Ethics committees in the time of COVID-19.

BACKGROUND: ethics committees (ECs) protect the rights, safety, and well-being of research participants and ensure the scientific correctness of clinical research. COVID-19 pandemic and the lockdown from 9 March to 16 May 2020 have potentially influenced several activities, including ECs. OBJECTIVES: to assess the impact of COVID-19 outbreak on Italian ECs and their performance during the lockdown. DESIGN: cross-sectional survey. SETTING AND PARTICIPANTS: the survey was conducted in mid-June 2020 in Italy contacting all the 90 local ECs. MAIN OUTCOME MEASURES: amount and kind of activities performed during the lockdown, characteristics of submitted studies and adoption of standard protocols of evaluation of research applications during the pandemic. Chi-square test was used to estimate the differences between territories with higher incidence (HI) and lower incidence (LI) of COVID-19. RESULTS: 258 questionnaires were collected from 46 ECs that participated in the study. Ten were excluded due to missing substantial data. Responses were divided into two groups according to location of EC: the HI (125 responses) and the LI (123 responses). Seventy-five percent of the HI describe an increase in the number of studies submitted, while 53% of the LI does not (p=0.001). Due to the pandemic and its effects on research, the 15% of participants belonging to HI territories reported that consideration and respect of research-related and general ethical principles could have decreased, as well the adoption of standard protocols of evaluation of research applications. EC secretariats located in HI Regions moved to smart working more than in LI ones (75% vs 59%; p=0.001). Where the EC workload increased significantly, it was reported that it was impossible to perform an accurate analysis of the submitted documentation, with the effect of providing a favorable opinion to studies of not excellent quality, though always ensuring the respect of ethical principles and patients' safety. CONCLUSIONS: COVID-19 impact on ECs has been heavier in HI territories, but smart working has been effective in ensuring EC activities and the subsequent activation of clinical studies potentially useful to face the pandemic. Clear differences arise between ECs belonging to the Italian Regions that have recorded a HI of COVID-19 cases compared to those located in Regions with a LI of cases. In some EC members' perception, the high number of studies in the most affected Regions together with the emergency experienced during the lockdown may have exposed ECs to the risk of decreasing the adoption of ethical principles and standard protocols of evaluation of research applications.

Unilateral Sensorineural Hearing Loss in Children: Etiology, Audiological Characteristics, and Treatment.

The aim of this study was to evaluate audiological characteristics and parents' opinions on hearing device use in children with unilateral sensorineural hearing loss (USNHL) who attended a tertiary-level audiologic center. The medical charts of 70 children aged 6 to 12 years with USNHL were reviewed. In 51.4% of cases, the children were diagnosed with USNHL after the age of 2 years. The main causes of USNHL were congenital cytomegalovirus infection (21.4%) and unilateral cochlear nerve hypoplasia (12.9%). The percentage of patients wearing a hearing device was 45.7% (32/70); of these, 28 (87.5%) wore a conventional hearing aid, 2 (6.3%) a CROS device, and 2 (6.3%) a cochlear implant. Regarding the choice to use a hearing device, no significant differences were found between the subcategories of hearing loss degree (p = 0.55) and audiometric configuration (p = 0.54). Most parents of children with mild-to-severe USNHL observed improved attention (90.9%), and reduced fatigue and restlessness (86.4%) using the hearing aid. These children performed significantly better on all audiological tests (speech perception in quiet and in noise conditions, and sound localization) while wearing the hearing aid (p < 0.001). More efforts should be made to raise awareness among professionals and parents about the negative consequences of uncorrected USNHL.

Postoperative hypoxaemic acute respiratory failure after neoadjuvant treatment for lung cancer: radiologic findings and risk factors.

OBJECTIVES: To investigate the rate of hypoxaemic acute respiratory failure (hARF) on patients undergoing surgery for non-small-cell lung cancer (NSCLC) after neoadjuvant chemotherapy, to describe clinical and radiological findings and to explore potential risk factors for this complication. METHODS: Retrospective review of medical records of all patients who underwent surgery for NSCLC after neoadjuvant chemotherapy at a single centre between 2014 and 2021. Computed tomography scans of patients who developed hARF were reviewed by an experienced radiologist to provide a quantitative assessment of radiologic alterations. RESULTS: The final cohort consisted of 211 patients. Major morbidity was 13.3% (28/211) and hARF was the most common major complication (n = 11, 5.2%). Postoperative mortality was 1.9% (4/211) and occurred only in patients who experienced hARF. Most patients who experienced hARF underwent major procedures, including pneumonectomy (n = 3), lobectomy with chest wall resection (n = 3), bronchial or vascular reconstructions (n = 3) and extended or bilateral resections (n = 2). Analysis of computed tomography findings revealed that crazy paving and ground glass were the most common alterations and were more represented in the non-operated lung. Male gender, current smoking status, pathologic stage III-IV and operative time resulted significant risk factors for hARF at univariable analysis (P < 0.05). CONCLUSIONS: hARF is the main cause of major morbidity and mortality after neoadjuvant therapy and surgery for NSCLC and occurs more frequently after complex and lengthier surgical procedures. Overall, our findings suggest that operative time may represent the most important risk factor for hARF.