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Readiness Brain Operation Optimization Training (ReBOOT) protocol: a feasibility randomised controlled trial for a cognitive prehabilitation programme for epilepsy surgery conducted at Cleveland Clinic, USA

Por: Arrotta · K. · Babiker · S. · Lake · J. · Thompson · N. · Lioi · A. · Najm · I. · Busch · R. M.
Introduction

Risk of cognitive decline following epilepsy surgery can be a significant barrier for patients pursuing surgery, and post-surgical cognitive changes can impact quality of life (QOL), surgical satisfaction and functional independence. Readiness Brain Operation Optimization Training (ReBOOT) is a virtual cognitive prehabilitation intervention that provides patients with psychoeducation and cognitive strategies prior to surgery to increase pre-surgical preparedness and post-surgical functional independence in the circumstance that a patient experiences cognitive decline after surgery. The primary aim of this feasibility trial is to evaluate the acceptability, adherence and procedural feasibility of implementing ReBOOT in patients being evaluated for epilepsy surgery. Secondary, explorative objectives include examining preliminary trends in QOL, compensatory strategy use, cognitive function and psychosocial outcomes to inform a future definitive trial.

Methods and analysis

This is a single-centre, parallel-group, feasibility randomised controlled trial of a standardised cognitive prehabilitation programme for patients who are considering epilepsy surgery. Participants are randomly assigned to intervention (n=32) or control groups (n=32). The intervention group is enrolled in ReBOOT, a virtual programme that includes two 1-hour individual sessions and four 1-hour group sessions. Feasibility outcomes include attendance, homework adherence, attrition and participant satisfaction for participants randomised to the intervention group. Exploratory analyses will use longitudinal linear mixed-effects models to describe trends in exploratory outcomes over time. Data will be used to refine procedures and estimate parameters (eg, effect sizes and variance) for a future fully powered trial.

Ethics and dissemination

Cleveland Clinic Institutional Review Board approved the study protocol, which is publicly available and registered on the National Institutes of Health ClinicalTrials.gov (NCT05992402) site. Results will be disseminated through conference presentations and academic publications, as well as shared with outside study sponsors (Society for Clinical Neuropsychology—Division 40 of the American Psychological Association; American Epilepsy Society).

Trial registration number

NCT05992402.

Whom to include? A cross-sectional survey study investigating how culture impacts diagnostic decision making for paediatric cancer in Pakistan

Por: Graetz · D. · Wardell · J. · Hameed · A. · Tul Quanita · A. · Najmi · A. · Ahmad · S. · Shafiq · M. · Naheed · A. · Munir · S. · Ferrara · G. · Staples · C. · Chen · Y. · Devidas · M. · Rodriguez-Galindo · C. · Jeha · S. · Mack · J. · Hamid · S. A. · Rafie Raza · M. · Ahmad · A.
Objectives

This study sought to explore decision making among caregivers of children with cancer in Pakistan, one of the largest lower middle-income countries in the world.

Design

Cross-sectional survey study

Setting

This study was conducted in Pakistan at Indus Hospital and Health Network in Karachi and Children’s Hospital of Lahore. Children’s Hospital of Lahore is a public sector hospital, and Indus Hospital has a foundation-based funding structure. Both are larger tertiary care centers. Over 2,500 new patients are seen at these centers annually, this accounts for almost 50% of all children with cancer in Pakistan

Participants

Eligible participants included bedside caregivers, defined as a parent or family member involved in communication with the medical team, of children with cancer (

Primary and secondary outcome measures

Primary outcome measures included caregiver priorities and experiences related to communication including decision-making role, involvement of the paediatric patient and decisional regret.

Results

Participants included 200 caregivers of children

Conclusions

Findings from this study highlight the importance of exploring preferences for decision making and empowering bedside caregivers while respecting cultural norms. In the Pakistani context, it may be specifically important to consider gender roles and the inclusion of extended family members. Future work should investigate paediatric patient involvement in diverse settings.

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