Standards Development for Person-Centered Decision Support Tools

J Clin Pathways. 2022;8(8):12-16.

Balancing the need to minimize inappropriate variation in care while maximizing appropriate variation in care is one of the great challenges in health care. The former is certainly important, but the latter is how the health care system can optimize care in an era of personalized medicine, value-based care, patient centricity, and health equity.

Decision support tools (DSTs) help patients and their health care providers make shared decisions about how to best personalize health care choices. At a minimum, DSTs utilize structured guidance to provide opportunities for open and honest communication about patient values and preferences.^1,2 In some cases, they are designed to encourage unbiased and meaningful discussion about the tradeoffs of treatment options.³

While many clinicians want and do conduct some form of what they perceive to be shared decision-making (SDM), multiple shortcomings and limitations still exist, such as:

• Incredible variation in the process for how and when SDM occurs;
• An emphasis on SDM related to treatment selection despite other critical opportunities in the care continuum to prepare for and make shared decisions; and
• A bias toward the clinician and clinical content in the agency of SDM.

Person-centered care selection and planning based on SDM principles optimize the likelihood of getting the right care to the right patient at the right time.⁴ DSTs, when designed and implemented in a person-centered manner, can help to standardize the processes by which appropriate personalization of care is achieved while reducing inappropriate variation in how and when SDM occurs.

To this end, the Patient Advocate Foundation (PAF) and the National Patient Advocate Foundation (NPAF) set out to establish standards for determining the extent to which a DST could be considered person-centered. Such standards could then be used as the basis for a “seal of approval,” and eventually, an accreditation or certification platform for person-centered DSTs.

To help guide and shape the task of defining a set of person-centered criteria, an expert advisory committee was convened that met regularly over the course of 2 years starting in 2020 to review and test the standards and criteria. Two multistakeholder summits also were convened: the first in December 2020 and the second in October 2021. These external experts were asked through surveys and small group sessions to provide feedback on the importance of criteria, the exact terminology of criteria, and the way to evaluate adherence to criteria (eg, binary vs scaled).

The foundations of this work for the NPAF began in 2015 with the release of a white paper that contained multiple recommendations for the development and implementation of clinical pathways as DSTs that could be used to help personalize care; it was later published in American Journal of Managed Care.⁵ In 2016, recommendations for how to optimize clinical pathways as DSTs were published in the Journal of Oncology Practice⁶ and Clinical Cancer Research.⁷ That same year, the National Health Council released a rubric for evaluating the patient voice in value frameworks⁸ and the National Comprehensive Cancer Network released recommendations for how to evaluate tools designed to prompt “value”-based discussions between the patient and clinician.⁹

These efforts were a collective attempt to better define a process for developing and using clinical tools that supported the expression and inclusion of patient values and preferences. Our process of developing a set of person-centered standards for DSTs began with a review and synthesis of these recommendations and guidelines.

One immediate need that surfaced was a means by which to define and differentiate between the types of DSTs. The ability to categorize DSTs by subtype is important because it both reflects how such tools are defined in the literature and recognizes the need for tools that serve different functions at different points in the care continuum. The use of a single DST is not sufficient to deliver person-centered care. Multiple types of DSTs are needed at various points in a patient’s decision-making journey to create a person-centered decision support system of care selection and planning.

DSTs can be distinguished by the extent to which they are primarily or exclusively oriented either to the patient or the clinician and then by whether they are intended to be used either independently by that primary user or collaboratively but with one user as the primary driver of the tool. As described in detail in a previous entry to this column,¹⁰ PAF and NPAF created a means by which to differentiate four types of DSTs:

1. Targeted: patient-facing
2. Targeted: clinician-facing
3. Collaborative: patient-initiated
4. Collaborative: clinician-initiated

Another important starting point was a review of the International Patient Decision Aid Standards, which were the result of an ongoing collaboration initiated in 2003 between researchers, practitioners, and other stakeholders who underwent a rigorous, multiyear process to identify a minimal set of standards that could be used to certify a patient decision aid.¹¹ The primary objective of these standards was to ensure transparency in the development of a DST and also to reduce the risk of making a biased decision. The result was a set of 44 criteria that were organized into three categories: qualifying, certifying, and quality.¹²

This first category was meant to define whether a DST could even be qualified as such. Pivotal to this determination was the presence and presentation of treatment options. Strict application of the International Patient Decision Aid Standards (IPDAS) framework requires a tool to meet all six qualifying criteria to be considered a decision aid. If that bar is met, then the six certifying criteria are applied, which focus on avoiding the risk of harmful bias. To be certified as a patient decision aid, the IPDAS framework recommends that a DST score of 3 or higher on a scale of 4 for all six qualifying criteria. These criteria are described in more detail later in this section.

