Bubble-PAPR: a phase 1 clinical evaluation of the comfort and perception of a prototype powered air-purifying respirator for use by healthcare workers in an acute hospital setting.

OBJECTIVES: We aimed to design and produce a low-cost, ergonomic, hood-integrated powered air-purifying respirator (Bubble-PAPR) for pandemic healthcare use, offering optimal and equitable protection to all staff. We hypothesised that participants would rate Bubble-PAPR more highly than current filtering face piece (FFP3) face mask respiratory protective equipment (RPE) in the domains of comfort, perceived safety and communication. DESIGN: Rapid design and evaluation cycles occurred based on the identified user needs. We conducted diary card and focus group exercises to identify relevant tasks requiring RPE. Lab-based safety standards established against British Standard BS-EN-12941 and EU2016/425 covering materials; inward particulate leakage; breathing resistance; clean air filtration and supply; carbon dioxide elimination; exhalation means and electrical safety. Questionnaire-based usability data from participating front-line healthcare staff before (usual RPE) and after using Bubble-PAPR. SETTING: Overseen by a trial safety committee, evaluation progressed sequentially through laboratory, simulated, low-risk, then high-risk clinical environments of a single tertiary National Health Service hospital. PARTICIPANTS: 15 staff completed diary cards and focus groups. 91 staff from a range of clinical and non-clinical roles completed the study, wearing Bubble-PAPR for a median of 45 min (IQR 30-80 (15-120)). Participants self-reported a range of heights (mean 1.7 m (SD 0.1, range 1.5-2.0)), weights (72.4 kg (16.0, 47-127)) and body mass indices (25.3 (4.7, 16.7-42.9)). OUTCOME MEASURES: Preuse particulometer 'fit testing' and evaluation against standards by an independent biomedical engineer.Primary:Perceived comfort (Likert scale).Secondary: Perceived safety, communication. RESULTS: Mean fit factor 16 961 (10 participants). Bubble-PAPR mean comfort score 5.64 (SD 1.55) vs usual FFP3 2.96 (1.44) (mean difference 2.68 (95% CI 2.23 to 3.14, p<0.001). Secondary outcomes, Bubble-PAPR mean (SD) versus FFP3 mean (SD), (mean difference (95% CI)) were: how safe do you feel? 6.2 (0.9) vs 5.4 (1.0), (0.73 (0.45 to 0.99)); speaking to other staff 7.5 (2.4) vs 5.1 (2.4), (2.38 (1.66 to 3.11)); heard by other staff 7.1 (2.3) vs 4.9 (2.3), (2.16 (1.45 to 2.88)); speaking to patients 7.8 (2.1) vs 4.8 (2.4), (2.99 (2.36 to 3.62)); heard by patients 7.4 (2.4) vs 4.7 (2.5), (2.7 (1.97 to 3.43)); all p<0.01. CONCLUSIONS: Bubble-PAPR achieved its primary purpose of keeping staff safe from airborne particulate material while improving comfort and the user experience when compared with usual FFP3 masks. The design and development of Bubble-PAPR were conducted using a careful evaluation strategy addressing key regulatory and safety steps. TRIAL REGISTRATION NUMBER: NCT04681365.

Standard patient training versus Vik-Asthme chatbot-guided training: 'AsthmaTrain' - a protocol for a randomised controlled trial for patients with asthma.

INTRODUCTION: Therapeutic education for patients with asthma has been shown to reduce asthma morbidity. The high availability of smart phones provides the opportunity to furnish patient training via specifically designed chatbot applications. The goal of this protocol is to perform a first pilot comparison of traditional face to face versus chatbot-guided patient therapeutic education programmes for patients with asthma. METHODS AND ANALYSIS: Eighty adult patients with a physician-confirmed diagnosis of asthma will be enrolled in a two-parallel-arm, randomised (1:1) controlled pilot trial. A single-Zelen consent procedure is deployed to first enrol all participants in the comparator arm, that is, the standard patient therapeutic education programme at the University Hospitals of Montpellier, France. This means of patient therapeutic education is based on reoccurring interviews and discussion with qualified nursing staff as per usual care. Following baseline data acquisition, randomisation will be performed. Those patients randomised to the comparator arm will not be informed of the second arm. Those patients randomised to the experimental arm will be proposed access to a specifically designed chatbot (Vik-Asthme) as the second tested means of patient training (refusals continue with standard training, though analysed as intention to treat). The primary outcome is change in the total Asthma Quality of Life Questionnaire score at the end of follow-up (6 months). Secondary outcomes cover asthma control, spirometry, general health status, programme adherence and burden for medical staff, exacerbations and medical resource use (medications, consults, emergency visits, hospitalisation and intensive care). ETHICS AND DISSEMINATION: This study ('AsthmaTrain' protocol version 4-20220330) has been approved by the Committee for the Protection of Persons Ile-de-France VII on 28 March 2022 (reference number 21.03617.000059). Enrolment began on 24 May 2022. Results will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05248126.

