 3.0); five died of prostate cancer in the radical prostatectomy group (0.9 per 1000 person-years, 95% confidence interval 0.4 to 2.2 per 1000 person years) and four died of prostate cancer in the radical radiotherapy group (0.7 per 1000 person-years, 95% confidence interval 0.3 to 2.0 per 1000 person years). More men developed metastases in the active monitoring group than in the radical prostatectomy and radical radiotherapy groups: active monitoring, n = 33 (6.3 per 1000 person-years, 95% confidence interval 4.5 to 8.8); radical prostatectomy, n = 13 (2.4 per 1000 person-years, 95% confidence interval 1.4 to 4.2 per 1000 person years); and radical radiotherapy, n = 16 (3.0 per 1000 person-years, 95% confidence interval 1.9 to 4.9 per 1000 person-years; p = 0.004). There were higher rates of disease progression in the active monitoring group than in the radical prostatectomy and radical radiotherapy groups: active monitoring (n = 112; 22.9 per 1000 person-years, 95% confidence interval 19.0 to 27.5 per 1000 person years); radical prostatectomy (n = 46; 8.9 per 1000 person-years, 95% confidence interval 6.7 to 11.9 per 1000 person-years); and radical radiotherapy (n = 46; 9.0 per 1000 person-years, 95% confidence interval 6.7 to 12.0 per 1000 person years; p < 0.001). Radical prostatectomy had the greatest impact on sexual function/urinary continence and remained worse than radical radiotherapy and active monitoring. Radical radiotherapy's impact on sexual function was greatest at 6 months, but recovered somewhat in the majority of participants. Sexual and urinary function gradually declined in the active monitoring group. Bowel function was worse with radical radiotherapy at 6 months, but it recovered with the exception of bloody stools. Urinary voiding and nocturia worsened in the radical radiotherapy group at 6 months but recovered. Condition-specific quality-of-life effects mirrored functional changes. No differences in anxiety/depression or generic or cancer-related quality of life were found. At the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year, the probabilities that each arm was the most cost-effective option were 58% (radical radiotherapy), 32% (active monitoring) and 10% (radical prostatectomy). LIMITATIONS: A single prostate-specific antigen test and transrectal ultrasound biopsies were used. There were very few non-white men in the trial. The majority of men had low- and intermediate-risk disease. Longer follow-up is needed. CONCLUSIONS: At a median follow-up point of 10 years, prostate cancer-specific mortality was low, irrespective of the assigned treatment. Radical prostatectomy and radical radiotherapy reduced disease progression and metastases, but with side effects. Further work is needed to follow up participants at a median of 15 years. TRIAL REGISTRATION: Current Controlled Trials ISRCTN20141297. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 37. See the National Institute for Health Research Journals Library website for further project information.

Prostate cancer is the most common cancer in men and is often found through a blood test called a prostate-specific antigen test and through biopsies of the prostate. Over the years, these tests led to the detection of many small cancers that do not cause harm. Some prostate cancers are harmful, but it is difficult to recognise them early. When cancer is still inside the prostate, the conventional treatments are surgery or radiotherapy, which carry side effects including leaking urine and difficulty getting an erection, so another option is repeat investigations at regular intervals (active monitoring), with treatments given if the cancer progresses. These options needed to be compared in a study called a 'randomised trial' in which men agree to be allocated to one of the three treatments. In the Prostate testing for cancer and Treatment (ProtecT) study, 200,000 men aged 50­69 years were invited to have a prostate-specific antigen test. Of the 82,849 men who agreed to be tested, 1643 of whom had prostate cancer that was still contained in the prostate agreed to be allocated to one of the three treatments. After an average of 10 years of follow-up, 99% of men were alive in each of the treatment groups. However, when compared with active monitoring, surgery and radiotherapy reduced the risk of disease spreading outside the prostate by half. Patients reported that urinary leakage and sexual function were worst with surgery, and sexual and bowel functions were affected by radiotherapy. Men on active monitoring had a gradual decline in their urinary and sexual function, particularly as around half of them later had surgery or radiotherapy. Radiotherapy was the treatment that seemed to be the best value for money. The findings from the Prostate testing for cancer and Treatment (ProtecT) study can help men make decisions about being tested and which treatment to have if they are found to have cancer within the prostate. We now need to find out the longer-term effects of these treatments on how long men live and their quality of life.

Protocol for a randomized controlled trial: peer-to-peer Group Problem Management Plus (PM+) for adult Syrian refugees in Turkey.

