We enrolled 125 neurologically normal patients with intracranial aneurysms in a multi-institution, prospective, double-blind, randomized, placebo-controlled trial within 96 hours of their subarachnoid hemorrhage, to determine whether treatment with the calcium blocker nimodipine would prevent or reduce the severity of ischemic neurologic deficits from arterial spasm. A deficit from cerebral arterial spasm that persisted and was severe or caused death by the end of the 21-day treatment period occurred in 8 of 60 patients given placebo and in 1 of 56 given nimodipine (P = 0.03, Fisher's exact test). Analysis of the amount of basal subarachnoid blood on pre-entry CAT scans in patients with deficits from spasm showed that an increase in subarachnoid blood was not associated with a worse neurologic outcome among patients who received nimodipine, unlike the situation in patients given a placebo. There were no side effects from nimodipine. We conclude that nimodipine should be given to patients who are neurologically normal after subarachnoid hemorrhage in order to reduce the occurrence of severe neurologic deficits due to cerebral arterial spasm.
Evidence supported the validity of both EQ-5D-3L and EQ-5D-5L in cancer. However, results suggest a 5-level classifier system has less ceiling effect and greater discriminative ability with potentially more power to detect differences between groups compared with EQ-5D-3L.
Background
Although the use of patient-reported outcome measures (PROs) has increased markedly, clinical interpretation of scores remains lacking. We developed a method to identify clinical severity thresholds for pain, fatigue, depression, and anxiety in people with cancer.
Methods
Using available Patient-Reported Outcomes Measurement Information System (PROMIS) item bank response data collected on 840 cancer patients, symptom vignettes across a range of symptom severity were developed and placed on index cards. Cards represented symptom severity at five-point intervals differences on the T score metric [mean = 50; standard deviation (SD) = 10]. Symptom vignettes for each symptom were anchored on these standardized scores at 0.5 SD increments across the full range of severity. Clinical experts, blind to the PROMIS score associated with each vignette, rank-ordered the vignettes by severity, then arrived at consensus regarding which two vignettes were at the upper and lower boundaries of normal and mildly symptomatic for each symptom. The procedure was repeated to identify cut scores separating mildly from moderately symptomatic, and moderately from severely symptomatic scores. Clinician severity rankings were then compared to the T scores upon which the vignettes were based.
Results
For each of the targeted PROs, the severity rankings reached by clinician consensus perfectly matched the numerical rankings of their associated T scores. Across all symptoms, the thresholds (cut scores) identified to differentiate normal from mildly symptomatic were near a T score of 50. Cut scores differentiating mildly from moderately symptomatic were at or near 60, and those separating moderately from severely symptomatic were at or near 70.
Conclusions
The study results provide empirically generated PROMIS T score thresholds that differentiate levels of symptom severity for pain interference, fatigue, anxiety, and depression. The convergence of clinical judgment with self-reported patient severity scores supports the validity of this methodology to derive clinically relevant symptom severity levels for PROMIS symptom measures in other settings.
Cancer fatigue has been defined and described as an important problem. However, few studies have assessed the relative importance of fatigue compared with other patient symptoms and concerns. To explore this issue, the authors surveyed 534 patients and 91 physician experts from 5 NCCN member institutions and community support agencies. Specifically, they asked patients with advanced bladder, brain, breast, colorectal, head and neck, hepatobiliary/pancreatic, kidney, lung, ovarian, or prostate cancer or lymphoma about their "most important symptoms or concerns to monitor." Across the entire sample, and individually for patients with 9 cancer types, fatigue emerged as the top-ranked symptom. Fatigue was also ranked most important among patients with 10 of 11 cancer types when asked to rank lists of common concerns. Patient fatigue ratings were most strongly associated with malaise (r = 0.50) and difficulties with activities of daily living, pain, and quality of life. Expert ratings of how much fatigue is attributable to disease versus treatment mostly suggested that both play an important role, with disease-related factors predominant in hepatobiliary and lung cancer, and treatment-related factors playing a stronger role in head and neck cancer.
The potential benefits of health-related quality of life (HRQL) assessment in oncology clinical practice include better detection of problems, enhanced disease and treatment monitoring and improved care. However, few empirical studies have investigated the effects of incorporating such assessments into routine clinical care. Recent randomized studies have reported improved detection of and communication about patients' concerns, but few have found effects on patient HRQL or satisfaction. This study examined whether offering interpretive assistance of HRQL results would improve these patient outcomes. Two hundred and thirteen participants with metastatic breast, lung or colorectal cancer were randomly assigned to one of three conditions: usual care; HRQL assessment or HRQL assessment followed by a structured interview and discussion. Interviews about patients' assessment responses were conducted by a research nurse, who then presented HRQL information to the treating nurse. HRQL and treatment satisfaction outcomes were assessed at 3 and 6 months. No significant differences were found between study conditions in HRQL or satisfaction. Results suggest that routine HRQL assessment, even with description of results, is insufficient to improve patient HRQL and satisfaction. It is suggested that positive effects may require supplementing assessment results with specific suggestions for clinical management changes.
Neurotransmitter receptors may be involved in a number of neuropsychiatric disease states. The ligand 3-N-[11C]methylspiperone, which preferentially binds to dopamine receptors in vivo, was used to image the receptors by positron emission tomography scanning in baboons and in humans. This technique holds promise for noninvasive clinical studies of dopamine receptors in humans.
Building on 40 years of progress in cancer detection and treatment, survival rates for childhood cancers have risen from 20 % to almost 80 % [1,2]. Approximately 270,000 Americans are childhood cancer survivors and, by 2010, an estimated 1 in every 250 adults will be living with a history of childhood cancer [2,3]. The early and late effects of treatment are beginning to take on greater importance for survivors, their families and providers [4]. Increasing numbers of childhood cancer survivors are beginning to face a new challenge in returning to normalcy after cancer.
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