Fibrinolytic therapy in patients with COVID-19 and ARDS: protocol for a systematic review and meta-analysis.

INTRODUCTION: In COVID-19-related acute respiratory distress syndrome (ARDS), the clot play a role in gas exchange abnormalities. Fibrinolytic therapy can improve alveolar ventilation by restoring blood flow. In this systematic review and meta-analysis protocol, we aim to assess the safety and efficacy of fibrinolytic therapy in such a population. METHODS: We will perform a systematic search in MEDLINE, EMBASE, Cochrane CENTRAL and LILACS databases without language restrictions for relevant randomised controlled trials (RCTs) and quasi-RCTs. Two review authors will independently perform data extraction and quality assessments of data from included studies. In case of divergence, a third author will be contacted. The Cochrane handbook will be used for guidance. If the results are not appropriate for a meta-analysis, a descriptive analysis will be performed. DISCUSSION: This systematic review and meta-analysis protocol will provide current evidence about the safety and efficacy of fibrinolytic therapy in patients with COVID-19 and ARDS. These findings will provide if fibrinolytic therapy might be an option for a desperate clinical setting, where all medical efforts have been used. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42020187482. ETHICS AND DISSEMINATION: Ethics committee approval is not necessary. We intend to update the public registry, report any protocol amendments and publish the results in a widely accessible journal.

Real-world effectiveness of casirivimab and imdevimab among patients diagnosed with COVID-19 in the ambulatory setting: a retrospective cohort study using a large claims database.

OBJECTIVE: To assess the real-world effectiveness of casirivimab and imdevimab (CAS+IMD) versus no COVID-19 antibody treatment among patients diagnosed with COVID-19 in the ambulatory setting, including patients diagnosed during the Delta-dominant period prior to Omicron emergence. DESIGN: Retrospective cohort study. SETTING: Komodo Health closed claims database. PARTICIPANTS: 13 273 128 patients diagnosed with COVID-19 (December 2020 through September 2021) were treated with CAS+IMD or untreated but treatment eligible under the Emergency Use Authorization (EUA). Each treated patient was exact and propensity score matched without replacement to up to five untreated EUA-eligible patients. INTERVENTIONS: CAS+IMD. PRIMARY AND SECONDARY OUTCOME MEASURES: Composite endpoint of 30-day all-cause mortality or COVID-19-related hospitalisation. Kaplan-Meier estimators were used to calculate outcome risks overall and across subgroups: age, COVID-19 vaccination status, immunocompromised status, and timing of diagnosis (December 2020 to June 2021, and July to September 2021). Cox proportional hazards models were used to estimate adjusted HRs (aHRs) and 95% CIs. RESULTS: Among 75 159 CAS+IMD-treated and 1 670 338 EUA-eligible untreated patients, 73 759 treated patients were matched to 310 688 untreated patients; matched patients were ~50 years, ~60% were women and generally well balanced across risk factors. The 30-day risk of the composite outcome was 2.1% and 5.2% in the CAS+IMD-treated and CAS+IMD-untreated patients, respectively; equivalent to a 60% lower risk (aHR 0.40; 95% CI, 0.38 to 0.42). The effect of CAS+IMD was consistent across subgroups, including those who received a COVID-19 vaccine (aHR 0.48, 95% CI, 0.41 to 0.56), and those diagnosed during the Delta-dominant period (aHR 0.40, 95% CI, 0.38 to 0.42). CONCLUSIONS: The real-world effectiveness of CAS+IMD is consistent with the efficacy for reducing all-cause mortality or COVID-19-related hospitalisation reported in clinical trials. Effectiveness is maintained across patient subgroups, including those prone to breakthrough infections, and was effective against susceptible variants including Delta. .

Hospitalised COVID-19 outcomes are predicted by hypoxaemia and pneumonia phenotype irrespective of the timing of their emergence.

Despite the known clinical importance of hypoxemia and pneumonia, there is a paucity of evidence for these variables with respect to risk of mortality and short-term outcomes among those hospitalised with COVID-19. OBJECTIVE: Describe the prevalence and clinical course of patients hospitalised with COVID-19 based on oxygenation and pneumonia status at presentation and determine the incidence of emergent hypoxaemia or radiographic pneumonia during admission. METHODS: A retrospective study was conducted using a Canadian regional registry. Patients were stratified according to hypoxaemia/pneumonia phenotype and prevalence. Clinical parameters were compared between phenotypes using χ2 and one-way Analysis of variance (ANOVA). Cox analysis estimated adjusted Hazard Ratios (HR) for associations between disease outcomes and phenotypes. RESULTS: At emergency department (ED) admission, the prevalence of pneumonia and hypoxaemia was 43% and 50%, respectively, and when stratified to phenotypes: 28.2% hypoxaemia+/pneumonia+, 22.2% hypoxaemia+/pneumonia-, 14.5% hypoxaemia-/pneumonia+ and 35.1% hypoxaemia-/pneumonia-. Mortality was 31.1% in the hypoxaemia+/pneumonia- group and 26.3% in the hypoxaemia+/pneumonia+ group. Hypoxaemia with pneumonia and without pneumonia predicted higher probability of death. Hypoxaemia either <24 hours or ≥24 hours after hospitalisation predicted higher mortality and need for home oxygen compared with those without hypoxaemia. Patients with early hypoxaemia had higher probability of Intensive care unit (ICU) admission compared with those with late hypoxaemia. CONCLUSION: Mortality in COVID-19 infection is predicted by hypoxaemia with or without pneumonia and was greatest in patients who initially presented with hypoxaemia. The emergence of hypoxaemia was predicted by radiographic pneumonia. Patients with early and emergent hypoxaemia had similar mortality but were less likely to be admitted to ICU. There may be delayed identification of hypoxaemia, which prevents timely escalation of care.

