Breast Cancer
Conditions
Brief summary
This prospective, non-interventional time and motion study will evaluate the costs of healthcare resource utilization associated with the administration of trastuzumab (Herceptin) SC and IV formulations in HER2-positive EBC. This is a sub-study of the clinical study MO22982 (NCT01401166/PrefHer).
Interventions
DRUGTrastuzumab
Trastuzumab will be given on Day 1 of each 3-week cycle for a total of 18 cycles. Dosage will be according to the local labeling: 600 milligrams (mg) SC or 6 milligrams per kilogram (mg/kg) via IV infusion. For those assigned to the IV arm or if IV treatment is delayed \>1 week, an initial loading/reloading dose of 8 mg/kg will be given instead. Due to the observational nature of this study, trastuzumab is not an investigational product but will be supplied in the MO22982 trial. Each route/device (SC single-use injection device, SC vial/syringe, IV infusion) will be observed in at least 12 episodes of care.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants from the MO22982 (PrefHer) clinical trial who consent to the presence of an observer to record data for the study during administration of trastuzumab * Members of the care team responsible for management of participants from the MO22982 (PrefHer) clinical trial who also consent to the presence of an observer during administration of trastuzumab
Exclusion criteria
* None specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab Single-Use Injection Device | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from National Health Service (NHS) reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab single-use injection device during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds. |
| Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from NHS reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab SC injection during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab SC injection was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes. |
| Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab IV infusion was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes. |
| Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the preparation of trastuzumab IV infusion was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes. |
| Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab single-use injection device was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes. |
| Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab SC injection was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes. |
| Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab IV infusion was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes. |
| Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from NHS reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the preparation and administration of trastuzumab IV infusion during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds. |
| Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab single-use injection device were counted during a single episode of care. The average number of each type of consumable used per episode was calculated. |
| Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab SC injection were counted during a single episode of care. The average number of each type of consumable used per episode was calculated. |
| Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab IV infusion were counted during a single episode of care. The average number of each type of consumable used per episode was calculated. |
| Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the preparation of trastuzumab IV infusion were counted during a single episode of care. The average number of each type of consumable used per episode was calculated. |
| Total Participant Time Per Episode of Care Spent in the Care Unit for Administration of Trastuzumab | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Arrival and discharge times were recorded to determine the total time spent in the care unit during a single episode of care. The average time spent in the care unit per episode was calculated and expressed in minutes. |
| Total Participant Time Per Episode of Care Spent in the Chair for Administration of Trastuzumab | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Start and stop 'chair' times were recorded to determine the total time spent in the treatment chair during a single episode of care. The average time spent in the chair per episode was calculated and expressed in minutes. |
| Total HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the preparation of trastuzumab IV infusion was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes. |
| Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | Data collection up to 1 year | The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab single-use injection device was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes. |
Countries
United Kingdom
Participant flow
Recruitment details
Eligible participants from the MO22982 (NCT01401166) trial were observed for this time and motion study of trastuzumab. The focus of the observation in this study was the HCP rather than the person being treated, so number of observations is reported everywhere instead of number of participants. Number of participants was not collected.
Pre-assignment details
Each arm included 12 observations of an episode of care independent of the person being treated. By design of the study, some individuals may have been observed more than once and there may have been fewer than 12 actual participants in each arm. As only a single observation was required to participate, there was no disposition recorded.
Participants by arm
| Arm | Count |
|---|---|
| Trastuzumab Single-Use Injection Device Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling. | 12 |
| Trastuzumab SC Injection Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling. | 12 |
| Trastuzumab IV Infusion Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling. | 12 |
| Total | 36 |
Baseline characteristics
| Characteristic | Trastuzumab Single-Use Injection Device | Trastuzumab SC Injection | Trastuzumab IV Infusion | Total |
|---|---|---|---|---|
| Age, Continuous | NA years | NA years | NA years | NA years |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from NHS reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab SC injection during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.
Time frame: Data collection up to 1 year
Population: Total Sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection | 33.15 pounds | Standard Deviation 10.74 |
Primary
Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab Single-Use Injection Device
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from National Health Service (NHS) reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab single-use injection device during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.
Time frame: Data collection up to 1 year
Population: Total Sample: All observations of an episode of care for the given treatment route.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab Single-Use Injection Device | 33.03 pounds | Standard Deviation 7.69 |
Secondary
Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from NHS reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the preparation and administration of trastuzumab IV infusion during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.
Time frame: Data collection up to 1 year
Population: Total Sample
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion | Preparation | 22.07 pounds | Standard Deviation 5.05 |
| Trastuzumab Single-Use Injection Device | Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion | Administration | 122.89 pounds | Standard Deviation 14.88 |
Secondary
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab IV infusion were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.
