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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 items, 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.
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| Definexmltable |
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| Extra | User Notes |
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| Dataset | ADAPCH |
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| Level | Value |
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| Purpose | Analysis |
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| Name | AVAL |
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Variable | Where | Type | Controlled Terms | Source | Derivation | User Notes |
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AVAL | PARAMCD NOT IN ("APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis), "APCH1TS" (APCH1-Total APACHE II Score - Analysis)) | Num |
| | Set AVAL=RS.RSSTRESN. | The analysis value is the result copied from SDTM. | AVAL | PARAMCD EQ "APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis) | Num |
| | The sum of RS.RSSTRESN for RS.RSTESTCD in ("APCH101"-"APCH112") if no questions items are missing. Note that one out of the following two items: RSTESTCD="APCH105A" or "APCH105B" must be answered or RSTESTCD="APCH106A" or "APCH106B" but not both. | The expectation is that issues with conditional branching are fixed in SDTM RS. | AVAL | PARAMCD EQ "APCH1TS" (APCH1-Total APACHE II Score - Analysis) | Num |
| | The sum of RS.RSSTRESN for RS.RSTESTCD in ("APCH101"-"APCH112") and "APCH114", "APCH115" if no questions items are missing. Note that one out of the following two items: RSTESTCD="APCH105A" or "APCH105B" must be answered or RSTESTCD="APCH106A" or "APCH106B" but not both. If a subject dies on or before Day 15, they are assigned the highest observed APACHE II score of any of the subjects at any time during the trial for their Total APACHE II Score at Day 15 (Day of Discharge). | The assignment of the highest observed APACHE II score is for illustration purposes only and not meant as a recommendation. | PARAMCD | PARAMCD NOT IN ("APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis), "APCH1TS" (APCH1-Total APACHE II Score - Analysis)) | Char | APCH1TC | | See CDISC Controlled Terminology for Clinical Classification Test Codes. RS.RSTESTCD for responses to individual questions items copied from SDTM. |
| PARAMCD | PARAMCD IN ("APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis), "APCH1TS" (APCH1-Total APACHE II Score - Analysis)) | Char | APCH1PC | | See CDISC Controlled Terminology for Parameter Codes. |
| PARAM | PARAMCD NOT IN ("APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis), "APCH1TS" (APCH1-Total APACHE II Score - Analysis)) | Char | APCH1TN | | See CDISC Controlled Terminology for Clinical Classification Test Names. RS.RSTEST for responses to individual questions items copied from SDTM. |
| PARAM | PARAMCD IN ("APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis), "APCH1TS" (APCH1-Total APACHE II Score - Analysis)) | Char | APCH1PN | | See CDISC Controlled Terminology for Parameter Names. |
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The APACHE II Complete Analysis Dataset table shows all of the individual question item responses for this example, as well as the computed total Acute Physiology score and the computed total APACHE II 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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