IMPROVE Case Report Form Completion Guidelines

Transcription

1 2012 IMPROVE Case Report Form Completion Guidelines

2 Suggested Check List for Data Capture For IMPROVE Trial ID no: Requirement Date Comments Initials Randomised patient data retrieved and checked for completion. Forms 1-3 completed Pre- Op Consent form signed and dated. Version: Copy for patient and notes Emergency consent form signed and dated. Version: Copy for patient and notes Fax consent form to study centre Locate pre op CT and forward to study centre Coordinator to visit patient on the ward at earliest available time Patient visited on the ward Copy of consent form and PI sheet in the notes and documented in notes with consent label Patient information given for open procedure Patient information given for EVAR

3 Post operative consent form signed and dated. Version: Post operative assent form signed and dated. Version: GP letter sent and copy in the notes At discharge Patient given 3mth questionnaire to complete before OPD Contact patient two weeks before OPD, reminder about questionnaire. Forms 4-6 completed Form 7 and 3mth questionnaire completed. Form 8 and 12mth questionnaire completed Communication sheet for any correspondence with patient Coordinator to complete in a timely manner Data entry onto ecrf Patient Log updated and faxed to trial centre Trial master file up to date

4 Carbon Copy Paper: 3 Copies 1. White Copy in Patient Trial File 2. One copy in Hospital tes 3. One copy given to the patient Fax a copy to the IMPROVE Trial Office. within 72 Hours ( Ensure patient ID is recorded IMPROVE England, Wales & rthern Ireland Ethics Ref : 08/H0505/173 Ethics Ref : 08/H0505/173 Patient ID Name of person taking the consent should be printed. This person should also be listed on the Delegation log (PI Site File) to confirm they are delegated by the Principle Investigator to take consent Name of patient (or relative / career) who had the patient information read to Immediate Management of the Patient with Ruptured aneurysm: Open Versus Endovascular repair them should be printed. CONSENT FORM for England, Wales and rthern Ireland Circle or underline patient / relative / carer to indicate who this is Dr John Smith I,, have <insert name of person taking consent> Susan Jones read the statement overleaf to.. <insert name and underline status of person (patient/relative/carer)giving consent> Peter Jones Verbal / written consent has been given for. < Insert name of patient> to be entered into the IMPROVE trial. Signed (patient/relative/carer) Date Name of patient (or relative / career) who had the patient information read to them should be printed Susan Jones 12 th Sep 2012 Circle or underline patient / relative / carer to indicate who this is Signature of person taking consent Date Dr John Smith 12 th Sep 2012 Title/Name: Dr John Smith, Vascular Consultant Person taking consent should Local Hospital: Charing Cross Hospital sign and date this form. This Local Contact: Francine Heatley should be the same date that consent was taken *Please ensure that consent is documented in the patient notes this should indicate when consent was taken, who by and whether the patient / relative / carer took consent* Name of the hospital and local trial contact / phone number should be completed

5 Ethics Ref : 08/H0505/173 This must be a senior clinician (must have completed 3 years of advanced clinical training) outside the intervention team (e.g. A&E) must first sign that the patient: 1. is considered to have raaa 2. cannot give informed consent Immediate Management of the Patient with Ruptured aneurysm: Open Versus Endovascular repair EMERGENCY ENROLMENT FORM for England, Wales and rthern Ireland: Enrolment when patient/relative/carer consents unavailable Dr Craig Hunter Carbon Copy Paper: 3 Copies 1. White Copy in Patient Trial File 2. One copy in Hospital tes 3. One copy given to the patient 4. Fax one copy to the IMPROVE Trials Office on I,, agree the diagnosis of <insert name of person enrolling patient> Simon Brown ruptured abdominal aortic aneurysm in. <insert name of patient> The patient cannot give informed consent and no relatives or carers are available for immediate consultation. Signature of enroller Dr Craig Hunter Name of the senior clinician should be printed and they should sign and give their job title Date 12 th Sep 2012 Title/Name: Dr Craig Hunter, A&E Consultant Witnessed: I agree that verbal / written consent cannot be obtained for this patient. Sarah Peters, RN Name of witness:.. Signature of witness Sarah Peters, RN Name of the witness should be printed Witness should sign and give Registered Nurse their job title Local Hospital: Charing Cross Hospital Title/Name: Local Contact: Francine Heatley Version 2.0 *Please ensure that consent is documented in the patient notes indicate when the emergency form was signed, who by and that the patient was entered into the trial under the Mental Capacity Act. 01-Dec-08 Name of the hospital and local trial contact / phone number should be completed

