Abstracts from the NIHR INVOLVE Conference 2017

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Colorectal liver metastases: Surgery versus thermal ablation (COLLISION) - a phase III single-blind prospective randomized controlled trial

Background: Radiofrequency ablation (RFA) and microwave ablation (MWA) are widely accepted techniques to eliminate small unresectable colorectal liver metastases (CRLM). Although previous studies labelled thermal ablation inferior to surgical resection, the apparent selection bias when comparing patients with unresectable disease to surgical candidates, the superior safety profile, and the competitive overall survival results for the more recent reports mandate the setup of a randomized controlled trial. The objective of the COLLISION trial is to prove non-inferiority of thermal ablation compared to hepatic resection in patients with at least one resectable and ablatable CRLM and no extrahepatic disease. Methods: In this two-arm, single-blind multi-center phase-III clinical trial, six hundred and eighteen patients with at least one CRLM (≤3cm) will be included to undergo either surgical resection or thermal ablation of appointed target lesion(s) (≤3cm). Primary endpoint is OS (overall survival, intention-to-treat analysis). Main secondary endpoints are overall disease-free survival (DFS), time to progression (TTP), time to local progression (TTLP), primary and assisted technique efficacy (PTE, ATE), procedural morbidity and mortality, length of hospital stay, assessment of pain and quality of life (QoL), cost-effectiveness ratio (ICER) and quality-adjusted life years (QALY). Discussion: If thermal ablation proves to be non-inferior in treating lesions ≤3cm, a switch in treatment-method may lead to a reduction of the post-procedural morbidity and mortality, length of hospital stay and incremental costs without compromising oncological outcome for patients with CRLM. Trial registration:NCT03088150 , January 11th 2017

Social Competence in Newly Diagnosed Pediatric Brain Tumor Patients

Brain tumors (BTs) are a common pediatric malignancy. Improved treatment has resulted in higher survival rates. There is, however, increasing concern about adverse effects of the disease and its treatment, including effects on social competence (i.e. effective social functioning in everyday life). The aim of this study is to examine multiple levels of social competence (i.e. social skills and social adjustment) in newly diagnosed pediatric BT patients. Thirty newly diagnosed BT patients aged 5–12 years were assessed shortly after diagnosis with a neuropsychological test battery focusing on social competence, including tests for IQ, social skills (i.e. social-affective and executive functioning) and social adjustment (rated by parents and teachers). Their performance was compared to 95 healthy controls who completed the same assessment. Patients and healthy controls were largely comparable with regard to demographic and environmental factors and did not differ on measures of IQ, social skills and social adjustment. Furthermore, age was found to have a positive significant effect on social skills independent of group. Shortly after diagnosis, pediatric BT patients did not perform different from healthy controls on IQ and measures of social skills and social adjustment. This is an encouraging finding. However, because of potentially neurotoxic adjuvant therapy and the ongoing development of social skills, longitudinal follow-up studies are needed to investigate long-term outcome regarding social competence in BT survivors

Social competence in children with brain disorders: A meta-analytic review

Social competence, i.e. appropriate or effective social functioning, is an important determinant of quality of life. Social competence consists of social skills, social performance and social adjustment. The current paper reviews social skills, in particular emotion recognition performance and its relationship with social adjustment in children with brain disorders. In this review, normal development and the neuro-anatomical correlates of emotion recognition in both healthy children and adults and in various groups of children with brain disorders, will be discussed. A systematic literature search conducted on PubMed, yielded nine papers. Emotion recognition tasks were categorized on the basis of task design and emotional categories to ensure optimal comparison across studies before an explorative meta-analysis was conducted. This meta-analytic review suggests that children with brain disorders show impaired emotion recognition, with the recognition of sad and fearful expressions being most impaired. Performance did not seem to be related to derivative measures of social adjustment. Despite the limited number of studies on a variety of brain disorders and control groups, outcomes were quite consistent across analyses and corresponded largely with the existing literature on development of emotion recognition in typically developing children. More longitudinal prospective studies on emotion recognition are needed to gain insight into recovery and subsequent development of children with distinct brain disorders. This will aid development, selection and implementation of interventions for improvement of social competence and quality of life in children with a brain disorder

