1,275 research outputs found
Breakthrough pain and its treatment: critical review and recommendations of IOPS (Italian Oncologic Pain Survey) expert group
No full textControversies exist about the definition and epidemiology of breakthrough cancer pain (BTcP), the pharmacological treatment options, drug dosing, and how to select the medications for BTcP among the new fentanyl products. Existing data were critically evaluated to provide recommendations by an expert group. An algorithm to diagnose BTcP should be used followed by a careful assessment. Fentanyl products provide efficacy and rapidity of action to counteract the temporal pattern of BTcP. The doses of opioids used for background pain should guide the choice of the doses of fentanyl products. The choice of fentanyl products should be based on individual clinical conditions
Breakthrough pain and its treatment: critical review and recommendations of IOPS (Italian Oncologic Pain Survey) expert group
No full textControversies exist about the definition and epidemiology of breakthrough cancer pain (BTcP), the pharmacological treatment options, drug dosing, and how to select the medications for BTcP among the new fentanyl products. Existing data were critically evaluated to provide recommendations by an expert group. An algorithm to diagnose BTcP should be used followed by a careful assessment. Fentanyl products provide efficacy and rapidity of action to counteract the temporal pattern of BTcP. The doses of opioids used for background pain should guide the choice of the doses of fentanyl products. The choice of fentanyl products should be based on individual clinical conditions
Breakthrough Cancer Pain: Preliminary Data of The Italian Oncologic Pain Multisetting Multicentric Survey (IOPS-MS)
No full textIntroduction: An ongoing national multicenter survey [Italian Oncologic Pain multiSetting Multicentric Survey (IOPS-MS)] is evaluating the characteristics of breakthrough cancer pain (BTP) in different clinical settings. Preliminary data from the first 1500 cancer patients with BTP enrolled in this study are presented here.
Methods: Thirty-two clinical centers are involved in the survey. A diagnosis of BTP was performed by a standard algorithm. Epidemiological data, Karnofsky index, stage of disease, presence and sites of metastases, ongoing oncologic treatment, and characteristics of background pain and BTP and their treatments were recorded. Background pain and BTP intensity were measured. Patients were also questioned about BTP predictability, BTP onset (≤10 or >10 min), BTP duration, background and BTP medications and their doses, time to meaningful pain relief after BTP medication, and satisfaction with BTP medication. The occurrence of adverse reactions was also assessed, as well as mucosal toxicity.
Results: Background pain was well controlled with opioid treatment (numerical rating scale 3.0 ± 1.1). Patients reported 2.5 ± 1.6 BTP episodes/day with a mean intensity of 7.5 ± 1.4 and duration of 43 ± 40 min; 977 patients (65.1%) reported non-predictable BTP, and 1076 patients (71.7%) reported a rapid onset of BTP (≤10 min). Higher patient satisfaction was reported by patients treated with fast onset opioids.
Conclusions: These preliminary data underline that the standard algorithm used is a valid tool for a proper diagnosis of BTP in cancer patients. Moreover, rapid relief of pain is crucial for patients' satisfaction. The final IOPS-MS data are necessary to understand relationships between BTP characteristics and other clinical variables in oncologic patients.
Funding: Molteni Farmaceutici, Italy
Factors Influencing the Clinical Presentation of Breakthrough Pain in Cancer Patients
No full textBackground: The aim of this study was to identify potential variables influencing the clinical presentation of breakthrough cancer pain (BTP). Methods: Cancer patients with a diagnosis of BTP were enrolled. Demographic and clinical characteristics, as well as background pain and BTP characteristics were collected. Multivariate analyses were conducted to assess the correlation between BTP characteristics and the variables examined. Results: Data of 4016 patients were analysed. Average daily number of BTP episodes was 2.4, mean intensity was 7.5, and a mean duration was 43.3 min. A short onset BTP was observed in 68.9% of patients. In 30.5% of patients BTP was predictable. There were 86.0% of participants who reported a marked interference of BTP with their daily activities. Furthermore, 86.8% of patients were receiving opioids for the management of BTP. The average time to meaningful pain relief was 16.5 min and 70.9% of patients were satisfied with their BTP medications. Age, head and