Increase in recruitment upon integration of trial into a clinical care pathway: an observational study.

INTRODUCTION: Many respiratory clinical trials fail to reach their recruitment target and this problem exacerbates existing funding issues. Integration of the clinical trial recruitment process into a clinical care pathway (CCP) may represent an effective way to significantly increase recruitment numbers. METHODS: A respiratory support unit and a CCP for escalation of patients with severe COVID-19 were established on 11 January 2021. The recruitment process for the Randomised Evaluation of COVID-19 Therapy-Respiratory Support trial was integrated into the CCP on the same date. Recruitment data for the trial were collected before and after integration into the CCP. RESULTS: On integration of the recruitment process into a CCP, there was a significant increase in recruitment numbers. Fifty patients were recruited over 266 days before this process occurred whereas 108 patients were recruited over 49 days after this process. There was a statistically significant increase in both the proportion of recruited patients relative to the number of COVID-19 hospital admissions (change from 2.8% to 9.1%, p<0.0001) and intensive therapy unit admissions (change from 17.8% to 50.2%, p<0.001) over the same period, showing that this increase in recruitment was independent of COVID-19 prevalence. DISCUSSION: Integrating the trial recruitment process into a CCP can significantly boost recruitment numbers. This represents an innovative model that can be used to maximise recruitment without impacting on the financial and labour costs associated with the running of a respiratory clinical trial.

Venous thromboembolism in patients with COVID-19 and correlation with D-dimers: a single-centre experience.

OBJECTIVE: To study the frequency of venous thromboembolism in hospitalised patients with COVID-19 and correlation with the D-dimers and thromboprophylaxis. DESIGN: Cross-sectional descriptive study. PLACE AND DURATION OF STUDY: Queen Elizabeth Hospital, 20 April 2020-13 May 2020. PATIENTS AND METHODS: One hundred and seven (n=107) patients of PCR-confirmed COVID-19 pneumonia admitted to Queen Elizabeth Hospital, Birmingham, between 20 April 2020 and 13 May 2020 were included in the study using consecutive sampling. Data were collected using the Excel audit tool and included age, gender, weight, estimated eGFR, D-dimer values on admission, intensive care unit admission, presence of respiratory failure, imaging results for evaluation of venous thromboembolism (VTE) and anticoagulation received on admission. The data were entered in the SPSS (V.17) and were analysed. Data were summarised as means±SD, number or percentage as appropriate. A p value of less than 0.05 was considered significant. RESULTS: The frequency of VTE was found to be 11.2% in patients hospitalised with COVID-19 pneumonia. The mean D-dimers were 3322.24 ng/mL±9603 ng/mL with the values significantly higher for patients with VTE and those requiring intensive care unit admission. All of the seven patients (100%) with D-dimers value above 2000 ng/mL who underwent imaging were found to have VTE. CONCLUSION: VTE is frequent in patients with COVID-19 pneumonia despite anticoagulation. A higher D-dimers value correlates well with the risk of VTE in these patients and further evaluation of such patients for VTE is necessary especially with D-dimers values above 2000 ng/mL.