For clinical pathway developers seeking to define the value of different treatments, quality-of-life (QOL) measures offer a means of capturing the factors that most define value to the patient and their caregivers. Particularly for chronic diseases such as cancers and diseases that affect the central nervous system (CNS), consideration of the physical, mental, and social effects of a particular treatment plan is necessary in order to account for not only the quantity but also the quality of years gained by the patient.
Increasingly, clinical pathway developers are making value judgments to determine selection and placement of treatments. These value comparisons can be based on a number of factors, typically starting with clinical outcomes; however, increasingly, a component of these determinations is the impact of treatments on quality of life (QOL).
QOL is a multidimensional concept that encompasses evaluations of positive and negative aspects of life, including physical, mental, and social domains.1 Health has been identified as one of the most important aspects of life, underscoring the close association between QOL and health.2 Traditionally, measures of health in the United States have had a narrow and negative focus, based on deficits to health such as measures of morbidity and mortality.1,2
The impact of health status and treatment on QOL is referred to as health-related QOL (HRQOL), a concept that also includes well-being, such as positive emotions and life satisfaction.1 The interconnectedness of these domains is reflected in the fact that HRQOL has been demonstrated to be highly correlated with morbidity, mortality, and health care costs.3
As the life expectancy of populations increases, attention to QOL and its measurement becomes increasingly important to capture the quality of years lived.1 This is reflected by the fact that divisions within major bodies such as the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), including the National Cancer Institute (NCI) and the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), respectively, consider HRQOL assessment and improvement to be public health priorities.1 More recently, measures of HRQOL have been cited as an important measure for assessing population health within settings of care in order to assess the impact of specific interventions and ultimately provide health care services that improve both outcomes as well as QOL.3
HRQOL is measured by various interview or questionnaire tools, including the NIH’s Patient Reported Outcomes Measurement Information System (PROMIS) that includes self-rated assessment of health, physical HRQOL, mental HRQOL, as well as fatigue, pain, emotional distress, social activities, and roles.1 The standard 4-item set of the CDC’s Healthy Days core questions (CDC HRQOL) has been used in the National Health and Nutrition Examination Survey (NHANES) and the Medicare Health Outcome Survey (HOS), which is part of the National Commission for Quality Assurance’s (NCQA) Healthcare Effectiveness Data and Information Set (HEDIS).4
QUALITY OF WHO'S LIFE?
HRQOL is most often discussed with regard to the individual patient. Perceived HRQOL has become increasingly important due to medical advances resulting in longer lives and consequently more people living with chronic diseases that have the potential to worsen overall health as a result of impairment to functional status, productivity, and overall satisfaction.5
But HRQOL can also be relevant for the caregivers of patients with chronic diseases. Caring for patients with chronic illness has been shown to have an adverse effect on the health, emotional status, and overall QOL of the caregiver.6 Severity of the patient’s condition has also been shown to have a more substantial impact on caregiver HRQOL. Caregiver burden—defined as the hardships experienced when caring for an ill person—is consistently inversely related to caregiver QOL.7 Because of the increasing number of patients living with chronic diseases—and the caregivers who support them—assessing caregiver HRQOL has become increasingly important. Various measures to assess caregiver QOL have been established, including the Caregiver Quality of Life Index (CQLI), the Caregiver Quality of Life Index-Cancer Scale (CQOLC), and most recently, the CareGiver Oncology Quality of Life (CarGOQoL).6
QOL: WHERE IT MATTERS
While all chronic diseases can impact HRQOL, cancer and diseases that affect the central nervous system (CNS) have the potential to have a particularly substantial impact due to the respective systemic and cognitive effects of the conditions.
For patients with cancer, HRQOL can be affected both by the disease as well as the difficult treatment regimens, which can induce difficult to tolerate side effects including pain, fatigue, depression, anemia, impotence, anorexia, and the inability to taste or smell, all of which be debilitating. When treatments for cancer do not extend life more for more than a few months, many have questioned the quality of patients’ lives during this time when they are burdened beyond the illness by the strong side effect profiles of the treatments.8 Because HRQOL is recognized as a critical consideration for patients with cancer, measurement has increasingly been incorporated as an end point in oncology clinical trials to assess the impact of cancer and treatment on patients’ lives.9 Variation in the HRQOL impact of treatment may vary depending on the type of cancer as well as the type of therapy (chemotherapy, targeted therapy, or surgery), as well as the type of cancer a patient.9 Apart from clinical and treatment considerations, HRQOL can also be impacted by other challenges such as cancer-related financial hardship.10 Because caregivers of patients with cancer are known to have impaired HRQOL, specific assessments have been developed for this group, such as the abovementioned CarGOQoL.
