Standard Operating Procedure 11. Completion of DAFNE Data Collection: Full Post Course Form F04.010, Version 8

Transcription

1 Standard Operating Procedure 11 Completion of DAFNE Data Collection: Full Post Course Form F04.010, Version 8 Date Version Issue Review Contact Approved Date Date Person October October 2013 March 2015 Susan Moore DAFNE P01.011, Version 9 October 2013 Page 1 of 17

2 CONTENTS Document history... 4 Introduction... 5 Patient DAFNE Number... 6 Method of data collection Data of data collection Year of birth Do you smoke? Where do you receive your diabetes care? Lab data Date of last full annual review Date of last retinal screening Date of last DAFNE review Weight Blood pressure Are you currently using an insulin pump? Date you started using an insulin pump Current MDI insulin regimen Number of injections per day Insulin type Current insulin regimen pump users only Appearance of injection sites Medication Have you been pregnant since your last DAFNE review? Complications prior to DAFNE Total number of diabetes related inpatient episodes in the last year Record reason and length of stay How many admissions due to DKA Number of telephone contacts Number of face to face contacts Number of blood glucose tests DAFNE P01.011, Version 9 October 2013 Page 2 of 17

3 27. Have you had a hypoglycaemic episode you were unable to treat? Total number of hypoglycaemic episodes unable to treat themselves Total number of hypoglycaemic episodes requiring paramedic assistance Total number of hypoglycaemic episodes requiring A&E Total number of hypoglycaemic episodes when patient unconscious Blood glucose range when symptoms of hypoglycaemia usually occur Signature Record of staff that have read this SOP DAFNE P01.011, Version 9 October 2013 Page 3 of 17

4 History of previous versions of this document: Approved Version Issue Date Review Date Contact Person Susan Moore September DAFNE Database September 2008 Aug 2010 Manager Central DAFNE Office Statement of changes made from Version 2 Version Date Description Version 2 Oct Q23 changed to state last DAFNE review instead of number in total. Version 3 Nov Changed to reflect requirement to record actual hypoglycaemic events rather than grouping events (questions 8, 9 and 10). 2. Inclusion of Document History 3. Inclusion of table (final page) for personnel to record that they have read the document. Version 4 March Amend format for dates from dd/mm/yy to dd/mm/yyyy throughout. 2. Minimum and maximum value information added to questions 5, 9, 10, 13, 14 and 27. Version 5 July Reference to DAFNE Data Collection: Full Post Course form (F04.010, Version 3) amended to DAFNE Data Collection: Full Post Course form (F04.010, Version 5) throughout. 2. Method of data collection added before question Option to tick No data available added to questions 5, 9, 10, 13, 14, 16, 21, 23, 24, 25, 27, 28, 29 and 30 Version 6 March Reference to DAFNE Data Collection: Full Post Course form (F04.010, Version 4) amended to DAFNE Data Collection: Full Post Course form (F04.010, Version 5) throughout. 2. Additional or revised information relating to validation rules and minimum and maximum values added. Version 7 June Updated to include requirements for entering HbA1c data. Version 8 August Reference to DAFNE Data Collection: Full Post Course form F amended to Version 7 throughout document. 2. Item 5, Lab results, paragraph 4 updated. 3. Questions 21, 22, 23, 24, 25, 26, 27, 28, 29 and 30 amended to replace the wording Since your last DAFNE review with In the last year Version 9 October Reference to DAFNE Data Collection: Full Post Course form F version number amended to Version 8 throughout. 2. Question 5, Lab data updates timeline for acceptable dates. 3. Questions 14 and 15 updated to include the word current. DAFNE P01.011, Version 9 October 2013 Page 4 of 17

5 Introduction This document lists the acceptable responses for each question on the DAFNE Data Collection: Full Post Course form (F04.010, Version 8). This data collection form must be used by the centres collecting data for the DAFNE research database with patients that have provided informed written consent to provide the required data as of 1 st October The DAFNE Data Collection: Full Post Course form (F04.010, Version 8) should not be used if the patient: completed their DAFNE course prior to 1 st October 2008, or did not consent to provide the full dataset. In such cases the DAFNE Data Collection: Core Post Course form (F04.008, Version 8) should be used. Everyone who completes a DAFNE Data Collection: Full Post Course form (F04.010, Version 8) should familiarise themselves with the contents of this SOP and complete their details in the table on the final page of this procedure. In addition a copy of this SOP should always be available for reference. The primary aims of this document are to enable uniformity of form completion across all centres and to help prevent inappropriate responses being recorded. It is of the utmost importance that every question is answered appropriately and no question is left blank. It is also important that clinical personnel appreciate that the people entering data onto the database may not be medically trained. Therefore please take care when recording responses. Patients should be reminded to bring along their blood monitoring diaries (if they have them) for the past 6 months, to enable the hypoglycaemia section of the form to be completed accurately. If there are any queries regarding this SOP or DAFNE Data Collection: Full Post Course form itself, please contact Susan Moore on DAFNE P01.011, Version 9 October 2013 Page 5 of 17

