a guide to completing the electronic case report forms
Contents
1. UJ N a W Fluency Name maximum number of words in one minute that begin with the letter F N 2 11 words ABSTRACTION Similarity between e g banana orange fruit train bicycle watch ruler Tam RECALL Has to recall words TY Prud TT Tl T reece UNCUED WITH NO CUE recall only Opti Der ee ee ee 0 ORIENTATION Date Month Year Day Place City 6 b N a Z Nasreddine MD www mocatest org Normal 226 30 TOTAL __ 30 Administered by Add 1 pointif lt 12 Figure 28 MoCA 37 Alternating Trail Making Administration The examiner instructs the subject Please draw a line going from a number to a letter in ascending order Begin here point to 1 and draw a line from then to A then to 2 and so on End here point to E Scoring Allocate one point if the subject successfully draws the following pattern 2 B 3 C 4 D 5 E without drawing any lines that cross Any error that is not immediately self corrected earns a score of O 2 Visuoconstructional Skills Cube Administration The examiner gives the following instructions pointing to the cube Copy this drawing as accurately as you can in the space below Scoring One point is allocated for a correctly executed drawing Drawing must be three dimensional e All lines are drawn No line is added Lines are relati2. eres eee esee esee eese teen ere tn tnt tn ene tn tne notntue 38 39 2 MEMO aes 39 PCE 40 7 Sentence repet ON a 4 Verbal MCNCY oonan r a E E mate taU a Da asa 4 2 UON E 41 O Delayed etie eu Eoi 42 EN Sli 43 TOTALS CORE ipie 43 OP LIFE EQSSIDSSI ht 45 MODIFEDI RANKIN SCALE EU ES DE greiner 48 50 PRUG MANAGEMENT 2 5 FOLLOW UP 5 VAIS ICSC OM dios od aac oars ada and o dolio aic o dn ans 52 POSITIVE EVENT FORMS 24242 eta tt e De t E t ai ee t t 55 Bleeding events cL RUNDEN ats S 55 Cardiac Or nam TREE EHE HERMES 56 StFOKG or BA siat nt nA Nn MN NAM 56 Death Notitication 57 WITADRAWALFORM S 58 INTRODUCTION The CROMIS 2 study now has an online a
3. a fade data in oda qu 13 bir M 14 es dro l6 Opening Queries xaxa nire e 16 Adding Ag scp en ee 7 sevciMtreiieite e H 18 LISTING QUEM M IERI 19 PARTIE USERMANUAL e MMM 22 STUDY a ee ee 23 PATEN M 24 Inclusion chan m deum om E IEEE EEUU 24 Exclusion FIG Ia coe om T ee 25 SCREENING T 26 PATIENT AINFCORPTACTIOO INE IINE ces ea 28 CONICAL PRESENTATION 30 PREVIOUS EVENTS AND VASCULAR RISK AND VASCULAR RISK FACTORS sss 32 PISTORY OFSTRONREA UA OR IC a tene etn INIRE EU I 33 35 How to calculate the final score of the 35 Scoring E 35 MOCA MONTREAL COGNITIVE ASSESMENT ADMINISTRATION AND SCORING Ix SONS egy ec ee 37 L JAlternating Trail cee duod odd Teens 38 2 Visuocoristr ctional Skills CUBE tote ette tee 38 3 Visuoconstructional Skills Clock
4. am moderately anxious or depressed am severely anxious or depressed L am extremely anxious or depressed COGNITION am able to remember most things think clearly and solve day to day problems L am able to remember most things but have a little difficulty when trying to think and solve day to day problems 0 am somewhat forgetful but able to think clearly and solve day to day problems am somewhat forgetful and have a little difficulty when trying to think or solve day to day problems L am very forgetful and have great difficulty when trying to think or solve day to day problems LI am unable to remember anything at all and unable to think solve day to day problems To score the descriptive system a sequential scoring system should be used For example if the patient has ticked the responses like this MOBILITY have no problems in walking about NM have slight problems in walking about LI have moderate problems in walking about have severe problems in walking about L am unable to walk about SELF CARE have no problems washing or dressing myself have slight problems washing or dressing myself NM have moderate problems washing or dressing myself LI have severe problems washing or dressing myself L am unable to wash or dress myself L USUAL ACTIVITIES e g work study housework family or leisure activities have no problems doing my usual activities
5. have slight problems doing my usual activities have moderate problems doing my usual activities have severe problems doing my usual activities L am unable to do my usual activities 46 PAIN DISCOMFORT have no pain or discomfort LI have slight pain or discomfort L have moderate pain or discomfort L have severe pain or discomfort N have extreme pain or discomfort L ANXIETY DEPRESSION am not anxious or depressed L am slightly anxious or depressed LI am moderately anxious or depressed am severely anxious or depressed am extremely anxious or depressed NM COGNITION am able to remember most things think clearly and solve day to day problems am able to remember most things but have a little difficulty when trying to think and solve day to day problems 0 am somewhat forgetful but able to think clearly and solve day to day problems am somewhat forgetful and have a little difficulty when trying to think or solve day to day problems L am very forgetful and have great difficulty when trying to think or solve day to day problems am unable to remember anything at all and unable to think solve day to day problems L The score would 123451 Please insert this score into the descriptive system box on the eCRF see Figure 30 The patient s gt C on the 0 100 scale should be recorded under visual analogue scale out of 100 on the eCRF al
6. cromis 2 Clinical Relevance Of Microbleeds In Stroke A GUIDE TO COMPLETING THE ELECTRONIC CASE REPORT FORMS ECRF VERSION 1 0 APRIL 2012 TABLE OF CONTENT A GUIDE TO COMPLETING THE ELECTRONIC CASE REPORT FORMS ECRF 0 TABLE OF CONTENT risit READER S HP rrr a ORE T a SEE e INTRODUC TION UCM n 3 PART 1 CROMIS 2 ELECTRONIC DATA 5 4 ACCESSING THE ELECTRONIC DATASYSTEM Od 4 lorgottehi passWOFdS a bie 5 Changing password or PIN ssssssesscessscsscssscescscescssscessscesessecesescssessscesessscessscesesssceseacecesssceeesceeeeeaceeeaeeces 5 adn eee eet le EE 5 Creating your ACC OUI rarest staat E E Ond DL Ceu IE 6 Editing ore 7 Deleting 7 uu 7 PATIENTS ea eo ee ee eee 9 Viewing existing patient 9 New patients aaen 9 Allocating study e 10 Overdue TON IIIS essa dtu te nei atte fue 12 M savieu P 12 Data entr ol TORS 2 0 ode fee denter
7. the patient details panel and CRF specific queries will also be shown when viewing the CRF In addition if a CRF has an open query attached a yellow warning symbol appears next to the form name in the patient details panel Note that creating a query or re opening a closed query linked to a CRF will cause the CRF to be marked as not validated 16 Patient details Patient ID 01002 Date entered study 10 10 2011 Site Site 01 University College London Site 1 United Ki Figure 12 How to create a query Adding messages Messages may be added to queries by investigators sites or administrators Co ordinating centre forming a conversation thread Figure 15 Administrators can close a query when the issue has been resolved Administrators may also re open a closed query by setting the action to Reopen when adding a new message to it When editing a query Figure 15 printing the web page will display an extra box that asks the investigator to write their response with signature and date This may be useful for the site s own records or workflow 17 Return to patient Create a query Related form Standard Study entry Related question C h CHOKE an Title Message Create query Figure 13 Entering query title and message Email notifications When a query is created or a message added to an existing query an email notification is sent out to all administrators and all investigators at the sa
