Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Example Composition: Outcome Measure Report for QUARTET USA Trial

Page standards status: Informative
Variable NameQUARTET USA Trial Quadpill groupQUARTET USA Trial Control GroupGroupAssignment: Quadpill vs. Candesartan
Systolic blood pressure at 12 weeks

out of 32: mean 122.3 mm Hg (95% confidence interval 118.2 to 126.5 mm Hg)

out of 24: mean 127.1 mm Hg (95% confidence interval 118.2 to 126.5 mm Hg)

out of 60: difference in means -4.5 mm Hg (95% confidence interval -10.82 to 1.32 mm Hg, p-value 0.123)

Results for Diastolic blood pressure at 12 weeksout of 32: mean 73 mm Hg (95% confidence interval 70.5 to 75.5 mm Hg)out of 28: mean 77.9 mm Hg (95% confidence interval 75.2 to 80.6 mm Hg)out of 60: difference in means -4.92 mm Hg (95% confidence interval -8.58 to 0.27 mm Hg)
Medication Adherence at 12 weeks

out of 32: percentage 65.6 %; The published study report (https://fevir.net/resources/Citation/367878) reported 20 affected with 65.6%, but the 65.6% implies 21 affected. The results reported at ClinicalTrials.gov (https://fevir.net/resources/Composition/370504) was 21 affected with 65.6% for this outcome.

out of 24: percentage 70 %; 30 (numberOfParticipants) matches 70% reported in table 2 of the published article and the data reported in ClinicalTrials.gov, instead of 28 as number analyzed as reported in Figure 1, so numberAnalyzed not reported in this Evidence Resource.

out of 54: odds ratio -0.37 (95% confidence interval 0.19 to 2.08, p-value 0.444)

Hypertension Control at 12 weeks

out of 32: percentage 65.517 %; The statistic as reported appears to use the number of participants without missing data (29) as the denominator rather than the number analyzed (32) as suggested in the paper. Either way, the reported percentage does not match the value reported for this outcome in ClinicalTrials.gov results reporting (66.7% at https://fevir.net/resources/Composition/370504)

out of 28: percentage 54.167 %; The statistic as reported appears to use the number of participants without missing data (24) as the denominator rather than the number analyzed (28) as suggested in the paper. Either way, the reported percentage does not match the value reported for this outcome in ClinicalTrials.gov results reporting (57.7% at https://fevir.net/resources/Composition/370504)

out of 60: odds ratio 2.85 (95% confidence interval 0.94 to 8.59, p-value 0.063)

Add-on Amlodipine at 6 weeks

out of 32: percentage 18.75 %

out of 28: percentage 53.333 %

out of 60: odds ratio -0.92 (95% confidence interval 0.02 to 0.41, p-value 0.003)

Adverse event free and hypertension control at 12 weeks

out of 29: percentage 17.241 %; The reported percentage (17.2%) does not match the value reported for this outcome in ClinicalTrials.gov results reporting (20% at https://fevir.net/resources/Composition/370504)

out of 24: percentage 33.333 %; The reported percentage (33.3%) does not match the value reported for this outcome in ClinicalTrials.gov results reporting (34.6% at https://fevir.net/resources/Composition/370504)

out of 53: odds ratio 0.83 (95% confidence interval 0.22 to 3.16, p-value 0.775)