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Kajal Gokal Deborah Wallis Samreen Ahmed Ion Boiangiu Kiran Kancherla Fehmidah Munir 《Supportive care in cancer》2016,24(3):1139-1166
Purpose
This study evaluated the effectiveness of a self-managed home-based moderate intensity walking intervention on psychosocial health outcomes among breast cancer patients undergoing chemotherapy.Methods
The randomised controlled trial compared a self-managed, home-based walking intervention to usual care alone among breast cancer patients receiving chemotherapy. Outcome measures included changes in self-report measures of anxiety, depression, fatigue, self-esteem, mood and physical activity. Fifty participants were randomised to either the intervention group (n?=?25), who received 12 weeks of moderate intensity walking, or the control group (n?=?25) mid-way through chemotherapy. Participants in the intervention group were provided with a pedometer and were asked to set goals and keep weekly diaries outlining the duration, intensity and exertion of their walking. Levels of psychosocial functioning and physical activity were assessed pre- and post-intervention in both groups.Results
The intervention had positive effects on fatigue (F?=?5.77, p?=?0.02), self-esteem (F?=?8.93, p?≤?0.001), mood (F?=?4.73, p?=?0.03) and levels of physical activity (x 2?=?17.15, p?=?0.0011) but not anxiety (F?=?0.90, p?=?0.35) and depression (F?=?0.26, p?=?0.60) as assessed using the HADS. We found an 80 % adherence rate to completing the 12-week intervention and recording weekly logs.Conclusion
This self-managed, home-based intervention was beneficial for improving psychosocial well-being and levels of physical activity among breast cancer patients treated with chemotherapy.Trial registration
Current Controlled Trials ISRCTN50709297.2.
Gloria Roberti Luca Agnifili Francesca Berardo Ivano Riva Michele Figus Gianluca Manni Luciano Quaranta Francesco Oddone 《Advances in therapy》2018,35(5):686-696
Introduction
To compare the effects of a preservative-free (PF) ophthalmic solution containing hyaluronic acid (HA) 0.4% and taurine (TAU) 0.5% with those of a PF ophthalmic solution containing HA 0.2% on ocular surface signs, symptoms, and morphological parameters in glaucoma patients under multiple long-term topical hypotensive therapy.Methods
Eligible patients underwent evaluation of ocular surface parameters by ocular surface disease index (OSDI) and glaucoma symptom scale (GSS) questionnaires, breakup time test (BUT), Schirmer I test, corneal and conjunctival staining (Oxford scale), and conjunctival in vivo confocal microscopy (Heidelberg Retina Tomograph 3, Heidelberg Engineering GmbH, Heidelberg, Germany). After the baseline visit, patients were randomized to use a PF ophthalmic solution containing HA 0.4% and TAU 0.5%, QID, in both eyes (group 1) or to use a PF ophthalmic solution containing HA 0.2%, QID (group 2) in addition to the ongoing preserved hypotensive treatment. Follow-up visits were scheduled at 30 and 90 days.Results
Thirty-nine eyes of 39 glaucoma patients were included in the study. At baseline, results of study tests of both groups were similar. After 90 days in group 1 the BUT (p?=?0.01), the Oxford score (p?=?0.03), the conjunctival goblet cells (CGC) density (p?=?0.0005) ,and the two questionnaires score significantly improved (OSDI, p?=?0.003; GSS, p?=?0.003) compared to baseline values, while in group 2 all these parameters did not differ from baseline (BUT, p?=?0.39; Oxford score, p?=?0.54; CGC density, p?=?0.33, OSDI p?=?0.65, GSS, p?=?0.25). The BUT and the CGC density were statistically different between groups both at 30 and 90 days (p?=?0.04 and p?=?0.04, respectively). The Schirmer I test did not statistically change after 90 days in both groups.Conclusions
The PF ophthalmic solution with HA 0.4% and TAU 0.5% seems to improve CGC density and reduce signs and symptoms of dry eye in glaucoma patients under long-term multiple preserved hypotensive therapy.Trial registration
ClinicalTrials.gov identifier, NCT03480295.3.
Xiao-feng Xiong Li-li Fan Hong-xia Wu Min Zhu De-yun Cheng 《Advances in therapy》2018,35(12):2201-2213
Introduction
Tiotropium bromide has been widely used in clinical practice, while theophylline is another treatment option for chronic obstructive pulmonary disease (COPD). However, only a few relevant studies have investigated the long-term outcomes and efficacy of both in patients with COPD. We evaluated the effects of tiotropium and low-dose theophylline on stable COPD patients of groups B and D.Methods
Eligible participants (n?=?170) were randomized and received either tiotropium 18 µg once daily with theophylline 100 mg twice daily (Group I) or tiotropium 18 µg once daily (Group II) for 6 months. COPD assessment test (CAT), modified Medical Research Council (mMRC) dyspnea scores and pulmonary function tests were measured before randomization and during the treatment.Results
After 6 months of treatment, the CAT scores in both groups decreased significantly (11.41?±?3.56 and 11.08?±?3.05, p?<?0.0001). The changes of CAT (p?=?0.028) and mMRC scores (p?=?0.049) between the two groups differed after 1 month of treatment. In Group I, forced expiratory flow after 25% of the FVC% predicted (MEF25% pred) was significantly improved after 3 months (4.84?±?8.73%, p?<?0.0001) and 6 months (6.21?±?8.65%, p?<?0.0001). There was a significant difference in small airway function tests (MEF50% pred, MEF25% pred, and MMEF% pred) between the two groups after 6 month of treatment (p?=?0.003, p?<?0.0001, and p?=?0.021, respectively).Conclusions
Tiotropium combined with low-dose theophylline significantly improved the symptoms and general health of patients with stable COPD of groups B and D after 6 months of follow-up. Additionally, this therapy also improved the indicators of small airway function.Trial Registration
Chinese Clinical Trial Registry (Registry ID: ChiCTR1800019027).4.
