Trial Outcomes & Findings for Validation of the Mercy TAPE (NCT NCT01507090)

Results Overview

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the percentage of participants whose weight estimations using the Mercy TAPEs are within 20% of their actual weight.

Recruitment status

COMPLETED

Target enrollment

642 participants

Primary outcome timeframe

study day 1

Results posted on

2015-02-10

Participant Flow

Enrollment from clinics, inpatient wards and referrals.

Participant milestones

Participant milestones
Measure	Normal Children Otherwise healthy children 2 months to 16 years of age were enrolled. The 2D and 3D Mercy TAPE was developed to measure two upper arm landmarks so as to arrive at the weight estimate for a given child. The 2D Mercy TAPE requires two serial measurements with simple addition. The 3D TAPE makes both measurements simultaneously also requiring simple addition.
Overall Study STARTED	642
Overall Study COMPLETED	624
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Normal Children Otherwise healthy children 2 months to 16 years of age were enrolled. The 2D and 3D Mercy TAPE was developed to measure two upper arm landmarks so as to arrive at the weight estimate for a given child. The 2D Mercy TAPE requires two serial measurements with simple addition. The 3D TAPE makes both measurements simultaneously also requiring simple addition.
Overall Study incomplete dataset	18

Baseline Characteristics

Validation of the Mercy TAPE

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normal Children n=642 Participants Otherwise healthy children 2 months to 16 years of age.
Age, Categorical <=18 years	642 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	8.4 years STANDARD_DEVIATION 4.9 • n=99 Participants
Sex: Female, Male Female	51.7 Participants n=99 Participants
Sex: Female, Male Male	48.3 Participants n=99 Participants
Region of Enrollment United States	642 participants n=99 Participants

PRIMARY outcome

Timeframe: study day 1

Population: Final population for data analysis.

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the percentage of participants whose weight estimations using the Mercy TAPEs are within 20% of their actual weight.

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Predictive Performance of the Mercy TAPE (Percent of Participants Predicted Within 20% of Their Actual Weight)	98.1 percentage of participants Interval 97.0 to 99.2	93.3 percentage of participants Interval 91.3 to 95.2	—

PRIMARY outcome

Timeframe: study day 1

Population: Final population for data analysis.

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the slope of the regression equation comparing observed vs. predicted weight.

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Predictive Performance of the Mercy TAPE (Slope)	0.980 unitless Interval 0.969 to 0.992	0.977 unitless Interval 0.964 to 0.99	—

PRIMARY outcome

Timeframe: study day 1

Population: Final population for data analysis.

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the intercept of the regression equation comparing observed vs. predicted weight.

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Predictive Performance of the Mercy TAPE (Intercept)	0.968 kilograms Interval 0.498 to 1.439	1.019 kilograms Interval 0.464 to 1.573	—

PRIMARY outcome

Timeframe: study day 1

Population: Final population for data analysis

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Predictive Performance of the Mercy TAPE (Mean Error)	0.28 kilograms Standard Deviation 3.3	0.22 kilograms Standard Deviation 3.9	—

PRIMARY outcome

Timeframe: study day 1

Population: Final population for data analysis

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Predictive Performance of the Mercy TAPE (Mean Percentage Error)	1.65 percentage error Standard Deviation 8.5	1.91 percentage error Standard Deviation 11.1	—

PRIMARY outcome

Timeframe: study day 1

Population: Final population for data analysis

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Predictive Performance of the Mercy TAPE (Corelation Coefficient)	0.979 correlation coefficient	0.971 correlation coefficient	—

PRIMARY outcome

Timeframe: study day 1

Population: Final population for data analysis

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Predictive Performance of the Mercy TAPE	3.33 root mean square error (kg)	3.92 root mean square error (kg)	—

PRIMARY outcome

Timeframe: study day 1

Population: Final population for data analysis.

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the slope of the regression equation comparing method predicted vs. TAPE predicted weight.

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Ratio)	0.998 unitless Interval 0.994 to 1.002	0.998 unitless Interval 0.991 to 1.005	—

PRIMARY outcome

Timeframe: study day 1

Population: Final population for data analysis.

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the intercept of the regression equation comparing method predicted vs. TAPE predicted weight.

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Concordance Corelation Coefficient)	0.996 unitless Interval 0.996 to 0.997	0.993 unitless Interval 0.991 to 0.994	—

PRIMARY outcome

Timeframe: study day 1

Population: Final population for data analysis.

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the percentage weight estimations using the Mercy TAPEs that are within 10% of the weight estimations using the Mercy Method.

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (% Within 10%)	91.7 percent of estimations Interval 89.5 to 93.8	76.4 percent of estimations Interval 73.1 to 79.8	—

SECONDARY outcome

Timeframe: study day 1

Population: All pre-qualified study coordinators

Intraclass correlation coefficient

Outcome measures

Outcome measures
Measure	2D-TAPE n=16 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE n=16 Participants Otherwise healthy children 2 months to 16 years of age.	Mercy Method n=16 Participants Study coordinators performing measurements
Inter-rater Reliability for the 2D and 3D Mercy TAPEs.	0.993 Intraclass correlation coefficient	0.980 Intraclass correlation coefficient	0.990 Intraclass correlation coefficient

SECONDARY outcome

Timeframe: study day 1

Geometric mean of the ratio (CV) of true to estimated weight calculated by TAPE version. Mercy TAPEs were printed in 2 batches numbers "1" and "2" accordingly.

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Device Print Batch Variability version 1	1.01 ratio Geometric Coefficient of Variation 0.08	1.02 ratio Geometric Coefficient of Variation 0.11	—
Device Print Batch Variability version 2	1.01 ratio Geometric Coefficient of Variation 0.09	1.01 ratio Geometric Coefficient of Variation 0.11	—

SECONDARY outcome

Timeframe: study day 1

Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Predictive Performance of the Mercy Method (Intercept)	1.083 kilograms Interval 0.584 to 1.581	—	—

SECONDARY outcome

Timeframe: study day 1

Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Predictive Performance of the Mercy Method (Slope)	0.980 unitless Interval 0.968 to 0.992	—	—

SECONDARY outcome

Timeframe: study day 1

Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg). The outcome measure below relfects the percent of participants with weight estimated within within 20% of actual weight.

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Predictive Performance of the Mercy Method (Percent of Participants)	97.3 percent of participants Interval 96.0 to 98.6	—	—

SECONDARY outcome

Timeframe: study day 1

Population: Final population for data analysis.

Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Predictive Performance of the Mercy Method (Mean Error)	0.39 kilograms Standard Deviation 3.5	—	—

SECONDARY outcome

Timeframe: study day 1

Population: Final population for data analysis.

Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Predictive Performance of the Mercy Method (Mean Percentage Error)	1.86 percentage error Standard Deviation 8.9	—	—

SECONDARY outcome

Timeframe: study day 1

Population: Final population for data analysis.

Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Predictive Performance of the Mercy Method	0.977 correlation coefficieint	—	—

SECONDARY outcome

Timeframe: study day 1

Population: Final population for data analysis.

Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)

Outcome measures

Outcome measures
Measure	2D-TAPE n=624 Participants Otherwise healthy children 2 months to 16 years of age.	3D-TAPE Otherwise healthy children 2 months to 16 years of age.	Mercy Method Study coordinators performing measurements
Predictive Performance of the Mercy Method	3.55 root mean square error (kg)	—	—

Adverse Events

Normal Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

Children's Mercy Hospital

Phone: 816-234-3059

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place