A Society of Gynecologic Oncology White PaperPatient reported outcomes measures in gynecologic oncology: A primer for clinical use, part I
Introduction
Health-related quality of life (HRQoL) has been increasingly recognized as a critical metric to ensure delivery of high quality, patient-centered cancer care. HRQoL can be measured in several ways, but often involves collecting patient reported outcomes (PROs). PROs collected on validated questionnaires are known as patient reported outcome measures (PROMs).
PROs may be one of the most meaningful measures of value delivered in healthcare, demonstrating when a patient's symptoms are improving or worsening in association with interactions with his or her care team. PROMs can address any potential discordance between the physician and the patient as to the magnitude of their symptoms, [[1], [2], [3]] and their use has led to improved overall survival in the setting of metastatic cancer. For these reasons, payors and regulators are also interested in the collection and use of PROs to assess the value of care delivered by a particular provider or health care system.
Oncology has a long and rich tradition of valuing PROs. The administration of PROMs plays an important role in identifying treatment toxicities, improving symptom management and end of life care and increasingly serves as a prognostic factor for survival in select clinical trial settings. It is important to note, however, that the knowledge base around PROMs has developed almost exclusively from the clinical trial setting. Though a growing body of literature suggests that collection of PROMs is feasible in the routine clinical setting and perhaps represents best practice, comparatively little is known about how to export these tools from clinical trials into routine clinical practice and determine what will be acceptable to patients and providers.
In early 2019, a survey was sent to 1146 SGO members in the US regarding their use of PROMs in clinical practice. While results are likely to be biased by the low response rate (10%), they are nevertheless informative. Among the 121 responders, tremendous variability was reported in the PRO instruments used, with 23% using (presumably nonvalidated) instruments developed within their institution, with the remainder equally divided between FACT, EORTC, and PRO-CTCAE, demonstrating an opportunity for standardization. While 57% of responders reported PROMs were integrated into their electronic health record, only 30% felt they were easy to use and 70% received no tabulated feedback on results. Time and support services were identified as the most common barriers to implementation. Other obstacles to routinely collecting PROs in clinical practice, discussed below, include: selection of the most appropriate PROM for a given symptom or disease site, building an infrastructure that can accommodate the administration of PROMs, training physician and nursing personnel on how to interpret and act upon the PROM, and data warehousing in order to analyze aggregate results [1].
Rather than duplicate exhaustive reviews of PROMs in the past [4], the intent of this two-part manuscript is the following:
- 1.
To affirm that the Society of Gynecologic Oncology (SGO) believes the collection and use of PRO data is an essential component of comprehensive, patient centered care.
- 2.
To provide an overview of the current landscape for clinical collection of PROMs.
- 3.
To discuss practical considerations for collecting PROMs in routine gynecologic oncology practice, including challenges to implementation and opportunities to standardize collection.
- 4.
To make pragmatic, disease-specific recommendations around specific PROMs that can be helpful in assessing women with gynecologic malignancies.
In December 2018, the Policy, Quality, and Outcomes Taskforce of the SGO convened a daylong seminar including experts in the field of PROs to further SGO's vision of integrating PROMs into routine clinical practice as a component of patient-centric care. Recognizing our role in managing cancer patients across the entire continuum of surgical and medical care, we believe gynecologic oncologists are uniquely positioned to make important contributions to this field and influence the delivery of care in the wider discipline of oncology.
Part I includes a primer on PROMs in oncology, a review of available instruments, and a discussion of challenges to consider prior to clinical implementation. Also included is a discussion of social determinants of health in the context of patient reported outcomes assessment. Part II includes recommendations for specific PROMs for clinical use in gynecologic oncology by disease site.
Section snippets
Background: a primer on PROMS in oncology
PROMs have evolved since the early 1990s, having been originally developed as self-reported symptoms for secondary aims in clinical research [5]. The most commonly used tools include the Functional Assessment of Cancer Therapy (FACT) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) [5,6]. Typical PRO surveys consist of four broad domains of well-being: physical, functional, social, and emotional, posing multiple questions within
Available PROM instruments
The instruments in Table 1 are a partial, but representative list of available measures ranging from general QoL questionnaires to cancer-specific questionnaires, symptom measures, and measures of sexuality, stress, and emotional health. The range and scope of all these options can be overwhelming, and many measures include questions that are not relevant for routine clinical purposes. Excessive survey length may discourage patients from participating. One strategy to render PROMs more
Obstacles to collecting PROMs in clinical practice
Previous sections have discussed challenges in PROM selection; this section will discuss challenges in PROMs program implementation. Implementing a high functioning PROM program into clinical practice requires a robust platform for PROMs collection, engagement of patients and providers, and an informatics infrastructure that is capable not only of collecting PROMs data, but making it actionable at the patient level and useful for quality improvement efforts at a system level. Challenges in each
Social determinants of health
A range of social, economic, and environmental factors directly and indirectly drive health and healthcare outcomes for all people across the world [30]. These are referred to as social determinants of health and include income, wealth, education, environment, and exposure to discrimination. The physical, emotional, functional, and social wellbeing domains of PROMs are all influenced by social determinants of health. For example, Medicaid insurance is associated with greater odds of
Summary
In Part I of this review, we discuss the importance of measuring PROs in clinical practice and identify obstacles to implementation. There is little published evidence available to guide appropriate clinical use of PROMs. Nevertheless, due to their importance, we encourage clinicians and clinical research to focus on the clinical use of PROMs. Challenges to implementation are significant and many solutions remain elusive. In particular, obstacles created by diverse and flawed EHR platforms are
CRediT authorship contribution statement
Rachel C. Sisodia: Conceptualization, Methodology, Writing - original draft, Writing - review & editing. Summer B. Dewdney: Conceptualization, Methodology, Writing - original draft, Writing - review & editing. Amanda N. Fader: Conceptualization, Methodology, Writing - original draft, Writing - review & editing. Stephanie L. Wethington: Writing - original draft, Writing - review & editing. Alexander Melamed: Writing - original draft, Writing - review & editing. Vivian E. Von Gruenigen: Writing -
Declaration of competing interest
The authors report no conflict of interest.
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