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Predicting Language Outcome and Recovery After Stroke (PLORAS)

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CRN FAQs

The role of the recruiting site is to:

  1. Identify potential participants.
  2. Provide participants with information about the study.
  3. Complete the Consent and Entry Forms with interested participants.
  4. Transfer the relevant data to the PLORAS Team.

If you cannot find a satisfactory answer to your question below or in our study protocol (version 9.0, 21/08/2023), please contact us directly.

Where to find answers to frequently asked questions, concerning:

  1. Inclusion criteria
  2. Exclusion criteria
  3. Recruitment of participants who are unwell
  4. Role of speech and language therapists (SLTs) with time and interest in the study
  5. Impact of multiple CAT assessments
  6. Consent form
  7. Entry form
  8. NIHSS scores
  9. Transferring data to PLORAS
  10. Level of participant engagement with PLORAS
  11. Site information
  12. Training
  13. Costs and agreements
  14. Recruitment data
  15. Other

Inclusion criteria

  • Participants with mild, moderate or severe spoken communication difficulties (difficulties expressing themselves in speech) as a consequence of stroke. Patients must have aphasia at the time of recruitment or have had problematic aphasia symptoms that lasted for at least a week after their stroke. Evidence can be from a variety of sources, such as the multidisciplinary team, interactions with the patient or patient/carer reports.
  • Priority will be given to participants who are within a year of the stroke that caused aphasia and especially to those who are less than 3 months post-stroke where possible. We will monitor these participants longitudinally to test their speed and degree of recovery; and the accuracy of our predictions.
  • Participants, with spoken communication difficulties who also have motor speech disorder (dysarthria, dyspraxia) or difficulties with speech comprehension, reading and writing can be included.
  • Participants who do not speak English as a first language can be included in part of the study; but only if they report that their spoken communication difficulties are a consequence of a stroke; and only if they have someone available who can translate our information booklet and questionnaires, which are written in English.
  • Participants with mild depression can be included.

Exclusion criteria

  • Participants whose spoken communication was not affected by their stroke, are not included, as there is no recovery to measure.
  • Participants with spoken communication difficulties that were not caused by aphasia after stroke (i.e. caused by developmental disorders or other aetiologies such as dementia, or Parkinson鈥檚 disease) are not included.
  • Participants without visible lesions, or lesions smaller than 1cm3 are not included, as we already have a high number on our database.
  • Participants with co-existing psychiatric disorders that affect their attention or cognitive abilities are not included.
  • Participants who have hearing and vision problems (unrelated to stroke) that cannot be corrected (i.e. using visual/hearing aids) may not be included. This is because we're unable to be certain that symptoms/errors on assessment result from stroke rather than poor vision/hearing only.
  • Intravenous drug use may result in long term neurological effects which impact stroke recovery. The likelihood of these effects may increase with the intensity and duration of use. Currently, our questionnaires do not assess or document the type of drug use or pre-stroke symptoms that participants might have experienced. Therefore, we are not accepting patients with a history of intravenous drug use at this time.

Recruitment of participants who are unwell

  • Participants who are unwell or bedbound may be approached if you feel it is appropriate, or you can follow-up with them later if necessary. If you are unsure, please check with others involved in their direct care. Please consider whether approaching the participant at this stage would overwhelm them, and whether they are able to provide informed consent.
  • Participants should be involved as much as possible in the recruitment process regardless of their capacity status. When completing the participant interview in the Entry Form, please clearly state on the first page who is contributing to the responses. If this is mainly the consultee that is okay, but we advise completing with the participant present if possible.

Role of Speech and Language Therapists (SLTs) with time and interest in the study

  • Informing the local CRN team about eligible participants.
  • Providing the CRN team with copies of participants鈥� existing clinical speech and language assessments and therapy records. An inability to provide this information would not exclude the participant from taking part.
  • Completing our online SLT questionnaire which asks about the amount, timing and content of therapy, and about participants鈥� motivation and engagement with therapy.
  • Helping to explain study information and consent forms to participants with speech comprehension and reading difficulties.
  • Helping to answer questions about language difficulties in the participant interview.
  • Please note, it is not a requirement of SLTs at sites to conduct language assessments for the PLORAS study. This is something the PLORAS Team do as part of our data collection process.
  • We are grateful for any SLT reports that might give us further insight into participants鈥� language abilities. In particular, if SLTs assess PLORAS participants using the Comprehensive Aphasia Test (CAT) prior to, or after, recruitment, we would love a copy of these results, with the participant's permission.
  • If SLTs are interested, we can provide an electronic (online) version of the CAT (known as e-CAT), that presents and saves the results via the computer, laptop or tablet. Just let us know if this would be helpful. It will make testing and scoring much easier.
  • If SLTs are interested in the CAT results that PLORAS collect, we can share these with you, with participant's permission.

