Guitart J.,Hospital Plato |
Vargas I.,Pain Unit |
De Sanctis V.,Hospital Universitari Capio Sagrat Cor |
Ferreras J.,Pain Unit |
And 13 more authors.
Clinical Drug Investigation | Year: 2013
Background and Objectives: The aim of this study was to evaluate the effectiveness and safety of sublingual fentanyl oral disintegrating tablets (sublingual fentanyl ODT) for the treatment of breakthrough pain (BTP), cancer or non-cancer related, in terms of relief of pain intensity, adverse events (AEs) and patient satisfaction, and to further examine the clinical and epidemiological profile of patients with BTP in a clinical setting. Methods: A multicentre, prospective, open-label study was conducted in 19 pain units from Catalonia hospitals (Spain) over a 1-month period. Opioid-tolerant adult patients experiencing episodes of BTP intensity >5 on a visual analogue scale (VAS) during the 12-24 h before screening or AEs related to their previous rescue medication for BTP received sublingual fentanyl ODT in the course of routine clinical practice and completed a 30-day study period consisting of five assessment points: days 0 (baseline), 3, 7, 15 and 30. The efficacy was assessed by collecting pain intensity and pain relief data at baseline and at each assessment. AEs were recorded by investigators throughout the study during clinic visits and telephone follow-ups. For all patients, titration was begun with an initial dose of 100 μg. No more than two doses were allowed to treat an episode and patients might wait at least 4 h before treating another BTP episode with sublingual fentanyl ODT. The dose was increased by 100 μg multiples up to 400 μg as needed; and by 200 μg multiples up from 400 to 800 μg, the maximum titration step. Results: A total of 182 patients were enrolled and 177 (97.2 %) completed the study: 37 had breakthrough cancer pain (BTcP) and 145 had breakthrough non-cancer pain (BTncP). The mean pain intensity showed a statistically significant improvement at the first assessment point and at all assessments thereafter (p < 0.0001). At the end of the study, the time lag between administration and first effect of sublingual fentanyl ODT was ≤10 min in 69.0 % (60 % BTcP and 71.2 % BTncP). The number of daily BTP episodes decreased in both groups, but it was statistically significant in BTcP. 114 patients (62.64 %) experienced AEs during the study. AEs recorded included nausea, vomiting, somnolence and constipation, and seven (4.49 %) were considered severe. No death or discontinuation was considered related to AEs. Conclusion: Sublingual fentanyl ODT provided rapid and consistent relief from BTP, both in cancer and non-cancer patients. It was well-tolerated and well-accepted by patients in routine clinical practice. © 2013 Springer International Publishing Switzerland.
Dennis K.,Ottawa Hospital Research Institute |
Zhang L.,University of Toronto |
Lutz S.,Blanchard Valley Health Systems |
Van Der Linden Y.,Leiden University |
And 14 more authors.
Supportive Care in Cancer | Year: 2013
Purpose: This study explored international radiation oncology trainee decision making in the management of radiotherapy-induced nausea and vomiting (RINV). Methods: Radiation oncology trainees who were members of the national radiation oncology associations of the USA, Canada, Netherlands, Australia, New Zealand, France, Spain and Singapore completed a Web-based survey. Respondents estimated the risks of nausea and vomiting associated with six standardised radiotherapy-only clinical case vignettes modelled after international anti-emetic guidelines and then committed to prophylactic, rescue or no therapy as an initial management approach for each case. Results: One hundred and seventy-six trainees from 11 countries responded. Only 28 % were aware of any anti-emetic guideline. In general, risk estimates and management approaches for the high-risk and minimal risk cases varied less and were more in line with guideline standards than were estimates and approaches for the moderate- and low-risk cases. Prophylactic therapy was the most common approach for the high-risk and a moderate-risk case (83 and 71 % of respondents respectively), while rescue therapy was the most common approach for a second moderate-risk case (69 %), two low-risk cases (69 and 76 %) and a minimal risk case (68 %). A serotonin receptor antagonist was the most commonly recommended prophylactic agent. On multivariate analysis, a higher estimated risk of nausea predicted for recommending prophylactic therapy, and a lower estimated risk of nausea predicted for recommending rescue therapy. Conclusions: Radiation oncology trainee risk estimates and recommended management approaches for RINV clinical case vignettes varied and matched guideline standards more often for high-risk and minimal risk cases than for moderate- and low-risk cases. Risk estimates of nausea specifically were strong predictors of management decisions. © 2013 Springer-Verlag Berlin Heidelberg.
Aguirrezabal A.,Autonomous University of Barcelona |
Duarte E.,Hospital de lEsperanca |
Duarte E.,Autonomous University of Barcelona |
Rueda N.,Autonomous University of Barcelona |
And 3 more authors.