Heather J. Leach Jessica M. Danyluk Kathryn C. Nishimura S. Nicole Culos-Reed 《Supportive care in cancer》2016,24(11):4597-4606
Purpose
Community exercise programs can help maintain or improve health in cancer survivors. However, the most effective and feasible duration of a community exercise program for breast cancer survivors who are undergoing treatment is not known. This pre-post-design study evaluated the effects of the “Breast cancer patients Engaging in Activity while Undergoing Treatment” (BEAUTY) program on physical and psychosocial outcomes after 12 and 24 weeks.Methods
BEAUTY is an ongoing community exercise and wellness program for breast cancer patients who are undergoing, or within 3 months of completing chemotherapy and radiation. Participants completed assessments at baseline, 12 weeks, and 24 weeks to measure body composition, hand-grip dynamometry, aerobic fitness, and flexibility. Self-report questionnaires assessed fatigue (FACIT-fatigue), cognitive function (FACT-cog), quality of life (QOL) (FACT-B), and depressive symptoms (CES-D). Main analyses were repeated measures general linear model for all outcomes.Results
Assessments at all three time points were completed by N?=?63 participants. At 24 weeks, waist to hip ratio (p?=?.019), duration of the submaximal treadmill test (p?=?.013), and estimated VO2max (p?=?.018) improved compared to baseline. Fatigue improved at 24 compared to 12 weeks (p?=?.002). FACT-B scores improved at 24 weeks when compared to both baseline (p?=?.002) and 12 weeks (p?=?.001). Depressive symptoms improved compared to baseline (p?=?.05) and 12 weeks (p?=?.009).Conclusions
Additional benefits were seen after 24 versus 12 weeks, suggesting that a longer duration exercise program during, or shortly after completing treatments for breast cancer, may be necessary to see improvements in fitness and psychosocial outcomes. Findings can be applied to community exercise and rehabilitation programs for breast cancer survivors.5.
Heringlake M Handke U Hanke T Eberhardt F Schumacher J Gehring H Heinze H 《Intensive care medicine》2007,33(12):2168-2172
Objective
The modified algorithm for the non-invasive determination of cardiac output (CO) by electrical bioimpedance—electrical velocimetry (EV®)—has been reported to give reliable results in comparison with echocardiography and pulmonary arterial thermodilution (PA-TD) in patients either before or after cardiac surgery. The present study was designed to determine whether EV®-CO measurements reflect intraindividual changes in CO during cardiac surgery.Design
Prospective, observational study.Setting
Operating room (OR) and intensive care unit (ICU) of a university hospital.Patients
Twenty-nine patients undergoing elective cardiac surgery.Interventions
None.Measurements
CO was determined simultaneously by PA-TD and EV® after induction of anesthesia (t1) and 4.9?±?3.5?h after ICU admission (t2).Results
TD-CO was 3.9?±?1.4 and 5.4?±?1.1 l/min at t1 and t2 (?p?0.0001). EV®-CO was 4.3?±?1.1 and 4.9?±?1.5 l/min at t1 and t2 (?p?=?0.013). Bland–Altman analysis showed a bias of ?0.4 l/min and 0.4 l/min and a precision of 3.2 and 3.6 l/min (34.3% and 67.4%) at t1 and t2, respectively. Analysis of the individual pre- to postoperative changes in CO with both methods revealed bidirectional changes in n?=?12 patients and unidirectional changes with a difference greater than 50% and less than 50% in n?=?9 and n?=?8 patients, respectively.Conclusions
The disagreement between PA-TD and EV®-CO measurements after anesthesia induction and after ICU admission, as well as the fact that thoracic bioimpedance did not adequately reflect pre- to postoperative changes in CO, questions the reliability of EV®-CO measurements in cardiac surgery patients and contrasts sharply with previous studies.6.
