Effectiveness and Tolerability of Istradefylline for the Treatment of Restless Legs Syndrome: An Exploratory Study in Five Female Patients

Background: Studies of istradefylline (KW6002), an adenosine A_2A-receptor antagonist, have provided evidence of its efficacy as a nondopaminergic antiparkinsonian drug. Antiparkinsonian drugs have also had efficacy in treating restless legs syndrome (RLS).Objectives: The aims of this study were to assess the effectiveness and tolerability of istradefylline in the treatment of RLS.Methods: This was a single-center, multiparametric, prospective trial of istradefylline as a treatment for moderate to severe idiopathic RLS. It was conducted at the Shands/Jacksonville Sleep Disorders Center, University of Florida, Jacksonville, Florida, from March 2003 to October 2003. Patients received a single PO 80-mg dose QD of istradefylline in the late afternoon or early evening for 6 weeks. Appropriate tolerability evaluations (ie, vital assessments, physical examination, clinical laboratory tests, and electrocardiogram) were performed at screening, while on study drug, and after withdrawal of study drug.Results: Fifteen participants (mean [SD] age, 61 [7.1] years; range, 50-69 years) were screened for enrollment. The mean duration of RLS was 18 years. Of the 15 potential patients, 6 did not meet entry criteria, 2 withdrew consent, 1 had not completed baseline procedures at the time of study suspension, and 1 was excluded for administrative reasons. Therefore, a total of 5 patients received the study drug. Of these, 3 (60%) patients responded favorably to istradefylline treatment. Improvement in the periodic limb movement index was observed in 3 patients compared with baseline (patients 2, 4, and 5 [index score: 6, 4, 9 vs 50, 35, 18, respectively]). Improvement in the International RLS Rating Scale scores was observed in 3 patients compared with baseline (patients 2, 4, and 5 [index score: 7, 23, 9 vs 35, 25, 20, respectively]). There was a return to baseline severity in 2 of the 3 patients after withdrawal of study drug. Improvement in RLS symptoms was observed in 3 patients treated with istradefylline for 6 weeks. A clinical worsening of baseline insomnia was observed in 2 patients.Conclusions: Although we could not definitively conclude a beneficial effect based on this small exploratory trial, we found the data to be encouraging. The study drug was well tolerated. Further study of this compound in the treatment of RLS is justified.     

The telephone interview is an effective method of data collection in clinical nursing research: a discussion paper

There are varying points of view regarding the advisability and utility of using the telephone to conduct research interviews. When undertaking the Women's Recovery from Sternotomy Study, we found the telephone was an effective mechanism for data collection. Our aim is to identify the advantages and challenges of using the telephone as a mechanism for data collection in clinical nursing research. The potential benefits associated with using telephone interviews as a mechanism of data collection include (a) using economic and human resources efficiently, (b) minimizing disadvantages associated with in-person interviewing, (c) developing positive relationships between researchers and participants, and (d) improving quality of data collection. The potential challenges to telephone interviewing include (a) maintaining participant involvement, (b) maintaining clear communication, (c) communicating with participants who offer extraneous information, (d) encountering participants with health concerns, and (e) communicating with a third party. Telephone interviewing can be an effective method of data collection when interviewers understand the potential benefits as well as challenges. We offer solutions to the identified challenges and make pragmatic recommendations to enhance researcher success based on the current literature and our research practice. Supportive training for interviewers, effective communication between interviewers and with research participants, and standardized telephone follow-up procedures are needed to ensure successful telephone data collection. We have found our 'Manual of Operations' to be an effective tool that assists research assistants to meet the requirements for successful telephone interviewing.     

Weaning from prolonged mechanical ventilation using an antipsychotic agent in a patient with acute stress disorder

OBJECTIVE: To report the use of a second-generation antipsychotic agent to assist weaning from prolonged mechanical ventilation in an anxious patient. DESIGN: Case report. SETTING: Medical intensive care unit at the Hospital of the University of Pennsylvania. PATIENT: A 39-yr-old white female whose severe anxiety prohibited weaning from prolonged mechanical ventilation. INTERVENTIONS: Initiation of quetiapine as treatment for severe anxiety that was unresponsive to sedative hypnotics. MEASUREMENTS AND MAIN RESULTS: Once a therapeutic dose of quetiapine was reached, ventilator support was removed within 24 hrs. CONCLUSIONS: A second-generation antipsychotic agent was successfully used to facilitate weaning in a very anxious patient, possibly secondary to anxiolysis or direct effect on respiratory drive. Further investigations of pharmacologic intervention should be done to inform practice guidelines in difficult-to-wean patients suffering from severe anxiety.     

Choosing an appropriate depression assessment tool for chinese older adults: a review of 11 instruments. The best tools take into account cultural differences

The purpose of this article is to compare the advantages and limitations of developed depression assessment tools and provide recommendations for clinical staff to select an appropriate tool for use with Chinese older adults. A total of 7 Western tools translated into Chinese and 4 tools developed specifically for assessing Chinese older adults were found in 12 articles. Variability in instrument psychometric properties and cutoff scores is discussed. A reasonable strategy to efficiently assess depression in Chinese older adults is to first administer the Single Question or Geriatric Depression Scale-4 (GDS-4). If depression is likely, the Chinese GDS-15 could be used to increase the probability of identifying depression in Chinese older adults.     

Development of the Comprehensive Inventory of Functioning-Cancer

The Comprehensive Inventory of Functioning-Cancer (CIF-CA) was developed to measure actual and desired functional status in women with cancer. CIF-CA items were taken from the Inventory of Functional Status-Cancer, which measures only actual performance of usual activities. Six CIF-CA subscales measure the extent to which women perform usual personal care, family care, household, social, community, and occupational activities following diagnosis of cancer (actual functional status) and the level at which they wish to perform those activities (desired functional status). Reliability and construct validity estimates were obtained using a sample of 190 women with breast, lung, or colon cancer. Internal consistency reliability using average correlations for subscale item to subscale total scores ranged from 0.68 to 0.93 for actual functional status and from 0.61 to 0.85 for desired functional status. Internal consistency reliability coefficients for subscale to total CIF-CA scores ranged from 0.46 to 0.86 for actual functional status and from 0.62 to 0.83 for desired functional status. Initial construct validity coefficients, using subscale to subscale scores, ranged from 0.10 to 0.61 for actual functional status and from 0.33 to 0.62 for desired functional status. The data support continued development of the CIF-CA.