8. Read the three number sequence at a rate of one digit per second Scoring Allocate one point for each sequence correctly repeated N B the correct response for the backwards trial is 2 4 7 Vigilance Administration The examiner reads the list of letters at a rate of one per second after giving the following instruction am going to read a sequence of letters Every time say the letter A tap your hand once If say a different letter do not tap your hand Scoring Give one point if there is zero to one errors an error is a tap on a wrong letter or a failure to tap on letter A Serial 7s Administration The examiner gives the following instruction Now will ask you to count by subtracting seven from 100 and then keep subtracting seven from your answer until tell you to stop Give this instruction twice if necessary Scoring This item is scored out of 3 points Give no 0 points for no correct subtractions point for one correction subtraction 2 points for two to three correct subtractions and 3 points if the participant successfully makes four or five correct subtractions Count each correct subtraction of 7 beginning at 100 Each subtraction is evaluated independently that is if the participant responds with an incorrect number but continues to correctly subtract 7 from it give a point for each correct subtraction For example a participant may respond 92 85 40 78 7 64 where th
9. Yes 9 No 11 Other MRI contraindication Yes 8 No Exclusion criteria Clinical contra indications 12 Any know previous anticoagulant use ever 5 12 Yes 9 No 13 Absolute contraindications to anticoagulant use as decided by the treating physician z e Yes 14 Serious head injury ever resulting in loss of consiousness 512 Yes No Figure 17 Example of Study II ICH exclusion criteria warning message Study Il ICH Question 16 The Patient Eligibility section of the eCRF shown below aims to identify patients taking oral anticoagulation at the time of the ICH but please note that this is not either an inclusion or exclusion criterion see Figure 18 25 Anticoagulation 16 Was the patient prescribed and known to be taken oral anticoagulation at the time of the ICH O Yes Unknown Study ICH questionl to obtain whether patient had an anticoagulant or non anticoagulant related bleed SCREENING LOGS For all the patients not eligible to enrolled or excluded from the study please complete the CROMIS 2 eligibility screening log and keep in your site file If a similar record is kept as part of the Stroke Network activities a copy should be kept in the site file highlighting the patients screened for the study The minimum information needed for these patients can be found in the following sample screening log Study 1 CROMIS 2 AF Screening Data Please
10. to update the account email address name and status active or suspended The user s name should only be changed to correct spelling mistakes Existing user accounts should not be re allocated to new users User accounts that are no longer in use should be suspended and new accounts created for new users Deleting accounts There is no facility for deleting accounts This is to preserve the audit trail and history of who performed which actions To remove the ability for an account to access the system the account should be edited and the status set to suspended Logging in After you have successfully logged in you will be presented with a welcome page with a short description of the trial and their user account role Figure 2 This screen can be returned to at any time by clicking on Home in the navigation bar at the top of the page Trials CROMIS 2 Study I Microbleeds and genetic risk factors to predict the risk of intracranial haemorrhage in patients treated with anticoagulation following cardioembolic stroke due to atrial fibrillation Your role in this trial is Administrator User accounts You receive notifications for this trial Stop sending me notifications CROMIS 2 Study II Observational and genetics study of intracerebral haemorrhage Your role in this trial is Administrator User accounts You receive notifications for this trial Stop sending me notifications Figure 2 Example home screen af
11. FORMS Please complete this form in the following circumstances Ifthe patient or consultee wishes to withdraw from the study 2 If the patient or consulttee wish to stop patients s ongoing participation in the study after the study has completed 3 If the patient is withdrawn from the study for any other reason 58 Withdrawal Details of withdrawal 1 Date of withdrawal from the study 29 03 2012 2 Why was the patient withdrawn patient wish _ Other 3 Please list any further information 4 Has the patient agreed that the data already collected can be used e Yes Figure 44 Withdrawal form Points to remember when completing this form e A patient has the right to withdraw from the study at any time and for any reason without prejudice to their medical care They are not obliged to provide a reason for their change of mind e Please clarify with the patients whether despite withdrawing consent they would agree for data collection to continue and any outstanding data collected Ensure the fact the patient has withdrawn is recorded in the patient notes 99
12. Numbers The patient ID will be obtained at the time of enrollment The first part of the ID represents the Site ID The second part of the ID represents the unique patient number The Centre ID and patient ID will not need to be entered at each visit and will populate automatically at the top of the screen after initial entry at the Baseline form The system will alert you to any missing patient information prior to moving to the next form The completed form will be saved and you can view this form at any point The Patient individual patient record is where you will see all saved patient forms see Figure 6 10 You can return to a patient home page by clicking return to patient or you can continue to the next section of the form Alternatively you can jump to a specific form using the drop down list Patient ID 01003 Date entered study 05 12 2011 UCL Site 1 United Kingdom Return to patient Add Clinical presentatian Jump to form Create a query Figure 6 Screen showing how to move to new forms or return to patient home screen ROMIS 2 Patients 1 Search Patient details Study I Sub Patient ID Date entered study 21 11 2011 Patient ID Site Site Site 01 University College London Site 1 United Kingdom Queries 01011 Site 01 University College Londo creates ous Forms o e sche e Study entry Withdrawal Baseline Patient eligibility Patient information Clinical pres
13. Yes The page at https evaluation sealedenvelope com says 2 Clinical diagnosis of atrial fik T 1 This patient is not eligible to enter this study Please do not continue completing this form Tau c Ma 3 Intention to treat with antica e ves No 4 MRI possible including gradient echo T2 before or lt 1 week of starting anticoagulants Yes No Figure 16 Example of Study AF inclusion criteria warning message Note The only inclusion criterion for Study II ICH is that the patient must present with spontaneous ICH confirmed on neuroimaging CT or MRI Patients with ICH secondary to an underlying cause e g trauma tumour etc are excluded from this study as well as patients with isolated intraventricular or subarachnoid haemorrhage and haemorrhagic transformation of an infarct 24 Exclusion Criteria If any of the exclusion criteria listed above is checked Yes the patient is NOT eligible for the study Exclusion criteria MRI contradictions 5 Heart pacemaker 3 No 6 Artificial metallic heart valve 4 i Yes 9 No 7 Is the patient pregnant ci Yes 9 No 8 Metal plates 12 O ves The page at https evaluation sealedenvelope com says No 9 CEsustrnplsobis lt 1 This patient i5 not eligible to enter this study Please do not continue completing this form Yes 10 Unable to enter the MRI scanner i