Rainbow T. H. Ho Ted C. T. Fong Phyllis H. Y. Lo Samuel M. Y. Ho Peter W. H. Lee Pamela P. Y. Leung David Spiegel Cecilia L. W. Chan 《Supportive care in cancer》2016,24(12):4929-4937
Purpose
This study aimed to evaluate the efficacy of supportive-expressive group (SEG) therapy and body-mind-spirit (BMS) intervention on emotional suppression and psychological distress in Chinese breast cancer patients.Methods
This three-arm randomized controlled trial assigned 157 non-metastatic breast cancer patients to BMS, SEG, or social support control group. SEG focused on emotional expression and group support, whereas BMS emphasized relaxation and self-care. All groups received 2-h weekly sessions for 8 weeks. The participants completed measurements on emotional suppression, perceived stress, anxiety, and depression at baseline and three follow-up assessments in 1 year.Results
Using latent growth modeling, overall group difference was found for emotional suppression (χ 2(2)?=?8.88, p?=?0.012), marginally for perceived stress (χ 2(2)?=?5.70, p?=?0.058), but not for anxiety and depression (χ 2(2)?=?0.19–0.94, p?>?0.05). Post-hoc analyses revealed a significant and moderate reduction (Cohen d?=?0.55, p?=?0.007) in emotional suppression in SEG compared to control group, whereas BMS resulted in a marginally significant and moderate fall (d?=?0.46, p?=?0.024) in perceived stress. Neither SEG nor BMS significantly improved anxiety and depression (d?<?0.20, p?>?0.05).Conclusions
The present results did not demonstrate overall effectiveness for either BMS or SEG therapy in the present sample of Chinese non-metastatic breast cancer patients. The participants appear to derive only modest benefits in terms of their psychological well-being from either intervention.7.
Aditya?Mantha Nathaniel?L.?Coggins Aditya?Mahadevan Rebecca?N.?Strehlow Matthew?C.?Strehlow S.V.?Mahadevan
Background
Paramedic trainees in developing countries face complex and chaotic clinical environments that demand effective leadership, communication, and teamwork. Providers must rely on non-technical skills (NTS) to manage bystanders and attendees, collaborate with other emergency professionals, and safely and appropriately treat patients. The authors designed a NTS curriculum for paramedic trainees focused on adaptive leadership, teamwork, and communication skills critical to the Indian prehospital environment.Methods
Forty paramedic trainees in the first academic year of the 2-year Advanced Post-Graduate Degree in Emergency Care (EMT-paramedic equivalent) program at the GVK-Emergency Management and Research Institute campus in Hyderabad, India, participated in the 6-day leadership course. Trainees completed self-assessments and delivered two brief video-recorded presentations before and after completion of the curriculum.Results
Independent blinded observers scored the pre- and post-intervention presentations delivered by 10 randomly selected paramedic trainees. The third-party judges reported significant improvement in both confidence (25 %, p?<?0.01) and body language of paramedic trainees (13 %, p?<?0.04). Self-reported competency surveys indicated significant increases in leadership (2.6 vs. 4.6, p?<?0.001, d?=?1.8), public speaking (2.9 vs. 4.6, p?<?0.001, d?=?1.4), self-reflection (2.7 vs. 4.6, p?<?0.001, d?=?1.6), and self-confidence (3.0 vs. 4.8, p?<?0.001, d?=?1.5).Conclusions
Participants in a 1-week leadership curriculum for prehospital providers demonstrated significant improvement in self-reported NTS commonly required of paramedics in the field. The authors recommend integrating focused NTS development curriculum into Indian paramedic education and further evaluation of the long term impacts of this adaptive leadership training.8.
Background
Nurses often have difficulties with using interdisciplinary stroke guidelines for patients with stroke as they do not focus sufficiently on nursing. Therefore, the Stroke Nursing Guideline (SNG) was developed and implemented. The aim of this study was to determine the implementation and feasibility of the SNG in terms of changes in documentation and use of the guideline in the care of stroke patients on Neurological and Rehabilitation wards, barriers and facilitators, and nurses’ and auxiliary nurses’ view of the implementation.Methods
A sequential explorative mixed method design was used including pre-test post-test measures and post intervention focus groups interviews. For the quantitative part retrospective electronic record data of nursing care was collected from 78 patients and prospective measures with Barriers and Facilitators Assessment Instrument (BFAI) and Quality Indicator Tool (QIT) from 33 nursing staff including nurses and auxiliary nurses. In the qualitative part focus groups interviews were conducted with nursing staff on usefulness of the SNG and experiences with implementation.Results
Improved nursing documentation was found for 23 items (N?=?37), which was significant for nine items focusing mobility (p?=?0.002, p?=?0.024, p?=?0.012), pain (p?=?0.012), patient teaching (p?=?0.001, p?=?0.000) and discharge planning (p?=?0.000, p?=?0.002, p?=?0.004). Improved guideline use was found for 20 QIT-items (N?=?30), with significant improvement on six items focusing on mobility (p?=?0.023), depression (p?=?0.033, p?=?0.025, p?=?0.046, p?=?0.046), discharge planning (p?=?0.012). Facilitating characteristics for change were significantly less for two of four BFAI-subscales, namely Innovation (p?=?0.019) and Context (p?=?0.001), whereas no change was found for Professional and Patient subscales. The findings of the focus group interviews showed the SNG to be useful, improving and providing consistency in care. The implementation process was found to be successful as essential components of nursing rehabilitation were defined and integrated into daily care.Conclusion
Nursing staff found the SNG feasible and implementation successful. The SNG improved nursing care, with increased consistency and more rigorous functional exercises than before. The SNG provides nurses and auxiliary nurses with an important means for evidence based care for patients with stroke. Several challenges of implementing this complex nursing intervention surfaced which mandates ongoing attention.9.