Time frame: Data collection up to 1 year
Population: Consumables Sample for Trastuzumab IV Infusion: All observations of an episode of care with trastuzumab IV infusion that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | Alcohol swabs (n=12) | 1.5 consumables | Standard Deviation 0.8 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | Aprons (n=8) | 2.8 consumables | Standard Deviation 0.7 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | Connectors (n=8) | 1.1 consumables | Standard Deviation 0.4 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | Dressing packs (n=6) | 1.5 consumables | Standard Deviation 0.5 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | Gauze swabs (n=7) | 2.3 consumables | Standard Deviation 1.9 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | Giving sets (n=12) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | Pairs of gloves (n=12) | 3.0 consumables | Standard Deviation 1 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | IV access equipment sets (n=11) | 1.5 consumables | Standard Deviation 0.9 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | Saline flushes (n=7) | 1.7 consumables | Standard Deviation 0.8 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | Small plasters (n=11) | 1.1 consumables | Standard Deviation 0.3 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | 10-mL syringes (n=4) | 2.0 consumables | Standard Deviation 1.2 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | Tegaderm IV dressings (n=10) | 1.3 consumables | Standard Deviation 0.7 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | 100-mL saline (n=9) | 1.6 consumables | Standard Deviation 0.5 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | Concept wound care packs (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | Tourniquets (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | 10-mL heparinised saline (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | 50-mL saline (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | 21-gauge needles (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | Mepore dressings (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | 50-unit heparin (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | Blue needles (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | 5-mL heparin (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | 250-mL saline (n=1) | 2.0 consumables | — |
Secondary
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab SC injection were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.
Time frame: Data collection up to 1 year
Population: Consumables Sample for Trastuzumab SC Injection: All observations of an episode of care with trastuzumab SC injection that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Alcohol swabs (n=6) | 1.3 consumables | Standard Deviation 0.5 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Aprons (n=6) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Dressing packs (n=8) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Gauze swabs (n=4) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Pairs of gloves (n=7) | 1.6 consumables | Standard Deviation 0.5 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Small plasters (n=7) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | 10-milliliter (mL) syringes (n=4) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Mepore dressings (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Blue needles (n=3) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Clini-wipes (n=3) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | 25-gauge needles (n=2) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Chloraprep swabs (n=2) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Wound care packs (n=2) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Mepore 9x10-centimeter (cm) dressings (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | 5-mL syringes (n=6) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Orange needles (n=7) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Needles (n=2) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | 6-mL syringes (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Green needles (n=3) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Leukomed T dressings (n=2) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Syringes (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Alco wipes (n=4) | 1.3 consumables | Standard Deviation 0.5 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | Syringe caps (n=4) | 1 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | 20-mL Industrial Molding Supply (IMS) sprays (n=2) | 1 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | 10-mL IMS sprays (n=1) | 1 consumables | — |
Secondary
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab single-use injection device were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.
Time frame: Data collection up to 1 year
Population: Consumables Sample for Trastuzumab Single-Use Injection Device: All observations of an episode of care with trastuzumab single-use injection device that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | Alcohol swabs (n=11) | 1.2 consumables | Standard Deviation 0.4 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | Aprons (n=7) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | Dressing packs (n=3) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | Gauze swabs (n=6) | 1.2 consumables | Standard Deviation 0.4 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | Pairs of gloves (n=10) | 1.6 consumables | Standard Deviation 0.5 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | Small plasters (n=7) | 1.0 consumables | Standard Deviation 0 |
Secondary
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the preparation of trastuzumab IV infusion were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.
Time frame: Data collection up to 1 year
Population: Consumables Sample for Trastuzumab IV Infusion; number (n) of observations per item are shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 10-mL water injections (n=8) | 4.0 consumables | Standard Deviation 0.9 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 100-mL water injections (n=4) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 10-mL syringes (n=12) | 3.0 consumables | Standard Deviation 1.7 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 19-gauge needles (n=6) | 2.7 consumables | Standard Deviation 2.6 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 21-gauge needles (n=8) | 2.6 consumables | Standard Deviation 1.8 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 23-gauge needles (n=2) | 3.5 consumables | Standard Deviation 0.7 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 250-mL saline bags (n=12) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 30-mL syringes (n=3) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | Alco/IMS wipes (n=10) | 5.8 consumables | Standard Deviation 3.3 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | Pairs of gloves (n=4) | 2.3 consumables | Standard Deviation 1.3 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 20-mL IMS sprays (n=4) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 50-mL IMS sprays (n=3) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 0.2-cm Minisart filters (n=4) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | Dressing packs (n=2) | 1.0 consumables | Standard Deviation 0 |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 1-mL syringes (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 10-mL sodium chloride (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | Aprons (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 50-mL syringes (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | Infusion hubs (n=1) | 1.0 consumables | — |
| Trastuzumab Single-Use Injection Device | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | Baxter caps (n=1) | 1.0 consumables | — |
Secondary
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab IV infusion was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.