6 General Instructions Once a patient has been randomised using the telephone randomisation system, an entry will automatically be created for them using their unique study ID on the IMPROVE website. Just click on the patients tab on the left, and select the desired patient from the list.. Initially, you will only see Form 1 for a newly randomised patient. Once Form 1 has been completed, additional case report forms (Form 2- Form6) will appear for that patient, except follow-up forms: Form 7 & Form 8. Forms 7 will only become visible if the patient is discharged alive on Form 4. Form 8 will only be visible if the patient is marked as still alive on form 7. When completing the forms, please note the following: Questions in bold are compulsory for successful submission of the form. When entering time, there s no need to type the colon sign (:); just enter the digits in 24 hour format (e.g. 2315), and the system will automatically insert the colon sign. Similarly, when entering the date, just enter relevant digits in eight digit format (e.g ). There s no need to put / or. as the system will automatically put these in. For all other parameters (e.g. Hb, creatinine, etc) you must put the decimal point.

7 Complete Form 1 for all patients England, Wales & rthern Ireland Ethics Ref : 08/H0505/173 Immediate Management of the Patient with Rupture: Open Versus Endovascular repair Form 1 Patient Log & Eligibility for Randomisation for all patients with a hospital clinical diagnosis of ruptured AAA (5 Sections) Section 1: Centre and patient identifiers Site ID Patient initials Date of Birth Age (if dob unavailable) years Gender male female Postcode where patient collected (if known) P J dd/mm/yy L S T R Ensure these match those entered at randomisation or confirm which is correct in notes section Section 2 is essential for randomised patients only Section 2: Details of this hospital episode Date of admission Time of admission Mode of arrival at hospital hh.mm dd/mm/yy Ambulance from home Ambulance from another hospital Self/other 2 Ensure these are prior to randomisation time/date or record reason why not in the notes section Diagnosis of AAA rupture (tick all that apply) Clinical assessment With an Ultrasound scan Other (e.g. transfer with CT scan) Admission blood pressure: Systolic mm Hg Diastolic Acute Myocardial Ischaemia on 3 or 12 lead ECG? Yes Did the patient lose consciousness before randomisation? Yes 8 0 mm Hg Hardman Index Components: Ensure these completed or record in the notes section they were not reported in the hospital notes See over page for Sections 3, 4 and 5

8 Section 3: Checklist to exclude ineligible patients (if any yes is ticked the patient is excluded) This patient has had a previous AAA repair Yes This patient has a Marfanoid syndrome Yes This patient is moribund (too ill to consider randomisation) Yes Eligible patient Other exclusions, give reasons: Section 4: Consent (including Mental Capacity Act enrolment) Has consent for randomisation been obtained? Yes If YES: Written: From the patient From relative/carer Verbal: From the patient (witnessed by relative/carer/nurse/other) Other: Emergency Enrolment under Mental Capacity Act Ensure consent type entered here is consistent with phone entry. If not, explain in notes section and confirm correct consent type. If you have a completed & signed consent or emergency enrolment form : Call for randomisation Study : 3873; Investigator : If NO: Refusal Unobtainable (Scotland and where Mental Capacity Act does not apply) If NO, do not randomise! Section 5: Randomisation details Treatment allocated (tick one only): CT & EVAR if possible Open repair Patient Randomisation ID: Please, write patient randomisation ID on either the consent form or emergency enrolment form

