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UKPDS Outcomes Model Manual - Diabetes Trials Unit

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1. Mean Years from diagnosis It is also possible to examine cumulative event rates adjusted for death as competing risk over the years specified in the simulation For example the MI sheet contains the expected incidence of myocardial infarction for both groups The cumulative incidence up to year X is estimated by adding the event rate by simulated year up to year X For example the expected cumulative number of events plateau at around 0 47 for patient one and 0 42 for patient two around 30 year of the simulation as almost all patients are dead and therefore cannot have an MI Example 2 We may also want to undertake a simulation based on a different assumed future time path for HbA values instead of following the default paths To undertake this type of simulation proceed as follows Step 1 Go to the HbA c sheet For the first subject enter 11 0 for year 1 and copy this value across the row to year 40 Repeat this for process for the second subject entering 7 0 instead of 11 0 Step 2 Go to the Run Model sheet Change Use risk factor sheets from N to Y to indicate the model is to use the values specified for each year simulated Step 3 Run the model and then look at the Outputs sheet Subject one s Life Expectancy will now be somewhat less at around 16 0 years as his HbA has remained elevated at its initial value of 11 0 Subject two will have an extended Life Expectancy of around 17 7 years as his HbA
2. Stroke Time in years since first stroke 0 if none MI Time in years since first myocardial infarction 0 if none Discounting start year The year of the simulation discounting of costs and outcomes commences The ability to set this is useful when a simulation is run that contains actual follow up data for the subjects specified Running the Model The Run Model worksheet is used to set the following parameters and then to start the simulation UKPDS Ohicomes Model Run Model Version 1 3 Isis Innovation Ltd 2010 Chttp yraw dtu ox ac uk outcomesmodel Number of subjects 8 available Number of loops 100 Number ofhootsiraps 500 Ofo 999 Start at bootstrap 1 fifo 999 Number of years simulated 40 lfo 40 Initial rate for n years Subsequent rate QALE Life expectancy discount rate 3 5 30 3 0 Oto 100 Total costs discount rate 3 5 30 3 0 Oto 100 Initial utility 0 785 Ofo I Cost in the absense of complications 374 00 At time of event In subsequent years Fatal Non fatal Utility decrement Cost Utility decrement THD 2 696 00 0 090 891 00 0 090 E ees MI 1 366 00 5 199 00 0 055 256 00 0 055 Heart failure 3 007 00 3 007 00 0 108 1 054 00 0 108 Stroke 4 011 00 3 180 00 0 164 601 00 0 164 TeL Amputation 10 354 00 10 354 00 0 280 598 00 0 280 Blindness 1 358 00 0 074 575 00 0 074 Renal failure 30 000 00 30 000 00 0 263 30 000 00 0 263 Use risk factor sheets Y Yor
3. 21 10 2010 12 25 Version 1 3 Isis Innovation Ltd 2005 http waw dtu ox ac ukoutcomesmodel Total cost of complications 6417 61 95 CI Lower 437690 845832 6335 24 420208 8468 40 6499 98 3994 74 9005 22 164 738 2399 7 2070 2 DIA ip i 6535 00 3839 8 9280 2 002B 8 3 7 1 9 5 6 3 54 7 2 5200 23 2062 6 78 gt Outputs Bootstraps IHD MI Heart failure Stroke Amputation Blindness Renal Failure lt gt Clarke P Gray A Legood R Briggs A amp Holman R The impact of diabetes related complications on healthcare costs results from the United Kingdom Prospective Diabetes Study UKPDS 65 Diabetic Medicine 2003 20 6 442 50 UKPDS Outcomes Model manual Page 19 of 32 n ay a lt a PR 2 a ae ee a a a a 3 Expected utility by simulated year Year Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year9 YearlO Yearll Yearl2 Year li 0 771 0 719 0 668 0 620 0 573 0 529 0 478 0 422 0 373 0 329 0 285 0 244 0 208 0 771 0 717 0 667 0613 0560 0511 0 458 0397 0343 0 297 0 251 0 211 0 174 0 772 0 720 0 670 0 627 0 585 0547 0 499 0 447 0 404 0361 0318 0 277 0 241 0 001 0 003 0 004 0 013 0 025 0 036 0 042 0 050 0 061 0 064 0 067 0 067 0 067 0 780 0 723 0 667 0 620 0 570 0 531 0 477 0 412 0 372 0 331 0 283 0 232 0 197 0 771 0 726 0 694 0 636 0 574 0 506 0 443 0 384 0 331 0 287 0 240 0 198 0 157 gt Dutputs Bootstraps IHD MI Heart failure Stroke Amputation Blindne
4. Red e Check worksheets Salmon e Output worksheets Green e Risk Factor Output worksheets Pink Input worksheets have been amended so that e Age is no longer checked against duration of diabetes e Alphanumeric data can be used in the ID column Windows Users can now choose a desired location for the install and the shared core dll is placed in the system folder In addition to the Microsoft Excel implementation of the UKPDS Outcomes Model a standalone implementation that runs on Windows Macintosh and Linux platforms has now been provided This implementation of the UKPDS Outcomes Model can handle an unlimited number of subjects See Standalone Implementation of the UKPDS Outcomes Model on page 17 and does not require Microsoft Excel Installation The UKPDS Outcomes Model is supplied on a CD containing 6 items namely ReadMe txt UKPDS Outcomes Manual pdf UKPDS Outcomes Model manual Page 5 of 32 e UKPDS Outcomes Model Windows setup exe e UKPDS Outcomes Model Macintosh dmg e oUutcomes tar gZ Standalone Sample The UKPDS Outcomes Model software is installed as follows The first time the software is used it will request a licence key to be entered This can be found on the installation CD Once accepted this will not be asked for again Windows Installation Double click or run the file UKPDS Outcomes Model Windows setup exe to install the UKPDS Outcomes Model software
5. 27 Year 28 Year 29 Year 30 Y ear 31 Year 32 Year 33 Year 34 Year 35 Year 36 Year 37 Year 38 Year 39 Year 40 Mean 120 0 130 0 120 0 154 0 120 0 5555555333555555333355553533 SI E E E A AS N 1 0 1 0 1 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 fname EstimatedSmokingStatus csv Smoking status values as estimated by the UKPDS Outcomes Model If updated risk factors are provided they are reproduced in this sheet The identifier for the subject as provided in the Inputs file Estimated value for year 1 or updated risk factor value if provided Estimated value for year 40 or updated risk factor value if provided fname EstimatedLipidRatio csv Lipid values as estimated by the UKPDS Outcomes Model Lipid values provided by the model are a ratio of Total Cholesterol to HDL If updated risk factors for Cholesterol and HDL are provided the ratio is reproduced in this sheet The identifier for the subject as provided in the Inputs file Estimated value for year 1 or updated risk factor value if provided Estimated value for year 40 or updated risk factor value if provided fname EstimatedSysBP csv Systolic blood pressure values as estimated by the UKPDS Outcomes Model If updated risk factors are provided they are reproduced in this sheet The identifier for the subject as provided in the Inputs file Estimated value for year 1 or updated risk factor value if provided Estimated value f
6. 5555555555559999999999999999900000L 0ng term history rate by simulated year Lower C1 5555599999999999999999999999999999999L 0Ng term history rate by simulated year upper Cl 555555599999999999999995999999 Id Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10 Year 11 Year 12 Year 13 Year 14 Year 15 Year 16 Year 17 Year 18 Year 19 Year 20 Year 21 Year 22 Year 23 Year 24 Y ear 25 Year 26 Y ear 27 Year 28 Year 29 Year 30 Year 31 Year 32 Year 33 Year 34 Year 35 Year 36 Year 37 Year 38 Year 39 Year 40 Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10 Year 11 Year 12 Year 13 Year 14 Year 15 Year 16 Year 17 Year 18 Year 19 Year 20 Year 21 Year 22 Year 23 Year 24 Year 25 Year 26 Y ear 27 Year 28 Year 29 Year 30 Year 31 Year 32 Y ear 33 Year 34 Year 35 Year 36 Year 37 Year 38 Year 39 Year 40 Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10 Year 11 Year 12 Year 13 Year 14 Year 15 Year 16 Year 17 Year 18 Year 19 Year 20 Year 21 Year 22 Year 23 Y ear 24 Y ear 25 Year 26 Y ear 27 Year 28 Year 29 Year 30 Year 31 Year 32 Year 33 Year 34 Year 35 Year 36 Year 37 Year 38 Year 39 Year 40 Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10 Year 11 Year 12 Year 13 Year 14 Year 15 Year 16 Year 17 Year 18 Year 19 Year 20 Year 21 Year 22 Year 23 Year 24 Year 25 Year 26 Y ear 27 Year 28 Year 29 Year 30 Year 31 Year 32 Year 33 Year 34 Year 35 Year 36 Year 37
