EX+EC+DA = ADDA A CDISC Approach to Calculating Drug ... · AccuClin Global Services ~Committed To...
Transcript of EX+EC+DA = ADDA A CDISC Approach to Calculating Drug ... · AccuClin Global Services ~Committed To...
AccuClin Global Services ~Committed To Quantitative Excellence~
EX+EC+DA = ADDA A CDISC Approach to Calculating
Drug Accountability
Haibin Shu Founder and Principal Consultant
March 12, 2015
AccuClin Global Services ~Committed To Quantitative Excellence~
0
5
10
15
20
25
30
35
Finance Life Sci/Healthcare
Based on SAS 2013 revenue
SAS Users Distribution
AccuClin Global Services ~Committed To Quantitative Excellence~
Disclaimer
• Thanks PhilaSUG for the opportunity
PhilaSUG 3/12/2015 3
AccuClin Global Services ~Committed To Quantitative Excellence~
Disclaimer
• Thanks PhilaSUG for the opportunity
• Any views or opinions in this presentation are solely those of the author.
PhilaSUG 3/12/2015 4
AccuClin Global Services ~Committed To Quantitative Excellence~
Introduction
• What is drug accountability?
Information related to the accountability of study drug such as receipt, dispensing, return, and packaging (SDTMIG3.1.2)
PhilaSUG 3/12/2015 5
AccuClin Global Services ~Committed To Quantitative Excellence~
Introduction
• What is drug accountability?
Information related to the accountability of study drug such as receipt, dispensing, return, and packaging (SDTMIG3.1.2)
Calculated as percentage:
Study Drug Taken/Dispensedx100%
PhilaSUG 3/12/2015 6
AccuClin Global Services ~Committed To Quantitative Excellence~
Introduction
• What is drug accountability? Generally require 80 – 120% < 80% > 120% Poor compliance is problematic < 80% > 120%
PhilaSUG 3/12/2015 7
AccuClin Global Services ~Committed To Quantitative Excellence~
Introduction
• Examples
Forgot to take my pills
PhilaSUG 3/12/2015 8
AccuClin Global Services ~Committed To Quantitative Excellence~
Introduction
• Examples
Forgot to take my pills
Forgot having taken my pills
PhilaSUG 3/12/2015 9
AccuClin Global Services ~Committed To Quantitative Excellence~
Introduction
• Examples
Forgot to take my pills
Forgot having taken my pills
Stolen
PhilaSUG 3/12/2015 10
AccuClin Global Services ~Committed To Quantitative Excellence~
Introduction
• Examples
Forgot to take my pills
Forgot having taken my pills
Stolen
Couldn’t open it
Too big to swallow
Somebody borrowed mine!
PhilaSUG 3/12/2015
11
AccuClin Global Services ~Committed To Quantitative Excellence~
Agenda
• CRF collection
• CDISC domains
• Compliance Calculation
• Challenges
• Easy case
• Difficult case
• Final thoughts
PhilaSUG 3/12/2015 12
AccuClin Global Services ~Committed To Quantitative Excellence~
CRF Collections – Root of Issues
• Log-page style
• Visit-by-Visit page style
• Diary style
PhilaSUG 3/12/2015 13
AccuClin Global Services ~Committed To Quantitative Excellence~
• Log-page style
PhilaSUG 3/12/2015
Start Date and Time (DD/MMM/YYYY) (00:00 ~ 23:59)
Stop Date and Time (DD/MMM/YYYY) (00:00 ~ 23:59)
Total Volume Dispensed
(ml)
Total Volume After Infusion
(ml)
Infusion Status
|__|__|/|__|__|__|/20|_1|__| |__|__| : |__|__|
|__|__|/|__|__|__|/20|_1|__| |__|__| : |__|__|
