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Table 5 Elements of construct validity and external validity

From: Efficacy and safety of mesenchymal stromal cells in preclinical models of acute lung injury: a systematic review protocol

Category Specific items
Death True death versus surrogate endpoints
Animal species Mouse, rat, sheep, pig, other
Strain Example for mice: BALB/c versus C57Bl/6
Animal age Mature adult versus middle-aged versus older adult for each species (for example mouse 3 to 10 months, 10 to 18 months, 18 to 24 months)
Gender Male versus female versus mix of genders used
Model of acute lung injury See Table 2
Presence of co-morbidities Yes versus no
Severity of lung injury Lung injury score
MSC preparation Fresh versus fresh from previously cryopreserved versus thawed cryopreserved product
Timing of MSC administration following induction of acute lung injury 0 to 1 hours versus 1 to 6 hours versus >6 hours
Route of MSC administration Intravenous versus intratracheal versus intraperitoneal versus intramuscular
Type of control PBS versus normal saline versus fibroblasts versus heat-killed MSCs
Use of co-interventions Resuscitation fluids: yes versus no Use of antibiotics in infectious models: yes versus no
Mechanical ventilation Yes versus no
Number of participating study centers Single versus multi-center
  1. MSC, mesenchymal stromal cell; PBS, phosphate buffered saline.