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Table 1 Data analysis plan

From: Team approach to polypharmacy evaluation and reduction: study protocol for a randomized controlled trial

Research question Hypothesis Outcome measure Timing Method of analysis
What is the effect of a structured medication discontinuation clinical pathway designed to reduce polypharmacy on mean number of medications and patterns of discontinuation compared to usual practice? Reduction in mean number of medications Mean number of medications (primary outcome) T0, T6 Linear regression
Proportion of participants with successful reduction in medication number or dose T6 Logistic regression
Composite variable of mean number of medication discontinuations and/or dose reductions T6 Linear regression
What is the effect of a structured medication discontinuation clinical pathway designed to reduce polypharmacy on patient quality of life, cognition, mobility-related fatigue, nutritional status, physical function capacity, pain, sleep, patient enablement, medication self-efficacy, medication confusion, grip strength, falls and adverse events, and hospital admissions compared to usual practice? Improved disease and treatment burden, quality of life, cognition, fatigue, nutritional status, physical function capacity and ability, pain, sleep, patient enablement, medication self-efficacy and lower/fewer falls, healthcare utilization, and adverse events will be reported in the intervention arm compared to the control arm at 6-months Disease burden T0, T6 Linear regression
Treatment burden T0, T6 Linear regression
Quality of life T0, T6 Linear regression for all continuous outcomes, Logistic regression for Categorical outcomes and Count data models (e.g., Poisson/negative binomial regression, zero-inflated models) for count outcomes
T0, T6
Cognition T0, T6
Fatigue T0, T6
Nutritional status T0, T6
Physical function capacity and ability T0, T6
T0, T6
T0, T6
T0, T6
Number of Falls T0, T6
Pain T0, T6
Sleep T0, T6
Patient enablement T0, T6
Medication self-efficacy T0, T6
Healthcare resource utilization (number of hospitalizations, emergency department visits, primary care visits, proportion of patients with at least one hospitalizations) T0, T6
T0, T6
T0, T6
T0, T6
Number of Serious adverse events and beneficial withdrawal T1, T3, T6
What is the cost-effectiveness of the structured medication discontinuation clinical pathway designed to reduce polypharmacy? Not applicable Cost per QALY T6 Cost utility analysis
What is the experience of patients as they go through a structured medication discontinuation clinical pathway designed to reduce polypharmacy? Not applicable Lived experience with deprescribing process T6 Descriptive analysis of Semi-structured interview/patient diaries
Satisfaction with the intervention (5-point Likert scale) T6 Descriptive statistics (M, SD)
Satisfaction with care around medications (5-point Likert scale) T0, T6 Linear regression
Strengths and weaknesses of intervention T6 Descriptive analysis
What are the experiences of the pharmacist and family physician of managing patients through the deprescribing process? Not applicable Lived experience with deprescribing process T6 Thematic analysis of semi-structured interviews/field notes
Confidence in medication discontinuation (5-point Likert scale) T0, T6 Linear regression
Five best/worst aspects of intervention T6 Descriptive analysis
Implementation processes Early/late implementation Descriptive analysis
  1. T0 baseline, T3 month 3, T6 month 6