PhEAST - recent changes

Date	CRF / version	Details of changes
20 Jul 2022	Day 000 clinical v1.1	Replaced single question for Barthel Index with a new section.
	Day 014 primary outcome v1.1	Replaced single question for Barthel Index with a new section.
4 Aug 2022	Protocol violation v1.0	New CRF added.
	Day 014 primary outcome v1.2	Add second signature.
1 Sep 2022	Day 000 IQCODE v1.0	New CRF added.
	Day 014 IQCODE v1.0	New CRF added.
	Day 090 IQCODE v1.0	New CRF added.
	Day 180 IQCODE v1.0	New CRF added.
	Day 365 IQCODE v1.0	New CRF added.
	Day 000 cognition v1.0	New CRF added.
	Day 014 cognition v1.0	New CRF added.
	Day 090 cognition v1.0	New CRF added.
	Day 000 clinical v1.2	Added calculation for NIHSS Cog4 score.
	Day 014 primary outcome v1.3	Added calculation for NIHSS Cog4 score. Added Name of person entering the data. Added Please sign the form.
	PES treatment 1 v1.1	Added Date of insertion of first catheter?.
	PES treatment 6 v1.1	Added Date of insertion of second catheter?.
	Serious Adverse Event v1.1	Added read-only Date of Treatments box (no change to questions on printable form, details are only shown if treatment applies).
3 Feb 2023	Eligibility v1.1	Added banner, warnings & question numbers Added new inclusion B3. dysphagia FOIS 3: Tube dependent with consistent oral intake of food or liquid (14-31 day post stroke) Added exclusion B17. Pregnant Added Section C: Eligibility check Added Section D: Consent (mandatory) Added E1a. Is an associate PI involved? Added E1b. Name of associate PI Updated E3a. What is your professional role? Added E3b. If 'Other', please specify your role Added E5. Please enter your name if you did not collect the information Added Comments and full explanation for missing data
	Day 000 v1.1	Added banner, warnings & question numbers Added Section A: Participant details Updated A6. Ethnicity Added A6b. If 'Other', please specify ethnicity Updated B1. Modified Rankin scale (mRS), premorbid / pre-stroke Changed B6. Stroke syndrome Changed Section D: Clinical state now at time of enrolment questions to include ND=Not done Added E6b. Schematic of where the frontal operculum is [Galovic et al. JAMA Neurology 11 Feb 2019]) Added F3b. Schematic of where the frontal operculum is [Galovic et al. JAMA Neurology 11 Feb 2019]) Updated G2. Already in any hyper-acute or acute stroke research trial(s)? ProFATE Updated H2a. What is his/her professional role? Added H2b. If 'Other', please specify role Added Comments and full explanation for missing data
	Day 000 clinical v1.3	Added banner, warnings & question numbers Added Section A: Participant details Updated C2. Functional oral intake scale (FOIS) 3: Tube dependent with consistent oral intake of food or liquid (14-31 day post stroke) inclusion added and now editable Updated C3. Feeding status score (FSS) now editable Added C4a. Calculated PRESS score. Updated Section D: EAT-10 swallowing screening tool at time of enrolment. questions can be ND=Not done or NK=Not known Updated E1. Modified Rankin Scale (mRS), now Updated Section H: Penetration aspiration score (PAS) questions can be ND=Not done or NK=Not known Added Section I: Glasgow Coma Scale (GCS) - Level of consciousness Updated J2a. What is his/her professional role? Added J2b. If 'Other', please specify role Added Comments and full explanation for missing data
	Day 000 EQ-5D-5L v1.1	Added banner, warnings & question numbers Added Section A: Participant details Added A5a. Who is answering the questions? Added A5b. If 'Other' or 'Not available', please specify who answered the questions Updated Section B: Quality of life EQ-5D and EQ-VAS questions at time of enrolment. questions can be ND=Not done or NK=Not known Added B7a. Is EQ-VAS rating between 0 and 100 available? Added Section C: Assessor information Added Comments and full explanation for missing data
	Day 000 IQCODE v1.1	Added banner, warnings & question numbers Added Section A: Participant details Added Section B: Informant Added B2. Has an informant been consented? Added B3a. Relationship to Participant Added B3b. If 'Other', please specify relationship Updated Section D: The 4A Test - Collateral information (4AT) removed questions and allow for ND=Not done Updated Section E: Neuropsychiatric Inventory, Questionnaire Version (NPI-Q) questions can be ND=Not done or NK=Not known Added Section G: Assessor information Added Comments and full explanation for missing data
	Day 000 cognition v1.1	Added banner, warnings & question numbers Added Section A: Participant details Updated A6. Is the participant available to answerthese questions? added 'Assessment by post' Added Alertness (4AT) B2. questions Updated Brief Fatigue Inventory (BFI) Updated Patient Health Questionnaire (PHQ) Updated Clinical Frailty Score (CFS) Updated B7. Most limited function care-home admission (R4VaD) Updated B8. Clinical diagnosis of dementia (R4VaD) Updated B8. Clinical diagnosis of dementia (R4VaD) Updated Section B9: Short Zung Interviewer-assisted Depression Rating Scale (Short Zung I.D.S.) Updated Section B10: Stroke Impact Scale (SIS) Added Section C1-C3: Cognitive impairment & Delirium Rating: 6-CiT, 4AT & R4VaD Updated Section C4-C25: Cognition tests allow for ND=Not done Added Section F: Cognition test Domain totals. Added Section J: Assessor information Added Comments and full explanation for missing data
	PES treatment 1 v1.2	Added banner, warnings & question numbers Added Section A: Participant details Updated A4a. Follow-up status for 1st treatment Added Section B: Show treatment description Show how to determine the treatment level Updated B1b. If not, why was the 1^st PES treatment not given? Added B1c. If 'Other', please specify reason for treatment not given Updated B2. Date of insertion of first catheter? Updated B4. First PES threshold mA? (lowest stimulation level) Updated B5. First PES tolerance mA? (highest stimulation level) Updated B6. First PES calculated stimulation level mA? (as per displayed on the device) now editable Added Show calculated stimulation levels Updated B8b. Please explain why actual stimulation differs from the calculated stimulation Added B9b. Please explain why actual treatment not done for 10:00 min. Added B9c. If 'Other', please specify reason why full 10:00 minutes not done Updated C1a. Were there any equipment/device problems during treatment 1? Added C1b. Description of device or equipment failure Added Section D: Urgent safety measure: (safety button used to stop PES) Added Section E: SWAT and reportable event Updated F2a. What is your professional role? Added F2b. If 'Other', please specify your role Added F4. Please enter your name if you did not do the treatment Added Comments and full explanation for missing data
	PES treatment 2 v1.1	Added banner, warnings & question numbers Added Section A: Participant details Updated A4a. Follow-up status for 2nd treatment Added Section B: Show treatment description Show how to determine the treatment level Updated B1b. If not, why was the 2^nd PES treatment not given? Added B1c. If 'Other', please specify reason for treatment not given Added B2. Date of insertion of first catheter? Updated B4. Second PES threshold mA? (lowest stimulation level) Updated B5. Second PES tolerance mA? (highest stimulation level) Updated B6. Second PES calculated stimulation level mA? (as per displayed on the device) now editable Added Show calculated stimulation levels Updated B8b. Please explain why actual stimulation differs from the calculated stimulation Added B9b. Please explain why actual treatment not done for 10:00 min. Added B9c. If 'Other', please specify reason why full 10:00 minutes not done Updated C1a. Were there any equipment/device problems during treatment 2? Added C1b. Description of device or equipment failure Added Section D: Urgent safety measure: (safety button used to stop PES) Added Section E: SWAT and reportable event Updated F2a. What is your professional role? Added F2b. If 'Other', please specify your role Added F4. Please enter your name if you did not do the treatment Added Comments and full explanation for missing data
	PES treatment 3 v1.1	Added banner, warnings & question numbers Added Section A: Participant details Updated A4a. Follow-up status for 3rd treatment Added Section B: Show treatment description Show how to determine the treatment level Updated B1b. If not, why was the 3^rd PES treatment not given? Added B1c. If 'Other', please specify reason for treatment not given Added B2. Date of insertion of first catheter? Updated B4. Third PES threshold mA? (lowest stimulation level) Updated B5. Third PES tolerance mA? (highest stimulation level) Updated B6. Third PES calculated stimulation level mA? (as per displayed on the device) now editable Added Show calculated stimulation levels Updated B8b. Please explain why actual stimulation differs from the calculated stimulation Added B9b. Please explain why actual treatment not done for 10:00 min. Added B9c. If 'Other', please specify reason why full 10:00 minutes not done Updated C1a. Were there any equipment/device problems during treatment 3? Added C1b. Description of device or equipment failure Added Section D: Urgent safety measure: (safety button used to stop PES) Added Section E: SWAT and reportable event Updated F2a. What is your professional role? Added F2b. If 'Other', please specify your role Added F4. Please enter your name if you did not do the treatment Added Comments and full explanation for missing data
	PES treatment 4 v1.1	Added banner, warnings & question numbers Added Section A: Participant details Updated A4a. Follow-up status for 4th treatment Added Section B: Show treatment description Show how to determine the treatment level Updated B1b. If not, why was the 4^th PES treatment not given? Added B1c. If 'Other', please specify reason for treatment not given Added B2. Date of insertion of first catheter? Updated B4. Fourth PES threshold mA? (lowest stimulation level) Updated B5. Fourth PES tolerance mA? (highest stimulation level) Updated B6. Fourth PES calculated stimulation level mA? (as per displayed on the device) now editable Added Show calculated stimulation levels Updated B8b. Please explain why actual stimulation differs from the calculated stimulation Added B9b. Please explain why actual treatment not done for 10:00 min. Added B9c. If 'Other', please specify reason why full 10:00 minutes not done Updated C1a. Were there any equipment/device problems during treatment 4? Added C1b. Description of device or equipment failure Added Section D: Urgent safety measure: (safety button used to stop PES) Added Section E: SWAT and reportable event Updated F2a. What is your professional role? Added F2b. If 'Other', please specify your role Added F4. Please enter your name if you did not do the treatment Added Comments and full explanation for missing data
	PES treatment 5 v1.1	Added banner, warnings & question numbers Added Section A: Participant details Updated A4a. Follow-up status for 5th treatment Added Section B: Show treatment description Show how to determine the treatment level Updated B1b. If not, why was the 5^th PES treatment not given? Added B1c. If 'Other', please specify reason for treatment not given Added B2. Date of insertion of first catheter? Updated B4. Fifth PES threshold mA? (lowest stimulation level) Updated B5. Fifth PES tolerance mA? (highest stimulation level) Updated B6. Fifth PES calculated stimulation level mA? (as per displayed on the device) now editable Added Show calculated stimulation levels Updated B8b. Please explain why actual stimulation differs from the calculated stimulation Added B9b. Please explain why actual treatment not done for 10:00 min. Added B9c. If 'Other', please specify reason why full 10:00 minutes not done Updated C1a. Were there any equipment/device problems during treatment 5? Added C1b. Description of device or equipment failure Added Section D: Urgent safety measure: (safety button used to stop PES) Added Section E: SWAT and reportable event Updated F2a. What is your professional role? Added F2b. If 'Other', please specify your role Added F4. Please enter your name if you did not do the treatment Added Comments and full explanation for missing data
	PES treatment 6 v1.2	Added banner, warnings & question numbers Added Section A: Participant details Updated A4a. Follow-up status for 6th treatment Added Section B: Show treatment description Show how to determine the treatment level Updated B1b. If not, why was the 6^th PES treatment not given? Added B1c. If 'Other', please specify reason for treatment not given Added B2. Date of insertion of first catheter? Updated B4. Sixth PES threshold mA? (lowest stimulation level) Updated B5. Sixth PES tolerance mA? (highest stimulation level) Updated B6. Sixth PES calculated stimulation level mA? (as per displayed on the device) now editable Added Show calculated stimulation levels Updated B8b. Please explain why actual stimulation differs from the calculated stimulation Added B9b. Please explain why actual treatment not done for 10:00 min. Added B9c. If 'Other', please specify reason why full 10:00 minutes not done Added LOT numbers and replaced catheter(s) Updated B10a. How many PES catheters were used? Updated C1a. Were there any equipment/device problems during treatment 6? Added C1b. Description of device or equipment failure Added Section D: Urgent safety measure: (safety button used to stop PES) Added Section E: SWAT and reportable event Added Section G: Summary of PES treatments Updated H2a. What is your professional role? Added H2b. If 'Other', please specify your role Added H4. Please enter your name if you did not do the treatment Added Comments and full explanation for missing data
	Day 014 primary outcome v1.4	Added banner, warnings & question numbers Added Section A: Participant details Updated A4a. Follow-up status at day 14 Added A4b. If follow-up 'Refused', please specify reason for refusal Updated C2. Functional oral intake scale (FOIS) 3: Tube dependent with consistent oral intake of food or liquid (14-31 day post stroke) inclusion added and now editable Updated C3. Feeding status score (FSS) now editable Added C4a. Calculated PRESS score. Updated Section D: EAT-10 swallowing screening tool at time of enrolment. questions can be ND=Not done or NK=Not known Updated E1. Modified Rankin Scale (mRS), now Added G1. Can NIHSS scores be obtained? Updated Section H: Penetration aspiration score (PAS) questions can be ND=Not done or NK=Not known Added Section I: Glasgow Coma Scale (GCS) - Level of consciousness Added Section J:Other clinical information Added Section K: Recruitment recollection Updated L2a. What is his/her professional role? Added L2b. If 'Other', please specify role Added Section M: 2nd Assessor information Added Comments and full explanation for missing data
	Day 014 EQ-5D-5L v1.1	Added banner, warnings & question numbers Added Section A: Participant details Added A5a. Who is answering the questions? Added A5b. If 'Other' or 'Not available', please specify who answered the questions Updated Section B: Quality of life EQ-5D and EQ-VAS questions at time of enrolment. questions can be ND=Not done or NK=Not known Added B7a. Is EQ-VAS rating between 0 and 100 available? Added Section C: Assessor information Added Comments and full explanation for missing data
	Day 014 IQCODE v1.1	Added banner, warnings & question numbers Added Section A: Participant details Added Section B: Informant Added B2. Has an informant been consented? Added B3a. Relationship to Participant Added B3b. If 'Other', please specify relationship Updated Section D: The 4A Test - Collateral information (4AT) removed questions and allow for ND=Not done Updated Section E: Neuropsychiatric Inventory, Questionnaire Version (NPI-Q) questions can be ND=Not done or NK=Not known Added Section G: Assessor information Added Comments and full explanation for missing data
	Day 014 cognition v1.1	Added banner, warnings & question numbers Added Section A: Participant details Updated A6. Is the participant available to answerthese questions? added 'Assessment by post' Added Alertness (4AT) B2. questions Updated Brief Fatigue Inventory (BFI) Updated Patient Health Questionnaire (PHQ) Updated Clinical Frailty Score (CFS) Updated B7. Most limited function care-home admission (R4VaD) Updated B8. Clinical diagnosis of dementia (R4VaD) Updated B8. Clinical diagnosis of dementia (R4VaD) Updated Section B9: Short Zung Interviewer-assisted Depression Rating Scale (Short Zung I.D.S.) Updated Section B10: Stroke Impact Scale (SIS) Added Section C1-C3: Cognitive impairment & Delirium Rating: 6-CiT, 4AT & R4VaD Updated Section C4-C25: Cognition tests allow for ND=Not done Added Section F: Cognition test Domain totals. Added Section J: Assessor information Added Comments and full explanation for missing data
	Discharge or died v1.1	Added banner, warnings & question numbers Added Section A: Participant details Updated Section E: Other clinical information Added Section F: Penetration aspiration score (PAS) Updated G2a. What is your professional role? Added G2b. If 'Other', please specify role Added Comments and full explanation for missing data
	Discharge or died EQ-5D-5L v1.1	Added banner, warnings & question numbers Added Section A: Participant details Added A5a. Who is answering the questions? Added A5b. If 'Other' or 'Not available', please specify who answered the questions Updated Section B: Quality of life EQ-5D and EQ-VAS questions at time of enrolment. questions can be ND=Not done or NK=Not known Added B7a. Is EQ-VAS rating between 0 and 100 available? Added Section C: Assessor information Added Comments and full explanation for missing data
	SWAT v1.1	Added banner, warnings & question numbers Added PES treatments Added Section A: Contact person Added A2a. Role of person contacted Added A2b. If 'Other', please specify the role Added A5. Please log time in minutes spent talking to the site Added Participant details Added Associated treatment Updated B5a. Trigger Added B5b. If 'Other', please specify trigger Added Section C: Reason Added Section E: Additional information Added Section F: Trainer Added Comments and full explanation for missing data
	Serious Adverse Event v1.2	Added banner, warnings & question numbers Updated Days in banner Added Section A: Participant details Added Status Added Show treatment dates Added B1. PES treatments given Added D1a (i). Definition of causality Updated F2a. What is your professional role? Added F2b. If 'Other', please specify role Added Comments and full explanation for missing data
	Device deficiency v1.1	Added banner, warnings & question numbers Added Section A: Participant details Added Status Updated B4a. Were there any equipment/device problems? Added B4b. If 'Other', please give a short description of the problem. Updated D2a. What is your professional role? Added D2b. If 'Other', please specify role Added D4. Please enter your name if you did not collect the information Added Comments and full explanation for missing data
	Protocol violation v1.1	Added banner, warnings & question numbers Added Section A: Participant details Added C2a. Type of protocol violation Added C2b. If 'Other', please specify protocol violation type Added C4. Device or equipment related deviation Added C5. Urgent safety measure related deviation. Added Section D: Assessor information. Added Comments and full explanation for missing data
	Protocol deviation v1.0	New CRF added.
	Withdrawal v1.0	New CRF added.
24 Feb 2023	Serious Adverse Event v1.3	Update heading version number.
18 May 2023	Eligibility v1.2	Updated B3. Clinical dysphagia defined as a functional oral intake scale (FOIS) score of 1 or 2 or 3? Updated D1a. Consent obtained from Independent physician (England, Wales, Northern Ireland & Austria)
	Day 000 clinical v1.4	Updated SECTION B note: DSRS supervision score 3 is always chosen when a patient is on limited or consistent oral trials and still requires NG/ PEG/ RIG tube. Updated C1. Feeding tube type : Percutaneous endoscopic gastrostomy (PEG or RIG) tube feeding Updated C2. Functional oral intake scale (FOIS) 3: Tube dependent with consistent oral intake of food or liquid Updated C2. Functional oral intake scale (FOIS): Eligibility: FOIS score of 1 or 2 or FOIS 3 Updated C3. Feeding status score (FSS) 4: Non-oral diet/fluids, percutaneous endoscopic gastrostomy (PEG or RIG) tube feeding
5 Jul 2023	Eligibility v1.3	Updated B15. Palliative care added as an exclusion.
	Day 000 clinical v1.5	Updated Section D: EAT-10 swallowing screening tool at time of enrolment, new option 5: Not eating, i.e. tube fed.
	Day 014 primary outcome v1.5	Updated A4a. Follow-up status at day 14, new option Randomised to control. Updated Section B label DSRS supervision score 3, with RIG. Updated C1. Feeding tube type with RIG. Updated C2. Functional oral intake scale (FOIS), removed (14-31 day post stroke). Updated C3. Feeding status score (FSS) with RIG. Updated Section D: EAT-10 swallowing screening tool, new option 5: Not eating, i.e. tube fed. Updated G9. NIHSS 9. Best language, removed An exclusion criterion . Updated G10. NIHSS 10. Dysarthria, removed An exclusion criterion . Updated Section K: Recruitment recollection, get assessor's opinion before getting participant's.
	Day 014 cognition v1.2	Updated A7. Presence of severe dysphasia?, removed An exclusion criterion .
	Device deficiency v1.2	Updated B4a. Were there any equipment/device problems? to remove instructions. Added B4c. Was there an associated: ADE, SADE, UADE, USADE.
	Discharge or died v1.2	Updated C4. Discharged with PEG or RIG. Added E3. An antiplatelet for thinning blood? Added E4. An oral anticoagulant for thinning blood? Added E5. A statin for lowering cholesterol? Added E6. One or more blood pressure lowering tablets? Added E7. A tablet for protecting the stomach from bleeding?
	PES treatment 1 v1.3	Updated A4a. Follow-up status for 1^st treatment, new option Randomised to control.
	PES treatment 2 v1.2	Updated A4a. Follow-up status for 2^nd treatment, new option Randomised to control.
	PES treatment 3 v1.2	Updated A4a. Follow-up status for 3^rd treatment , new option Randomised to control.
	PES treatment 4 v1.2	Updated A4a. Follow-up status for 4^th treatment , new option Randomised to control.
	PES treatment 5 v1.2	Updated A4a. Follow-up status for 5^th treatment , new option Randomised to control.
	PES treatment 6 v1.3	Updated A4a. Follow-up status for 6^th treatment , new option Randomised to control.
	Serious Adverse Event v1.4	Added SAE number for reference. Added Section G: PI review. Added G1. Reviewed by PI. Added G2. I have reviewed and agree with this SAE. Added G3. Please enter PI name. Added G4. Please sign the form.
	SWAT v1.2	Updated D1. Training route, added 4: Email.
30 Oct 2023	Day 000 v1.2	Updated G2. Already in any hyper-acute or acute stroke research trial(s)? to include MACE-ICH
27 Nov 2023	Eligibility v1.4	Updated B2. Recent IS or ICH stroke between 2 and 31 days previously? Added B18. Known presence of a pharyngeal pouch. Added B19. Investigator believes dysphagia will be short-term.
	Day 000 v1.3	Updated B3. Date of Stroke (Eligibility: within 2-31 days).
29 Nov 2023	Day 000 IQCODE v1.2	Added B4. Informant ID
	Day 014 IQCODE v1.2	Added B4. Informant ID
	Day 090 IQCODE v1.2	Added B4. Informant ID
	Day 180 IQCODE v1.2	Added B4. Informant ID
	Day 365 IQCODE v1.2	Added B4. Informant ID
18 Jan 2024	Day 000 clinical v1.6	Added IDD FDS to Section C label Feeding information. Added subsection C4 IDDSI Functional Diet Scale score. Added C4a. Food prescription. Added C4b. Drink prescription. Calculated IDDSI Functional Diet Scale. Renumbered C4 PRESS section scores to C5.
	Day 014 primary outcome v1.6	Added IDD FDS to Section C label Feeding information. Added subsection C4 IDDSI Functional Diet Scale score. Added C4a. Food prescription. Added C4b. Drink prescription. Calculated IDDSI Functional Diet Scale. Renumbered C4 PRESS section scores to C5.
18 Dec 2024	Eligibility v1.5	Added inclusion criterion B4: Baseline DSRS supervision score of either 3 (requiring therapeutic feeding by SALT team; on oral trials) or 4 (No oral feeding). Changed exclusion criterion B9: ~~Use or planned use of electrical or magnetic stimulation (e.g. NMES, rTMS) for dysphagia?~~ to B10. Ongoing treatment of dysphagia with other forms of electrical/magnetic stimulation (e.g. NMES, TCDS, rTMS or Ampcare), or devices (e.g. EMST, IQORO, IOPI, biofeedback that uses EMG electrodes, or chin tuck against resistance using a ball/chin depressor) - this applies for the duration of the trial. Added exclusion criterion B21: Participant is risk-feeding at time of screening.
	PES treatment 1 v1.4	Removed text: ~~The catheter will be replaced once only if pulled out before 3 treatments have been administered.~~
	PES treatment 2 v1.3	Removed text: ~~The catheter will be replaced once only if pulled out before 3 treatments have been administered.~~
	PES treatment 3 v1.3	Removed text: ~~The catheter will be replaced once only if pulled out before 3 treatments have been administered.~~
	PES treatment 4 v1.3	Removed text: ~~The catheter will be replaced once only if pulled out before 3 treatments have been administered.~~ Corrected 'forth' typos.
	PES treatment 5 v1.3	Removed text: ~~The catheter will be replaced once only if pulled out before 3 treatments have been administered.~~
	PES treatment 6 v1.4	Removed text: ~~The catheter will be replaced once only if pulled out before 3 treatments have been administered.~~ Changed note for B10a: How many PES catheters were used? from ~~(Should have been 1 or 2)~~ to instead read (Up to 6) Changed B10b: Date of insertion of new catheter? from ~~second~~ to new.
	Protocol violation v1.2	Added new protocol violation option to C2a: Other electrical/magnetic stimulation device used.