Symptom Assessment, Patient-Reported Outcomes, and Quality of Life Considerations in Perioperative Care for Patients With Cancer

Introduction

It is imperative that patients with cancer are followed closely, so as to maximize treatment benefit while minimizing complications; thus monitoring the severity of symptoms and functional impairment is a critical component of patient care. Many stakeholder groups (e.g., clinicians, patients, patient advocates, those interested in quality assurance) have made a strong case for the inclusion of patient-reported outcomes (PROs) in routine oncology practice. ^, A PRO has been defined as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.” PRO assessments can detect worsening of symptoms (whether disease- or treatment-related) and decline in functioning, either before a clinic visit or between visits, when active symptom intervention is possible. Although PROs have been widely accepted in clinical research ^, and are endorsed by the US Food and Drug Administration (FDA) for use in drug labeling-claim trials , the introduction of PROs in perioperative patient care has not been well established. PRO use has been limited mainly to tracking pain (and, more recently, fatigue and distress).

Recognition of the potential benefits of incorporating PROs into the trajectory of surgical care has been tempered somewhat by various practical difficulties with implementing PROs. Nonetheless, significant progress has been made toward using PROs to support patient-centered care and recognizing the value of PROs in perioperative care. Studies show that PRO-based measures of symptom severity and functional impairment are sensitive to the posttreatment recovery trajectory when administered frequently and that PRO-based quality-of-life (QoL) measures can predict objective clinical outcomes, such as surgical complications. ^,

Patients with cancer who undergo major surgery experience an acute systemic inflammatory, neuroendocrine, and metabolic stress response to procedure-related tissue injury and the medications used during the perioperative period. Collectively, this response often encompasses a cluster of systemic symptoms (e.g., fatigue, poor appetite, drowsiness, disturbed sleep) and organ-specific symptoms (e.g., pain, abdominal bloating). Morbidity, including high symptom burden and other complications, may cause significant postoperative functional impairment, prolong the patient’s convalescence and recovery trajectory, lead to unscheduled clinic or emergency department visits, and delay the return to intended cancer treatment.

Insufficient empirical research has combined the patient’s perspective (PROs) with clinical outcomes (risk for complications, length of hospital stay, return to planned treatment) in order to assess such issues as recovery to preoperative symptom levels or the effectiveness of Enhanced Recovery Programs (ERPs). ^, The knowledge gained from such research could be a clinically relevant and a critical component of routine surgical practice. Additionally, this kind of information is vital for clinicians, as it may help to determine the patient’s ability to resume additional intended cancer therapies. Thus integrating PROs into standard postoperative care has multiple advantages for monitoring and evaluating recovery from cancer surgery.

Recent advances in data-gathering methods are facilitating the use of PROs in routine clinical practice. ^, In the past few years, a transition from earlier methods, such as paper-and-pencil assessment at clinic visits, to electronic data capture via telephone-computer interactive voice or web-based methods on computers or smartphones has enabled frequent PRO assessments to be obtained from patients at home. These newer methods increase the feasibility of tracking patients after discharge repeatedly and with relatively little patient burden, while making these data available to clinicians in real time.

Breakthrough projects are needed to establish (1) a workable methodology for using PRO measures to characterize postoperative recovery from the patient’s perspective after complex procedures, focusing on symptom burden and functional impairment (especially once the patient is discharged from hospital), and (2) knowledge about barriers to adopting PROs in routine patient care. This chapter presents considerations for the development and use of PROs in perioperative care.

Defining PRO concepts

Ideal PRO Instruments

The ideal PRO instrument will satisfy the FDA requirements for certain development procedures that promote reliability, validity, and sensitivity (see later). Beyond such formal requirements, a good PRO instrument will also be brief, simple, and understandable by patients with diverse educational and cultural backgrounds. We find that a 0–10 numeric severity rating scale is ideal for obtaining reliable information directly from patients, because only the anchors have to be translated and adapted for different cultures, thereby minimizing possible misunderstanding. However, categorical responses (i.e., none, mild, moderate, severe) are used on many scales, including the PROMIS assessment method and the PRO-based version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Finally, the ideal PRO instrument will have been validated for repeated use and will include specific symptoms related to the site, disease stage, and treatment to be studied—in other words it will be “fit for purpose”—and will allow acquisition of real-time data during recovery, which can be viewed as a continuous process.

PRO Instrument Development

In 2009 the FDA set forth guidance on how to develop PRO instruments that are acceptable to the FDA for supporting labeling claims in medical product development. In accordance with this guidance, the development of procedure-specific PRO instruments for use in surgical settings must include both qualitative studies to establish content validity (i.e., which symptomatic outcomes might be expected) and psychometric validation studies to establish reliability, validity, and sensitivity. Besides reliability and validity, responsiveness (change in ratings when they are to be expected) also is important. To acquire comparable clinical data across various patient populations, the impact of cultural and linguistic factors on patient-reported symptoms should be reviewed and minimized to support the use of these methods in other languages and cultures.

Similarities and Differences Between Symptoms and QoL as Concepts

A long history of QoL research within clinical cancer research has focused on various dimensions of the patient’s perspective. Wilson and Cleary established a classic conceptual model of PROs that well defines the differences among the terms “symptom,” “functional status,” and “heath perception,” as they relate to overall QoL. They noted that “Patient-reported symptoms not only cause patients to enter the medical system, they also may affect subsequent use and the costs of medical care.” Their model indicates that how the individual evaluates his or her overall QoL depends on multiple levels of PROs; symptom status is one important determinant of functioning, whereas the physical, psychologic, social, and role functioning domains are indicative of health status. Wilson and Cleary conceived of overall QoL as “distinct from health, though related to it.”

Indeed, the similarity among these various health-related QoL domains (symptoms, functional status, health status, and overall QoL) is that all are measurable by PROs; the difference among them is that only one—symptom burden (symptoms and/or functional status)—has clinically relevant outcomes that could point to medically actionable targets for implementation in routine patient care.

Clinical Research on Pro Application in Perioperative Care

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