neck cancer, Karnofsky, background pain intensity, predictable and fast onset BTP were independently associated with the number of BTP episodes. BTP pain intensity was independently associated with background pain intensity, fast onset BTP, and Karnofsky. Neuropathic pain mechanism was independently associated with unpredictable BTP. Variables independently associated with a longer duration of BTP were age, place of visit, cancer diagnosis, disease-oriented therapy, background pain intensity and mechanism, and unpredictable BTP. Age, Karnofsky, background pain intensity, fast onset, and long duration of BTP were independently associated with interference with daily activity. Conclusions: BTP has a variable presentation depending on interdependent relationships among its different characteristics
Utilization of mechanical power and associations with clinical outcomes in brain injured patients : a secondary analysis of the extubation strategies in neuro-intensive care unit patients and associations with outcome (ENIO) trial
No full textFunding Information: The authors received no direct funding for this work. SW is supported by institutional research grants and the National Institutes of Health. MS receives support from NIMH K01MH115789. ST is supported by the Eliot Phillipson Clinician Scientist Training Program and Clinician Investigator Program at the University of Toronto. RDS is supported on NIA R33AG071744. Publisher Copyright: © 2023, The Author(s).Peer reviewe
Relevance of cognitive deterioration in early relapsing-remitting MS: a 3-year follow-up study
No full textObjective: To assess longitudinally cognitive functioning in relapsing-remitting multiple sclerosis (RRMS) patients and its relationship with clinical and MRI variables. Methods: Early RRMS patients and matched healthy controls were assessed in parallel in three testing sessions over 3 years, using the Rao's Brief Repeatable Battery of Neuropsychological Tests. Patients also underwent an MRI analysis of T2-weighted lesion volume (T2LV), number of gadolinium-enhanced lesions and whole brain atrophy. Forty-nine RRMS patients (mean age 36.9 ± 8.9 years; mean disease duration 2.9 ± 1.7 years, mean Expanded Disability Status Scale, 1.7 ± 0.7) and 56 healthy controls were recruited. Results: At baseline, cognitive impairment was detected in 15 patients (30.6%). After 3 years, cognitive functioning worsened in the 29.3% of patients, whereas Expanded Disability Status Scale progression was observed in only three patients. The most sensitive test to detect cognitive deterioration over time was the Symbol Digit Modalities Test (SDMT). Only the presence of moderate cognitive impairment at baseline predicted further cognitive deterioration (p = 0.03). Among MRI variables, T2LV showed a weak to moderate relationship with some cognitive tasks. Conclusions: Over a 3-year period cognitive deterioration can be expected in approximately one-third of MS patients with relatively short disease duration. The SDMT is particularly suitable for longitudinal assessment of MS-related cognitive changes. © The Author(s) 2010
A prospective, randomised study of the effect of fixation sutures during phacotrabeculectomy on intraocular pressure and incidence of ptosis
No full textAbstract We investigated the effects of different intraoperative eyeball fixation techniques (superior rectus muscle suture [MS] and traction suture at the corneal limbus [CS]), on intraocular pressure (IOP) and the incidence of ptosis after phacotrabeculectomy. Forty-one eyes with different glaucoma types which qualified for phacotrabeculectomy were included. Twenty-three and eighteen patients were included in the CS and MS groups, respectively. The IOP, best-corrected visual acuity (BCVA), and margin reflex distance were assessed preoperatively and 3, 6, and 12 months post-operatively. Preoperatively, the mean IOPs (± standard deviation) in the CS and MS groups were 23.6 ± 7.3 mmHg and 24.3 ± 6.6 mmHg (p > 0.05), respectively. At 3 and 6 months post-surgery, the mean IOPs were significantly lower in the CS group than in the MS group: 13.9 ± 3.0 mmHg vs. 17.7 ± 3.5 mmHg (p = 0.001), and 13.9 ± 4.9 mmHg vs. 17.2 ± 3.5 mmHg (p = 0.005), respectively (mean difference: 3.9, 95% confidence interval 1.7–6.1). At 12 months, the mean postoperative IOPs were 15.2 ± 3.5 mmHg and 14.9 ± 3.6 mmHg in the CS and MS groups, respectively (p > 0.05). At 6 months, the BCVAs were 0.91 ± 0.15 and 0.71 ± 0.3 (p = 0.029) in the CS and MS groups, respectively; BCVAs were 0.91 ± 0.15 and 0.71 ± 0.3 (p = 0.029) in the CS and MS groups, respectively; the difference was non-significant 12 months post-surgery (0.78 ± 0.32 vs. 0.74 ± 0.30, p = 0.553). Postoperative ptosis was observed in 4 (17%) and zero patients in the CS and MS groups, respectively, but the difference was not statistically significant (p = 0.118). The study was not powered sufficiently to detect statistically significant changes in exploratory endpoints. The study was not powered sufficiently to detect statistically significant differences between groups in exploratory endpoints
