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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 Reference	Clinical Classification Supplement to the Analysis Data Model Implementation Guide
QRS Short Name	APACHE II
ADQRS Permission Status	Public Domain
Team	CDISC ADaM Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version	1.0 (or higher as appropriate when doing a supplement revision)
Status	DRAFT (or "REVISION DRAFT" or "FINAL", as appropriate). Status will not be considered "Final" until the supplement is ready to be sent for publication.
Date	2022 (date current version released, regardless of status)
Notes	This 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

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

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 supplements. There 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

Dataset	Label	Structure	Keys	Class
ADAPCH	APACHE II Analysis	1 record per subject per analysis visit per parameter.	USUBJID, AVISITN, ADT, PARAMN	BASIC DATA STRUCTURE

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

Variable Name	Variable Label	Type	Controlled Terms	Source	Derivation	User Notes
STUDYID	Study Identifier	Char		QS.STUDYID
USUBJID	Unique Subject Identifier	Char		QS.USUBJID
SITEID	Site Identifier	Char		ADSL.SITEID
QSSEQ	Sequence Number	Num		QS.QSSEQ		QSSEQ is included to provide traceability back to SDTM.
ASEQ	Analysis Sequence Number	Num			After sorting by key variables, renumber all the records from 1 to n within a subject.	Provides a sequence number to derived rows which are not present in QSSEQ.
ITTFL	Intent-to-Treat Population Flag	Char	“Y”, “N”	ADSL.ITTFL		Conditional; must include at least 1 population flag.
TRTP	Planned Treatment	Char				Derivation should be defined by sponsor according to analysis needs. Conditional; should include at least 1 treatment variable (e.g., TRTP, TRTA, TRTSEQP, TRT01P).
PARAM	Parameter	Char	GDS02TN, GDS02PN		QS.QSTEST for responses to individual questions copied from SDTM. Set PARAM to "GDS02- Total Score - Analysis" for the derived total score.
PARAMCD	Parameter Code	Char	GDS02TC, GDS02PC		QS.QSTESTCD for responses to individual questions copied from SDTM. Set PARAMCD to "GDS02TS" for the derived total score.
PARAMN	Parameter Number	Num			Number of the item in the order it appears on the form; assign a higher value to the derived total score record.
PARCAT1	Parameter Category 1	Char	"GDS SHORT FORM"		Set to QS.QSCAT for records that come directly from SDTM and "GDS SHORT FORM" for any derived records such as total scores or last observed value (LOV).
VISIT	Visit Name	Char		QS.VISIT		QS.VISIT included for traceability.
VISITNUM	Visit Number	Num		QS.VISITNUM		QS.VISITNUM included for traceability.
AVISIT	Analysis Visit	Char				AVISIT represents the analysis visit for the record. Refer to the SAP for additional details.
AVISITN	Analysis Visit (N)	Num			A numeric representation of AVISIT.
QSDTC	Date/Time of Finding	Char		QS.QSDTC		QS.QSDTC included for traceability.
ADT	Analysis Date	Num			Date portion of QS.QSDTC converted to numeric and displayed in a format such as DATE9. For derived total score records where PARAMCD="GDS02TS", this information will be copied from the individual records that comprise that instrument.
ADY	Analysis Relative Day	Num			ADT-ADSL.TRTSDT+1 if ADT≥TRTSDT; else, ADT-ADSL.TRTSDT if ADT<TRTSDT.	This derivation is for example only.
QSORRES	Finding in Original Units	Char		QS.QSORRES
AVAL	Analysis Value	Num			See Parameter Value Level List - ADGDSSF table.
AVALCAT1	Analysis Value Category 1	Char	"Normal”, "Possible Depression", "Likely Depression",		If AVAL<5, then AVALCAT1="Normal"; If 5<AVAL<10, then AVALCAT1="Possible Depression"; If AVAL>10, then AVALCAT1="Likely Depression".	Source: Yesavage[1]
BASE	Baseline Value	Num			BASE=AVAL where ABLFL="Y".	Only the derived total score records where PARAMCD="GDS02TS" should have BASE populated in this example.
CHG	Change from Baseline	Num			CHG=AVAL-BASE	Only populate for post-baseline total score records in this example (where PARAMCD="GDS02TS" and ADY>1).
DTYPE	Derivation Type	Char	“AVERAGE”, “LOV”		For PARAMCD="GDS02TS": If the scoring instructions on the GDS SHORT FORM web page are followed and 1-5 responses are missing on the instrument, then populate DTYPE with "AVERAGE". Other missing value imputations for individual questions are indicated with DTYPE="AVERAGE", and imputations for a completely missing total score and a derived endpoint record can be indicated with DTYPE="LOV" in this example. Otherwise, leave NULL.
ABLFL	Baseline Record Flag	Char	“Y”		Set ABLFL="Y" on the record defined as the baseline value. This flag will only be populated on the derived total score records (PARAMCD="GDS02TS") in this example.
ANL01FL	Analysis Record Flag 01	Char	“Y”		Set ANL01FL="Y" on derived total score records (PARAMCD="GDS02TS") associated with scheduled visits in this example (VISIT is not of the form "UNSCHEDULED XXX.XX").	Permissible and useful for selecting records that are used in SAP-specified analyses.
INVNAM	Investigator Name	Char		ADSL.INVNAM		Permissible if needed for analysis.

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]

Variable

Where

Type

Controlled Terms

Source

Derivation

User Notes

AVAL

PARAMCD NE "GDS02TS" (GDS02- Total Score - Analysis)

Num

Set AVAL=QS.QSSTRESN.

The analysis value is the result copied from SDTM.

AVAL

PARAMCD EQ "GDS02TS" (GDS02- Total Score - Analysis)

Num

The sum of QS.QSSTRESN for QS.QSTESTCD in ("GDS0201"-"GDS0215") if no question are missing.

If ≤5 responses are missing on an instrument, then AVAL is 15*(sum of non-missing QS.QSSTRESN for QS.QSTESTCD in ("GDS0201"-"GDS0215")/number of non-missing questions for QS.QSTESTCD in ("GDS0201"-"GDS0215"). If the result is a fraction, round up to the nearest integer.
If >5 responses are missing, do not calculate a total score, and do not create a total score record.

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.

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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

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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.