7. gt Bootstraps Worksheet This worksheet tabulates estimated mean Life Expectancy QALYS and complication costs by bootstrap replication The number of results reported depends on the number of bootstrap replications requested with each result showing the mean value for that bootstrap averaged across the total number of loops Monte Carlo trials requested B E D E F G H I J K UKPDS Ouicories Model Bootstraps Version 1 3 Isis Innovation Ltd 2005 http www dtu ox ac ukfoutcomesmodef pom Gop Gop Ciffevence Noxon ote aga IREE te nas tan gr S te nto ae Number ex a Total QALE complications expectanc Total QALE complications expectanc Total QALE complications expectanc Total QALE complications 1 5 169 25 4 779 08 5 559 Al 780 32 2 5 744 80 5 984 52 5 505 08 479 44 gt 4 Cholesterol i HDL SysBP 7 TA F Run Model Inputs e 4 more Bootstraps IHD MI tH Heart failure 7 iE 4 Amputation acne lt gt UKPDS Outcomes Model manual Page 13 of 32 IHD Ischaemic Heart Disease MI Myocardial Infarction Heart failure Stroke Amputation Blindness Renal failure Diabetes related death Other death All death Worksheets These worksheets show the expectation by year that a subject experienced an event of these types IHD example shown This value is calculated by dividing the total simulated instances where a subject has previously had an event and is still alive by the tota
8. 288 9636912558475501 236 2419291742924372 216 5438596199406902 207 7899263368996969 182 50792 15687728436 158 4277245896 527404 145 1086024818217481 131 3233972301899257 108 9700237832884397 111 3538320973237177 72 0 663680430542257 51 7877408462884858 29 4682019165932267 14 5962613391459168 9 1261526447824455 44 1205930520657503 2 28 197564615697 16 0 8780300027352269 0 0000000000000000 0 0000000000000000 0 0000000000000000 0 0000000000000000 0 0000000000000000 0 0000000000000000 0 0000000000000000 0 0000000000000000 0 0000000000000000 0 0000000000000000 0 0000000000000000 0 0000000000000000 0 0000000000000000 0 0000000000000000 UKPDS Outcomes Model manual Page 27 of 32 fname Bootstraps csv Bootstrap Number Life expectancy All Total QALE All Total cost of complications All Life expectancy Group 1 D Total QALE Group 1 Total cost of complications Group 1 Life expectancy Group 2 Total QALE Group 2 Total cost of complications Group 2 e g Bootstrap Number Life expectancy Total QALE Total cost of complications 1 5 527663982 4 272755081 5509 484561 9 134222203 7 100436072 5226 466521 1 921105761 1 445074089 5792 502601 2 8 883901823 6 782036675 7071 075513 9 606008875 7 328607168 5532 870861 8 161794771 6 235466182 8609 280166 3 7 938116905 6 077276854 6578 451473 7 383042576 5 715983362 4583 544646 8 493191234 6 438570345 8573 3583 fname IHD csv fname MI csv fname HeartFailure csv name
9. 83955696194 0 0193782022985551 0 021944573 1994618 0 0209 162369 124732 0 0263649126067406 0 02540 84904610522 0 0240939827384057 0 025 1660092300710 0 0193760007778418 0 0250694359233842 0 02218 16879858381 0 0265539070816561 0 0236191369186809 0 0167953810323810 0 0130302077857054 0 01304 96423802634 0 0160216151299828 0 0102026050558394 0 0107345326192693 0 0132268493606319 0 01370 66085810752 0 0070602569269 159 0 008628 1423 182958 0 0040370214731161 0 0064618283261883 0 003 14 28 133984696 0 0027248 1 17098985 0 0022850473 199477 0 0016508925372658 0 001 1877729372233 0 00089 08323981535 0 0007 152362004261 0 0004764211313533 0 0004979943067948 0 0003492101808367 0 0002 1 34151109926 0 00875661669825 0 0040 0 0090 0 0130 0 0190 0 0240 0 0270 0 0290 0 0380 0 0440 0 0530 0 0 530 0 0510 0 0550 0 0570 0 0590 0 0560 0 0530 0 0490 0 0420 0 0370 0 0380 0 0330 0 0270 0 0290 0 0220 0 0 160 0 0110 0 0030 0 0020 0 0020 0 0020 0 0010 0 0010 0 0010 0 0010 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 1387907047768261 0 205632175898 7614 0 2600173254000258 0 30852263 16798767 0 35 13561558953 182 0 3872479996587594 0 41814746393 1 9138 0 4525939094500950 0 479805 1709549 1 18 0 50697683379863 15 0 5219795466740100 0 53 1029857457 8877 0 54292569703 10395 0 5487837238289270 0 5524959583 1
10. Expectancy and complication costs estimates The software contains full sets of model equation parameters derived from bootstrap samples of the UKPDS trial population which were generated by sampling with replacement from the original data set When the desired number of bootstraps has been chosen each bootstrap run will use a different set of model equation parameters drawing from those available The current version of the software is limited to a maximum of 1 000 bootstraps Ideally 1 000 bootstraps should be specified although 100 may be sufficient to obtain approximate confidence intervals estimates If the number of bootstraps 1s set to 0 or 1 then no confidence intervals will be generated Sets which of the 1000 bootstrap parameters sets supplied should be used first Parameter sets are used in order with wrap round to the first set if necessary Number of years simulated Sets the maximum possible number of years simulated per Discount rates Initial Utility value subject The time taken to run the model can be reduced by not specifying more years to be simulated than required The current version of the software is limited to a maximum of 40 years Sets the annual discount rate to be applied to Life Expectancy Quality Adjusted Life Expectancy and complication costs estimates Two different discount rates can be applied for example a discount rate of 3 can be specified for the first 10 years and then 1 5 for all subsequent
11. Outcomes Model UKPDS no 68 PM Clarke AM Gray A Briggs AJ Farmer P Fenn RJ Stevens DR Matthews IM Stratton RR Holman Diabetologia 2004 47 1747 1759 UKPDS Outcomes Model manual Page 3 of 32 significantly from that included in the UKPDS or that include ethnic groups other than White Caucasian Afro Caribbean or Asian Indian The model was developed using data from patients with newly diagnosed type 2 diabetes who participated in the UKPDS and were followed up for between six and twenty years It predicts likely outcomes using risk factors that include age sex ethnicity duration of diabetes height weight smoking status total cholesterol HDL cholesterol systolic blood pressure and HbA By default the model is able to forecast changes over time in smoking status total cholesterol HDL cholesterol systolic blood pressure and HbA risk factor levels However if any or all of these risk factors have values available at any time points simulated the model can incorporate them The main outputs for the UKPDS Outcomes Model are estimates of Life Expectancy Quality Adjusted Life Expectancy and costs of complications all with 95 confidence intervals and with discounting applied if requested Quality Adjusted Life Expectancy values can also be listed for each year simulated for each subject The model also outputs cumulative event rates and long term history rates intermediate outputs which the user may find useful Changes
12. Stroke csv fname Amputation csv name Blindness csv fname RenalFailure csv fname DiabDeath csv fname OtherDeath csv fname AllDeath csv Contain the cumulative event rates for each type of event Each of these files has the following format The identifier for the subject as provided in the Inputs file Event rate for year 1 point estimate Event Year 40 Event rate for year 40 point estimate Lower CI Year 1 Event rate for year 1 lower CI Lower CI Year 40 Event rate for year 40 lower CI Upper CI Year 1 Event rate for year upper CI Upper CI Year 40 Event rate for year 40 upper CI Long term history Year 1 Long term history rate for year 1 point estimate Long term history Year 40 Long term history rate for year 40 point estimate Long term history Lower CI Year 1 Long term history rate for year 1 lower CI Long term history Lower CI Year Long term history rate for year 40 lower CI 40 Long term history Upper CI Year 1 Long term history rate for year 1 upper CI Long term history Upper CI Year Long term history rate for year 40 upper CI 40 UKPDS Outcomes Model manual Page 28 of 32 e g Event rate by simulated year Point estimate 555555599999999999999999999000Lvent rate by simulated year Lower C1 55555999999999999995999 99999 999999999L VEnt rate by simulated year upper C1 55555555999999999999999999999995L 0ng term history rate by simulated year Point estimate
13. UKPDS Outcomes Model manual Page 14 of 32 UKPDS Ohicomes Model Estimated lipid ratio mmoL l by simulated year Version 1 3 Isis Innovation Ltd 2010 Chttp favuny dtu ox ac uk outcomesmodel Year Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year9 YearlO Yearll Ye 001A 7 2222222 7 2222222 7 2222222 72222222 7 2222222 72222222 7 2222222 58158932 5 0760273 46867858 44820069 4 35 002B 3 7272727 40170925 41695659 42497312 4 2919831 46363636 4 4953628 4 4211826 4 3821567 4 3616252 43508236 43 003 41040458 4 258993 43405103 43833964 44059586 44178285 44240733 44273586 4 429087 44299963 44304747 4 4 gt wtf Diab Death f Other Death f Estimated Smoking Status Estimated Lipid Ratio Estimated SysBP E gt Estimated SysBP This worksheet shows systolic blood pressure values by simulated year as estimated by the UKPDS Outcomes Model If updated systolic blood pressure values are provided as inputs they are reproduced in this sheet Estimated HbA Ic This worksheet shows HbA values by simulated year as estimated by the UKPDS Outcomes Model If updated HbA values are provided as inputs they are reproduced in this sheet It is essential that e Workbook worksheets are not rearranged in any way e Columns are not reordered Note All output sheets are cleared each time the model is run UKPDS Outcomes Model manual Entering Population Information Enter data for subjects by typing it directly into th
