Patient Decision Aids
Q: What is a decision aid?
A: Patient decision aids are tools that help people become involved in decision making by giving them information about their options and the possible outcomes of those options and by encouraging patients to think about and express their personal values. They are designed to complement, rather than replace, counseling from a health professional.
The Foundation for Informed Medical Decision Making is responsible for the clinical content of decision aids and chronic disease management programs that we produce in video/DVD, print, and/or web formats with our partner, Health Dialog. Called Shared Decision Making® Programs, the decision aids focus on decisions about screening or treatment for which patients might reasonably make different choices based on their values or preferences. The Foundation’s decision aids are intended to accomplish the following:
1. To frame the decision and the available options in a balanced, unbiased way.
2. To explain what is and is not known about the potential risks and benefits of each of the reasonable options, including the probabilities of key outcomes, based on the best available evidence.
3. To model common alternative ways of thinking about the decision that might lead to different choices, and to share with patients what the experience of the various choices might be, including what it would be like to experience some of the most frequent side effects or complications of the treatment options. This is often done with the use of patient interviews.
Overall, the goal is to help patients understand their condition, the available options, and the possible outcomes of these options so that they can work with their health care providers to make an informed choice. Programs on chronic conditions are designed to help patients better understand their disease and their role in managing it.
Development Process
Q: How are health care providers involved in decision aid development?
A: Every program has a Medical Editor, usually a generalist physician (general internal medicine) who has done research in the subject matter being addressed. The Medical Editor works with Foundation staff to review and summarize the relevant clinical evidence, and continues to work with the Foundation and Health Dialog throughout the program’s development and evaluation to ensure its accuracy.
In addition to the Medical Editor, each program has three to five Clinical Advisors who represent different clinical specialties that are involved in the management or treatment of the target condition. Clinical Advisors review and comment on drafts of the materials that are provided to the production team as well as drafts of the program materials during development.
The Foundation often conducts focus groups with health care providers to gather their insights before developing a program.
Q: How are patients involved in decision aid development?
A: An early step in the development process is to talk with patients who have faced the decision that will be presented in the program. This is done via focus groups of patients recruited from two or three locations around the United States. Recruitment approaches may include clinical referrals, mass media such as newspaper ads, or databases of clinical research participants. Participants are screened to determine eligibility, with the goal of recruiting people who represent the program’s target audience and the range of possible approaches to the decision of interest.
Individuals who attend the 1.5 to 2-hour focus groups are paid a nominal fee for their time and transportation expenses. Participants also receive a meal or snack. With participants’ consent, the group discussions are videotaped.
A trained facilitator leads the participants in a discussion of their experiences leading up to the decision, the rationales for the choices they made, and the subsequent consequences and experiences. The goal of this discussion is not to reach a consensus, but gain greater understanding of the range of patients’ rationales, perspectives, and experiences related to the decision. These group discussions, which are documented in the materials that form the basis for the program’s development, often reveal information gaps, misperceptions, concerns, and adverse consequences that can be addressed in a program.
Patients are also involved in formal program evaluations during development and every two years while the program is in distribution; see below.
Evidence
Q: How does the Foundation select and summarize the research evidence?
A: The Medical Editor and Foundation staff review the relevant clinical literature to determine the most appropriate sources for estimates of outcome probabilities related to each treatment option. In most cases, this involves systematic literature searches to identify both the primary literature (published clinical trials) as well as systematic reviews such as those published by the Cochrane Collaboration, the United States Preventive Services Task Force, and the American College of Physicians. While the Foundation usually does not conduct formal systematic reviews or meta-analyses of the primary literature, we review that literature carefully and reference high-quality systematic reviews conducted by these well-respected organizations, which strive to remain free of potential conflicts of interest and provide a clear explanation of how the evidence was rated and evaluated. Additional sources of clinical evidence may include practice guidelines published by the National Institutes of Health, expert groups, and professional societies.
In addition to review of the clinical literature, the Foundation also reviews and summarizes the available research on patient perspectives related to the condition and/or decision; this literature review is complemented by a summary of findings from the focus groups conducted by the Foundation.
A summary of the key clinical literature and outcome probabilities that will be presented in the program materials is reviewed by Clinical Advisors; after their feedback and recommendations are incorporated, the summary of evidence is provided to the Health Dialog production team that develops draft scripts and booklets for Foundation clinical review.
Final program materials include a list of citations on which outcome probabilities and other key program data are based.
Evaluation
Q: How are decision aids reviewed and evaluated during development?
A: All decision aids undergo formal evaluation by clinicians and patients throughout the development process.
