Outcomes in patients treated with loop diuretics without a diagnosis of heart failure: a retrospective cohort study.

BACKGROUND: Loop diuretics are commonly prescribed in the community, not always to patients with a recorded diagnosis of heart failure (HF). The rate of HF events in patients prescribed loop diuretics without a diagnosis of HF is unknown. METHODS: This was a propensity-matched cohort study using data from the Clinical Practice Research Datalink, Hospital Episode Statistics and Office of National Statistics in the UK. Patients prescribed a loop diuretic without a diagnosis of HF (loop diuretic group) between 1 January 2010 and 31 December 2015 were compared with patients with HF (HF group)-analysis A, and patients with risk factors for HF (either ischaemic heart disease, or diabetes and hypertension-at-risk group)-analysis B. The primary endpoint was an HF event (a composite of presentation with HF symptoms, HF hospitalisation, HF diagnosis (analysis B only) and all-cause mortality). RESULTS: From a total population of 180 384 patients (78 968 in the loop diuretic group, 28 177 in the HF group and 73 239 in the at-risk group), there were 59 694 patients, 22 352 patients and 57 219 patients in the loop diuretic, HF and at-risk groups, respectively, after exclusion criteria were applied. After propensity matching for age, sex and comorbidities, patients in the loop diuretic group had a similar rate of HF events as those in the HF group (71.9% vs 72.1%; HR=0.92 (95% CI 0.90 to 0.94); p<0.001), and twice as those in the at-risk group (59.2% vs 35.7%; HR=2.04 (95% CI 2.00 to 2.08); p<0.001). CONCLUSIONS: Patients prescribed a loop diuretic without a recorded diagnosis of HF experience HF events at a rate comparable with that of patients with a recorded diagnosis of HF; many of these patients may have undiagnosed HF.

A randomised controlled trial of Pre-Operative Oncotype DX testing in early-stage breast cancer (PRE-DX study) - Study protocol.

BACKGROUND: The Oncotype DX® Breast Recurrence Score assay can guide recommendations made to patients with oestrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer regarding post-surgery adjuvant therapy. Standard practice is to order the test in the post-operative setting on a specimen from the excised invasive carcinoma. However, it has been shown to be technically possible to perform the test on the diagnostic core biopsy. By testing the diagnostic core biopsy in the pre-operative setting, the wait for excised invasive carcinoma Recurrence Score results could be reduced allowing patients to be more accurately counselled regarding their treatment pathway sooner with any adjuvant treatment recommendations expedited. This would allow for more efficient streaming of follow up appointments. The aim of this study is to compare the impact on the patient treatment pathway of performing the Oncotype DX® test on the diagnostic core biopsy pre-operatively (intervention) as opposed to the excised invasive carcinoma (control). METHODS AND ANALYSIS: This parallel group randomised controlled trial aims to recruit 330 newly diagnosed patients with grade 2 or grade 3, ER+, HER2-, invasive intermediate risk early-stage breast cancer. Participants will be randomised 2:1 to the preoperative testing of the diagnostic core biopsy compared to the post-operative testing of the excision specimen. The primary endpoint is number of clinical touchpoints between treating team and patient from initial approach until offer and prescription of the first adjuvant treatment. Secondary endpoints include time from diagnosis to offer and prescription of the first adjuvant treatment, patient-reported anxiety scores and health cost impact analysis collected at baseline, following the post-operative clinic and following the offer of adjuvant treatment, and number of alterations in treatment sequence from original planned surgical treatment to neoadjuvant therapy. TRIAL REGISTRATION: The study was registered on ISRCTN (ISRCTN14337451) on the 16th August 2022.

A pipeline for rapidly evaluating activity and inferring mechanisms of action of prospective antifungal compounds.

BACKGROUND: Fungal phytopathogens are a significant threat to crops and food security, and there is a constant need to develop safe and effective compounds that antagonize them. In-planta assays are complex and tedious and are thus not suitable for initial high-throughput screening of new candidate antifungal compounds. We propose an in vitro screening pipeline that integrates five rapid quantitative and qualitative methods to estimate the efficacy and mode of action of prospective antifungal compounds. RESULTS: The pipeline was evaluated using five documented antifungal compounds (benomyl, catechol, cycloheximide, 2,4-diacetylphloroglucinol, and phenylacetic acid) that have different modes of action and efficacy, against the model soilborne fungal pathogen Fusarium oxysporum f. sp. radicis cucumerinum. We initially evaluated the five compounds' ability to inhibit fungal growth and metabolic activity using green fluorescent protein (GFP)-labeled F. oxysporum and PrestoBlue staining, respectively, in multiwell plate assays. We tested the compounds' inhibition of both conidial germination and hyphal elongation. We then employed FUN-1 and SYTO9/propidium iodide staining, coupled to confocal microscopy, to differentiate between fungal growth inhibition and death at the cellular level. Finally, using a reactive oxygen species (ROS)-detection assay, we were able to quantify ROS production in response to compound application. CONCLUSIONS: Collectively, the proposed pipeline provides a wide array of quantitative and qualitative data on the tested compounds that can help pinpoint promising novel compounds; these can then be evaluated more vigorously using in planta screening assays. © 2024 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