14. Year 1 Cholesterol in mmol l Cholesterol Year 40 Cholesterol in mmol l c g OOTA 30300030 O aaa a ers ah iia udsasaae 002B 4 l PE o vl EE EEEE E P E A A E nacs 010 O E E A T E A E mame HDL csv This file contains the updated risk factors for HDL cholesterol It is only required if you select the Use updated risk factor files option The format is as follows D An identifier for the subject HDL Year 1 HDL in mmol l HDL Year 40 HDL in mmol l Cc e OTA 0 0 9 0909 0 9 0V0 Ji ana cca lencnduceane 002B l s l 99999 l i E E E E E EE T OD O E E E PE E E E E sas Sacha fname SysBP csv This file contains the updated risk factors for Systolic blood pressure It 1s only required if you select the Use updated risk factor files option The format is as follows ID An identifier for the subject SysBP Year 1 Sys BP mmHg SysBP Year 40 Sys BP mmHg e g DOLA 2 Hae 686 Batre 27 0 Rien eee erent ten nen nn x eer nO EE 0002B0 l S Pe ete er a nr OB ss asthe ek Race ato fname HbAIc csv This file contains the updated risk factors for HbAIc It is only required if you select the Use updated risk factor files option The format is as follows ID An identifier for the subject HbA lc Year 1 HbA Ic HbA Ic Year 40 HbA 1c UKPDS Outcomes Model manual Page 26 of 32 e g OOUAGS 0 9 6 9 0 950 9 0 916 5 0 sisstass cans dss aa aO 002 B A Tanpa ube eas o eso su nas hs OU Cerner te
15. Year9 YearlO Yearll Yearl2 Year li 0 771 0 719 0 668 0 620 0 573 0 529 0 478 0 422 0 373 0 329 0 285 0 244 0 208 0 771 0 717 0 667 0613 0560 0511 0 458 0397 0343 0 297 0 251 0 211 0 174 0 772 0 720 0 670 0 627 0 585 0547 0 499 0 447 0 404 0361 0318 0 277 0 241 0 001 0 003 0 004 0 013 0 025 0 036 0 042 0 050 0 061 0 064 0 067 0 067 0 067 0 780 0 723 0 667 0 620 0 570 0 531 0 477 0 412 0 372 0 331 0 283 0 232 0 197 0 771 0 726 0 694 0 636 0 574 0 506 0 443 0 384 0 331 0 287 0 240 0 198 0 157 gt Outputs Bootstraps IHD MI Heart failure Stroke Amputation Blindness A Renal Failure lt gt AY AZ BA BB BC BD BE BF BG BH BHI BJ BK Total cost by simulated year Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year9 YearlO Yearll Yearl2 Year 1l 455024 454414 450285 450635 441510 410 134 457804 395014 364 746 407468 373 100 321668 258 421 445805 474923 495518 481 164 459 156 402652 415 145 399330 350949 402014 372221 332507 288286 464 243 433906 405053 420 107 423 864 417617 500464 390698 378543 412923 373979 310828 22799 18 438 41017 90465 61057 35 292 14965 85319 8 631 27 594 10909 1 757 21679 60873 443 600 546338 423 879 344425 450204 364659 314422 349546 253 799 503457 511 180 446523 355 110 444700 353 749 383 337 381 446 324142 403 886 337 810 461 770 375096 283 532 266 699 198908 128 247 gt Outputs Bootstraps IHD MI Heart failure Stroke Amputation Blindness Renal Failure lt
16. all of the years to be simulated UKPDS Outcomes Model Updated smoking status 0 Never 1 Past smoker or 2 Current smoker of tobacco by simulated year Version 1 3 Isis Innovation Ltd 2010 http farare dtu ox ac uk outcomesmodel LC ID Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10 001A 1 2 1 002E 0 2 2 gt mi About Inputs Smoking Status Cholesterol HDL SysBP HbAic AMEE Inputs Check fofa Cholesterol Worksheet This worksheet is used to enter total cholesterol values mmol l by subject for any or all of the years to be simulated Ideally these should be from a CDC Centre for Disease Control aligned assay UKPDS Outcomes Model manual Page 10 of 32 UKPDS Ohicomes Model Updated total cholesterol mmmolL l by simulated year Version 1 3 Isis Innovation Ltd 2010 Chttp vrrw dtu ox ac uk outcomesmodel Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year9 YearlO Yearll Ye 0014 6 5 6 5 6 5 6 5 6 5 6 5 6 5 002B 41 5 1 gt Pil Cholesterol HDL SysBP HbAic AEA Inputs Check Outputs Bootstraps IHD MI He al b HDL Worksheet This worksheet is used to enter HDL cholesterol values mmol l by subject for any or all of the years to be simulated Ideally these should be from a CDC aligned assay SysBP Worksheet This worksheet is used to enter systolic blood pressure values mmHg by subject for any or all of the years to be simulated HbAIc Worksheet This w
17. can use the X statement see the Running DOS or Windows Commands from within SAS section of SAS Companion for the Microsoft Windows Environment Please note that the full path to the outcomes file must be specified in order for the system to work That is you cannot simply use samples outcomes or samples outcomes If the folder containing the UKPDS Outcomes Model software has not been placed on the system path you will need to use the full path to the executable in order for it to work correctly
18. files fname Inputs csv This file contains the following items Ethnic group 1 White 2 Afro Caribbean 3 Asian Indian Age dt Ageinyears S Diagnosis Smoking Smoking status at diagnosis O Never 1 Past smoker or 2 Current smoker of tobacco Current vor status O Never 1 Past smoker or 2 Current smoker of tobacco Discounting start year e g 001A 1 1 M 60 10 85 1 80 N N 0 4 00 1 15 125 7 0 0 4 00 1 15 125 7 0 0 0 0 0 0 0 0 0 002B 1 1 M 60 10 85 1 80 N N 0 4 00 1 10 130 7 5 0 4 00 1 10 130 7 5 0 0 0 0 0 0 0 0 003C 1 1 M 60 10 85 1 80 N N 0 4 00 1 05 135 8 0 0 4 00 1 05 135 8 0 0 0 0 0 0 0 0 0 fname SmokingStatus csv UKPDS Outcomes Model manual Page 25 of 32 This file contains the updated risk factors for Smoking status It is only required 1f you select the Use updated risk factor files option The format is as follows An identifier for the subject Smoking Year 1 smoking status O Never 1 Past smoker or 2 Current smoker of tobacco Smoking Year 40 smoking status O Never 1 Past smoker or 2 Current smoker of tobacco e g OO Ue 2a Lee nen cepa iene pe ea Ue Oe Ten Tee 1102s ROO ere E Oona TO Oe DRE AT EN SPOT Tee 005C saaa ee iment oe ere Onn ear serene fname Cholesterol csv This file contains the updated risk factors for cholesterol It is only required if you select the Use updated risk factor files option The format is as follows D An identifier for the subject Cholesterol
19. in Version 1 3 Corrections a The Smoking status check in the Standalone version has been corrected b The Amputation output in the Standalone version was being written to the IHD file and this has been corrected c The Standalone version now produces cohort outputs d The smoking status for a patient is now estimated once per loop instead of once per patient New Features a Cumulative Event rate output for events has been replaced with Event rate and Long term history rate b Diabetes Related death has been separated into a separate output sheet from Other death c A new group column has been added to the Inputs sheet after the ID column This allows outputs of 2 patient groups to be compared Enter 1 for all patients if not dividing into groups Please note that any input files previously used for the Standalone model will need this column added d The Input Checks have been combined into a single sheet Changes in Version 1 2 1 Corrections a Corrected an issue on page 17 of this manual where the example incorrectly stated that the age entered should be 60 The correct value is 59 New Features a There is now an option to run the Standalone Implementation of the model without user intervention from the command line and other suitable applications UKPDS 8 Study design progress and performance Turner RC Holman RR Matthews DR Oakes SF Bassett PA Stratton IM Cull CA Manley SE Frighi V Diabetologia 1991 34 877 890
20. of the file Enable All Content Always enable this document s active content make this a Trusted Document Advanced Options Select which active content should be enabled This content will be enabled for this session only The following Security Options dialog will appear Microsoft Office Security Options eC Security Alert Macros Macros Macros have been disabled Macros might contain viruses or other security hazards Do not enable this content unless you trust the source of this file Note The digital signature is valid but the signature is from a publisher whom you have not yet chosen to trust More information File Path C UKPDS Outcomes Model v1 3 xls r Signature Signed by University of Oxford Certificate expiration 06 01 2014 Certificate issued by GlobalSign ObjectSign CA Show Signature Details amp Help protect me from unknown content recommended Enable content for this session Trust all documents from this publisher Open the Trust Center Cancel 4 Check the Always trust macros from this publisher box Click OK You will now be able to run the model When the model is opened again this dialog will not appear UKPDS Outcomes Model manual Page 9 of 32 Description of software The UKPDS Outcomes Model software has been embodied in a Microsoft Excel workbook to provide users with a straightforward method for entering or importing details of populations to be e
