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Information for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Title

Acute Physiology and Chronic Health Evaluation II Clinical Classification (APACHE II)

CDISC ReferenceClinical Classification Supplement to the Analysis Data Model Implementation Guide
QRS Short NameAPACHE II
ADQRS Permission StatusPublic Domain
TeamCDISC ADaM Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0 (or higher as appropriate when doing a supplement revision)
StatusDRAFT (or "REVISION DRAFT" or "FINAL", as appropriate). Status will not be considered "Final" until the supplement is ready to be sent for publication.
Date2022 (date current version released, regardless of status)
NotesThis supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Analysis Data Model Implementation Guide. Naming conventions follow ADaMIG v1.1 or higher.


Revision History

DateVersion
2023  (update whenever text is modified below, even during development)1.0 Draft

© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.

1     General Considerations

This section describes the implementation of the analysis dataset for QRS instruments as based on the Basic Data Structure (BDS) described in the Analysis Data Model Implementation Guide (ADaMIG). The ADaMIG can be found on the CDISC website at https://www.cdisc.org/standards/foundational/adam. The BDS was chosen as the model for analysis datasets of QRS instruments because it supports a wide variety of analyses, including summaries of total score by timepoint as well as change from baseline by timepoint. This data structure allows the ADaM variables PARAM and PARAMCD to come directly from Study Data Tabulation Model (SDTM) variables RS.RSTEST and RS.RSTESTCD, respectively, for individually captured questions, thus ensuring traceability between SDTM and ADaM data. If other analyses are required that are not supported by the BDS, then consideration would be needed as to the appropriate structure. Analysis requirements always drive the design of the analysis datasets.

This ADaM supplement is based on the Acute Physiology and Chronic Health Evaluation II (APACHE II) Clinical Classification Supplement Version 1.1 to the SDTM Implementation Guide for Human Clinical Trials (SDTMIG). 

Note that source SDTM score values may not be suitable for analysis because the values may need to be imputed or transformed. In addition, recalculation of collected values may be needed per analysis rules. In these cases, the derivation of AVAL may not be a simple copying of RS.RSSTRESN. 

These specific analysis implementation details for the APACHE II are meant to be used in conjunction with ADaMIG. All completed questionnaires, ratings, and scales documentation can be found on the CDISC website at: https://www.cdisc.org/foundational/qrs.

1.1   Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the ADaMIG and is covered under Appendix C of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix C of the ADaMIG for a complete version of this material.

CDISC does not endorse any QRS instrument and does not specify how to conduct clinical assessments, protocols, or analyses. CDISC disclaims any liability for your use of this material.

Include this line only for supplements that the US FDA will be reviewing: Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.  

1.2   Copyright Status

CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the APACHE II in the CDISC library of QRS data standards supplementsThere may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use the version attached to the QRS supplement to the SDTMIG, and the QRS supplement to the ADaMIG is based on the same version.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent versions of the SDTM and ADaM controlled terminologies should be accessed through the CDISC website (https://www.cdisc.org/standards/terminology).

1.3   Known Issues

The Acute Physiology and Chronic Health Evaluation (APACHE II) is a severity of disease measurement and mortality estimation tool for adult patients applied within 24 hours of admission to an intensive care unit (ICU). The instrument consists of individual items that are summed up to create a total score. This instrument is generally collected once at Screening/Baseline and used as a predictor of mortality rather than an outcome measure. The total score is normally collected as part of the instrument with no instructions provided for handling missing data. In the majority of cases, where APACHE II is only assessed once and the collected total score used as a baseline covariate, the SDTM RS domain may be sufficient to support the analysis requirements.

2     Rules and References

The primary source used in the development of this supplement is Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Critical Care Medicine 1985; 13(10):818–29. 

All links are valid and referenced information is current as of the date of this ADaMIG QRS supplement. This supplement does not make recommendations for the handling of missing data or adoption of imputation methods.

3     Scoring Software

There is no known publicly available scoring software as of the date of this ADaMIG QRS supplement.

4     Introduction to the Instrument   

The APACHE II, is a severity-of-disease classification system that uses a point score based on the initial values of 12 routine physiologic measurements, age, and previous health status. Scores range from 0 to 71 and higher scores correspond to more severe disease and a higher risk of death. The composite score is based on findings represented in other SDTM domains such as Laboratory Test Results (LB) and Vital Signs (VS).