Effectiveness of trauma-focused cognitive behavioral therapy compared to psychosocial counseling in reducing HIV risk behaviors, substance use, and mental health problems among orphans and vulnerable children in Zambia: a community-based randomized controlled trial.

Orphans and vulnerable children (OVC) in sub-Saharan Africa are at high risk for HIV infection and transmission. HIV prevention and treatment efforts with OVC are hindered by mental health and substance use problems. This randomized controlled trial compared a mental health intervention, Trauma Focused Cognitive Behavioral Therapy (TF-CBT), to an enhanced version of an existing HIV Psychosocial Counseling (PC+) program among 610 adolescents who met PEPFAR criteria for OVC and had HIV risk behaviors in Lusaka, Zambia. Outcomes included HIV risk behaviors (e.g., risky sexual behaviors), mental health (internalizing symptoms, externalizing behaviors, PTSD) and substance use. At 12-month follow-up, there were significant within group reductions in both groups for all outcomes, with the only significant between group difference being for substance use, in which OVC who received TF-CBT had significantly greater reductions than OVC who received PC+. In a subgroup analysis of OVC with high levels of PTSD symptoms, TF-CBT was superior to PC + in reducing internalizing symptoms, functional impairment, and substance use. Findings support TF-CBT for reducing substance use among OVC. Subgroup analysis results suggest that a robust intervention such as TF-CBT is warranted for OVC with significant mental and behavioral health comorbidities. The similar performance of TF-CBT and PC + in the overall sample for risky sexual behavior and mild mental health problems indicates that enhancing existing psychosocial programs, such as PC, with standard implementation factors like having a defined training and supervision schedule (as was done to create PC+) may improve the efficacy of HIV risk reduction efforts.Clinical Trials Number: NCT02054780.

Family-Based Psychosocial Care for Transgender and Gender-Diverse Children and Youth.

Parental and caregiver inclusion is critical in providing psychosocial care for transgender and gender-diverse (TGD) children and adolescents. High levels of trauma among TGD youth call for the use of evidence-based models and resources to decrease family rejection and increase affirmation and support while healing trauma that is both related to and unrelated to the child's gender identity and expression. The integrated Family Acceptance Project-Trauma-Focused Cognitive Behavioral Therapy treatment model provides a structured and effective approach to engaging TGD youth with trauma and their parents.

Modified-release morphine or placebo for chronic breathlessness: the MABEL trial protocol.

Chronic breathlessness, a persistent and disabling symptom despite optimal treatment of underlying causes, is a frightening symptom with serious and widespread impact on patients and their carers. Clinical guidelines support the use of morphine for the relief of chronic breathlessness in common long-term conditions, but questions remain around clinical effectiveness, safety and longer term (>7 days) administration. This trial will evaluate the effectiveness of low-dose oral modified-release morphine in chronic breathlessness. This is a multicentre, parallel group, double-blind, randomised, placebo-controlled trial. Participants (n=158) will be opioid-naïve with chronic breathlessness due to heart or lung disease, cancer or post-coronavirus disease 2019. Participants will be randomised 1:1 to 5 mg oral modified-release morphine/placebo twice daily and docusate/placebo 100 mg twice daily for 56 days. Non-responders at Day 7 will dose escalate to 10 mg morphine/placebo twice daily at Day 15. The primary end-point (Day 28) measure will be worst breathlessness severity (previous 24 h). Secondary outcome measures include worst cough, distress, pain, functional status, physical activity, quality of life, and early identification and management of morphine-related side-effects. At Day 56, participants may opt to take open-label, oral modified-release morphine as part of usual care and complete quarterly breathlessness and toxicity questionnaires. The study is powered to be able to reject the null hypothesis and an embedded normalisation process theory-informed qualitative substudy will explore the adoption of morphine as a first-line pharmacological treatment for chronic breathlessness in clinical practice if effective.

Structural equation modeling of treatment-related changes in neural connectivity for youth with PTSD.