Nocturnal Oxygen Desaturation and Disordered Sleep as a Potential Factor in Executive Dysfunction in Sickle Cell Anemia

Previous research has identified cognitive impairment in children with sickle cell anemia (SCA, Hemoglobin SS) compared with controls, partly accounted for by overt neuropathology after clinical stroke, covert (silent) infarction, and severity of anemia. However, cognitive deficits have also been identified in children with SCA with no history of stroke and a normal T2-weighted magnetic resonance imaging (MRI) scan. Our aim was to investigate whether nocturnal hemoglobin oxygen desaturation and sleep fragmentation could be associated with cognitive impairment in children with SCA. We assessed 10 children with SCA (9 with normal MRI) using neuropsychological measures of executive function. Cognitive assessment was immediately followed by overnight polysomnography to record nocturnal hemoglobin oxygen saturation and sleep arousals. Decreases in hemoglobin oxygen saturation and/or increased sleep arousals were associated with reduced performance on cognitive assessment. Nocturnal hemoglobin oxygen desaturation and sleep fragmentation may be a contributing factor to executive dysfunction in SCA.</p

Social competence in newly diagnosed pediatric brain tumor patients

Brain tumors (BTs) are a common pediatric malignancy. Improved treatment has resulted in higher survival rates. There is, however, increasing concern about adverse effects of the disease and its treatment, including effects on social competence (i.e. effective social functioning in everyday life). The aim of this study is to examine multiple levels of social competence (i.e. social skills and social adjustment) in newly diagnosed pediatric BT patients. Thirty newly diagnosed BT patients aged 5–12 years were assessed shortly after diagnosis with a neuropsychological test battery focusing on social competence, including tests for IQ, social skills (i.e. social-affective and executive functioning) and social adjustment (rated by parents and teachers). Their performance was compared to 95 healthy controls who completed the same assessment. Patients and healthy controls were largely comparable with regard to demographic and environmental factors and did not differ on measures of IQ, social skills and social adjustment. Furthermore, age was found to have a positive significant effect on social skills independent of group. Shortly after diagnosis, pediatric BT patients did not perform different from healthy controls on IQ and measures of social skills and social adjustment. This is an encouraging finding. However, because of potentially neurotoxic adjuvant therapy and the ongoing development of social skills, longitudinal follow-up studies are needed to investigate long-term outcome regarding social competence in BT survivors

Colorectal liver metastases: surgery versus thermal ablation (COLLISION) – a phase III single-blind prospective randomized controlled trial

Abstract Background Radiofrequency ablation (RFA) and microwave ablation (MWA) are widely accepted techniques to eliminate small unresectable colorectal liver metastases (CRLM). Although previous studies labelled thermal ablation inferior to surgical resection, the apparent selection bias when comparing patients with unresectable disease to surgical candidates, the superior safety profile, and the competitive overall survival results for the more recent reports mandate the setup of a randomized controlled trial. The objective of the COLLISION trial is to prove non-inferiority of thermal ablation compared to hepatic resection in patients with at least one resectable and ablatable CRLM and no extrahepatic disease. Methods In this two-arm, single-blind multi-center phase-III clinical trial, six hundred and eighteen patients with at least one CRLM (≤3 cm) will be included to undergo either surgical resection or thermal ablation of appointed target lesion(s) (≤3 cm). Primary endpoint is OS (overall survival, intention-to-treat analysis). Main secondary endpoints are overall disease-free survival (DFS), time to progression (TTP), time to local progression (TTLP), primary and assisted technique efficacy (PTE, ATE), procedural morbidity and mortality, length of hospital stay, assessment of pain and quality of life (QoL), cost-effectiveness ratio (ICER) and quality-adjusted life years (QALY). Discussion If thermal ablation proves to be non-inferior in treating lesions ≤3 cm, a switch in treatment-method may lead to a reduction of the post-procedural morbidity and mortality, length of hospital stay and incremental costs without compromising oncological outcome for patients with CRLM. Trial registration NCT03088150, January 11th 2017