Clinical Trials Unit » News (tag [Urgent Public Health])

Patient Information Sheet and Consent Form Clarification

Wed, 10 Feb 2021 08:20:00 GMT

Recent version control monitoring checks have revealed some discrepancies with the wrong versions of Patient Information Sheets and Consent forms used as sites have found the naming of documents confusing to navigate. We apologise for the confusion caused and to help provide clarity of which version to use please see the following table:

	Patient Information Sheet	Consent Form
For patients with mental capacity prior to randomisation	RECOVERY-RS PIS on commencement	RECOVERY-RS Consent Form on Commencement
For patient with mental capacity post randomisation	RECOVERY-RS Patient Information Sheet	RECOVERY-RS Patient Deferred Consent
For consultees where patients do not have capacity post randomisation or by/after hospital discharge	RECOVERY-RS Patient Information Sheet	RECOVERY-RS Declaration Consent Form Consultee

As a reminder, if you are unable to obtain consent from a patient with mental capacity or consultee post randomisation before they are discharged/transferred from hospital, you should attempt to contact the patient/consultee up to 3 times by telephone to seek verbal agreement. If you are unsuccessful in reaching them after 3 attempts you do not need to contact them further as we have permission from our REC for the patient’s data to remain in the trial.

RECOVERY-RS is now the largest global non-invasive respiratory support trial for COVID-19

Tue, 09 Feb 2021 17:02:16 GMT

RECOVERY-RS is now the largest global non-invasive respiratory support trial for COVID-19 with 1,106 patients recruited as of this morning. We would like to say a huge thank you to all the staff, patients and families involved for helping us reach this incredible milestone!

RECOVERY-RS DMC update

Mon, 01 Feb 2021 11:02:54 GMT

The DMC for RECOVERY-RS met at the end of January. They noted the considerable progress that had been made since the last DMC meeting, with over 1000 participants now enrolled, making the trial the world’s largest trial of non-invasive ventilation in acute respiratory failure. After careful consideration of the available data, the committee recommended that recruitment continues. A further review will be considered in 4 weeks time. The committee requested that we prioritise obtaining the outcome data for those enrolled to date. We plan to work with NHS Digital, ICNARC and our recruiting sites to obtain as much information as possible to inform the next review.

The investigator team would like to extend their sincere thanks to the patients, families, clinicians and research teams who have supported the trial to date. We plan to provide a further update following the next interim analysis.

RECOVERY-RS team.

900th patient recruited!

Tue, 19 Jan 2021 14:41:00 GMT

A big thank you to all of our recruitment sites, patients and families for helping us reach the milestone of 900 patients recruited. Recruitment has been phenomenal the last few weeks and your hard work does not go unnoticed. Thank you!

RECOVERY-RS 836 patients recruited!

Wed, 13 Jan 2021 10:46:31 GMT

836 patients have now been recruited to RECOVERY-RS. We would like to say a huge thank you to our recruitment sites, patients and their families for helping us to reach this milestone. These are very challenging times and we appreciate all of your hard work. Recruitment has been exceptional over the Christmas period with over 250 patients recruited in the last month alone. We look forward to our next interim analysis taking place soon and thank sites for your hard work with data collection.

Safety Reporting Clarification and updated CRF

Mon, 21 Dec 2020 11:04:22 GMT

We wish to provide clarification regarding the Safety Reporting requirements for the RECOVERY-RS Trial and notify you of the updated Data Collection CRF.

When assessing whether to record Adverse Events (AE’s) on the e-CRF, please only capture events that are CLEARLY RELATED (i.e. are suspected to have been caused by the administration of CPAP or HFNO). The list below are examples of SAEs that can be caused by non-invasive ventilation. This list is not exhaustive so any other event that has a potential causal relationship should still be captured on the e-CRF:

Interface intolerance due to excessive air leaks
Pain
Cutaneous pressure sore or pressure area
Claustrophobia
Oro-nasal dryness
Respiratory acidosis with pH <7.25 prior to intubation
Haemodynamic instability
Vomiting
Aspiration of gastric contents

Examples of other related events are pneumothorax and pneumomediastinum. Please note these events are now listed on the updated Data Collection CRF – v4.0 08 December 2020. Please use and file this version moving forward alongside the updated <u>master documents version log</u> – v9.0 21 Dec 2020.

When assessing Serious Adverse Events, as per protocol section 4.1.4, events that commonly occur in this population and those that are collected as outcomes of the trial should NOT be reported as SAEs.

As a reminder this means the following events are EXEMPT from SAE reporting:

Death
Organ failure
Pneumonia
Intubation
Trachostomy

Events that are related to the patient’s underlying disease or condition should not be reported as this is not a relevant requirement for the trial.

RECOVERY-RS 500 patients recruited!

Thu, 03 Dec 2020 16:22:57 GMT

Over 500 patients have now been recruited to the RECOVERY-RS trial! Thank you to everyone involved for all your hard work at sites and to patients & families for your generous participation.

RECOVERY-RS Group Site Teleconference feedback

Thu, 03 Dec 2020 15:19:00 GMT

A big thank you to everyone who joined the recent site teleconferences for RECOVERY-RS. We appreciate all of your feedback and hope you found these sessions useful & informative. Recruitment has been phenomenal these last few weeks and we have now reached a total of 509 patients recruited! Thank you to all involved.

Thanks again to Dr Messer & Dr Rostron for sharing their local experiences during the meeting of recruiting to RECOVERY-RS and how they have overcome challenges to embed the trial in to their clinical pathways. Thank you also to Dr Stephen Webb at Royal Papworth who provided really insightful comments yesterday regarding his altered view on CPAP. Experience during the second wave has shown concerns from ECMO centres about barotrauma from prolonged CPAP/NIV. This has led to a change in NHS guidance regarding ECMO criteria. Prolonged use of CPAP therefore may preclude option for ECMO leading to potential harm for CPAP. The only way to resolve these uncertainties is in a trial setting and through recruitment to RECOVERY-RS which will provide us with the evidence we need.

Summary minutes from the teleconferences will be circulated in the near future.

- Recording from TC held 24 Nov 20: https://files.warwick.ac.uk/eskilton/files/RECOVERY-RS+recordings/Site+TC+24Nov20+recording.mp4

- Slides from the TC meeting

- Local poster used at Heartlands (patient cards & poster) to assist with recruitment as a useful tool

- Trial certificate of appreciation to use to award trainees/staff involved in the study

- Slides from a recent TRIC & RAFT trainee meeting to share amongst trainee colleagues. Trainees can be critical to helping capture patients early on in their clinical pathway. A recording of Prof Gavin Perkins delivering these slides can be found here: https://files.warwick.ac.uk/eskilton/files/RECOVERY-RS+recordings/RECOVERY-RS+RAFT++TRIC+presentation+recording_23Nov20_.mp4

As a reminder all trial documentation including other aid memoirs can be downloaded from our trial website: https://warwick.ac.uk/fac/sci/med/research/ctu/trials/recovery-rs/sitestaff/

RECOVERY-RS in The Times

Mon, 12 Oct 2020 08:29:00 GMT

An article was recently published in The Times emphasising the need for RECOVERY-RS to resolve doubts around the best respiratory support to provide to COVID-19 patients. Clinical equipoise at sites to essential to provide us with the answers we need.

RECOVERY-RS is the only large trial investigating whether intervening with CPAP and delivering oxygen under pressure into the nose really do speed recovery times and reduce the need for people to be intubated.

RECOVERY-RS Patient story

Wed, 01 Jul 2020 16:37:00 GMT

Phil was hospitalised with COVID-19 in early April 2020. Struggling to breathe, he was grateful to have the chance to take part in the RECOVERY-RS trial and hoped he would be able to help other people as a result. He tells his story here.

[media]https://www.youtube.com/watch?v=2nfLLBLRJxk&feature=youtu.be[/media]