Comparison of COVID-19 survival in relation to CPAP length of treatment and by comorbidity and transmission setting (community or hospital acquired) in a medium-sized UK hospital in 2020: a retrospective study.

OBJECTIVE: To estimate continuous positive airway pressure (CPAP) length of treatment effect on survival of hospitalised COVID-19 patients in a medium-sized UK Hospital, and how this effect changes according to the patient's comorbidity and COVID-19 route of acquisition (community or nosocomial) during the two waves in 2020. SETTING: The acute inpatient unit in Wrightington, Wigan and Leigh Teaching Hospitals National Health Service (NHS) Foundation Trust (WWL), a medium-sized NHS Trust in north-west of England. DESIGN: Retrospective cohort of all confirmed COVID-19 patients admitted in WWL during 2020. PARTICIPANTS: 1830 patients (568 first wave, 1262 s wave) with antigen confirmed COVID-19 disease and severe acute respiratory syndrome admitted between 17 March 2020 (first confirmed COVID-19 case) and 31 December 2020. OUTCOME MEASURE: COVID-19 survival rate in all patients and survival rate in potentially hospital-acquired COVID-19 (PHA) patients were modelled using a predictor set which include comorbidities (eg, obesity, diabetes, chronic ischaemic heart disease (IHD), chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD)), wave, age, sex and care home residency, and interventions (remdesivir, dexamethasone, CPAP, intensive care unit (ICU), intubation). Secondary outcome measure was CPAP length, which was modelled using the same predictors of the survival rate. RESULTS: Mortality rate in the second wave was significantly lower than in the first wave (43.4% vs 28.1%, p<0.001), although for PHA COVID-19 patients mortality did not reduce, remaining at very high levels independently of wave and CPAP length. For all cohort, statistical modelling identified CPAP length (HR 95% CI 0.86 to 0.96) and women (HR 95% CI 0.71 to 0.81) were associated with improved survival, while being older age (HR 95% CI 1.02 to 1.03) admitted from care homes (HR 95% CI 2.22 to 2.39), IHD (HR 95% CI 1.13 to 1.24), CKD (HR 95% CI 1.14 to 1.25), obesity (HR 95% CI 1.18 to 1.28) and COPD-emphysema (HR 95% CI 1.18 to 1.57) were associated with reduced survival. Despite the detrimental effect of comorbidities, patients with CKD (95% CI 16% to 30% improvement in survival), IHD (95% CI 1% to 10% improvement in survival) and asthma (95% CI 8% to 30% improvement in survival) benefitted most from CPAP length, while no significant survival difference was found for obese and patients with diabetes. CONCLUSIONS: The experience of an Acute Trust during the COVID-19 outbreak of 2020 is documented and indicates the importance of care home and hospitals in disease acquisition. Death rates fell between the first and second wave only for community-acquired COVID-19 patients. The fall was associated to CPAP length, especially for some comorbidities. While uncovering some risk and protective factors of mortality in COVID-19 studies, the study also unravels how little is known about PHA COVID-19 and the interaction between CPAP and some comorbidities.

Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial.

INTRODUCTION: Long COVID-19, where symptoms persist 12 weeks after the initial SARS-CoV-2-infection, is a substantial problem for individuals and society in the surge of the pandemic. Common symptoms are fatigue, postexertional malaise and cognitive dysfunction. There is currently no effective treatment and the underlying mechanisms are unknown, although several hypotheses exist, with chronic inflammation as a common denominator. In prospective studies, hyperbaric oxygen therapy (HBOT) has been suggested to be effective for the treatment of similar syndromes such as chronic fatigue syndrome and fibromyalgia. A case series has suggested positive effects of HBOT in long COVID-19. This randomised, placebo-controlled clinical trial will explore HBOT as a potential treatment for long COVID-19. The primary objective is to evaluate if HBOT improves health-related quality of life (HRQoL) for patients with long COVID-19 compared with placebo/sham. The main secondary objective is to evaluate whether HBOT improves endothelial function, objective physical performance and short-term HRQoL. METHODS AND ANALYSIS: A randomised, placebo-controlled, double-blind, phase II clinical trial in 80 previously healthy subjects debilitated due to long COVID-19, with low HRQoL. Clinical data, HRQoL questionnaires, blood samples, objective tests and activity metre data will be collected at baseline. Subjects will be randomised to a maximum of 10 treatments with hyperbaric oxygen or sham treatment over 6 weeks. Assessments for safety and efficacy will be performed at 6, 13, 26 and 52 weeks, with the primary endpoint (physical domains in RAND 36-Item Health Survey) and main secondary endpoints defined at 13 weeks after baseline. Data will be reviewed by an independent data safety monitoring board. ETHICS AND DISSEMINATION: The trial is approved by the Swedish National Institutional Review Board (2021-02634) and the Swedish Medical Products Agency (5.1-2020-36673). Positive, negative and inconclusive results will be published in peer-reviewed scientific journals with open access. TRIAL REGISTRATION NUMBER: NCT04842448.