BACKGROUND: Previous studies suggest that improvement in symptoms of posttraumatic stress disorder (PTSD) is accompanied by changes in neural connectivity, however, few studies have investigated directional (effective) connectivity. The current study assesses treatment-related changes in effective connectivity in youth with PTSD undergoing Trauma-Focused Cognitive Behavioral Therapy (TF-CBT). METHODS: Functional MRI scans before and after 16 weeks of TF-CBT for 20 youth with PTSD, or the same time interval for 20 healthy controls (HC) were included in the analysis. Structural equation modeling was used to model group differences in directional connectivity at baseline, and changes in connectivity from pre- to post-treatment. RESULTS: At baseline, the PTSD group, relative to the HC group, had significantly greater connectivity in the path from dorsal cingulate to anterior cingulate and from dorsal cingulate to posterior cingulate corticies. From pre- to post-treatment, connectivity in these paths decreased significantly in the PTSD group, as did connectivity from right hippocampus to left superior temporal gyrus. Connectivity from the left amygdala to the lateral orbital frontal cortex was significantly lower in PTSD vs HC at baseline, but did not change from pre- to post-treatment. CONCLUSION: Although based on a small sample, these results converge with previous studies in suggesting a central role for the dorsal cingulate cortex in PTSD symptoms. The direction of this connectivity suggests that the dorsal cingulate is the source of modulation of anterior and posterior cingulate cortex during trauma-focused cognitive behavioral therapy.

Improving asthma care through implementation of the SENTINEL programme: findings from the pilot site.

Aim: Short-acting ß2-agonist (SABA) overuse adversely impacts asthma-related outcomes and the environment. The SABA rEductioN Through ImplemeNting Hull asthma guidELines (SENTINEL) programme aims to reduce SABA overuse through supported implementation of an adult asthma guideline, which advocates for a SABA-free maintenance and reliever therapy (MART)-preferred treatment where appropriate, across six primary care networks (PCNs) in the UK. We present findings on patient/disease characteristics, asthma prescribing patterns and exacerbation rates from the pilot PCN. Methods: Patients (aged ≥18 years, prescribed at least one inhaled therapy) and their prescribed asthma treatments were characterised using National Health Service data. Asthma treatments and exacerbations were analysed for three periods: 24‒12 months pre-, 12 months pre- and 12 months post-SENTINEL implementation (November 2020‒January 2021). Results: Of the 2571 registered asthma patients, 33.6% (n=864) underwent an asthma review, of whom 44.7% (n=386) were transitioned to MART. Fewer patients were prescribed three or more SABA canisters per year post-implementation in the overall asthma population (45.4% and 46.2% during 24‒12 months and 12 months pre-implementation, respectively, and 23.9% 12 months post-implementation), and in the two subgroups: 1) those who had an asthma review (74.5% and 83.6% during 24‒12 months and 12 months pre-implementation, respectively, and 26.5% post-implementation); and 2) those transitioned to MART following a review (76.4% and 86.5% during 24‒12 months and 12 months pre-implementation, respectively, and 16.3% post-implementation). A higher proportion of patients were exacerbation-free post-implementation in the overall asthma population and in the two subgroups. At least 71.5% of patients transitioned to MART were still prescribed MART 12 months post-implementation, of whom ≥86.7% were SABA-free. Conclusion: SENTINEL implementation led to reduced SABA prescribing, increased inhaled corticosteroid uptake and fewer asthma exacerbations. MART was considered appropriate for ∼50% of reviewed patients, with improved prescribing patterns sustained post-implementation.

Implementation of an evidence-based trauma-focused treatment for traumatised children and their families during the war in Ukraine: a project description.

The full-scale invasion of Ukraine by Russia in February 2022 led to an increase of traumatic events and mental health burden in the Ukrainian general population. The (ongoing) traumatisation can have a crucial impact on children and adolescents as they are especially vulnerable for developing trauma-related disorders such as Post Traumatic Stress Disorder (PTSD) or Depression. To date, these children have only very limited access to trauma-focused evidence-based treatments (EBTs) by trained mental health specialists in Ukraine. The fast and effective implementation of these treatments in Ukraine is crucial to improve the psychological wellbeing of this vulnerable population. This letter to the editor describes an ongoing project which implements a trauma-focused EBT called 'Trauma-Focused Cognitive Behavioural Therapy' (TF-CBT) in Ukraine during the war. In collaboration with Ukrainian and international agencies, the project 'TF-CBT Ukraine' was developed and implemented starting in March 2022. The project entails a large training programme for Ukrainian mental health specialists and the implementation of TF-CBT with children and their families in and from Ukraine. All components of the project are scientifically evaluated on a patient and therapist level, cross-sectionally and longitudinally, in a mixed-methods design. All together nine training cohorts with N = 133 Ukrainian therapists started the programme, all monthly case consultations (15 groups) and treatments of patients are still ongoing. Lessons learnt from this first large-scale implementation project on an EBT for children and adolescents impacted by trauma in Ukraine will help inform the field on challenges and also possibilities to expand such efforts. On a broader level, this project could be one small step in the process of helping children overcome the negative effects and experience resilience in the context of a war-torn nation.