Clinical Review: Draft program scripts and accompanying printed materials are reviewed for clinical accuracy by the program’s Medical Editors and Clinical Advisors. During development, a ‘rough cut’ of the video/DVD portion of the program also undergoes formal external evaluation by clinicians who were not involved in the production process.
Patient Review: the program ‘rough cut’ is formally evaluated by patients who were not involved in the program’s production. Professional focus group moderators who also were not involved in the development process facilitate focus groups involving at least 30 patients who have recently experienced the decision addressed by the program. These "ex-patients" are familiar with the issues, can report what they needed to know and what they wished they’d known earlier, and can identify with any emotional distress that may be associated with the choice. They are carefully selected and screened to ensure that their clinical situations match the target audience for the completed program .The Foundation believes that it is inappropriate to ‘test’ a program on people who are actually facing the decision, and that evaluation by ‘ex-patients’ is a reasonable alternative.
For program evaluations, patient focus groups are recruited from at least two regions around the United States. Recruitment approaches may include clinical referrals, mass media such as newspaper ads, or databases of clinical research participants. Participants are screened to determine eligibility. Individuals who attend the 1.5 to 2-hour focus groups are paid a nominal fee for their time and transportation expenses. Participants also receive a meal or snack.
After consenting to participate and to be filmed, focus group participants view the ‘rough cut’ and fill out questionnaires to assess their knowledge of key program facts and their impressions of its clarity, balance, length, and credibility. Participants then take part in a moderated discussion.
The results from the clinical review and patient focus groups are carefully reviewed and summarized by the Foundation staff. In close collaboration with the Medical Editor and the production team, the program is revised as necessary to address any identified issues of clinical accuracy, balance, bias, and clarity.
Program materials are evaluated to ensure ease of comprehension; this may be done via formal assessments of program scripts by literacy experts or by use of automated tools to determine the readability score for printed materials.
Q: What is the review and update policy for decision aids?
A: Each program is reviewed every six months by the Medical Editor to ensure continued clinical accuracy.
Every two years, every program undergoes a formal external evaluation by clinicians who were not involved in the program development and by focus groups of patients who have recently dealt with the decision. The Medical Editor and Foundation staff oversee this process and summarize findings.
Programs are revised when needed to correct clinical inaccuracies.
Q: Are the decision aids evaluated in clinical practice with patients and health professionals?
A: The Foundation works with health care delivery sites around the country to foster the implementation of shared decision-making. Some of these sites now have the experience and knowledge to illustrate several models of care that recognize patient preferences as an integral part of medical practice. For example, the Dartmouth Hitchcock Medical Center Comprehensive Breast Program has found that it is feasible and beneficial to integrate decision support, using Foundation/Health Dialog decision aids, into routine care. The Center has documented improved quality of patient/surgeon interaction, increased satisfaction with the decision-making process, and reduced distress and decisional conflict. These sites also collect data from patients about their perceptions of the programs (balance, clarity, completeness) and the extent to which the key messages are conveyed. This information is incorporated into our regular decision aid reviews.
Disclosures and Conflicts of Interest
Q: What is the funding source for decision aid development?
A: The Foundation does not accept funding from any source with a financial interest in any particular approach to medical testing or treatment. In addition, Foundation employees and Medical Editors do not accept support from companies that commercially market any kind of treatment or device that might be relevant to a program.
Medical Editors and Foundation staff must divest themselves of any financial relationships in excess of $1000 with any group or an organization that has, or may generally be perceived to have, an interest or investment in certain treatment choices or approaches, over others. These organizations include, but are not limited to, makers of medical devices and drug manufacturers.
Clinical Advisors must annually report any such relationships, but they do not have to divest or make other changes in order to work with the Foundation.
The primary funding for the Foundation comes from an agreement with Health Dialog. Health Dialog has acquired the exclusive rights to commercially market the decision aids they develop based on the material the Foundation develops. The Foundation maintains editorial control over the clinical content of these products. Health Dialog pays the Foundation royalties for the use of its intellectual property. Those royalties are the source of funding for the Foundation’s work.
Q: Are the patients in the videos real patients or actors?
A: The patients who appear in programs are actual patients, not actors. They volunteer to share their stories and are paid a small fee for their time. Patients are never scripted. They are selected to appear in a program because they effectively express a particular perspective or experience. Because of limits on program length, the mix of comments about both positive and negative treatment outcomes is not proportionate to the probabilities of those outcomes in the general population. A range of comments is included to show the reasons patients choose the various treatments discussed as well as what it is like to experience different treatment results.