Inclusion / Exclusion criteria
Is aspiration pneumonia/hospital-acquired pneumonia included?
No, Hospital acquired pneumonia is also excluded e.g post op pneumonia etc.
If it is not / never sure what the infection is – can they be included?
Yes, diagnoses are always a bit uncertain so we include anyone who, in the best judgement of the treating team, meets the inclusion criteria.
Do pathogens need to be confirmed? Should we wait to recruit until micro is back for suspected flu & RSV patients?
To meet the criteria for flu/RSV, the pathogen needs to be confirmed using routine clincal tests in your hospital (near-patient rapid tests are OK). If the patient presents with primary pneumonia, then they meet the entry criteria even without identifying any pathogen.
Is it ok to recruit a 70 year old or is 69 the oldest permitted?
The oldest patient who will meet our criteria would be 69 years old on the first date that they meet the criteria.
What is classed as a “quantifiable sterile injury”?
This term is used in the protocol to describe the rationale for the study. Perhaps the best example is burns, in which the injury is sterile (that is, not infectious) and the severity of the initial injury can be accurately measured. For decisions about inclusion, the entry criteria should be applied.
What is classed as functionally limited?
Anyone whose day-to-day function is changed by chronic health problems. For example, many asthmatics are functionally unlimited, but carry inhalers. Others are breathless on exertion, and hence have some functinal limitation.
Can blood & saliva samples be stored over the weekend or do they need to be refrigerated, if so at what temperature?
Both blood and saliva can be stored at room temperature for up to 7 days before arriving in our lab.
Our EDTA tubes fall just short of the 9mls required. Is 8mls acceptable?
Yes, 8mls is fine.
Do sites have to do anything now or in the future for repeat sampling?
No. This part of the study is intended to recruit very carefully-selected patients on a small scale, where local infrastructure exists. We will contact you directly about this if necessary.
Is the GP letter just for repeat sampling patients?
Who is considered the patients “consultee”?
This is the patients representative, next of kin, or other appropriate individual who can make a competent assessment of the decision to participate, on behalf of the patient.
Regained capacity consent. If the patient leaves hospital prior to regaining capacity or they are missed prior to discharge, how do we get regained capacity consent?
We expect this scenario to be rare. Patients who do not regain capacity before hospital discharge are unlikely to ever regain capacity. If there is a reasonable expectation that a patient may regain capacity after discharge, we would ask that you create a pragmatic arrangement in discussion with the relevant carers and the patient's consultee. This may include occasional contact from the research team. In those circumstances you can decide how often to make contact, based on your clinical expectation of how rapidly it is likely that the patient might recover capacity.
How is the GenOMICC patient I.D number generated?
We'll tell you these: you'll find them on the sample labels in the sample postage boxes which each site has been provided with.
What is the national database audit number?
ICNARC number in England/Wales or SICSAG number in Scotland.
Is there a lab manual?
No – samples are sent to Edinburgh for all processing.
How do I obtain a blood sample and can I use invasive lines?
Yes. An appropriately-trained individual can obtain peripheral venous, central venous, or arterial blood for GenOMICC according to local policies.
Is GenOMICC on the portfolio?
Yes - we have received confirmation that GenOMICC is eligible for NIHR CRN support.
How many patients in total are being recruited?
What is the start/end date?
GenOMICC is already recruiting. The end date for the study is 31/08/29
Are you only recruiting prospectively?
Any patient who has met our entry criteria at any time in their life is eligible for inclusion in the study. These will require individual consent and sampling, so they will count as accruals. However we are not at the moment able to provide funding to sites to search through clinical/audit databases for patients who met GenOMICC criteria and have now been discharged (retrospective recruitment). We do hope to do this in the future, subject to funding. Our reason for focusing on prospective recruitment is that we can also recruit nonsurvivors prospectively.
See the full study overview here.
Is co-enrolment allowed with other studies?
We encourage co-enrolment with other studies, including interventional studies.
How early in a ICU admission would blood samples need to be obtained?
The sample can be obtained at any time, and we don't want to put patients, relatives or research staff under excessive pressure. However, since we're studying immediately life-threatening conditions, earlier recruitment is desirable to maximise the number of very severe cases we can recruit.
Are blood samples processed at the recruiting site?
No processing of any kind is needed. Whole blood is shipped at ambient temperature. We will provide the packaging.
Are blood bottles provided for sample collection?
We are able to provide blood tubes to sites if necessary and we recognise that this is an unfunded component of the study. However most hospitals have been happy to agree to provide a small number of EDTA (full blood count) tubes from their normal clinical stock. Click here for examples of tubes to use.
Is professional consent allowed from medic independent from the research ?
This fits with our protocol as long as the initial approach is made by a member of the clinical team.
What follow up is carried out via telephone and at what time point? How long is this likely to take?
Follow-up is limited to mortality outcomes and late micro results. In our experience so far, it usually takes less than 30mins to complete the whole process.
Is there participation fee?
Sadly our funding is very tight and much of it comes from charitable donations (from clinicians, in the case of the ICS, and from the public through FEAT). For this reason we aren't able to pay for the unfunded components of the work (screening). Of course, we recognise that this will limit some sites' ability to participate. We have tried to make this as light as possible - no screening log is needed, and the CRN-supported parts of the study (consent, sampling and CRF completion) can be very quick.
We are very grateful to receive funding from the Fiona Elizabeth Agnew Trust (FEAT), the Wellcome Trust, and the UK Intensive Care Society in support of the GenOMICC study.