21. the means standard deviations and count n for HDL cholesterol values by simulated year UKPDS Outcomes Model manual Page 12 of 32 Inputs Check Worksheet SysBP Check This section provides the means standard deviations and count n for systolic blood pressure values by simulated year Inputs Check Worksheet HbAIc Check This worksheet provides the means standard deviations and count n for HbA values by simulated year Outputs Worksheet This worksheet tabulates Life Expectancy Quality Adjusted Life Expectancy and cumulative complication costs together with their respective 95 confidence intervals for each subject specified Overall values for the population are provided as well as Quality Adjusted Life Expectancy values and costs by subject for each year simulated B pk ee ee eed E Ea ese a H I J UKPDS Outcomes Model Outputs Last run 21 10 2010 12 25 Version 1 3 Isis Innovation Ltd 2005 http Ayuny dtu ox ac uk outcomesmode Life 95 CI Total cost of 95 CI expectanc Lower pper complications Lower pper 6417 61 437690 845832 6335 24 420208 8468 40 6499 98 3994 74 9005 22 164 738 2399 7 2070 2 6585 00 3889 8 9280 2 5200 23 2062 6 337 8 gt gt Outputs Bootstraps IHD d MI Heart failure Fi Stroke F4 Amputation F Blindness 4 Renal Failure lt gt ee ae M Ss aS ce RG Ae Sie ee ae ee Se ae ee Expected utility by simulated year Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8
22. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 SysBP check rows Contains three rows the first row will contain the mean value the second row the standard deviation and the third the number of observations for each year Label Row 1 Mean Row 2 SD Row 3 N Year 1 Row mean Row 2 standard deviation Row 3 number of values Year 40 Row I mean Row 2 standard deviation Row 3 number of values e g Id Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10 Year 11 Year 12 Year 13 Year 14 Year 15 Year 16 Year 17 Year 18 Year 19 Y ear 20 Y ear 21 Y ear 22 Y ear 23 Y ear 24 Y ear 25 Year 26 Y ear 27 Year 28 Ycear 29 Y ear 30 Y ear 31 Year 32 Y ear 33 Year 34 Year 35 Y ear 36 Year 37 Y ear 38 Year 39 Y ear 40 Mean 120 0 130 0 120 0 154 0 120 0 5555555555999999999959999 N 1 0 1 0 1 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 HbA Ic check rows Contains three rows the first row will contain the mean value the second row the standard deviation and the third the number of observations for each year UKPDS Outcomes Model manual Page 31 of 32 Row Mea Row SD Row oN Row mean Row 2 standard deviation Row 3 number of values Year 40 Row I mean Row 2 standard deviation Row 3 number of values e g Id Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10 Year 11 Year 12 Year 13 Year 14 Year 15 Year 16 Year 17 Year 18 Year 19 Year 20 Year 21 Year 22 Year 23 Year 24 Year 25 Year 26 Y ear
23. 000 00 0 263 30 000 00 0 263 Use risk factor sheets ta Yor N Repeat random number seed 1 i fo 100 Pre flighi check N Yor N Run Model Percent Complete 100 0 Run complete Time taken 00 00 27 Serial No 1956 Estimated total time Core Version 1 302 Lastrun 10 11 2010 11 52 gt hl Run Model Inputs Check Outputs Bootstraps IHD MI Heart failure Stroke Amputation Blindn 4 Inputs Check Worksheet Subject Characteristics This worksheet provides the means and standard deviation SD or counts by column for Inputs Worksheets parametric or categorical data respectively UKPDS Outcomes Model manual Page 11 of 32 B C D E F G H I J K L MM N O UKPDS Cutcomes Model Inputs check Version 1 3 Isis Innovation Ltd 2005 http Aavew dtu ox ac uk outcomesmodel Subject Characteristics Demographic characteristics Risk factor values at diagnosis of type 2 diabetes Height HbAlec Duration of m i Chol HDL Sys BP 0 Ethnicity Gender Age y diabetes y Weight kg Mean S ib PYD Smoking mmol mmol l mmHg Mean SD ean ean ean D ine pan SD pan SD pan SD 8 8 4 60 63 10 2 50 1 75 1 1 7 403 1 09 133 75 7 71 0 4 1 65 0 2 5 0 05 7 7 0 0 07 0 07 5 99 0 58 0 8 8 8 8 1 8 8 8 8 Group 4 4 4 60 00 10 5 00 1 30 0 0 4 400 1 08 132 50 7 75 0 0 0 00 0 0 0 00 4 4 0 0 00 0 06 5 59 0 56 0 4 4 4 4 0 4 4 4 4 aA About f Inputs Smoking Status Cholesterol HDL SysBP
24. 003 0 009 0 016 0 023 0 029 0 038 0 041 0 045 0 050 0 045 0 050 0 048 0 003 0 008 0 020 0 028 0 033 0 045 0 048 0 055 0 063 0 055 0 058 0 053 0 003 0 010 0013 0018 0 025 0 030 0 035 0 035 0 038 0 035 0 043 0 043 0000 0003 0 008 0 010 0 008 0 015 0 013 0 020 0 025 0 020 0 015 0 010 0 010 0 020 0 050 0 050 0 050 0 050 0 050 0 060 0 060 0 060 0 060 0 060 0 000 0 000 0 000 0 020 0 020 0 020 0 020 0 040 0 060 0 040 0 050 0 040 gt Outputs Bootstraps IHD MI Heart failure Stroke Amputation Blindness lt gt Estimated Smoking Status Worksheet This worksheet shows smoking status values by simulated year as estimated by the UKPDS Outcomes Model If updated smoking status values are provided as inputs they are reproduced in this worksheet UKPDS Outcomes Model Estimated smoking status 0 Non smoker 1 Current smoker of tobacco by simulated year Version 1 3 Isis Innovation Ltd 2010 Chttp yraw dtu ox ac uk outcomesmodel Ye Year Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 YearlO Yearll Year 2 0 0 0 0 gt Diab Death Other Death Estimated Smoking Status Estimated Lipid Ratio Estimated SysBP E gt Estimated Lipid Ratio Worksheet This worksheet shows lipid ratio total to HDL cholesterol values by simulated year as estimated by the UKPDS Outcomes Model If updated risk total and HDL cholesterol values are provided as inputs their ratios are reproduced in this worksheet
25. 52282 0 5445 124442181591 0 533608492109 8486 0 5177780993761616 0 4952035586139475 0 46995 12070178809 0 4474930647829551 0 415502640052 4543 0 3812803861886661 0 3523016758245 1 14 0 3 140333 131927079 0 2763 140229828763 0 238161802185 0538 0 2007580577890224 0 1704081017079923 0 14439 1624023 1226 0 1219905429723924 0 099344929687 4953 0 0806460725548624 0 0645985747096144 0 052243 1 174343482 0 03958 19821623 122 0 031110114802 6426 0 02585 19262670773 0 0195990199754988 0 00 fname InputsCheck csv Each section contains 3 rows For parametric columns the first row will contain the mean value and the second row the standard deviation of the data the equivalent column in the UKPDS Outcomes Model manual Page 29 of 32 inputs sheet For non parametric columns the first row contains the number of values that match the first category value the second row the second value etc These 3 rows are repeated for All subjects Group 1 and Group 2 Subject characteristics rows Age e g Group Count Ethnicity 1 2 3 Gender M F Age y Mean SD N Duration of diabetes y Mean SD N Weight kg Mean SD N Height m Mean SD N Atrial Fib Y N PVD Y N Smoking 0 1 2 Chol mmol l Mean SD N HDL mmol l Mean SD N Sys BP mmHg Mean SD N HbAIc Mean SD N Smoking 0 1 2 Chol mmol l Mean SD N HDL mmol l Mean SD N Sys BP mmHg Mean SD N HbAIc Mean SD N IHD Mean SD N CHF Mean SD N Amp Mean SD N Blind Mean SD N Rena
26. A minimum of 3MB free space needs to be available on windows system drive and a further 5MB in the installation folder The setup program will allow you to select a folder to install into The following files are installed in the folder e UKPDSOutcomesModell 3 xls is the Microsoft Excel workbook in which the UKPDS Outcomes Model is embodied e UKPDSOutcomesModel exe is the standalone implementation of the UKPDS Outcomes Model e OQOutcomesCore 3 dll which is installed in the windows system folder and must not be renamed moved or amended in any way A link to the UKPDS Outcomes Model website is provided along with an uninstaller Macintosh Installation Double click or run the file UKPDS Outcomes Model Macintosh dmg to mount the disk image Install the Application by dragging it to the applications folder The Microsoft Excel implementation of UKPDS Outcomes Model is not currently available for the Macintosh platform Linux Installation Copy the outcomes tar gz and extract the installation files from the archive using the following commands gunzip outcomes tar gz tar xf outcomes tar Alternatively you may be able to double click the archive and drag the outcomes folder to a location of your choice This folder contains five items the application UKPDSOutcomesModel two folders UKPDSOutcomesModel Libs and Resources which must be kept in the same folder as the application and two example input files Sample ou
27. HbAic AWE E Inputs Check Outputs Bootstraps IHD MI lt P Q R S T U y w x Y z AA AB Current risk factor values Chol HDL Sys BP smoking mmol l mmol l mmHg HbAlc 0 0 1 2 ean S D ean S D ean S D ean SD 7 4 03 1 09 133 75 771 0 0 07 0 07 5 99 0 58 1 8 8 8 8 4 4 00 1 08 132 50 775 0 0 00 0 06 5 59 0 56 0 4 4 4 4 gt ot About Inputs Smoking Status Cholesterol HDL SysBP HbAic Ae Inputs Check f Outputs Bootstrans IHD MI lt Inputs Check Worksheet Smoking Status Check This section provides counts of the number of 0 1 or 2 smoking status values by simulated year Smoking status check by simulated year All Yearl Year2 Year3 Year 4 Year 5 Year 6 Year Year8 Year9 Yearl0 Os 1 0 0 0 0 0 0 0 0 0 ls 1 0 0 0 0 0 0 1 0 0 2s 1 0 2 1 2 1 0 0 0 0 Group 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 1 0 1 1 0 0 0 0 Group 2 Inputs Check Worksheet Cholesterol Check This section provides the means standard deviations and count n for total cholesterol values by simulated year Cholesterol check by simulated year All Year Year2 Year3 Year 4 Year 5 Year 6 Year7 Year8 Year9 Year 10 Mean 5 30 6 50 6 50 6 50 6 50 5 80 6 50 SD 1 20 0 00 0 00 0 00 0 00 070 0 00 N 4 2 2 2 2 4 2 0 0 0 Group Mean 5 30 6 50 6 50 6 50 6 50 5 80 6 50 SD 1 20 0 70 N 2 1 1 1 1 2 1 0 0 0 Group 2 Inputs Check Worksheet HDL Check This section provides