TOFA-PREDICT study protocol: a stratification trial to determine key immunological factors predicting tofacitinib efficacy and drug-free remission in psoriatic arthritis (PsA)
No full textINTRODUCTION: Psoriatic arthritis (PsA) is a chronic, inflammatory, musculoskeletal disease that affects up to 30% of patients with psoriasis. Current challenges in clinical care and research include personalised treatment, understanding the divergence of therapy response and unravelling the multifactorial pathophysiology of this complex disease. Moreover, there is an urgent clinical need to predict, assess and understand the cellular and molecular pathways underlying the response to disease-modifying antirheumatic drugs (DMARDs). The TOFA-PREDICT clinical trial addresses this need. Our primary objective is to determine key immunological factors predicting tofacitinib efficacy and drug-free remission in PsA. METHODS AND ANALYSIS: In this investigator-initiated, phase III, multicentre, open-label, four-arm randomised controlled trial, we plan to integrate clinical, molecular and imaging parameters of 160 patients with PsA. DMARD-naïve patients are randomised to methotrexate or tofacitinib. Additionally, patients who are non-responsive to conventional synthetic (cs)DMARDs continue their current csDMARD and are randomised to etanercept or tofacitinib. This results in four arms each with 40 patients. Patients are followed for 1 year. Treatment response is defined as minimal disease activity at week 16. Clinical data, biosamples and images are collected at baseline, 4 weeks and 16 weeks; at treatment failure (treatment switch) and 52 weeks. For the first 80 patients, we will use a systems medicine approach to assess multiomics biomarkers and develop a prediction model for treatment response. Subsequently, data from the second 80 patients will be used for validation. ETHICS AND DISSEMINATION: The study was approved by the Medical Research Ethics Committee in Utrecht, Netherlands, is registered in the European Clinical Trials Database and is carried out in accordance with the Declaration of Helsinki. The study's progress is monitored by Julius Clinical, a science-driven contract research organisation. TRIAL REGISTRATION NUMBER: EudraCT: 2017-003900-28
Diroximel Fumarate Demonstrates an Improved Gastrointestinal Tolerability Profile Compared with Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III EVOLVE-MS-2 Study
No full textAbstractBackground Diroximel fumarate (DRF) is a novel oral fumarate approved in the
USA for relapsing forms of multiple sclerosis. DRF is converted to monomethyl
fumarate, the pharmacologically active metabolite of dimethyl fumarate (DMF).
DRF 462 mg and DMF 240 mg produce bioequivalent exposure of monomethyl fumarate
and are therefore expected to have similar efficacy/safety profiles; the
distinct chemical structure of DRF may contribute to its tolerability profile.Objectives The objective of this study was to compare the gastrointestinal
tolerability of DRF and DMF over 5 weeks in patients with relapsing–remitting
multiple sclerosis.Methods EVOLVE-MS-2 was a phase III, randomized, double-blind,
head-to-head, 5-week study evaluating the gastrointestinal tolerability of DRF
462 mg vs DMF 240 mg, administered twice daily in patients with
relapsing–remitting multiple sclerosis, using two self-administered
gastrointestinal symptom scales: Individual Gastrointestinal Symptom and Impact
Scale (IGISIS) and Global Gastrointestinal Symptom and Impact Scale (GGISIS).
The primary endpoint was the number of days with an IGISIS intensity score ≥ 2
relative to exposure. Other endpoints included the degree of gastrointestinal
symptom severity measured by IGISIS/GGISIS and assessment of
safety/tolerability.Results DRF-treated patients experienced a statistically significant
reduction (46%) in the number of days with an IGISIS symptom intensity score ≥
2 compared with DMF-treated patients (rate ratio [95% confidence interval]:
0.54 [0.39–0.75]; p
= 0.0003). Lower rates of gastrointestinal
adverse events (including diarrhea, nausea, vomiting, and abdominal pain) were
observed with DRF than DMF (34.8% vs 49.0%). Fewer patients discontinued DRF
than DMF because of adverse events (1.6% vs 5.6%) and gastrointestinal adverse
events (0.8% vs 4.8%).
