Radiotherapy trial quality assurance processes: a systematic review.

Quality assurance remains a neglected component of many trials, particularly for technical interventions, such as surgery and radiotherapy, for which quality of treatment is an important component in defining outcomes. We aimed to evaluate evidence for the processes used in radiotherapy quality assurance of clinical trials. A systematic review was undertaken focusing on use of a pre-trial outlining benchmark case and subsequent on-trial individual case reviews of outlining for recruited patients. These pre-trial and on-trial checks are used to ensure consistency and standardisation of treatment for each patient recruited to the trial by confirming protocol compliance. Non-adherence to the trial protocol has been shown to have a negative effect on trial outcomes. 29 studies published between January, 2000, and December, 2022, were identified that reported on either outlining benchmark case results or outlining individual case review results, or both. The trials identified varied in their use of radiotherapy quality assurance practices and reporting of outcomes was inconsistent. Deviations from trial protocols were frequent, particularly regarding outlining. Studies correlating benchmark case results with on-trial individual case reviews provided mixed results, meaning firm conclusions could not be drawn regarding the influence of the pre-trial benchmark case on subsequent on-trial performance. The optimal radiotherapy quality assurance processes were unclear, and there was little evidence available. Improved reporting of outcomes from radiotherapy quality assurance programmes is needed to develop an evidence base for the optimal approach to radiotherapy quality assurance in trials.

Using evidence in mental health policy agenda-setting in low- and middle-income countries: a conceptual meta-framework from a scoping umbrella review.

The purpose of this article is to close the gap in frameworks for the use of evidence in the mental health policy agenda-setting in low- and middle-income countries (LMICs). Agenda-setting is important because mental health remains a culturally sensitive and neglected issue in LMICs. Moreover, effective evidence-informed agenda-setting can help achieve, and sustain, the status of mental health as a policy priority in these low-resource contexts. A scoping 'review of reviews' of evidence-to-policy frameworks was conducted, which followed preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. Nineteen reviews met the inclusion criteria. A meta-framework was developed from analysis and narrative synthesis of these 19 reviews, which integrates the key elements identified across studies. It comprises the concepts of evidence, actors, process, context and approach, which are linked via the cross-cutting dimensions of beliefs, values and interests; capacity; power and politics; and trust and relationships. Five accompanying questions act as a guide for applying the meta-framework with relevance to mental health agenda-setting in LMICs. This is a novel and integrative meta-framework for mental health policy agenda-setting in LMICs and, as such, an important contribution to this under-researched area. Two major recommendations are identified from the development of the framework to enhance its implementation. First, given the paucity of formal evidence on mental health in LMICs, informal evidence based on stakeholder experience could be better utilized in these contexts. Second, the use of evidence in mental health agenda-setting in LMICs would be enhanced by involving a broader range of stakeholders in generating, communicating and promoting relevant information.

Introducing visual participatory methods to develop local knowledge on HIV in rural South Africa.

INTRODUCTION: South Africa is a country faced with complex health and social inequalities, in which HIV/AIDS has had devastating impacts. The study aimed to gain insights into the perspectives of rural communities on HIV-related mortality. METHODS: A participatory action research (PAR) process, inclusive of a visual participatory method (Photovoice), was initiated to elicit and organise local knowledge and to identify priorities for action in a rural subdistrict underpinned by the Agincourt Health and Socio-Demographic Surveillance System (HDSS). We convened three village-based discussion groups, presented HDSS data on HIV-related mortality, elicited subjective perspectives on HIV/AIDS, systematised these into collective accounts and identified priorities for action. Framework analysis was performed on narrative and visual data, and practice theory was used to interpret the findings. FINDINGS: A range of social and health systems factors were identified as causes and contributors of HIV mortality. These included alcohol use/abuse, gender inequalities, stigma around disclosure of HIV status, problems with informal care, poor sanitation, harmful traditional practices, delays in treatment, problems with medications and problematic staff-patient relationships. To address these issues, developing youth facilities in communities, improving employment opportunities, timely treatment and extending community outreach for health education and health promotion were identified. DISCUSSION: Addressing social practices of blame, stigma and mistrust around HIV-related mortality may be a useful focus for policy and planning. Research that engages communities and authorities to coproduce evidence can capture these practices, improve communication and build trust. CONCLUSION: Actions to reduce HIV should go beyond individual agency and structural forces to focus on how social practices embody these elements. Initiating PAR inclusive of visual methods can build shared understandings of disease burdens in social and health systems contexts. This can develop shared accountability and improve staff-patient relationships, which, over time, may address the issues identified, here related to stigma and blame.