Surgical mask wearing behaviour in COVID-19 pandemic and influenza seasons: a cross-sectional study on healthcare professional students and staff's perspective in Southern California.

OBJECTIVE: To investigate healthcare professional staff and students' perception of wearing surgical masks before and after their experience with the COVID-19 pandemic, and to evaluate the impact on mask wearing behaviour in future influenza seasons. DESIGN: Cross-sectional study using anonymous survey. SETTING AND PARTICIPANTS: Healthcare students and staff from a healthcare academic institution in Southern California participated in the mask survey study. Survey results were collected from June to November 2021. A total of 305 respondents responded to the survey, with 173 being healthcare students and 132 being working healthcare staff. OUTCOMES: The study examined respondents' perceptions and hospital mask wearing behaviour before and after their COVID-19 pandemic experience, as well as during previous and future influenza seasons. RESULTS: Two hundred and sixty-four (86.6%) respondents agreed that wearing a surgical mask reduces infection and limits transmission of infectious disease, yet prior to the pandemic, only a small proportion wore a mask in the hospital or during patient care. After experiencing the COVID-19 pandemic, more respondents indicated that they would continue to wear a mask when they are in a hospital in general (n=145, 47.5%), during patient care (n=262, 85.9%), during influenza seasons throughout the hospital (n=205, 67.2%) and during influenza seasons during patient care (n=270, 88.5%). CONCLUSION: The pandemic experience has greatly influenced the health prevention behaviours of healthcare students and staff. After the pandemic, many respondents will continue to practice surgical mask wearing behaviour in the hospital, especially during face-to-face patient care. This demonstrates a significant change in health prevention perceptions among the current and the future generation of healthcare professionals.

Assessing the impact of COVID-19 measures on COPD management and patients: a simulation-based decision support tool for COPD services in the UK.

OBJECTIVES: To develop a computer-based decision support tool (DST) for key decision makers to safely explore the impact on chronic obstructive pulmonary disease (COPD) care of service changes driven by restrictions to prevent the spread of COVID-19. DESIGN: The DST is powered by discrete event simulation which captures the entire patient pathway. To estimate the number of COPD admissions under different scenario settings, a regression model was developed and embedded into the tool. The tool can generate a wide range of patient-related and service-related outputs. Thus, the likely impact of possible changes (eg, COVID-19 restrictions and pandemic scenarios) on patients with COPD and care can be estimated. SETTING: COPD services (including outpatient and inpatient departments) at a major provider in central London. RESULTS: Four different scenarios (reflecting the UK government's Plan A, Plan B and Plan C in addition to a benchmark scenario) were run for 1 year. 856, 616 and 484 face-to-face appointments (among 1226 clinic visits) are expected in Plans A, B and C, respectively. Clinic visit quality in Plan A is found to be marginally better than in Plans B and C. Under coronavirus restrictions, lung function tests decreased more than 80% in Plan C as compared with Plan A. Fewer COPD exacerbation-related admissions were seen (284.1 Plan C vs 395.1 in the benchmark) associated with stricter restrictions. Although the results indicate that fewer quality-adjusted life years (in terms of COPD management) would be lost during more severe restrictions, the wider impact on physical and mental health must also be established. CONCLUSIONS: This DST will enable COPD services to examine how the latest developments in care delivery and management might impact their service during and beyond the COVID-19 pandemic, and in the event of future pandemics.

Effectiveness and feasibility of telerehabilitation in patients with COVID-19: a systematic review and meta-analysis.

