Long-term cognitive and pulmonary functions following a lower versus a higher oxygenation target in the HOT-ICU and HOT-COVID trials: A protocol update.

BACKGROUND: The Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU) trial was a multicentre, randomised, parallel-group trial of a lower oxygenation target (arterial partial pressure of oxygen [PaO2 ] = 8 kPa) versus a higher oxygenation target (PaO2 = 12 kPa) in adult ICU patients with acute hypoxaemic respiratory failure; the Handling Oxygenation Targets in coronavirus disease 2019 (HOT-COVID) tested the same oxygenation targets in patients with confirmed COVID-19. In this study, we aim to evaluate the long-term effects of these oxygenation targets on cognitive and pulmonary function. We hypothesise that a lower oxygenation target throughout the ICU stay may result in cognitive impairment, whereas a higher oxygenation target may result in impaired pulmonary function. METHODS: This is the updated protocol and statistical analysis plan of two pre-planned secondary outcomes, the long-term cognitive function, and long-term pulmonary function, in the HOT-ICU and HOT-COVID trials. Patients enrolled in both trials at selected Danish sites and surviving to 1 year after randomisation are eligible to participate. A Repeatable Battery for the Assessment of Neuropsychological Status score and a full-body plethysmography, including diffusion capacity for carbon monoxide, will be obtained. The last patient is expected to be included in the spring of 2024. CONCLUSION: This study will provide important information on the long-term effects of a lower versus a higher oxygenation target on long-term cognitive and pulmonary functions in adult ICU patients with acute hypoxaemic respiratory failure.

Depression and cognitive sequelae after a traumatic brain lesion.

INTRODUCTION: To improve rehabilitation in young people with an acquired brain injury, the Danish Ministry of Health initiated the "National study on young brain injury survivors" in 2012. Using data from this initiative, we examined the changes in depression, cognition, global functional outcome and return to work/school among young traumatic brain injury (TBI) survivors. METHOD: This was an observational one-year follow-up study based on data from "Danish registry for young adults with acquired brain injury". The main measures were Major Depression Inventory, neuropsychological examination, and Glasgow Outcome Scale - extended (GOS-E). RESULTS: A total of 76 young TBI survivors attended two interdisciplinary examinations and had complete data. Sixty-six (86.8%) had rehabilitation between the two visits, and the global functional outcome was vastly higher at the second visit (z = -3.373, p = 0.0007). At the first versus the second visit, the prevalence proportion of depression was 14.5% (95% confidence interval (CI): 7.5-24.4) versus 10.5% (95% CI: 4.7-19.7), and for cognitive sequelae it was 31.6% (95% CI: 21.4-43.3) versus 19.7% (95% CI: 11.5-30.5). Patients with depression and/or cognitive sequelae had a lower GOS-E score (p = 0.0016) than patients without depression/cognitive sequelae and a negative association was found between depression, cognitive sequelae and return to work/school (p = 0.045). CONCLUSION: Emotional and cognitive rehabilitation for young TBI survivors seems essential as depression and cognitive sequelae are associated with a lower global functional outcome and return to work/school. FUNDING: none. TRIAL REGISTRATION: not relevant.

Depression and cognitive sequelae registered within the first year among young Danish TBI survivors.

The aim of the study was to determine the proportion of depression and cognitive sequelae among young (15-30 years) Danish TBI survivors referred to interdisciplinary evaluation through a nationwide government-initiated health initiative. The cross-sectional study is based on data from the "Danish register for young adults with acquired brain injury" on TBI survivors included from October 2013 to December 2016. The main measures were Major depression inventory, Trail making test A and B, Fluency, Word learning with selective reminding, Matrix reasoning, Coding and Glasgow outcome scale - extended (GOS-E). During the study period, 131 young TBI survivors were referred to one of five national outpatient clinics. Ninety-six had complete data and of these 14.6% fulfilled the ICD-10 diagnostic criteria for depression and 34.4% had cognitive sequelae. An association was found between depression and cognitive sequelae (p = 0.004). Patients with both depression and cognitive sequelae (n = 10) had a significantly lower mean score on GOS-E (p = 0.0001). Depression and cognitive sequelae were frequent and associated with a poorer global functional outcome among young TBI survivors referred within a year after trauma. This finding and the notion that only 20% of the expected TBI population was referred to this nationwide health initiative indicate an unacknowledged need for interdisciplinary follow-up.

Cognitive function after adjuvant treatment for early breast cancer: a population-based longitudinal study.

The purpose of this study was to examine cognitive function in patients with early breast cancer before and after adjuvant chemotherapy or 6 months of tamoxifen. We performed a population-based study in the county of North Jutland, Denmark, including 120 women aged <60 years who received adjuvant chemotherapy with seven cycles of cyclophosphamide, epirubicin and fluoruracil or adjuvant tamoxifen for 6 months for early breast cancer from 2004 to 2006. They were compared with an aged-matched group of 208 women without previous cancer selected randomly from the same population. Data were collected before start of adjuvant treatment and after 6 months by neuropsychological tests and questionnaires to evaluate cognitive function, quality of life and psychological distress. Neuropsychological tests did not reveal any differences in cognitive function between breast cancer patients after chemotherapy and healthy controls. Patients rated their own cognitive functions as improved after 6 months, and patients, who did not receive adjuvant medical treatment, reached the same level as controls within 6 months. Patients receiving chemotherapy or tamoxifen were up to three times more likely than controls to rate themselves as impaired at 6 months. Our results do not support that adjuvant chemotherapy is associated with cognitive side effects in breast cancer patients.

Cognitive function and quality of life after surgery for early breast cancer in North Jutland, Denmark.

OBJECTIVE: The aim of this study was to assess cognitive function, quality of life, and psychological distress after surgery for early breast cancer but before initiation of adjuvant treatment. MATERIAL AND METHODS: We performed a population-based study in the county of North Jutland, Denmark, including 124 women aged less than 60 years who had surgery for early breast cancer from 2004 - 2006. They were compared with an aged-matched group of 224 women without previous cancer selected randomly from the same population. The cognitive function of patients and controls was tested using a revised battery from the ISPOCD study. Data were collected on quality of life (EORTC QLQ-C30) and psychological distress (POMS). RESULT: The neuropsychological tests did not reveal significant differences between patients and controls. Compared to the control group, breast cancer patients had a significantly 3 - 4 fold increased risk of experiencing cognitive impairment. Quality of life and psychological distress were also significantly poorer among patients. CONCLUSION: This study demonstrated that women diagnosed with breast cancer experience a significant deterioration of their perceived cognitive functioning, quality of life and of psychological well being.