9 Complete Form 2 for all randomised patients (including those who were found not to have an aneurysm or rupture) England, Wales & rthern Ireland Scotland Ethics Ref : 08/H0505/173 Ethics Ref : 08/MRE00/90 Patient ID Immediate Management of the Patient with Ruptured aneurysm: Open Versus Endovascular repair Form 2 Baseline patient data and imaging details 1 General baseline information Admission haemoglobin (to one decimal point). g/dl Hardman Index Components: Ensure these completed or record in the notes section they were not reported in the hospital notes Admission creatinine µmol/l Acute ischaemia demonstrated or reported on admission ECG Yes Total volume of iv fluid given before patient arrived in theatre 2. 0 litres Where possible please split by: Pre-hospital 2. 0 litres A&E 0. 0 litres If no fluid given please record zero (0). If unknown please state in notes CT scan (dicom format) sent to core laboratory Yes Patient identification log* completed for flagging? Yes (*See your Principal Investigator Site file) Lowest recorded blood pressure before transfer to either CT or theatre: systolic mmhg diastolic 7 0 mmhg

10 England, Wales & rthern Ireland Scotland Ethics Ref : 08/H0505/173 Ethics Ref : 08/MRE00/90 Patient ID CT Scanning Patient received CT Scan? Yes If yes: At the trial hospital If no, go to Form 3 At a different hospital Date of CT scan: dd/mm/yy Patient arrived alive in CT scan Yes Time of arrival hh:mm Blood pressure on arrival: systolic mmhg diastolic 7 0 mmhg Ensure that the randomisat ion date/times are in agreement with the CT date/time to ensure this is an admission CT scan. If the diagnosis indicated in Form 2 Q:13(a) is not AAA, please ensure that Q:15 records any other obvious diagnosis (e.g. perforated gastric ulcer, etc.). Summary of CT findings: AAA confirmed Yes Rupture observed Yes Suitable for EVAR Yes If not suitable for EVAR, tick all reasons that apply: Neck Iliacs Access Other If no AAA, give any other obvious diagnosis:.. Please ensure reason for nonsuitability for EVAR is recorded. If the reason is other please record why the patient was not suitable in the notes section Must be completed to indicate whether the CT findings indicate (a) whether the patient had a AAA (b) If so, whether there was evidence of rupture on the CT scan Please complete for every patient that had a CT scan regardless of whether they underwent EVAR or Open repair.

11 Complete Form 3 for all randomised patients that underwent an operation Date of operation: Form 3: Operation data dd/mm/yy Date/ time of operation MUST be after the date/time of randomisation. If not please contact the IMPROVE office Patient sent to: (tick one only) theatre endovascular suite If the procedure was initiated with local anaesthetic please confirm if general anaesthetic was used later Patient arrived alive for aneurysm repair Yes Time of arrival in theatre/endovascular suite hh:mm Blood pressure on arrival : systolic diastolic mm Hg mm Hg Was supracoeliac balloon inflated? Yes Anaesthesia: Initiated procedure with: LA GA GA used later Yes Procedure (tick one only): EVAR EVAR Converted to open Open repair AAA op, palliation Other If other, specify procedure/diagnoses: This is time of arrival in the theatre / suite (not knife to skin) If this is different to the allocation given at randomisation please record reason why in the notes section. Graft type (tick one only) Tube Bifurcated Aortouni-iliac Cook Graft manufacturer/type (optional): Volume of contrast used in procedure ml Was Fem-fem crossover also performed? Yes This is often left blank. If it is unknown whether a fem-fem crossover was performed please note this in the notes section. If this was not performed please tick no If volume of contrast is not recorded int the notes please check the Radiology Information systems (legal requirement to record the contrast volume). If your site has a standard policy for the volume contrast please record this in the notes section.