Masashi Hirooka Yohei Koizumi Yusuke Imai Atsushi Yukimoto Takao Watanabe Osamu Yoshida Masanori Abe Yoichi Hiasa 《Journal of Medical Ultrasonics》2018,45(4):555-564
Purpose
The aim of this study was to clarify whether ultrasound quantitative methods were positively correlated with volume of ascites evaluated by whole abdominopelvic CT.Methods
Sixty-eight patients with cirrhotic ascites were retrospectively analyzed. First, to confirm that virtual ultrasonography (VUS) is an alternative method to conventional ultrasound, 22 patients underwent both conventional ultrasonography and VUS. Second, the efficacy of US quantitative methods (3-point method, 4-point method, 5-point method, and Matsumoto’s method) was confirmed by VUS in 68 patients. We assessed whether the ascites volume predicted by VUS corresponded with that calculated by 3D-CT. Of the 68 patients, 23 patients were analyzed before and after administration of tolvaptan.Results
The predictive volumes calculated by VUS were remarkably relative to those yielded by conventional US. Correlations between exact volume and those measured by VUS were significantly high (3-point method: r?=?0.882, p?<?0.001; 4-point method: r?=?0.797, p?<?0.001; 5-point method: r?=?0.836, p?<?0.001; Matsumoto’s method: r?=?0.453, p?<?0.001). Correlations between decreasing volume on 3D-CT and that measured by VUS were also significantly high in patients with administration of tolvaptan.Conclusion
Ascites volume measured by ultrasound was effective, especially the 3-point and 5-point methods. It was useful to assess the efficacy of diuretics in cirrhotic patients.10.
Anne-Marie H. Krebber Femke Jansen Pim Cuijpers C. René Leemans Irma M. Verdonck-de Leeuw 《Supportive care in cancer》2016,24(6):2541-2548
Purpose
The purpose of the study is to investigate screening in follow-up care to identify head and neck cancer (HNC) patients with untreated psychological distress.Methods
From November 2009 until December 2012, we investigated the use of OncoQuest (a touch screen computer system to monitor psychological distress (Hospital Anxiety and Depression Scale (HADS)) and quality of life (HRQOL; EORTC QLQ-C30 and H&N35 module) in routine follow-up care. Patients who screened positive for psychological distress (HADS-T >14, HADS-A >7, or HADS-D >7) were asked whether they received psychological or psychiatric treatment.Results
During the study period of 37 months, OncoQuest was used by 720 individual HNC patients, of whom 714 had complete HADS data. Psychological distress was present in 206 patients (29 %). Of those patients who fulfilled in- and exclusion criteria (n?=?137), 25 received psychological treatment (18 %). Receipt of psychological treatment was significantly related to a higher score on the HADS total scale (19.6 vs. 16.9; p?=?0.019), a lower (worse) score on the EORTC QLQ-C30 scale emotional functioning (46.0 vs. 58.6; p?=?0.023), a higher (worse) score on fatigue (58.2 vs. 46.4; p?=?0.032), problems with sexuality (44.1 vs. 34.4; p?=?0.043), oral pain (43.8 vs. 28.8; p?=?0.011) and speech problems (37.0 vs. 25.3; p?=?0.042).Conclusions
Screening for psychological distress via OncoQuest is beneficial because 82 % of HNC patients identified with an increased level of distress who do not yet receive mental treatment were identified. Patients who did receive treatment reported more distress and worse quality of life, which may be explained because patients with more severe problems maybe more inclined to seek help or might be detected easier by caregivers and referred to supportive care more often.11.