Impact of multiple CAT assessments

  • We are aware that some patients may improve their CAT scores when they are assessed multiple times in the same way.
  • We are not concerned about this. To the contrary, we are monitoring how language abilities change over time and how this depends on lesion site.
  • We already have extensive data from individuals who had repeat CATs within days and weeks of each other. This shows that while participants may become more familiar with some of the stimuli, their speech and language scores typically remain remarkably consistent. We haven't published this data yet but the findings are consistent with an emerging consensus that recovery of language skills post-stroke requires extensive practice, with minimal impact from single session learning.

Consent form

  • The Participant Consent Form should be signed by the participant.
  • Participants with capacity should be encouraged to mark (initial, signature) the Consent Form where appropriate. If their written mark is not legible or they cannot make any written mark (e.g. they have a physical weakness but can indicate 'yes' or 'no' through other means such as speaking, gesture) an independent witness (someone who is not involved in the study) should also sign the Consent Form.
  • If the participant lacks capacity, a consultee should be sought (if appropriate) to complete and sign the Consultee Declaration Form.
  • We encourage all CRN staff to complete the Participant Consent Form and Entry Form in discussion with the participant, and, if needed, their consultee or other family/carer/friend/health professional. Please do not ask them to complete the forms on their own. After completion, the form must be signed by either the participant or consultee.
  • When completing the Consent Form, and other documents (3, 3C or 4), please note your study site code and the unique participant number in the designated footer box (i.e. 0001 for the first participant recruited from your site, 0002 for the second, etc).

Entry form

  • The Participant Interview section of the Entry Form is to be completed by CRN staff in discussion with the participant (and their consultee or other family/carer/friend/health professional where applicable). If there is no one available to help the participant, or the questions are found to be upsetting/it is not appropriate to administer it, the CRN staff can complete what they know and leave the other questions blank. Notify us if this is the case. We can follow up on the questions with the participant later. A point will still be awarded for an incomplete participant interview.
  • When completing the participant interview section of the Entry Form, please provide further details about any communication difficulties that have resolved in section B5 (i.e. "participant had slurred speech lasting 3 days").

NIHSS scores

  • Please provide NIHSS scores on the Entry Form. We request a 'Best Language' score of 1-3 (admission and/or post admission scores).
  • If NIHSS scores are not available or symptoms remain unclear on the Entry Form, we may ask for additional evidence in the form of SLT reports to confirm eligibility for the study.
  • If your site is generally unable to provide us with NIHSS scores, please get in touch with the PLORAS Team to discuss other options.

Transferring data to PLORAS

  • Please see your site opening letter for full details on data transfer, including our NHS.net address.
  • The following are transferred to the PLORAS Team: (i) Participant Consent Form/Consultee Declaration Form, (ii) Entry Form, (iii) brain imaging reports and (iv) a copy of the participant鈥檚 hospital brain scans.
  • The Consent and Entry Forms should be scanned, saved as pdfs and transferred to the PLORAS Research Team via email. If you are not sending NHS.net to NHS.net, please encrypt attachments to AES-256 before sending (i.e. using software such as 7-Zip or Sophos) and communicate the password via a separate means.
  • Please use a combination of your Site Code and the Participant Number, plus the document ID in the name of attachments (i.e. 香港六合彩中特网H0001_Scan_Report / 香港六合彩中特网H0001_Consent / 香港六合彩中特网H0001_Entry_Form)
  • If sending speech and language therapy records, please remove information identifying other individuals (i.e. Next of Kin details or individual therapists 鈥� unless they have consented to this information being shared) 鈥� and follow the same principles for data transfer as for other PLORAS patient documents.
  • Imaging data should be transferred to the PLORAS Research Team via the PLORAS External Site or via the Sectra Image Exchange Portal (IEP).
  • Personal identifiable details should be removed from imaging (and replaced with the participant鈥檚 unique recruit number i.e. 香港六合彩中特网H0001) before sharing. Skull stripping is not required. Please do not remove the scan date, protocol or sequence information.
  • Imaging data can be anonymised using programs such as Syngo or VIA (usually installed free to any Trust purchasing Siemens scanners). Some Trusts also have advanced image manipulation software called TeraRecon, or export images to a teaching file and fix them up to a dummy patient.
  • To upload imaging data via PLORAS External Site, go to our data upload page in a Chrome web browser. Then enter your unique User ID and Pin (that we can confirm to you) and a reference (participant鈥檚 unique ID, i.e. 香港六合彩中特网H0001) and select the type of scan you are uploading (CT or MRI or both). Then upload a zip folder with the anonymised raw scan files (DICOM format). A confirmation email will be sent to you if the scan transfer was successful.
  • To upload imaging data via IEP, login and select the 鈥渢ransfer data to鈥� and 鈥渋ndividual or 3rd party鈥�. If your site has never sent PLORAS a scan before, you will need to register us by selecting 鈥�+create new individual or Patient鈥�. Please check with the PLORAS Team for the latest contact details to use.
  • If necessary, we can accept imaging data supplied on a CD which is sent via special delivery and marked 'Private and Confidential' to: The PLORAS Research Team, 12 Queen Square, London, WC1N 3AR. CDs should not be sent in the same envelope as documents containing personal identifiable data.

Level of participant engagement with PLORAS

  • Participants are free to withdraw at any time. Therefore, they do not have to complete multiple assessments if they don鈥檛 want to.
  • Participants who maintain interest and continue to have aphasia, will be assessed by the PLORAS Team every 3-6 months in first year and every 6-12 months in the following years until the participants thinks that their speech and language is back to normal or almost back to normal.
  • The assessment at one week after stroke will be part of the Entry Form (conducted by research nurses) or assessed later (retrospectively) by the PLORAS Team.
  • Assessment time points are relative to the time of the stroke, not the time of consent / recruitment. The timing of the assessments will depend on when the participant is available. Therefore, they may not necessarily be at e.g. 3 months exactly.
  • If multiple strokes have occurred, the assessment will be relative to the most recent stroke and the PLORAS Team will establish whether their aphasia was the consequence of a previous stroke.
  • We are not asking research nurses to conduct the Comprehensive Aphasia Test (CAT). The CAT will be administered by the PLORAS Team but, if the local SLT has also administered a CAT, we would be delighted if this information could be shared with us (providing the participant has given consent). It is not essential for recruitment.

Site information

  • If you need to record the recruitment end date on your systems we advise you to use 30/06/2027. This will be reviewed annually, until we meet our recruitment target.
  • See site opening letter for location of PLORAS protocol and latest recruitment forms.
  • Study sites should localise documents 1d, 3, 3C and 4, and add their local contact details to the last page of the PLORAS Participant Information Booklet (2) before using.
  • Documents 2 and 2a (A5 booklets) will be provided by post. For these documents, you will need to contact the PLORAS Team directly to request a new batch to be sent to your study site.
  • Study sites will need to confirm capacity and capability to deliver PLORAS with their local R&D prior to recruitment.

Training

  • Prior to recruiting, all study site staff should read the PLORAS protocol.
  • Ongoing support is available from the PLORAS Team via telephone and email.
  • Principal Investigators at study sites are responsible for ensuring that staff are suitably trained to take informed consent and have completed Good Clinical Practice (GCP) training.
  • We have the following training resources to support you with recruiting participants with aphasia. Our aim is to increase your confidence and skills and support you in obtaining informed consent:

1. Interaction Aid and Online Guide

  • See site opening letter for Online Guide URL.
  • A printed booklet is provided to all sites which provides pictorial support for the Consent Form (Part 1).
  • The Interaction Aid is accompanied by an online guide that includes important instructions聽and demonstration videos of all sections.

2. PLORAS aphasia eLearning

  • See site opening letter for aphasia eLearning URL.
  • This covers: practical strategies needed to interact with someone with aphasia (Part 1) and how to apply the strategies to PLORAS recruitment (Part 2).
  • We kindly request all research practitioners recruiting to PLORAS complete at least Part 2 (if you are not also an SLT). The Interaction Aid accompanies Part 2 of the eLearning.