12 If no blood products used please complete zero (0). If this information is not available please leave blank and confirm in notes section Blood products used: Blood Platelets Fresh frozen plasma units units units Clinicians present: Surgeon Radiologist Both Patient left theatre alive Yes Time out of theatre hh:mm Patient sent to (tick one only): Recovery ward ITU/HDU Routine ward

13 Complete Form 4 for all randomised patients (including those who were found not to have an aneurysm or rupture) Form 4 Hospital discharge and death form for primary admission Was patient discharged from hospital alive? Yes If yes: Date of discharge dd/mm/yy Patient discharged to (tick one) Home Another hospital Routine bed Another hospital ITU/HDU* Nursing home Residential home Sheltered accom. Other If transferred to another hospital: Date of discharge If discharged to another hospital please complete this section, with date of discharge from transferred hospital when known. dd/mm/yy If no: Date of death * If ITU at another hospital please obtain ITU discharge form and complete a further Form 5 wherever possible All patients who survive AAA repair must be approached for post-operative consent before discharge from the trial hospital.

14 Complete patient log for all randomised patients (including those who were found not to have an aneurysm or rupture) Patient details are entered into the patient master log to enable flagging for eventual date and cause of death with MRIS. Coun t Last name First Name Date of Birth NHS number Home Postcode Randomisation number Date of presentation Jones Peter 09/01/ LS17 8PQ /09/2012 PLEASe send completed log to Trial Manager by fax ( ). **Do NOT send via or post** PLEASE FA THIS FORM TO THE TRIAL OFFICE DO NOT SEND BY / POST AS IT CONTAINS PATIENT IDENTIFIABLE DATA

15 When the patient is awake and fully aware, discuss with them the trial, providing them with the appropriate Post-operative Patient Information form. For those willing to take part in the study, post operative consent should be taken prior to discharge. Send the general practitioner the letter regarding the patient s treatment and participation in the trial at this time. Must be printed on Trust headed paper, with name and contact details of the local Principal POST-OPERATIVE CONSENT FORM for England, Wales and rthern Ireland The post-operative information sheet dated 5 th March 2010 (version 4.1) has been read by: Peter Jones <insert name of patient> Print patient s name They have agreed to their continued participation in the IMPROVE Trial. Peter Jones <patient signature / initials> Patient must sign / initial themselves They have also agreed to their personal data being kept for up to 5 years. Furth information about their health status may be obtained from NHS Information Centre and NHS Central Register. Peter Jones <patient signature / initials> Signed Peter Jones Date 9 th Dec 2012 Signature of person taking consent Date Title/Name: Dr John Smith Dr John Smith, Vascular Consultant 9 th Dec 2012 When completed, original to be kept in medical notes, one copy for patient, one copy for investigator site file IMPROVE Trial Contacts: Trial Chief Investigator: Professor Janet T Powell Trial Manager: Dr Pinar Ulug j.powell@imperial.ac.uk p.ulug@imperial.ac.uk Tel: Fax: Tel: Fax: Vascular Surgery Research Group, Imperial College at Charing Cross Hospital St. Dunstan s Road, London W6 8RP Local Contact: Francine Heatley Version Person taking consent should sign and date this form Mar-10 This should be the same date that consent was taken

16 Complete Form 5 for all patients that underwent an operation Form 5 Critical care resources used in primary admission For second and each subsequent admission please complete a separate Form 5 Care level Organ systems Date ITU = 1 supported HDU = 2 use 0-6 score CCU = 3 Day dd/mm/yy Day Please ensure that days of ITU/HDU/ CCU stay entered in this section correspo nds to total number of days entered at the bottom of form. Please also ensure total duration of hospital ward days coincides with admission and d/c date entered in previous forms. Day 3 Day 4 Day 5 Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13 Day 14 Maximum intra-abdominal pressure recorded on ITU or HDU (Optional) Days in intensive care Days in high dependency Days on routine ward Other specialist care provided Renal replacement therapy Yes Days on coronary care unit Was percutaneous coronary intervention necessary? Yes Days on stroke unit Please complete using Guidance for completion of Form 5: Critical Care Resources If no days on each unit please complete zero (0) rather than leaving it blank. Please ensure that the whole hospital stay (i.e. from admission date on Form 1 to discharge date on Form 4) is accounted for. If no days on each ward please complete zero (0) rather than leaving it blank x

17 Guidance for completion of Form 5: Critical care resources The number of organ systems supported on ITU/HDU/CCU is calculated from the following six systems: 1. respiratory 2. cardiovascular 3. renal 4. neurological 5. gastrointestinal 6. dermatological Organ system support definitions have been provided in pages 2-4. Please report the maximum number of systems reported in any one day on Form 5, using a score between 0 and 6. This number is used to estimate costs of care on specialist units. ITU = Intensive Therapy Unit HDU = High Dependency Unit CCU = Coronary Care Unit

18 ORGAN SYSTEM SUPPORT DEFINITIONS (From the Augmented Care Period (ACP) dataset) 1. Respiratory System Support Basic Respiratory Support Indicated by one or more of the following: More than 50% oxygen delivered by face mask. Close observation due to the potential for acute deterioration to the point of needing advanced respiratory support (eg severely compromised airway or deteriorating respiratory muscle function). Physiotherapy or suction to clear secretions at least two hourly, whether via tracheostomy, minitracheostomy, or in the absence of an artificial airway. Patients recently extubated after a prolonged period of intubation and mechanical ventilation, (eg. More than 24 hours of tracheal intubation). Mask CPAP or non-invasive ventilation. Patients who are intubated to protect the airway but needing no ventilatory support and who are otherwise stable. Advanced Respiratory Support Indicated by: Invasive mechanical ventilatory support (excluding mask (CPAP) or non-invasive methods e.g. mask ventilation but including BIPAP or CPAP applied via a tracheal tube). Extracorporeal respiratory support.

19 2. Cardiovascular Support Basic Cardiovascular Support Indicated by one or more of the following: Treatment of circulatory instability due to hypovolaemia from any cause. Use of a CVP line for basic monitoring or central venous access to deliver therapeutic agents. Use of an arterial line for basic monitoring of arterial pressure or sampling of arterial blood. Single intravenous vasoactive drug used to support arterial pressure, cardiac output or organ perfusion. Intravenous drugs to control cardiac arrhythmias. n-invasive measurement of cardiac output (eg. echocardiography, thoracic impedance). Advanced Cardiovascular Support Indicated by one or more of the following: Multiple intravenous vasoactive and/or rhythm controlling drugs used to support arterial pressure, cardiac output or organ perfusion (eg. inotropes, amiodarone, nitrates). Patients resuscitated after cardiac arrest where intensive therapy is considered clinically appropriate. Observation of cardiac output and derived indices (eg. pulmonary artery catheter, lithium dilution, pulse contour analyses, oesophageal doppler). Intra aortic balloon pumping. Insertion of a temporary cardiac pacemaker (criteria valid for each day of connection to a functioning external pacemaker unit). Placement of a gastrointestinal tonometer. 3. Renal Support Indicated by: Acute renal replacement therapy (e.g. haemodialysis, haemofiltration, etc.)

20 4. Neurological Support Indicated by one or more of the following: Central nervous system depression sufficient to prejudice the airway and protective reflexes, excepting that caused by therapeutic sedation prescribed to facilitate mechanical ventilation. Invasive neurological monitoring e.g. ICP, jugular bulb sampling. Severely agitated or epileptic patients requiring constant nursing attention and/or heavy sedation. 5. Gastrointestinal Support Indicated by: Feeding with parenteral or enteral nutrition. 6. Dermatological Support Indicated by one or more of the following: Patients with major skin rashes, exfoliation or burns (e.g. greater than 30% body surface area affected). Use of multiple trauma dressings (e.g. multiple limb or limb and head dressings). Use of complex dressings (e.g. open abdomen or large skin area greater than 30% body surface area).