Effectiveness of abbreviated trauma-focused cognitive behavioural therapy for South African adolescents: a randomized controlled trial.

Background: In low- and middle- income countries (LMICs) trauma exposure among youth is high, but mental health services are critically under-resourced. In such contexts, abbreviated trauma treatments are needed.Objective: To evaluate the efficacy of an abbreviated eight-session version of Trauma-Focused Cognitive Behavioural Therapy (TF-CBT) for improving posttraumatic stress disorder (PTSD) and depression symptoms in a sample of South African adolescents.Method: 75 trauma-exposed adolescents (21 males, 54 females; mean age = 14.92, range = 11-19) with posttraumatic stress disorder (PTSD) symptoms were randomly assigned to eight sessions of TF-CBT or to usual services. At baseline, post-treatment and three-month follow-up, participants completed the Child PTSD Symptom Scale for DSM 5 (CPSS-5) and the Beck Depression Inventory II (BDI-II). The trial is registered on the Pan African Trial Registry (PACTR202011506380839).6.Results: 95% of TF-CBT participants completed treatment while only 47% of TAU participants accessed treatment. Intention-to-treat analyses found that the TF-CBT group had a significantly greater reduction in CPSS-5 PTSD symptom severity at post-treatment (Cohen's d = 0. 60, p < .01) and three-month follow-up (Cohen's d = 0.62, p < . 01), and a greater reduction in the proportion of participants meeting the CPSS-5 clinical cut-off for PTSD at both time points (p = .02 and p = .03, respectively). There was also a significantly greater reduction in depression symptom severity in the TF-CBT group at post-treatment (Cohen's d = 0.51, p = .03) and three-month follow-up (Cohen's d = 0.41, p = .05), and a greater reduction in the proportion of TF-CBT participants meeting the BDI clinical cut-off for depression at both time points (p = .02 and p = .03, respectively).Conclusion: The findings provide preliminary evidence of the efficacy of an abbreviated eight-session version of TF-CBT for reducing PTSD and depression symptoms in a LMIC sample of adolescents with multiple trauma exposure.

Trauma-Focused Cognitive Behavioural Therapy (TF-CBT) is one of the leading evidence-based treatments for child and adolescent posttraumatic stress, but an abbreviated version has not been evaluated in low- and middle-income countries (LMICs).At post-treatment and three-month follow-up, eight sessions of TF-CBT were more effective than treatment-as-usual in reducing posttraumatic stress and depression symptoms in an LMIC sample of South African adolescents exposed to multiple traumas.Effect sizes were similar to those reported for standard length TF-CBT, indicating that abbreviated TF-CBT may be a suitable option for resource-constrained child and adolescent mental health services in LMICs.

The Cognitive Daisy (COG-D) for improving care for residents with dementia in care homes: protocol of a feasibility RCT.

BACKGROUND: Cognitive problems associated with dementia affect a large proportion of older adults living in residential care. Knowledge of cognitive impairments is important for providing person-centred care (PCC). The impact of specific cognitive impairments on residents' needs is often overlooked in dementia training and information about residents' individual cognitive profiles are frequently underspecified in care-plans, potentially undermining the delivery of PCC. This can lead to reduced resident quality of life and increased distressed behaviours-a major cause of staff stress and burnout. The COG-D package was developed to fill this gap. Daisies provide a visual representation of a resident's individual cognitive strengths and weaknesses in a colourful flower (Daisy) representing five cognitive domains. By viewing a resident's Daisy, care-staff can flexibly adjust in-the-moment care-decisions and can consult Daisies in care-plans for longer-term planning. The primary aim of this study is to assess the feasibility of implementing the COG-D package in residential care homes for older adults. METHODS/DESIGN: This 24-month feasibility cluster randomized controlled trial involves a 6-month intervention of the use of Cognitive Daisies in 8-10 residential care homes for older adults after training of care staff on the use of Cognitive Daisies in daily care (basic training) and on conducting the COG-D assessments with residents (advanced training). The key feasibility outcomes include % residents recruited, % COG-D assessments completed, and % staff completing the training. Candidate outcome measures for residents and staff will be obtained at baseline, and at 6 and 9 months post-randomization. COG-D assessments of residents will be repeated 6 months after the first assessment. A process evaluation will assess intervention implementation and barriers and facilitators to this through care-plan audits, interviews and focus groups with staff, residents, and relatives. Feasibility outcomes will be analysed against progression criteria to a full trial. DISCUSSION: The results of this study will provide important information about the feasibility of using COG-D in care homes and will inform the design of a future large-scale cluster RCT to assess the effectiveness and cost-effectiveness of the COG-D intervention in care homes. TRIAL REGISTRATION: This trial was registered on 28/09/2022 (ISRCTN15208844) and is currently open to recruitment.

Provision and delivery of survivorship care for adult patients with haematological malignancies: A scoping review protocol.

INTRODUCTION: Haematological malignancies are a heterogenous group of blood and lymphatic cancers. Survivorship care is a similarly diverse term concerning patients' health and wellbeing from diagnosis to end of life. Survivorship care for patients with haematological malignancies has traditionally been consultant-led and secondary care-based, although shifts away from this model have been occurring, largely via nurse-led clinics and interventions with some remote monitoring. However, there remains a lack of evidence regarding which model is most appropriate. Although previous reviews exist, patient populations, methodologies, and conclusions are varied, and further high-quality research and evaluation has been recommended. AIMS: The aim of the scoping review this protocol describes is to summarise current evidence on the provision and delivery of survivorship care for adult patients diagnosed with a haematological malignancy, and to identify existing gaps to inform future research. METHODOLOGY: A scoping review will be carried out utilising Arksey and O'Malley's guidelines as its methodological framework. Studies published in the English language from December 2007 to the present will be searched on bibliographic databases, including Medline, CINAHL, PsycInfo, Web of Science, and Scopus. Papers' titles, abstracts, and full text will predominantly be screened by one reviewer with a second reviewer blind screening a proportion. Data will be extracted using a customised table developed in collaboration with the review team, and presented in tabular and narrative format, arranged thematically. Studies included will contain data regarding adult (25+) patients diagnosed with any haematological malignancy in combination with aspects related to survivorship care. The survivorship care elements could be delivered by any provider within any setting, but should be delivered pre- or post-treatment, or to patients on a watchful waiting pathway. REGISTRATION: The scoping review protocol has been registered on the Open Science Framework (OSF) repository Registries (https://osf.io/rtfvq; DOI: 10.17605/OSF.IO/RTFVQ).

Short- and long-term effects of continuous compost amendment on soil microbiome community.

Organic amendment, and especially the use of composts, is a well-accepted sustainable agricultural practice. Compost increases soil carbon and microbial biomass, changes enzymatic activity, and enriches soil carbon and nitrogen stocks. However, relatively little is known about the immediate and long-term temporal dynamics of agricultural soil microbial communities following repeated compost applications. Our study was conducted at two field sites: Newe Ya'ar (NY, Mediterranean climate) and Gilat (G, semi-arid climate), both managed organically over 4 years under either conventional fertilization (0, zero compost) or three levels of compost amendment (20, 40 and 60 m3/ha or 2, 4, 6 L/m2). Microbial community dynamics in the soils was examined by high- and low-time-resolution analyses. Annual community composition in compost-amended soils was significantly affected by compost amendment levels in G (first, second and third years) and in NY (third year). Repeated sampling at high resolution (9-10 times over 1 year) showed that at both sites, compost application initially induced a strong shift in microbial communities, lasting for up to 1 month, followed by a milder response. Compost application significantly elevated alpha diversity at both sites, but differed in the compost-dose correlation effect. We demonstrate higher abundance of taxa putatively involved in organic decomposition and characterized compost-related indicator taxa and a compost-derived core microbiome at both sites. Overall, this study describes temporal changes in the ecology of soil microbiomes in response to compost vs. conventional fertilization.

Mixed-methods feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE): study findings.

Introduction: One-fifth of emergency department presentations by ambulance are due to acute-on-chronic breathlessness. We explored the feasibility of an evaluation-phase, cluster randomised controlled trial (cRCT) of the effectiveness and cost-effectiveness of a paramedic-administered, non-pharmacological breathlessness intervention for people with acute-on-chronic breathlessness at ambulance call-out (BREATHE) regarding breathlessness intensity and conveyance to hospital. Methods: This mixed-methods, feasibility cRCT (ISRCTN80330546) randomised paramedics to usual care or intervention plus usual care. Retrospective patient consent to use call-out data (primary end-point) and prospective patient/carer consent for follow-up was sought. Potential primary outcomes included breathlessness intensity (numerical rating scale) and conveyance. Follow-up included: interviews with patients/carers and questionnaires at 14 days, 1 and 6 months; paramedic focus groups and surveys. Results: Recruitment was during COVID-19, with high demands on paramedics and fewer call-outs by eligible patients. We enrolled 29 paramedics; nine withdrew. Randomisation/trial procedures were acceptable. Paramedics recruited 13 patients, not meeting recruitment target (n=36); eight patients and three carers were followed-up. Data quality was good but insufficient for future sample size estimation. The intervention did not extend call-out time, was delivered with fidelity and was acceptable to patients, carers and paramedics. There were no repeat call-outs within 48 h. All trained paramedics strongly recommended BREATHE as a highly relevant, simple intervention. Conclusion: Patient recruitment to target was not feasible during the pandemic. Training and intervention were acceptable and delivered with fidelity. Results include valuable information on recruitment, consent, attrition and data collection that will inform the design and delivery of a definitive trial.

Cortical activation predicts posttraumatic improvement in youth treated with TF-CBT or CCT.

BACKGROUND: Identifying neural activation patterns that predict youths' treatment response may aid in the development of imaging-based assessment of emotion dysregulation following trauma and foster tailored intervention. Changes in cortical hemodynamic activity measured with functional near-infrared spectroscopy (fNIRS) may provide a time and cost-effective option for such work. We examined youths' PTSD symptom change following treatment and tested if previously identified activation patterns would predict treatment response. METHODS: Youth (N = 73, mean age = 12.97, SD = 3.09 years) were randomly assigned to trauma-focused cognitive behavioral therapy (TF-CBT), cue-centered therapy (CCT), or treatment as usual (TAU). Parents and youth reported on youth's PTSD symptoms at pre-intervention, post-intervention, and follow-up. Neuroimaging data (N = 31) assessed at pre-intervention were obtained while youth engaged in an emotion expression task. Treatment response slopes were calculated for youth's PTSD symptoms. RESULTS: Overall, PTSD symptoms decreased from pre-intervention through follow-up across conditions, with some evidence of relative benefit of TF-CBT and CCT over TAU but significant individual variation in treatment response. Cortical activation patterns were correlated with PTSD symptom improvement slopes (r = 0.53). In particular, cortical responses to fearful and neutral facial stimuli in six fNIRS channels in the bilateral dlPFC were important predictors of PTSD symptom improvement. CONCLUSIONS: The use of fNIRS provides a method of monitoring and assessing cortical activation patterns in a relatively inexpensive and portable manner. Associations between functional activation and youths' PTSD symptoms improvement may be a promising avenue for understanding emotion dysregulation in clinical populations.

Subjective distress, self-harm, and suicidal ideation or behavior throughout trauma-focused cognitive-behavioral therapy in transitional age youth.

OBJECTIVE: Elevations in distress, self-harm, and suicidal ideation or behavior are of significant concern in clinical practice. We examined these in a pilot trial of Trauma Focused-Cognitive Behavioral Therapy (TF-CBT) for transitional age youth (aged 15-25 years) with histories of interpersonal trauma and symptoms of posttraumatic stress disorder. METHOD: Participants were 20 young people (13 females, M = 19.5 years) from a pilot study of TF-CBT. Frequencies of elevated distress, self-harm, and suicidal ideation or behavior were measured throughout treatment sessions and across the treatment phases of TF-CBT. RESULTS: Across the 279 sessions of TF-CBT (m = 15.5 sessions), there were 16 incidents of elevated distress in seven participants (i.e., six in Phase I and five each in Phases II and III); 15 incidents of self-harming behavior in seven participants (five incidents in each of the three phases) and one incident of both elevated distress and suicide ideation (Phase I). CONCLUSION: Findings indicate that there may be a relationship between the experience of in session distress and self-harming behaviors. The importance of safety planning and coping skills (acquired in Phase 1) is stressed to ensure the effective implementation of TF-CBT. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Trauma-focused cognitive behavioral therapy with Puerto Rican youth in a post-disaster context: Tailoring, implementation, and program evaluation outcomes.