Todd Schwedt Uwe Reuter Stewart Tepper Messoud Ashina David Kudrow Gregor Broessner Guy P. Boudreau Peter McAllister Thuy Vu Feng Zhang Sunfa Cheng Hernan Picard Shihua Wen Joseph Kahn Jan Klatt Daniel Mikol 《The journal of headache and pain》2018,19(1):92
Background
Subcutaneous erenumab reduced monthly migraine days and increased the likelihood of achieving a?≥?50% reduction at all monthly assessment points tested in 2 pivotal trials in episodic migraine (EM) and chronic migraine (CM). Early efficacy of migraine preventive medications is an important treatment characteristic to patients. Delays in achievement of efficacy can result in failed adherence. The objective of these post-hoc analyses were to evaluate efficacy in the first 4 weeks after initial subcutaneous administration of erenumab 70 mg, erenumab 140 mg, or placebo.Methods
There is no generally accepted methodology to measure onset of action for migraine preventive medications. We used a comprehensive approach with data from both studies to evaluate change from baseline in weekly migraine days (WMD), achievement of ≥?50% reduction in WMD, and proportion of patients experiencing migraine measured on a daily basis. The 7-day moving averages were overlaid with observed data.Results
In both studies (EM: N?=?955; CM: N?=?667), there was evidence of onset of efficacy of erenumab vs. placebo during the first week of treatment, which in some cases reached nominal significance. For EM the changes in WMD were (least squares mean [LSM] [95% CI]): placebo, ??0.1 (??0.3, 0.0); erenumab 70 mg, ??0.3 (??0.5, ??0.2) p?=?0.130; erenumab 140 mg, ??0.6 (??0.7, ??0.4) p?<?0.001. For CM the changes were: placebo, ??0.5 (??0.8, ??0.3); erenumab 70 mg, ??0.9 (??1.2, ??0.7) p?=?0.047; erenumab 140 mg, ??0.8 (??1.1, ??0.5) p?=?0.18. Achievement of ≥?50% reduction in WMD was observed as early as Week 1 (adjusted OR [95% CI] erenumab vs placebo) in EM: erenumab 70 mg, 1.3 (1.0, 1.9) p?=?0.097; erenumab 140 mg, 2.0 (1.4, 2.7) p?<?0.001. A similar outcome was observed for CM: erenumab 70 mg, 1.8 (1.1, 2.8) p?=?0.011; erenumab 140 mg, 1.9 (1.2, 2.9) p?=?0.009. Seven-day moving averages of observed data showed each treatment arm differed from placebo by Week 1 (OR [95% CI]): in EM Day 3 for erenumab 140 mg, 0.7 (0.5, 1.0) p?=?0.031 and at Day 7 for 70 mg, 0.6 (0.4, 0.8) p?=?0.002; in CM: Day 6 for erenumab 70 mg, 0.6 (0.4, 0.9) p?=?0.022 and at Day 7 for 140 mg, 0.7 (0.4, 1.0); p?=?0.038.Conclusion
Erenumab showed early onset of efficacy with separation from placebo within the first week of treatment in both chronic and episodic migraine patients.12.
Miltiadis Fiorentzis Arne Viestenz Anja Viestenz Berthold Seitz 《Advances in therapy》2017,34(8):1928-1935
Introduction
The aim of this observational study is to evaluate the effectiveness of an adjuvant intracameral corticosteroid injection (ICI) in cases of severe endothelial immune reaction (SEIR) (anterior chamber cells and flare, retrocorneal precipitates, Descemet’s folds, and corneal edema) after penetrating keratoplasty and posterior lamellar keratoplasty.Methods
In this retrospective study, 24 subjects treated between November 2011 and September 2014 were divided into two groups. The control group received topical and systemic steroid therapy while the study group received additionally ICI (400 µg dexamethasone). Outcome measures included changes in best corrected visual acuity (BCVA), central corneal thickness (CCT, Pentacam), endothelial cell count (ECC), and intraocular pressure (IOP). The follow-up examinations were conducted after a period of 6 weeks and 3 months. Results were compared using the Wilcoxon signed-rank test.Results
BCVA of the patients in the study group increased from logMAR 1.5 ± 0.77 at baseline to 0.99 ± 0.44 (p = 0.009) at 6 weeks and to 0.78 ± 0.45 (p = 0.017) at 3 months following the ICI. The CCT decreased from 835 ± 211 µm at baseline to 609 ± 63 µm (p = 0.005) after 3 months. ECC showed a significant reduction 12 weeks after treatment in both groups (p = 0.012 in the control group and p = 0.005 in the study group). This reflects a mean ECC loss of 17% and 19% due to the immune reaction in the control and study group, respectively. A significant temporary increase in the IOP was documented only in the control group (p = 0.005).Conclusion
The ICI seems to be a safe adjuvant approach, which improves therapeutic efficacy of SEIR after keratoplasty.13.