14. form N Other 11 Position Research Nurse Research Practitioner Figure 19 Patient Information form 28 IMPORTANT NOTE If consultee consent has been obtained question 4 written informed consent from patient been obtained must be no Instead question 6 written informed consent consultee been obtained must be yes and date entered accordingly 4 Has written informed consent from patient been obtained Yes No 5 Date consent from patient obtained E d m m is La pe pex m j d a a a Has written informed consent from consultee been obtained help Yes 7 Date consent from consultee obtained 11 11 2011 fF D e Figure 20 Showing consent marked as instead consultee consent has been obtained and marked yes with date inserted accordingly Date baseline data collected please use date completing the patient contact details 29 CLINICAL PRESENTATION Please complete this information to provide basic details of the current event Clinical presentation Clinical presentation 1 History collected at Stroke TIA clinic Stroke Unit Other 2 If other please specify Current stroke history 3 Date of stroke TIA onset of symptoms 31 10 2011 fF d d mm YYYY 4 Is this the patient s first ever TIA stroke Yes No Unknown Figure 21 Study AF
15. the following Paraesthesia focal weakness speech disturbance limb shaking or jerking visual disturbances or headaches Yes 3 Episodes of focal paraesthesias pins and needles tingling affecting part of the face or body Yes 4 Face paraesthesias Left only gt Figure 25 History of transient focal neurological episodes A detailed description of these attacks will be very useful when available and can be enter in Question 67 see Figure 26 57 Please provide a description of the episodes in as much detail as possible help Numbness and a tingling sensation around the corner of the mouth on the right she is not sure whether the tongue is also involved after 2 3 minutes the abnormal sensations spread to the right hand over 1 2 minutes without any obvious weakness Figure 26 Description of episodes 34 SCALES AND SCORES APPLIES FOR BOTH STUDIES The scales and scores should be completed during patient s admission Scales and scores to be completed include IQ CODE short version to be given to the patient s relative carers other informant to complete 2 MoCA Montreal Cognitive Assesment to be administered to the patient by a research practitioner or other appropriate member of the research team 3 EQ 5D 5L to be given to the patient to complete 4 Modified Rankin Scale to be completed by the researcher completing the CRF Please find below detailed instructions of how to complete each
16. Clinical Presentation form IMPORTANT NOTE Date of stroke enter date of stroke onset If this is unknown please enter date patient was admitted to hospital with this event 30 Clinical presentation Current ICH history 1 Date of ICH onset of symptoms 28 03 2012 2 First ever symptomatic ICH ves Mo Unknown Symptoms at onset Yes a No F Unknown Symptoms at onset weaknes 4 Face weakness a Yes No Unknown 5 If yes right or left Right Figure 22 Study II ICH Clinical Presentation form 31 PREVIOUS EVENTS AND VASCULAR RISK AND VASCULAR RISK FACTORS Patient ID 01030 Date entered study 06 03 2012 Site o1 University College London Site 1 United Kingdom Return to patient Previous events and vascular risk factors Past medical history 1 Hypertension on anti hypertensive treatment pre event or 140 90 persisting gt 7 days after stroke or on two occasions before the stroke e Yes Unknown 2 If yes please specify year of diagnosis 2009 wear Up CO digits 3 Hypercholesterolemia on treatment pre stroke or fasting cholesterol total gt 5 2 mmol L after stroke 2 Yes Unknown 4 Diabetes type I II pre event diagnosis or random 11 immol L or 21 fasting 7 mmol L after the event 2 Yes Unknown 5 Smoking status Ex smoker 6 If current or ex smoker number of cig
17. Mar 12 Done Withdrawal at any time Baseline Form Due Patient eligibility 6 Mar 12 Overdue Patient information 6 Mar 12 Overdue Clinical presentation 6 Mar 12 Overdue Previous events and vascular risk factors 6 Mar 12 Overdue History of stroke TLA or ICH 6 Mar 12 Overdue Family history 6 Mar 12 Overdue Investigations Mar 12 Overdue Scales and scores 6 Mar 12 Overdue Management Mar 12 Overdue Drug management medications on admission 6 Mar 12 Overdue Drug management new medications started amp Mar 12 Overdue Drug management medications on discharge amp Mar 12 Overdue Confirmation of anticoagulation initiation 6 12 Overdue 6 month follow up Form Due Visit record 6 months 6 Sep 12 12 month follow up Form Due Visit record 12 months amp Mar 13 Figure 8 Showing schedule of patient 12 Data entry of forms CRFs withdrawal forms follow up form event forms and death notification forms can be completed by clicking on the Add link shown on the patient details home screen next to the name of the CRF 6 month follow up Visit record 6 months Add GP 6 month follow up questionnaire Patient 6 month follow up questionnaire 17 month follow up Visit record 12 months Add GP 12 month follow up questionnaire Patient 12 month follow up questionnaire 24 month follow up Visit record 24 months Add GP 24 month follow up questionnaire Patient 24 month follow up questionnaire Events Death notifi
18. NITIVE ASSESMENT ADMINISTRATION AND SCORING INSTRUCTIONS The Montreal Cognitive Assessment MoCA was designed as a rapid screening instrument for mild cognitive dysfunction It assesses different cognitive domains attention and concentration executive functions memory language visuoconstructional skills conceptual thinking calculations and orientation Time to administer the MoCA is approximately 0 minutes The total possible score is 30 points a score of 26 or above is considered normal NAME MONTREAL COGNITIVE ASSESSMENT MOCA Education Date of birth Version 7 1 Original Version Sex DATE VISUOSPATIAL EXECUTIVE Draw CLOCK Ten past eleven 3 points POINTS Contour Numbers Hands NAMING M MEMORY Read list of words subject must p FACE VELVET CHURCH DAISY RED repeat them Do 2 trials even if 1st trial is successful 1st tria E 10 3 Do a recall after 5 minutes Isttrial coup n ATTENTION Read list of digits 1 digit sec Subject has to repeat them in the forward order 121854 Subject has to repeat them in the backward order 1742 Serial 7 subtraction starting at 100 93 86 79 72 65 4 5 correct subtractions pts 2 or 3 correct 2 pts 1 correct 1 0 correct 0 pt LANGUAGE Repeat only know that John is the one to help today The cat always hid under the couch when dogs were in the room
19. age ICH ves No Unknown 10 Total number of all previous ICH events Figure 24 History of stroke TIA or ICH form 33 IMPORTANT NOTE This section should not be confused with the next questionnaire see next page which is about the history of transient neurological episodes other than transient ischaemic attacks TIAs which may have occurred prior to the ICH Research suggests that such transient focal neurological episodes with symptoms that are different to those of typical TIAs can precede ICH in some patients Most commonly these attacks are described as paraesthesia pins and needles By contrast generally cause loss of neurological function for example focal weakness or loss of sensation To elicit a possible history of these episode please ask both the patient and any relative next of kin and also check the medical notes History of transient focal neurological episodes Research suggests that transient focal neurological episodes can precede ICH in some patients Often these attacks are described as paraesthesias pins and needles that move from one part of the body to another The questions below are important to understand more about these attacks History of transient focal neurological episodes 1 Can the participant or reliable informant e g a relative or close friend provide a reliable history 9 Yes 2 No 2 Before the patient had an ICH were there any attacks of