Conclusions DRF demonstrated an improved gastrointestinal tolerability profile
compared with DMF, with less severe gastrointestinal events and fewer days of
self-assessed gastrointestinal symptoms, fewer gastrointestinal adverse events,
and lower discontinuation rates because of gastrointestinal adverse events.Disclosures
Potential
Conflicts of Interest
Robert T. Naismith received compensation as an advisor, consultant, or speaker for Alexion, Alkermes, Biogen, Celgene, EMD Serono, Genentech, Novartis, Sanofi Genzyme, TG Therapeutics, and Viela Bio. Annette Wundes received research support from AbbVie, Alkermes, and Biogen, and compensation as an advisor from Biogen. Tiaf Ziemssen received fees for participation in scientific advisory boards from Bayer, Biogen Idec, Sanofi Genzyme, Merck Serono, Novartis, Synthon, and Teva; speaker honorarium from Almirall, Bayer, Biogen, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Sanofi Genzyme, and Teva; and research support from Bayer, Biogen, Novartis, Sanofi Genzyme, and Teva. Elzbieta Jasinska received fees for participation in scientific advisory boards from Biogen and speaker honorarium from Adamed, Allergan, Hoffman-La Roche, Krka, Novartis, Polpharma, and Teva. Mark S. Freedman received research or educational grants from Genzyme Canada; honoraria or consultation fees from Actelion, Bayer, Biogen, Celgene, Chugai, EMD Serono Canada, Hoffman-La Roche, Merck Serono, Novartis, PendoPharm, Sanofi-Aventis, and Sanofi Genzyme; participated as a member in a company advisory board, board of directors, or other similar group for Actelion, Bayer, Biogen, Clene, Hoffman-La Roche, MedDay, Merck Serono, Novartis, and Sanofi-Aventis; and served on company-sponsored speaker’s bureau for Sanofi Genzyme. Anthony J. Lembo received fees for participation in scientific advisory boards from Bayer, Biogen Idec, Ironwood, Salix, Shire, and Takeda. Krzysztof Selmaj received consulting fees from Genzyme, Novartis, Ono, Roche, Synthon, and Teva, and speaker fees from Biogen. Ilda Bidollari, Richard Leigh-Pemberton, Maria Lopez-Bresnahan, and David Rezendes are employees of and hold stock/stock options in Alkermes. Hailu Chen, Jerome Hanna, Jennifer Lyons, and Catherine Miller are employees of and hold stock/stock options in Biogen. Jerry S. Wolinsky received compensation for consulting, scientific advisory boards, or other activities with AbbVie, Acorda Therapeutics, Alkermes, Brain Cell Therapeutics, Celgene (Exp 11 2019), Clene Nanomedicine, EMD Serono, Forward Pharma, GeNeuro, GW Pharma, MedDay Pharmaceuticals, NervGen Pharma Corp., Novartis, Otsuka, PTC Therapeutics, Roche/Genentech, Sanofi Genzyme; compensation for CME activities with AcademicCME, PlatformQ Health Education, PRIME, Strategic Consultants Intl,; and royalties for out-licensed monoclonal antibodies through UTHealth from Millipore Corporation.
Ethical
Approval
The study was
approved by central and local ethics committees and conducted in accordance with the
International Council on Harmonisation Guidelines for Good Clinical Practice
and the Declaration of Helsinki.
Informed
Consent
All patients in
EVOLVE-MS-2 provided written informed consent prior to study participation.
Funding
This study was
funded by Alkermes Inc. (Waltham, MA, USA) and Biogen (Cambridge, MA, USA). The
open access fee was funded by Biogen.
Data
Availability Statement
EVOLVE-MS-2 was
registered with ClinicalTrials.gov (NCT03093324). Study data will be shared in
accordance with applicable regulations and laws.© The Author(s) 2020</p
Having a lot of a good thing: multiple important group memberships as a source of self-esteem.
No full textCopyright: © 2015 Jetten et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are creditedMembership in important social groups can promote a positive identity. We propose and test an identity resource model in which personal self-esteem is boosted by membership in additional important social groups. Belonging to multiple important group memberships predicts personal self-esteem in children (Study 1a), older adults (Study 1b), and former residents of a homeless shelter (Study 1c). Study 2 shows that the effects of multiple important group memberships on personal self-esteem are not reducible to number of interpersonal ties. Studies 3a and 3b provide longitudinal evidence that multiple important group memberships predict personal self-esteem over time. Studies 4 and 5 show that collective self-esteem mediates this effect, suggesting that membership in multiple important groups boosts personal self-esteem because people take pride in, and derive meaning from, important group memberships. Discussion focuses on when and why important group memberships act as a social resource that fuels personal self-esteem.This study was supported by 1. Australian Research Council Future Fellowship (FT110100238) awarded to Jolanda Jetten (see http://www.arc.gov.au) 2. Australian Research Council Linkage Grant (LP110200437) to Jolanda Jetten and Genevieve Dingle (see http://www.arc.gov.au) 3. support from the Canadian Institute for Advanced Research Social Interactions, Identity and Well-Being Program to Nyla Branscombe, S. Alexander Haslam, and Catherine Haslam (see http://www.cifar.ca)
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