Kelly Thompson Colman Taylor Stephen Jan Qiang Li Naomi Hammond Manoj Saxena Balasubramanian Venkatesh Simon Finfer 《Intensive care medicine》2018,44(8):1249-1257
Purpose
To determine differences in health-related quality of life (HRQoL), survival and healthcare resource use of critically ill adults with and without sepsis.Methods
We conducted a primary propensity score matched analysis of patients with and without sepsis enrolled in a large multicentre clinical trial. Outcomes included HRQoL at 6 months, survival to 2 years, length of ICU and hospital admission and cost of ICU and hospital treatment to 2 years.Results
We obtained linked data for 3442 (97.3%) of 3537 eligible patients and matched 806/905 (89.0%) patients with sepsis with 806/2537 (31.7%) without. After matching, there were no significant differences in the proportion of survivors with and without sepsis reporting problems with mobility (37.8% vs. 38.7%, p?=?0.86), self-care (24.7% vs. 26.0%, p?=?0.44), usual activities (44.5% vs. 46.8%, p?=?0.28), pain/discomfort (42.4% vs. 41.6%, p?=?0.54) and anxiety/depression (36.9% vs. 37.7%, p?=?0.68). There was no significant difference in survival at 2 years: 482/792 (60.9%) vs. 485/799 (60.7%) (HR 1.01, 95% CI 0.86–1.18, p?=?0.94). The initial ICU and hospital admission were longer for patients with sepsis: 10.1?±?11.9 vs. 8.0?±?9.8 days (p?<?0.0001) and 22.8?±?21.2 vs. 19.1?±?19.0 days, (p?=?0.0003) respectively. The cost of ICU admissions was higher for patients with sepsis: A$43,345?±?46,263 (€35,109?±?35,043) versus 34,844?±?38,281 (€28,223?±?31,007), mean difference $8501 (€6885), 95% CI $4342–12,660 (€3517?±?10,254), p?<?0.001 as was the total cost of hospital treatment to 2 years: A$74,120?±?60,750 (€60,037?±?49,207) versus A$65,806?±?59,856 (€53,302?±?48,483), p?=?0.005.Conclusions
Critically ill patients with sepsis have higher healthcare resource use and costs but similar survival and HRQoL compared to matched patients without sepsis.14.
Carlo Cattaneo Jaime Kulisevsky Viviana Tubazio Paola Castellani 《Advances in therapy》2018,35(4):515-522
Introduction
Chronic pain is an important yet overlooked non-motor symptom of Parkinson’s disease (PD), caused by an imbalance of the dopaminergic and glutamatergic systems. Safinamide has a multimodal mechanism of action, dopaminergic (reversible MAO-B inhibition) and non-dopaminergic (modulation of the abnormal glutamate release), that might be beneficial for both motor and non-motor symptoms.Objectives
To investigate the long-term (2-year) efficacy of safinamide on PD chronic pain and to confirm the positive effects observed after 6 months of treatment.Methods
This is a post hoc analysis of the data from the 2-year study 018, focused on the reduction of concomitant pain treatments and on the scores of pain-related items of the Parkinson’s disease quality of life questionnaire (PDQ-39).Results
Safinamide, compared with placebo, significantly improved the PDQ-39 items 37 (“painful cramps or spasm,” p?=?0.0074) and 39 (“unpleasantly hot or cold,” p?=?0.0209) and significantly reduced the number of concomitant pain treatments by 26.2% (p?=?0.005). A significantly greater proportion of patients in the safinamide group was not using pain drugs after 2 years of treatment (p?=?0.0478).Conclusions
The positive effects of safinamide on PD chronic pain were maintained in the long term. Further investigations are desirable to confirm their clinical relevance.Funding
Zambon SpA.15.
Casper Emil Christensen Samaira Younis Marie Deen Sabrina Khan Hashmat Ghanizada Messoud Ashina 《The journal of headache and pain》2018,19(1):105
Background
Migraine prevention with erenumab and migraine induction by calcitonin gene-related peptide (CGRP) both carry notable individual variance. We wanted to explore a possible association between individual efficacy of anti-CGRP treatment and susceptibility to migraine induction by CGRP.Methods
Thirteen migraine patients, previously enrolled in erenumab anti-CGRP receptor monoclonal antibody trials, received CGRP in a double-blind, placebo-controlled, randomized cross-over design to investigate their susceptibility to migraine induction. A standardized questionnaire was used to assess the efficacy of previous antibody treatment. The patients were stratified into groups of high responders and poor responders. Primary outcomes were incidence of migraine-like attacks and area under the curve of headache intensity after infusion of CGRP and placebo. All interviews and experiments were performed in laboratories at the Danish Headache Center, Copenhagen, Denmark.Results
Ten high responders and three poor responders were included. CGRP induced migraine-like attacks in ten (77%) patients, whereof two were poor responders, compared to none after placebo (p?=?0.002). The area under the curve for headache intensity was greater after CGRP, compared to placebo, at 0–90 min (p?=?0.009), and 2–12 h (p?=?0.014). The median peak headache intensity score was 5 (5–9) after CGRP, compared to 2 (0–4) after placebo (p?=?0.004).Conclusions
Patients with an excellent effect of erenumab are highly susceptible to CGRP provocation. If an association is evident, CGRP provocation could prove a biomarker for predicting antibody treatment efficacy.Trial registration
Retrospectively registered at clinicaltrials.gov with identifier: NCT03481400.16.