20. arettes per day 20 Er Up ulus un 7 If ex smoker year stopped smoking 2008 ul C E Luo 1 git m y 8 Alcohol consumption Current 9 If current drinker how many units a week fonts A i am 10 If current drinker type of alcohol the patient generally consumes the most in units Spirits Figure 23 Previous events form 32 HISTORY OF STROKE TIA OR ICH The Past Medical History section is followed by a brief section regarding the previous history of ischaemic stroke transient ischaemic attack TIA or intracerebral haemorrhage ICH which is relatively straight forward to be completed see below History of stroke or ICH History of previous ischaemic stroke transient ischaemic attack intracerebral haemorrhage ICH 1 Previous ischaemic stroke ves No Unknown 2 Total number of all previous ischaemic stroke events 1 Number up to 2 digits 3 Please record date of most recent previous ischaemic stroke event 01 01 2008 J F HU La E od 5 Previous transient ischaemic attack TIAs Yes No Unknown 6 Total number of all previous transient ischaemic attack TIA events Number up to 2 digits 7 Please record date of most recent previous TIA event E ddimmiyyyy Date of the first ewer TIA dd mmyyyyy 9 Previous intracerebral haemorrh
21. as the stroke fatal Yes 9 nuo 4 Type of stroke Ischaemic includes haemorragic transformation of infarct 5 Ischaemic mechanism Cardioemboalic Figure 42 Stroke TIA form Death Notification Form Please complete this form for all deaths of patients recruited to the CROMIS 2 study When this form has been completed return to the CROMIS 2 study office with all reports you have available to you i e death certificate post mortem report If when completing the form positive event is notified a pop up message will appear asking you to complete the relevant form in addition to the death notification form see Figure 43 o Patient ID 01030 Date entered study 06 03 2012 Site o1 University College London Site 1 United Kingdom Death notification Detail of death 1 Date of death zl 2 Cause of death 3 Ischaemic stroke e Yes RUE eer eee The page at https www sealedenvelope com says Please complete the positive events form 5 Myocardial infarction MI wor Yes 6 Pulmonary embolus Yes 7 Sudden death presumed cardiovascular Yes Ne B Other d amp esth w Yes 9 Please provide details of other vascular dest 10 Other death Im em 11 Please prowide deta of other non vascular death Figure 43 Death notification form with message requesting a positive event form is completed WITHDRAWAL
22. before proceeding Red error messages require either a change to the value entered or providing a justification for overriding the validation check before proceeding Figure 10 A comprehensive guide to completing study AF and Study II ICH baseline forms positive event forms death notification forms follow up forms and withdrawal forms can be found in Part Il of this guide s History of stroke TIA or ICH History of previous ischaemic stroke transient ischaemic attack TIA or intracerebral haemorrhage ICH History 1 Previous ischaemic stroke No 2 Total number of all previous ischaemic stroke events 3 Please record date of most recent previous ischaemic stroke event 4 Date of the first ever ischaemic stroke 5 Previous transient ischaemic attack TIAs amp Total number of all previous transient ischaemic attack TIA events Der od 1 4 OIGIUS 7 Please record date of most recent previous TIA event Date of the first ever 9 Previous intracerebral haemorrhage ICH Mo 10 Total nurnber of all previous ICH events aL iu 11 Please record date of most recent previous ICH event 12 Date of the first ever ICH ad Figure 11 Review page presented after saving form 15 Some fields are always required these are displayed in bold text whilst others may become required or not applicable depending
23. cardial Infarction Report 3 Detection of rise and or fall of cardiac biomarkers preferably cardiac troponin with at least one value above the 99th percentile of the upper reference limit URL Yes Ono 4 Symptoms of ischaemia e g chest pain Yes 5 ECG changes indicative of new ischaemia new ST T changes or new left bundle branch block LBBE 6 Development of pathological Q waves in the ECG No 7 Imaging evidence of new loss of viable myocardium new regional wall motion abnormality F 8 Sudden unexpected cardiac death involving cardiac arrest often with symptoms suggestive of myocardial ischaemia and accompanied by presumably new ST elevation or new LBBB and or evidence of fresh thrombus by coronary angiography and or at autopsy but death occurring before blood samples could be obtained or at a time before the appearance of cardiac biomarkers in the blood No 9 If the cardiac event was not a myocardial infarction please provide details of what the event was Figure 41 Cardiac Event form Stroke This form must completed when patient recruited to the CROMIS 2 study has experienced a suspected or confirmed stroke or TIA event including any form of intracranial bleeding 96 Stroke or Details of suspected stroke or TIA 1 Date of onset of suspected stroke or TI A Ti 2 Duration of symptoms hrs mins 05 00 i15 rT 3 W
24. cation Add Bleeding event Add Cardiac event Add Stroke or TIA Add 6 month follow up Visit record 6 months Add GP 6 month follow up questionnaire Patient 6 month follow up questionnaire Events Death notification Add Bleeding event Add Cardiac event Add Stroke or TIA Add Figure 9 Follow up forms and event forms in patient for study I and study II 13 At the top of every form is a banner reminding the user of which patient they are entering data on Date fields can be completed manually or by using the date picker that appears when a user clicks on the calendar icon Tip When entering dates or times manually just type the numbers the will be filled in automatically Validation Validation e g range checking is carried out on the form to reduce errors There are two types of error messages those in the form of popup messages and those displayed in red on the form The popup message alerts may warn the user of a value that may be incorrect such as a high blood pressure or give some other message CROMIS 2 Patient ID 01022 Date entered study 23 01 2012 Studv I Clinical presentation Chr cal presentation 1 History collected at Stroke clinic w Stroke Unit Other This mH requeredd Justification for overriding validation Th eld 1s required 2 If other please specify Figure 10 Red error message 14 The user must click OK to dismiss the alert
25. d for self completion by respondents You must provide the paper copy for the patient to complete The EQ 5D self report questionnaire EQ 5D essentially consists of two pages comprising the EQ 5D descriptive system see below and the EQ visual analogue scale VAS Under each heading please tick the ONE box that best describes your health TODAY MOBILITY have no problems in walking about L have slight problems in walking about LI have moderate problems in walking about have severe problems in walking about L am unable to walk about SELF CARE have no problems washing or dressing myself have slight problems washing or dressing myself have moderate problems washing or dressing myself L have severe problems washing or dressing myself L am unable to wash or dress myself LI USUAL ACTIVITIES e g work study housework family or leisure activities have no problems doing my usual activities have slight problems doing my usual activities have moderate problems doing my usual activities have severe problems doing my usual activities L am unable to do my usual activities PAIN DISCOMFORT have no pain or discomfort LI have slight pain or discomfort L have moderate pain or discomfort L have severe pain or discomfort L have extreme pain or discomfort L ANXIETY DEPRESSION am not anxious or depressed L am slightly anxious or depressed LI 45