Treatment and prognosis of leptomeningeal disease secondary to metastatic breast cancer: A single-centre experience.

PURPOSE: Leptomeningeal disease (LMD) is an uncommon complication of advanced breast cancer. The prognosis is poor, and although radiotherapy (RT), systemic and intra-thecal (IT) chemotherapy are accepted treatment modalities, efficacy data are limited. This study was designed to evaluate potential predictors of survival in this patient group. METHODS: Breast cancer patients with LMD diagnosed by MRI in a 10-year period (2004-2014) were identified from electronic patient records. PFS and OS estimates were calculated using Kaplan-Meier method, with planned sub-group analysis by treatment modality. Cox regression was employed to identify significant prognostic variables. RESULTS: We identified 182 eligible patients; all female, median age at LMD diagnosis 52.5 years (range 23-80). Ninety patients (49.5%) were ER positive/HER2 negative; 48 (26.4%) were HER2 positive, and 27 (14.8%) were triple negative. HER2 status was unknown in 17 (9.3%). Initial management of LMD was most commonly whole or partial brain RT in 62 (34.1%), systemic therapy in 45 (24.7%) or supportive care alone in 37 (20.3%). Fourteen patients (7.7%) underwent IT chemotherapy, of whom two also received IT trastuzumab. From diagnosis of LMD, the median PFS was 3.9 months (95%CI 3.2-5.0) and median OS was 5.4 months (95%CI 4.2-6.6). Patients treated with systemic therapy had the longest OS (median 8.8 months, 95%CI 5.5-11.1), compared to RT; 6.1 months (95%CI 4.2-7.9 months), IT therapy; 2.9 months (95%CI 1.2-5.8) and supportive care; 1.7 months (95%CI 0.9-3.0). On multivariable analysis, triple negative histology, concomitant brain metastases, and LMD involving both the brain and spinal cord were associated with poor OS. CONCLUSIONS: Breast cancer patients with triple negative LMD, concomitant brain metastases or LMD affecting both the spine and brain have the poorest prognosis. Clinical trials to identify more effective treatments for these patients are urgently needed.

Acute Toxicity Related to 25G-NBOMe Use: An Internet High.

The NBOMe series is an emerging class of synthetic hallucinogens with limited data available on their use and effects. Whilst toxicity to related substances exist in the literature, no such cases exist for 25G-NBOMe. This case describes a 17-year old male who presented to the Emergency Department with seizures having ingested 25G-NBOMe that had been purchased over the Internet. He was tachycardic, hypotensive and hyperthermic on arrival and required admission to the Intensive Care Unit (ICU) due a persistently low Glasgow Coma Scale (GCS) and profound metabolic derangement. His inpatient stay was prolonged by a persistently high creatine kinase with associated transient acute kidney injury. In contrast, an accompanying friend who had ingested the same drug developed no adverse effects. Our patient's clinical presentation was consistent with reports of adverse outcomes associated with other drugs in the series and demonstrates that acute toxicity can also be seen with 25G-NBOMe with potentially life threatening outcomes.

Maternal coping, appraisals and adjustment following diagnosis of fetal anomaly.

OBJECTIVE: So far, associations between appraisals, maternal adjustment and coping following diagnosis of fetal anomaly have not been investigated in women who continue with their pregnancy. METHOD: This study measured maternal coping and adjustment after and appraisal of a diagnosis of fetal anomaly in 40 mothers who had continued with their pregnancy using a cross-sectional questionnaire design. RESULTS: Based on retrospective reporting, 35% of participants met full diagnostic criteria for post-traumatic stress disorder after having received the diagnosis. Women were significantly more depressed (p < 0.001) and anxious (p < 0.001) and reported significantly less positive affect (p < 0.05) after having received the diagnosis in comparison to the time after childbirth. There were no significant differences between emotion-focused and problem-focused coping. Stressful life events, women's age, number of people providing support and problem-focused coping explained 57.6% of variance in anxiety and depression after childbirth. Satisfaction with social support, emotion-focused coping and problem-focused coping significantly explained 40.6% of variance in positive affect after childbirth. CONCLUSION: Following a prenatal diagnosis and for the remainder of their pregnancy, particular attention should be paid to older mothers, those experiencing additional stressful life events and those who are socially isolated, as these women may experience greater distress after childbirth.