5     Key Data Checks

The computed total score consists of integer values ranging from 0 to 71. The classification system consists of 11 physiology measures based on a numeric rating scale (0-4) where 0 reflects values within the normal range and an increase in the numeric rating scale represents an increase in the abnormality of the physiology measure in either the high or low direction. the score for The final physiology measure, the Glasgow Coma Score (GCS), is reversed; so that lower scores indicate mild or no head injury and higher scores represent more severe head injury and range from (0-12). Chronological age is divided into disjoint categories and assigned values of (0, 2, 3, 5, 6). For patients with a history of severe organ system insufficiency or who are immunocompromised, a numeric rating of 2 or 5 is assigned for chronic health points, where 2 is assigned “for elective postoperative patients” and 5 is assigned “for nonoperative or emergency postoperative patients”.

6     Example

6.1   Background

Analyses based on ADaM datasets may vary depending on the sponsor, therapeutic area, and the needs of regulatory authorities in their decision-making processes. This fictional example is provided for illustrative purposes only. The ADaM dataset describing the analysis results from an instrument is based on the protocol and statistical analysis plan (SAP) for the individual study.

The example dataset described here is intended to support a variety of analyses, ranging from simple univariate summary statistics on both the actual total scores and change in total score from baseline by visit to other types of by-visit and repeated-measure analyses. For that reason, standard ADaM BDS variables such as AVAL (analysis value) and CHG (change from baseline) have been included in the example. In addition, the APACHE II total score can be divided into categories reflecting disease severity or risk of death and the frequency of subjects reporting in each category may be generated or used for analysis.

In the example presented here, it is assumed that the final APACHE II analysis dataset (ADAPCH) contains all of the original records, plus a record for the computed total score for each patient and assessment timepoint. The date of the assessment—and time of the assessment, if collected—should also be included in the dataset. For traceability, raw item-level responses from the SDTM RS.RSORRES variable, stored separately from the analysis variable AVAL, are included. Derivation type (DTYPE) should be used to clearly indicate records where missing values have been imputed using sponsor-defined imputation methods. If useful for analysis, a summary analysis dataset which includes only the computed total score records may also be created.

6.2   Example Analysis Dataset, Variable and Value-level Metadata

The ADAPCH Dataset Metadata table shows an example of how the APACHE II may be implemented in ADaM. The dataset metadata is a recommendation for the dataset name, label, structure, and keys. These can be modified for sponsor-specific standards and analyses. 

(Use the table macros to insert these tables. they reside at the end of the document like an appendix)

ADAPCH Dataset Metadata

The ADAPCH Variable Metadata table contains an example of analysis variable metadata for a subset of possible variables available for the APACHE II. Example value-level metadata are found in the Parameter Value Level List - ADGDSSF [AVAL] metadata table. Derivations for AVALCAT1 and AVAL included in the Derivation column were obtained from the scoring instructions  for the GDS SHORT FORM[1] and are described in the Introduction to the Instrument section of this supplement. The ADAPCH Variable Metadata table does not include all of the possible variables that may be present in the Subject-Level Analysis Dataset (ADSL) and copied to the BDS structure analysis dataset, with the exception of the required STUDYID and USUBJID. For a complete list of available ADSL variables, consult the ADaMIG. Some ADSL variables (e.g., INVNAM) were included in this example for stratification, and are not required. Additional covariates or other variables may be added as needed for analysis. There is no specific ordering of variables recommended in this supplement. The SDTM variables were placed next to the corresponding derived ADaM variables for illustration purposes only. 

Update the below table according to the current QRS Short_Name instrument.  

ADGDSSF Variable Metadata

The following SDTM variables can be copied into the corresponding equivalent ADaM variables. Note that the SDTM variable values can be converted to mixed case as needed for analysis purposes.  The Action column shown in the table below is optional, and can be removed if all values for these variables are simply copied over from SDTM.  For supplements where the SDTM values are modified, please provide a description of what was done.  For example, in the CHART-SF supplement, PARAM/PARAMCD are modified by replacing the version number with 'A', so that action is described here as "Harmonizing the two methods of administration (Paper and Interview) for individual items.  Fragment representing version number is changed to an 'A'."