26. e 92 is incorrect but all subsequent numbers are subtracted correctly This is one error and the item would be given a score of 3 7 Sentence repetition Administration The examiner gives the following instructions am going to read you a sentence Repeat it after me exactly as say it pause only know that John is the one to help today Following the response say Now am going to read you another sentence Repeat it after me exactly as say it pause The cat always hid under the couch when dogs were in the room Scoring Allocate point for each sentence correctly repeated Repetition must be exact Be alert for errors that are omissions e g omitting only always and substitutions additions e g John is the one who helped today substituting hides for hid altering plurals etc 8 Verbal fluency Administration The examiner gives the following instruction Tell me as many words as you can think of that begin with a certain letter of the alphabet that will tell you in a moment You can say any kind of word you want except for proper nouns like Bob or Boston numbers or words that begin with the same sound but have a different suffix for example love lover loving will tell you to stop after one minute Are you ready Pause Now tell me as many words as you can think of that begin with the letter F time for 60 sec Stop Scoring Allocate one point if the subject generates w
27. e per second giving the following instructions This is a memory test am going to read a list of words that you will have to remember now and later on Listen carefully When am through tell me as many words as you can remember It doesn t matter in what order you say them Mark a check in the allocated space for each word the subject produces on this first trial When the subject indicates that s he has finished has recalled all words or can recall no more words read the list a second time with the following instructions am going to read the same list for a second time Try to remember and tell me as many words as you can including words you said the first time Put a check in the allocated space for each word the subject recalls after the second trial At the end of the second trial inform the subject that s he will be asked to recall these words again by saying I will ask you to recall those words again at the end of the test Scoring No points are given for Trials One and Two 39 6 Attention Forward Digit Span Administration Give the following instruction am going to say some numbers and when through repeat them to me exactly as said them Read the five number sequence at a rate of one digit per second Backward Digit Span Administration Give the following instruction Now am going to say some more numbers but when am through you must repeat them to me in the backwards order
28. eds without assistance 5 Severe disability bedridden incontinent and requiring constant nursing care and attention 6 Dead Figure 32 Modified Rankin Scale score descriptions 49 Management Management 1 Reversal of anticoagulation Yes No Unknown 2 If yes was Fresh Frozen Plasma FFP used Yes so 3 If yes was Octaplex used No 4 If yes was Fibrinogen used No 5 Intravenous blood pressure treatment C Unknown 6 If yes was Labetalol used Choose 7 If yes was Glyceryl trinitrate GTN used B If yes was Nitroprusside used 9 If yes was Calcium channel blocker used 10 Calcium channel blocker used Choose Figure 33 Study II ICH Management form 90 DRUG MANAGEMENT Complete the three drug management forms to provide accurate information on drugs on admission drugs whilst in hospital and drugs on discharge Study AF It is important to note that if the patient does not start anticoagulants before discharge a confirmation of anticoagulation form must be completed message will appear to inform you this form MUST be completed see Figure 34 4 GPIIIa TIb e g Abciximab 2 Yes 9 No Unknown The page at https www sealedenvelope com says 5 Warfarin A Please complete the confirmation of anticoagulation form A Yes No Unknown Ok 6 Direct thrombin inhibitors Dabigatran 150mg Figure 34 Warning messa
29. entation Previous events and vascular risk factors History of stroke TIA or ICH Family history Investigations Scales and scores Management Add Drug management medications on admission Drug management new medications started Drug management medications on discharge Confirmation of anticoagulation initiation Visit record 6 months GP 6 month follow up questionnaire Patient 6 month follow up questionnaire 12 month fol Visit record 12 months GP 12 month follow up questionnaire Patient 12 month follow up questionnaire 24 1 Visit record 24 months GP 24 month follow up questionnaire Patient 24 month follow up questionnaire Events Death notification Bleeding event Cardiac event Stroke or TIA Figure 7 Viewing an individual patient record Clicking on a patient in the list shows patient details from the study entry form any queries and provides links to add the baseline CRF and positive event forms and follow up forms for that patient The search box searches through patient IDs and returns a list of patients that match the terms entered Note that CRF data is not searched 11 Overdue forms Overdue CRFs for all patients may be viewed by clicking the Overdue CRFs link in the left hand side bar View Schedule Patient ID 01030 Date entered study 06 03 2012 Site o1 University College London Site 1 United Kingdom Return to patient Schedule Standard Form Due Study entry amp
30. ers as your allocated site number The last 3 numbers will be the next available number working upwards from 001 A site specific study number allocation form is provided to keep track of these figures Patient Identifier is a required field and must be entered to save the Study Entry form Entry the date the patient was recruited to the study Date of study entry is a required field and must be entered to save the Study Entry form Study entry Enter the patient identifier and the date of entry to the study Study entry 1 Patient identifier 01001 2 Date of study entry 29 03 2012 Mates Save form Figure 17 Study entry form 23 PATIENT ELIGIBILITY This form must be completed to ensure all inclusion and exclusion criteria are met and the patient is eligible to participate in the study These criteria are explained in detail in the CROMIS 2 Researcher s Handbook All data must be entered in order to successfully save the eligibility form Inclusion Criteria If any of the inclusion criteria listed above are checked No the patient is NOT eligible for the study A warning message will appear on the screen if any exclusion are checked no Figure 16 Patient eligibility Please do not complete this farm unless the patient meets ALL inclusion criteria and NO exclusion criteria Inclusion criteria 1 Has the patient presented with an ischaemic stroke or TIA within the last month help e
31. fter 6 months after which time a user is forced to change their password or PIN Users with expired passwords have no access to the system except for the change password screen Auto time out After a set period of inactivity 20 minutes you will be automatically logged out of the system Creating your account The CROMIS 2 Study Co ordinator can create new user accounts To create an account the user s real name and email address must be supplied Figure 8 Once the account is created an automatically generated email is sent to the email address supplied containing the randomly generated password and PIN necessary to access the account An example of the generated email is From automated sealedenvelope com Subject Confidential new account details Date 15 July 2009 11 10 17 BDT To joe trialsite org Dear Joe Bloggs An account with investigator privileges has been created for you to access CROMIS 2 https www sealedenvelope com CROMIS 2 Email jbloggs gmail com Password LkFXkaju PIN 9996 Note this message was auto generated on Tue 21 Feb 2012 11 10 Europe London GMT 0100 and was sent from an email address that does not accept replies After you have logged in ideally you should change your password and PIN number and delete this email If you have any difficulties please contact Clare Shakeshaft c shakeshaft Q ucl ac uk Editing accounts Existing accounts may be edited the CROMIS 2 Study Co ordinator