OBJECTIVES: To determine the pooled effectiveness and feasibility of telerehabilitation in patients with COVID-19. DESIGN: Systematic review and meta-analysis of randomised controlled trials (RCTs). DATA SOURCES: PubMed, CINAHL, Science Direct, PEDro, Google Scholar and Cochrane Library databases were systematically searched to the end of March 2022. ELIGIBILITY CRITERIA AND OUTCOMES: RCTs investigating the effects of telerehabilitation in the management of patients with COVID-19 were included. The outcomes of interest were functional capacity, cardiopulmonary exercise tests, quality of life and other variables where data are available. DATA EXTRACTION AND SYNTHESIS: Two reviewers screened, extracted data and performed methodological quality assessment independently. The revised Cochrane Risk of Bias tool was used to assess the risk of bias. Review Manager V.5.4 and Stata V.14.0 software were used for statistical analysis. Mean difference (MD) with 95% CI and the corresponding p value were used to determine the treatment effect between groups. A fixed-effect model was used for all variables as no significant heterogeneity was observed. RESULTS: Four studies with 334 patients with COVID-19 were included. The pooled result of telerehabilitation showed statistically significant improvement on 6-minute walking test (MD 75.50; 95% CI 54.69 to 96.30; p=0.48), 30-second sit-to-stand test (MD 1.76; 95% CI 1.47 to 2.04; p=0.30), Borg Scale (MD 2.49; 95% CI 2.16 to 2.83; p=0.28) and level of dyspnoea (MD 6.26; 95% CI 5.42 to 7.10; p=0.66). The overall treatment completion rate was 88.46%, and the most common reason for withdrawal after randomisation was lost to follow-up or uncooperativeness. CONCLUSIONS: The findings showed that telerehabilitation interventions could improve functional capacity and exercise perception among patients affected by COVID-19 and can be implemented with a high completion rate and minimal adverse events. However, more studies are required to investigate the effects on cardiopulmonary function, quality of life, anxiety, depression and other variables. PROSPERO REGISTRATION NUMBER: CRD42021287975.

Volume sweep imaging lung teleultrasound for detection of COVID-19 in Peru: a multicentre pilot study.

OBJECTIVES: Pulmonary disease is a significant cause of morbidity and mortality in adults and children, but most of the world lacks diagnostic imaging for its assessment. Lung ultrasound is a portable, low-cost, and highly accurate imaging modality for assessment of pulmonary pathology including pneumonia, but its deployment is limited secondary to a lack of trained sonographers. In this study, we piloted a low-cost lung teleultrasound system in rural Peru during the COVID-19 pandemic using lung ultrasound volume sweep imaging (VSI) that can be operated by an individual without prior ultrasound training circumventing many obstacles to ultrasound deployment. DESIGN: Pilot study. SETTING: Study activities took place in five health centres in rural Peru. PARTICIPANTS: There were 213 participants presenting to rural health clinics. INTERVENTIONS: Individuals without prior ultrasound experience in rural Peru underwent brief training on how to use the teleultrasound system and perform lung ultrasound VSI. Subsequently, patients attending clinic were scanned by these previously ultrasound-naïve operators with the teleultrasound system. PRIMARY AND SECONDARY OUTCOME MEASURES: Radiologists examined the ultrasound imaging to assess its diagnostic value and identify any pathology. A random subset of 20% of the scans were analysed for inter-reader reliability. RESULTS: Lung VSI teleultrasound examinations underwent detailed analysis by two cardiothoracic attending radiologists. Of the examinations, 202 were rated of diagnostic image quality (94.8%, 95% CI 90.9% to 97.4%). There was 91% agreement between radiologists on lung ultrasound interpretation among a 20% sample of all examinations (κ=0.76, 95% CI 0.53 to 0.98). Radiologists were able to identify sequelae of COVID-19 with the predominant finding being B-lines. CONCLUSION: Lung VSI teleultrasound performed by individuals without prior training allowed diagnostic imaging of the lungs and identification of sequelae of COVID-19 infection. Deployment of lung VSI teleultrasound holds potential as a low-cost means to improve access to imaging around the world.

Burden, clinical features and outcomes of post-tuberculosis lung disease in sub-Saharan Africa: a protocol for a systematic review and meta-analysis.

INTRODUCTION: Tuberculosis (TB) is significantly associated with multiple postinfectious, non-communicable diseases after microbiological cure. For example, those with a history of TB disease have a higher risk of developing chronic lung diseases at a younger age. However, the extent and nature of post-TB complications are not well described. Here, we present a protocol for a systematic review and meta-analysis, which aims to synthesise literature on the burden of post-TB lung disease (PTLD) in sub-Saharan Africa, describe phenotypes, long-term outcomes and the health-related quality of life of people with PTLD. METHODS AND ANALYSIS: A systematic search will be conducted using PubMed, EMBASE, Web of Science, African Journals Online and the Cochrane Library of Systematic Reviews. Papers published in English and French languages that report the prevalence, clinical features, quality of life and long-term outcomes of people with PTLD in sub-Saharan Africa will be considered. We will assess and critically appraise the methodological quality of all studies using the modified covidence. Qualitative and quantitative (network and meta-analysis) synthesis will be performed and STATA V.16 will be used to estimate the burden of PTLD. ETHICS AND DISSEMINATION: Ethical approval is not required for this systematic review and meta-analysis. Our results will be published in peer-reviewed journals. PROSPERO REGISTRATION NUMBER: CRD42021274018.

Development of an Australia and New Zealand Lung Cancer Clinical Quality Registry: a protocol paper.

INTRODUCTION: Lung cancer is the leading cause of cancer mortality, comprising the largest national cancer disease burden in Australia and New Zealand. Regional reports identify substantial evidence-practice gaps, unwarranted variation from best practice, and variation in processes and outcomes of care between treating centres. The Australia and New Zealand Lung Cancer Registry (ANZLCR) will be developed as a Clinical Quality Registry to monitor the safety, quality and effectiveness of lung cancer care in Australia and New Zealand. METHODS AND ANALYSIS: Patient participants will include all adults >18 years of age with a new diagnosis of non-small-cell lung cancer (NSCLC), SCLC, thymoma or mesothelioma. The ANZLCR will register confirmed diagnoses using opt-out consent. Data will address key patient, disease, management processes and outcomes reported as clinical quality indicators. Electronic data collection facilitated by local data collectors and local, state and federal data linkage will enhance completeness and accuracy. Data will be stored and maintained in a secure web-based data platform overseen by registry management. Central governance with binational representation from consumers, patients and carers, governance, administration, health department, health policy bodies, university research and healthcare workers will provide project oversight. ETHICS AND DISSEMINATION: The ANZLCR has received national ethics approval under the National Mutual Acceptance scheme. Data will be routinely reported to participating sites describing performance against measures of agreed best practice and nationally to stakeholders including federal, state and territory departments of health. Local, regional and (bi)national benchmarks, augmented with online dashboard indicator reporting will enable local targeting of quality improvement efforts.

Diagnostic performance of mycological tests for invasive pulmonary aspergillosis in non-haematological patients: protocol for a systematic review and meta-analysis.

INTRODUCTION: Increasing numbers of patients with non-haematological diseases are infected with invasive pulmonary aspergillosis (IPA), with a high mortality reported which is mainly due to delayed diagnosis. The diagnostic capability of mycological tests for IPA including galactomannan test, (1,3)-ß-D-glucan test, lateral flow assay, lateral flow device and PCR for the non-haematological patients remains unknown. This protocol aims to conduct a systematic review and meta-analysis of the diagnostic performance of mycological tests to facilitate the early diagnosis and treatments of IPA in non-haematological diseases. METHODS AND ANALYSIS: Database including PubMed, CENTRAL and EMBASE will be searched from 2002 until the publication of results. Cohort or cross-sectional studies that assessing the diagnostic capability of mycological tests for IPA in patients with non-haematological diseases will be included. The true-positive, false-positive, true-negative and false-negative of each test will be extracted and pooled in bivariate random-effects model, by which the sensitivity and specificity will be calculated with 95% CI. The second outcomes will include positive (negative) likelihood ratio, area under the receiver operating characteristic curve and diagnostic OR will also be computed in the bivariate model. When applicable, subgroup analysis will be performed with several prespecified covariates to explore potential sources of heterogeneity. Factors that may impact the diagnostic effects of mycological tests will be examined by sensitivity analysis. The risk of bias will be appraised by the Quality Assessment tool for Diagnostic Accuracy Studies (QUADAS-2). ETHICS AND DISSEMINATION: This protocol is not involved with ethics approval, and the results will be peer-reviewed and disseminated on a recognised journal. PROSPERO REGISTRATION NUMBER: CRD42021241820.

Early risk assessment in paediatric and adult household contacts of confirmed tuberculosis cases by novel diagnostic tests (ERASE-TB): protocol for a prospective, non-interventional, longitudinal, multicountry cohort study.

INTRODUCTION: The WHO End-TB Strategy calls for the development of novel diagnostics to detect tuberculosis (TB) earlier and more accurately. Better diagnostics, together with tools to predict disease progression, are critical for achieving WHO End-TB targets. The Early Risk Assessment in TB Contacts by new diagnoStic tEsts (ERASE-TB) study aims to evaluate novel diagnostics and testing algorithms for early TB diagnosis and accurate prediction of disease progression among household contacts (HHCs) exposed to confirmed index cases in Mozambique, Tanzania and Zimbabwe. METHODS AND ANALYSIS: A total of 2100 HHCs (aged ≥10 years) of adults with microbiologically-confirmed pulmonary TB will be recruited and followed up at 6-month intervals for 18-24 months. At each time point, a WHO symptom screen and digital chest radiograph (dCXR) will be performed, and blood and urine samples will be collected. Individuals screening positive (WHO symptom screen or dCXR) will be requested to provide sputum for Xpert MTB/Rif Ultra. At baseline, HHCs will also be screened for HIV, diabetes (HbA1c), chronic lung disease (spirometry), hypertension and anaemia. Study outcomes will be coprevalent TB (diagnosed at enrolment), incident TB (diagnosed during follow-up) or no TB at completion of follow-up. Novel diagnostics will be validated using fresh and biobanked samples with a nested case-control design. Cases are defined as HHCs diagnosed with TB (for early diagnosis) or with incident TB (for prediction of progression) and will be matched by age, sex and country to HHCs who remain healthy (controls). Statistical analyses will include assessment of diagnostic accuracy by constructing receiver operating curves and calculation of sensitivity and specificity. ETHICS AND DISSEMINATION: ERASE-TB has been approved by regulatory and ethical committees in each African country and by each partner organisation. Consent, with additional assent for participants <18 years, is voluntary. Attestation by impartial witnesses is sought in case of illiteracy. Confidentiality of participants is being maintained throughout. Study findings will be presented at scientific conferences and published in peer-reviewed international journals. TRIAL REGISTRATION NUMBER: NCT04781257.Cite Now.

