Results Summary

What was the research about?

Clinical practice guidelines are recommendations for doctors about when and how to treat health problems. Guidelines are often based on research that compares the benefits and harms of different tests or treatments for one health problem. But this research doesn’t always consider that people may have other health problems or different preferences. Guideline developers need to know what is important to patients.

In this study, the research team developed a process to inform development of clinical guidelines. The team wanted to learn how the balance of benefits and harms of treatment options changes when it includes patient preferences. In this new process, the team

  • Defined questions comparing treatment options based on input from patients with three or more long-term health problems
  • Used data from prior research studies to answer these questions and assess the balance of benefits and harms of treatment options
  • Used results from a patient survey, looking to see if the balance of benefits and harms could change when patients have different preferences.

What were the results?

Using their process, the research team identified two research questions that looked at

  1. Comparing different blood pressure goals for patients with high blood pressure
  2. Comparing two medicines to treat diabetes if the most common medicine, metformin, is not enough

The research team found that the balance of benefits and harms for treatment options changed when looking at how much patients worried about different outcomes. For example, the balance of benefits and harms was about the same for the two medicines to treat diabetes. But this balance changed when taking into account that some people want to avoid shots.

What did the research team do?

To identify research questions, the research team had group discussions with 27 patients and their caregivers who had three or more long-term health problems. Next, the team reviewed data from prior studies related to these research questions and looked at the harms and benefits of treatment options. The team also received survey data from 434 patients with two or more long-term health problems. The surveys asked patients about their preferences, with questions about the importance of benefits and harms relative to one another.

The research team looked at whether the balance of benefits and harms is different for some groups of people, and whether preferences matter.

A total of four patients with long-term health problems and caregivers of people with long-term health problems, or both, were part of the research team. They helped plan and conduct the study. Researchers who create guidelines gave feedback on the usefulness of the study results.

What were the limits of the study?

Studies don’t exist for some treatment harms that were important to patients. The balance of benefits and harms may differ when this information becomes available.

Future research could study treatment harms that are important to patients with more than one long-term health problem.

How can people use the results?

Organizations that create guidelines can consider using the new process to include patient preferences when making guidelines.

Final Research Report

View this project's final research report.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:

  • Reviewers commended the sophisticated analytic strategies and novel approaches used in this study. Also, they commented that the study’s main limitations included factors beyond the investigators’ control, such as the complexity of the topic and gaps in the literature.
  • Reviewers noted that using the number of chronic conditions was not an adequate way to identify the most complex subjects among the elderly without also considering frailty and disability. The researchers agreed that frailty and disability are important factors that affect decision making and added a comment to this effect. However, the focus of the study was on multiple chronic conditions.
  • Reviewers noted that the type of work described in this study is time-intensive and asked for a more nuanced discussion of how insights from this study could be scaled up and applied more broadly. The researchers acknowledged in the discussion that these methods for benefit-harm analysis were time- and resource-intensive, so priorities would need to be set about when to use these methods based on the potential for a benefit-harm analysis to change clinical practice guidelines.

Conflict of Interest Disclosures

Project Information

Cynthia Boyd, MD, MPH
Johns Hopkins University School of Medicine
$1,095,150
10.25302/04.2020.ME.130307619
Informing Patient-Centered Care for People with Multiple Chronic Conditions

Key Dates

July 2014
March 2019
2014
2018

Study Registration Information

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Last updated: March 4, 2022