Results Summary and Professional Abstract

Results Summary

Download Summary Español (pdf) Audio Recording (mp3)

Results Summary

What was the research about?

Osteoarthritis is a health problem that causes the cartilage in joints to wear away. People may have painful or stiff joints and find it hard to move. Some people choose joint replacement surgery to relieve pain and stiffness. But the surgery has risks, such as infection or nerve damage.

In this study, the research team compared two decision aids to help patients decide if they want surgery for knee or hip osteoarthritis. Decision aids help people choose between two or more healthcare options based on what’s most important to them. One group of patients used a long decision aid with a 45-minute DVD and a 40-page booklet. The other group used a short decision aid with an interactive website and a 17-page pamphlet. The team also wanted to learn if sharing a report on a patient’s preferences with their surgeon improved decision making.

What were the results?

The two decision aid groups didn’t differ in the

• Rate of patients who reported making an informed decision about surgery
• Number of patients whose treatment matched their preferences
• Rate of patients who had surgery

Patients who received the short decision aid had more knowledge about different treatment options than patients who received the long decision aid.

Sharing the report with surgeons didn’t improve decision making more than the decisions aids alone.

Who was in the study?

The study included 1,124 patients ages 21 and older who were considering surgery for knee or hip osteoarthritis. Of these patients, 91 percent were white and non-Hispanic; 11 percent were other races or ethnicities. The average age was 65, and 57 percent were women.

What did the research team do?

The research team assigned patients by chance to receive the short or long decision aid. Patients reviewed the aids before they visited their doctor to talk about surgery. The team also assigned patients’ surgeons by chance to receive the patient preference report or not. The one-page report included patients’ goals for the visit and their treatment preferences. It also had the impact of the condition on their daily life.

Patients completed three surveys during the study. One survey took place before the visit and the second survey took place one week after. The final survey was six months after the visit or six months after surgery if patients chose surgery.

Patients with knee or hip osteoarthritis, surgeons, and staff from health plans and health systems gave input on the study.

What were the limits of the study?

Only a small number of surgeons used the patient report, making it hard to study the effect of the report. Most patients in the study were white and non-Hispanic. Results may differ for patients of other races and ethnicities.

Future research could continue to look at the best ways to include patient preferences in decisions about surgery.

How can people use the results?

Surgeons can use the results when considering ways to help patients decide on surgery for knee or hip osteoarthritis.

Professional Abstract

Professional Abstract

Objective

To evaluate the effectiveness of two patient decision aids for knee or hip osteoarthritis and surgeon receipt of a patient preference report on improving informed surgical decisions

Study Design

Design Elements	Description
Design	Randomized controlled trial
Population	1,124 patients ages 21 and older visiting an orthopedic surgeon for diagnosed knee or hip osteoarthritis
Interventions/ Comparators	Shorter, interactive patient decision aid and no patient preference report shared with surgeon Shorter, interactive patient decision aid with patient preference report shared with surgeon Longer, video-based patient decision aid and no patient preference report shared with surgeon Longer, video-based patient decision aid with patient preference report shared with surgeon
Outcomes	Primary: rate of informed patient-centered decisions assessed through the Hip/Knee Osteoarthritis Decision Quality Instrument Secondary: knowledge about knee osteoarthritis treatment options, concordance rate between patient preferences and patient decision, level of shared decision making, surgical rates
Timeframe	1-week follow-up for primary outcome

This randomized controlled trial with a 2x2 factorial design compared the effectiveness of two patient decision aids for knee or hip osteoarthritis and sharing versus not sharing a patient preference report with surgeons on improving informed surgical decisions.

Researchers randomly assigned patients to receive one of two patient decision aids designed to help patients decide between surgical and non-surgical options to treat their knee or hip osteoarthritis. One intervention was a long, video-based decision aid that included a 45-minute DVD and 40-page booklet. The same information was available on the internet. The other was a short, interactive decision aid available on the internet or as a 17-page pamphlet. Researchers also randomly assigned patients’ surgeons to receive a one-page patient preference report or no report. The report included patient responses about their goal for the visit, the impact of their condition on daily life, and treatment preference.

Patients took three surveys on outcomes—before the visit, one week after the visit, and six months after the visit or six months after surgery if patients chose surgery. Researchers compared outcomes between the decision aid groups and then between surgeon patient preference report groups.

The study included 1,124 patients ages 21 and older who were considering surgery for knee or hip osteoarthritis. Of these patients, 91% were white and non-Hispanic and 11% were other races or ethnicities. The average age was 65, and 57% were female.

Patients who had experience with knee or hip osteoarthritis, nurses, primary care doctors, surgeons, and staff from health plans and health systems provided input on the study design, recruitment, data collection, and analysis.

Results

Shortly after the visit with the surgeon, the rate of informed decisions did not differ significantly between decision aid or patient preference report groups. Across groups, most participants reported having made informed decisions (67.4% overall).

Patients who received the shorter decision aid had significantly more knowledge about treatment options than patients who received the longer decision aid (p<0.001). The two decision aid groups and two patient preference report groups did not differ significantly in the number of patients whose treatment matched their preferences or the rate of patients who had surgery.

Limitations

Surgeons reported low use of the patient preference report, which may have contributed to the observed lack of differences. Most participants were white and non-Hispanic. Results may differ for patients of other races and ethnicities.

Conclusions and Relevance

In this study, the two decision aids showed similar rates of effectiveness in supporting informed patient-centered decisions. Sharing the patient preference report with surgeons did not significantly improve outcomes compared with the decision aids alone.

Future Research Needs

Future research could continue to examine how surgeons can effectively incorporate patient goals and treatment preferences into decision making.

More on this Project  

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. Those comments and responses included the following:

• The reviewers questioned the odds ratios of several outcomes that were based on whether or not patients were able to make informed, patient-centered (IPC) decisions using the patient decision aids used in this study. The reviewers noted that the odds for surgery, and for less hip pain and knee pain seemed unusually high for the IPC group versus the non-IPC group, and suggested that there was an unaccounted-for bias in the analyses. The researchers refuted the claim of bias but acknowledged that risk ratios would be more appropriate measures for these outcomes than odds ratios. The researchers changed the results in the report to provide the risks of surgery, hip pain, and knee pain related to IPC decisions rather than the odds of these outcomes.
• The reviewers raised questions about the use of an existing patient advisory committee, whose members appeared to have varying levels of experience with orthopedic conditions. The reviewers also questioned how engaged the patient advisors were in various aspects of the research study. The researchers said the patient advisory committee had been created by their institution specifically to support the development of patient decision aids for orthopedic research. The patient advisors they worked with all had experience with orthopedic conditions, either osteoarthritis or low back pain, and were involved in developing the research proposal, designing aspects of the project, selecting outcomes, supporting patient recruitment efforts, and interpreting the data. The researchers added that they invited the patient advocates to participate as authors on publications but the patient advocates asked to be acknowledged instead after reviewing authorship requirements for peer-reviewed reports.
• The reviewers had questions about the study’s primary outcome, which was the proportion of IPC decisions. The researchers explained that the IPC measure was a composite measure of two key elements that patient advocates had emphasized: whether patients are informed and whether they receive their preferred treatment. The study found a lack of concordance between these two elements in some patients, and the researchers said they plan to explore the reasons for this discordance in future studies.
• The reviewers challenged the researchers’ statement advocating the use of either of the two tested patient decision aids, since there was no evidence in this study that either decision aid produced better outcomes than usual care. The researchers responded that while their study did not include a usual care arm, past studies show that patients in usual care had about half the level of IPC decision-making levels as observed in this study. The researchers agreed that including a usual care arm would be helpful in future, similar studies.

Conflict of Interest Disclosures

View the COI disclosure form.

Project Details

Principal Investigator

Karen Sepucha, PhD

Project Status

Completed; PCORI Public and Professional Abstracts, and Final Research Report Posted

Project Title

Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery

Board Approval Date

September 2015

Project End Date

November 2020

Organization

Massachusetts General Hospital

Year Awarded

2015

State

Massachusetts

Year Completed

2020

Project Type

Research Project

Health Conditions  

Muscular and Skeletal Disorders

Joint Replacement

Arthritis

Intervention Strategies

Other Health Services Interventions
Technology Interventions

Populations

Low Health Literacy/Numeracy
Older Adults

Funding Announcement

Communication and Dissemination Research

Project Budget

$1,834,685

DOI - Digital Object Identifier

10.25302/02.2021.CDR.150328799

Study Registration Information

HSRP20162043

NCT02729831