PURPOSE: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) has not yet been systematically evaluated in the Caribbean context, particularly with Hispanic youth exposed to multiple disasters. The objective of this project was twofold: 1) to train mental health providers in Puerto Rico in TF-CBT as part of a clinical implementation project within the largest managed behavioral health organization (MBHO) on the island, and 2) to conduct a program evaluation to determine the feasibility of implementation and the effectiveness of the treatment. METHOD: Fifteen psychologists were trained in TF-CBT. These psychologists then provided TF-CBT to 56 children and adolescents, ages 5-18, in community-based mental health clinics and one primary care clinic with a co-located psychologist in Puerto Rico. The mean number of traumatic events reported by youth referred for TF-CBT was 4.11. RESULTS: Thirty-six out of 56 children enrolled in the project (64.3%) successfully completed all components of TF-CBT. Results demonstrated large effect sizes for reduction in youth-reported posttraumatic stress symptoms (PTSS) (Cohen's d = 1.32), depressive symptoms (Cohen's d = 1.32), and anxiety symptoms (Cohen's d = 1.18). CONCLUSIONS: These results suggest that it was feasible to train providers in TF-CBT, that providers were able to deliver TF-CBT in community-based settings both in person and via telehealth (due to the COVID-19 pandemic), and that TF-CBT was an effective treatment option to address trauma-related concerns for youth in Puerto Rico in a post-disaster context. This project is an important first step in the dissemination and implementation of evidence-based trauma-focused treatment for Hispanic youth and disaster-affected youth in the Caribbean.

Child and parent secondary outcomes in stepped care versus standard care treatment for childhood trauma.

INTRODUCTION: Stepped care trauma-focused cognitive behavioral therapy (SC-TF-CBT) is comparable in efficacy to standard TF-CBT for child posttraumatic stress symptoms (PTSS), but less is known about the effectiveness of SC-TF-CBT on child and parent secondary outcomes. The aim of this community-based randomized clinical trial was to compare child- and caregiver-secondary outcomes among SC-TF-CBT versus TF-CBT participants. METHODS: Children (ages 4 to 12) with PTSS and their caregivers were randomly assigned to either SC-TF-CBT (n = 91) or TF-CBT (n = 92). Secondary child (internalizing and externalizing behavior problems, anger outburst and sleep disturbances) and parent outcomes (PTSS, depression symptoms, and parenting stress) were measured at baseline, post-treatment and 6- and 12-month follow-up. RESULTS: There were comparable changes at all-time points in child and caregiver secondary outcomes. Non-inferiority tests indicated that for completers and intent-to-treat samples, SC-TF-CBT was non-inferior to TF-CBT for all outcomes except parenting stress at 6-months. The analysis with completers did not support non-inferiority at post-treatment for internalizing and externalizing problems and at 6- and 12-month follow-up assessments for externalizing problems, but the intent-to-treat analysis did support non-inferiority. LIMITATIONS: Limitations included modest rates of attrition, excluding in vivo component for standard TF-CBT, parent-only assessments, and no control condition. CONCLUSIONS: SC-TF-CBT is an effective alternative treatment method although parents with high stress may need more support and children with externalizing problems may need more standard TF-CBT sessions.

Endometrial scratch to increase live birth rates in women undergoing first-time in vitro fertilisation: RCT and systematic review.

BACKGROUND: In vitro fertilisation is a widely used reproductive technique that can be undertaken with or without intracytoplasmic sperm injection. The endometrial scratch procedure is an in vitro fertilisation 'add-on' that is sometimes provided prior to the first in vitro fertilisation cycle, but there is a lack of evidence to support its use. OBJECTIVES: (1) To assess the clinical effectiveness, safety and cost-effectiveness of endometrial scratch compared with treatment as usual in women undergoing their first in vitro fertilisation cycle (the 'Endometrial Scratch Trial') and (2) to undertake a systematic review to combine the results of the Endometrial Scratch Trial with those of previous trials in which endometrial scratch was provided prior to the first in vitro fertilisation cycle. DESIGN: A pragmatic, multicentre, superiority, open-label, parallel-group, individually randomised controlled trial. Participants were randomised (1 : 1) via a web-based system to receive endometrial scratch or treatment as usual using stratified block randomisation. The systematic review involved searching electronic databases (undertaken in January 2020) and clinicaltrials.gov (undertaken in September 2020) for relevant trials. SETTING: Sixteen UK fertility units. PARTICIPANTS: Women aged 18-37 years, inclusive, undergoing their first in vitro fertilisation cycle. The exclusion criteria included severe endometriosis, body mass index ≥ 35 kg/m2 and previous trauma to the endometrium. INTERVENTIONS: Endometrial scratch was undertaken in the mid-luteal phase of the menstrual cycle prior to in vitro fertilisation, and involved inserting a pipelle into the cavity of the uterus and rotating and withdrawing it three or four times. The endometrial scratch group then received usual in vitro fertilisation treatment. The treatment-as-usual group received usual in vitro fertilisation only. MAIN OUTCOME MEASURES: The primary outcome was live birth after completion of 24 weeks' gestation within 10.5 months of egg collection. Secondary outcomes included implantation, pregnancy, ectopic pregnancy, miscarriage, pain and tolerability of the procedure, adverse events and treatment costs. RESULTS: One thousand and forty-eight (30.3%) women were randomised to treatment as usual (n = 525) or endometrial scratch (n = 523) and were followed up between July 2016 and October 2019 and included in the intention-to-treat analysis. In the endometrial scratch group, 453 (86.6%) women received the endometrial scratch procedure. A total of 494 (94.1%) women in the treatment-as-usual group and 497 (95.0%) women in the endometrial scratch group underwent in vitro fertilisation. The live birth rate was 37.1% (195/525) in the treatment-as-usual group and 38.6% (202/523) in the endometrial scratch group: an unadjusted absolute difference of 1.5% (95% confidence interval -4.4% to 7.4%; p = 0.621). There were no statistically significant differences in secondary outcomes. Safety events were comparable across groups. No neonatal deaths were recorded. The cost per successful live birth was £11.90 per woman (95% confidence interval -£134 to £127). The pooled results of this trial and of eight similar trials found no evidence of a significant effect of endometrial scratch in increasing live birth rate (odds ratio 1.03, 95% confidence interval 0.87 to 1.22). LIMITATIONS: A sham endometrial scratch procedure was not undertaken, but it is unlikely that doing so would have influenced the results, as objective fertility outcomes were used. A total of 9.2% of women randomised to receive endometrial scratch did not undergo the procedure, which may have slightly diluted the treatment effect. CONCLUSIONS: We found no evidence to support the theory that performing endometrial scratch in the mid-luteal phase in women undergoing their first in vitro fertilisation cycle significantly improves live birth rate, although the procedure was well tolerated and safe. We recommend that endometrial scratch is not undertaken in this population. TRIAL REGISTRATION: This trial is registered as ISRCTN23800982. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 10. See the NIHR Journals Library website for further project information.