BACKGROUND: A large proportion of Syrians have been exposed to potentially traumatic events, multiple losses, and breakdown of supportive social networks and many of them have sought refuge in host countries where they also face post-migration living difficulties such as discrimination or integration problems or both. These adversities may put Syrian refugees at high risk for common mental disorders. In response to this, the World Health Organization (WHO) developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM+) to reduce psychological distress among populations exposed to adversities. PM+ has been adapted for Syrian refugees and can be delivered by non-specialist peer lay persons in the community. METHODS: A randomized controlled trial (RCT) will be conducted with 380 Syrian refugees in Turkey. After providing informed consent, participants with high levels of psychological distress (scoring above 15 on the Kessler-10 Psychological Distress Scale (K10)) and functional impairment (scoring above 16 on the WHO Disability Assessment Schedule 2.0, or WHODAS 2.0) will be randomly assigned to Group PM+/enhanced care as usual (Group PM+/E-CAU) (n = 190) or E-CAU (n = 190). Outcome assessments will take place 1 week after the fifth session (post-assessment), 3 months after the fifth session and 12 months after baseline assessment. The primary outcome is psychological distress as measured by the Hopkins Symptom Checklist (HSCL-25). Secondary outcomes include functional impairment, post-traumatic stress symptoms, self-identified problems, and health system and productivity costs. A process evaluation will be conducted to explore the feasibility, challenges and success of the intervention with 25 participants, including participants, facilitators, policy makers and mental health professionals. DISCUSSION: The treatment manual of the Syrian-Arabic Group PM+ and training materials will be made available through the WHO once the effectiveness and cost-effectiveness of Group PM+ have been established. TRIAL REGISTRATION: Clinical Trial Registration: ClinicalTrials.gov Identifier NCT03960892. Unique protocol ID: 10/2017. Prospectively registered on 21 May 2019.

Acute Assessment of Traumatic Brain Injury and Post-Traumatic Stress After Exposure to a Deployment-Related Explosive Blast.

Introduction: Traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD) are two of the signature injuries in military service members who have been exposed to explosive blasts during deployments to Iraq and Afghanistan. Acute stress disorder (ASD), which occurs within 2-30 d after trauma exposure, is a more immediate psychological reaction predictive of the later development of PTSD. Most previous studies have evaluated service members after their return from deployment, which is often months or years after the initial blast exposure. The current study is the first large study to collect psychological and neuropsychological data from active duty service members within a few days after blast exposure. Materials and Methods: Recruitment for blast-injured TBI patients occurred at the Air Force Theater Hospital, 332nd Air Expeditionary Wing, Joint Base Balad, Iraq. Patients were referred from across the combat theater and evaluated as part of routine clinical assessment of psychiatric and neuropsychological symptoms after exposure to an explosive blast. Four measures of neuropsychological functioning were used: the Military Acute Concussion Evaluation (MACE); the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS); the Headminder Cognitive Stability Index (CSI); and the Automated Neuropsychological Assessment Metrics, Version 4.0 (ANAM4). Three measures of combat exposure and psychological functioning were used: the Combat Experiences Scale (CES); the PTSD Checklist-Military Version (PCL-M); and the Acute Stress Disorder Scale (ASDS). Assessments were completed by a deployed clinical psychologist, clinical social worker, or mental health technician. Results: A total of 894 patients were evaluated. Data from 93 patients were removed from the data set for analysis because they experienced a head injury due to an event that was not an explosive blast (n = 84) or they were only assessed for psychiatric symptoms (n = 9). This resulted in a total of 801 blast-exposed patients for data analysis. Because data were collected in-theater for the initial purpose of clinical evaluation, sample size varied widely between measures, from 565 patients who completed the MACE to 154 who completed the CES. Bivariate correlations revealed that the majority of psychological measures were significantly correlated with each other (ps ≤ 0.01), neuropsychological measures were correlated with each other (ps ≤ 0.05), and psychological and neuropsychological measures were also correlated with each other (ps ≤ 0.05). Conclusions: This paper provides one of the first descriptions of psychological and neuropsychological functioning (and their inter-correlation) within days after blast exposure in a large sample of military personnel. Furthermore, this report describes the methodology used to gather data for the acute assessment of TBI, PTSD, and ASD after exposure to an explosive blast in the combat theater. Future analyses will examine the common and unique symptoms of TBI and PTSD, which will be instrumental in developing new assessment approaches and intervention strategies.

Evaluating effectiveness and cost-effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict-affected rural Pakistan: study protocol for a randomised controlled trial.

BACKGROUND: The impact of humanitarian disasters upon mental health is well recognised. The evidence for psychological interventions for mental health is mounting, but few interventions have been rigorously tested in humanitarian settings. To be sustainable in humanitarian settings interventions need to be short, simple, deliverable by nonspecialists under supervision, and adopt a transdiagnostic approach where an array of mental health outcomes are addressed simultaneously. These elements have been incorporated into the newly developed WHO Problem Management Plus (PM+) Group intervention. The aim of this trial is to evaluate the locally adapted PM+ Group intervention for women in Swat, Pakistan. METHODS: This PM+ Group trial is a two-arm, single-blind, cluster randomised controlled trial conducted in a community-based setting with women in rural Pakistan. PM+ is delivered in partnership with the Lady Health Worker (LHW) Programme which provides community-based health care to women in Pakistan. Thirty-four LHW clusters will be randomised in a 1:1 allocation ratio using a permuted-block randomisation method. Participants screened and found to meet the inclusion criteria will be allocated to either the PM+ intervention group (n = 306), or the control arm (n = 306). The manualised PM+ intervention involves five sessions, each lasting 3 h, and introduces four strategies applied by participants to problems that they are facing. It is delivered by local female facilitators with a minimum of 16 years of education who are provided with targeted training and supervision. The primary outcome is individual psychological distress, measured by levels of anxiety and depression on the Hospital Anxiety and Depression Scale at 20 weeks after baseline. Secondary outcomes include major depression, post-traumatic stress disorder, levels of social support, levels of functioning, and economic effectiveness. Intervention acceptability will be explored through an embedded qualitative study. DISCUSSION: The PM+ Group trial will provide important evidence on the effectiveness of an empirically supported psychological treatment delivered by nonspecialists in a humanitarian setting. If proven effective, the qualitative component will inform strategies for PM+ Group scale-up in health systems in other humanitarian settings. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, identifier: ACTRN12616000037404. Registered on 19 January 2016; WHO Protocol ID RPC705, v.4, 2 November 2015.

Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial.

Importance: The mental health consequences of conflict and violence are wide-ranging and pervasive. Scalable interventions to address a range of mental health problems are needed. Objective: To test the effectiveness of a multicomponent behavioral intervention delivered by lay health workers to adults with psychological distress in primary care settings. Design, Setting, and Participants: A randomized clinical trial was conducted from November 1, 2014, through January 28, 2016, in 3 primary care centers in Peshawar, Pakistan, that included 346 adult primary care attendees with high levels of both psychological distress and functional impairment according to the 12-item General Health Questionnaire and the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Interventions: Lay health workers administered 5 weekly 90-minute individual sessions that included empirically supported strategies of problem solving, behavioral activation, strengthening social support, and stress management. The control was enhanced usual care. Main Outcomes and Measures: Primary outcomes, anxiety and depression symptoms, were independently measured at 3 months with the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes were posttraumatic stress symptoms (Posttraumatic Stress Disorder Checklist for DSM-5), functional impairment (WHODAS 2.0), progress on problems for which the person sought help (Psychological Outcome Profiles), and symptoms of depressive disorder (9-item Patient Health Questionnaire). Results: Among 346 patients (mean [SD] age, 33.0 [11.8] years; 78.9% women), 172 were randomly assigned to the intervention and 174 to enhanced usual care; among them, 146 and 160 completed the study, respectively. At baseline, the intervention and control groups had similar mean (SD) HADS scores on symptoms of anxiety (14.16 [3.17] vs 13.64 [3.20]; adjusted mean difference [AMD], 0.52; 95% CI, -0.22 to 1.27) and depression (12.67 [3.27] vs 12.49 [3.34]; AMD, 0.17, 95% CI, -0.54 to 0.89). After 3 months of treatment, the intervention group had significantly lower mean (SD) HADS scores than the control group for anxiety (7.25 [3.63] vs 10.03 [3.87]; AMD, -2.77; 95% CI, -3.56 to -1.98) and depression (6.30 [3.40] vs 9.27 [3.56]; AMD, -2.98; 95% CI, -3.74 to -2.22). At 3 months, there were also significant differences in scores of posttraumatic stress (AMD, -5.86; 95% CI, -8.53 to -3.19), functional impairment (AMD, -4.17; 95% CI, -5.84 to -2.51), problems for which the person sought help (AMD, -1.58; 95% CI, -2.40 to -0.77), and symptoms of depressive disorder (AMD, -3.41; 95% CI, -4.49 to -2.34). Conclusions and Relevance: Among adults impaired by psychological distress in a conflict-affected area, lay health worker administration of a brief multicomponent intervention based on established behavioral strategies, compared with enhanced usual care, resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months. Trial Registration: anzctr.org.au Identifier: ANZCTR12614001235695.

Advantages and psychometric validation of proximal intensive assessments of patient-reported outcomes collected in daily life.

OBJECTIVES: Ambulatory assessment data collection methods are increasingly used to study behavior, experiences, and patient-reported outcomes (PROs), such as emotions, cognitions, and symptoms in clinical samples. Data collected close in time at frequent and fixed intervals can assess PROs that are discrete or changing rapidly and provide information about temporal dynamics or mechanisms of change in clinical samples and individuals, but clinical researchers have not yet routinely and systematically investigated the reliability and validity of such measures or their potential added value over conventional measures. The present study provides a comprehensive, systematic evaluation of the psychometrics of several proximal intensive assessment (PIA) measures in a clinical sample and investigates whether PIA appears to assess meaningful differences in phenomena over time. METHODS: Data were collected on a variety of psychopathology constructs on handheld devices every 4 h for 7 days from 62 adults recently exposed to traumatic injury of themselves or a family member. Data were also collected on standard self-report measures of the same constructs at the time of enrollment, 1 week after enrollment, and 2 months after injury. RESULTS: For all measure scores, results showed good internal consistency across items and within persons over time, provided evidence of convergent, divergent, and construct validity, and showed significant between- and within-subject variability. CONCLUSIONS: Results indicate that PIA measures can provide valid measurement of psychopathology in a clinical sample. PIA may be useful to study mechanisms of change in clinical contexts, identify targets for change, and gauge treatment progress.