6 Patient DAFNE Number Insert the patient s unique DAFNE number at the top of each page. It is important that this information is on all pages, so that in the event of pages becoming detached, the patient can be identified. The patient s unique DAFNE number will have been allocated to them at their Baseline (pre course) data collection clinic. This number should be referenced on the copy of the Baseline data collection form, held within the patient s notes. For information on the structure of the unique patient number please refer to the Standard Operating procedure P Version 8 Completion of DAFNE Data Collection: Full Baseline Form F04.009, Version 8. Note: The patient s name and hospital number must not be used as the DAFNE patient number. Method of data collection Record the method of data collection used by placing a tick or cross in the relevant box. If more than one method used record all methods. 1. Date of data collection Record the day, month and year (dd/mm/yyyy) that the data is collected from the patient. The date of data collection must not be more than 4 months either side of the post course event (i.e. for 1 year post course, date of data collection should be between 8 and 16 months of course date). 2. Year of birth Record the year (yyyy) of the patient s birth 3. Do you smoke? Record the smoking status of the patient by placing a tick or cross in the appropriate box. 4. Where do you receive your diabetes care? Record where the patient receives their routine diabetes care by placing a tick or cross in the appropriate box. Note: This does not apply to where the patient received their DAFNE course, but where they attend for annual reviews and diabetes checks. 5. Lab data The results of 7 separate analytical tests are required as detailed in the table. Ideally these tests are to be performed on blood samples provided on the day of data collection. However, if the patient has a result for any of the tests listed that is less than 4 months old this result may be used, rather than taking additional blood samples. Recorded values for HbA1c are changing from % to mmol/mol values. This change will take effect over a two year period. Note: Only enter one value for HbA1c, mmol/mol if available otherwise %. The value entered should be taken direct from the source data. The database will automatically calculate the remaining value. DAFNE P01.011, Version 9 October 2013 Page 6 of 17

7 Where a value is entered, a corresponding date must also be entered. The date must be no more than 4 months before the date of data collection If no data is available, e.g. if a local lab has a policy in place which prevents one of the tests being obtained (e.g. HDL cholesterol analysis not performed if cholesterol is <4mmol/l), leave both the date and results areas blank for the relevant tests and select the No data available tick box. Refer to Example 1 below. Example 1 Test Date Result HbA1c % No data available HbA1c 24/10/ mmol/mol No data available Creatinine 24/10/ umol/l No data available Cholesterol 24/10/ mmol/l No data available Triglyceride 24/10/ mmol/l No data available HDL cholesterol mmol/l No data available LDL cholesterol mmol/l No data available egfr 24/10/ mls/min No data available Where the egfr test result is greater than 90, record this by placing a tick or a cross in the Above 90 box. Some centres receive lab results of above 60 for egfr. If this is the case, record this by placing a tick or a cross in the Above 60 box. Minimum and maximum values have been identified for the lab tests and these are shown in example 2 below. Where the format is decimal it should be recorded to one decimal place. Values outside of these ranges will not be accepted by the database. Example 2 Test Minimum Value Maximum Format Value HbA1c - % Decimal HbA1c mmol/mol Whole Creatinine Decimal Cholesterol Decimal Triglyceride Decimal HDL cholesterol Decimal LDL cholesterol Decimal egfr Above 60 Above 90 Whole The database will not accept a value which is less than the minimum value or greater than the maximum value. 6. Date of last full annual review Record the day, month and year (dd/mm/yyyy) of the last annual review that the patient attended. You may have to obtain this date from the patient s hospital records. DAFNE P01.011, Version 9 October 2013 Page 7 of 17

