A real-world study of the first use of palbociclib for the treatment of advanced breast cancer within the UK National Health Service as part of the novel Ibrance® Patient Program.

BACKGROUND: The Ibrance® Patient Program was established to provide access to palbociclib for UK National Health Service (NHS) patients with metastatic breast cancer (MBC), pending a funding decision. METHODS: Non-interventional cohort study involving a retrospective medical record review of patients commenced on palbociclib between April and December 2017 at eight UK centres. Primary outcomes included clinicopathological characteristics, treatment patterns, clinical outcomes and selected adverse events. RESULTS: Overall, 191 patients were identified, median age of 57.0 years (range 24.3-90.9); 30% were diagnosed with de novo MBC; 72% received first-line and 10% as ≥ second-line treatment. Median progression-free survival (95% CI) was 22.8 months (16.5-not reached [NR]) in first-line; NR in patients with de novo MBC; 7.8 months (6.8-NR) in ≥ second-line (median follow-up: 24 months). Median overall survival (OS) was NR in the overall cohort; OS rate (95% CI) at 24 months was 74.2% (67.1-81.9%) in first-line; 82.1% (72.6-92.8%) in patients with de novo MBC; 55.0% (37.0-81.8%) in ≥ second-line. Forty-seven per cent of patients developed grade 3-4 neutropenia; 3% febrile neutropenia. CONCLUSION: This study supports the effectiveness of palbociclib and demonstrates the benefit to patients of early access schemes that bridge the gap between regulatory approval and NHS funding for new medicines. CLINICAL TRIAL REGISTRATION: Clinical trial: ClinicalTrial.gov:NCT03921866.

Military personnels' experience of deployment: An exploration of psychological trauma, protective influences, and resilience.

BACKGROUND: Military personnel are at a heightened risk of being exposed to potentially traumatic incidents in the line of duty. Evidence would suggest that the risk of developing psychological trauma and/or PTSD after a traumatic event is predicted by the interaction of pre-trauma, peri-trauma and post-trauma risk and protective factors. OBJECTIVE: This research will explore military personnels' experience of potentially traumatic events while deployed. In particular, the research aims to gain an understanding of both protective and risk factors which influence personnels' experience of potentially traumatic events. METHOD: One to one, semi-structured interviews were conducted with 12 members of the Irish Defence Forces. We conducted a thematic analysis in line with the recommendations provided by Braun & Clarke 2006. RESULTS: There was a wide variety of potentially traumatic events experienced by participants, ranging from stressful naval migrant rescues to armed standoffs. Aside from more pointed events, chronic stress was reported to negatively affect personal resilience while factors such as positive mindset and a belief in the mission had a galvanizing effect. Both the family back home and the "military family" were reported to provide sources of comfort and support, while at times being a source of significant stress. The organisational context of the military, including training and formal psychological supports was viewed with mixed opinions by our participants. CONCLUSIONS: The findings of this research illuminate the unique stress and strains faced by Irish military personnel at pre, peri and post deployment. The results highlight the need for effective predeployment resilience building programmes to equip personnel with the tools to deal with traumatic events. This foundational work provides the basis for further research into the military peacekeeper and humanitarian domain. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Pre-deployment programmes for building resilience in military and frontline emergency service personnel.