32. ge to complete the confirmation of anticoagulation form if the patient has not started anticoagulation prior to discharge FOLLOW UP Initial routine follow up will be carried out by the Co ordinating Centre by postal questionnaire When data is received back from patients and GPs the data will be entered into the electronic data system under the relevant patient These forms are also available for sites to view and enter the data should the Co ordinating Centre not be able to obtain this data for either GP or Patient Local teams are requested to complete the follow up data by telephone To enter the data click on the relevant follow up time point within the patient home screen Click on visit record This will enable you to access the rest of the form 51 6 month follow up Visit record 6 months Add GP 6 month follow up questionnaire Patient 6 month follow up questionnaire 17 month follow up Visit record 12 months Add GP 12 month follow up questionnaire Patient 12 month follow up questionnaire 24 month follow up Visit record 24 months Add GP 24 month follow up questionnaire Patient 24 month follow up questionnaire Fvents Death notification Add Bleeding event Add Cardiac event Add Stroke or TIA Add Figure 35 Follow up time points for study I AF 6 month follow up Visit record 6 months Add GP 6 month follow up questionnaire Patient 6 month follow up questionnaire Events Death notificat
33. he patient currently taking any of the following If other please state name Figure 38 GP follow up form requesting a Bleeding event form to be completed Since visit to hospital clinic for stroke TIA 10 Told by a doctor or other healthcare professional that had a stroke e Yes 11 Told by a doctor other healthcare professional that had a TIA mini stroke or transient ischaemic attack Yes 12 Told by a doctor or other healthcare professional that had a brain haemorrhage Yes e Mao 13 Had a sudden painless weakness on one side of body Yes No 14 Had a sudden numbness or a dead feeling on one sid ins 1 Important Please complete a stroke or event form No 15 Had a sudden painless loss of vision in one eye or bo mr ves No Figure 39 Patient follow up form requesting a Stroke or TIA form is completed 54 POSITIVE EVENT FORMS Outcomes for the study are death recurrent stroke TIA bleeding events and cardiac events Therefore we have provided forms to collect data regarding any patient events that occur during follow up This are explained in this section Bleeding events form This form must be completed by a member of the local research team when a patient recruited to the CROMIS 2 study has experienced a suspected or confirmed bleeding event If when entering the form a further event is notified such as death an electronic me
34. insert MONTH AND YEAR e g January 2012 Please insert name of hospital Mumber of patients screened Number of potentially eligible patients for Study i e All ischemic stroke patients with Number recruited for Study AF SudyMAF Figure 18 CROMIS 2 screening log Examples Study 1 Patients with ischaemic stroke and AF o Not cardioembolic stroke e g atherothrombotic o Cannotuse anti coagulants o Previous anti coagulant use 26 27 o Relative not available Study 1 Patients with presumed ICH o ICH due to secondary cause e g tumour AVM o Not ICH o Relative not available PATIENT INFORMATION Please complete this section to provide basic demographic information on the patient and to confirm that consent either patient or consultee has been obtained and the date consent was obtained Patient information Patient information 1 Sex Male amp Female 2 Ethnicity Black or Black British Any other black background 3 Hand preference amp Right e Left Unknown 4 Has written informed consent from patient been obtained help Yes m 5 Date consent from patient obtained 6 Has written informed consent from consultee been obtained help Yes 7 Date consent from consultee obtained 11 11 2011 8 Consent to inform GP obtained help Yes No 9 Date baseline data collected help 03 11 2011 J 10 Name of person completing this
35. ion Add Bleeding event Add Cardiac event Add Stroke or TIA Add Figure 36 Follow up forms and event forms in patient for study II ICH Visit record The visit record screen enables a date to be entered of the visit in this case when the questionnaire was completed Important Note Please enter to Did the patient attend this visit 52 Visit record 6 months Attendance 1 Did the patient attend this visit e Teg 2 If yes date of attendance 26 03 2012 m 3 If give reason Figure 37 Visit record form for follow up Once the visit form is completed you can enter the Patient or GP follow up questionnaire by clicking on add and entering the relevant data Important Note When entering the data a positive event is notified the form will raise a message box requesting you complete the relevant Event form for the patient see Figure 38 and Figure 39 53 Problems with bleeding 2 Please indicate whether the patient has experienced any problems with bleeding in the last 6 months E Yum The page at https www sealedenvelope com says 4 Is the patient currently taking anticoagulants C Yes A Important Please complete a bleeding event form Ou 5 If yes confirm the name of the drug they are taking 6 If other pleaze ztate name of drug 7 If was the anticoagulant drug stopped because of bleeding B Is t
36. me and unique user ID number is always shown at the top of every page in the navigation bar Once you have finished using the database application it is good practice to log out This is particularly important if the user is not using his or her own computer To log out click on the Logout link in the navigation bar at the top of the page Note that to comply with good clinical practice GCP it is very important that users do not share accounts or allow others to access their accounts even temporarily Forgotten passwords If you forget your password or log in details they should contact the CROMIS 2 study co ordinator Administrators can reset a user s password and PIN in the User accounts section This sends out a new password and PIN by email to the account holder Note that there is no way to see a user s current password and PIN they are stored in an encrypted format that not even Sealed Envelope staff can decrypt Requests for password resets made by investigators to Sealed Envelope will be referred to the study co ordinator since Sealed Envelope has no way of authenticating the validity of such requests Changing password or PIN Using the account link shown in the top navigation bar you can change your own email address password and or PIN To change a password or PIN it is necessary to enter your existing password New passwords must be at least 6 characters long New PINs must be 4 digit numbers Passwords expire a