8 7. Date of last retinal screening (including retinal photography) Record the day, month and year (dd/mm/yyyy) when dilated fundoscopy with retinal photography was last performed. You may have to obtain this date form the patient s hospital records. 8. Date of last DAFNE review Record the day, month and year (dd/mm/yyyy) of the last DAFNE data collection that the patient attended. You may have to obtain this date from the patient s hospital records. 9. Weight Record the patient s weight on the day of data collection. Weight must be recorded in Kg and not stones and pounds. If no data available please select the relevant No data available tick box. Minimum and maximum values have been identified for weight. These are minimum of 30.0 and maximum of Where the format is decimal it should be recorded to one decimal place. The database will not accept values outside of this range. 10. Blood pressure Record the patient s blood pressure on the day of data collection. If no data available please select the relevant No data available tick box. Minimum and maximum values for blood pressure are shown in the example below. Values outside of this range will not be accepted by the database. Blood pressure Minimum Maximum Format Value Value Blood Pressure Whole Blood Pressure Whole 11. Are you currently using an insulin pump? Record whether or not the patient is now using insulin pump therapy by placing a tick or a cross in the appropriate response. If the patient is using an insulin pump proceed to Q12. If the patient is not using an insulin pump proceed directly to Q Date you started using an insulin pump Record the day, month and year (dd/mm/yyyy) that the patient commenced using an insulin pump. 13. Current MDI insulin regimen (MDI only) Note: This question should only be completed for patients on MDI and must not be completed for insulin pump users. Record: The typical daily dose of quick acting insulin. Minimum and maximum values have been identified as minimum of 0 and maximum of 199. The database will not accept values outside of this range. The response to this question must be a whole number and not a range. DAFNE P01.011, Version 9 October 2013 Page 8 of 17

9 Quick acting: carbohydrate portion ratios for breakfast midday meal evening meal supper Minimum and maximum values for quick acting: carbohydrate portion ratios have been identified as minimum of 0.25 and maximum of The database will not accept values outside of this range. The format is decimal and values should be recorded to two decimal places. Daily dose of background insulin. Minimum and maximum values have been identified as minimum of 0 and maximum of 199. The database will not accept values outside of this range. The response to this question must be a whole number. Use the previous day doses and ratios if the patient believes the previous day was a usual day or record what the patient believes is a usual day. The patients blood glucose monitoring diary should be used to obtain this data. If no data available please select the relevant No data available tick box. 14. Current number of injections per day Note: This question should only be completed for patients on MDI and must not be completed for insulin pump users. Record the total number of quick acting and background insulin injections the patient has each day. Minimum and maximum values for number of injections per day are shown below. Number of Minimum Value Maximum Format injections per day Value QA 0 10 Whole BI 0 4 Whole The database will not accept values outside of this range. If no data available please select the relevant No data available tick box. 15. MDI and Pump users: Current insulin type Note: This question should be completed for patients on MDI and insulin pump users. Record the type of quick acting and background insulin used by the patient by circling the appropriate responses. 16. Current Insulin regimen Pump Users only Note: This question should only be completed for insulin pump users and must not be completed for patients on MDI. Record The typical daily bolus total of quick acting insulin. Minimum and maximum values are minimum of 5 and maximum of 200. The database will DAFNE P01.011, Version 9 October 2013 Page 9 of 17

10 not accept values outside of this range. The response to this question must be a whole number and not a range. Insulin: carbohydrate ratios for breakfast midday meal evening meal supper Minimum and maximum values for Insulin: carbohydrate rations have been identified as minimum of 0.25 and maximum of The database will not accept values outside of this range. The format is decimal and values should be recorded to two decimal places. 24 hour basal dose. Minimum and maximum values are minimum of 5 and maximum of 200. The database will not accept values outside of this range. Average number of boluses per day. Use the previous day doses and ratios if the patient believes the previous day was a usual day or record what the patient believes is a usual day. The patients blood glucose monitoring diary should be used to obtain this data. If no data available please select the relevant No data available tick box. 17. Appearance of injection sites Record whether or not the injection sites exhibit lipohypertrophy by placing a tick or a cross in the Yes or No box as appropriate. 18. Medication Record if the patient is currently taking any of the prescribed drugs listed by placing a tick or a cross in either the Yes or No box as appropriate for each drug listed. 19. Have you been pregnant since your last DAFNE review? To be completed for Female patients only. Record if the patient has been pregnant since their last DAFNE review by placing a tick or a cross in the Yes or No box as appropriate. Record whether the patient is currently pregnant by placing a tick or a cross in either the Yes or No box as appropriate. If the patient is currently pregnant record the gestation at the time of data collection in weeks. Minimum and maximum values for pregnancy gestation are minimum 6 weeks and maximum 45 weeks. 20. Complications post DAFNE Record whether or not the patient has developed any complications following their DAFNE course, by placing a tick or a cross in the Yes or No box as appropriate. Do not record any complications that were present before the patient attended their DAFNE course. DAFNE P01.011, Version 9 October 2013 Page 10 of 17

