TriangleNCT02728596 · OUTCOME
Percentage of Participants With CSF Prescribed as Primary Prophylaxis
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline to up to 14 days
What was measured
To compare the use of primary prophylactic colony stimulating factor (PP-CSF) according to recommended clinical practice guidelines among participants registered at intervention components versus usual care components. Primary prophylaxis of CSF (PP-CSF) is defined as the initiation of granulocyte CSFs during the first cycle of myelosuppressive systemic therapy, given 24 to 72 hours after cessation of systemic therapy. Separate mixed effects logistic models will be fit to assess the effect of the intervention on PP-CSF use. The rate of CSF prescribing is defined as the percent of participants prescribed CSF as primary prophylaxis out of the total number of participants within each arm.
Analysis population: There was one participant in Arm 4, that was deemed as having an unavailable outcome and was excluded from this analysis population. Leaving Arm 4 with 972 analyzable participants rather than 973.
Groups in this outcome
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.
| Group | Source count |
|---|---|
| Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing) | 707 |
| Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing) | 644 |
| Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) | 1281 |
| Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | 972 |
Reported measurements
Low Risk Group
| Group | Source count |
|---|---|
| Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing) | 121 |
| Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing) | 128 |
| Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) | 249 |
| Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | 208 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing) | 8.3 | Not reported | Not reported | Not reported | Not reported |
| Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing) | 5.5 | Not reported | Not reported | Not reported | Not reported |
| Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) | 7.2 | Not reported | Not reported | Not reported | Not reported |
| Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | 5.3 | Not reported | Not reported | Not reported | Not reported |
Intermediate Risk Group
| Group | Source count |
|---|---|
| Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing) | 202 |
| Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing) | 207 |
| Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) | 542 |
| Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | 304 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing) | 37.1 | Not reported | Not reported | Not reported | Not reported |
| Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing) | 18.8 | Not reported | Not reported | Not reported | Not reported |
| Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) | 37.1 | Not reported | Not reported | Not reported | Not reported |
| Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | 9.9 | Not reported | Not reported | Not reported | Not reported |
High Risk Group
| Group | Source count |
|---|---|
| Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing) | 384 |
| Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing) | 309 |
| Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) | 490 |
| Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | 460 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing) | 93.0 | Not reported | Not reported | Not reported | Not reported |
| Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing) | 95.8 | Not reported | Not reported | Not reported | Not reported |
| Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) | 91.8 | Not reported | Not reported | Not reported | Not reported |
| Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | 86.3 | Not reported | Not reported | Not reported | Not reported |
All FN Risk Groups
| Group | Source count |
|---|---|
| Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing) | 707 |
| Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing) | 644 |
| Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) | 1281 |
| Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | 972 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing) | 62.5 | Not reported | Not reported | Not reported | Not reported |
| Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing) | 53.1 | Not reported | Not reported | Not reported | Not reported |
| Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) | 52.2 | Not reported | Not reported | Not reported | Not reported |
| Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | 45.1 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.12
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.57
- group Description
- PP-CSF use in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).
- group Ids
- OG001
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.21
- param Type
- Odds Ratio (OR)
- param Value
- 0.44
- statistical Comment
- Adjusted for age group, comorbidity, race, and Hispanic ethnicity.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 0.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.20
- group Description
- PP-CSF use in the low risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).
- group Ids
- OG001
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.74
- param Type
- Odds Ratio (OR)
- param Value
- 1.18
- statistical Comment
- Adjusted for age, sex, and cancer type.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 7.08
- group Description
- PP-CSF use in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the SOE for PP-CSF intervention group (Arm 3).
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.17
- param Type
- Odds Ratio (OR)
- param Value
- 2.23
- statistical Comment
- Adjusted for age, sex, and cancer type.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 0.11
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.19
- group Description
- PP-CSF use in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the alert against PP-CSF intervention group (Arm 4).
- group Ids
- OG001
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.094
- param Type
- Odds Ratio (OR)
- param Value
- 0.36
- statistical Comment
- Adjusted for age, sex, and cancer type.
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 0.12
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.57
- group Description
- PP-CSF use in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).