Illustration 1
14
AccuClin Global Services ~Committed To Quantitative Excellence~
• Log-page style
PhilaSUG 3/12/2015
Start Date and Time (DD/MMM/YYYY) (00:00 ~ 23:59)
Stop Date and Time (DD/MMM/YYYY) (00:00 ~ 23:59)
Total Volume Dispensed
(ml)
Total Volume After Infusion
(ml)
Infusion Status
|__|__|/|__|__|__|/20|_1|__| |__|__| : |__|__|
|__|__|/|__|__|__|/20|_1|__| |__|__| : |__|__|
EXSTDTC EXENDTC EXADJ DAORRES DAORRES
DATESTCD = DISPAMT
DATESTCD = RETAMT
Illustration 1
15
AccuClin Global Services ~Committed To Quantitative Excellence~
• Log-page style
PhilaSUG 3/12/2015
Start Date and Time (DD/MMM/YYYY) (00:00 ~ 23:59)
Stop Date and Time (DD/MMM/YYYY) (00:00 ~ 23:59)
Total Volume Dispensed
(ml)
Total Volume After Infusion
(ml)
Infusion Status
|__|__|/|__|__|__|/20|_1|__| |__|__| : |__|__|
|__|__|/|__|__|__|/20|_1|__| |__|__| : |__|__|
EXSTDTC EXENDTC EXADJ DAORRES DAORRES
DATESTCD = DISPAMT
DATESTCD = RETAMT
% CMP = (DISPAMT – RETAMT)/PROJAMTx100%
Illustration 1
16
AccuClin Global Services ~Committed To Quantitative Excellence~
• Visit-by-Visit page style
PhilaSUG 3/12/2015
Pills Dispensed (DD/MMM/YYYY) (00:00 ~ 23:59)
Pills Returned (DD/MMM/YYYY) (00:00 ~ 23:59)
DAORRES DAORRES
DATESTCD = DISPAMT
DATESTCD = RETAMT
Pills Dispensed (DD/MMM/YYYY) (00:00 ~ 23:59)
Pills Returned (DD/MMM/YYYY) (00:00 ~ 23:59)
VISITNUM = a
VISITNUM = b
Illustration 2
17
AccuClin Global Services ~Committed To Quantitative Excellence~
• Visit-by-Visit page style
PhilaSUG 3/12/2015
Pills Dispensed (DD/MMM/YYYY) (00:00 ~ 23:59)
Pills Returned (DD/MMM/YYYY) (00:00 ~ 23:59)
DAORRES DAORRES
DATESTCD = DISPAMT
DATESTCD = RETAMT
%CMP=(DISPAMTa–RETAMTb)/PROJAMTEXx100%
Pills Dispensed (DD/MMM/YYYY) (00:00 ~ 23:59)
Pills Returned (DD/MMM/YYYY) (00:00 ~ 23:59)
VISITNUM = a
VISITNUM = b
Illustration 2
18
AccuClin Global Services ~Committed To Quantitative Excellence~
• Visit-by-Visit page style
DISPAMTa
RETAMTb
PROJAMTEX
PhilaSUG 3/12/2015
19
AccuClin Global Services ~Committed To Quantitative Excellence~
• (e)Diary style
PhilaSUG 3/12/2015
Day 1 Day 2 Day 3 Day 4 Day 5 …
√ √ √
ECSTDTC
ECOCCUR
EC
Illustration 3
20
AccuClin Global Services ~Committed To Quantitative Excellence~
• (e)Diary style
PhilaSUG 3/12/2015
Day 1 Day 2 Day 3 Day 4 Day 5 …
√ √ √
ECSTDTC
ECOCCUR
EX
EC
Derive EXSTDTC, EXENDTC, EXDUR, etc.
Illustration 3
21
AccuClin Global Services ~Committed To Quantitative Excellence~
• (e)Diary style
PhilaSUG 3/12/2015
Day 1 Day 2 Day 3 Day 4 Day 5 …
√ √ √
ECSTDTC
ECOCCUR
EX
EC
Derive EXSTDTC, EXENDTC, EXDUR, etc.
DA Cross reference DISPAMT, RETAMT etc.
Illustration 3
22
AccuClin Global Services ~Committed To Quantitative Excellence~
• (e)Diary style
PhilaSUG 3/12/2015
Day 1 Day 2 Day 3 Day 4 Day 5 …
√ √ √
ECSTDTC
ECOCCUR
EX
EC
Derive EXSTDTC, EXENDTC, EXDUR, etc.
DA
DA
Cross reference DISPAMT, RETAMT etc.
Derive actual usage etc.
Illustration 3
23
AccuClin Global Services ~Committed To Quantitative Excellence~
• (e)Diary style
PhilaSUG 3/12/2015
Day 1 Day 2 Day 3 Day 4 Day 5 …
√ √ √
ECSTDTC
ECOCCUR
EX
EC
Derive EXSTDTC, EXENDTC, EXDUR, etc.
DA
DA
ADDA
Cross reference DISPAMT, RETAMT etc.
Derive actual usage etc. CMP % etc.