SDTM Variable

ADaM Variable

Action

QSTESTCD

PARAMCD

Copy directly in from SDTM on individual items

QSTEST

PARAM

Copy directly in from SDTM on individual items

QSCAT

PARCAT1

Copy directly in from SDTM on individual items and retain on total scores

QSSTRESN

AVAL

Copy directly in from SDTM on individual items

All controlled terminology for instruments in both SDTM and ADaM is associated with a specific version of the instrument. When integrating responses from an instrument across studies, it is important to know which version of the instrument was used for each study. When multiple versions of the same instrument exist in an integration, a pooled analysis of responses across different versions can only be performed if determined to be clinically and statistically acceptable. In that case, sponsor-defined terminology, similar to CDISC Controlled Terminology but without the reference to a specific version, should be used for PARAMCD, PARAM and PARCATy.

Parameter Value List - ADGDSSF [AVAL]

6.3   Example Analysis Dataset 

The APACHE II Summary Analysis Dataset table shows the terminology and variables for implementing the example analysis dataset for this instrument in the BDS. This specific example is taken from a multicenter, randomized, double-blind, active-controlled parallel design study conducted in elderly patients with major depressive disorder. The purpose of the analysis is to compare the effect of Drug A to Drug B on depression in elderly patients using the APACHE II to construct an endpoint. All analyses are conducted on an intent-to-treat basis, and the planned duration of treatment is 5 months. The baseline measurement is defined as the last non-missing value collected at or prior to the start of treatment; change from the last non-missing post-baseline value to baseline is used to construct an endpoint. The SAP specifies that planned collected visits, including baseline measurements, are to be used in analyses and displays of results, whereas unscheduled visits appear only in listings. The total score records for 1 subject were collected at 3 visits, plus a derived last observed value (LOV) endpoint record for the APACHE II. Visit 1 is remapped to AVISIT = "BASELINE". There are 2 visits at AVISIT = "VISIT 2". However, because 1 visit was unscheduled, it is not used in the analysis and the ANL01FL value is null. Visits 5 and 6 are missing because the subject discontinued early due to an adverse event unrelated to treatment.

Update the below dataset and title according to the current QRS Short_Name instrument.  

GDS SHORT FORM Complete Analysis Dataset

The APACHE II Complete Analysis Dataset table shows all of the individual question responses for this example, as well as the computed total score. This example is considered to be the final analysis dataset for submission. Computed total scores can appear after the individual item responses, with appropriate labels for identification.

