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Table 1 Outcomes, variables, measures and methods of analysis

From: The low indexes of metabolism intervention trial (LIMIT): design and baseline data of a randomized controlled clinical trial to evaluate how alerting primary care teams to low metabolic values, could affect the health of patients aged 75 or older

Outcome Hypothesis Outcome Measure Analysis Methods
Primary
Deathsa Intervention decreases overall mortality All-cause mortality [binary] Chi-squared test
Secondary
Nurse evaluation Intervention enhances rate Having a nurse evaluation within a year [binary] Chi-squared test
Dietitian visit in low BMI (<23 kg/m2) participants Intervention enhances rate Having a dietitian visit within a year [binary] Chi-squared test
Dispensed anti-diabetic drugs in criterion b patients Intervention reduces drug-dispensing WHO DDD of anti-diabetics in first 3 months [continuous] T-test/ Wilcoxon
Dispensed cholesterol-lowering drugs in criterion c patients Intervention reduces drug-dispensing DDD of cholesterol-lowering drugs in first 3 months [continuous] T-test/ Wilcoxon
Cost Intervention reduces medical costs Total CHS expense per patient [continuous] T-test/ Wilcoxon
Total drug use Intervention reduces use Yearly average total DDD [continuous] T-test/ Wilcoxon
Emergency room visits Intervention reduces visits Annual ER visits [continuous] T-test/ Wilcoxon
BMI - in low BMI (<23 kg/m2) participants Intervention decreases weight-loss BMI change in a year [continuous] T-test/ Wilcoxon
HbA1c% - in criterion b patients Intervention increases HbA1c% HbA1c in a year [continuous] T-test/ Wilcoxon
Hypoglycemia - in criterion b patients Intervention decreases hypoglycemia risk Number of glucose measures <70 mg/dL [continuous] T-test/ Wilcoxon
Hypocholesterolemia - in criterion c patients Intervention decreases hypocholesterolemia Number of cholesterol measures <160 mg/dL in a year [continuous] T-test/ Wilcoxon
Subgroup analyses will include
Tertiles of BMI, HbA1c% and cholesterol Participants with lower indexes may benefit more   Regression methods with appropriate interaction
Tertiles of Age Older participants may benefit more   
Gender A difference may be found   
Prior cardiovascular diagnosis vs. none A difference may be found   
North vs. South district Outcomes may be better in the North due to the direct participation of nurses   
  1. DDD Defined daily dose
  2. aThe effect on mortality will also be analyzed for each LIMIT subgroup that has a sufficient number of participants (groups: A, B, C, F; see Table 4)