Inclusion decisions
Answer: No, the exclusion criteria (functional limitation, reduced exercise tolerance etc.) was removed on Version 3 of the protocol.
Answer: No, only patients who have been admitted to HDU/ICU with primary COVID-19 should be considered.
Answer: Yes, as long as patients are being cared for in the HDU/ICU environment and are being continuously monitored.
Answer: The ICU Perspectives Study provides a comprehensive survey of 1400 critically-ill patients/families and staff. They found that people are much happier to be approached about research than staff anticipate.
Answer: No, aspiration and hospital acquired pneumonia is excluded, e.g post op pneumonia etc.
Answer: Yes, diagnoses are always a bit uncertain so we include anyone who, in the best judgement of the treating team, meets the inclusion criteria.
Answer: 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.
Answer: Samples predating critical care admission (prior to day zero) can be included in the section 'Presumed Primary infection' if they are the primary cause of the patient's illness.
Answer: 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.
Answer: Patients with burns have a uniquely quantifiable sterile injury, meaning that they can be accurately compared to each other with a level of certainty that is very difficult to find in real clinical populations. Two patients the same age might present with 40% body surface area burns. One lives, and the other develops complications and dies. If there are genetic factors that influence the chance of dying, even slightly, then these might lead us to new biological "levers" we can pull - for example, new drugs - that might improve survival not only in burns but also for patients with other forms of critical illness.
Answer: Capacity checks are in the view of the treating clinician.
Answer: Yes. We can recruit patients at any time after they meet the criteria - on the ward, in out-patient clinics, even at home if feasible.
Answer: Yes! We are recruiting across all eligible groups. Please screen and recruit if you can - thank you.
Answer: The recorded age should be when the patient met the eligibility criteria.
Samples
Answer: The GenOMICC ID numbers are generated by us and sent to you in the sample packs. Each strip of 4 sticky labels represents one patient. Multiple labels are provided in case you provide blood in multiple tubes and one for the consent form. Please discard any unused labels. Please enter this number in the RedCAP form exactly as it appears on the sticky label.
Answer: Please place the barcode along the tube, not around. This makes it easier for the laboratory staff to scan it.
Answer: Both blood and saliva can be stored at room temperature for up to 7 days before arriving in our lab.
Answer: Please send what you have obtained. We have calculated optimal quantaties but it is possile to obtain DNA with slightly less.
Answer: No, any EDTA blood tubes can be used. The total volume of blood sent back to GenOMICC should be as close to 4ml as possible. Although smaller amounts are obtained for children and babies.
Answer: 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.
Answer: Yes.
Answer: Day zero = day of critical care admission. So if a patient is admitted on Monday, then record samples taken within the first 3 calendar days. e.g. Monday - Tuesday - Wednesday and Thursday (Monday would count as day zero).
Answer: No. The specimen transport boxes that we provide are UN3373 Biological Substance Category-B approved packaging, and can be used to send the blood samples to us via Royal Mail.
Answer: No – samples are sent to Edinburgh for all processing.
Answer: Yes. An appropriately-trained individual can obtain peripheral venous, central venous, or arterial blood for GenOMICC according to local policies.
Consent
Answer: 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.
Answer: Yes, we have forms in 7 other languages - Polish, French, Portuguese, Urdu, Welsh, Bengali, Punjabi
Answer: 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. We do have an ethically approved regained capacity consent letter for this purpose.
Answer:
The local PI should determine if a probation officer is the most appropriate person to obtain consent on behalf of the participant. If no one else is available then this is allowed according to HRA guidelines under the Mental Capacity Act.
The Mental Capacity Act says that consultees for intrusive research other than Clinical Trials of Investigational Medicinal Products (CTIMPs), in England and Wales are:
- A personal consultee, i.e. a person who cares for the adult lacking capacity or is interested in that person's welfare, but is not doing so for remuneration or acting in a professional capacity.
- A nominated consultee i.e. a professional who is independent of the study, can do so if a personal consultee is not available or is unwilling to give advice.
There is further provision for emergency situations.
Answer:
Science works best when scientists can share data and work together to solve difficult problems. Sometimes, opportunities might arise to answer different questions (that is, not related to critical illness) using information or samples that we already hold from participants. For example, a new kind of DNA sequencing might shed light on heart disease, or a different kind of computational analysis might help explain how the genome works.
Rather than contact participants when these questions arise, we rely on independent scrutiny by "ethics committees" to review new research projects and decide if it is acceptable. These committees are broadly representative of science and society, are completely independent of the GenOMICC researchers, and they have the power to stop any research they don't approve.
This includes research done by commercial organisations. To be clear, we're only talking about healthcare research here - your data will never be used for research relating to insurance, marketing or politics. Research by pharmaceutical companies, for example to make a new drug to treat critically-ill patients, or patients with other problems, would be undertaken using GenOMICC samples, if it is approved by an ethics committee.
Redcap
Answer: The GenOMICC ID numbers are generated by us and sent to you in the sample packs. Each strip of 4 sticky labels represents one patient. Multiple labels are provided in case you provide blood in multiple tubes and one for the consent form. Please discard any unused labels.
Answer: Please enter the number exactly as it appears on the sticky label - 'GCC followed by 5 digits' (see How is the GCC number generated above).
Answer: ICNARC number in England/Wales or SICSAG number in Scotland. These numbers are assigned to patients upon their admission to intensive care.
Study Administration
Answer: true
Answer: 40000
Answer: GenOMICC is already recruiting. The end date for the study is 31/08/29
Answer: No, GenOMICC is not a regulated study so no delegation log is necessary. We collect the PI's CV at each site, but no other CVs. Each PI is responsible for delegating recruitment activity at their site and can record delegation to whole teams of research staff without specifically recording the name of each team member.
Answer: Regarding authorship, we will adhere to the policy here.
Answer: Retrospective recruitment has started. Read the Retrospective FAQ for more information.
Answer: Retrospective recruitment has started. Read the Retrospective FAQ for more information.
Answer: The sub-study involving repeat sampling will be co-ordinated and run from Roslin.
Answer: We encourage co-enrolment with other studies, including interventional studies.
Answer: 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.
Answer: No processing of any kind is needed. Whole blood is shipped at ambient temperature. We will provide the packaging.
Answer: We are able to provide blood tubes to sites and send vacutainer as standard. Please let us know if you prefer monovette tubes. Click here for examples of tubes to use.
Answer: This fits with our protocol as long as the initial approach is made by a member of the clinical team.
Answer: 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.
Answer: We have tried to make this as light as possible and no screening log is needed. Most research sites have a well defined screening process and we can help advise on any eligibility queries.
Answer: Please use our secure NHS email account for this - loth.genomiccstudy@nhslothian.scot.nhs.uk