IPDAS also identified 28 quality criteria that could improve the experience of using the decision aid. However, these were considered secondary factors not included in the proposed certification process because a tool’s inability to meet any one of these would not be expected to influence the individual’s decision in a negative way.¹³

While robust and rigorous, the IPDAS framework has several limitations. First, it can only be applied to a DST that explicitly delineates treatment options as part of the tool. While the choice of a specific care regimen is a critical decision, the information needed to personalize a treatment choice based on the patient and what matters to them requires dedicated time and effort both prior to and in conjunction with any discussion of treatment options. Moreover, the process for gathering such patient insights can be separated sequentially and functionally from a clinical synopsis of treatment options. Thus, some DSTs focus primarily or exclusively on surfacing the values and preferences of patients and contain little to no clinical content and/or require little to no direct involvement from the clinician.

Second, the IPDAS framework does not address tools that support decisions related to care planning or patient-reported outcome selection. These activities also involve important decisions that require careful consideration of clinical considerations as well as patient preferences and values related to issues like transportation, caregiver support, and time off work.¹⁴

And finally, when finalizing its qualifying and certifying criteria, IPDAS focused primarily on standards that reduce the risk of harm to patients due to bias either in the tool’s development and/or content.¹⁵ While certainly important as a floor for certifying a DST, there remains a need to define criteria for what might qualify as person-centered attributes of a DST as secondary or enhanced level of certification/recognition.

PAF and NPAF identified more than 150 standards and recommendations related to various tools that could be used to support clinical decision-making. Because any DST regardless of subtype should be able to first meet IPDAS criteria to establish its transparency and objectivity, the first step was to analyze the applicability of the six IPDAS qualifying criteria and six certifying criteria to the four types of DSTs.

At least three of the criteria from both sets were specific to treatment options. As previously stated, DSTs can and should exist that do not list or explain treatment options. When they do list treatment options, the relevant IPDAS qualifying and certifying criteria should apply. When treatment options are not listed, then those criteria should not apply. The remaining three qualifying and three certifying criteria are not specific to treatment options and can apply to any type of DST. However, some minor modifications were necessary to the exact language of two of the three non–treatment-related qualifying criteria in order for them to apply to a broader array of DSTs, especially those that focused more on patient values and preferences and/or those designed to support decisions related to care planning and patient-reported outcome selection. Rigorous analyses of the IPDAS framework revealed the need for changes and modifications to expand application across a range of different DST types.¹⁶

Table 1 contains the IPDAS qualifying criteria and Table 2 contains the certifying criteria applied to the four DST subtypes. In the case of both categories, three of the criteria could universally be applied to all four DST subtypes; while three were applicable only to DSTs that delineate treatment options.

Beyond the application of the IPDAS qualifying and certifying criteria, the degree to which a DST can be considered person-centered is a critical secondary analysis.

The promise of person-centered care is to align two very important sources of knowledge to enable the delivery of cocreated care that integrates the medical evidence with personal preference. The process must be grounded in a collaborative, cooperative relationship and open communication that personalizes choices about treatment, care planning, and goals of care-based individual patient preferences and characteristics.

PAF and NPAF developed 11 additional standards related to the person-centeredness of a DST to complement the existing IPDAS framework. Table 3 is a list of these standards in rank order based on input from the aforementioned advisory groups and the two multistakeholder summits.

Next steps in this effort to establish a rigorous framework for certifying a DST as person-centered is a scoring/rating system. Of the 11 criteria, some could be adequately and objectively assessed based on a simple yes/no while others may be better suited to a Likert scale that recognizes relevant variability in how well a tool meets a specific criterion. Once a rigorous and feasible scoring system has been established, the challenge will be to establish the thresholds for scoring the various criteria. Some routes to certification recognize a minimum set of criteria that must be met or a point score threshold on specific criteria that must be achieved to qualify for certification. Other certification processes allow more flexibility by equally weighing all criteria and allowing certification levels to be reached even when scores are low on certain criteria provided that higher scores are achieved on others. Regardless of the outcome of these procedural decisions, there will exist an ability for multiple stakeholders to discern between DSTs based on which ones are more likely to optimize the chances of selecting and receiving the right care to the right patient at the right time.

Authors: Alan J. Balch, PhD; Rebekah SM Angove, PhD; and Kathleen D. Gallagher, MPH

Affiliations: Patient Advocate Foundation

Disclosure: Financial support for multistakeholder engagement and education as well as project-related research and dissemination of findings was provided by Amgen and Takeda Oncology.