37. me site as the patient the query relates to The format of the email is From Sealed Envelope lt automated sealedenvelope com gt Subject CROMIS 2 Query updated Date Wed 28 March 2012 15 43 22 0100 To joe trialsite org admin trialcentre org A query Incorrect date has just been created by Clare Shakeshaft ID 4 You can view the query here https www sealedenvelope com redpill cromis2study query view 18 Query ID 2 Incorrect date of entry s Edit Current status Open This query relates to the Standard Study entry form View patient Messages Action Open Clare Shakeshaft ID 4 on 28 Mar 2012 at 04 13 56 PM 2 Date of ztudy entry is feted as 20097 should the bz 201 27 T 3 4 4 m EH OM mr i 712471 H i Figure 14 Response box shown when editing query User must click edit Listing queries A list of queries grouped by site is displayed by clicking on the Queries link in the sidebar Figure 15 The conversation thread for a query can be viewed by clicking on the query in the list This view also displays links for editing the query or viewing the related patient or CRF 19 Query ID 2 Incorrect date of entry Current status Open 2 Date of study entry is listed as 2009 should this be 20127 Message This query relates to the following form Study entry Enter the patient identifier and the date of entry to the study Study entr
38. of these scales and scores These scores should be entered in the eCRF under scales and scores IQ CODE The Informant Questionnaire on Cognitive Decline in the Elderly IQCODE short version This assessment is directed at the patient s carer family member or friend and is designed for them to complete Generally this test is completed without interference by a doctor or nurse but it can be talked through with them if they need clarification Please give the questionnaire to patient s carer family member or friend and ask them to follow the instructions for completing it How to calculate the final score of the test Scoring the IQ code Much improved 2 A bit improved 35 3 Not much change 4 bit worse 5 Much worse The electronic CRF will calculate the scores To manually score the test add up the result of each question ie if Much improved the result is for that question then divide this number by the total number of questions Record the final score of the test in the box below and also add this score to the patient s cognitive assessment record form Sum of the results of all of the questions The total number of questions l6 Patient ID 01030 Date entered study 06 03 2012 Site o1 University College Scales and scores Cognition IO CODE 1 IQ CODE completed e Yes If completed please gre the reason Figure 27 IQ code form 36 MOCA MONTREAL COG
39. on the answers to previous questions Other fields are optional and may be left blank if desired Once the form has been completed without errors the Save form button will present the user with a review page Figure 11 If there are errors the user may return to the previous page to make changes Once successfully completed the form is saved to the database If at any time before this the user navigates away from the page e g they click on the return to patient link the data entered will be lost The user is warned of this by a pop up message that appears when navigating away from the form QUERIES Queries are intended to be used by administrators Co ordinating Centre to raise questions about the CRF data for investigators Pl Research teams at sites to answer and for investigators to notify administrators of any issues they are aware of Queries can be linked generally to a patient or more specifically to a particular CRF for a patient Queries may only be closed by administrator users Investigators can create new queries and add messages to existing queries Opening queries A query can be opened either on the patient details panel or when viewing a CRF by clicking on the Create a query link Figure 12 The query must be given a title and an initial message To link the query to a specific CRF choose the appropriate form from the related CRF drop down control Figure 13 Once it has been created the query will be shown
40. ords or more in 60 sec Record the subject s response in the bottom or side margins 9 Abstraction Administration The examiner asks the subject to explain what each pair of words has in common starting with the example Tell me how an orange and a banana are alike f the subject answers in a concrete manner then say only one additional time Tell me another way in which those items are alike If the subject does not give the appropriate response fruit say Yes and they are also both fruit Do not give any additional instructions or clarification After the practice trial say Now tell me how a train and a bicycle are alike Following the response administer the second trial saying Now tell me how a ruler and a watch are alike Do not give any additional instructions or prompts 41 Scoring Only the last two item pairs are scored Give point to each item pair correctly answered The following responses are acceptable Train bicycle means of transportation means of travelling you take trips in both Ruler watch lt measuring instruments used to measure The following responses are not acceptable Train bicycle lt they have wheels Rulerwatch lt they have numbers 10 Delayed recall Administration The examiner gives the following instruction I read some words to you earlier which asked you to remember Tell me as many of those words as you can remember Make a check mark V for each of the
41. pplication for collecting and managing data on patients recruited the study It has been created for the CROMIS 2 study by a company called Sealed Envelope Ltd This user guide is intended for users with level privileges to the application and describes the features available to users with these privileges This hand book is divided into Part I and Part II PART 1 CROMIS 2 ELECTRONIC DATA SYSTEM ACCESSING THE ELECTRONIC DATA SYSTEM Access to the application is via a URL specific to the CROMIS 2 study https www ucl ac uk cromis 2 This URL will be contained in the automated email that should have been sent out to you when you needed to create a new user account Click on the secure log in button You will be requested to authenticate yourself before access is granted to the system by providing your email address password and PIN number see Figure log i To log in you must enter your registered email address password and PIN Email address Password PIN Log in A Figure Log in screen If you do not have an account or provides an incorrect password or PIN you will not be allowed access New users can request an account by asking an existing administrator user to create one for them The administrator account has been created for the CROMIS 2 Study Co ordinator The Study Co ordinator can create new accounts as required When a user has logged in their na
42. s due to encoding failures performance does not improve with a cue 1 Orientation Administration The examiner gives the following instructions Tell me the date today If the subject does not give a complete answer then prompt accordingly by saying Tell me the year month exact date and day of the week Then say Now tell me the name of this place and which city it is in Scoring Give one point for each item correctly answered The subject must tell the exact date and the exact place name of hospital clinic or office No points are allocated if subject makes an error of one day for the day and date TOTAL SCORE Sum all sub scores listed on the right hand side Add one point for an individual who has 12 years or fewer of formal education for a possible maximum of 30 points 43 m mi Cogrmitiaen MOCA 5 MOCA completed ia Yas o Ho T MOCA total score Number up ta 2 digitz zubscalz Humber up ta 1 digit subscales naming Humber up ta 1 digit 10 HOCA zubz alez attention Number up ta 1 digit 11 HOCA subecesle onentation Number up ta 1 digit Humber up ta 1 digit Humber up ta 1 digit 14 MOCA subscales delayed recall Humber up ta 1 digit Figure 29 Screen to enter MoCA scores 44 QUALITY OF LIFE EQ 5D 5L EQ 5D is a standardized instrument for use as a measure of health outcome It is designe