What are the respiratory health research priorities in Alberta, Canada? A stakeholder consultation.

OBJECTIVE: The Respiratory Health Strategic Clinical Network (RHSCN) was launched to facilitate respiratory and sleep health through implementation of innovative, patient-centred, evidence-informed coordinated services in Alberta. In collaboration with project partners, the RHSCN aimed to determine the respiratory research priorities for Alberta. DESIGN: The four phases of this research prioritisation project were (1) identifying research questions from stakeholders, (2) determining which research questions had been answered in existing literature, (3) prioritising unanswered questions and (4) finalising the priorities through an inperson workshop. SETTING: The study occurred in Alberta, Canada over a 2-year period beginning in March 2017. PARTICIPANTS: A total of 448 patients, clinicians and other stakeholders consented to participate in the survey. RESULTS: A total of 595 possible questions were submitted, with 343 unique questions identified. Of the questions, 94 were out of scope, 155 answered by existing literature and 10 were combined with others, while 83 were determined to be unanswered in the literature. Stakeholders were surveyed again to prioritise the remaining 83 questions and they were reviewed by the project's Steering Committee (clinicians and patients). At the inperson workshop, the Steering Committee identified 17 research topics as priority areas for respiratory and sleep research in Alberta. CONCLUSION: A stakeholder-led research prioritisation process identified optimal clinical management/follow-up, equitable access to services, and management of social, psychological and mental health issues related to respiratory/sleep health as priority research areas.

Chronic lung lesions in COVID-19 survivors: predictive clinical model.

OBJECTIVE: This study aimed to propose a simple, accessible and low-cost predictive clinical model to detect lung lesions due to COVID-19 infection. DESIGN: This prospective cohort study included COVID-19 survivors hospitalised between 30 March 2020 and 31 August 2020 followed-up 6 months after hospital discharge. The pulmonary function was assessed using the modified Medical Research Council (mMRC) dyspnoea scale, oximetry (SpO2), spirometry (forced vital capacity (FVC)) and chest X-ray (CXR) during an in-person consultation. Patients with abnormalities in at least one of these parameters underwent chest CT. mMRC scale, SpO2, FVC and CXR findings were used to build a machine learning model for lung lesion detection on CT. SETTING: A tertiary hospital in Sao Paulo, Brazil. PARTICIPANTS: 749 eligible RT-PCR-confirmed SARS-CoV-2-infected patients aged ≥18 years. PRIMARY OUTCOME MEASURE: A predictive clinical model for lung lesion detection on chest CT. RESULTS: There were 470 patients (63%) that had at least one sign of pulmonary involvement and were eligible for CT. Almost half of them (48%) had significant pulmonary abnormalities, including ground-glass opacities, parenchymal bands, reticulation, traction bronchiectasis and architectural distortion. The machine learning model, including the results of 257 patients with complete data on mMRC, SpO2, FVC, CXR and CT, accurately detected pulmonary lesions by the joint data of CXR, mMRC scale, SpO2 and FVC (sensitivity, 0.85±0.08; specificity, 0.70±0.06; F1-score, 0.79±0.06 and area under the curve, 0.80±0.07). CONCLUSION: A predictive clinical model based on CXR, mMRC, oximetry and spirometry data can accurately screen patients with lung lesions after SARS-CoV-2 infection. Given that these examinations are highly accessible and low cost, this protocol can be automated and implemented in different countries for early detection of COVID-19 sequelae.

Comparing lung ultrasound: extensive versus short in COVID-19 (CLUES): a multicentre, observational study at the emergency department

BackgroundBedside lung ultrasound (LUS) is an affordable diagnostic tool that could contribute to identifying COVID-19 pneumonia. Different LUS protocols are currently used at the emergency department (ED) and there is a need to know their diagnostic accuracy.DesignA multicentre, prospective, observational study, to compare the diagnostic accuracy of three commonly used LUS protocols in identifying COVID-19 pneumonia at the ED.Setting/patientsAdult patients with suspected COVID-19 at the ED, in whom we prospectively performed 12-zone LUS and SARS-CoV-2 reverse transcription PCR.MeasurementsWe assessed diagnostic accuracy for three different ultrasound protocols using both PCR and final diagnosis as a reference standard.ResultsBetween 19 March 2020 and 4 May 2020, 202 patients were included. Sensitivity, specificity and negative predictive value compared with PCR for 12-zone LUS were 91.4% (95% CI 84.4 to 96.0), 83.5% (95% CI 74.6 to 90.3) and 90.0% (95% CI 82.7 to 94.4). For 8-zone and 6-zone protocols, these results were 79.7 (95% CI 69.9 to 87.6), 69.0% (95% CI 59.6 to 77.4) and 81.3% (95% CI 73.8 to 87.0) versus 89.9% (95% CI 81.7 to 95.3), 57.5% (95% CI 47.9 to 66.8) and 87.8% (95% CI 79.2 to 93.2). Negative likelihood ratios for 12, 8 and 6 zones were 0.1, 0.3 and 0.2, respectively. Compared with the final diagnosis specificity increased to 83.5% (95% CI 74.6 to 90.3), 78.4% (95% CI 68.8 to 86.1) and 65.0% (95% CI 54.6 to 74.4), respectively, while the negative likelihood ratios were 0.1, 0.2 and 0.16.ConclusionIdentifying COVID-19 pneumonia at the ED can be aided by bedside LUS. The more efficient 6-zone protocol is an excellent screening tool, while the 12-zone protocol is more specific and gives a general impression on lung involvement.Trial registration numberNL8497.