28. N Repeat random number seed 1 fi fo 100 Pre flight check N Yor N Run Model Percent Complete 100 0 Run complete Time taken 00 00 27 Serial No 1956 Estimated total time Core Version 1 302 Lastrun 10 11 2010 11 52 gt Pil Run Model Inputs Check f Outputs Bootstraps IHD MI Heart failure Stroke Amputation Blindn 4 Number of subjects Sets the number of subjects to be included in the simulation number with data available shown alongside Number of loops Sets the number of internal loops or Monte Carlo trials per subject to reduce Monte Carlo error sometimes termed variability or first order uncertainty The predicted outcome for each subject varies with each Monte Carlo trial but will stabilise if a sufficient number of Monte Carlo simulations are performed This is done by running the simulation repeatedly on the same patient but with different sets of random numbers Performing more loops will produce more stable predicted outcomes for each subject but will take longer At least 1 000 UKPDS Outcomes Model manual Page 17 of 32 Number of bootstraps Start at bootstrap loops are required to obtain stable estimates for subjects A minimum of 100 may be appropriate when looking at overall values for a cohort Sets the number of bootstraps to address parameter uncertainty sometimes termed second order uncertainty and estimate confidence intervals around Life Expectancy Quality Adjusted Life
29. UKPDS Outcomes Model manual Page 4 of 32 Changes in Version 1 2 Bug Fixes a b Incorrect handling of updated smoking status risk factor values has been fixed In version 1 1 past smokers value 1 were treated as current smokers value 2 and current smokers were treated as a doubling of the smoking effect Updated risk factor values are now applied correctly at the end of the year stated rather than at the start as in version 1 1 New Features a b c d e g h There is now an option to use any of 100 random number sequences This allows different random number sequences to be selected and exactly the same sequence to be used repeatedly as desired The 1000 bootstrap parameter sets are always used in the same sequence with wrap round to the first set if necessary In version 1 2 the option to choose which bootstrap parameter set is to be used at the start of a model run has been added Updated estimated annual risk factor levels generated by the model for each subject are now provided on output worksheets for inspection or can to be copied to input sheets for use in further model runs 1f desired A pre flight check option ensures that all of the input data are present and within acceptable ranges BEFORE the model is run Worksheet tabs have been coloured for ease of identification PC version only as follows e Input worksheets Yellow e Run worksheet
30. UNIVERSITY OF OXFORD UKPDS Outcomes Model User Manual ISIS Innovation Ltd 2010 Version 1 3 21st January 2011 Produced by the University of Oxford Diabetes Trials Unit DTU and Health Economics Research Centre HERC www dtu ox ac uk outcomesmodel UKPDS Outcomes Model manual Page 2 of 32 Conditions of use and copyright Software for the UKPDS Outcomes Model ISIS Innovation Ltd 2010 is available to third parties under license from Isis Innovation Ltd the technology transfer company of the University of Oxford subject to the following copyright and conditions No charge is made to academic organisations but commercial organisations must pay an appropriate fee The University is a charitable foundation devoted to education and research and in order to protect its assets for the benefit of those objects the University must make it clear that no condition is made or to be implied nor is any warranty given or to be implied as to the accuracy of this Tool or that it will be suitable for any particular purpose or for use under any specific conditions Furthermore the University disclaims all responsibility for the use which is made of the Tool However nothing in this statement will operate to exclude or restrict any liability which the University may have for death or personal injury resulting from negligence It is a further condition that the software obtained from this site is not distributed further without the same co
31. Year 38 Year 39 Year 40 Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10 Year 11 Year 12 Year 13 Year 14 Year 15 Year 16 Year 17 Year 18 Year 19 Year 20 Year 21 Year 22 Year 23 Year 24 Year 25 Year 26 Year 27 Year 28 Year 29 Year 30 Year 31 Year 32 Year 33 Year 34 Year 35 Year 36 Year 37 Year 38 Year 39 Year 40 Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10 Year 11 Year 12 Year 13 Year 14 Year 15 Year 16 Year 17 Year 18 Year 19 Year 20 Year 21 Year 22 Year 23 Year 24 Year 25 Year 26 Y ear 27 Year 28 Year 29 Year 30 Year 31 Year 32 Year 33 Year 34 Year 35 Year 36 Year 37 Year 38 Year 39 Year 40 001A 0 0080 0 0100 0 0130 0 0130 0 0120 0 0140 0 0130 0 0180 0 0170 0 0160 0 0170 0 0110 0 0170 0 0140 0 0180 0 0160 0 0090 0 0050 0 0060 0 0090 0 0030 0 0040 0 0070 0 0080 0 0020 0 0040 0 00 0 0030 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 001 755652859873 7 0 0027598374665755 0 0065230780564 837 0 00592 16044303806 0 0046217977014449 0 0060554268005382 0 0050837630875268 0 0096350873932 594 0 0085915095389478 0 0079060172615943 0 0088339907699290 0 0026239992221582 0 0089305640766 158 0 0058183120141619 0 0094460929183439 0 0083808630813191 0 0012046189676190 0 00 0 00 0 00197 83848700172 0 00 0 00 0 000773 1506393681 0 0022933914189248 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 0 0 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 0142443471401263 0 0172401625334245 0 01947692 19435 163 0 02007
32. ble in this workbook or all macros may be disabled In office 2007 you will also see a message like this Clipboard Font e Security Warning Macros have been disabled Options NumSubjects v It will be displayed at the top of your worksheet Clicking the Options button opens the following dialog box UKPDS Outcomes Model manual Page 7 of 32 Microsoft Office Security Options eo Security Alert Macro Macro Macros have been disabled Macros might contain viruses or other security hazards Do not enable this content unless you trust the source of this file Note The digital signature is valid but the signature is from a publisher whom you have not yet chosen to trust More information File Path J 5 Outcomes Model Release 1 3 Excel UKPDS Outcomes Model v1 3 xls r Signature Signed by University of Oxford Certificate expiration 06 01 2014 Certificate issued by GlobalSign ObjectSign CA Show Signature Details Help protect me from unknown content recommended Enable this content Open the Trust Center L Cancel ZA Check the Trust all documents from this publisher box then click OK You will now be able to run the model When the model is opened again this dialog will not appear Microsoft office 2010 This behaves in the same way as MS Office 2007 in that clicking Run will open the following dialog Microsoft Office Excel x Cann
33. ct two Start of discounting 0 for both subjects Step 2 Go to the Run Model sheet To obtaining point estimates in an initial simulation we will deal only with Monte Carlo error Set the Number of subjects to 2 the Number of loops to 10 000 to reduce Monte Carlo error the Maximum years simulated to 40 and the Discount rate to 0 At this stage we will not estimate confidence intervals so set the Number of bootstraps to 0 Set the Use risk factor sheets to N Step 3 Run the model and then look at the Outputs sheet The Life Expectancy for subject one should be approximately 16 6 years 12 3 QALEs and for subject two with the lower HbAi somewhat greater at approximately 17 5 years 13 1 QALEs Estimates may differ slightly between simulations as the Outcomes model may have used a different set of random UKPDS Outcomes Model manual Page 21 of 32 numbers To produce these estimates the model has forecast values for smoking status total amp HDL cholesterol systolic blood pressure and HbA for each year simulated based on the current risk factor values entered The time paths for the risk factor equations used are those plotted below from figure 3 of UKPDS paper 68 It can be seen that subjects with high initial HbA levels will tend to have lower values over time whereas those with low levels initially will tend to have higher values over time os so s so os so s 5 l7 al 12