43. so see Figure 30 47 Quality of life and dizability core 15 EQ 5D 5L dezcriptive system g 123451 18 Date EQ 5D 5L vizual analkxgue salk completed ne Figure 30 EQ 5D 5L scores MODIFIED RANKIN SCALE Please provide an estimated score before the current event and score on discharge from hospital or clinic The score descriptions are listed over the page Figure 32 Enter the scores for both on the eCRF along with the date the Modified Rankin Scale was completed on discharge see Figure 31 19 Modified Rankin Scale store before the current TIA stroke event men 20 Modified Rankin Seale score on discharge from hospital or clinic s a T NM ILLE 21 Date Rankin completed on decharge zl m 7 3 Figure 31 Modified Rankin Scores Modified Rankin Scale 48 Estimated score before the current event Total Score 0 6 Score on discharge from hospital or clinic Score Description O No symptoms at all No significant disability despite symptoms able to carry out all usual duties and activities 2 Slight disability unable to carry out all previous activities but able to look after own affairs without assistance 3 Moderate disability requiring some help but able to walk without assistance 4 Moderately severe disability unable to walk without assistance and unable to attend to own bodily ne
44. ssage will pop up requesting a Death Notification form is also completed see Figure 40 overleaf This way all outcome events can be collected Bleeding event Definition of Severity and Site of Bleeding Event 1 Did the patient have a fatal bleeding event Yes 2 Did the patient have symptomatic bleeding in any of the following areas vas No The page at https www sealedenvelope com says 3 Intracranial anywhere inside the skull Choose A Please complete the death notification form 4 Intraspinal c h 5 5 Intraocular in the Choose 6 Retroperitoneal Choose 7 Intra articular in the joint Choose 8 Pericardial around the heart Choose 5 Intramuscular with compartment syndrome Choose 10 Gastrointestinal tract e g blood in stool haematemesis blood in vomit Choose 11 Did the bleeding cause a fall in haemoglobin level of 22 412 Yes 12 Did the bleeding lead to transfusion of two or more units of whole blood or red cells Yes Figure 40 Bleeding Event form with message requesting death notification to also be completed 55 Cardiac event form This form must be completed when a patient recruited to the CROMIS 2 study has experienced a suspected or confirmed cardiac event Cardiac event Details of the cardiac event 1 Date of suspected cardiac event 28 03 2012 2 Was the event fatal l Yes No Myo
45. ter logging in Choose appropriate study Study AF or study ll ICH Click on the relevant study and you will be presented with the study log and the ability to add patients see overdue forms view queries and reports Each of these functions will be discussed cromis 2 Clinical Relevance Of Microbleeds In Stroke in the next sections Home Logout Clare Shakeshaft ID 4 CROMIS 2 Study I Study I CROMIS 2 AF Prospective cohort study of patients anticoagulated after cardioembolic stroke Figure 3 Example study specific screen after selecting study AF or study II ICH on the home screen PATIENTS Viewing existing patient data Patient records can be viewed by clicking on the Patients link in the left hand sidebar This shows a list of all patients entered into the study to date at your hospital New patients New patients may be added to the list by clicking on the add patient link near the top of the page CROMIS 2 ients Study I Patient ID Site Figure 4 Screen showing how to add a new patient This opens the study entry form After you have entered the information and ensured data accuracy select the Save form option Study entry Enter the patient identifier and the date of entry to the study Study entry 1 Patient identifier 01001 2 Date of study entry 29 03 2012 1 LL Hotes Save form Figure 5 A new study entry form Allocating Study
46. vely parallel and their length is similar rectangular prisms are accepted A point is not assigned if any of the above criteria are not met 3 Visuoconstructional Skills Clock Administration Indicate the right third of the space and give the following instructions Draw a clock Put in all the numbers and set the time to 10 past 1 Scoring One point is allocated for each of the following three criteria 38 Contour 1 pt the clock face must be a circle with only minor distortion acceptable e g slight imperfection on closing the circle Numbers pt all clock numbers must be present with no additional numbers numbers must be in the correct order and placed in the approximate quadrants on the clock face Roman numerals are acceptable numbers can be placed outside the circle contour e Hands I pt there must be two hands jointly indicating the correct time the hour hand must be clearly shorter than the minute hand hands must be centred within the clock face with their junction close to the clock centre A point is not assigned for a given element if any of the above criteria are not met 4 Naming Administration Beginning on the left point to each figure and say Tell me the name of this animal Scoring One point each is given for the following responses 1 lion 2 rhinoceros or rhino 3 camel or dromedary 5 Memory Administration The examiner reads a list of 5 words at a rate of on
47. words correctly recalled spontaneously without any cues in the allocated space Scoring Allocate point for each word recalled freely without any cues Optional Following the delayed free recall trial prompt the subject with the semantic category cue provided below for any word not recalled Make a check mark V in the allocated space if the subject remembered the word with the help of a category or multiple choice cue Prompt all non recalled words in this manner If the subject does not recall the word after the category cue give him her a multiple choice trial using the following example instruction Which of the following words do you think it was NOSE FACE or HAND Use the following category and or multiple choice cues for each word when appropriate FACE category cue part of the body multiple choice nose face hand VELVET category cue type of fabric multiple choice denim cotton velvet CHURCH category cue type of building multiple choice church school hospital DAISY category cue type of flower multiple choice rose daisy tulip 42 RED category cue a colour multiple choice red blue green Scoring No points are allocated for words recalled with a cue cue is used for clinical information purposes only and can give the test interpreter additional information about the type of memory disorder For memory deficits due to retrieval failures performance can be improved with a cue For memory deficit
48. y 1 Patient identifier 01003 2 Date of study entry 14 03 2012 d dim m y y y y Figure 15 Adding a message to an open query linked to Form 20 keshaft 4 CROMIS 2 Queries Study I Qu ID Title Status Crest feum Site 01 University College London ee ss Queries 1 Incorrect date Queries ID Title Status Site 01 University College London Figure 16 Viewing the details of a query 21 2 Incorrect date of entry Open Open Query ID 1 Incorrect date Current status Open This query relates to the Standard Study entry form View patient Messages Action Open Clare Shakeshaft ID 4 on 28 Mar 2012 at 04 05 12 PM 2 Date of study entry m PART USER MANUAL Part Il of this handbook provides a guide for completing the electronic Case Report Forms eCRFs for both Study Atrial fibrillation AF and Study ll Intracerebral haemorrhage ICH In addition for the Scales and Scores to be collected as part of the eCRFs this guide is provided for their administration and calculation 22 STUDY ENTRY FORM Enter the patient identifier and the date of entry to the study The site should be automatically entered from the drop down box applicable to your log in The patient identifier is the study number assigned to the patient with the Enter the study number assigned to the patient using a 5 digit format with the first two numb
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