Invasive pneumococcal disease, pneumococcal pneumonia and all-cause pneumonia in Hong Kong during the COVID-19 pandemic compared with the preceding 5 years: a retrospective observational study

ObjectivesTo compare the incidence and severity of invasive pneumococcal diseases (IPDs), pneumococcal pneumonia and all-cause pneumonia during the COVID-19 pandemic period with universal masking and social distancing with that of previous 5 years.DesignRetrospective observational study on incidence of IPDs, pneumococcal pneumonia and all-cause pneumonia between January 2015–December 2019 and March 2020–March 2021. January–February 2020 was excluded from analysis as it was treated as a transitional period between normal time and pandemic.SettingEpisode-based data by retrieval of hospitalisation records from the Hospital Authority’s territory-wide electronic medical record database in Hong Kong.ParticipantsHospitalised patients with IPD (n=742), pneumococcal pneumonia (n=2163) and all-cause pneumonia (including COVID-19 pneumonia, n=453 999) aged 18 years or above. Control diagnoses were included to assess confounding from health-seeking behaviours.Primary and secondary outcomesPrimary outcome is the incidence of diseases between two periods. Secondary outcomes include disease severity surrogated by length of stay and mortality.ResultsMonthly average number of IPD, pneumococcal pneumonia and all-cause pneumonia hospitalisation significantly decreased by 88.9% (95% CI 79.8% to 98.0%, p<0.0005), 72.5% (95% CI 65.9% to 79.1%, p<0.0005) and 17.5% (95% CI 16.8% to 18.2%, p<0.0005), respectively. Changes in trend from January 2015–December 2019 to March 2020–March 2021 were −70% (95% CI −87% to −35%, p=0.0025), –43% (95% CI −59% to −19%, p=0.0014) and −11% (95% CI −13% to −10%, p<0.0005), respectively. Length of stay for IPD and pneumococcal pneumonia episodes were insignificantly different in the two periods. No reductions in hospitalisations for control diagnoses were observed.ConclusionsIncidence of IPD, pneumococcal pneumonia and all-cause pneumonia decreased during the COVID-19 pandemic. This was observed with universal masking and social distancing. We postulated this is related to reduced transmission of respiratory viruses and bacteria.

Factors associated with high compliance behaviour against COVID-19 in the early phase of pandemic: a cross-sectional study in 12 Asian countries

IntroductionRegardless of having effective vaccines against COVID-19, containment measures such as enhanced physical distancing and good practice of personal hygiene remain the mainstay of controlling the COVID-19 pandemic. Countries across Asia have imposed these containment measures to varying extents. However, residents in different countries would have a differing degree of compliance to these containment measures potentially due to differences in the level of awareness and motivation in the early phase of pandemic.ObjectivesIn our study, we aimed to describe and correlate the level of knowledge and attitude with the level of compliance with personal hygiene and physical distancing practices among Asian countries in the early phase of pandemic.MethodsA multinational cross-sectional study was carried out using electronic surveys between May and June 2020 across 14 geographical areas. Subjects aged 21 years and above were invited to participate through social media, word of mouth and electronic mail.ResultsAmong the 2574 responses obtained, 762 (29.6%) participants were from East Asia and 1812 (70.4%) were from Southeast Asia (SEA). A greater proportion of participants from SEA will practise physical distancing as long as it takes (72.8% vs 60.6%). Having safe distancing practices such as standing more than 1 or 2 m apart (AdjOR 5.09 95% CI (1.08 to 24.01)) or more than 3 or 4 m apart (AdjOR 7.05 95% CI (1.32 to 37.67)), wearing a mask when they had influenza-like symptoms before the COVID-19 pandemic, preferring online news channels such as online news websites/applications (AdjOR 1.73 95% CI (1.21 to 2.49)) and social media (AdjOR 1.68 95% CI (1.13 to 2.50) as sources of obtaining information about COVID-19 and high psychological well-being (AdjOR 1.39 95% CI (1.04 to 1.87)) were independent factors associated with high compliance.ConclusionsWe found factors associated with high compliance behaviour against COVID-19 in the early phase of pandemic and it will be useful to consider them in risk assessment, communication and pandemic preparedness.