The endometrial scratch is a simple procedure that involves 'scratching' the lining of the womb (the endometrium). Several small studies have shown that undertaking this before the first in vitro fertilisation cycle may improve live birth rates; however, other studies have contradicted this. This large study was carried out to confirm whether or not having an endometrial scratch before the first in vitro fertilisation cycle would increase the number of women having a live birth compared with those having 'usual' in vitro fertilisation treatment (known as the 'control' group). We collected information about pregnancy, miscarriage, stillbirth, pain during the procedure and costs of treatment to find out if there were any meaningful differences. A total of 1048 women aged between 18 and 37 years were randomly allocated to the two groups, so participants had a 50% chance of having the endometrial scratch. Women were followed up throughout their pregnancy to ascertain the outcome of their in vitro fertilisation cycle. Although the live birth rate was 1.5% higher in the endometrial scratch group (38.6%) than in the control group (37.1%), the difference was not large enough to show any benefit of having the procedure. Other outcomes did not differ significantly between the two groups. However, the procedure was safe and tolerable. We found that the cost of treatment was, on average, £316 per participant higher in the group that received endometrial scratch than in the control group; the difference was not large enough to show that receiving endometrial scratch was more cost-effective. We combined the results of this trial with those of previous trials that looked to answer a similar question, and found that, overall, the endometrial scratch procedure does not enhance the chances of achieving a live birth. We conclude that endometrial scratch before first-time in vitro fertilisation does not improve the outcome of treatment, and we recommend that this procedure is not undertaken prior to a first cycle of in vitro fertilisation.

A prospective registry-based cohort study of the diagnosis and management of acute leukaemia in pregnancy: Study protocol.

BACKGROUND: Acute leukaemias (AL) are aggressive but potentially curable blood cancers that can potentially affect women of childbearing age. When a pregnancy is complicated by a diagnosis of AL, clinicians face a complex dilemma: to balance risking the mother's survival through delayed AL treatment, against the potential harm to the foetus through exposure to anti-cancer drugs. Up until now, all guidance and advice regarding the management of AL in pregnancy, have been based on expert opinion and small case studies. There is a pressing need for more studies in the subject to address this evidence gap. METHODS AND ANALYSIS: This study is a registry-based observational cohort study which aims to monitor and record the treatment outcomes of patients diagnosed with AL during pregnancy. Additionally, the study aims to assess pregnancy outcomes in patients who become pregnant following successful treatment. Prospective and historical cases from August 2009 onwards will be identified from AL treating haematology units within the UK. Details of diagnosis, AL treatment delivered, antenatal and postnatal outcomes for mother and neonate will be collected. This study will establish a new research database for Leukaemia in Pregnancy. TRIAL REGISTRATION: The study was registered on Clinicaltrials.gov (NCT04182074) on the 2nd December 2019.