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POPPY SIV, tutorials & FAQs

On this page you will be able to watch a recording of one of our virtual site initiation visits, tutorials on how to use the online NewcastlePROMs POPPY online platform to register your site and collect participant data and frequently asked questions.

01

Site Initiation Visit 

A introduction to the POPPY study with everything you need to prepare and set up and conduct the POPPY study at your site.

02

Data collection

This tutorial will show you how to input data on the POPPY NewcastlePROMs secure online platform. 

Please share the link below with everyone in your local team so they can learn how to use the platform:

https://www.youtube.com/watch?v=T4M2rpHhkGA

  • Can patients just be approached and consented on the day of surgery or do they require to have the patient information sheet for 24 hours like most trials and be approached prior to surgery? Are we allowed to recruit ‘cold’ on the day or have they all got to give consent prior to this?
    Different sites will have different approaches that work best for them. The PIS can be given to patients in clinics or sent to them by their usual care team with appointment letters for instance. However, members of the researcher cannot contact patients until this initial approach has been made. Patients can be approached for the first time about this study on the day of their operation. This has been approved by the Research & Ethics Committee as this is a non interventional observational study. When piloting POPPY in Plymouth this summer we found that the below worked well, all our participants were recruited on the day of surgery. Their feedback on the acceptability of the study was overwhelmingly positive: 1. All healthcare staff involved in areas where day surgery took place were made aware of the study and encouraged to get involved. This included presentations at audit meetings, talking to clinical leads and matrons and the wider clinical team. 2. Usual care providers (most frequently nurses) did initial approach to patients, gave PIS to patients on the day of surgery and asked if a member of the research could speak to them about the study. 3. If the patient told their usual healthcare provider that they were happy to be approached by a member of the research team this was fed back to the research team (for example our nurses drew a simple poppy by their name on the patient board). 4. Research team member would talk to the patient about the study, answer questions and recruit if patient eligible and agreed to consent.
  • Someone asked about should we have IT issues could we complete paper CRFs with patients to upload later in the day. Will a copy of the CRF’s be made available?
    This is a paperless CRF study and ran successfully during the pilot phase, we will not be making paper CRFs available. We encourage sites to get in touch is there are any IT issues that cannot be locally resolved during the study.
  • Do you have a target for sites or are you happy for us to set our own?
    Your team should aim to recruit all eligible day case patients during the 5 day snapshot period. We found from the pilot we found most sites managed to easily recruit 50 participants over the 5 days i.e. 10 participants per day. However if you think your team can recruit more go for it!
  • If a patient requires a GP letter being sent how will the sponsor notify the site team?
    A safeguarding letter needs to be sent to the GPs of participants that report new chronic pain or opiate use 3 months after surgery who are also identified as being at risk of moderate to severe depression &/or anxiety. They will be identified from day 97 data collection and you will be able to find a list of these patients on the NewcastlePROMs platform under site safeguarding soon after. These participants will also receive an automated text specially designed by pain clinicians and pain psychologists signposting them to healthcare services. It is the responsibility of the PI and trainee lead for each site to send these letters to the appropriate participants’ General Practice. The procedure for identifying these patients is made clear in our tutorial video which is available on our website.
  • How can PIS sheets be distributed prior to the day of surgery by the ‘usual care team’? If this is not possible can we give them to patients on the day of their operation?
    Prior to the day of surgery patient information sheets could be handed out at clinic appointments by a member of the usual care team. However as day case surgery can often be booked late and with a growing number of telephone and virtual appointments it is perfectly reasonable for patients to receive an information leaflet on the day of their operation from a member of their usual care team. If they are happy to be approached by a member of the research team after this you can consent them on the day of their operation to take part in the study.
  • Where should I send the OID and Capacity & Capability?
    Please send these documents to our sponsor representative victoriayates@nhs.net
  • Who should we send out delegation log and first 5 consents forms?
    You need to send a copy of the delegation log and the first 5 consent forms from the first day you do the study. Please send these from an nhs.net mail account to simon.clark14@nhs.net & laura.garner3@nhs.net
  • When will our site be issued green light?
    Once you have sent our sponsor the OID and C&C they will issue green light at the start of January. Please continue with all your set up plans, you will be issued green light!
  • Is there any specific training required other than SIV and GCP? Do you require copies of GCP certificates and CVs?
    All researchers collecting data will need to be GCP certified. The PI, trainee lead and R&D contact for each site must attend one of our site initiation visits or watch the SIV recording. Our sponsor requires a copy of the PI's CV and GCP certificate to be sent to the following email: simon.clark14@nhs.net & laura.garner3@nhs.net
  • With the screening log would you like patients who are overnight stays included and marked as excluded, or only patients who are day case?
    If they were intended as day case and a member of the research team approached them to take part in the study, then stayed overnight they should be recorded as excluded on the screening log.
  • If we have IT issues could we complete paper CRFs with patients to upload later in the day. Will a copy of the CRF’s be made available?
    This is a paperless study and ran successfully during the pilot phase, we will not be making paper CRFs available. The accurate timing of inputting data effects participant SMS text follow up. We encourage sites to get in touch is there are any IT issues that cannot be locally resolved during the study.
  • Is there one login for the NewcastlePROMs POPPY platform per site or individual logins for collaborators?
    Each site will have one login that will be shared amongst the site's local research team. This will allow site leads to have oversight of data to ensure post-operative data is filled in appropriately and safeguarding GP letters are sent correctly. Several people can be logged in to a site account at the same time and input data.
  • Does the electronic data collection form on NewcastlePROMs generate a patient study number?
    Yes, this is autogenerated by the platform and is visible to local sites and the central study team. The study number will be used for the screening log. The hospital ID seen on local teams NewcastlePROMs page cannot be seen by the central study team and serves as a way for local team members to identify participants that require a GP safeguarding letter to be sent.
  • Is there a way to edit data once it is submitted?
    If a patient stays overnight you can update this until 0930 on day 1. Other than that once data is submitted onto the platform, you cannot edit it. If you feel the data needs changing, please email the study team to let them know, quoting the participant’s study number: plhtr.poppystudy.raft@nhs.net
  • How long do I have to enter the post-operative data about patients who are recruited?
    We advice that you try to complete as much post-operative data as possible towards the end of the day. However if this is not possible you have until 9.30am the day after a participant's operation to complete this. It will not be possible to enter this data after 09:30. This deadline exists because the first follow-up message goes out to patients at 10am that day.
  • How do we register on the POPPY platform?
    If you are a PI, Associate PI or taking a leadership role at your hospital you will have received a link to set up a single site account on the POPPY NewcastlePROMs platform. If you are a local collaborator please contact your local team lead so they can share the login details with you so that you can input data.
  • Are day case emergencies included?
    Yes, if they meet the other eligibility criteria.
  • Are pain injections included in procedures?
    No, these are not included.
  • Are GA dental extractions included?
    Yes, if they meet the other eligibility criteria.
  • Should we include cases that are done under regional blocks which are performed by an anaesthetist who may not necessarily be present for the whole case/operation itself e.g. awake hand surgery?
    These patients should be included as the block is done by an anaesthetist and although we appreciate they may not be in the operating theatre for the whole operation, they will be within the theatre complex and close by to deal with any complications or block failure and thus involved in patient care for the case.
  • What should I do if I am not sure if an operation/procedure can be included in the study?
    Your first port of call should be your PI, associate PI or local lead. If they are not sure then they can get in touch with the central study team to ask.
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