- group Ids
- OG001
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.21
- param Type
- Odds Ratio (OR)
- param Value
- 0.44
- statistical Comment
- Adjusted for age group, comorbidity, race, and Hispanic ethnicity.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 0.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.20
- group Description
- PP-CSF use in the low risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).
- group Ids
- OG001
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.74
- param Type
- Odds Ratio (OR)
- param Value
- 1.18
- statistical Comment
- Adjusted for age, sex, and cancer type.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 7.08
- group Description
- PP-CSF use in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the SOE for PP-CSF intervention group (Arm 3).
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.17
- param Type
- Odds Ratio (OR)
- param Value
- 2.23
- statistical Comment
- Adjusted for age, sex, and cancer type.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 0.11
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.19
- group Description
- PP-CSF use in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the alert against PP-CSF intervention group (Arm 4).
- group Ids
- OG001
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.094
- param Type
- Odds Ratio (OR)
- param Value
- 0.36
- statistical Comment
- Adjusted for age, sex, and cancer type.
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8.3
- group Id
- OG001
- value
- 5.5
- group Id
- OG002
- value
- 7.2
- group Id
- OG003
- value
- 5.3
- denoms
- counts
- group Id
- OG000
- value
- 121
- group Id
- OG001
- value
- 128
- group Id
- OG002
- value
- 249
- group Id
- OG003
- value
- 208
- units
- Participants
- title
- Low Risk Group
- categories
- measurements
- group Id
- OG000
- value
- 37.1
- group Id
- OG001
- value
- 18.8
- group Id
- OG002
- value
- 37.1
- group Id
- OG003
- value
- 9.9
- denoms
- counts
- group Id
- OG000
- value
- 202
- group Id
- OG001
- value
- 207
- group Id
- OG002
- value
- 542
- group Id
- OG003
- value
- 304
- units
- Participants
- title
- Intermediate Risk Group
- categories
- measurements
- group Id
- OG000
- value
- 93.0
- group Id
- OG001
- value
- 95.8
- group Id
- OG002
- value
- 91.8
- group Id
- OG003
- value
- 86.3
- denoms
- counts
- group Id
- OG000
- value
- 384
- group Id
- OG001
- value
- 309
- group Id
- OG002
- value
- 490
- group Id
- OG003
- value
- 460
- units
- Participants
- title
- High Risk Group
- categories
- measurements
- group Id
- OG000
- value
- 62.5
- group Id
- OG001
- value
- 53.1
- group Id
- OG002
- value
- 52.2
- group Id
- OG003
- value
- 45.1
- denoms
- counts
- group Id
- OG000
- value
- 707
- group Id
- OG001
- value
- 644
- group Id
- OG002
- value
- 1281
- group Id
- OG003
- value
- 972
- units
- Participants
- title
- All FN Risk Groups
- denoms
- counts
- group Id
- OG000
- value
- 707
- group Id
- OG001
- value
- 644
- group Id
- OG002
- value
- 1281
- group Id
- OG003
- value
- 972
- units
- Participants
- description
- To compare the use of primary prophylactic colony stimulating factor (PP-CSF) according to recommended clinical practice guidelines among participants registered at intervention components versus usual care components. Primary prophylaxis of CSF (PP-CSF) is defined as the initiation of granulocyte CSFs during the first cycle of myelosuppressive systemic therapy, given 24 to 72 hours after cessation of systemic therapy. Separate mixed effects logistic models will be fit to assess the effect of the intervention on PP-CSF use. The rate of CSF prescribing is defined as the percent of participants prescribed CSF as primary prophylaxis out of the total number of participants within each arm.
- groups
- description
- CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.
- id
- OG000
- title
- Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)
- description
- CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
- id
- OG001
- title
- Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)
- description
- CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.
- id
- OG002
- title
- Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)
- description
- CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.
- id
- OG003
- title
- Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)
- param Type
- NUMBER
- population Description
- There was one participant in Arm 4, that was deemed as having an unavailable outcome and was excluded from this analysis population. Leaving Arm 4 with 972 analyzable participants rather than 973.
- reporting Status
- POSTED
- time Frame
- Baseline to up to 14 days
- title
- Percentage of Participants With CSF Prescribed as Primary Prophylaxis
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice