BNT162b2 against COVID-19 in Brazil using a test-negative design: Study protocol and statistical analysis plan.

INTRODUCTION: Real-world data on COVID-19 vaccine effectiveness are needed to validate evidence from randomized clinical trials. Accordingly, this study aims to evaluate, in a real-world setting in Brazil, the effectiveness of Pfizer-BioNTech BNT162b2 against symptomatic COVID-19 and COVID-19-related complications across diverse populations. MATERIALS AND METHODS: A test-negative case-control study with follow-up of cases is currently being conducted in Toledo, a city in southern Brazil, following a mass COVID-19 vaccination campaign with BNT162b2. The study is being conducted among patients aged 12 years or older seeking care in the public health system with acute respiratory symptoms and tested for SARS-CoV-2 on reverse transcription polymerase chain reaction (RT-PCR). Cases are RT-PCR positive and controls RT-PCR negative. Test-positive cases are prospectively followed through structured telephone interviews performed at 15 days post-enrollment, and at 1, 3, 6, 9 and 12 months. Baseline demographic, clinical, and vaccination data are being collected by means of structured interviews and medical registry records reviews at the time of enrollment. All RT-PCR-positive samples are screened for mutations to identify SARS-CoV-2 variants. ETHICS AND DISSEMINATION: The study protocol has been approved by the research ethics committee of all participant sites. Study findings will be disseminated through peer-reviewed publications and conference presentations. TRAIL REGISTRATION: Clinicatrials.gov: NCT05052307.

Exploring Patients' Perceptions on ICU Diaries: A Systematic Review and Qualitative Data Synthesis.

OBJECTIVES: This study aims to summarize the current qualitative evidence on patients' experiences of reading the ICU diaries. DATA SOURCES: We searched the online databases PubMed, Ovid, EMBASE, and EBSCO host from inception to July 2020. STUDY SELECTION: All studies that presented any qualitative findings regarding patients' experiences of reading an ICU diary were included. DATA EXTRACTION: Study design, location, publication year, data collection method, and mode, all qualitative themes identified and reported, and participant quotations, when appropriate. We also extracted data regarding the diary structure, when available. A thematic synthesis approach was used to analyze and synthesize qualitative data. DATA SYNTHESIS: Seventeen studies were analyzed. Most patients reported positive experiences with the ICU diary, such as understanding what they survived during critical illness, better understanding the process of recovery, gaining coherence of nightmares and delusional memories, realizing the importance of the presence of family and loved ones during ICU stay, and humanizing healthcare professionals that helped them survive critical illness. Patients also reported which components of the diary were important for their recovery, such as the presence of photographs and reading the diary with a healthcare professional, allowing the improvement of the concept of the ICU diary. CONCLUSION: This qualitative synthesis shows that patients recommend having an ICU diary, enlightening benefits such as better coping with the slow recovery from critical illness, strengthening family ties, and humanizing the ICU staff. It also identifies characteristics of the diary valued by the patients, in order to standardize the ICU diary according to their perspectives, and allowing future comparability between randomized controlled trials.

Effects of Mechanical Insufflation-Exsufflation on Airway Mucus Clearance Among Mechanically Ventilated ICU Subjects.

BACKGROUND: Few studies have evaluated the effects of mechanical insufflation-exsufflation (MI-E) in subjects on mechanical ventilation. Therefore, this study aimed to evaluate the effectiveness of MI-E on airway mucus clearance among mechanically ventilated ICU subjects. METHODS: A randomized, parallel-group, open-label trial was conducted between June and November 2017 in a single, mixed ICU. Adult ICU subjects receiving mechanical ventilation for > 24 h with stable ventilatory and hemodynamic status were randomized to receive either standard respiratory physiotherapy alone (control group) or respiratory physiotherapy by using an MI-E device (intervention group). The primary outcome was the weight of aspirated airway mucus after study interventions. Secondary outcomes included variation in static lung compliance (ΔCL), airway resistance (ΔRaw), work of breathing (ΔWOB) in relation to the pre-intervention period, and hemodynamic and ventilator complications during the procedures. RESULTS: There were 90 subjects in each group. The mean ± SD weight of the aspirated airway mucus was higher in the intervention group than in the control group (2.42 ± 2.32 g vs 1.35 ± 1.56 g, P < .001). The ΔCL values in the intervention group were higher than those in the control group (1.76 ± 4.90 mL/cm H2O vs -0.57 ± 4.85 mL/cm H2O, P = .001). The ΔRaw and ΔWOB values were similar between the groups. No hemodynamic or ventilatory complications were observed. CONCLUSIONS: Among the general ICU subjects receiving mechanical ventilation, use of an MI-E device during respiratory physiotherapy resulted in a larger amount of airway mucus clearance than respiratory physiotherapy alone. (ClinicalTrials.gov registration NCT03178565.).