The development of a patient-reported outcome measure for assessing nighttime symptoms of chronic obstructive pulmonary disease.

BACKGROUND: The assessment of symptoms of chronic obstructive pulmonary disease (COPD) is important for monitoring and managing the disease and for evaluating outcomes of interventions. COPD patients experience symptoms during the day and night, and symptoms experienced at night often disturb sleep. The aim of this paper is to describe methods used to develop a patient-reported outcome (PRO) instrument for evaluating nighttime symptoms of COPD, and to document evidence for the content validity of the instrument. METHODS: Literature review and clinician interviews were conducted to inform discussion guides to explore patients' nighttime COPD symptom experience. Data from focus groups with COPD patients was used to develop a conceptual framework and the content of a new PRO instrument. Patient understanding of the new instrument was assessed via cognitive interviews with COPD patients. RESULTS: The literature review confirmed that there is no instrument with evidence of content validity currently available to assess nighttime symptoms of COPD. Additionally, the literature review and clinician interviews suggested the need to understand patients' experience of specific symptoms in order to evaluate nighttime symptoms of COPD. Analyses of patient focus group data (N = 27) supported saturation of concepts and aided in development of a conceptual framework. Items were generated using patients' terminology to collect data on concepts in the framework including the occurrence and severity of COPD symptoms, use of rescue medication at night, and nocturnal awakening. Response options were chosen to reflect concepts that were salient to patients. Subsequent cognitive interviewing with ten COPD patients demonstrated that the items, response options, recall period, and instructions were understandable, relevant, and interpreted as intended. CONCLUSIONS: A new PRO instrument, the Nighttime Symptoms of COPD Instrument (NiSCI), was developed with documented evidence of content validity. The NiSCI is ready for empirical testing, including item reduction and evaluation of psychometric properties.

Racial Differences in the Health of Older-Adult Long-Term Cancer Survivors.

This article focuses on differences between African-American and White older adults who were long-term (five or more years postdiagnosis) survivors of cancer regarding reported health problems, symptoms of illness, functional difficulties, health worries and concerns, and overall perceptions of health. A conceptual model examined the relationship between demographic factors (e.g., race, age, cancer- and treatment-related factors) and perceptions of health (e.g., burden of disability, health concerns and worries, and self-rated global health). Regression analysis examined quantitative data from in-person interviews with 180 survivors of breast, colorectal, or prostate cancer obtained from the tumor registry of the Ireland Cancer Center at University Hospitals Health System of Cleveland. African Americans were oversampled to represent 50% of the total sample. The analysis indicated that African Americans experienced poorer functional health after cancer, even after disease and treatment factors were controlled for. However, compared with White survivors, African Americans did not report significantly more symptoms attributed to either cancer or its treatment, suggesting that their poorer health after cancer may not have been a result of either factor but to other comorbid conditions. Moreover, because the extensiveness of treatment is a significant predictor of functional disability, attention must be paid to the degree to which more extensive treatment among African Americans translates into greater disability.

Cancer survivorship and psychological distress in later life.

Recent research in psychosocial oncology has pointed to the traumatic nature of the stress experienced by cancer survivors. Most of this research has focused on children, young adults survivors and their families. This investigation proposes a conceptual model for understanding general psychological distress (anxiety, hostility and depression) and symptoms of posttraumatic stress (hyper-arousal, avoidance and intrusiveness) that may be associated with cancer survivorship among older adults. Findings from a survey of 180 older adult, long-term cancer survivors are used to illustrate the key features of this model. Results of multivariate analysis show that most older adult long-term cancer survivors do not demonstrate clinical levels of posttraumatic stress disorder (PTSD), although over 25% evidence clinical levels of depression. However, many survivors display important symptoms of psychological distress that are related to the continuing effects of cancer and its treatment. Current cancer-related symptoms are the strongest predictors of depression (beta=0.27, p=0.046) and the PTSD sub-dimension of hyper-arousal (beta=0.377, p=0.004). These effects persist even when the effects of other stressors and non-cancer illness symptoms are statistically controlled. Additionally, it appears in this sample that symptoms of PTSD are significantly correlated with traditional measures of psychological distress.