$titleHtml

adgdssf.xpt

Row

STUDYID

USUBJID

SITEID

QSSEQ

ASEQ

ITTFL

TRTP

PARAM

PARAMCD

PARAMN

PARCAT1

VISIT

VISITNUM

AVISIT

AVISITN

QSDTC

ADT

ADY

QSORRES

AVAL

AVALCAT1

BASE

CHG

DTYPE

ABLFL

ANL01FL

INVNAM

1

STUDYX

X-101-P0001

101

1

1

Y

DRUG A

GDS02-Satisfied With Life

GDS0201

1

GDS SHORT FORM

VISIT 1

1

BASELINE

0

2012-11-16

16NOV2012

1

YES

0







DR. JOHN SMITH

2

STUDYX

X-101-P0001

101

2

2

Y

DRUG A

GDS02-Dropped Activities and Interests

GDS0202

2

GDS SHORT FORM

VISIT 1

1

BASELINE

0

2012-11-16

16NOV2012

1

YES

1







DR. JOHN SMITH

3

STUDYX

X-101-P0001

101

3

3

Y

DRUG A

GDS02-Life Is Empty

GDS0203

3

GDS SHORT FORM

VISIT 1

1

BASELINE

0

2012-11-16

16NOV2012

1

NO

0







DR. JOHN SMITH

4

STUDYX

X-101-P0001

101

4

4

Y

DRUG A

GDS02-Bored Often

GDS0204

4

GDS SHORT FORM

VISIT 1

1

BASELINE

0

2012-11-16

16NOV2012

1

YES

1







DR. JOHN SMITH

5

STUDYX

X-101-P0001

101

5

5

Y

DRUG A

GDS02-Good Spirits Most of Time

GDS0205

5

GDS SHORT FORM

VISIT 1

1

BASELINE

0

2012-11-16

16NOV2012

1

NO

1







DR. JOHN SMITH

6

STUDYX

X-101-P0001

101

6

6

Y

DRUG A

GDS02-Afraid of Something Bad Happening

GDS0206

6

GDS SHORT FORM

VISIT 1

1

BASELINE

0

2012-11-16

16NOV2012

1

YES

1







DR. JOHN SMITH

7

STUDYX

X-101-P0001

101

7

7

Y

DRUG A

GDS02-Feel Happy Most of Time

GDS0207

7

GDS SHORT FORM

VISIT 1

1

BASELINE

0

2012-11-16

16NOV2012

1

NO

1







DR. JOHN SMITH

8

STUDYX

X-101-P0001

101

8

8

Y

DRUG A

GDS02-Often Feel Helpless

GDS0208

8

GDS SHORT FORM

VISIT 1

1

BASELINE

0

2012-11-16

16NOV2012

1

YES

1







DR. JOHN SMITH

9

STUDYX

X-101-P0001

101

9

9

Y

DRUG A

GDS02-Prefer to Stay Home

GDS0209

9

GDS SHORT FORM

VISIT 1

1

BASELINE

0

2012-11-16

16NOV2012

1

NO

0







DR. JOHN SMITH

10

STUDYX

X-101-P0001

101

10

10

Y

DRUG A

GDS02-Memory Problems

GDS0210

10

GDS SHORT FORM

VISIT 1

1

BASELINE

0

2012-11-16

16NOV2012

1

YES

1







DR. JOHN SMITH

11

STUDYX

X-101-P0001

101

11

11

Y

DRUG A

GDS02-Wonderful to Be Alive

GDS0211

11

GDS SHORT FORM

VISIT 1

1

BASELINE

0

2012-11-16

16NOV2012

1

NO

1







DR. JOHN SMITH

12

STUDYX

X-101-P0001

101

12

12

Y

DRUG A

GDS02-Feel Worthless

GDS0212

12

GDS SHORT FORM

VISIT 1

1

BASELINE

0

2012-11-16

16NOV2012

1

YES

1







DR. JOHN SMITH

13

STUDYX

X-101-P0001

101

13

13

Y

DRUG A

GDS02-Feel Full of Energy

GDS0213

13

GDS SHORT FORM

VISIT 1

1

BASELINE

0

2012-11-16

16NOV2012

1

YES

0







DR. JOHN SMITH

14

STUDYX

X-101-P0001

101

14

14

Y

DRUG A

GDS02-Feel Hopeless

GDS0214

14

GDS SHORT FORM

VISIT 1

1

BASELINE

0

2012-11-16

16NOV2012

1

YES

1







DR. JOHN SMITH

15

STUDYX

X-101-P0001

101

15

15

Y

DRUG A

GDS02-Most People Better Off Than You

GDS0215

15

GDS SHORT FORM

VISIT 1

1

BASELINE

0

2012-11-16

16NOV2012

1

NO

0







DR. JOHN SMITH

16

STUDYX

X-101-P0001

101


16

Y

DRUG A

GDS02- Total Score - Analysis

GDS02TS

16

GDS SHORT FORM

VISIT 1

1

BASELINE

0

2012-11-16

16NOV2012

1


10

Possible Depression

10



Y

Y

DR. JOHN SMITH

17

STUDYX

X-101-P0001

101

16

17

Y

DRUG A

GDS02-Satisfied With Life

GDS0201

1

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

YES

0







DR. JOHN SMITH

18

STUDYX

X-101-P0001

101

17

18

Y

DRUG A

GDS02-Dropped Activities and Interests

GDS0202

2

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

NO

0







DR. JOHN SMITH

19

STUDYX

X-101-P0001

101

18

19

Y

DRUG A

GDS02-Life Is Empty

GDS0203

3

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

NO

0







DR. JOHN SMITH

20

STUDYX

X-101-P0001

101

19

20

Y

DRUG A

GDS02-Bored Often

GDS0204

4

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

YES

1







DR. JOHN SMITH

21

STUDYX

X-101-P0001

101

20

21

Y

DRUG A

GDS02-Good Spirits Most of Time

GDS0205

5

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

NO

1







DR. JOHN SMITH

22

STUDYX

X-101-P0001

101

21

22

Y

DRUG A

GDS02-Afraid of Something Bad Happening

GDS0206

6

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

YES

1







DR. JOHN SMITH

23

STUDYX

X-101-P0001

101

22

23

Y

DRUG A

GDS02-Feel Happy Most of Time

GDS0207

7

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

NO

1







DR. JOHN SMITH

24

STUDYX

X-101-P0001

101

23

24

Y

DRUG A

GDS02-Often Feel Helpless

GDS0208

8

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

YES

1







DR. JOHN SMITH

25

STUDYX

X-101-P0001

101

24

25

Y

DRUG A

GDS02-Prefer to Stay Home

GDS0209

9

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

NO

0







DR. JOHN SMITH

26

STUDYX

X-101-P0001

101

25

26

Y

DRUG A

GDS02-Memory Problems

GDS0210

10

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

NO

0







DR. JOHN SMITH

27

STUDYX

X-101-P0001

101

26

27

Y

DRUG A

GDS02-Wonderful to Be Alive

GDS0211

11

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

NO

1







DR. JOHN SMITH

28

STUDYX

X-101-P0001

101

27

28

Y

DRUG A

GDS02-Feel Worthless

GDS0212

12

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

YES

1







DR. JOHN SMITH

29

STUDYX

X-101-P0001

101

28

29

Y

DRUG A

GDS02-Feel Full of Energy

GDS0213

13

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

YES

0







DR. JOHN SMITH

30

STUDYX

X-101-P0001

101

29

30

Y

DRUG A

GDS02-Feel Hopeless

GDS0214

14

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

YES

1







DR. JOHN SMITH

31

STUDYX

X-101-P0001

101

30

31

Y

DRUG A

GDS02-Most People Better Off Than You

GDS0215

15

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

NO

0







DR. JOHN SMITH

32

STUDYX

X-101-P0001

101


32

Y

DRUG A

GDS02- Total Score - Analysis

GDS02TS

16

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30


8

Possible Depression

10

-2



Y

DR. JOHN SMITH

33

STUDYX

X-101-P0001

101

31

33

Y

DRUG A

GDS02-Satisfied With Life

GDS0201

1

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

YES

0







DR. JOHN SMITH

34

STUDYX

X-101-P0001

101

32

34

Y

DRUG A

GDS02-Dropped Activities and Interests

GDS0202

2

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

NO

0







DR. JOHN SMITH

35

STUDYX

X-101-P0001

101

33

35

Y

DRUG A

GDS02-Life Is Empty

GDS0203

3

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

YES

1







DR. JOHN SMITH

36

STUDYX

X-101-P0001

101

34

36

Y

DRUG A

GDS02-Bored Often

GDS0204

4

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

YES

1







DR. JOHN SMITH

37

STUDYX

X-101-P0001

101

35

37

Y

DRUG A

GDS02-Good Spirits Most of Time

GDS0205

5

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

NO

1







DR. JOHN SMITH

38

STUDYX

X-101-P0001

101

36

38

Y

DRUG A

GDS02-Afraid of Something Bad Happening

GDS0206

6

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

YES

1







DR. JOHN SMITH

39

STUDYX

X-101-P0001

101

37

39

Y

DRUG A

GDS02-Feel Happy Most of Time

GDS0207

7

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

NO

0







DR. JOHN SMITH

40

STUDYX

X-101-P0001

101

38

40

Y

DRUG A

GDS02-Often Feel Helpless

GDS0208

8

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

YES

1







DR. JOHN SMITH

41

STUDYX

X-101-P0001

101

39

41

Y

DRUG A

GDS02-Prefer to Stay Home

GDS0209

9

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

NO

0







DR. JOHN SMITH

42

STUDYX

X-101-P0001

101

40

42

Y

DRUG A

GDS02-Memory Problems

GDS0210

10

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

NO

0







DR. JOHN SMITH

43

STUDYX

X-101-P0001

101

41

43

Y

DRUG A

GDS02-Wonderful to Be Alive

GDS0211

11

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

NO

1







DR. JOHN SMITH

44

STUDYX

X-101-P0001

101

42

44

Y

DRUG A

GDS02-Feel Worthless

GDS0212

12

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

YES

1







DR. JOHN SMITH

45

STUDYX

X-101-P0001

101

43

45

Y

DRUG A

GDS02-Feel Full of Energy

GDS0213

13

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

YES

0







DR. JOHN SMITH

46

STUDYX

X-101-P0001