Time frame: Data collection up to 1 year
Population: Total Sample; number (n) of observations per task are shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion | Pre-infusion set-up (n=12) | 8.6 minutes | Standard Deviation 4.3 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion | Drug collection and check (n=9) | 4.6 minutes | Standard Deviation 3 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion | Drug administration (n=12) | 32.5 minutes | Standard Deviation 2.1 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion | Monitoring during administration (n=4) | 2.5 minutes | Standard Deviation 1.9 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion | Saline flush (n=12) | 9.4 minutes | Standard Deviation 6.5 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion | Remove and discard supplies (n=11) | 1.6 minutes | Standard Deviation 0.8 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion | Post-administration monitoring (n=2) | 3.0 minutes | Standard Deviation 1.4 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion | Patient discharge (n=9) | 1.8 minutes | Standard Deviation 1.1 |
Secondary
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab SC injection was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.
Time frame: Data collection up to 1 year
Population: Total Sample; number (n) of observations per task are shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection | Pre-infusion set-up (n=9) | 2.9 minutes | Standard Deviation 1.8 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection | Drug preparation (n=12) | 12.5 minutes | Standard Deviation 9.1 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection | Pre-administration monitoring (n=8) | 3.5 minutes | Standard Deviation 3.1 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection | Drug administration (n=12) | 5.3 minutes | Standard Deviation 2.2 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection | Remove and discard device (n=3) | 0.3 minutes | Standard Deviation 0.6 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection | Post-administration monitoring (n=9) | 1.9 minutes | Standard Deviation 0.8 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection | Patient discharge (n=7) | 1.4 minutes | Standard Deviation 0.8 |
Secondary
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab single-use injection device was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.
Time frame: Data collection up to 1 year
Population: Total Sample; number (n) of observations per task are shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | Pre-infusion set-up (n=9) | 4.0 minutes | Standard Deviation 2.4 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | Drug collection and check (n=10) | 4.2 minutes | Standard Deviation 4 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | Drug administration (n=12) | 6.1 minutes | Standard Deviation 0.5 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | Remove and discard device (n=12) | 1.4 minutes | Standard Deviation 1.1 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | Post-administration monitoring (n=5) | 2.2 minutes | Standard Deviation 1.1 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | Patient discharge (n=6) | 2.2 minutes | Standard Deviation 1.9 |
Secondary
Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the preparation of trastuzumab IV infusion was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.
Time frame: Data collection up to 1 year
Population: Total Sample; number (n) of observations per task are shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion | Prepare worksheet (n=9) | 4.6 minutes | Standard Deviation 3 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion | Decontamination before aseptic unit (n=12) | 7.2 minutes | Standard Deviation 5.6 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion | Ingredient check (n=12) | 2.3 minutes | Standard Deviation 1.6 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion | Decontamination in aseptic unit (n=11) | 20.7 minutes | Standard Deviation 15 |
| Trastuzumab Single-Use Injection Device | Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion | Final product check and release (n=12) | 2.6 minutes | Standard Deviation 1.2 |
Secondary
Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab IV infusion was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.
Time frame: Data collection up to 1 year
Population: Total Sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion | 58.1 minutes | Standard Deviation 5.8 |
Secondary
Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab SC injection was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.
Time frame: Data collection up to 1 year
Population: Total Sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection | 24.6 minutes | Standard Deviation 13.2 |
Secondary
Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab single-use injection device was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.
Time frame: Data collection up to 1 year
Population: Total Sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | 16.0 minutes | Standard Deviation 3.9 |
Secondary
Total HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the preparation of trastuzumab IV infusion was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.
Time frame: Data collection up to 1 year
Population: Total Sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Total HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 34.5 minutes | Standard Deviation 13.6 |
Secondary
Total Participant Time Per Episode of Care Spent in the Care Unit for Administration of Trastuzumab
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Arrival and discharge times were recorded to determine the total time spent in the care unit during a single episode of care. The average time spent in the care unit per episode was calculated and expressed in minutes.
Time frame: Data collection up to 1 year
Population: Total Sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Total Participant Time Per Episode of Care Spent in the Care Unit for Administration of Trastuzumab | 56.7 minutes | Standard Deviation 30.3 |
| Trastuzumab SC Injection | Total Participant Time Per Episode of Care Spent in the Care Unit for Administration of Trastuzumab | 30.3 minutes | Standard Deviation 14.9 |
| Trastuzumab IV Infusion | Total Participant Time Per Episode of Care Spent in the Care Unit for Administration of Trastuzumab | 94.5 minutes | Standard Deviation 29.7 |
Secondary
Total Participant Time Per Episode of Care Spent in the Chair for Administration of Trastuzumab
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Start and stop 'chair' times were recorded to determine the total time spent in the treatment chair during a single episode of care. The average time spent in the chair per episode was calculated and expressed in minutes.
Time frame: Data collection up to 1 year
Population: Total Sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab Single-Use Injection Device | Total Participant Time Per Episode of Care Spent in the Chair for Administration of Trastuzumab | 30.0 minutes | Standard Deviation 14.4 |
| Trastuzumab SC Injection | Total Participant Time Per Episode of Care Spent in the Chair for Administration of Trastuzumab | 19.8 minutes | Standard Deviation 12.4 |
| Trastuzumab IV Infusion | Total Participant Time Per Episode of Care Spent in the Chair for Administration of Trastuzumab | 75 minutes | Standard Deviation 20.9 |