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.

Assembly Line ICU: what the Long Shops taught us about managing surge capacity for COVID-19.

OBJECTIVES: To safely expand and adapt the normal workings of a large critical care unit in response to the COVID-19 pandemic. METHODS: In April 2020, UK health systems were challenged to expand critical care capacity rapidly during the first wave of the COVID-19 pandemic so that they could accommodate patients with respiratory and multiple organ failure. Here, we describe the preparation and adaptive responses of a large critical care unit to the oncoming burden of disease. Our changes were similar to the revolution in manufacturing brought about by 'Long Shops' of 1853 when Richard Garrett and Sons of Leiston started mass manufacture of traction engines. This innovation broke the whole process into smaller parts and increased productivity. When applied to COVID-19 preparations, an assembly line approach had the advantage that our ICU became easily scalable to manage an influx of additional staff as well as the increase in admissions. Healthcare professionals could be replaced in case of absence and training focused on a smaller number of tasks. RESULTS: Compared with the equivalent period in 2019, the ICU provided 30.9% more patient days (2599 to 3402), 1845 of which were ventilated days (compared with 694 in 2019, 165.8% increase) while time from first referral to ICU admission reduced from 193.8±123.8 min (±SD) to 110.7±76.75 min (±SD). Throughout, ICU maintained adequate capacity and also accepted patients from neighbouring hospitals. This was done by managing an additional 205 doctors (70% increase), 168 nurses who had previously worked in ICU and another 261 nurses deployed from other parts of the hospital (82% increase).Our large tertiary hospital ensured a dedicated non-COVID ICU was staffed and equipped to take regional emergency referrals so that those patients requiring specialist surgery and treatment were treated throughout the COVID-19 pandemic. CONCLUSIONS: We report how the challenge of managing a huge influx of patients and redeployed staff was met by deconstructing ICU care into its constituent parts. Although reported from the largest colocated ICU in the UK, we believe that this offers solutions to ICUs of all sizes and may provide a generalisable model for critical care pandemic surge planning.

Mitigating seabird bycatch during hauling by pelagic longline vessels.

Bycatch in longline fisheries threatens the viability of some seabird populations. The Hawaii longline swordfish fishery reduced seabird captures by an order of magnitude primarily through mitigating bycatch during setting. Now, 75% of captures occur during hauling. We fit observer data to a generalized additive regression model with mixed effects to determine the significance of the effect of various factors on the standardized seabird haul catch rate. Density of albatrosses attending vessels during hauling, leader length and year had largest model effects. The standardized haul catch rate significantly increased with increased albatross density during hauling. The standardized catch rate was significantly higher the longer the leader: shorter leaders place weighted swivels closer to hooks, reducing the likelihood of baited hooks becoming available to surface-scavenging albatrosses. There was a significant linear increasing temporal trend in the standardized catch rate, possibly partly due to an observed increasing temporal trend in the local abundance of albatrosses attending vessels during hauling. Swivel weight, Beaufort scale and season were also significant but smaller model effects. Most (81%) haul captures were on branchlines actively being retrieved. Future haul mitigation research should therefore focus on reducing bird access to hooks as crew coil branchlines, including methods identified here of shorter leaders and heavier swivels, and other potentially effective methods, including faster branchline coiling and shielding the area where hooks becomes accessible. The proportion of Laysan albatross (Phoebastria immutabilis) captures that occurred during hauling was significantly, 1.6 times, higher than for black-footed albatrosses (P. nigripes), perhaps due to differences in the time of day of foraging and in daytime scavenging competitiveness; mitigating haul bycatch would therefore be a larger benefit to Laysans. Locally, findings identify opportunities to nearly eliminate seabird bycatch. Globally, findings fill a gap in knowledge of methods to mitigate seabird bycatch during pelagic longline hauling.