NeuroRehabilitation | Year: 2013
BACKGROUND: Active information and training improves patient and carer knowledge of stroke and aspects of patient satisfaction, as well as reduces patient depression. OBJECTIVE: To evaluate the effect of a post-stroke information and carer training intervention provided in the rehabilitation hospital setting on patient and carers' satisfaction. METHODS: Nonrandomized, controlled trial with 241 patients consecutively admitted in a post-stroke rehabilitation unit and their carers. The first 140 underwent a standard rehabilitation program (control group) and the 131 following attended an additional class (intervention group). Satisfaction was assessed with the Satisfaction Pound Scale administered by telephone 6 months after stroke in 74 patients and 85 carers from the control group and in 76 patients and 73 carers from the intervention group. RESULTS: Over 80% of patients in both groups were satisfied with information, care and therapy during hospitalization. The amount of therapy and support at discharge were the issues that arouse greater dissatisfaction. Patient and carers' satisfaction with information, support and accessibility to rehabilitation team after hospital discharge improved after the intervention (p < 0.001). CONCLUSIONS: Systematic active information, training and community support provision for stroke patients and carers improves satisfaction with stroke rehabilitation programs and support received after hospital discharge. © 2013 - IOS Press and the authors. All rights reserved.
Di Giovanni J.,University of Toronto |
Zeng L.,University of Toronto |
Zhang L.,University of Toronto |
Vassiliou V.,Bank of Cyprus Oncology Center |
And 7 more authors.
Journal of Pain Management | Year: 2013
From February 2009 to May 2010, patients receiving treatment for bone or brain metastases from five cancer centers across the world completed the EORTC QLQ-C15- PAL. Demographic information as well as various disease characteristics were recorded. To compare baseline QLQ-C15-PAL scores between patients with bone and brain metastases, univariate linear regression analysis was performed with or without confounders. A Bonferroni adjusted p-value < 0.003 (0.05/15 items) was considered statistically significant. A total of 109 patients with brain metastases and 233 patients with bone metastases completed the QLQ-C15-PAL. As expected, primary cancer site and previous systemic treatments were different between groups: there was a significantly greater number of patients with prostate and renal cell cancers and fewer patients with lung or gastrointestinal cancers with bone metastases, compared to patients with brain metastases (p<0.005). Prior to accounting for these two confounding factors, there were two QLQ-C15-PAL symptom scales significantly different between patients with bone metastases and patients with brain metastases. Patients with bone metastases had greater severity in pain (baseline mean score: 53.7 vs. 22.8; p<0.001) and fatigue (47.8 vs. 40.4; p=0.0029), compared to those with brain metastases. After accounting for confounders, only pain was significantly different (p<0.0001). Patients with bone metastases experience more pain at baseline compared to those with brain metastases. Patients with either bone or brain metastases otherwise experienced similar QOL profiles as assessed by the QLQ-C15-PAL. Supplementing of QLQ- C15-PAL by disease-specific instruments such as the QLQ- BM22 or QLQ-BN20 is therefore recommended in future trials depending on patient population included. © Nova Science Publishers, Inc.
Sabate S.,Fundacio Puigvert IUNA |
Mases A.,Hospital Del Mar |
Guilera N.,Hospital de Sabadell |
Canet J.,Hospital Germans Trias i Pujol |
And 8 more authors.
British Journal of Anaesthesia | Year: 2011
Background. Major adverse cardiac and cerebrovascular events (MACCE) represent the most common cause of serious perioperative morbidity and mortality. Our aim was to identify risk factors for MACCE in a broad surgical population with intermediate-to-high surgery-specific risk and to build and validate a model to predict the risk of MACCE. Methods. A prospective, multicentre study of patients undergoing surgical procedures under general or regional anaesthesia in 23 hospitals. The main outcome was the occurrence of at least one perioperative MACCE, defined as any of the following complications from admittance to discharge: cardiac death, cerebrovascular death, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmia, angina, or stroke. The MACCE predictive index was based on β-coefficients and validated in an external data set. Results. Of 3387 patients recruited, 146 (4.3%) developed at least one MACCE. The regression model identified seven independent risk factors for MACCE: history of coronary artery disease, history of chronic congestive heart failure, chronic kidney disease, history of cerebrovascular disease, preoperative abnormal ECG, intraoperative hypotension, and blood transfusion. The area under the receiver-operating characteristic curve was 75.9% (95 confidence interval, 71.2-80.6%). Conclusions. The risk score based on seven objective and easily assessed factors can accurately predict MACCE occurrence after non-cardiac surgery in a population at intermediate-to-high surgery-specific risk. © The Author . Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved.