SITS Open Artery by Thrombectomy in Acute Occlusive Stroke Study

Transcription

1 The SITS Open Artery by Thrombectomy in Acute Occlusive Stroke Study Users Guide An international, multicentre controlled study of safety and efficacy of thrombectomy in acute occlusive stroke

2 An open, prospective, blinded evaluation, international, multicentre, controlled study of safety and efficacy of thrombectomy and standard stroke care in clinical routine treatment of acute occlusive stroke compared to standard stroke care only Sponsored by In collaboration with

3 Table of contents Definitions of concepts in SITS Registry 5 ecrf... 5 Protocols... 5 Timepoints... 5 Structure of the database 5 Mandatory, Optional and Free Data Fields... 5 Confirm and lock... 5 Data Completeness... 6 Study personnel Roles and rights 6 Sub-investigator application and approval... 7 Centre application and approval... 7 Initiation meeting... 7 Agreement... 7 Getting ethical approval for the study... 7 Before recruitment 8 Check entry criteria... 8 Telephone registration of you patient... 8 Informed consent... 9 Getting started 9 Log in to SITS Registry... 9 Entering patient data 11 My Patients Filter function and viewing patients Adding a new study patient Only for TBY centres The Patient Summary The Patient Scoreboard Adding data Adverse Reaction documentation 20 Death page 21 Confirm and lock patient s data 23 Un-confirm and unlock patient s data 23 Handling of imaging data 24 Assessment of 3-months outcome 25 Video recording... 25

4 Saving the Assessment and Upload to the Endpoints Centre Instructions for mrs assessment Status list 29 List of clinical variables 30 Variable Options Comments... 30

5 SITS Open Users Guide Definitions of concepts in SITS Registry ecrf This abbreviation means an electronic case record form for the study patient, which contains all the data collected from a study participant. Protocols Each patient will follow a protocol for data entry. The protocol directs what data is mandatory and what data is optional. So for example some data may be mandatory in the study protocol but if entering a regular IVT patient that has not been included in the study the same data can be optional. The system will automatically follow the right protocol depending on what intervention is chosen and if the patient is included in the study when adding a patient. Timepoints To simplify following a particular protocol, data entry is organised around timepoints. The current timepoints for SITS Open study have slightly different definitions in the TBY arm and Control arm. Timepoint of outcome assessment is 3 months = 90 ± 14 days after stroke onset. Adverse Reaction and Death timepoints do not have any time frames. It is also possible to add data outside the given timepoints by adding it via Free data fields. Structure of the database Mandatory, Optional and Free Data Fields Almost all data fields in the SITS Open protocol are mandatory, e.g. patient gender and age. If data are not available, fields Mark if not available and Unknown should be used; if the field is not relevant to the individual case, Not applicable should be chosen. If the investigation or procedure is not compulsory in the study protocol, related data fields are optional. Free data provides the possibility to enter data outside the given timepoints. Examples of field set that provide the Free data possibility; CT and MR, mrs, blood pressure and NIHSS. Confirm and lock Confirmation and locking of data is needed to enable data to be analysed and published. You can confirm data when all mandatory fields for a specific timepoint have been filled out.

6 6 SITS Open Users Guide When every mandatory timepoint is confirmed you can lock the patient file. The data completeness indicators will quickly show you what data is complete and what data need to be complemented. Data Completeness Different colours and symbols indicates level of data completeness: Indicates that mandatory data is missing or incomplete Indicates that all mandatory data is completed Indicates that all data is completed and confirmed Indicates that optional data can be entered Study personnel Roles and rights Principle investigator (PI) neurologist: Responsible for the SITS Open study site. The PI must be a neurologist authorized by the medical head of the department whom is responsible for the stroke unit. Principle investigator (PI) interventionist: Responsible for the intervention-related issues in the SITS Open TBY arm study site. Sub-investigator: all other users who are connected to a specific centre. Study manager: SITS Open Coordination office PI neurologist PI - interventionist Subinvestigator Add patients Yes Yes Yes Yes Study manager View/edit patients Centre s patients Centre s patients Centre s patients All patients Delete patients Yes Yes No Yes Confirm/Un-confirm/Lock data Yes Yes Yes Yes Unlock data Yes Yes No Yes Download reports Centre s patients Centre s patients Centre s patients All patients Edit contact data Delete users Approve Centre/Local Coordinator applications Own profile and centre s subinvestigators Centre s subinvestigators Own profile and centre s subinvestigators Centre s subinvestigators Own profile No No No All Approve User applications Centre s Local Centre s Local Users No All No All profiles All Users applications

7 SITS Open Users Guide Opening/approval of study centre Imaging records preparation and sending Thrombectomy procedure records preparation and related data entry 3-month outcome assessment and video upload Users applications applications No No No Yes Yes No Yes Yes No Yes Yes Yes Yes No Yes Yes View/edit study scoreboard Centre Centre Centre All applications Sub-investigator application and approval To register as a study sub-investigator, please go to and click on the link Join now and then choose "Become a SITS user". You will be directed to the application process and asked to follow some simple steps. You will be asked to provide information about yourself, and to confirm that you will conform to SITS research ethics. Thereafter, SITS and the PI at your center will review your application. Once your application is approved you will receive an notification with log in details. Centre application and approval Only the centres approved by the SITS Open Scientific Committee will have an access to the SITS Open data entry form. If your centre is not yet a member of SITS, please go to and click on the link Join now and then choose "Become a SITS centre". You will be directed to the centre application process. You will be asked to provide information about yourself and your centre, and to confirm that you will conform to SITS research ethics. Thereafter, SITS and the National Coordinator at your centre will review your application. Once your application is approved you will receive an notification with log in details. Initiation meeting Before the recruitment of patients starts in the given centre, a telephone conference with the members of the research/coordinating team will be organized to discuss the key points of the study run. Agreement Each study centre will have an agreement, i.e. signed contract, with the Sponsor of the study i.e., Karolinska Institute, describing the obligations of the Sponsor and the study centre, ownership of results and data, reimbursement etc. This will be signed before the start of recruiting patients. Getting ethical approval for the study SITS Open Coordinating centre has submitted an application to Ethics Committee in Sweden. This approval will be valid for all Swedish hospitals. However, the investigator will be

8 8 SITS Open Users Guide responsible for getting the ethical approval in any other country in accordance with national legislation. Study protocol will be translated into the native language of non-englishspeaking countries which participate in the study. The form of patient s informed consent is attached to the protocol. A written ethical approval should be obtained before the recruitment of patients starts. After all the preparations are finished and confirmation is provided to the Coordinating centre, your centre will be assigned an TBY centre or control centre role, and the possibility to add a SITS-Open patient will appear as an option in the patient entry page. Only one ecrf form, either TBY or Control, will be enabled for one centre. Before recruitment Check entry criteria The full list of inclusion and exclusion criteria is provided in the study protocol. Patients who meet all of the inclusion criteria and none of the exclusion criteria, including identification of a major (terminal carotid, proximal middle cerebral or basilar) artery occlusion on CTA, will be registered for preliminary enrolment in the study to a 24 h automatic telephone service. For a patient to be included in the study the first (baseline) CT needs to be performed within 15 min of IVT start (if performed). For patients not treated with IVT, CTA be preferably performed within 15 minutes of completion of the non-contrast CT but must be performed within 6 hours after stroke onset. Telephone registration of you patient Every participating hospital will call the following phone number to notify when they have a patients fulfilling the inclusion criteria for the study. The telephone call to the coordinating centre must be done before initiation of thrombectomy and/or within two hours of initiation of IVT /plain CT (baseline) (if IVT is not given). Information will include few details of the case; no patients ID will be documented in the call. The recorded information will be sent to the coordinating team and regarded as a part of the screening log. The centre will later be asked to provide a motivation if patients recorded on the screening log were not enrolled in the study. Registration call of your patient is done to the following international phone number: Be ready to tell: Your name The name of your hospital/clinic Was IVT performed? If yes, when was IVT performed? If no, when was CT Baseline performed? Patient initials

9 SITS Open Users Guide Informed consent Since TBY and control centres use their treatments in clinical practice, consent for the treatment is granted by clinical routine procedures, as will all routine treatments. The informed consent will be collected for participation in the study and for documentation of the data after the treatments have been initiated to avoid delays in clinical management. This should be done as soon as practically possible, and always within 20 h after baseline (7 days approved in applicable countries). In case a patient is unable to personally provide consent, e.g. because of aphasia, this can be done by a legal representative of the patient. Alternatively, a similar measure as approved by the IRB would be applied according to local regulations. In case a patient can provide informed consent, but unable to personally sign the consent form, a witness, independent from the study, may certify the consent in writing. After appropriate informed consent from the patient, or an acceptable representative, in agreement with local law, the patient will be registered in SITS Open. Getting started Log in to SITS Registry 1. Go to 2. Click Login 3. Enter your address and password 4. Click Sign in 3 4 2

10 10 SITS Open Users Guide Understanding the different parts of the Registry The Database is built around five elements: 1. The Navigation Panel: All pages include the navigation panel to the left. Based on your context, i.e. where in the Database you are and your role and rights, different options will appear. 2. The Breadcrumb: The context indicator tells you exactly where you are in the Database. 3. The Preferences: The Preferences page allows you to manage your profile, i.e. changing password and contact information by clicking on your own name. 4. The Content Fields: The Content Field is the main part of the user interface. Depending on your role and where you are in the database this is where you can view your patients and specific observations as well as manage the administrative part such as centre applications, local user applications, edit centre information etc. 5. The Live Search Field: The Live Search Field enables you to find anything in the Database in a simple text search. For instance, this is a quick way to find a specific patient by entering the treatment file number

11 SITS Open Users Guide Entering patient data The patient section contains instruction on how to add, edit or view any patient data into the ecrf. My Patients Depending on what role you have, after login you will be navigated to different start pages of the SITS Registry. As a sub-investigator your start page will be the My Patients page. If you are a PI, you will see an administrative page over your centres and/or users. You will find My Patients at the Navigation panel. My Patients page lists all patients that have been included at your centre. The list shows basic data of the patient Filter function and viewing patients Use the filter function to narrow down the patient list after your needs. 1. Batch size controls how many patients you want to view per page. 2. Protocol shows patients that follow a specific protocol; this can both be a protocol in the general registry or the SITS Open study protocol. 3. Review state has four status forms: initial, locked, overdue, and frozen. Initial state shows patient files that is added but not confirmed. Locked state shows patient files where all mandatory data has been entered and the whole file is confirmed and locked, a file with this state can be unlocked if needed. Overdue state shows patient files that lack 3 months follow-up data (overdue= >90 days after stroke onset occurs). Frozen state is similar to the locked state however, this patient file cannot be unlocked by any user, this state is activated when a patient file has been locked for over one year or has not been edited in two years time or after database lock in the study.

12 12 SITS Open Users Guide Click on the treatment file number, patient ID or date of stroke to view the Patient summary. 5. If you want to view a specific timepoint for a patient you can click directly on the coloured dot that indicates data completeness. 6. The column Actions will show different action buttons depending on your rights. The Lock button is visible for all users. However, unlock is only visible for PIs.

13 SITS Open Users Guide Adding a new study patient Click Add New Patient in the Navigation Panel. The Add New Patient page will open. Here you will fill in the most basic information about the study patient. The page is divided into two figures. The small thumbnail in upper left corner shows an overview of the page Inclusion in clinical study: When the checkbox SITS-OPEN is ticked, study specific variables such as patient informed consent, enrolment criteria, phone notification etc. will be shown and are mandatory. 2. Patient data: The variable Social security number is used internally as patient id. 3. Acute phase intervention: When you tick the checkbox for including the patient in SITS Open, the choice of acute phase interventions is pre-selected. The pre-selected option will vary depending on if you belong to an TBY centre or a Control centre, i.e., an TBY centre will have Thrombectomy and IVT Thrombolysis ticked and a Control centre will only have IVT Thrombolysis ticked. These options cannot be unselected, but any other options can be added as preferred. A specific question if IVT was performed or not will be asked at timepoint Treatment. If IV is not performed, the reason must be clarified.

14 14 SITS Open Users Guide In TBY centres only, there is an additional question at timepoint treatment if Thrombectomy was performed according to protocol (timepoint treatment ). In case of an intention to treat patient this check box will be ticked as no and the reason for not performing the TBY must be clarified. 4a 4b 4c 6b 5 6a 4. Logistics: 4a. Stroke onset: Enter best estimated date and time of stroke onset. If you do not have a specific time (hour and minute), it is possible to bypass this by ticking Time unknown. 4b. Patient admission before time of stroke onset: Should the patient already be admitted to hospital at the time of stroke onset, tick this checkbox and it enables you to enter an earlier time for arrival to hospital than time of stroke onset. 4c. Arrival to first hospital: Enter date and time of arrival to the first hospital. The first hospital can be yours or other s. Also select this first hospital in the drop down list. 5. Save: Once you press the Save button the patient study file will be created and a Study number will be generated by the system. The format of the Study number is: SITSOPEN-0001 (the number will follow the recruitment rate). Only for TBY centres 6. Arrival to additional hospital: 6a. Add more arrivals: For some TBY centres, the patient is transferred from another hospital where the IVT. Thrombolysis has been initiated before the patient was sent to your centre for rescue Thrombectomy. In such case you have to specify the hospital of first arrival, which probably will be a hospital other than yours, and then

15 SITS Open Users Guide press the button Add more arrivals to add additional rows to specify your own hospital details. Add more arrivals if needed. 6b. Chronological order: The list of hospitals will be arranged in chronological order, based on the time of arrival, when you save the page. If the time is not available, you can adjust the order manually with the arrows to the right. All data entered at this page can be edited after the file has been created, with an exception of the Study number. The Patient Summary The Patient Summary shows a summary of all data you have entered in the created patient file. It enables you to view and edit the data that has been entered. Adding new data to a patient file can be done in two ways, one via the Patient Summary and one via the Patient Scoreboard. 1 2a 2 3 4a 4b 4 1. Patient data: You can at any time, before confirming the patient, make changes in this field. To edit, click on the Edit button. 2. Data Completeness: This table shows you the completeness of your data per timepoint (see page 6 for description of symbols) and is also where you add new data for any of the timepoints, death and/or Adverse Reactions. As mentioned, there are two ways of adding new data. To add data from the summary, click on the

16 16 SITS Open Users Guide corresponding coloured dot for the desired timepoint (2a). Adding data from the summary is suitable when you want to enter data for more than one field set in a timepoint. For example, if you want to enter all baseline data. 3. Acute interventions: Shows which acute interventions you entered at the Add new patient page, and controls which protocol this patient is following. All SITS Open TBY patients will automatically follow the bridging protocol (IVTP-S + TBYP), all control patients - the IVTP-S protocol. 4. Treatments, Observations, Imaging, Logistics: Shows the data that you have entered in the patient file. To edit entered data, click on the corresponding link for this field set (4a). It is also possible to sort any data in the summary by clicking on the small arrow that you will find next to each subtitle (4b). The Patient Scoreboard The Patient Scoreboard can be used in several ways. There is a more detailed overview of data completeness for the patient file (see page 6 for description of symbols). When you enter mandatory data, the symbols (dots) for the different fieldsets will change in order to help you see where you need to complete data and where you are done. From the scoreboard you can also add new data, one fieldset at a time at a specific timepoint or you can add Free data, which is not connected to any specific timepoint. Add, edit or view data by clicking on any symbol (dot) in the scoreboard

17 SITS Open Users Guide Columns Rows 1. Shows which fieldsets are available and/or mandatory at each timepoint. 2. Shows which fieldsets can be added as Free, i.e., outside a specific timepoint. 3. Lists all fieldsets that exist within the SITS Registry (regardless of protocol). 4. Group title for different fieldsets Symbols (coloured dots) 5. Based on what protocol the patient file is following, symbols indicate which fieldsets are available in the current protocol, but also a detailed view over data completeness. For example: This patient follows the bridge protocol IVTP+TBYP. At the timepoint 24 h, Blood pressure, NIHSS and Global outcome are mandatory data to enter whilst CT, MR and TCD data are optional. The remaining fieldsets at the 24 h timepoint are not included in this protocol, therefore are not open for data entry. The scoreboard also tells us that some mandatory data is missing and NIHSS is completed. 6. These symbols indicate which data can be added as Free data. In this case mrs, Laboratory, Blood pressure, NIHSS, Global outcome, CT and MR can be added with an optional date and time (after admission and before discharge from hospital).

18 18 SITS Open Users Guide Adding data You can add data via the Patient Summary per timepoint or you can add data via the scoreboard per question. Regardless of which way you choose to enter your data, same principles apply when doing so. This example shows Baseline via the Patient summary

19 SITS Open Users Guide Fieldset label. 2. The Red square means that it is mandatory to enter data for this field. 3. The blue symbol with an i in it stands for Information. The symbol is clickable and can contain definitions, help texts or other useful information. 4. The button Smart Fill is used to make it easier for you to fill out fieldsets. For example, at NIHSS the Smart Fill sets all values to 0 and you can increase where appropriate. At CT, it sets the date and time to stroke onset or arrival to hospital depending on which one is the latest. 5. Save This button will save any data entered and navigate you back to the Patient Summary or Scoreboard (depending on where you came from). 6. Cancel This button will disregard any changes and navigate you back the Patient Summary or Scoreboard (depending on where you came from).

20 20 SITS Open Users Guide Adverse Reaction documentation In case of any untoward, unintended medical occurrence related to treatment, this should be added in the section Adverse Reaction You can add an unlimited number of Adverse Reactions from Patient summary Click on the symbol for Adverse Reaction to get to this page. To enter an AR, answer the questions in the form (2) and press Add (3). The new AR will appear on top of the page (4). All reactions that you add will be listed here. You also have the possibility to edit or delete any incorrectly entered AR

21 SITS Open Users Guide Death page If the patient dies you should fill out the death page and the Adverse Reaction page (as a Serious Adverse Reaction (SAR). Depending on what protocol the patient is following, there are several places where you can fill in that a patient has died. For the data for Global Outcome is mandatory at the timepoints 24h and 7d follow up. The mrs (Modified Ranking Scale) is mandatory at 7d and 3m follow up. Both Global Outcome and mrs contain the variable dead. This is not to be replaced by filling out the Death page (and AR page) since the Death page contains date and time of death and primary cause of death Go to the Patient Summary, click on corresponding dot for death. 8. Fill in date and time (if possible), otherwise tick Time unknown. 9. Fill in Cause of death 10. Save 2 3 4

22 22 SITS Open Users Guide After you have entered the mandatory data and saved, the Data Completeness dot for Death will change to a green dot with checkmark. OBS! If you enter that the patient is dead at 7d follow up in the fieldset mrs or Global outcome but you have not filed in the death page, the dot will shift from green (optional) to red (mandatory). This means you have to complement with filling in death page.

23 SITS Open Users Guide Confirm and lock patient s data All data needs to be confirmed and locked. This is done in two steps: 1. Confirm each timepoint where mandatory data has been completed. You confirm each timepoint from the Patient Summary by clicking on the button Confirm. 2. After each timepoint has been confirmed you are able to lock the whole patient file. This is also done from the Patient summary by clicking on the button Lock out to the right. If you are a PI, this button is also visible out in My Patients list. 1 If you have completed all data for a timepoint we recommend you to control that all data is correct and then confirm as soon as possible, even if the other timepoints are still incomplete. 2 Un-confirm and unlock patient s data Depending on your role, you have different rights when it comes to un-confirming/unlocking a patient file. All users have the right to un-confirm a specific timepoint. However, this can only be done if the whole patient is not locked yet. Read more about roles and rights at page 6.

24 24 SITS Open Users Guide Handling of imaging data For detailed information please see Imaging Procedure Manual. Baseline CT/CTA and 24 h CT/CTA (or MRI/MRA) as well as thrombectomy imaging records from TBY centres, should be uploaded for independent core lab evaluation. In case of any ICH on 24 h assessment imaging should be repeated on the next day, and sent for further assessment by core lab. 1. All images shall be saved in DICOM format 2. The CD shall only contain raw data 3. All identifying information about the patient must be removed both from images and physical CD/DVD. 4. All identifying information about the hospital (except centre code) must be removed and/or anonymized both from images and physical CD/DVD. Enrolment number as well as date, time and timepoint of the imaging shall be saved as the file name. Enrolment number and timepoint shall be written on the physical disc. 5. Keep the raw data on the hospital server 6. In case of repeated follow-up imaging in suspicion of ICH, the second follow-up record may be downloaded on a separate disc. 7. Sent images to University of Edinburgh (address below) within 3 working days. 8. Centre will be alerted in case of any missing images, information or quality. Control centres: 2 files should be saved on separate CD/DVDs: Baseline CT scan and CT angiography. 24 h CT/MR scan and CT/MR angiography. TBY centres: 3 files should be saved on separate CD/DVDs: Baseline CT scan and CT angiograpghy. 24 h CT/MR scan and CT/MR angiography. Thrombectomy records Corresponding address: University of Edinburgh (Neurosciences Imaging) Centre for Clinical Brain Sciences Att: Eleni Sakka The Chancellor's Building 49 Little France Crescent, Edinburgh EH16 4SB United Kingdom

25 SITS Open Users Guide Assessment of 3-months outcome Video recording Each site must submit a test video assessment to the Rankin Outcome Adjudication web portal during the pilot phase of the trial to ensure familiarity with technical issues and confirm correct operation of procedures. This will be reviewed by a member of the endpoint assessment committee. The mrs assessment should be recorded with the head and shoulders of the patient in camera shot, unless the participant clearly has the most severe level of disability (for example a mrs score of 5) or where coma or intubation render assessment impractical. In this scenario we advise that a proxy be used to provide information and that they should be interviewed on video alongside or in place of the patient. If the patient has any cognitive impairment or relies on external support it may be helpful to include a carer or relative in the interview. The local investigator will assign a mrs score which will be recorded on the SITS Open trial ecrf website. They will also be asked to comment whether there is significant dysarthria or dysphasia (relevant for non-english assessments). Those performing mrs assessments should state the participant s study number and time of follow up visit at the beginning of the assessment. There are 3 important points to remember. 1. The rater should endeavour to record the entire interview in a single file. 2. Both the rater and the patient should not give any information, which may reflect treatment allocation during the recording. 3. Both the rater and the patient should not use any identifying information such as the participant s name during the recording; instead, give the patient s SITS Open study number and visit at the start of recording. The camera should be placed approximately 160 to 200 cm from the trial participant and include their face and torso. A proxy can be used for mrs assessment in line with each centre s normal practice for those unable to converse or where other barriers such as intubation or coma exist. Participants can wear their normal clothing for the assessment. Inclusion of a carer or family member even for communicative patients can assist interpretation of answers. The assessor does not need to be seen on the recording and should sit alongside the camera. The digital recordings will be transferred to the Rankin Outcome Adjudication web portal. The clip can be uploaded from within the SITS Open trial ecrf website. No conversion or editing is needed. The video file should also be recorded to compact disc (CD) and archived locally. A Philips CAM295W camcorder will be used. The camera records to a micro SD card which will be provided. This is inserted into the camera and thereafter does not need to be removed. An easily portable desktop tripod will be used to mount the video camera.

26 26 SITS Open Users Guide It is crucial to that the camera has sufficient battery power for the recording. When fully charged, it will record for up to 2 hours between charges. It takes approximately 5.5 hours to fully charge via the inbuilt USB connection (it can be charged via mains electricity also). We recommend that prior to any recording, raters place a do not disturb sign outside the room that will be used and that ward or clinic staff is informed recording is taking place to restrict external noise. Philips CAM295W camcorder This is the Philips CAM295W camcorder. The record switch can be seen (1). The on switch is shown on the inside of the camera (2) and the in-built USB socket is located at the bottom of the camera and is opened by pressing the adjacent button(3). The camera also has a still mode for pictures so please ensure that it is set to video mode (4). The camcorder has a touch screen. Figure 3. The Philips CAM295W Once the equipment is set up, simply press the record switch to begin recording and you can verify that camera position is appropriate from the LCD screen. Always ensure the red light on the LCD screen is present (which means the camera is recording) before starting your assessment. Saving the Assessment and Upload to the Endpoints Centre First, the camera needs to be connected to a USB port on your computer. The computer should automatically recognise the camera. Sometimes a window of files located on the camera will automatically open. This can be closed but does allow you to view the clip. The recorded clips will be approximately 20 to 70 megabytes.

27 SITS Open Users Guide The file can be uploaded via the SITS Open trial ecrf system. This links seamlessly to the Glasgow Outcomes Centre website. Once you have logged in, select your patient, the appropriate follow up visit and then the outcome fieldset (Modified Rankin Scale). You will then have to enter the locally-measured mrs score before you click the Upload button. Clicking this button (see figure) should open the Glasgow upload portal (with you already logged in) in a new pop-up window. Once you have entered the Glasgow portal, follow the instructions. First you will need to locate the video recording. The recoded files are located by opening the My Computer folder, then the CAM295 SD device (not CAM295). Double click on this, then the DCIM folder, then the 100MEDIA folder. This will open a list of clips on the camera numbered chronologically in order of date filmed (from the first to most recent). Once the correct file has been identified, click on it and it will be added to the upload box and then click on upload. Progress will be shown in green on the bar below. The duration of the upload will depend upon the size of the file and the network speed but should be under 5 minutes. Once upload is complete, click on save uploads and you should then be informed that the file has been successfully uploaded and incorporated into the database. After that you can close this pop-up window.

28 28 SITS Open Users Guide Instructions for mrs assessment Note that only symptoms arising since the stroke should be considered. In determining the Rankin score walking aids or other necessary mechanical devices are disregarded provided that the patient can use these without external assistance. The score of 0 is awarded to patients who have no residual symptoms after their stroke, not even minor symptoms. If patients have any symptoms resulting from the stroke, whether physical or mental, then they should be scored at least 1 on the Rankin scale. For example, if they have any new difficulty in speech, reading or writing, in physical movement, sensation, vision or swallowing, or any change in their mood that does not limit their activities, they still should score 1. Patients in this category can continue to take part in all of their previous work, social and leisure activities. For this purpose, usual is regarded as any activity that they used to undertake for a monthly basis or more frequently. If there is any activity that they used to undertake that they can no longer do since the stroke, whether because of a physical limitation or because they have chosen to give up the activity as a result of the stroke, then they should be scored 2 on the Rankin. In this category the patient has slight disability and is unable to carry out all his previous activities, but he is still able to look after all of his own affairs without any external assistance. For example, a patient would be scored in this category if he used to play golf and is no longer able to do so, or if he used to have a job whereas he now no longer works. The patient should still be able to look after himself without any daily help. In other words he will be able to dress, move around, eat, go to the toilet, prepare simple meals, undertake shopping and make short journeys by himself. He will not require any supervision from other people and could safely be left at home for periods of a week or more without any concern. An inability to drive purely because of legal impediment, i.e. where the participant is otherwise physically able, would not warrant a score of 2. Rankin category 3 is for patients who have moderate disability. These patients require some external help for daily activities but are able to walk without assistance. They may use a stick or a frame for walking but the assistance of another person is not required for this. They will be able to manage daily activities such as dressing, toileting, feeding etc., but will need help for more complex tasks such as shopping, cooking or cleaning or will need to be visited more often than weekly for some other purpose. The external help may simply be advisory, for example supervision for their financial affairs. Patients with moderately severe disability who are unable to walk without assistance and are unable to attend to their own bodily needs by themselves are given a score of 4. These patients are not independently mobile and will need help with daily tasks such as dressing, toileting or eating. They will need to be visited at least daily or will need to live in close proximity to a carer. To discriminate patients in category 4 from those in the most severe category, consider whether the patient can regularly be left along for moderate periods of a few hours during the day.

29 SITS Open Users Guide Patients who cannot be left alone even for a few hours should be given the score of 5. Patients in category 5 have severe disability and are usually bedridden, incontinent and require constant nursing care and attention. Someone else will always need to be available during the day and at time during the night, although this will not necessarily be a trained nurse. Thus, in summary, to distinguish between patients in category 0 or 1 consider whether the patient has any remaining symptoms. To distinguish between categories 1 and 2 consider whether the patient can undertake all of his previous activities. If the patient is independent of others in activities of daily living, then he should be scored 2 rather than 3. To distinguish between category 3 and category 4 the crucial question is whether the patient can walk without the assistance of other people. Finally, a patient who can be left by himself for a few hours during the day would be given a score of 4 rather than 5. It is important to note that patients do not always fall neatly into one category and some judgement is usually required when scoring them. When in doubt between 2 categories, always stick to the key discriminators of the scale. Thus if the patient has remaining symptoms he scores at least 1. If the patient is unable to undertake previous activities he scores at least 2. If he is dependent upon others in activities of daily living he must score at least 3. If the patient is unable to walk without assistance he must score at least 4 and if the patient is bedridden and requires constant nursing care he will score 5. Finally, if there is still some doubt between two alternatives on the scale, and both options appear equally valid, then the worse option should be chosen.

30 30 SITS Open Users Guide List of clinical variables Variable Options Comments Patient information SITS Study number Contact person for patient Hospital information Hospital name Person who completed the data form Logistics Modified Rankin Scale (mrs; before onset of this stroke) Participation in stroke clinical trial Other treatments First name Family name Date of birth Social security number / Personal ID number Gender Phone number Mobile phone number First name Family name Phone / mobile phone number Name Date Date and time of stroke onset Admission before stroke onset Date and time for arrival at hospital Date and time of arrival to first hospital Specify hospital of first arrival Arrival to additional hospital Mark if not available (mrs before stroke) mrs score before stroke (0-5) Prior disability (mrs 1-5) has other cause than stroke Observational trial Interventional trial Aspirin (If yes, which dose) Dipyridamole, slow release Clopidogrel Other antiplatelet Anticoagulant warfarin, oral (If PK-INR is known, specify value) Anticoagulant dabigatran, oral (If yes, specify dose) Heparin/heparinoids for stroke prevention/limitation Heparin/heparinoids for profyaxis of deep Always complete this section, even if you will not use it in database. If date of birth is not available, specify age at stroke onset Provided by database after patient has been added. Details for contact person. Not used in database. Centre code for the centre will be provided by the database. If exact time of stroke onset is not known, please provide last time/day patient was free of symptoms or best estimate. If time is unknown, point the appropriate tickbox. For explanations how to handle multiple arrival see text on page 13 Is the patient already participating in any trial (before this stroke onset)? If yes, please specify. Participating in other interventional stroke trial is not compatible with SITS Open inclusion criteria. As taken at the present stroke onset

31 SITS Open Users Guide Risk factors Weight Height Laboratory findings Blood pressure (before treatment) NIHSS at baseline (before IVT) Imaging-CT at baseline venous thrombosis Anti-diabetic, oral Insulin Antihypertensive, IV (If yes, which treatment) Antihypertensive, oral (If yes, which treatment) Statin Other treatment (specify) Hypertension Diabetes Hyperlipidemia Current smoker (at stroke onset) Previous smoker (stopped before stroke onset) Previous stroke earlier than 3 months (based on clinical symptoms) Previous stroke within the latest 3 months (based on clinical symptoms) Previous TIA/ Amaurosis fugax Atrial fibrillation (permanent or paroxysmal) Congestive heart failure Hormone replacement therapy: Oestrogen Anti-conceptions Glucose Cholesterol Body temperature APTT Systolic Diastolic NIHSS total score NIHSS subscores (1-11; for details see study protocol) CT done Date and time for CT CT current infarct CT ASPECTS Score CT Dense artery sign Collateral infarcts CTA occlusion Localization of occlusion TICI score (before intervention) Was stenosis noted proximal to occlusion(s)? Localization of stenosis Degree of stenosis Type of stenosis Both known risk factors and newly discovered should be recorded. Weight (estimated or measured) and height of the patient Mark the appropriate tickbox if not available. Date and time for any lab finding should be specified. Mark the appropriate tickbox if not available. If data not available, mark the appropriate tickbox. Collateral infarct = if the patient have old infarct(s) in the symptomatic hemisphere or vascular territory. If occlusion is revealed, please specify location. The description of its location is organized in the following order: Side Territory Segment Branch (e.g. Right MCA M2 Frontal). Fill as many fields as needed to describe all occlusions. If stenosis was revealed, its description is entered using the same order: Side Territory Segment Branch (e.g. Right MCA M2 Frontal).

32 32 SITS Open Users Guide Imaging MR at baseline Acute interventions CT perfusion deficit Side Territory CT perfusion deficit volume CT infarct volume CT perfusion/infarct mismatch Local haemorrhage HI1/HI2/PH1/PH2/extravasation of contrast Remote haemorrhage PHr1/PHr2 Cerebral oedema COED1/COED2/COED3 Subarachnoid/Intraventricular haemorrhage No/Significant/Minor (traces of blood) MR done Date and time for MR MR current infarct MR ASPECTS Score Collateral infarcts MRA occlusion Localization of occlusion TICI score before intervention Was stenosis noted proximal to occlusion(s)? Localization of stenosis Degree of stenosis Type of stenosis MR perfusion deficit Side Territory MR perfusion deficit volume MR infarct volume MR perfusion/infarct mismatch MR local haemorrhage HI1/HI2/PH1/PH2/extravasation of contrast MR remote haemorrhage PHr1/PHr2 MR cerebral oedema COED1/COED2/COED3 Subarachnoid/Intraventricular haemorrhage No/Significant/Minor (traces of blood) No specific intervention IVT thrombolysis Stroke unit care I.a thrombolysis Degree of stenosis in %. If CT perfusion deficit is present, side and territory should be specified. Fill in as many fields as needed. CT perfusion deficit volume should be specified in millilitres if measured. Analysis may be not applicable due to bilateral stenosis (check the tickbox). CT infarct volume should be specified in millilitres if measured. For definitions and classifications please see study protocol. The same guidelines apply as for filling the data form for CT imaging. Collateral infarct = if the patient have old infarct(s) in the symptomatic hemisphere or vascular territory. Multiple selection is possible. If "Any other specific intervention" is selected, please specify which.

33 SITS Open Users Guide Thrombectomy I.V.T thrombolysis Thrombectomy Hemicraniectomy Carotid endarterectomy Angioplasty/stenting, intracranial Angioplasty/stenting, extracranial Any other specific intervention Performed at hospital Thrombectomy was completed per-protocol? If not performed the reason must be clarified Has IVT Thrombolysis been performed If I.V.T was not performed the reason must be clarified. Dose of actilyse Date and time for start of Actilyse treatment Date and time for end of Actilyse treatment Initiated at hospital NIHSS (before endovascular procedure) Choose hospital where TBY was performed in case of multiple arrival. Please specify was the case managed per protocol or as intention-to treat Choose hospital where IVT was performed or started in case of multiple arrival. Put the subscores and the total score will be calculated Thrombectomy Duration of the procedure Enter date and time of the start and the end of procedure, defined as femoral access and femoral closure correspondingly Intubation and anesthesia Duration Heparin during procedure Total dose Heparin after procedure Initial occlusion and angiographical result Localization of occlusion TICI score before and after intervention Date and time of recanalization Proximal stenosis occurrence (angiographical result) Endovascular procedure(s) Mechanical thrombectomy device (MTD) Distal access catheter (DAC) Number of attempts Balloon guide Aspiration in guide during thrombectomy Delayed reocclusion (5-10 min) Incubation of device 5 min Angioplasty Adjunctive stenting TICI score after each device If general anesthesia was used, please choose Yes and specify duration of general anesthesia If heparin flushes were used, please choose Yes and specify total dose of heparin during procedure Localization of occlusion is described according to the following order: Side Territory Segment Branch (e.g. Right MCA M2 Frontal). TICI scores, date and times should be entered for all occlusions. Stenosis is described according to the same order. Fill as many fields as needed to describe all occlusions/stenoses. Please specify the endovascular procedure(s), or choose Not applicable if no specific procedure was done. Most popular devices are listed in the database, alternatively other device name may be entered.

34 34 SITS Open Users Guide Was the device successful? Administration of drugs Drugs administrated at the occlusion site Lytics/Anticoagulants/Antiplatelets/Vaso dilators Drugs administrated systemically Anticoagulants/Aspirin/ReoPro (Abciximab) Blood pressure (systolic/diastolic) before procedure during procedure end of procedure 2 hours after procedure 4 hours after procedure Rehabilitation Other treatments during hospital stay 12h timepoint 24h timepoint Evaluation made by physiotherapist? 24h/> 24h but 48h/> 48h/No/Unknown Evaluation made by occupational therapist? 24h/> 24h but 48h/> 48h/No/Unknown Aspirin Specify dose Dipyridamole Clopidogrel Other antiplatelet Warfarin Specify INR Dabigatran Specify dose Heparin/heparinoids for stroke prevention/limitation Heparin/heparinoids for prophylaxis of deep venous thrombosis Anti-diabetic, oral Insulin Antihypertensive, IV Specify treatment Antihypertensive, oral Specify treatment Statin Other Specify treatment Blood pressure (systolic/diastolic) NIHSS total score NIHSS subscores (1-11; for details see study protocol) Blood pressure (systolic/diastolic) NIHSS total score NIHSS subscores (1-11; for details see study If Yes or Unknown, please mark has the patient received any physiotherapy/ occupational therapy If data not available, mark the appropriate tickbox.

35 SITS Open Users Guide protocol) Imaging-CT (22-36h after treatment) CT done Date and time for CT CT current infarct CT ASPECTS Score CT Dense artery sign Collateral infarcts CTA occlusion Localization of occlusion TICI score (after intervention) Was stenosis noted proximal to occlusion(s)? Localization of stenosis Degree of stenosis Type of stenosis CT perfusion deficit Side Territory CT perfusion deficit volume (specify volume) CT infarct volume (specify volume) CT perfusion/infarct mismatch Local haemorrhage HI1/HI2/PH1/PH2/extravasation of contrast Remote haemorrhage PHr1/PHr2 Cerebral oedema COED1/COED2/COED3 Subarachnoid/Intraventricular haemorrhage No/Significant/Minor (traces of blood) Imaging-MR (22-36h after treatment) MR done Date and time for MR MR current infarct MR ASPECTS Score Collateral infarcts MRA occlusion Localization of occlusion TICI score (after intervention) Was stenosis noted proximal to occlusion(s)? Localization of stenosis Degree of stenosis Type of stenosis MR perfusion deficit Side Territory MR perfusion deficit volume (specify The description of occlusion is organized in the following order: Side Territory Segment Branch (e.g. Right MCA M2 Frontal). Fill as many fields as needed to describe all occlusions. For TICI scale refer to the study protocol. CT perfusion deficit volume should be specified in millilitres if measured. If analysis is not applicable due to bilateral stenosis, check the appropriate tickbox. The same guidelines apply as for filling the data form for CT imaging. Collateral infarct = if the patient have old infarct(s) in the symptomatic hemisphere or vascular territory.

36 36 SITS Open Users Guide TCD Day 7 timepoint Discharge and death volume) MR infarct volume (specify volume) MR perfusion/infarct mismatch Local haemorrhage HI1/HI2/PH1/PH2/extravasation of contrast Remote haemorrhage PHr1/PHr2 Cerebral oedema COED1/COED2/COED3 Subarachnoid/Intraventricular haemorrhage No/Significant/Minor (traces of blood) Date and time TIBI grade Global outcome at 24h Much better/better/ Unchanged/ Worse/ Much worse or Dead (also fill in death page) Blood pressure (systolic/diastolic) NIHSS total score NIHSS subscores (1-11; for details see study protocol) Global outcome at day 7 Much better/better/ Unchanged/ Worse/ Much worse or Dead (also fill in death page) Modified Rankin Scale (mrs score; 0-7) Was patient discharged from hospital due to death? Logistics Date and time of discharge Discharge to Own home Special facility (excl. rehab, i.e. group-, service-, nursing home) Stroke diagnosis Type of stroke ICD code Other diagnosis (which) Involved vascular territory Anterior/ Posterior Right/Left Other acute clinic Geriatric/Rehab Other (i.e. patient lives in other country) Discharged from clinic, but still in hospital Other stroke unit Unknown According to the judgment of treating clinician. For details see study protocol. Global outcome at day 7 compared to baseline.