M. Mücke C. Carter H. Cuhls M. Prüß L. Radbruch W. Häuser 《Schmerz (Berlin, Germany)》2016,30(1):25-36
Background
Cannabinoids have multiple medical indications in palliative care, such as relief of pain or nausea or increase of appetite and weight stabilisation. The value of cannabinoids for these indications is not resolved sufficiently for palliative patients. A systematic review with meta-analysis of the efficacy, tolerability and safety on the basis of randomised controlled studies (RCT) or randomised open label or crossover studies has not yet been conducted.Materials and methods
An extensive search for RCTs, randomised open label or crossover studies dealing with the underlying question was performed in the databases of Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PsycINFO, PubMed, Scopus and Clinicaltrials.gov up to April 2015. Studies with a duration of ≥?2 weeks and ≥?10 participants per treatment group were included into analysis. Using a random effects model, pooled estimates of event rates for categorical data and standardized mean differences (SMD) for continuous variables and risk differences (RD) for dichotomous variables were calculated.Results
Out of initially 108 studies 9, with a total of 1561 participants suffering from advanced or end stage diseases, were included. The median study duration of the cancer research was 8 weeks (16 days–11 weeks), of the HIV research 6 weeks (3–12 weeks) and of the study concentrating on Alzheimer?s 2?×?6 weeks. The outcome results for cannabis/cannabinoids vs. placebo in patients with cancer were not significant for the 30?% decrease in pain (RD: 0.07; 95?% confidence interval (CI): ??0.01 to 0.16; p?=?0.07), caloric intake (SMD: 0.2; 95?% CI: ??0.66 to 1.06; p?=?0.65) or sleep problems (SMD: ??0.09; 95?% CI: ??0.62 to 0.43; p?=?0.72). In the treatment of HIV cannabinoids were superior to placebo for the outcome of weight change (SMD: 0.57; 95?% CI: 0.22–0.92; p?=?0.001). Change in appetite was significant for the treatment of HIV (SMD: 0.57; 95?% CI: 0.11–1.03; p?=?0.02), but not for treatment of cancer (SMD: 0.81; 95?% CI: ??1.14 to 2.75; p?=?0.42). Nausea/vomiting (SMD: 0.20; 95?% CI: ??0.03 to 0.44; p?=?0.09) and health-related quality of life (HRQoL; SMD: 0.00; 95?% CI: ??0.19 to 0.18; p?=?0.98) did not show significant differences in the therapy of the two diseases. For the outcomes of tolerability the results were not significant for occurrence of dizziness (RD: 0.03; 95?% CI: ??0.02 to 0.08; p?=?0.23) or psychiatric diseases, such as hallucinations or psychosis (RD: ??0.01; 95?% CI: ??0.04 to 0.03; p?=?0.69) in the therapy of cancer. The outcome of psychiatric diseases in the treatment of HIV was significant (RD: 0.05; 95?% CI: 0.00–0.11; p?=?0.05). The number of withdrawals due to adverse events, as a marker for tolerability, and the reports of serious adverse events as a measure of safety was not significantly different (RD: 1.20; 95?% CI: 0.85–1.71; p?=?0.30 and RD: 1.15; 95?% CI: 0.88–1.49; p?=?0.30, respectively). Dronabinol vs. megestrol acetate showed a superiority of megestrol in the therapy of cancer-associated anorexia for the endpoints change of appetite (49 vs. 75?%; p?=?0.0001), weight gain (3 vs. 11?%; p?=?0.02), HRQoL (p?=?0.003) and tolerability (p?=?0.03). There was no difference in the safety of the therapies (p?=?0.12). In the treatment of HIV-associated wasting syndrome megestrol acetate was better than dronabinol for the endpoint of weight gain (p?=?0.0001), whereas tolerability and safety did not differ. In the therapy of Alzheimer’s dronabinol was better than placebo in the endpoint of weight gain according to one study (n?=?15). A difference between herbal cannabis and synthetic cannabinoids, analysed by one study (n?=?62) could not be found.Conclusion
Cannabinoids can lead to an increase in appetite in patients with HIV wasting syndrome but the therapy with megestrol acetate is superior to treatment with cannabinoids. The included studies were not of sufficient duration to answer questions concerning the long-term efficacy, tolerability and safety of therapy with cannabis or cannabinoids. Due to the sparse amount of data it is not possible to recommend a favoured use of cannabis or cannabinoids at this point.17.
Inna Y. Gong Bandar Al-Amro G. V. Ramesh Prasad Philip W. Connelly Rachel M. Wald Ron Wald Djeven P. Deva Howard Leong-Poi Michelle M. Nash Weiqiu Yuan Lakshman Gunaratnam S. Joseph Kim Charmaine E. Lok Kim A. Connelly Andrew T. Yan 《Journal of cardiovascular magnetic resonance》2018,20(1):83
Background
Cardiovascular disease is a significant cause of morbidity and mortality in patients with end-stage renal disease (ESRD) and kidney transplant (KT) patients. Compared with left ventricular (LV) ejection fraction (LVEF), LV strain has emerged as an important marker of LV function as it is less load dependent. We sought to evaluate changes in LV strain using cardiovascular magnetic resonance imaging (CMR) in ESRD patients who received KT, to determine whether KT may improve LV function.Methods
We conducted a prospective multi-centre longitudinal study of 79 ESRD patients (40 on dialysis, 39 underwent KT). CMR was performed at baseline and at 12?months after KT.Results
Among 79 participants (mean age 55 years; 30% women), KT patients had significant improvement in global circumferential strain (GCS) (p?=?0.007) and global radial strain (GRS) (p?=?0.003), but a decline in global longitudinal strain (GLS) over 12?months (p?=?0.026), while no significant change in any LV strain was observed in the ongoing dialysis group. For KT patients, the improvement in LV strain paralleled improvement in LVEF (57.4?±?6.4% at baseline, 60.6%?±?6.9% at 12?months; p?=?0.001). For entire cohort, over 12?months, change in LVEF was significantly correlated with change in GCS (Spearman’s r?=???0.42, p?<?0.001), GRS (Spearman’s r?=?0.64, p?<?0.001), and GLS (Spearman’s r?=???0.34, p?=?0.002). Improvements in GCS and GRS over 12?months were significantly correlated with reductions in LV end-diastolic volume index and LV end-systolic volume index (all p?<?0.05), but not with change in blood pressure (all p?>?0.10).Conclusions
Compared with continuation of dialysis, KT was associated with significant improvements in LV strain metrics of GCS and GRS after 12?months, which did not correlate with blood pressure change. This supports the notion that KT has favorable effects on LV function beyond volume and blood pessure control. Larger studies with longer follow-up are needed to confirm these findings.18.