101

44

46

Y

DRUG A

GDS02-Feel Hopeless

GDS0214

14

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

YES

1







DR. JOHN SMITH

47

STUDYX

X-101-P0001

101

45

47

Y

DRUG A

GDS02-Most People Better Off Than You

GDS0215

15

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

NO

0







DR. JOHN SMITH

48

STUDYX

X-101-P0001

101

46

48

Y

DRUG A

GDS02- Total Score - Analysis

GDS02TS

16

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43


9

Possible Depression

10

-1




DR. JOHN SMITH

49

STUDYX

X-101-P0001

101


49

Y

DRUG A

GDS02-Satisfied With Life

GDS0201

1

GDS SHORT FORM

VISIT 3

3

VISIT 3

3





0.46




AVERAGE



DR. JOHN SMITH

50

STUDYX

X-101-P0001

101


50

Y

DRUG A

GDS02-Dropped Activities and Interests

GDS0202

2

GDS SHORT FORM

VISIT 3

3

VISIT 3

3





0.46




AVERAGE



DR. JOHN SMITH

51

STUDYX

X-101-P0001

101

47

51

Y

DRUG A

GDS02-Life Is Empty

GDS0203

3

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

NO

0







DR. JOHN SMITH

52

STUDYX

X-101-P0001

101

48

52

Y

DRUG A

GDS02-Bored Often

GDS0204

4

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

NO

0







DR. JOHN SMITH

53

STUDYX

X-101-P0001

101

49

53

Y

DRUG A

GDS02-Good Spirits Most of Time

GDS0205

5

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

YES

0







DR. JOHN SMITH

54

STUDYX

X-101-P0001

101

50

54

Y

DRUG A

GDS02-Afraid of Something Bad Happening

GDS0206

6

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

YES

1







DR. JOHN SMITH

55

STUDYX

X-101-P0001

101

51

55

Y

DRUG A

GDS02-Feel Happy Most of Time

GDS0207

7

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

NO

1







DR. JOHN SMITH

56

STUDYX

X-101-P0001

101

52

56

Y

DRUG A

GDS02-Often Feel Helpless

GDS0208

8

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

YES

1







DR. JOHN SMITH

57

STUDYX

X-101-P0001

101

53

57

Y

DRUG A

GDS02-Prefer to Stay Home

GDS0209

9

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

NO

0







DR. JOHN SMITH

58

STUDYX

X-101-P0001

101

54

58

Y

DRUG A

GDS02-Memory Problems

GDS0210

10

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

NO

0







DR. JOHN SMITH

59

STUDYX

X-101-P0001

101

55

59

Y

DRUG A

GDS02-Wonderful to Be Alive

GDS0211

11

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

NO

1







DR. JOHN SMITH

60

STUDYX

X-101-P0001

101

56

60

Y

DRUG A

GDS02-Feel Worthless

GDS0212

12

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

YES

1







DR. JOHN SMITH

61

STUDYX

X-101-P0001

101

57

61

Y

DRUG A

GDS02-Feel Full of Energy

GDS0213

13

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

YES

0







DR. JOHN SMITH

62

STUDYX

X-101-P0001

101

58

62

Y

DRUG A

GDS02-Feel Hopeless

GDS0214

14

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

YES

1







DR. JOHN SMITH

63

STUDYX

X-101-P0001

101

59

63

Y

DRUG A

GDS02-Most People Better Off Than You

GDS0215

15

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

NO

0







DR. JOHN SMITH

64

STUDYX

X-101-P0001

101


64

Y

DRUG A

GDS02- Total Score - Analysis

GDS02TS

16

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58


7

Possible Depression

10

-3

AVERAGE


Y

DR. JOHN SMITH

65

STUDYX

X-101-P0001

101

60

65

Y

DRUG A

GDS02-Satisfied With Life

GDS0201

1

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

YES

0







DR. JOHN SMITH

66

STUDYX

X-101-P0001

101

61

66

Y

DRUG A

GDS02-Dropped Activities and Interests

GDS0202

2

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0







DR. JOHN SMITH

67

STUDYX

X-101-P0001

101

62

67

Y

DRUG A

GDS02-Life Is Empty

GDS0203

3

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0







DR. JOHN SMITH

68

STUDYX

X-101-P0001

101

63

68

Y

DRUG A

GDS02-Bored Often

GDS0204

4

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0







DR. JOHN SMITH

69

STUDYX

X-101-P0001

101

64

69

Y

DRUG A

GDS02-Good Spirits Most of Time

GDS0205

5

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