Illustration 3
24
AccuClin Global Services ~Committed To Quantitative Excellence~
Comparisons – Challenges of Diversity
PhilaSUG 3/12/2015
Log Visit-by-Visit
Diary/eDiary
Quality Control
+ +++ ++/+++
Programming +++ + ++
Cost Estimate +++ ++ +
+++: Most favored in the corresponding categories +: Least favored in the corresponding categories 25
AccuClin Global Services ~Committed To Quantitative Excellence~
Comparisons – Challenges of Diversity
PhilaSUG 3/12/2015
Log Visit-by-Visit
Diary/eDiary
Quality Control + +++ ++/+++
Programming +++ + ++
Cost Estimate +++ ++ +
+++: Most favored in the corresponding categories +: Least favored in the corresponding categories 26
AccuClin Global Services ~Committed To Quantitative Excellence~
Comparisons – Challenges of Diversity
PhilaSUG 3/12/2015
Log Visit-by-Visit
Diary/eDiary
Quality Control
+ +++ ++/+++
Programming +++ + ++
Cost Estimate
+++ ++ +
+++: Most favored in the corresponding categories +: Least favored in the corresponding categories 27
AccuClin Global Services ~Committed To Quantitative Excellence~
To Summarize: CDISC Domains
• EX: EXSTDTC, EXENDTC etc. => PROJAMT
• EC:
• DA:
PhilaSUG 3/12/2015 28
AccuClin Global Services ~Committed To Quantitative Excellence~
To Summarize: CDISC Domains
• EX: EXSTDTC, EXENDTC etc. => PROJAMT
• EC: ECSTDTC, ECENDTC etc. => EX, DA
• DA:
PhilaSUG 3/12/2015 29
AccuClin Global Services ~Committed To Quantitative Excellence~
To Summarize: CDISC Domains
• EX: EXSTDTC, EXENDTC etc. => PROJAMT
• EC: ECSTDTC, ECENDTC etc. => EX, DA
• DA: DISPAMT, RETAMT, DAORRES => %CMP
PhilaSUG 3/12/2015
30
AccuClin Global Services ~Committed To Quantitative Excellence~
Challenges
• For Visit-by-Visit pages, it’s not always easy to connect DISPAMTa
with RETAMTb
PhilaSUG 3/12/2015 31
AccuClin Global Services ~Committed To Quantitative Excellence~
Challenges
• For Visit-by-Visit pages, it’s not always easy to connect DISPAMTa
with RETAMTb
Practically not all packs/kits were returned at the following Visit – it is difficult to construct CMP % at a Visit level
PhilaSUG 3/12/2015 32
AccuClin Global Services ~Committed To Quantitative Excellence~
Challenges
• For Visit-by-Visit pages, it’s not always easy to connect DISPAMTa
with RETAMTb
Practically not all packs/kits were returned at the following Visit – it is difficult to construct CMP % at a Visit level
PhilaSUG 3/12/2015
Overall CMP % was used: ∑ DISPAMTa - ∑ RETAMTb
33
AccuClin Global Services ~Committed To Quantitative Excellence~
Challenges
• Supporting listing, like
PhilaSUG 3/12/2015
USUBJID VISITNUM Dispensed Bottles
Dispensed Amount
Returned Bottles
Returned Amount
Other Information such as pills lost
a A, B, C, etc. (DASCAT)
(DISPAMT) A, C, etc. (DASCAT)
(RETAMT)
b D, E, etc. (DASCAT)
B, D, E, etc. (DASCAT)
34
AccuClin Global Services ~Committed To Quantitative Excellence~
Challenges
• Supporting listing, like
PhilaSUG 3/12/2015
USUBJID VISITNUM Dispensed Bottles
Dispensed Amount
Returned Bottles
Returned Amount
Other Information such as pills lost
a A, B, C, etc. (DASCAT)
(DISPAMT) A, C, etc. (DASCAT)
(RETAMT)
b D, E, etc. (DASCAT)
B, D, E, etc. (DASCAT)
Every dispensed bottle should be accounted for! 35
AccuClin Global Services ~Committed To Quantitative Excellence~
Pseudo Code Samples
1. Assign dispense sequence based on Dispense/Visit Date
if prev_DISPDT<cur_DISPDT | 0<prev_Visit<cur_Visit then seq_disp+1;
PhilaSUG 3/12/2015 36
AccuClin Global Services ~Committed To Quantitative Excellence~
Pseudo Code Samples
1. Assign dispense sequence based on Dispense/Visit Date
if prev_DISPDT<cur_DISPDT | 0<prev_Visit<cur_Visit then seq_disp+1;
2. Derive return sequence to intertwine with dispense sequence
if seq_disp=1 then seq_ret = 2;
if seq_disp=2 then seq_ret = 3;
…
PhilaSUG 3/12/2015
37
AccuClin Global Services ~Committed To Quantitative Excellence~
Final Thoughts
• CRF design – having the end in mind
PhilaSUG 3/12/2015 38
AccuClin Global Services ~Committed To Quantitative Excellence~
Final Thoughts
• CRF design – having the end in mind
• Equipping with relevant CDISC domains knowledge – will help in preparations and making thoughtful decisions
PhilaSUG 3/12/2015 39
AccuClin Global Services ~Committed To Quantitative Excellence~
Final Thoughts
• CRF design – having the end in mind
• Equipping with relevant CDISC domains knowledge – will help in preparations and making thoughtful decisions
• Benefit of standards – quality, efficiency, and cost-effectiveness
PhilaSUG 3/12/2015 40
AccuClin Global Services ~Committed To Quantitative Excellence~
Appreciation
T h a n k s C D I S C
organization and all
who vo lunteered
their valuable time
and efforts on the
ongoing standards
p r o j e c t s !
PhilaSUG 3/12/2015 41
AccuClin Global Services ~Committed To Quantitative Excellence~
Q & A
Further discussions:
610.457.8118
PhilaSUG 3/12/2015 43