21 Complete Form 6 for all patients that underwent an operation (even if no reinterventions were performed) Form 6 Summary of re-interventions For each further procedure please complete a separate Form 6 Further interventional procedures on primary admission Return to endovascular suite for reintervention? Yes Yes Treatment coexisting condition unrelated to AAA? Yes Yes If yes: Date: endovascular suite dd/mm/yy Time in 9 mins 0 Mins OR Return to operating theatre for re-intervention or treatment of coexisting condition? Yes Yes If yes: Date: Time in operating theatre dd/mm/yy mins Reason for further intervention: Reason for reintervention must be given. If other please state the reason as free text Control bleeding Yes Limb ischaemia Yes Mesenteric ischaemia Yes Abdominal compartment syndrome Yes Other (give main reason).. *Please complete a separate Form 6 for each reintervention the patient received*

22 Complete Form 7 for all patients that underwent an operation and were discharged alive Form 7 Form 7 completion date: 1-3 month follow-up form For patients leaving hospital after EVAR dd/mm/yy Has a 1-3 month* CT scan been obtained? Yes * flexible timeline; follow-up CT can be obtained anywhere between 1-3 months post aneurysm repair, depending on your hospital's standard EVAR surveillance protocol. If yes, has a copy of the scan been sent to the core laboratory for endoleak analysis? Yes Also due at this if the patient is alive: EuroQol form Health Resources questionnaire 2.For all patients Is patient still alive? Yes If no, date of death if known: dd/mm/yy 3.Aneurysm-related resources since discharge after primary admission Re-intervention to support AAA repair Yes For each further re-intervention, please complete an additional Form 6 If yes give principal reason Adjunct Endovascular Procedure Conversion to Open Repair Adjunct abdominal surgery Distal angioplasty Distal surgery Other If yes, please complete another Form 6 4.Out-patient & in-patient visits to trial hospital (aneurysm related only) Outpatient visits, give total number Date of in-patient admission Date of discharge/death dd/mm/yy dd/mm/yy Inpatient stay (including day case =1) Number of days on ITU days If the patient did not have any outpatient visits/ inpatient admissions/days on ITU, please complete as zero (0) rather than leaving blank. Do not include the 3 month visit in this count.

23 Complete Form 8 for all patients that were alive at the 3 month follow-up Form 8 12 month follow-up form Form 8 completion date: dd/mm/yy 1.For all patients Is patient still alive? Yes If no, date of death if known: Also due at this if the patient is alive: EuroQol form Health Resources questionnaire will be supplied for UK patients to complete at home dd/mm/yy Please note that copies of any 12-month CT scan images are not required to be sent to the trial office. 2.Aneurysm-related resources Re-intervention to support AAA repair Yes For each further re-intervention, please complete an additional Form 6 If yes give principal reason Adjunct Endovascular Procedure Conversion to Open Repair Adjunct abdominal surgery Distal angioplasty Distal surgery Other If yes, please complete another Form 6 3.Out-patient & in-patient visits to trial hospital (aneurysm related only) Outpatient visits, give total number Date of in-patient admission Date of discharge/death In-patient stay (including day case =1) Number of days on ITU dd/mm/yy dd/mm/yy days If the patient did not have any outpatient visits/ inpatient admissions/days on ITU, please complete as zero (0) rather than leaving blank. Please complete a Form 5 for each hospital stay

24 Immediate Management of the Patient with Rupture: Open Versus Endovascular repair Health Questionnaire English version for the UK (validated for Ireland) The EQ-5D form must be completed at both 3-months and 12-months following aneurysm repair. Please tick the relevant box to indicate: 3-month follow-up 12-month follow-up Date of questionnaire completion: dd/mm/yy

25 By placing a tick in one box in each group below, please indicate which statements best describe your own health state today. Mobility I have no problems in walking about I have some problems in walking about I am confined to bed Self-Care I have no problems with self-care I have some problems washing or dressing myself I am unable to wash or dress myself Usual Activities (e.g. work, study, housework, family or leisure activities) I have no problems with performing my usual activities I have some problems with performing my usual activities I am unable to perform my usual activities Pain/Discomfort I have no pain or discomfort I have moderate pain or discomfort I have extreme pain or discomfort Anxiety/Depression I am not anxious or depressed I am moderately anxious or depressed I am extremely anxious or depressed

26 IMPROVE Trial ID To help people say how good or bad a health state is, we have drawn a scale (rather like a thermometer) on which the best state you can imagine is marked 100 and the worst state you can imagine is marked 0. We would like you to indicate on this scale how good or bad your own health is today, in your opinion. Please do this by drawing a line from the box below to whichever point on the scale indicates how good or bad your health state is today. Best imaginable health state Your own health state today 5 0 The score here would be The score here would be Worst imaginable health state EuroQoL Group 1990

27 Immediate Management of the Patient with Ruptured aneurysm: Open Versus Endovascular repair QUESTIONNAIRE ON USE OF HEALTH SERVICES 3 MONTHS AFTER ANEURYSM REPAIR We would be grateful if you would take a few minutes to answer the following questions about services you may have used since you left hospital following repair of your aneurysm. Section A (Questions 1-5) is about services you may have used because of your aneurysm. Section B (Questions 6) is about services you may have used for other health reasons. *local trial co-ordinator to insert the date of discharge from the main trial hospital at the top of page 3

28 Trial ID HOW TO FILL IN THE QUESTIONNAIRE Most questions can be answered by ticking the box next to the answer that applies to you. Please tick one box only for each question. Ensure that the trial ID is completed Example: Since you left hospital after your aneurysm repair have you had further hospital treatment of your aneurysm, by either a doctor or nurse? Yes If yes, where was this? Name of Hospital: e.g. West Middlesex If yes, did you have another operation? Yes Example: How many more operations have you had? Exact number of operations OR if you can t remember the exact number of operations tick one of the following boxes ops 1 or 2 3 or more Example: How many appointments have you had with the doctor or nurse at an outpatient s department because of your aneurysm? Who? How many times? OR if you can t remember the exact number of times tick one of the following boxes 1 A doctor 1 or 2 3 or 4 5 or more 2 A nurse none 1 or 2 3 or 4 5 or more Health Resources Questionnaire Version 3.0 Examples for filling in the questionnaire 08-Feb-12

29 Trial ID Services following discharge from the main trial hospital on <please insert date> Section A: Service use for reasons related to your aneurysm 1.1 Since you left hospital after your aneurysm repair have you had further hospital treatment of your aneurysm? Should be the same as the date of discharge on Form 4 Yes 1.2 If yes, where was this? Name of Hospital: 1.3 If yes, did you have another operation? Yes 1.4 How many more operations have you had? Exact number of operations OR if you can t remember the exact number of operations tick one of the following boxes op(s) 1 or 2 3 or more 1.5 How many appointments have you had with the doctor or nurse at an outpatients department because of your aneurysm? Who? How many times? OR if you can t remember the exact number of times tick one of the following boxes 1 A doctor 1 or 2 3 or 4 5 or more 2 A nurse 1 or 2 3 or 4 5 or more 1.6 Have you seen your GP because of your aneurysm? Yes 1.7 If yes, how many times have you seen the GP? Exact number of times OR if you can t remember the exact number of times tick one of the following boxes time(s) 1 or 2 3 or 4 5 or more Health Resources Questionnaire Version 3.0 Services following discharge 08-Feb-12

30 Trial ID 2 District nurse visits 2.1 Since you left hospital following your aneurysm repair, has a district nurse been to visit you at home? Yes 2.2 If yes, how often has the district nurse been to see you? Several times a week Once a week Once a fortnight Once a month Other (please specify) 2.3 For how many weeks has the district nurse been to see you? Exact number of weeks OR if you can t remember exactly how many weeks tick one of the following boxes weeks 1 to 3 weeks 4 to 7 weeks 8 to 12 weeks 3 Stay in a convalescent home or nursing home 3.1 Since you left hospital following your aneurysm repair, have you stayed in either a convalescent home or nursing home? Yes 3.2 If yes, how many weeks you have stayed there? Exact number of weeks OR if you can t remember exactly how many weeks tick one of the following boxes weeks 1 week or less 1 to 4 weeks Health Resources Questionnaire Version 3.0 District nurse visits & Stay in a convalescent or nursing home 08-Feb-12

31 4 Use of social services 4.1 Since you left hospital following your aneurysm repair have you seen a social worker for reasons related to your aneurysm? Yes 4.2 If yes, how many times? Exact number of times OR if you can t remember the exact number of times tick one of the following boxes time(s) 1 or 2 3 or 4 5 or more 4.3 Since you left hospital has a home carer (someone from social services who comes to assist with cleaning and feeding) visited you? Yes 4.4 If yes, how often has the home carer visited you? Once a day Once a month 1 2 times a week Other (please specify) 4.5 Since you left hospital, for how many weeks have you had a home carer? Exact number of weeks OR if you can t remember exactly how many weeks tick one of the following boxes weeks 1-3 weeks 4-7 weeks 8-12 weeks 4.6 Did you have a home carer before your aneurysm repair? Yes Health Resources Questionnaire Version 3.0 Use of social services 08-Feb-12

32 5 Input from patients and carers 5.1 Have you had to leave paid employment because of your aneurysm? Yes 5.2 Have you had to take time off work because of your aneurysm? Yes 5.3 If yes, how many days? Exact number of days OR if you can t remember the exact number of days tick one of the following boxes days 1-5 days 6-10 days more than 10 days 5.4 Have any of your friends or relatives had to have time off work for reasons relating to your aneurysm? Yes 5.5 If yes, how many days? Exact number of days OR if you can t remember the exact number of days tick one of the following boxes days 1-5 days 6-10 days more than 10 days 5.6 Do any of your family or friends help you with feeding, washing or dressing? Yes 5.7 If yes, on average for how many hours a day? Exact number of hours OR if you can t remember the exact number of hours tick one of the following boxes hours 2 hours or less 3 to 5 hours More than 5 hours

33 Trial ID Section B: Service use for reasons not related to your aneurysm 6.1 Since you left hospital after your aneurysm repair, have you had hospital treatment by either a doctor or nurse for anything other than your aneurysm? (examples might include breathing problems, skin rashes, constipation etc) Yes 6.2 If yes, where was this? Name of Hospital: 6.3 If yes, what was the treatment for? 6.4 How many appointments have you had with the doctor or nurse at an outpatients department for reasons unrelated to your aneurysm? Who? How many times? OR if you can t remember the exact number of times tick one of the following boxes A doctor 1 or 2 3 or 4 5 or more A nurse 1 or 2 3 or 4 5 or more 6.5 Since you left hospital following your aneurism repair, have you seen your GP for reasons unrelated to your aneurysm? Yes 6.6 If yes, how many times have you seen the GP for reasons unrelated to your aneurysm? Exact number of times OR if you can t remember the exact number of times tick one of the following boxes times 1 or 2 3 or 4 5 or more Many thanks for your help.

34 CT Scans: DICOM copy of pre-operative CT scan to be sent to core laboratory at Imperial College London (Charing Cross) after removing the demographic data from the images and replacing it with the unique trial ID: Pre-operative CT scans: A CT scan is required for all patients that underwent EVAR but please forward all diagnostic CT scan to the trial coordinating centre (if CT was done) for independent confirmation by IMPROVE Core Lab. This includes patient s that were diagnosed with a non-ruptured AAA by the local team. Post-operative CT scans: Patients with endovascular repair will have a CT scan 1-3 months after the operation please forward all follow-up CT scans to the trial coordinating centre Please note that copies of any 12-month CT scan images are not required to be sent to the trial office.