YES

0







DR. JOHN SMITH

70

STUDYX

X-101-P0001

101

65

70

Y

DRUG A

GDS02-Afraid of Something Bad Happening

GDS0206

6

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

YES

1







DR. JOHN SMITH

71

STUDYX

X-101-P0001

101

66

71

Y

DRUG A

GDS02-Feel Happy Most of Time

GDS0207

7

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

1







DR. JOHN SMITH

72

STUDYX

X-101-P0001

101

67

72

Y

DRUG A

GDS02-Often Feel Helpless

GDS0208

8

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0







DR. JOHN SMITH

73

STUDYX

X-101-P0001

101

68

73

Y

DRUG A

GDS02-Prefer to Stay Home

GDS0209

9

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0







DR. JOHN SMITH

74

STUDYX

X-101-P0001

101

69

74

Y

DRUG A

GDS02-Memory Problems

GDS0210

10

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0







DR. JOHN SMITH

75

STUDYX

X-101-P0001

101

70

75

Y

DRUG A

GDS02-Wonderful to Be Alive

GDS0211

11

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

1







DR. JOHN SMITH

76

STUDYX

X-101-P0001

101

71

76

Y

DRUG A

GDS02-Feel Worthless

GDS0212

12

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0







DR. JOHN SMITH

77

STUDYX

X-101-P0001

101

72

77

Y

DRUG A

GDS02-Feel Full of Energy

GDS0213

13

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

YES

0







DR. JOHN SMITH

78

STUDYX

X-101-P0001

101

73

78

Y

DRUG A

GDS02-Feel Hopeless

GDS0214

14

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0







DR. JOHN SMITH

79

STUDYX

X-101-P0001

101

74

79

Y

DRUG A

GDS02-Most People Better Off Than You

GDS0215

15

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0







DR. JOHN SMITH

80

STUDYX

X-101-P0001

101


80

Y

DRUG A

GDS02- Total Score - Analysis

GDS02TS

16

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90


3

Normal

10

-7



Y

DR. JOHN SMITH

81

STUDYX

X-101-P0001

101


81

Y

DRUG A

GDS02- Total Score - Analysis

GDS02TS

16

GDS SHORT FORM

VISIT 4

4

ENDPOINT

7

2013-02-13

13FEB2013

90


3

Normal

10

-7

LOV


Y

DR. JOHN SMITH

$warningHtml
Update the below dataset and title according to the current QRS Short_Name instrument.  

GDS SHORT FORM Summary Analysis Dataset

Due to the number of items on the instrument and the fact that only the total score records are required for analysis, the separate summary dataset shown in the following example, which contains only the total score records, may also be created.  QSSEQ was not included in this example because it would be null for all computed total score records. QSORRES is not shown because only derived total score records are displayed.

$titleHtml

adgdssfs.xpt

RowSTUDYIDUSUBJIDSITEIDITTFLTRTPPARAMPARAMCDPARAMNPARCAT1VISITVISITNUMAVISITAVISITNADTADYAVALAVALCAT1BASECHGDTYPEABLFLANL01FL

1

STUDYX

X-101-P0001

101

Y

DRUG A

GDS02- Total Score - Analysis

GDS02TS

16

GDS SHORT FORM

VISIT 1

1

BASELINE

0

16NOV2012

1

10

Possible Depression

10



Y

Y

2

STUDYX

X-101-P0001

101

Y

DRUG A

GDS02- Total Score - Analysis

GDS02TS

16

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

15DEC2012

30

8

Possible Depression

10

-2



Y

3

STUDYX

X-101-P0001

101

Y

DRUG A

GDS02- Total Score - Analysis

GDS02TS

16

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

VISIT 2

2

28DEC2012

43

9

Possible Depression

10

-1




4

STUDYX

X-101-P0001

101

Y

DRUG A

GDS02- Total Score - Analysis

GDS02TS

16

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

12JAN2013

58

7

Possible Depression

10

-3

AVERAGE


Y

5

STUDYX

X-101-P0001

101

Y

DRUG A

GDS02- Total Score - Analysis

GDS02TS

16

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

13FEB2013

90

3

Normal

10

-7



Y

6

STUDYX

X-101-P0001

101

Y

DRUG A

GDS02- Total Score - Analysis

GDS02TS

16

GDS SHORT FORM



ENDPOINT

7

13FEB2013

90

3

Normal

10

-7

LOV


Y

$warningHtml

7   References

  1. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Critical Care Medicine 1985; 13(10):818–29. 

End of Document




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