Betânia Ferreira Fabiana Moura da Motta Silveira Flávia Augusta de Orange 《Supportive care in cancer》2016,24(3):1035-1042
Purpose
The purpose of this study is to evaluate the effectiveness of low-level laser therapy for the prevention of oral mucositis in patients undergoing hematopoietic stem cell transplantation.Methods
This is a randomized, parallel, superiority trial including 35 patients divided into the following: laser (n?=?17) and sham (n?=?18). The variables assessed were oral mucositis (grade 2 of the World Health Organization oral toxicity scale), severe oral mucositis (grade 3 or 4), and pain (according to a visual analogue scale). In the laser group, a InGaAlP laser, wavelength of 650 nm, power 100 mW, energy per point of 2 J, time 20 s by point, extremity fiber optic 0.028 cm2, and energy density 70 J/cm2, was used, applied the first day of conditioning until D + 5, while the sham group received simulated laser over the same period.Results
No statistically significant difference was found in the incidence of oral mucositis (p?=?0.146). Severe mucositis was found in 40 % of the patients (14/35), 3 in the intervention group (17.65 %) and 11 in the sham group (61.11 %) (p?=?0.015). The cumulative probability of survival with respect to the development of severe oral mucositis was >0.6 for the intervention group and 0 for the control group (p?=?0.0397). On the day on which pain was considered the worst, patients in the sham group were more likely to classify their pain as severe compared to those in the laser group (p?=?0.041).Conclusion
Low-level laser therapy proved effective for the prevention of severe oral mucositis and intense oral pain in patients submitted to hematopoietic stem cell transplantation.19.
Sunnie Kim James E. Signorovitch Hongbo Yang Oscar Patterson-Lomba Cheryl Q. Xiang Brian Ung Monika Parisi John L. Marshall 《Advances in therapy》2018,35(10):1564-1577
Introduction
nab-Paclitaxel plus gemcitabine (nab-P?+?G) and FOLFIRINOX (FFX) are among the most common first-line (1L) therapies for metastatic adenocarcinoma of the pancreas (MPAC), but real-world data on their comparative effectiveness are limited.Methods
This retrospective cohort study compared the efficacy and safety of 1L nab-P?+?G versus FFX, overall and under specific treatment sequences. Medical records were reviewed by 215 US physicians who provided information on MPAC patients who initiated 1L therapy with nab-P?+?G or FFX between April 1, 2015 and December 31, 2015. Study outcomes were overall survival (OS) and tolerability. OS was compared using Kaplan–Meier curves and adjusted Cox proportional hazards models.Results
In total, 654 medical records were reviewed, including those of 337 and 317 patients initiated on nab-P?+?G and FFX as 1L MPAC therapy, respectively. nab-P?+?G-initiated patients were older, less likely to have ECOG?≤?1, and had more comorbidities than FFX-initiated patients. Median OS (mOS) was 12.1 and 13.8 months for nab-P?+?G- and FFX-initiated patients, respectively (HR?=?0.99, P?=?0.96). Among patients with ECOG?≤?1, mOS was 14.1 and 13.7 months, respectively (HR?=?1.00, P?=?0.99). Among patients with 1L nab-P?+?G and FFX, 36.1% and 41.3% received 2L therapy and experienced mOS of 16.3 and 16.6 months, respectively (HR?=?1.04, P?=?0.76). The rates of diarrhea, fatigue, mucositis, and nausea and vomiting were significantly higher in the FFX than nab-P?+?G cohort.Conclusion
The real-world survival was similar between patients receiving 1L nab-P?+?G or FFX both overall and among patients who received active 2L treatments. In addition, nab-P?+?G was associated with significantly lower rates of common AEs compared with FFX.Funding
Celgene.20.
Alfonso Gil-Martínez Mónica Grande-Alonso Ibai López-de-Uralde-Villanueva Almudena López-López Josué Fernández-Carnero 《The journal of headache and pain》2015,17(1):103