34. e appropriate Inputs worksheet cells or by copying and pasting it from other software applications No results will be produced for subjects that have missing data items It is the responsibility of the user to ensure that only valid values are entered as the software applies few data entry checks The workbook supplied contains sample data from 8 hypothetical subjects for the user to experiment with or to replace with their own data UKPDS Outcomes Model Inputs Version 1 3 Isis Innovation Ltd 2005 http Aavew dtu ox ac uk outcomesmodel Subject Characteristics Smoking O Never 1 Past smoker or 2 Current smoker of tobacco Py gt gt I Input TOU 1 1 1 1 2 2 2 2 Smoking Status Cholesterol lt HDL SysBP HbAic AS Inputs Check Demographic characteristics Risk factor values at diagnosis of type 2 diabetes Ageat Duration of diagnosis diabetes Weight Height Chol HDL Sys BP Hb lc o Atrial Fib PVD Smoking mmol1 mmol z 1 15 1 10 1 05 1 00 1 15 1 10 1 05 1 00 utputs Boo lt Gender ee a N OIlS oc o 09 eo 9 oo The items that need to be provided for each subject are ID Subject identifier optional Demographic characteristics Ethnicity 1 White Caucasian 2 Afro Caribbean 3 Asian Indian Group Gender Age Dur Weight Height l or 2 to compare subject groups Enter 1 if not comparing subject groups M Male F Female Age in years at d
35. ear 39 Year 40 Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Y ear 9 Year 10 Year 11 Year 12 Year 13 Year 14 Year 15 Year 16 Year 17 Year 18 Year 19 Year 20 Year 21 Y ear 22 Year 23 Year 24 Year 25 Year 26 Year 27 Year 28 Year 29 Year 30 Year 31 Year 32 Year 33 Year 34 Year 35 Year 36 Year 37 Year 38 Year 39 Year 40 001A 8 3597820337959075 7 4544194001062234 9 265 1446674855915 6 3940489786605417 5 71017857889 12593 7 0779193784298240 5387 2546766092 182224 4175 3904489306460164 6599 1189042877904285 0 77 26364999999970 0 7175888888888760 0 65906928983 17443 0 6026370775342688 0 5483205998113291 0 48 5693905248 6692 0 4249759905889489 0 3790787243920463 0 3346897595845 152 0 2892488557981878 0 24 73733209905486 0 2 10997869587 1526 0 1762716066573453 0 1412459758940239 0 1112532337019749 0 08 67413384797937 0 06570295 11098423 0 048225987 1 100626 0 0347657473087408 0 0237508289787507 0 01 53888 186642400 0 00877038 16469612 0 0047712619147892 0 0027693485783616 0 0015046017334943 0 00 05761146258911 0 0000000000000000 0 0000000000000000 0 0000000000000000 0 0000000000000000 0 00 QO000000000000 0 0000000000000000 0 0000000000000000 0 0000000000000000 0 0000000000000000 0 00 00000000000000 0 0000000000000000 0 0000000000000000 0 0000000000000000 0 0000000000000000 444 5269999999999868 479 2144927536298269 490 5365352750278589 463 5 133 171276767712 443 2882824335 0972 12 390 7765862023767340 385 863693 1 112786783 317 9785380768437903
36. has remained low rather than tending to rise over time Example 3 UKPDS Outcomes Model manual Page 22 of 32 To obtain confidence intervals for Life Expectancy and Quality of Life Expectancy estimates proceed as follows Step 1 Go to the Run Model sheet Set the Number of loops to 1 000 and the Number of bootstraps to 1 000 Run the model The simulation will take a little longer to run approximately 20 minutes on PC with a Pentium IV processor Go to the Outputs sheet The Life Expectancy and Quality of Life Expectancy estimates will now have 95 confidence intervals around them Example 4 To compare the impact of different risk factor profiles on two groups of subjects enter the population characteristics for group one and group two Run the model Go to the Outputs sheet The average life years quality adjusted life expectancy and costs are provided for all patients All row and for each of the two groups The incremental life years quality adjusted life years and costs are provided in the Difference row UKPDS Outcomes Model manual Page 23 of 32 Standalone Implementation of the UKPDS Outcomes Model This implementation of the UKPDS Outcomes Model is a standalone program that does not require Microsoft Excel and can handle an unlimited number of subjects When the program is started the user 1s presented with a dialog box which is the equivalent of the Run Model worksheet in the Excel implementation T
37. his is used to set the program parameters and to start a simulation UKPDS Outcomes Model version 1 3 7 O x File Edit Number of loops kooo Pre flight check Number of bootstraps 10 0 to 999 Start at bootstrap 1 1 to 999 Number of years simulated 40 1 to 40 F Use risk Factor files Initial rate for n years Subsequent rate QALE Life expectancy discount rate 3 5 30 3 0 Total costs discount rate 3 5 30 3 0 Initial utility 0 785 Random number sequence 1 1 to 100 Cost in the absense of complications 374 00 Reset Costs At time of event In subsequent years Fatal Non Fatal Utility decrement Cost Utility decrement Reset QALEs IHD 2696 00 0 090 891 00 0 090 MI 1366 00 5199 00 0 055 656 00 0 055 Heart Failure 3007 00 3007 00 0 108 1054 00 0 108 Stroke 4011 00 3180 00 0 164 601 00 0 164 Amputation 10354 00 10354 00 0 280 598 00 0 280 Blindness 1358 00 0 074 575 00 0 074 Renal Failure 30000 00 30000 00 0 263 30000 00 0 263 Percent complete 0 00 Number of subjects Time taken Serial no Estimated total time Core version The standalone implementation of the UKPDS Outcomes Model reads inputs required from individual data files rather than worksheets in a Microsoft Excel workbook Similarly each set of program outputs are written to separate data files This implementation of the UKPDS Outc
38. iagnosis of diabetes Duration in years since diagnosis of diabetes Weight in kilograms at diagnosis of diabetes 1 0 Kg 2 2 pounds Height in metres at diagnosis of diabetes 1 0 metre 39 inches Risk factor values at diagnosis of type 2 diabetes Atrial Fib Presence of atrial fibrillation Y Yes N No PVD Smoking Chol HDL SysBP HbAle Presence of peripheral vascular disease Y Yes N No Smoking status O Never 1 Past smoker 2 Current smoker of tobacco Total cholesterol mmol l 1 0 mmol l 38 6 mg dl HDL cholesterol mmol l 1 0 mmol l 38 6 mg dl Systolic blood pressure mm Hg HbA Current risk factor values leave blank if data not available Smoking Chol HDL SysBP HbAlec Smoking status O Never 1 Past smoker 2 Current smoker of tobacco Total cholesterol mmol l 1 0 mmol l 38 6 mg dl HDL cholesterol mmol l 1 0 mmol l 38 6 mg dl Systolic blood pressure mm Hg HbA Years since pre existing event Full definitions of the input variables used are given in UKPDS paper 68 Page 15 of 32 UKPDS Outcomes Model manual Page 16 of 32 IHD Time in years since first diagnosis of ischaemic heart disease 0 if none CHF Time in years since first diagnosis of chronic heart failure 0 if none Amp Time in years since first amputation 0 if none Blind Time in years since first diagnosed blind in one eye 0 if none Renal Time in years since first diagnosed with renal failure 0 if none
39. l Mean SD N Stroke Mean SD N MI Mean SD N Discounting offset y Mean SD N All 8 8 4 60 0 10 0 82 5 1 7 0 0 8 4 0 1 1 132 5 7 8 8 4 0 1 1 132 5 7 8 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 4 0 0 0 0 4 9 0 1 8 8 0 0 0 0 1 11 0 1 1 0 0 0 0 1 11 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 8 8 8 8 0 8 8 8 8 0 8 8 8 8 8 8 8 8 8 8 8 8 Smoking status rows Contains three rows for each group the first row contains the number of values that match the first category value the second row the second value etc Row 1 Us R 1s Row 2 Row Never Row 2 Past smoker Row 3 Current smoker of tobacco Row I Never Row 2 Past smoker Row 3 Current smoker of tobacco e g Id Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10 Year 11 Year 12 Year 13 Year 14 Year 15 Year 16 Year 17 Year 18 Year 19 Year 20 Year 21 Year 22 Year 23 Year 24 Year 25 Year 26 Year 27 Year 28 Year 29 Year 30 Y ear 31 Year 32 Year 33 Year 34 Year 35 Y ear 36 Year 37 Year 38 Year 39 Year 40 UKPDS Outcomes Model manual Page 30 of 32 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Cholesterol check rows Contains three rows for each group the first row will contain the mean value the second row the standard deviation and the third the number of
40. l number of loops Monte Carlo trials Note that a subject may have events such as a myocardial infarction in a particular year as well as a diabetes related death as these events are not mutually exclusive ae ait ae ae wae wae a UKPDS Ow comes Model IHD events Version 1 3 Isis Innovation Ltd 2005 http w dtu ox ac uk outcomesmodel Event rate by simulated year point estimate ID Year Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year9 Year 10 All 0 003 0 006 0 008 0 008 0 006 0 009 0 008 0 006 0 006 0 000 Group 1 0 003 0 005 0 013 0 010 0 005 0 013 0 003 0013 0 010 0 000 Group 2 0 003 0 008 0 003 0 005 0 008 0 005 0 013 0 000 0 003 0 000 Difference 0 000 0 003 0 010 0 005 0 003 0 008 0 010 0013 0 008 0 000 001A 0 010 0 010 0 030 0 000 0 000 0 000 0 000 0 010 0 000 0 000 0025 0 000 0 000 0 000 0 030 0 000 0 000 0 000 0 020 0 020 0 000 gt Outputs Bootstrans IHD MI_ Heart failure Stroke Amputation Blindness lt gt Also shown is the expectation of the subject being still alive with a long term history of the event see IHD example below This value is calculated by dividing the total simulated number of events by the total number of loops Monte Carlo trials where the subject is alive DR ps pr pu pv pw _ px by bz EFA EB Long term history rate by simulated year point estimate Yearl Year2 Year3 Year4 Years Year6 Year Year8 Year9 YearlO Yearll Yearl2 0
