Abstract

Objectives

In a previous project aimed at informing patient-centered care for people with multiple chronic conditions, we performed highly stratified quantitative benefit–harm assessments for 2 top priority questions. In this current work, our goal was to describe the process and approaches we developed and to qualitatively glean important elements from it that address patient-centered care.

Methods

We engaged patients, caregivers, clinicians, and guideline developers as stakeholder representatives throughout the process of the quantitative benefit–harm assessment and investigated whether the benefit–harm balance differed based on patient preferences and characteristics (stratification). We refined strategies to select the most applicable, valid, and precise evidence.

Results

Two processes were important when assessing the balance of benefits and harms of interventions: (1) engaging stakeholders and (2) stratification by patient preferences and characteristics. Engaging patients and caregivers through focus groups, preference surveys, and as co-investigators provided value in prioritizing research questions, identifying relevant clinical outcomes, and clarifying the relative importance of these outcomes. Our strategies to select evidence for stratified benefit–harm assessments considered consistency across outcomes and subgroups. By quantitatively estimating the range in the benefit–harm balance resulting from true variation in preferences, we clarified whether the benefit–harm balance is preference sensitive.

Conclusions

Our approaches for engaging patients and caregivers at all phases of the stratified quantitative benefit–harm assessments were feasible and revealed how sensitive the benefit–harm balance is to patient characteristics and individual preferences. Accordingly, this sensitivity can suggest to guideline developers when to tailor recommendations for specific patient subgroups or when to explicitly leave decision making to individual patients and their providers.