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Description
Abstract: Measurement of health-related quality of life (HRQL) is of particular importance in neurology clinical trials, where differences in clinical measurements or laboratory data may not translate into significant benefit to the patients. A fundamental consideration in the development and use of an HRQL instrument is whether the instrument's conceptual framework accurately reflects the HRQL experience of the population of interest. This study details the findings from formative research that focused on the identification of content area for an HRQL measurement system in neurology. Specifically, 11 focus groups were conducted with caregivers and patients diagnosed with 7 neurological conditions that represented a range of symptomatology and ages. Through an analytic process using techniques derived from grounded theory, several themes emerged that describe the complexity of HRQL issues and the impact of neurological disorders on multiple areas of life functioning and experience. Findings suggest that although HRQL is comparable across neurological disorders, the contribution of specific domains to overall HRQL may differ among disorders.
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Health-related quality of life (HRQL) is a multidimensional construct (Aaronson et al., 1991; Spitzer, 1987) and is an important outcome in neurology clinical care and clinical trials (Murrell, 1999). Usually applied to ill populations (Spitzer), the concept of HRQL evokes a sense of holism by spanning domains such as social and emotional functioning, the experience of disease-specific symptoms and physical limitations, and an individual's general outlook on life. Similarly, the World Health Organization (WHO; 1946) defines health as a condition of total well-being, inclusive of multiple domains of well-being, and not only the lack of disease. WHO has developed the following domains as constituting HRQL: physical functioning; social functioning, including relationships with others, and role functioning; and emotional or mental state (WHO, 1946). Researchers in the field agree that assessments derived to measure HRQL should evaluate the actual or perceived impact of a disease or its treatment on at least some aspects of these domains (Cella, 1992, 2000; Cella & Bonomi, 2003) and "in terms that matter most to ... people, such as the capacity to function in everyday life" (Ware, 1993, p. 53). In this way, HRQL is, in part, a subjective evaluation, and patient input is a critical source of information about HRQL.
HRQL assessments are particularly important in the evaluation of neurology clinical care and clinical trials, since many neurological disorders are incurable and chronic, and they cause impairment in multiple domains of functioning. Many disorders often progress gradually, with unpredictable and inconspicuous changes in function. As a result, healthcare professionals may underestimate or fail to recognize the full scope of the impact of neurological diseases and related treatment on their patients' HRQL. Despite the relevance of HRQL assessment for neurological illness, the status of HRQL research with neurological populations is relatively underdeveloped, and there remains a paucity of literature on the multidimensionality of HRQL, especially regarding the impact of neurological conditions on various domains affecting the patient (Murrell, 1999).
As a response to this predicament, the National Institute of Neurological Disorders and Stroke (NINDS) has funded a study called Quality of Life Outcomes in Neurological Disorders (Neuro-QOL), with the objective of constructing a clinically relevant and useful HRQL measurement system for major neurological disorders that affect the U.S. population. This measurement system must be consistent enough across the selected conditions to allow for cross-disease comparisons and yet flexible enough to capture condition-specific HRQL issues. To accomplish this, the study aims to develop, modify, and test item banks, or finite sets of questions, that are designed to assess common concepts that traverse virtually all selected diseases. Separate sets of unique, targeted scales will be developed and field-tested to augment the generic item banks as a means of evaluating symptoms, concerns, or issues that are relevant only to a subset of diseases or treatments. The primary end users of this measurement system will be clinical trialists and other clinical neurology researchers; however, the item banks will also be appropriate for use in clinical practice.
The primary aim of this article is to present findings from a critical step in the Neuro-QOL instrument development process: the focus group discussions with patients affected by a representative cross section of neurological conditions and their caregivers. As the Food and Drug Administration has noted, the development of patient-reported outcome instruments is incomplete without patient input (U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, & Center for Devices and Radiological Health, 2006). The importance of patient perceptions in assessing HRQL implies that the instrument must be developed using information from patients themselves. The development process must incorporate the input of a wide range of patients with the condition of interest to ensure that the conceptual framework and instrument items are appropriate to that population with respect to age, sex, ethnic identity, cognitive ability, and life experience (U.S. Department of Health and Human Services et al.). Otherwise, the instrument may omit significant information that is important from the patient perspective (Donovan, Sanson-Fisher, & Redman, 1989).
This article highlights the findings that emerged from patient and caregiver focus groups in relation to HRQL. Specifically, focus groups were conducted across a variety of neurological conditions with patients representing a range of symptomatology and ages. Although several studies have investigated HRQL within a particular neurological condition, significantly fewer studies have examined HRQL across multiple disorders (Arnold et al., 2004). Since different neurological conditions may have a differential impact on HRQL, we included several neurological conditions within one study to facilitate the conceptualization of domains that are common across several neurological disorders, as well as those that are unique to a specific disorder. The authors sought to confirm relevant, and highlight missing, domains in the conceptual framework proposed for the Neuro-QOL instrument from the patient perspective and provide the research team with direct access to the language participants use when describing HRQL (Detmar et al., 2006; Kitzinger, 1995). Through firsthand accounts and summaries of themes discussed by patients and caregivers, this study offers a unique examination of the experiences and social and environmental construction of HRQL for patients with targeted neurological conditions.
Methods
Participants
A total of 11 focus groups were conducted. Of these 11 groups, 7 were patient focus groups, representing Alzheimer disease, multiple sclerosis (MS), amyotrophic lateral sclerosis syndrome (ALS), Parkinson disease, stroke, and adult and pediatric epilepsy conditions. Two groups were conducted with MS patients. The research team also conducted focus groups with caregivers of Alzheimer disease, stroke, and pediatric epilepsy patients because these patients may be unable to reliably report their subjective perceptions of HRQL due to cognitive impariment or age. In total, 83 people (64 patients, 19 caregivers) participated in the focus groups. Of the patients, 32 were males and 32 were females; of the caregivers, 7 were males and 12 were females.
The age range in the adult patient focus groups was 25-84 years (M = 55.41, SD = 13.70), and for the pediatric patient group, it was 14-20 years (M = 15.83, SD = 2.23). For the adult caregiver groups, the age range of their care recipients was 40-82 years (M = 62.75, SD = 9.63). For the pediatric caregiver group, the age range of their care recipients was 11-18 years (M = 13.17, SD = 2.79).
Focus Group Guides
Semistructured focus group guides were developed to assess participants' experiences related to HRQL, specific to three participant populations: pediatric patients, adult patients, and caregivers of patients. All guides began with broad, open-ended questions, allowing participants to free-list responses for their definition of HRQL and what areas of HRQL are most impacted by their disease, the treatment, or both. The guide then progressed to questions regarding specific HRQL domains, such as physical functioning, emotional functioning, social aspects, and treatment effects, which have been shown to be relevant in the literature. Caregivers were instructed to respond from the perspective of their care recipient.
Procedures
Recruitment. Participants were recruited through various settings (e.g., hospitals, clinics, patient advocacy associations) in several metropolitan and rural cities across the United States to ensure a sample of participants that represented socioeconomic, geographic, and ethnic diversity. Physicians and clinic staff aided in the recruitment process by identifying and obtaining consent from prospective participants according to a standard protocol. Eligibility criteria were as follows: adult patients and caregivers were age... |
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