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Table 4 Sensitivity analysis: differences between EXPEDITION and GERAS in change from baseline in propensity score-adjusted outcomes

From: Representativeness of European clinical trial populations in mild Alzheimer’s disease dementia: a comparison of 18-month outcomes with real-world data from the GERAS observational study

  Difference versus GERAS (95% CI)  
Outcome EU EXPEDITION EU/NA EXPEDITION All EXPEDITION Population(s) showing significant difference
MMSE total score −0.53 (−1.46, 0.40) 0.06 (−0.62, 0.74) 0.40 (−0.20, 1.00) NS
ADAS-Cog14 score 1.81 (−0.30, 3.92) 0.66 (−1.06, 2.39) −0.36 (−1.85, 1.13) NS
ADCS-ADL basic score −0.003 (−0.76, 0.75) 0.41 (−0.16, 0.98) 0.67 (0.20, 1.15) Full only a
ADCS-ADL instrumental score −0.13 (−2.22, 1.96) 1.51 (−0.11, 3.12) 2.42 (1.02, 3.82) Full only a
EQ-5D UK population-based index score 0.03 (−0.02, 0.08) 0.06 (0.02, 0.10) 0.07 (0.03, 0.10) Full, EU/NA b
EQ-5D VAS score 1.51 (−2.42, 5.44) 4.66 (1.69, 7.63) 4.63 (2.01, 7.25) Full, EU/NA b
NPI-12 total score −0.82 (−3.28, 1.63) −2.36 (−4.17, −0.56) −3.11 (−4.67, −1.55) Full, EU/NA b
NPI-12 Caregiver Distress score −0.11 (−1.49, 1.27) −1.22 (−2.21, −0.24) −1.64 (−2.51, −0.78) Full, EU/NA b
Caregiver time on basic ADL (hours/month) −9.41 (−23.81, 4.99) −12.27 (−22.91, −1.63) −9.69 (−19.66, 0.28) EU/NA only c
Caregiver time on instrumental ADL (hours/month) −26.02 (−42.86, −9.18) −20.44 (−34.16, −6.72) −21.96 (−34.52, −9.40) All d
Supervision time (hours/month) −63.55 (−94.89, −32.22) −57.33 (−79.81, −34.86) −57.46 (−77.09, −37.83) All d
Overall caregiver time (hours/month) −75.01 (−110.37, −39.64) −71.67 (−98.28, −45.06) −76.33 (−100.07, −52.58) All d
  1. Data presented as least squares mean difference (95% CI). Results in bold are significantly different for EXPEDITION versus GERAS populations (p < 0.05)
  2. ADAS-Cog14 14-item cognitive subscale of the Alzheimer’s Disease Assessment Scale, ADCS-ADL Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory, ADL activities of daily living, CI confidence interval, EQ-5D EuroQoL-5-Dimensions questionnaire, EU European, EU/NA European/North American, MMSE Mini-Mental State Examination, NPI Neuropsychiatric Inventory, NS No significant differences at 18 months in any analysis, UK United Kingdom, VAS visual analogue scale
  3. aGreater impairment in GERAS based on the full EXPEDITION population only
  4. bGreater impairment in GERAS based on the full EXPEDITION and EU/NA populations only
  5. cGreater impairment in GERAS based on EU/NA population only
  6. dGreater impairment in GERAS for all populations