41. ll subsequent years are listed in column F The default costs are derived from UKPDS paper 65 updated to 2004 prices using the Hospital and Health Services Price Index and reflect health care resource use in the United Kingdom in year 2000 Other costs can be entered by the user Click this button to revert to default Costs as supplied with this version of the Outcomes Model Click this button to revert to the default QALE decrements as supplied with this version of the Outcomes Model Allows user to specify incorporation of data for risk factor entry worksheets The model will forecast values for any missing data Sets which of the 100 random number sequences available is to be used This option ensures that all of the input data are present and within acceptable ranges BEFORE the simulation is run Click this button to start the simulation Provides an indication of progress Provides an indication of elapsed time taken Provides an indication of the estimated time to completing all simulations The model can be stopped at any time by holding down the control key and pressing the break key This worksheet displays the Life Expectancy Quality Adjusted Life Expectancy and complication cost estimates for each subject together with their respective 95 confidence intervals The overall results for the population simulated are shown in the first row of the table B c pb E F G H UKPDS Outcomes Model Outputs Last run
42. mated SysBP Estimated HbAic These output sheets display the updated estimated annual risk factor levels for individual subjects Data from these sheets can be used to populate the annual risk factor values sheets by copying and pasting To use the estimated annual lipid ratio data in this fashion copy the values to the Cholesterol worksheet and set all values in the HDL worksheet to 1 UKPDS Outcomes Model manual Page 20 of 32 Worked Examples Example 1 To determine the likely impact of a fixed difference in HbA values over time say 11 0 versus 7 0 on Life Expectancy and Quality Adjusted Life Expectancy for a sixty year old patient with type 2 diabetes of one year s duration proceed as follows Step 1 Using the nputs sheet enter characteristics for two patients that have identical risk factor levels e g Demographic characteristics Group l Ethnicity 1 White Gender M Male Age at diagnosis 59 years Duration of diabetes 1 year Weight 100 Kg Height 1 74 metres Risk factor values at diagnosis of type 2 diabetes Atrial Fib N No PVD N No Smoking 0 Never smoked Chol 4 0 mmol l HDL 1 0 mmol l SysBP 120 mm Hg HbAIc 11 0 for subject one HbAlc 7 0 for subject two Current risk factor values Smoking 0 Never smoked Chol 4 0 mmol l HDL 1 0 mmol l SysBP 130 mm Hg Note the value is higher than at diagnosis HbAIc 11 0 for subject one HbAlIc 7 0 for subje
43. nditions and copyright statements being imposed Those seeking to incorporate any part of the UKPDS Outcomes Model into other software projects must seek the permission of the copyright holders before distribution or publication of their software Licensing the software To obtain a copy of the UKPDS Outcomes Model software and a license to use it please contact Brendan Spillane Project Manager Isis Innovation Ewert House Ewert Place Summertown Tel 44 0 1865 614423 Oxford OX2 7SG Fax 44 0 1865 280831 United Kingdom Email brendan spillane i1sis ox ac uk For all queries concerning the UKPDS Outcomes Model and its appropriate use please read this manual and the web site FAQ www dtu ox ac uk outcomesmodel If your question remains unanswered email erc dphpc ox ac uk For technical enquiries concerning software installation email outcomes model dtu ox ac uk Background The UKPDS Outcomes Model is a computerised simulation designed to estimate Life Expectancy Quality Adjusted Life Expectancy and costs of complications in people with type 2 diabetes It uses the equations and algorithms published in the UK Prospective Diabetes Study UKPDS paper 68 which should be read prior to using this software Caution should be applied if model results are extrapolated to populations that differ A model to estimate the lifetime health outcomes of patients with Type 2 diabetes the United Kingdom Prospective Diabetes Study UKPDS
44. observations for each year Label Row Mean Row 2 SD Row 3 N Year 1 Row 1 mean Row 2 standard deviation Row 3 number of values Year 40 Row I mean Row 2 standard deviation Row 3 number of values e g Id Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10 Year 11 Year 12 Year 13 Year 14 Year 15 Year 16 Year 17 Year 18 Year 19 Year 20 Year 21 Year 22 Year 23 Year 24 Year 25 Year 26 Y ear 27 Year 28 Year 29 Year 30 Y ear 31 Year 32 Year 33 Year 34 Year 35 Year 36 Year 37 Year 38 Year 39 Year Mean 0 5 0 0 0 0 0 0 2 0 l O0 Uana SD l rO E E ny ears ee N 2 1 1 1 1 2 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 HDL check rows Contains three rows the first row will contain the mean value the second row the standard deviation and the third the number of observations for each year Label Row Mean Row 2 SD Row 3 N Year 1 Row mean Row 2 standard deviation Row 3 number of values Year 40 Row I mean Row 2 standard deviation Row 3 number of values e g Id Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10 Year 11 Year 12 Year 13 Year 14 Year 15 Year 16 Year 17 Year 18 Year 19 Year 20 Year 21 Year 22 Year 23 Year 24 Year 25 Year 26 Year 27 Year 28 Year 29 Year 30 Year 31 Year 32 Year 33 Year 34 Year 35 Year 36 Year 37 Year 38 Year 39 Year Mean 0 5 0 0 0 0 0 0 2 0 l BOF OG EE E E N SD l A E E EE T N 2 1 1 1 1 2 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
45. omes Model uses a comma separated values CSV format for both input and output data files Once the parameters for running a particular simulation have been entered they must be saved to a file before the model can be run By convention the parameter set filename name is used as prefix identifier for files related to this particular simulation For example if the parameter set file is Sample it will be saved as Sample outcomes and the program will look to read patient characteristics from a file called Sample Inputs csv smoking status data from Sample SmokingStatus csv etc UKPDS Outcomes Model manual Page 24 of 32 Previously saved parameter set files can be loaded amended and saved under a different filename in order to run different simulations Parameter set files must only be modified using the standalone implementation of the UKPDS Outcomes Model to preserve their integrity CSV File Format Each row in UKPDS Outcomes Model CSV files contains data for one subject Data items within each row must be separated by a comma and rows by a carriage return line feed is optional Each row within the file must contain a complete set of the data items required for the file in question Missing values are indicated simply by leaving nothing between concomitant delimiters Input files An Inputs file is essential but files for risk factor value changes over time are optional No heading rows should be used in input
46. or year 40 or updated risk factor value if provided fname EstimatedHbA Ic csv HbAlIc values as estimated by the UKPDS Outcomes Model If updated risk factors are provided they are reproduced in this sheet The identifier for the subject as provided in the Inputs file Estimated value for year 1 or updated risk factor value if provided Estimated value for year 40 or updated risk factor value if provided Automating runs of the model As of version 1 2 1 of the Standalone Implementation of the UKPDS Outcomes Model it is possible to start a simulation of the model without user intervention This feature called batch mode allows the model to be run from the command line or even from other suitable applications To run the model in batch mode you need to issue the following command UKPDS Outcomes Model manual Page 32 of 32 UKPDS Outcomes Model exe run lt name of outcomes file gt For example UKPDS Outcomes Model exe run c Sample outcomes This would start the Standalone Implementation of the software load the specified parameter set file and start the simulation Once the simulation is complete the program will quit leaving the output files in the same directory as the outcomes file In order to use this facility the application wishing to start the simulation must be able to issue commands to the operating system For example applications written in Visual Basic are able to do this using the Shell function From SAS you