BACKGROUND: Military personnel and frontline emergency workers may be exposed to events that have the potential to precipitate negative mental health outcomes such as depression, symptoms of post-traumatic stress and even post-traumatic stress disorder (PTSD). Programmes have been designed to build psychological resilience before staff are deployed into the field. This review presents a synthesis of the literature on these "pre-deployment resilience-building programmes". OBJECTIVES: The objective of this review was to assess the effectiveness of programmes that seek to build resilience to potentially traumatic events among military and frontline emergency service personnel prior to their deployment. These resilience programmes were compared to other interventions, treatment as usual or no intervention. SEARCH METHODS: Studies were identified through searches of electronic databases including Ovid MEDLINE, Embase, PsycINFO, Web of Science and Google Scholar. The initial search took place in January 2019, with an updated search completed at the end of September 2020. SELECTION CRITERIA: Only studies that used a randomised controlled trial (RCT)/cluster-RCT methodology were included. The programmes being evaluated must have sought to build resilience prior to exposure to trauma. Study participants must have been 18 years or older and be military personnel or frontline emergency workers. DATA COLLECTION AND ANALYSIS: Studies that met the inclusion criteria were assembled. Data extracted included methods, participants' details, intervention details, comparator details, and information on outcomes. The primary outcomes of interest were resilience, symptoms of post-traumatic stress and PTSD. Secondary outcomes of interest included acute stress disorder, depression, social support, coping skills, emotional flexibility, self-efficacy, social functioning, subjective levels of aggression, quality of sleep, quality of life and stress. Assessment of risk of bias was also completed. A total of 28 studies were included in a narrative synthesis of results. MAIN RESULTS: All 28 included studies compared an experimental resilience building intervention versus a control or no intervention. There was a wide range of therapeutic modalities used, including cognitive behavioural therapy (CBT) informed programmes, biofeedback based programmes, stress-management programmes, mindfulness and relaxation programmes, neuropsychological-based programmes, and psychoeducational-informed programmes. The main outcomes are specified here, secondary outcomes such as depression, social support, coping skills, self-efficacy, subjective levels of aggression and stress are reported in text. No studies reported on the following pre-specified outcomes; acute stress disorder, emotional flexibility, social functioning, quality of sleep and quality of life. Resilience Eight studies reported resilience as an outcome. We narratively synthesised the data from these studies and our findings show that five of these interventions had success in building resilience in their respective samples. Two of the studies that reported significant results utilised a CBT approach to build resilience, while the other three successful programmes were mindfulness-based interventions. Symptoms of post-traumatic stress Our narrative synthesis of results included eight studies. Two of the eight studies produced significant reductions in symptoms of post traumatic stress compared to controls. These interventions used neuropsychological and biofeedback intervention models respectively. PTSD caseness Four studies reported PTSD caseness as an outcome. Our narrative synthesis of results suggests that evidence is mixed as to the effectiveness of these interventions in reducing clinical diagnosis of PTSD. One study of a neuropsychology-orientated Attention Bias Modification Training (AMBT) programme had success in reducing both symptoms of post-traumatic stress and numbers of participants receiving a diagnosis of PTSD. A stress-management programme reported that, when baseline differences in rates of pre-deployment mental health issues were controlled for, participants in the control condition were at 6.9 times the risk of a diagnosis of PTSD when compared to the intervention group. Given the diversity of intervention designs and theoretical orientations used (which included stress-management, neuropsychological and psychoeducational programmes), a definitive statement on the efficacy of pre-deployment programmes at reducing symptoms of post-traumatic stress and PTSD cannot be confidently offered. AUTHORS' CONCLUSIONS: While a number of evaluations of relevant programmes have been published, the quality of these evaluations limits our ability to determine if resilience-building programmes 'work' in terms of preventing negative outcomes such as depression, symptoms of post-traumatic stress and diagnoses of PTSD. Based on our findings we recommend that future research should: a) report pre-/post-means and standard deviation scores for scales used within respective studies, b) take the form of large, RCTs with protocols published in advance, and c) seek to measure defined psychological facets such as resilience, PTSD and stress, and measure these concepts using established psychometric tools. This will provide more certainty in future assessments of the evidence base. From a clinical implications point of view, overall there is mixed evidence that the interventions included in this review are effective at safe guarding military personnel or frontline emergency workers from experiencing negative mental health outcomes, including PTSD, following exposure to potentially traumatic events. Based on this, practitioners seeking to build resilience in their personnel need to be aware of the limitations of the evidence base. Practitioners should have modest expectations in relation to the efficacy of resilience-building programmes as a prophylactic approach to employment-related critical incident traumas.

Counter-narratives for the prevention of violent radicalisation: A systematic review of targeted interventions.

Background: In the field of terrorism research, the violent radicalisation of individuals towards perpetrating acts of terror has been the subject of academic enquiry for some time. One core focus by social scientists has been the role of narratives in this process. Narratives have the ability to present a socially constructed version of reality which serves the interest of the narrator(s). In the context of terrorism, by depicting violence as a viable antidote to individual vulnerabilities, the narratives purported for propagandistic purposes have the potential to thwart perceptions of instrumentality (a key characteristic of violent radicalisation). In order to prevent this from happening, researchers and counter-terrorism practitioners have increasingly sought to explore the potential for counter-narratives; targeted interventions that challenge the rationalisation(s) of violence purported in dominant narratives which, in turn, reconstructs the story. However, there is overwhelming consensus in both government and academic spheres that the concept of the counter-narrative is underdeveloped and, to date, there has been no synthesis of its effectiveness at targeting violent radicalisation-related outcomes. Objectives: The objective of this review was to provide a synthesis of the effectiveness of counter-narratives in reducing the risk of violent radicalisation. Search Methods: After a scoping exercise, the literature was identified through four search stages, including key-word searches of 12 databases, hand searches of reference lists of conceptual papers or books on the topic of counter-narratives, as well as direct contact with experts and professional agencies in the field. Selection Criteria: Studies adopting an experimental or quasiexperimental design where at least one of the independent variables involved comparing a counter-narrative to a control (or comparison exposure) were included in the review. Data Collection and Analysis: Accounting for duplicates, a total of 2,063 records were identified across two searches. Nineteen studies across 15 publications met the inclusion criteria. These studies were largely of moderate quality and 12 used randomised control trial designs with varying types of controls. The publication years ranged from 2000 to 2018, with the majority of studies published after 2015. The studies represented a range of geographical locations, but the region most heavily represented was North America. In most cases, the dominant narrative(s) "to-be-countered" comprised of hostile social constructions of an adversary or "out-group". The majority of studies challenged these dominant narratives through the use of stereotype-challenging, prosocial, or moral "exemplars". Other techniques included the use of alternative accounts, inoculation and persuasion. Results: In terms of risk factors for violent radicalisation, there was some disparity on intervention effectiveness. Overall, when pooling all outcomes, the intervention showed a small effect. However, the observed effects varied across different risk factors. Certain approaches (such as counter-stereotypical exemplars) were effective at targeting realistic threat perceptions, in-group favouritism and out-group hostility. However, there was no clear reduction in symbolic threat perceptions or implicit bias. Finally, there was a sparse yet discouraging evidence on the effectiveness of counter-narrative interventions at targeting primary outcomes related to violent radicalisation, such as intent to act violently. Authors' Conclusions: The review contributes to existing literature on violent radicalisation-prevention, highlighting the care and complexity needed to design and evaluate narrative-based interventions which directly counter existing, dominant narratives. The authors note the challenges of conducting high-quality research in the area, but nonetheless encourage researchers to strive for experimental rigour within these confines.