Children's Oxygen Administration Strategies And Nutrition Trial (COAST-Nutrition): a protocol for a phase II randomised controlled trial.

Background: To prevent poor long-term outcomes (deaths and readmissions) the integrated global action plan for pneumonia and diarrhoea recommends under the 'Treat' element of Protect, Prevent and Treat interventions the importance of continued feeding but gives no specific recommendations for nutritional support. Early nutritional support has been practiced in a wide variety of critically ill patients to provide vital cell substrates, antioxidants, vitamins, and minerals essential for normal cell function and decreasing hypermetabolism. We hypothesise that the excess post-discharge mortality associated with pneumonia may relate to the catabolic response and muscle wasting induced by severe infection and inadequacy of the diet to aid recovery. We suggest that providing additional energy-rich, protein, fat and micronutrient ready-to-use therapeutic feeds (RUTF) to help meet additional nutritional requirements may improve outcome. Methods: COAST-Nutrition is an open, multicentre, Phase II randomised controlled trial in children aged 6 months to 12 years hospitalised with suspected severe pneumonia (and hypoxaemia, SpO 2 <92%) to establish whether supplementary feeds with RUTF given in addition to usual diet for 56-days (experimental) improves outcomes at 90-days compared to usual diet alone (control). Primary endpoint is change in mid-upper arm circumference (MUAC) at 90 days and/or as a composite with 90-day mortality. Secondary outcomes include anthropometric status, mortality, readmission at days 28 and 180. The trial will be conducted in four sites in two countries (Uganda and Kenya) enrolling 840 children followed up to 180 days. Ancillary studies include cost-economic analysis, molecular characterisation of bacterial and viral pathogens, evaluation of putative biomarkers of pneumonia, assessment of muscle and fat mass and host genetic studies.   Discussion: This study is the first step in providing an option for nutritional support following severe pneumonia and will help in the design of a large Phase III trial. Registration: ISRCTN10829073 (6 th June 2018) PACTR202106635355751 (2 nd June 2021).

Providing psychological support to people in intensive care: development and feasibility study of a nurse-led intervention to prevent acute stress and long-term morbidity.

OBJECTIVES: Adverse psychological outcomes, following stressful experiences in critical care, affect up to 50% of patients. We aimed to develop and test the feasibility of a psychological intervention to reduce acute stress and prevent future morbidity. DESIGN: A mixed-methods intervention development study, using two stages of the UK Medical Research Council framework for developing and testing complex interventions. Stage one (development) involved identifying an evidence base for the intervention, developing a theoretical understanding of likely processes of change and modelling change processes and outcomes. Stage two comprised two linked feasibility studies. SETTING: Four UK general adult critical care units. PARTICIPANTS: Stage one: former and current patients, and psychology, nursing and education experts. Stage two: current patients and staff. OUTCOMES: Feasibility and acceptability to staff and patients of content and delivery of a psychological intervention, assessed using quantitative and qualitative data. Estimated recruitment and retention rates for a clinical trial. RESULTS: Building on prior work, we standardised the preventative, nurse-led Provision Of Psychological support to People in Intensive Care (POPPI) intervention. We devised courses and materials to train staff to create a therapeutic environment, to identify patients with acute stress and to deliver three stress support sessions and a relaxation and recovery programme to them. 127 awake, orientated patients took part in an intervention feasibility study in two hospitals. Patient and staff data indicated the complex intervention was feasible and acceptable. Feedback was used to refine the intervention. 86 different patients entered a separate trial procedures study in two other hospitals, of which 66 (80% of surviving patients) completed questionnaires on post-traumatic stress, depression and health 5 months after recruitment. CONCLUSION: The 'POPPI' psychological intervention to reduce acute patient stress in critical care and prevent future psychological morbidity was feasible and acceptable. It was refined for evaluation in a cluster randomised clinical trial. TRIAL REGISTRATION NUMBER: ISRCTN61088114; Results.

Determining best methods to screen for religious/spiritual distress.

PURPOSE: This study sought to validate for the first time a brief screening measure for religious/spiritual (R/S) distress given the Commission on Cancer's mandated screening for psychosocial distress including spiritual distress. METHODS: Data were collected in conjunction with an annual survey of adult hematopoietic cell transplantation (HCT) survivors. Six R/S distress screeners were compared to the Brief RCOPE, Negative Religious Coping subscale as the reference standard. We pre-specified validity as a sensitivity score of at least 85 %. As no individual measure attained this, two post hoc analyses were conducted: analysis of participants within 2 years of transplantation and of a simultaneous pairing of items. Data were analyzed from 1449 respondents whose time since HCT was 6 months to 40 years. RESULTS: For the various single-item screening protocols, sensitivity ranged from 27 (spiritual/religious concerns) to 60 % (meaning/joy) in the full sample and 25 (spiritual/religious concerns) to 65 % (meaning/joy) in a subsample of those within 2 years of HCT. The paired items of low meaning/joy and self-described R/S struggle attained a net sensitivity of 82 % in the full sample and of 87 % in those within 2 years of HCT but with low net specificities. CONCLUSIONS: While no single-item screener was acceptable using our pre-specified sensitivity value of 85 %, the simultaneous use of meaning/joy and self-described struggle items among cancer survivors is currently the best choice to briefly screen for R/S distress. Future research should validate this and other approaches in active treatment cancer patients and survivors and determine the best times to screen.

Spiritual or religious struggle in hematopoietic cell transplant survivors.

BACKGROUND: This study describes the prevalence of religious or spiritual (R/S) struggle in long-term survivors after hematopoietic cell transplantation (HCT), demographic and medical correlates of R/S struggle, and its associations with depression and quality of life. METHODS: Data were collected in conjunction with an annual survey of adult (age ≥18 years) survivors of HCT. Study measures included R/S struggle (negative religious coping, NRC, from Brief RCOPE), measures of quality of life (subscales from 36-item Short Form Health Survey and McGill), and the Patient Health Questionnaire 8. R/S struggle was defined as any non-zero response on the NRC. Factors associated with R/S struggle were identified using multi-variable logistic regression models. RESULTS: The study analyzed data from 1449 respondents who ranged from 6 months to 40 years after HCT. Twenty-seven percent had some R/S struggle. In a multi-variable logistic regression model, R/S struggle was associated with greater depression and poorer quality of life. R/S struggle was also associated with younger age, non-White race, and self-identification as either religious but not spiritual or spiritual but not religious. R/S struggle was not associated with any medical variables, including time since transplant. CONCLUSIONS: Religious or spiritual struggle is common among HCT survivors, even many years after HCT. Survivors should be screened and, as indicated, referred to a professional with expertise in R/S struggle. Further study is needed to determine causal relationships, longitudinal trajectory, impact of struggle intensity, and effects of R/S struggle on health, mood, and social roles for HCT survivors. Copyright © 2015 John Wiley & Sons, Ltd.