Pilot Project: Engaging Patients, Doctors, and Healthcare Experts in Creating Guidelines for Cancer Screening

PCORI funded the Pilot Projects to explore how to conduct and use patient-centered outcomes research in ways that can better serve patients and the healthcare community. Learn more.

Background

Clinical practice guidelines are recommendations for doctors about when and how to test for or treat various conditions. These guidelines are based on research that compares the benefits and harms of different tests or treatments. Sometimes the research evidence conflicts or is complicated, so people might disagree about what a guideline should recommend.

Usually, medical experts write guidelines with little input from patients or other interested parties. According to the National Academy of Medicine, patients, doctors, public health officials, and other interested individuals need to play bigger roles in developing clinical guidelines. However, there is not much research on how these groups can help create guidelines.

Project Purpose

This study tested a way for patients, doctors, public health officials, and other interested individuals to develop guidelines for cancer screening.

Methods

The researchers created two groups to develop guidelines. One group focused on prostate cancer screening, and the other group focused on lung cancer screening. Each group had 21 people and included patients, primary care doctors, specialty doctors, public health officials, health system administrators, and representatives of health insurance companies.

Each group followed the same process to develop the guidelines. A team of doctors, medical researchers, and scientists presented research summaries to the group. Each group met in person four times. Each meeting was three hours long and led by a professional moderator. Smaller groups met in web conferences to talk about different parts of the guidelines. The groups used email to make final decisions about the guidelines.

At the beginning and end of the project, the researchers asked participants how they felt about their group’s work, their understanding of cancer screening, and their understanding of the evidence. Researchers also listened to the meetings and took notes about how the members of each group talked to one another.

Findings

Patients, doctors, public health officials, and other interested groups worked together to develop clinical practice guidelines for lung and prostate cancer screening. Study participants were able to make recommendations even when there was not much evidence, when some research contradicted other research, or when it was necessary to balance the benefits and harms of a test.

 Patients participated more in the groups when moderators built relationships among group members at the start of discussions and encouraged patients to share their ideas and values.

Limitations

The study only looked at guidelines for prostate and lung cancer screening. The group method may not work for other health problems or when a treatment decision is complicated.

Conclusions

Researchers found that patients, doctors, public health officials, and other interested groups can work together to create clinical guidelines, even if they do not know the topic well.

Sharing the Results

The Massachusetts Department of Public Health used the prostate cancer guideline to develop a decision aid to help doctors and patients talk about prostate cancer screening and to share information about prostate screening with the public. The researchers have presented their work at a national conference.

PCORI funded the Pilot Projects to explore how to conduct and use patient-centered outcomes research in ways that can better serve patients and the healthcare community. Learn more.

Background

Clinical Practice Guideline (CPG) development is a key step in translating comparative effectiveness research into clinical practice. The Institute of Medicine has identified deficiencies in CPG development in the United States, including failure to involve patients/consumers and other stakeholders. Research on patient involvement in CPG development has been limited to CPG processes dominated by experts and including few patients, who are usually peripheral to the decision making. Research is also limited on the engagement of other stakeholders, such as primary care providers (PCPs) and public health officials. In this study, researchers sought to address the research gap on CPG development processes that allow patients and other typically excluded stakeholders to play a significant role.

Project Purpose

The researchers hypothesized that a CPG panel dominated by patients and PCPs and including representatives of other relevant stakeholder groups could develop and reach consensus on a high‑quality CPG that required dealing with complex evidence and clinical controversies. The researchers proposed to develop and evaluate methods for engaging patients/consumers, clinicians, payers, health system leaders, and public health officials in creating CPGs on screening for prostate and lung cancer for Massachusetts. The researchers also hypothesized that CPGs developed by stakeholders from within a single state may be more trusted and widely adopted within the state than other CPGs.

Study Design

An implementation and evaluation study with data collection by survey, interview, and observation at several points in time.

Participants, Interventions, Settings, and Outcomes

Patients were recruited through statewide organizations (American Lung Association, Massachusetts Health Quality Partners [MHQP]) and PCP referrals. The research team recruited PCPs through email lists from Massachusetts healthcare systems. The prostate cancer panel included six PCPs, six patients, three urologists, two healthcare systems representatives, two payer representatives, and two Massachusetts Department of Public Health (MDPH) staff. The lung cancer panel included seven patients, six PCPs, two payer representatives, two MDPH representatives, two thoracic surgeons, a radiologist, and a pulmonologist.

Both panels involved four in-person, three-hour panel meetings; webinars for subgroups to address assigned topics (e.g., shared decision making); and final review and polling on CPGs through email. An Evidence Team provided evidence compilations and reviews and presented lectures on key topics, followed by discussions focused on the benefits and harms of the screening tests. Four professional facilitators/mediators helped plan agendas and managed panel deliberations. Project investigators prepared drafts of the CPGs. The investigators sought the MHQP prevention guideline group’s endorsement of the CPGs as CPGs adopted by MHQP are typically accepted by Massachusetts payers and the MDPH.

Process, participant, and product outcomes were assessed using mixed methods. Process outcomes included assessments of stakeholder engagement, responses to the evidence and related controversies, and panelists’ efforts to achieve consensus. Researchers also tracked CPG adoption and dissemination. Participant outcomes included: changes in attitudes about stakeholder groups and cancer screening; satisfaction with the education provided about evidence; satisfaction with facilitation; and satisfaction with their overall experience. Product outcomes included CPG quality and differences with national CPGs.

Data Sources

Data sources included participant surveys at three time points, phone interviews with a sample group of participants, group interviews with the facilitators, observations of the panel meetings and webinars documented in field notes and audio recordings, and documents generated by the Evidence Team and project staff.

Data Analysis

Quantitative analyses of survey data focused on changes in attitudes and beliefs and on summary statistics for satisfaction measures. For qualitative analyses of the data from panel meetings, researchers grouped sections of field notes by research question and then coded the grouped notes for key constructs relevant to each question. Team members reviewed the data related to each of the constructs and draft analytic memos capturing convergence and divergence among participants. The team used notes from interviews, supplemented as needed by review of voice recordings, to summarize and compare responses to interview questions across interviews.

Findings

The panels developed and endorsed comprehensive guidelines that addressed eligibility for lung and prostate cancer screening, shared decision making on screening, follow‐up testing, and the qualifications of sites offering lung cancer screening. Researchers demonstrated the feasibility of involvement of patients in CPG development and have specified a replicable model. Researchers found that multi-stakeholder panels dominated by patients and PCPs can effectively grapple with complex decisions involving interpretation of incomplete and conflicting evidence and with balancing modest benefits against significant harms when appropriate education and support are provided. Patients and other stakeholders supported access to screening tests that offer the possibility of avoiding cancer deaths even when the benefit of screening is modest, evidence for benefit is limited, and significant harms may occur often. Professional facilitation was well received and effective.

Conclusions

Stakeholders without topic-related expertise, including patients and PCPs, can be effectively engaged in the development of CPGs with appropriate attention to education provided to panel members about facilitation and support of patients. To ensure the fullest patient participation, facilitators should engage the panel in relationship building at the outset, provide individualized support for patient participation, and ensure that values underlying panel members’ opinions are articulated and discussed.

Future Research

Researchers used supplemental funds from PCORI to convene a statewide conference involving representatives of screening sites, insurers, MDPH, and patients that has set the stage for the possible development of a statewide quality improvement collaborative involving screening sites. The lung-cancer-screening CPG provided a framework for discussions of challenges faced by screening sites in implementing high-quality lung-cancer-screening programs.