Journal of pain and symptom management
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J Pain Symptom Manage · Oct 2005
Multicenter Study Clinical TrialEfficacy and safety of palliative sedation therapy: a multicenter, prospective, observational study conducted on specialized palliative care units in Japan.
Although palliative sedation therapy is often required in terminally ill cancer patients, its efficacy and safety are not sufficiently understood. The primary aims of this multicenter observational study were to 1) explore the efficacy and safety of palliative sedation therapy, and 2) identify the factors contributing to inadequate symptom relief and complications, using a prospective study design, clearly defined measurement methods, and a consecutive sample from 21 specialized palliative care units in Japan. A sample of 102 consecutive adult cancer patients who received continuous deep sedation were enrolled. ⋯ Palliative sedation therapy is effective and safe in the majority of terminally ill cancer patients with refractory symptoms. However, a small number of patients experience fatal complications related to sedation. Comparison studies of different sedation regimens are needed to determine the most effective and safe sedation protocol.
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J Pain Symptom Manage · Oct 2005
Multicenter Study Clinical TrialEthical validity of palliative sedation therapy: a multicenter, prospective, observational study conducted on specialized palliative care units in Japan.
Although palliative sedation therapy is often required in terminally ill cancer patients to achieve acceptable symptom relief, empirical data supporting the ethical validity of this approach are lacking. The primary aim of this study was to systematically investigate whether empirical evidence supports the ethical validity of sedation. This was a multicenter, prospective, observational study, which was conducted by 21 specialized palliative care units in Japan. ⋯ In the remaining 34 patients, previous wishes for sedation were noted in 4 patients, and in the other 30 patients, the families were involved in the decision-making process. The chief reason for patient non-involvement in the decision making was cognitive impairment. These data indicate that palliative sedation therapy performed in specialized palliative care units in Japan generally followed the principles of double effect, proportionality, and autonomy.
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J Pain Symptom Manage · Jul 2005
Multicenter Study Comparative StudyWhich mini-mental state exam items can be used to screen for delirium and cognitive impairment?
Cognitive impairment is common in palliative care patients, but it is frequently undetected. The clinical consequence is that psychiatric states such as delirium, which often present with cognitive impairment, are inadequately treated. ⋯ Cases of cognitive impairment are considered indicated by an MMSE score of less than 24 of the total 30. We found that caseness could be fairly accurately screened by using four of the original 20 MMSE items, and that a six-item questionnaire further greatly improved the discrimination.
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J Pain Symptom Manage · Jun 2005
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialComparative efficacy of oral extended-release hydromorphone and immediate-release hydromorphone in patients with persistent moderate to severe pain: two randomized controlled trials.
Two multicenter, randomized, double-blind, crossover studies with identical designs evaluated the efficacy of oral extended-release hydromorphone (HHER) administered q24h compared with immediate-release hydromorphone (HHIR) dosed four times daily in patients with persistent moderate to severe pain. Patients titrated to a stable HHER dose were randomized to individualized doses of HHER or HHIR for 3 to 7 days before crossover to the second treatment. Primary efficacy end point was the mean of average pain intensity (API) scores, rated on a 0- to 10-point numeric scale, over the last 2 days before the pharmacokinetics/pharmacodynamics day of each double-blind period. ⋯ No reduction in pain control occurred in patients administered HHER at the end of the 24-hour dosing period. Most treatment-emergent adverse events were opioid-related. In these studies, HHER administered q24h and HHIR dosed four times daily provided comparable analgesia at an equivalent total daily dose.
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J Pain Symptom Manage · Mar 2005
Multicenter StudyA multicenter study of the revised Edmonton Staging System for classifying cancer pain in advanced cancer patients.
The comparative analysis of analgesic interventions for cancer pain is greatly compromised by the lack of well-validated and clinically acceptable tools, which allow a composite classification of pain and patient population characteristics. Although the Edmonton Staging System (ESS) for cancer pain was developed for this purpose, clinical and research utility has been limited due to problems associated with the assessment of some items, especially in relation to definitions and terminology. To overcome these limitations, we designed a revised ESS (rESS) and conducted a multicenter study to determine its inter-rater reliability and predictive value. ⋯ A comparison of the rESS with the ESS demonstrated the ineffectiveness of the ESS prognostic staging system for predicting achievement of stable pain control. These findings confirm the study hypothesis, suggesting that the rESS appears to have good predictive value and a moderate to high inter-rater reliability. We suggest the rESS should prove to be a useful tool in clinical practice, and in the comparison of cancer pain populations in research studies.