Costs and agreements

  • We do not routinely pay for scans; however, costs for copying and transferring images can be covered by our research grant when required. Specifically, we can contribute up to 拢30 for scans that cannot be sent electronically (covering disc and postage), and up to 拢20 for scans that are sent electronically but incur a PACS/radiology team charge for preparing the imaging. Sites should let us know (prior to sending scan data and invoicing) if and which of the above costs, may be incurred.
  • When required, we can send study sites a batch of 2nd class stamps and envelopes, to cover costs for the participant reply slips which are sent back to the site (part of document 1d).
  • If required, invoices can be emailed to the PLORAS Team at ploras[at]ucl.ac.uk
  • In February 2023, we introduced an Organisation Information Document (OID) to our Local Information Pack. This is the only formal agreement we currently provide and replaces the former PLORAS Data Sharing Agreement that was in place since 2014.
  • For sites completing the OID retrospectively (i.e. after opening to recruitment), please use a predicted start date in the immediate future rather than the date your site originally started recruitment. This is because the OID reflects the latest site activities (following Substantial Amendment 10, 13/10/2022).
  • We do not impose any site-specific targets and are grateful for all recruits with spoken communication difficulties we receive.

Recruitment data

  • Recruitment points are awarded for participants who meet the study inclusion criteria and for whom we have received i) a completed Participant Consent Form or Consultee Declaration Form, ii) a completed Entry Form (both sections), and iii) a minimum of one post-stroke brain scan with a visible lesion (CT and/or MRI imaging) with the associated reports.
  • Our recruitment data is uploaded to the NIHR Central Portfolio Management System (CPMS) at the end of each month. The upload reflects those participants who have been received in that month that meet the above. Participants received after our upload has taken place will be included in the following month鈥檚 upload.
  • The activity date we enter into CPMS for each participant recruited will be the date on their Consent Form.
  • Where there is outstanding essential information (e.g. stroke date), insufficient paperwork (e.g. incorrect forms or missing signatures) or unresolved inclusion queries, we will not process the participant further (and may not include them in the upload) until these have been satisfied.
  • If a participant withdraws from the study after their data has been transferred to us, a recruitment point will still be awarded. If they withdraw before their data is transferred a recruitment point cannot be awarded.
  • If a participant deceases, after their data has been collected, a recruitment point will still be awarded if their data are transferred to us.
  • We send annual recruitment summaries to our open sites every April. If necessary we can provide individual site recruitment numbers ad hoc, though this will depend on the PLORAS Team鈥檚 current capacity to take on this task.

Other

  • We do not provide a GP information sheet (as we are not a CTIMP or interventional study, we are not required to inform GPs that their patient is taking part in PLORAS). Should there be a local requirement for you to inform GPs about participant research involvement, we'd be happy for you to draft your own letter which includes our contact information and signposts the GP to our website () for more details.
  • To avoid a patient being recruited by multiple sites, we ask that 'Recruited to PLORAS Study' is added to discharge summary notes. Please also follow your own procedures or methods to prevent this kind of overlap with neighbouring sites. If you have concerns about this, please contact the PLORAS Team.
  • In general, we are happy with co-enrolment, providing other studies do not involve drugs which interfere with the participants capacity to speak or affect cognitive function as this could impact the assessments we do. Please contact the PLORAS Team if there are any studies you are considering co-enrolling with PLORAS, so we can give a definite answer on a case-by-case basis. We ask that you ensure that it is not a burden on a participant to be enrolled onto multiple studies. If needed, we are happy to co-ordinate with the other study the patient is taking part in, to ensure appointments are well-spaced.
  • We will not routinely ask sites for sample or screening logs, but we do encourage sites to keep a log in case we need to request feedback on recruitment progress. Please feel free to use your own screening logs for this.
  • All study site staff should sign a delegation log. We do not require a copy of these, but may request them. However, please do keep us informed of any local staff changes so we can update our contact details.
  • We are planning to introduce electronic devices (tablets) which will enable sites to recruit and submit referrals electronically. This is still in development and we will be in touch in due course with an update. Please continue to recruit participants as normal using the paper versions of our documents.