Conditions that affect the CNS—including multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, and the associated psychosis with which they are associated—can have a substantial impact on patients’ HRQOL. For patients with Parkinson’s disease, psychosocial functioning was shown to have the biggest impact on HRQOL, with depression, psychiatric complications, autonomic dysfunction and motor symptoms also important determinants.11 Psychosis associated with Parkinson’s disease has been found to be an important determinant of HRQOL-worsening for patients and is recognized as a source of persistent social and emotional stress for caregivers that can become more severe as the patient’s disease progresses. The hallucinations and delusions that occur in patients with psychosis associated with Parkinson’s disease are an independent predictor of nursing home placement.12
IMPACT OF QOL ON PRICING
As mentioned above, measurement of HRQOL is considered to be an important end point in assessing the impact of a given treatment in a clinical trial. Improvements in clinical end points as well as HRQOL scores would indicate a real benefit for patients, and a reduction in symptoms that are known to negatively impact caregiver HRQOL could be seen as incrementally beneficial.
When it comes to drug pricing—a particularly hot topic in recent times—the set cost of a medication is typically associated with the research and development investment as well as potential cost savings that might result from a reduction in the need for costly services such as emergency room (ER) visits, hospital admissions, extended length of hospital stays, or even clinical consequences of long-term disease progression.13 Reductions in health care utilization due to treatment with what have been considered costly medications have been shown for various disease states, including HIV/AIDS and psychiatric illness, drawing some researchers to conclude that high-priced drugs may be the cheapest way to reduce total medical expenses.13 Although patient HRQOL is now important enough to be incorporated into clinical trial designs, it is seldom used as a criteria for supporting drug price. Many clinically important drugs also provide a meaningful benefit to patients’ and caregivers’ lives and effectively increase life expectancy and reduce disability for patients with chronic conditions. Yet, these medications are often associated with increased cost burdens for the vulnerable populations who need them, based on the increase in pharmacy spend associated with their coverage and use.13
IMPACT OF QOL ON VALUE
Value is an increasingly central concept in health care today and is defined as the health outcomes achieved per dollar spent.14 High-value therapies will benefit all stakeholders; however, it is the value to the patient that ultimately drives the rewards for providers, payers, and suppliers. Although the importance of HRQOL has been established, historically, health care delivery has been limited in the outcomes measured, with providers assessing endpoints that they directly control or those that can be easily measured, in contrast with outcomes that may be more impactful.14 As value to the patient is considered a driver of benefits across the system, there is a need to define and support value assessments at the level of the patient as well as the caregiver. Patients and caregivers can become more involved in the value equation by helping to identify the outcomes that matter the most to them.15 Similarly, it is essential that comparative-effectiveness research and health technology assessments also consider often-overlooked measures that matter most to patients and caregivers, such as QOL and the patient experience.15 The oncology category, which is making rapid strides in the sophistication of therapies and their impact on life expectancy, is a key area to incorporate a patient-centered approach. Recognition of this need is reflected by the fact that QOL measures are being included in value assessment tools for oncology treatments by both the American Society of Clinical Oncology and the European Society for Medical Oncology.16,17
IMPACT OF THE CLINICAL PATHWAY ON QOL
Clinical pathways are decision-support tools that are used as a means of reducing the variability of care provided, improving the quality of care delivered, and reducing excess costs.18 Clinical pathways are increasingly used in oncology based on the degree of variance in cancer care recognized across hospitals and geographic areas.19 Clinical pathways have been assessed for their impact on evidence-based quality-of-care indicators across a number of cancer types, with adherence to the clinical pathway being associated with beneficial outcomes as well as reduced resource utilization including a shorter length of hospital stay and reduction in ER visits, both of which can have a substantial impact on patient QOL. Evidence-based clinical pathway programs have also been beneficial for patients with dementia and psychosis due to Alzheimer’s disease or Parkinson’s disease, which are implemented by a dedicated care team who help to improve care and reduce hospital readmissions through support and education for patients and their caregivers.20
It is increasingly recognized that well-designed, patient-centered pathways will facilitate informed treatment decisions and enable physicians to consider the patient’s perspective on treatment goals and preferences. As such, these should include evidence on the range of outcomes important to patients and caregivers, such as QOL, patient preference and satisfaction, survival, and productivity.21
The potential for clinical pathways to drive improvements in quality of care and health care costs is reflected by the fact that more and more US physician compensation—particularly at the integrated delivery network level—is tied to adherence to clinical pathways.19
QOL AND ACHIEVING THE TRIPLE AIM
The increased life span of Americans due to scientific advancements has meant that more people are living longer with chronic diseases. Living longer with conditions that can impact physical and psychological function make the concept of HRQOL increasingly important, not only for patients but also for the caregivers who support them during their older years and throughout their illnesses. As such, measurement of QOL is a critical component of health and should be incorporated into clinical trials as well as tools for assessing the value of various interventions. The continued move toward patient-centered health care must include measurement of an intervention’s impact on both patient and caregiver HRQOL. The efficacy and safety of a new treatment has little value to patients and caregivers if an associated benefit on HRQOL is not observed. As such, including QOL impact in the value determination of a treatment when assessing which and where certain treatments belong in clinical pathways will be critical in achieving the Triple Aim health care goals of improving quality of care and patient experience and reducing excess costs.
References
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