11 If the patient has developed complications tick the Yes box and complete the complications table indicating with a tick or a cross which complications are present. For each complication which is present, record the date of onset in dd/mm/yyyy format (see example below). If the patient does not have any complications, tick or cross the No box and leave the complications table blank. Example Have any complications developed post DAFNE? Yes No If yes, please record below which complications are and are not present, and the date of onset for each where applicable. Present () Date of Complication onset Hypertension 2010 MI Coronary revascularisation Peripheral revascularisation CVA Painful neuropathy Foot ulcer Amputation toe Amputation above toe level Retinopathy Proliferative Laser Rx Registered partially sighted Registered blind Microalbuminuria (Female = greater than 3.5 on 2 occasions, at least 1 early morning urine) (Male = greater than 2.5 on 2 occasions, at least 1 early morning urine) Proteinuria (Dipstick positive and/or ACR greater than 30 on 2 occasions and/or greater than 300mg/l in 24 hours) Dialysis Renal Transplantation Erectile Dysfunction 21. Total number of diabetes related inpatient episodes in the last year Record the total number of diabetes related inpatient episodes the patient has experienced in the last year. If the patient has not experienced any diabetes related inpatient admissions, record 0 (zero). If no data available please select the relevant No data available tick box. DAFNE P01.011, Version 9 October 2013 Page 11 of 17

12 A minimum value of 0 and maximum value of 20 is permitted for total number of diabetes related inpatient episodes, however if a value of 10 or more is entered the database will prompt the user to confirm the value. Values outside of this range will not be accepted by the database. Do not record any non diabetes related inpatient episodes. Note: Record the number of diabetes related inpatient episodes not the number of inpatient days this data is recorded in question Record the primary reason and length of stay for each diabetes related inpatient episode in the last year in the table below If the patient has had diabetes related inpatient episodes in the last year complete the table for each admission indicating the primary reason for the admission by placing a tick or a cross in the box to the right of the appropriate reason. Next, enter the number of inpatient days for that admission in the far right hand column. Note: If the patient has not experienced any diabetes related inpatient episodes since their last DAFNE review please skip this question. There is space in the table to record 3 separate inpatient episodes in detail. If the patient has experienced more than 3 diabetes related inpatient episodes in the last 12 months, then the remaining episodes should be grouped together in the All Remaining Admissions section of the table. The number of inpatient days for All Remaining Admissions should be totalled and entered in the All Remaining Admissions section of the table. The reasons for All Remaining Admissions are not recorded. Do not record any non diabetes related inpatient episodes. Minimum, prompt and maximum values for primary reasons and all remaining admissions length of stay are shown below. The database will automatically accept any whole value between the minimum and maximum values, however if the value entered is equal to or above the prompt value the database will prompt the user to confirm the value. Values outside of the minimum/maximum range will not be accepted by the database. Admission Minimum Prompt Maximum Format Value Value Value Admission Whole Admission Whole Admission Whole All Remaining Admissions Whole DAFNE P01.011, Version 9 October 2013 Page 12 of 17

13 Below is an example of a completed table. Admission 1 Primary Reason For Admission No of days in Hospital (Select 1 reason only) DKA Hypoglycaemia 2 Myocardial Infarction Ischaemic Heart Disease Unstable Angina Heart Failure Foot Ulcer Renal Disease Admission 2 Primary Reason For Admission No of days in Hospital (Select 1 reason only) DKA Hypoglycaemia Myocardial Infarction 4 Ischaemic Heart Disease Unstable Angina Heart Failure Foot Ulcer Renal Disease Admission 3 Primary Reason For Admission No of days in Hospital (Select 1 reason only) DKA Hypoglycaemia 2 Myocardial Infarction Ischaemic Heart Disease Unstable Angina Heart Failure Foot Ulcer Renal Disease All Remaining Admissions No of days in Hospital Do not record reasons only number of days How many admissions due to Diabetic Ketoacidosis (DKA) have you had? Record the total number of DKA episodes requiring admission in the last year Minimum and maximum values for admissions due to DKA are shown below. If the value entered is equal to or above the prompt value the database will prompt the user to confirm the value. Values outside of minimum/maximum range will not be accepted by the database. DKAs Minimum Prompt Maximum Format Value Value Value Total number in last year Whole If the patient has never had any such episodes record 0 (zero) in each case. If no data available please select the relevant No data available tick box. DAFNE P01.011, Version 9 October 2013 Page 13 of 17

14 24. Number of telephone contacts regarding your diabetes with any Healthcare Professional in the last year Record the number of telephone contacts the patient has had in the last year with any Healthcare Professional with regard to their diabetes. If no data available please select the relevant No data available tick box. A minimum value of 0 and maximum value of 120 is permitted for total number of diabetes related inpatient episodes, however if the value entered is equal to or above 20 the database will prompt the user to confirm the value. Values outside of the minimum/maximum range will not be accepted by the database. Note: Healthcare Professional relates to any HCPs in either primary or secondary care. 25. Number of face to face contacts regarding your diabetes with any Healthcare Professional in the last year Record the number of face to face contacts the patient has had in the last year with any Healthcare Professional with regard to their diabetes. If no data available please select the relevant No data available tick box. A minimum value of 0 and maximum value of 19 is permitted for total number of diabetes related inpatient episodes. Values outside of the minimum/maximum range will not be accepted by the database. Note: Healthcare Professional relates to any HCPs in either primary or secondary care. 26. Number of Blood Glucose Tests Record the total number of blood glucose tests the patient has: a) Performed: this is the average number of all blood tests done each day. Record the number by placing a tick or a cross in the relevant box. Values of 7 or above should be recorded in the 7 or more category. If no data is available please select the relevant No data available tick box. b) Recorded: this is the average frequency, over the last 2 weeks, the patient has written down / recorded in their DAFNE diary or other format (ie personal diary, spreadsheet etc.) the number of blood tests performed. To obtain the correct response, calculate the percentage for number of blood tests recorded compared to the number performed. Place a tick or a cross in the relevant box. If no data is available please select the relevant No data available tick box. 27. In the last year have you had a hypoglycaemic episode you were unable to treat yourself? Record whether or not the patient has had a hypo that they were unable to treat themselves (i.e. had to have someone to help them) in the last year by placing a tick or a cross in the appropriate box If the patient has experienced a hypo requiring third party assistance complete all remaining questions. If the patient has not had a hypo requiring third party assistance miss out questions 27 to 30 and proceed directly to question 31. DAFNE P01.011, Version 9 October 2013 Page 14 of 17

15 28. Total Number of hypoglycaemic episodes unable to treat themselves in the last year. Record the number of hypoglycaemic episodes that the patient was unable to treat themselves in the last year by entering the actual number in the box provided. If no data available please select the relevant No data available tick box. The minimum value is set to 0, maximum value set to 99. Both values are whole number format. Values outside of minimum/maximum range will not be accepted by the database. 29. Total number of hypoglycaemic episodes requiring paramedic assistance in the last year. Record the number of hypoglycaemic episodes experienced by the patient in the last year requiring paramedic assistance by entering the actual number in the box provided. If no data available please select the relevant No data available tick box. The minimum value is set to 0, maximum value set to 99. Both values are whole number format. Values outside of minimum/maximum range will not be accepted by the database. Note: The number needing paramedics cannot be given without the number that the patient was unable to treat themselves. Additionally, the number needing paramedics cannot be greater than the number that the patient was unable treat themselves. 30. Total number of hypoglycaemic episodes requiring A&E attendance or hospital admission in the last year. Record the number of hypoglycaemic episodes experienced by the patient in the last year requiring A&E attendance or hospital admission by entering the actual number in the box provided. If no data available please select the relevant No data available tick box. The minimum value is set to 0, maximum value set to 99. Both values are whole number format. Values outside of minimum/maximum range will not be accepted by the database. Note: The number needing A&E or hospital admittance cannot be given without the number that the patient was unable to treat themselves. Additionally, the number needing A&E or hospital admittance cannot be greater than the number that the patient was unable treat themselves. 31. Total number of hypoglycaemic episodes when you have lost consciousness in the last year. Record the actual number of hypoglycaemic episodes experienced by the patient in the last year when the patient lost consciousness by entering the actual number in the box provided. If no data available please select the relevant No data available tick box. DAFNE P01.011, Version 9 October 2013 Page 15 of 17

16 The minimum value is set to 0, maximum value set to 99. Both values are whole number format. Values outside of minimum/maximum range will not be accepted by the database. Note: The number with lost consciousness cannot be given without the number that the patient was unable to treat themselves. Additionally, the number lost consciousness cannot be greater than the number that the patient was unable treat themselves. 32. Blood Glucose range when symptoms of hypoglycaemia usually occur. Record the BG range when the patient s hypo symptoms usually occur or if the patient does not feel symptoms by placing a tick or a cross in the most appropriate box. Signature Ensure that the person who has collected the data prints their name and signs the form at the bottom of page 5. This will enable the data entry clerk to contact the relevant person, should there be any queries regarding the data. DAFNE P01.011, Version 9 October 2013 Page 16 of 17

17 Please list the names of all your members of staff below that are involved in completing the DAFNE Full Post Course data collection form, and ask them to sign in the space provided when they have read this procedure. DAFNE Centre:. Name (please print) Job Title Date Signature DAFNE P01.011, Version 9 October 2013 Page 17 of 17