47. orksheet is used to enter HbA values by subject for any or all of the years to be simulated Ideally these should be from a DCCT Diabetes Control and Complications Trial or NGSP National Glycohemoglobin Standardization Programme aligned assay Run Model Worksheet This worksheet is used to set run time parameters including initial and subsequent discount rates and to run the model If desired the default complication associated costs and utility values can be replaced with user defined values UKPDS Ohtcomes Model Run Model _ Version 1 3 Isis Innovation Ltd 2010 Chttp vraw dtu ox ac uk outcomesmodel Number of subjects 8 available Number of loops 100 Number ofhootstraps 500 Ofo 999 Start at bootstrap 1 1 fo 999 Number of years simulated 40 lfo 40 Initial rate for n years Subsequent rate QALE Life expectancy discount rate 3 5 30 3 0 Oto 100 Total costs discount rate 3 5 30 3 0 Oto 100 Initial utility 0 785 Otol Cost in the absense of complications 374 00 At time of event In subsequent years Fatal Non fatal Utility decrement Cost Utility decrement THD 2 696 00 0 090 891 00 0 090 Pe eee MI 1 366 00 5 199 00 0 055 56 00 0 055 Heart failure 3 007 00 3 007 00 0 108 1 054 00 0 108 Stroke 4011 00 3 180 00 0 164 601 00 0 164 Reset QALEs i Amputation 10 354 00 10 354 00 0 280 598 00 0 280 Blindness 1 358 00 0 074 575 00 0 074 Renal failure 30 000 00 30
48. ot run the macro UKPDS Outcomes Model xis RunModelPage The macro may not be available in this workbook or all macros may be disabled Wrap Ta ad Merge amp Alignment fe UKPDS Outcomes Model Run Model UKPDS Outcomes Model manual Page amp of 32 Click File The Microsoft Office Backstage view appears In the Security Warning area on the Enable Content button click the down arrow Home Insert Page Layout Formulas Data Review View Acrobat Lal Save Gl Save As Information about UKPDS Outcomes Model v1 3 C UKPDS Outcomes Model v1 3 xls 7 Open Gi Close A pm Security Warning Active content might contain viruses and other security hazards The following content has been disabled Enable Recent Content 7 Macros You should enable content only if you trust the contents of the file Trust Center Settings Properties 7 New s Learn more about Active Content Print Compatibility Mode Some new features are disabled to prevent problems when working with previous versions of Office Converting this file will enable these features but Related Dates Help may result in layout changes Save amp Send Last Modified ay Add Ins 7 2 Options Permissions learn more about the publisher Security Warning Active content might contain viruses and other security hazards The following content has been disabled Macros You should enable content only if you trust the contents
49. r eres nrery rete Ore mmree we aren ee Output files Each time the program is run a complete set of output files using the parameter set filename as their prefix will be produced Successive program runs using the same name will overwrite previously saved files Header rows are provided for each output file fname Outputs csv D Life expectancy Life expectancy point estimate 95 CI Lower Life expectancy lower CI 95 CI Upper Life expectancy upper CI Total QALE Total quality adjusted life expectancy point estimate 95 CI Lower Total quality adjusted life expectancy lower CI 95 CI Upper Total quality adjusted life expectancy upper CI Total cost of complications Total cost of complications point estimate 95 CI Lower Total cost of complications lower CI 95 CI Upper Total cost of complications upper CI Utility Year 1 Utility for year 1 Cost for year Cost for year 40 e g 3999999999 Xpected utility by simulated year 555555555559999999999999999990009 L Otal cost by simulated year Id Life expectancy 95 CI Lower 95 CI Upper Total QALE 95 CI Lower 95 CI Upper Total cost of complications 95 CI Lower 95 CI Upper Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10 Year 11 Year 12 Year 13 Year 14 Year 15 Year 16 Year 17 Year 18 Year 19 Year 20 Year 21 Y ear 22 Year 23 Year 24 Year 25 Year 26 Year 27 Year 28 Year 29 Year 30 Year 31 Year 32 Year 33 Year 34 Year 35 Year 36 Year 37 Year 38 Y
50. ss Renal Failure lt gt AY Az BA BB Be BD BE BF BG BH BE BF BK Total cost by simulated year Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year9 YearlO Yearll Yearl2 Year 1l 455024 454414 450285 450635 441510 410 134 457804 395014 364 746 407468 373 100 321668 258 42 445805 474923 495518 481 164 459 156 402652 415 145 399330 350949 402014 372221 332507 288 386 464 243 433906 405053 420 107 423 864 417617 500464 390698 378543 412923 373979 310828 227 99 18438 41017 90465 61057 35 292 14965 85319 8 631 27 594 10 909 1 757 21 679 60873 443 600 546 338 423 879 344425 450204 364659 314 422 349546 253 799 503 457 511 180 446523 355 11C 444700 353 749 383 337 381446 324142 403 886 337 810 461 770 375096 283 532 266699 198908 128 247 gt Outputs Bootstraps IHD MI Heart failure Stroke Amputation Blindness Renal Failure lt gt Annual Risk Factor Values f Smoking Status g Cholesterol HDL SysBP HbAic A Input worksheets are provided where values for each year to be simulated can be entered for smoking status total cholesterol HDL cholesterol systolic blood pressure and HbA if desired If no values are entered the software will forecast values by default The use of these annual risk factor values can be selected or deselected for any run on the Run Model sheet Annual Estimated Risk Factor Values Estimated Smoking Status f Estimated Lipid Ratio f Esti
51. tcomes and Sample inputs csv Test the application has been installed correctly by running it and selecting the example input file Sample outcomes using the File gt Open menu option The Microsoft Excel implementation of UKPDS Outcomes Model is not currently available for the Linux platform UKPDS Outcomes Model manual Page 6 of 32 Excel Issues The UKPDS Outcomes Model requires VBA macros in order to run the model If they are disabled then the software will not function Microsoft Office 2003 Start Excel and open UKPDS Outcomes Model v1 3 xls The following dialog will show Security Warning x JASoftwaret UKPDS Outcomes Model Release 1 3 Excel UKPDS Outco contains macros by ETAN Details University of Oxford Macros may contain viruses It is usually safe to disable macros but if the macros are legitimate you might lose some Functionality Always trust macros From this publisher i Enable Macros More Info Check the Always trust macros from this publisher box then click Enable Macros You will now be able to run the model When the model is opened again this dialog will not appear Microsoft office 2007 By default Microsoft office 2007 disables VBA macros Attempting to run the model with macros disabled will result in a dialog similar to this Microsoft Office Excel a xi A Cannot run the macro UKPDS Outcomes Model xls RunModelPage The macro may not be availa
52. valuated running the model viewing the results and the ability to print or export them easily to other software packages The workbook contains a series of worksheets for the various inputs and outputs which can be accessed by clicking on the appropriate tab as follows About Worksheet This contains a brief description of the UKPDS Outcomes Model Inputs Worksheet This worksheet is used to enter patient group baseline characteristics risk factor values and history of previous events with one row for each subject Enter 1 for all patients if not dividing into groups UKPDS Outcomes Model Inputs Version 1 3 Isis Innovation Ltd 2005 http favuny dtu ox ac uk outcomesmodel Subject Characteristics Smoking O Never 1 Past smoker or 2 Current smoker of tobacco Demographic characteristics Risk factor values at diagnosis of type 2 diabetes Ageat Durationof diagnosis diabetes Weight Height ID kg 001A 1 1 M 60 10 85 1 30 N N 0 4 00 1 15 125 7 0 002B 1 1 M 60 10 85 1 30 N N 0 4 00 1 10 130 75 gt gt About Inputs Smoking Status Cholesterol HDL SysBP HbSic AGMAT Inputs Check Outpur lt gt Current risk factor values Years since pre existing event Smoking mumnoLT mmoll g 0 4 00 1 15 125 0 4 00 1 10 130 gt About Inputs Smoking Status Cholesterol HDL SysBP HbAic At lt gt Smoking Status Worksheet This worksheet is used to enter the smoking status by subject for any or
53. years If discounting 1s not required enter 0 Sets the utility value for a subject without any complications Used in the calculation of QALYs Cost in the absence of complications Utility Decrements Sets the annual cost incurred by a subject without any of the complications simulated in the model Sets utility decrements for each of seven diabetes related complications IHD MI Heart Failure stroke amputation blindness in the year in which they occur At time of event and thereafter In subsequent years The default values are taken from UKPDS paper 62 except for renal failure If the Philip Clarke Alastair Gray amp Rury Holman Estimating utility values for health states of type 2 diabetic patients using the EQ 5D UKPDS 62 Medical Decision Making 2002 22 340 349 gt Kiberd BA amp Jindal KK Screening to prevent renal failure in insulin dependent diabetic patients an economic evaluation BMJ 1995 311 702 1595 1599 UKPDS Outcomes Model manual Cost Reset Costs ResetQALES Use risk factor sheets Random number sequence Pre flight check Percent Complete Time taken Estimated time remaining Outputs Worksheet Page 18 of 32 user has utility decrements for subsequent years they can be entered in the next column The health care costs associated with each fatal or non fatal diabetes related complication are listed in columns C amp D i e the acute costs The costs that accrue in a

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